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NobelZygoma TiUltra implants

The NobelZygoma TiUltra implants are endosseous dental implants intended to be surgically placed in the zygomatic bone to support a dental prosthesis in the upper arch, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Multi-Unite Abutment Xeal Zygoma

The Multi-unit Abutments Xeal Zygoma are indicated to support the placement of multiple unit, screw-retained prosthetic restorations in the maxilla including full arch dentures.

NobelZygoma Multi-Unite Abutment Xeal Zygoma Screws

The NobelZygoma Multi-Unit Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation.

The Subject Device NobelZygoma TiUltra Implant system is composed of three device lines: NobelZygoma TiUltra Implants, Multi-unit Abutments Xeal Zygoma and NobelZygoma Multi-unit Abutment Xeal Zygoma Screws.

The NobelZygoma TiUltra Implants are endosseous dental implants surgically placed in the zygomatic bone to provide support for prosthetic devices. They are used with patients with severe bone resorption in the maxilla to provide multi-point support of the dental reconstruction. The NobelZygoma TiUltra Implants are used to support the rehabilitation of a fully or a partially edentulous maxilla. The Subject Devices are only intended for extra-maxillary placement.

The subject Implants are made from unalloyed titanium grade 4 (ASTM F67) and present a two-level anodized surface with a soluble salt (protective) layer. Two variants of the Implants are available based on the collar angulation: the NobelZygoma 0° and the NobelZygoma 45° TiUltra Implants. The NobelZygoma 0° CC TiUltra Implants feature a conical connection platform with an internal hex (size RP). The NobelZygoma 45° Ext Hex TiUltra Implants include an external hexagonal platform (size RP).

The NobelZygoma TiUltra implants are available in lengths ranging from 30 mm to 60 mm, in 2.5 mm increments. They feature a partially threaded design. The neck portion, measuring 3.6 mm from the platform, and the shaft portion which varies depending on the implant length, are unthreaded. For all implant lengths, threading consistently begins at the apex and extends 18 mm coronally.

The NobelZygoma TiUltra Implants are co-packed with an implant mount, which is attached via a pre-assembled implant mount screw to the platform of the implant.

The Multi-unit Abutments Xeal Zygoma are premanufactured prosthetic components intended to be connected to the compatible NobelZygoma TiUltra Implants to support the placement of a dental prosthesis.

The Multi-unit Abutment (MUA) Xeal Zygoma are made from Titanium alloy (Ti-6Al-4V (90% titanium, 6% aluminum, 4% vanadium, ASTM F136) and feature a non-porous oxide layer with a soluble salt (protective) layer. The Multi-unit Abutments Xeal Zygoma are attached to the respective NobelZygoma TiUltra Implants by the compatible NobelZygoma Multi-unit Abutment Xeal Zygoma Screw.

The Multi-unit Abutment Xeal Zygoma are available in four different angulations (straight or 0°, 17°, 45° and 60°) and in different heights ranging from 3 to 9mm (2mm increase). The 45° and 60° angulations are used with the NobelZygoma 0° TiUltra implants, while the Straight (or 0°) and 17° angulations are compatible with the NobelZygoma 45° TiUltra Implants. The 17° MUA is only available in two heights (3 and 5mm).

The Multi-unit Abutments Xeal Zygoma are provided sterile and co-packed with the respective abutment handle and NobelZygoma Multi-Unit Abutments Xeal Zygoma Screw.

The NobelZygoma Multi-unit Abutment Xeal Zygoma Screws are dental implant screws designed to fasten dental implant system components to a dental implant or to another component.

The subject screws are made of titanium alloy (Ti-6Al-4V (90% titanium, 6% aluminum, 4% vanadium, ASTM F136) and are partially DLC-coated. They are available in different design and sizes to fit the different Multi-unit Abutments Xeal Zygoma. The Straight NobelZygoma Multi-unit Abutment Xeal Zygoma Screws are available in four sizes to fit the respective Straight Multi-Unit Abutment heights. The screws for the 45°/60° Multi-Unit Abutments and the 17° Multi-Unit Abutment are only available in one size that fits all abutment sizes.

The NobelZygoma Multi-unit Abutment Xeal Zygoma Screws are co-packed with the compatible Mult-unit Abutment Xeal Zygoma and are also available separately.

The provided document is a 510(k) Clearance Letter from the FDA for the "NobelZygoma TiUltra Implant system." This type of document primarily focuses on establishing substantial equivalence to previously cleared predicate devices, rather than explicitly detailing acceptance criteria and presenting a single, comprehensive study proving the device meets those criteria.

However, the document does contain information about non-clinical and clinical testing performed to support the substantial equivalence claim. I will extract the relevant information to answer your questions to the best of my ability, acknowledging that not all requested details may be explicitly present in this type of regulatory submission summary.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly list acceptance criteria in a formal table with pass/fail values. Instead, it describes various tests performed and compares the subject device's performance to predicate devices or established standards. The "Reported Device Performance" column reflects the summary of findings from the validation studies described.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not provide specific sample sizes for the non-clinical tests (fatigue, torque, MR, biocompatibility, packaging, sterilization, endotoxin, surface roughness). These are typically determined by relevant standards.
  • For clinical published literature, the sample sizes varied:
    • Three studies on non-full arch applications involved 176 similar zygomatic implants.
    • Systematic literature review on quad configuration reported data for a mean implant survival rate (implies a larger, unspecified number of cases).
    • Two clinical studies involving Nobel Biocare zygomatic implants: n=15 (minimum 79 months follow-up) and n=302 (mean 7.9 years follow-up).
    • A total of 40 clinical publications were provided to support the established history of safe clinical use (number of implants/patients unspecified in this summary).
    • Seven clinical cases with a total of 16 NobelZygoma TiUltra implants were presented.
    • 36 clinical publications on NobelReplace and TiUltra implant family (number of implants/patients unspecified in this summary).
• Data Provenance:
  • Clinical Studies: Published literature (implies peer-reviewed, multi-center, potentially international data).
  • Real-world evidence (RWE): Post-market surveillance for the Subject Devices from July 2024 to May 2025. This is prospective data specific to the subject device after initial market introduction (likely under a different clearance or within a broader market).
  • Clinical Case Studies: Seven cases presented directly by the submitter.
  • The document implies that data from various regions would be included in "published literature" and "post-market surveillance." No specific countries of origin are mentioned beyond "Nobel Biocare" (Sweden/Switzerland) and "Southern Implants (Pty) Ltd" (implies South Africa). The nature of most clinical data is retrospective (published studies, post-market surveillance).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts used to establish ground truth for the test set (clinical studies). Clinical studies typically rely on diagnoses and assessments made by treating clinicians (dental surgeons, prosthodontists) based on established medical practices and diagnostic criteria, rather than a separate "ground truth" panel for the study itself, unless it's a specific adjudication or consensus study. Such details are usually found within the full study protocols and reports, which are not part of this 510(k) summary.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

The document does not specify any adjudication methods for the clinical data presented. This information would typically be detailed in the methodology sections of the individual clinical studies or systematic reviews referenced, which are not provided in this summary.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document describes a dental implant system (hardware), not an AI-powered diagnostic or assistive tool. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human reader improvement with/without AI assistance is not applicable and was not performed.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable as the device is a dental implant system, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Non-Clinical Tests: Ground truth is based on established engineering and materials science principles, international standards (ISO, ASTM), and FDA guidance documents. Performance is evaluated against these benchmarks.
• Clinical Performance Data: Ground truth is primarily based on outcomes data, specifically:
  • Implant survival rate: Directly reported as percentage (e.g., 97.4%, 100%, 89.9%, 99.5%).
  • Reported adverse events and complications: Clinical observations and diagnoses by treating dentists/surgeons. Resolution of these events are considered outcomes.
  • Osseointegration: Inferred from success rates and lack of failure/complaints related to implant stability.
  • Patient esthetics and chewing function: These are indications, and clinical data indirectly supports their achievement through successful implant function.

8. The Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning or AI algorithms. Since this is a physical medical device (dental implant system), it primarily relies on engineering design, materials science, and clinical validation. Therefore, a "training set" in the context of an algorithm is not applicable. The development and testing would involve design iterations and validation studies, but not an algorithmic training process with a distinct training set.

9. How the Ground Truth for the Training Set Was Established

As noted in point 8, the concept of a "training set" in the context of an AI/ML algorithm is not applicable to this physical device. Therefore, the establishment of ground truth for such a set is also not applicable. The "ground truth" for the device's design and performance validation is derived from established scientific principles, pre-clinical testing, and clinical outcomes for the device itself and its predicates.

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MIS dental implant system is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.

Narrow implants (Ø3.30mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The subject devices, MIS Implants, are supplied sterile and packaged together with a cover screw which can be connected to the implant during the initial healing period after implant placement.

The implants and cover screws are made of titanium alloy (Ti-6Al-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant). The design and material of the implants and cover screws remain unchanged since most recently cleared 510(k).

The implants are also used with a wide range of previously cleared abutments which are sold separately.

This document is a 510(k) clearance letter for dental implants, not an AI/software as a medical device (SaMD) submission. Therefore, it does not contain the information requested regarding acceptance criteria and study proving device meets acceptance criteria for an AI/SaMD product.

The document discusses dental implants and their physical and material characteristics, regulatory classifications, predicate devices, and performance testing for mechanical properties, sterility, and packaging. The "Performance Data" section specifically mentions "Hydrophilicity testing" for "wet-packed implants" and other physical tests, but none of these relate to AI/SaMD performance metrics like sensitivity, specificity, or reader studies.

Therefore, I cannot provide a table of acceptance criteria, sample sizes for test sets, expert qualifications, or details on MRMC studies, standalone performance, or ground truth establishment relevant to an AI/SaMD product based on the provided text.

The prompt asks for information that this type of medical device submission (dental implants) would not typically include.

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Zirconia Implants:
The Neodent Implant System is intended to be surgically placed in the bone of upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusion loading. Multiple teeth applications can be rigidly splinted. The implants with length of 5 mm (short implants) may be used only with two-stage surgical procedures. The recommended healing time before loading is between 10 to 12 weeks.

Zi Transmucosal Cover Screw and Healing:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.

Zi Transmucosal Provisional Coping:
The Neodent Implant System is intended for surgical procedures in maxilla or mandible, providing support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single- or multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Zi Transmucosal Abutment Replacement Screw:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Zi Transmucosal Universal Base:
The Universal Ceramic Base Zi Transmucosal 5.0 is an abutment placed over Neodent Zi Transmucosal 5.0 Ceramic Implant System in order to provide support for custom-made prosthetic restorations, such as copings or crowns. It may be used for cement or screw-retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

Zirconia Base for Bridge:
The Zirconia Base for Bridge is an abutment placed over Neodent Zirconia Implants in order to provide support for custom-made prosthetic restorations. It may be used for cement or screw-retained multi-unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

Zirconia Base C:
The Zirconia Base C is an abutment placed over Neodent Zirconia Implants in order to provide support for customized prosthetic restorations, such as copings or crowns. It may be used for single-unit restorations that are screw- or cement-retained in esthetic areas over implants installed in the maxilla or mandible. All copings and/or crowns digitally designed for use with the Titanium Base C are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

This premarket notification includes new ceramic devices into Neodent Implant System, which are compatible with Zirconia Implant System. The Zirconia Implants and Abutments proposed on this submission are similar to devices already cleared in previous submissions of Neodent Implant System – Zirconia Implant System, according to predicate devices described above. This submission intends to expand the portfolio with new solutions and diameter, in order to provide more treatment options to the customers.

The Zirconia Implants are manufactured in Zirconia Y-TZP and are available in Bone Level (BL) or Tissue Level (TL or Transmucosal) configurations. The Zirconia Implants (BL) are available in a diameter of 5.0 mm and lengths in a range of 8 to 13 mm. The Zi Transmucosal Implants (TL) are available in a diameter of 5.0 mm and lengths in a range of 5 to 11.5 mm.

The Zi Transmucosal Healing and Cover Screw are temporary abutments manufactured in PEEK and used during the healing phase. They are compatible with the Zi Transmucosal Implants Ø5.0. The Zi Transmucosal Healing Abutment is available in the heights of 2 and 3.5mm.

The Zi Transmucosal Provisional Coping is a temporary abutment made of polycarbonate (PC) and has a double function: used for molding procedures or production of provisional restoration.

The Zi Transmucosal Abutment Replacement Screw is a prosthetic component manufactured in titanium alloy and used to fix the fix the Zi Transmucosal Base to the Zi Transmucosal Implant.

The Zi Transmucosal Universal Base is a two-piece abutment of base and top-half prosthetic structure to provide support for customized single-unit restorations over Zi Transmucosal Implant (TL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of 4mm and is available with gingival heights of 0.3, 1.0 and 1.5 mm. The top-half prosthetic structure to be used with Zi Transmucosal Universal Base must be designed and milled in a Straumann Validated Milling center, using the following restoration materials and dimensions:
Material: IPS e.max CAD HT, Associated Material 510(k): K132209, Minimum wall thickness: 0.9 mm, Maximum angulation: 30°
Material: IPS e.max CAD LT, Associated Material 510(k): K132209, Minimum wall thickness: 0.9 mm
Material: N!ce, Associated Material 510(k): K171773, Minimum wall thickness: 1.0 mm
Material: IVOCLAR Multilink cement, Associated Material 510(k): K130436, Minimum wall thickness: N/A
Material: Zirconia N!ce® LT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: Zirconia N!ce® HT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: Zirconia N!ce® XT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: PMMA N!ce, Associated Material 510(k): K071548, Minimum wall thickness: 0.7 mm
Material: Panavia—Kuraray Cement, Associated Material 510(k): K150704, Minimum wall thickness: N/A, Maximum angulation: N/A

The Zi Base for Bridge is a two-piece abutment of base and top-half prosthetic structure to provide support for customized multi-unit restorations over Zirconia Implants (BL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of 4mm and is available with gingival heights of 1.5, 2.5 and 3.5 mm. The top-half prosthetic structure to be used with Zi Base for Bridge must be designed and milled in a Straumann Validated Milling center, using the following restoration materials and dimensions:
Material: Zirconia N!ce® LT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm, Maximum angulation: 30°
Material: Zirconia N!ce® HT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: Zirconia N!ce® XT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: PMMA N!ce, Associated Material 510(k): K071548, Minimum wall thickness: 0.7 mm
Material: Panavia—Kuraray Cement, Associated Material 510(k): K150704, Minimum wall thickness: N/A, Maximum angulation: N/A

The Zi Base C is a two-piece abutment of base and top-half prosthetic structure to provide support for customized single-unit restorations over Zirconia Implants (BL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of 4mm and is available with gingival heights of 1.5, 2.5, 3.5 and 4.5 mm. The top-half prosthetic structure to be used with Zi Base C must be designed and milled in a Sirona InLab Validated Workflow, using the following restoration materials and dimensions:
Material: IPS e.max CAD, Associated Material 510(k): K132209, Minimum wall thickness: 0.9 mm, Maximum angulation: 20°
Material: IVOCLAR Multilink cement, Associated Material 510(k): K130436, Minimum wall thickness: N/A, Maximum angulation: N/A

All these abutments have an internal connection with the implants (ZiLock) and the prosthetic platform is identical for all subject devices described in this submission. They are intended for single use and provided sterile via Ethylene Oxide method, along with undergoing moist heat sterilization after end-user customization.

The provided FDA 510(k) clearance letter and its associated summary for the Neodent Implant System - Zirconia Implant System contain extensive information about the device, its intended use, and comparisons to predicate devices. However, it does not include specific acceptance criteria with numerical thresholds directly stated within the tables, nor does it detail a study that directly proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or image quality assessments.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through various tests, implying that if the new device performs similarly to or better than previously cleared devices, it meets the necessary standards. The performance testing section describes the types of tests conducted (e.g., dynamic fatigue, torsion, insertion, pull-out, and software validation), but it does not present clear quantitative acceptance criteria or the specific performance results in a comparative table format.

Therefore, many of the requested fields cannot be directly extracted from the provided text as they pertain more to the performance evaluation of AI/software in interpreting medical images, which is not the primary focus of this dental implant submission.

Here's an attempt to answer the questions based on the available information, noting where information is not explicitly provided in the document:

Acceptance Criteria and Device Performance Study for Neodent Implant System - Zirconia Implant System

The FDA 510(k) summary for the Neodent Implant System - Zirconia Implant System focuses on demonstrating substantial equivalence to predicate devices through a combination of bench testing, software validation, MRI compatibility, biocompatibility, and sterilization validation. It does not present specific quantitative acceptance criteria or performance metrics directly from a comparative study in the way one might expect for an AI/software-based medical device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implicitly met by demonstrating that the proposed devices perform at a level substantially equivalent to legally marketed predicate devices under standardized testing conditions.

1. A table of acceptance criteria and the reported device performance

As mentioned, explicit numerical acceptance criteria and reported device performance in a comparative table (e.g., for diagnostic accuracy) are not provided in this 510(k) summary. The summary indicates that tests were conducted according to relevant ISO standards and FDA guidance, and the results demonstrated that the subject devices exhibit a level of performance substantial equivalent to the predicate and reference devices.

Below is a conceptual table based on the types of tests mentioned, noting that specific numerical acceptance criteria and performance data are not detailed in the provided text.

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S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. dental implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

S.I.N. Dental Implant System implants with lengths of 18, 20, 22 or 24mm may be tilted up to 30º. When used in the mandible or maxilla with implants with lengths of 18, 20, 22 or 24 mm at an angulation of 30º, a minimum of four implants must be used and must be splinted. When placed in the maxilla with lengths of 18, 20, 22 or 24 mm at angulations between 0º and less than 30º, the S.I.N. Dental Implant System implants are only indicated for multiple unit restoration in splinted applications that utilize at least two implants.

The purpose of this submission is to add components to the S.I.N. Dental Implant System, which includes various endosseous implants with 16° Morse tapers interface connection. This submission adds to the S.I.N. Dental Implants System, the Versalis S implants line.

The Versalis S implant line has the Versalis S and Versalis S Plus implants, and both have a Morse taper connection with an internal 16° cone taper. The Versalis S implants have implant body lengths from 8.5 to 24mm and body diameter Ø from 3.5 to 7.0mm., they are manufactured from unalloyed titanium conforming to ASTM F67, with a double acid-etched surface treatment. The Versalis S Plus implants have implant body lengths from 8.5 to 24mm and body diameter Ø from 3.5 to 7.0mm., they are manufactured from unalloyed titanium conforming to ASTM F67, with a double acid-etched surface treatment plus hydroxyapatite surface coating.

All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700), Grade 4. The material used to manufacture the dental implants in this submission (conforming to ASTM F67) is identical to the material used to manufacture the device implants cleared in primary predicate K170392 and in additional predicate K222231.

The provided text is a 510(k) clearance letter for a dental implant system. It does not contain any information about acceptance criteria or a study proving that an AI/ML device meets acceptance criteria. The "Performance Data" section discusses non-clinical testing for the dental implant itself, such as sterilization validation, shelf-life testing, and biocompatibility, as well as fatigue testing and MRI environment compatibility. This is for a physical medical device, not a software device that relies on AI/ML.

Therefore, I cannot provide the requested information as it is not present in the given document.

To reiterate, the document is about a physical dental implant system and the performance data pertains to its physical properties, sterility, and biocompatibility, not to the performance of an AI/ML algorithm.

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Straumann® RidgeFit Implants ∅ 2.4 mm are indicated for oral endosteal implantation in the fully edentulous mandible and/or maxilla for the stabilization of removable dentures. The implants can be placed with immediate function when primary stability is achieved for all implants or with conventional loading if primary stability is not achieved on all implants.

• Mandibular restorations require at least 4 Straumann® RidgeFit Implants ∅ 2.4 mm.
• Maxillary restorations require at least 6 Straumann® RidgeFit Implants ∅ 2.4 mm.

The Straumann® RidgeFit Implants are tapered implants manufactured from Roxolid® (Titanium-Zirconium alloy, TiZ) with a finished SLA surface. The implant neck is machined with an Optiloc® attachment portion, which is coated in Titanium Nitride (TiN) coating, resulting in a one-piece implant system acting as a retention feature for dentures. The Straumann® RidgeFit Implants have an external diameter of 2.4 mm and are available in implant lengths 10 mm, 12 mm and 14 mm with a gingival height of 2.8 mm and implant lengths 10 mm and 12 mm for gingival heights 3.8 mm and 4.8 mm. The Straumann® RidgeFit Implants ∅ 2.4 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully edentulous patients. Conventional loading is recommended if primary stability cannot be achieved immediately on all implants.

The provided FDA 510(k) clearance letter and summary for the Straumann® RidgeFit Implants contains information regarding the device's technical specifications and non-clinical testing. However, it does not include any information about acceptance criteria or a study that uses a test set with ground truth established by experts to prove the device meets these criteria.

The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical engineering tests (fatigue, insertion torque, biocompatibility, sterilization, packaging stability, MRI compatibility). These are performance tests on the device itself, not evaluations based on human-in-the-loop or standalone AI performance using a study with a test set and expert-established ground truth.

Therefore, I cannot provide the requested information for the following points as they are not present in the given text:

• A table of acceptance criteria and the reported device performance: The document implicitly states that passing the non-clinical tests demonstrates "substantial equivalence," but does not define explicit acceptance criteria or performance metrics directly from a comparative study with a test set and ground truth.
• Sample sized used for the test set and the data provenance: No such test set or study is described within the provided text.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set or expert ground truth establishment is described.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned. The clearance is for an endosseous dental implant, which is a physical device, not an AI software intended for interpretation or diagnostic assistance that would typically undergo such studies.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

What the document does provide regarding testing:

The device's performance is proven through a summary of non-clinical testing, which includes:

1. Dynamic fatigue testing: Conducted according to FDA guidance (Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments) and ISO 14801 ("Dentistry — Implants — Dynamic loading test for endosseous dental implants"). This testing demonstrated the subject devices are equivalent to primary predicate and reference devices.
2. Insertion torque and Torque-to-failure test: Conducted and demonstrated substantial equivalence to the primary predicate device.
3. Biocompatibility evaluation: Referenced K211052 and K191895 for evaluation in accordance with ISO-10993-1:2018 and FDA guidance.
4. Sterilization validation: Referenced K211052 and K191895 for validation in accordance with ISO 11137-1:2006 (VDmax25 method).
5. Packaging stability and shelf-life study: Referenced K211052 and K191895 for studies in accordance with ISO 11607-1:2019, ASTM F1886, ASTM F1929, and ASTM F88.
6. MRI simulations: Conducted to demonstrate that the devices are MR Conditional.

These tests are primarily physical and chemical performance assessments of the implant materials and design, aimed at establishing safety and effectiveness, and equivalence to existing cleared devices, not at evaluating an AI's diagnostic performance against human experts.

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MIS Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. MIS LYNX short implants are indicated for delayed loading only.

The two additional implant size offerings which are being added to the predicate MIS LYNX Conical Connection Dental Implant System (K241692), and are the subject of this submission, consist of a standard platform, 4.20 mm diameter implant and a wide platform, 5.00 mm diameter implant, each available in a 6 mm length.

The proposed implant offerings, as their predicate K241692, are root-form, bone-level, self-tapping, two-piece, screw-type implants which are intended for one- or two-stage dental implant procedures and are used in the upper or lower jaw for supporting tooth replacement to restore chewing function.

Each implant offering is provided with a compatible cover screw based on the implant platform (standard and wide). The cover screws are identical to those cleared in K241692 and are intended to be used in a two-stage surgical procedure as temporary components to the proposed endosseous implant to allow healing of the soft tissue. The cover screw is screwed into the implant's internal thread and the gums are sutured over the cover screw. The cover screw's purpose is to let the osseointegration begin without any forces being applied to the implant. After a healing period, the cover screw is exposed and is then removed and replaced by either a healing cap or an abutment.

The implants and cover screws are manufactured from titanium alloy (Ti-6Al-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant).

The proposed implants feature an outer profile which has a coronal section which is cylindrical and an apical section which is conical. The outer threads are designed so the implant has a self-drilling property. The implant's geometric design includes a dual thread feature and spiral channels (flutes) stemming from the apex. These spiral channels are designed to enable insertion torque reduction when applying reverse torque. The proposed implant design also includes circumferential grooves at the coronal area which are called "micro-rings". These horizontal micro-rings are designed to increase the BIC (Bone to Implant Contact) of the implant with the bone. The proposed implants feature a round (cylindrical) neck.

The proposed MIS LYNX Conical Connection Implants have a conical connection with an anti-rotation index of six positions and an internal thread for cover screws, screw-retained abutments and screwed healing caps. The implant-abutment connection surface of the proposed implants is anodized for color coding purposes to indicate the platform: purple for standard platform implants, and green for wide platform implants. The cover screws are also anodized for platform color coding.

The proposed implants are packaged in either a dry or wet package. Implants packaged in the wet packaging configuration are packaged in NaCl solution and are not anodized. The liquid environment is intended to maintain the super-hydrophilic (contact angle exhibited by water in contact with the surface is equal to zero degrees) property of the proposed dental implants until the implants are installed in patients.

This 510(k) clearance letter pertains to an Endosseous Dental Implant System, which is a physical medical device, not a software-driven AI device. Therefore, the concepts of acceptance criteria, study data, expert adjudication, MRMC studies, standalone algorithm performance, ground truth establishment for AI models, and training set sizes are not applicable to the information provided.

The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in the context of an AI-driven system. The "acceptance criteria" here are implicitly the standards and performance levels demonstrated by the predicate and reference devices, as well as relevant ISO and ASTM standards.

Here's an analysis of the provided information, framed as closely as possible to your request, but acknowledging the device type:

Device: MIS LYNX Conical Connection Implant System

This device is an endosseous dental implant system, a physical medical device. The FDA clearance is based on demonstrating substantial equivalence to legally marketed predicate devices, not on the performance of an AI algorithm. Therefore, many of the requested fields related to AI model evaluation are not applicable.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally understood to be compliance with relevant international and national standards for dental implants, and performance comparable to or exceeding established predicate/reference devices.

Table of Acceptance Criteria (Inferred from testing) and Reported Device Performance:

Regarding the other requested information (primarily relevant to AI/Software-as-a-Medical-Device):

2. Sample size used for the test set and the data provenance: Not applicable. The testing done was laboratory-based mechanical and MR safety testing, not evaluation of an AI model with a clinical test set. The implant dimensions analyzed for surface area were "smallest implant length (6 mm) and diameter (4.20 mm)" for proposed and reference devices. Pull-out testing and fatigue testing would have involved a number of physical samples per test, but specific quantities are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI (e.g., expert labels on medical images) is not relevant here. The "ground truth" for mechanical testing is established by physical measurements and engineering principles.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical dental implant, not an AI assistance system for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical properties, the "ground truth" is derived from established engineering test methods and their performance metrics (e.g., load at failure, cycles to failure). For MR safety, it's compliance with established safety limits for magnetic fields.

8. The sample size for the training set: Not applicable. There is no AI model or training set mentioned.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is an FDA 510(k) clearance letter for a conventional physical medical device (dental implant system). The evaluation and clearance process for such devices involve demonstrating safety and effectiveness by showing substantial equivalence to existing legally marketed devices, typically through non-clinical (laboratory) testing, materials characterization, and compliance with recognized standards. The concepts and terminology in your request are largely tailored to the evaluation of AI/Machine Learning-driven medical devices, which is not what this document addresses.

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The SD TL Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Abutments are indicated for screw-retained single restorations or cement-retained single of multi-unit restorations. SD TL Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. All digitally-designed abutments are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture.

SD TL Implant System consist of below:
Fixture

• SD Tissue Level Fixture
• SD Bone Level Fixture

Abutment

• Multi Angled Cylinder
• Multi Digital Cylinder
• Multi Ti Cylinder
• Multi Healing Cap
• Healing Abutment
• Temporary Abutment

1. Fixture
   This product is a dental implant which is placed into alveolar bone to replace the function of missing teeth. To enhance the osseointegration with the alveolar bone, this titanium dental implant is treated with SLA (Sandblasted with Large-grit and Acid-etching). As a dental implant which is placed into alveolar bone to support dental prostheses such as artificial teeth used to rehabilitate a patient's masticatory function, the product is used as a substructure implanted into the human body.

An endosseous dental implant is a device made of a material as Pure Titanium (Conforming to ASTM F67) which will be placed in the alveolar bone to replace the function of the missing tooth. The SD TL Implant System consists of dental implants, abutments for use in one or two-stage dental implant placement and restorations.

The implant-abutment connection is tight and precise fitting with non-submerged external connection and with submerged internal connection. The surface of the fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone).

The dimension ranges of the subject device are below:

1. SD Tissue Level Fixture: Ø 3.7, 4.2, 4.6, 5.0 (D) x 7.0, 8.5, 10.0, 11.5, 13.0 mm (L)
2. SD Bone Level Fixture: Ø 6.48 (D) x 7.0, 8.5, 10.0, 11.5 mm (L)

2. Abutment
   The abutment is made of Ti-6Al-4V Eli (Conforming to ASTM F136) to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screw-and cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician. The Multi Angled cylinders come in engaging and non-engaging types.

1. Multi Angled Cylinder: Ø 5.5 (D) x 9.5, 10.5 mm
2. Multi Digital Cylinder: Ø 5.5 (D) x 6.5, 7.5, 8.5, 9.5 mm
3. Multi Ti Cylinder: Ø 4.8 (D) x 4.5 mm, Ø 5.5 (D) x 8.0, 9.0 mm
4. Multi Healing Cap: Ø 4.8, 5.7 (D) x 4.35, 5.85, 7.35 mm
5. Healing Abutment: Ø 3.5, 3.67, 4.2, 5.2, 6.2, 7.5, 8.5 (D) x 6.9 ~ 13.3mm
6. Temporary Abutment: Ø 3.7, 4.0 (D) x 10.4, 10.45, 12.4, 12.45 mm

Tolerance of dimension shall be within ± 1% range.

Multi Digital Cylinder and Multi Ti Cylinder are used as part of a two-piece abutment, where the base is premanufactured from titanium alloy (Ti-6Al-4V Eli) and the top half is a CAD/CAM zirconia superstructure, milled at a validated milling center. These pieces are cemented together to form the final abutment.

The Titanium Base abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The zirconia superstructure is straight only and is not to be designed to provide an angle or divergence correction.
For the Multi Digital Cylinder and Multi Ti Cylinder the design parameters for the CAD/CAM zirconia superstructure are:

• Minimum wall thickness – 0.5 mm;
• Minimum post height for single-unit restorations – 4.5 mm;
• Maximum gingival height – 5.0 mm;
• Minimum gingival height – 0.5 mm;
• Angulation - 0°
  *The post height is defined as measured above the gingival height of the final patient-matched design.

The digital workflow requires the use of the following equipment:

• Restorative Material: Non-Sterile Zirconia Block (K190112)
• Dental Cement: U-Cem Premium & MAZIC Cem (K193260)

The SD TL Implant System is compatible with the SD Bone Level Fixtures and NB Implant Systems. (as the below table).

The provided FDA 510(k) Clearance Letter for the "SD TL Implant System" does not contain information about acceptance criteria or a study proving the device meets those criteria in the context typically seen for Artificial Intelligence (AI) or software as a medical device (SaMD) products.

This document is for a physical medical device (dental implants and associated components), specifically an endosseous dental implant (Product Code: DZE, NHA; Regulation Number: 21 CFR 872.3640; Regulatory Class: Class II).

The "performance data" section in this document describes:

• Biocompatibility testing (ISO 10993-5, ISO 10993-12) to ensure the materials are safe for use in the human body.
• Sterilization validation (ISO 11137-1, 11137-2, ANSI/AAMI ST79, ISO 17665-1, -2, ISO 11737-1,-2, ISO 11138-1, AAMI / ANSI ST72:2011/(R)2016) to ensure the device is sterile.
• Shelf-life testing (ASTM F1980) to confirm stability over time.
• Mechanical performance testing (ISO 14801) for static compression and compression fatigue, which are standard tests for the structural integrity of dental implants.
• Scanning electron microscopy (SEM) and Energy dispersive X-ray spectroscopy (EDS) for surface characteristics.
• MR environment condition review to assess safety in MRI environments.

These tests are standard for a physical implantable device to demonstrate substantial equivalence to a predicate device. They are not related to AI/software performance criteria (like accuracy, sensitivity, specificity, AUC) or human reader study designs (like MRMC studies, ground truth establishment by experts, adjudication methods).

Therefore, I cannot populate the requested table or answer the questions related to AI/software performance, ground truth, expert consensus, or MRMC studies, as this information is not present in the provided document.

The document explicitly states: "Non-clinical testing data submitted, referenced or relied on in this submission support demonstrating substantial equivalence." and "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the primary predicate." This refers to the physical and material properties, not AI algorithm performance.

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DESS® dental implants are indicated for surgical placement in the upper or lower jaw in edentulous or partially edentulous patients for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. They are designed to support single or multi-unit restorations in splinted or non-splinted applications, as well as to support overdenture attachment systems. DESS® dental implants may be used for immediate or early implantation following extraction or loss of natural teeth, and may be used for immediate or delayed loading techniques. Implants may be loaded immediately when good primary stability is achieved and occlusal loading is appropriate.

DESS® NEO GM Dental Implants are compatible with DESS® Dental Smart Solutions abutments having the identical NEO GM connection manufactured by Terrats Medical SL.

DESS® NEO GM Dental Implants with a diameter of 3.5 mm are indicated for use in reduced interdental spaces, where there is not enough alveolar bone for a larger diameter implant. The use of 3.5 mm implants is intended only for rehabilitation of the anterior region of the mouth.

DESS® Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed custom abutments for use with DESS® Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.

This submission includes dental implants that are compatible with DESS® Dental Smart Solutions abutments having the identical NEO GM connection manufactured by the sponsor of this submission, Terrats Medical SL, and cleared under K212628, K222288, K233316, K240208, and K242340. No claims of compatibility between the subject device implants and abutments from any OEM other than DESS® Dental Smart Solutions will be made. This submission also includes DESSLoc abutments that are compatible with eight (8) dental implant lines from five (5) OEM manufacturers. Also included in this submission is one (1) Pre-Milled Blank abutment that is compatible with three (3) implant lines manufactured by Alpha Dent Implants GmbH.

This submission includes one implant line, the Dental Implant NEO GM, a series of self-tapping, threaded, root-form dental implants to be placed at bone level. The subject device implants are provided in body diameters of 3.55 mm, 3.75 mm, 4.0 mm, 4.3 mm, 5.0 mm, 6.0 mm, and 7.0 mm. The subject device implant body diameters will be labeled as 3.5 mm, 3.75 mm, 4.0 mm, 4.3 mm, 5.0 mm, 6.0 mm, and 7.0 mm. Implant with body diameters ranging from 3.55 mm to 5.0 mm are provided in overall lengths of 7.9 mm, 9.9 mm, 11.4 mm, 12.9 mm, 15.9 mm, and 17.9 mm. Implants with body diameters 6.0 mm and 7.0 mm are provided in overall lengths of 7.9 mm, 9.9 mm, and 11.4 mm. The subject device implant lengths will be labeled as 8 mm, 10 mm, 11.5 mm, 13 mm, 16 mm, and 18 mm. All subject device implants, regardless of body diameter, have an internal Morse taper connection with a 16° included angle and 2.99 mm diameter opening at the top of the implant. This NEO GM connection is identical to the connection for abutments cleared previously in K242340.

All subject device implants are made of unalloyed titanium conforming ASTM F67 and ISO 5832-2. The entire endosseous surface, except for a small coronal bevel, features a grit blasted and double acid etched (SLA) surface, which is identical to the surface treatment for DESS® implants that were cleared in K212538.

This submission also includes DESSLoc Abutments designed for overdenture retention. The subject device DESSLoc Abutments are straight, non-engaging abutments that attach directly to the implant and are compatible with eight (8) dental implant lines from five (5) OEM manufacturers.

The subject device DESSLoc Abutments are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The subject device DESSLoc abutments have a zirconium nitride (ZrN) coating produced by a physical vapor deposition (PVD) process. The ZrN coating is applied to increase the surface hardness and reduce wear of the abutment surface. The ZrN coating for the subject device DESSLoc Abutments is identical to the ZrN coating applied to DESSLoc Abutments cleared in K242340, K240208, K222288, K191986, and K170588.

This submission also includes one (1) Pre-Milled Blank Abutment that is compatible with three (3) implant lines manufactured by Alpha Dent Implants GmbH, including Implant Active Konus, Implant Classic Konus, and Implant Active Bio, cleared in cleared in K210499. Reverse engineering compatibility analysis of the Alpha Dent implants, abutments, and abutment screws and Terrats Medical SL abutments and abutment screws was provided in the prior Terrats Medical SL submission K243212.

The Pre-Milled Blank Abutment has a maximum (before milling) diameter of 10 mm and a solid cylindrical design and an engaging implant connection. The Pre-Milled Blank Abutment is manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. All patient-specific custom abutment fabrication for the Pre-Milled Blank Abutment is by prescription on the order of the clinician and will be done at a Terrats Medical validated milling center under FDA quality system regulations. The design parameters for the CAD-CAM fabrication of a custom abutment from the Pre-Milled Blank Abutment are:

• Minimum wall thickness – 0.45 mm
• Minimum post height for single-unit restoration – 4.0 mm (post height measured above the gingival height of the final patient-matched design)
• Minimum gingival height – 0.5 mm
• Maximum gingival height – 6.0 mm
• Pre-Milled Blanks are for straight abutments only

The abutment screw for use with the Pre-Milled Blank Abutment and the Alpha Dent implants was cleared previously in K243212.

All subject device implants are provided sterile, and all subject device abutments are provided non-sterile. The Pre-Milled Blank Abutment is supplied with the previously-cleared non-sterile abutment screw for attachment to the corresponding compatible implant. All subject device components are provided in single-unit packages for single-patient, single-use only.

The provided FDA 510(k) Clearance Letter for DESS® Dental Implants (K251280) does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the context of AI/ML device performance.

The document is a clearance letter for a dental implant system, which is a physical medical device, not an AI/ML-driven diagnostic or treatment planning software. Therefore, the questions related to AI/ML device performance (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth) are not applicable to the content provided.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use and Indications for Use
• Technological Characteristics (design, materials, surface treatment, sterilization methods, dimensions)
• Performance Data (non-clinical data such as MRI review, sterilization validation, bacterial endotoxin testing, shelf life, biocompatibility, and mechanical testing according to ISO 14801).

Since the request specifically asks for AI/ML-related performance evaluation, and the provided document is not for an AI/ML device, I cannot fulfill the request as stated with the given input.

However, I can extract the non-clinical performance data and the comparison to predicate devices, which serve as the "study" and "acceptance criteria" for this type of physical medical device in the context of a 510(k) submission.

Non-Clinical Performance Data (Serving as "Study" for Substantial Equivalence):

1. Worst-Case MRI Review:

   • Method: Scientific rationale and published literature (T.O. Woods, J.G. Delfino, and S. Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation Volume 49, No. 2 (March/April 2021): 783–795).
   • Scope: Evaluated all compatible implant bodies, abutments, and fixation screws and their material composition.
   • Parameters: Magnetically induced displacement force and torque, per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."
   • Outcome: Rationale addressed parameters; device components found suitable for the MR environment.

2. Gamma Irradiation Sterilization Validation (for implants):

   • Method: Selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2.
   • Acceptance Criteria: Sterility Assurance Level (SAL) of $10^{-6}$.
   • Outcome: Analysis showed the subject device implants met the SAL and did not create a new worst case compared to predicate device K212538.

3. Bacterial Endotoxin Testing:

   • Method: Limulus amebocyte lysate (LAL) testing according to ANSI/AAMI ST72.
   • Acceptance Criteria: Limit of

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The Hexim Implant - The HEXIM Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The HEXIM Implant System is for two stage surgical procedures. It is intended for delayed loading.

Samwon General Abutments - Couple Abutments are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Healing abutments are used to make a natural soft tissue shape before setting up prosthetics and removing cover screw after osseointegration. Cover Screws are used to protect the internal portion of the implant, preventing soft tissue growth into the implant, facilitating provisional restorations when necessary, and enabling the transition to final restoration components once osseointegration is complete.

The HEXIM Implant with Samwon General Abutments is a Root-form Endosseous Dental Implant and Endosseous Dental Abutment system designed for use in dental implant surgery. These devices have special controls as described by the document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments – Class II Special Controls Guidance for Industry and FDA Staff.

The HEXIM Implant is a threaded root-form endosseous dental implant with an internal hexagon connection. The HEXIM implants are surgically inserted into the upper and/or lower jawbone to provide a stable foundation for restorations. Geometrically, the implant is screw type. It has external self-tapping threads with chip pocket vertical flutes to facilitate implantation. The HEXIM implant also includes a cavity which extends through the bottom of the implant and connects to 5 channels running perpendicular to the implant body long axis to aid in intra bone fixation. The bottom cavity is not directly interconnected to the internal hex connection nor to the internal threading feature used to fix abutments to the implant.

The Samwon General Abutments are connected to the implant through the implant's internally threaded hole and an internal hex connection. Samwon General Abutments come in several types: Cover Screw, Healing Abutment, Hex type Couple Abutment, and Abutment Screw. Cover Screws are used to protect the internal portion of the implant, preventing soft tissue growth into the implant, facilitating provisional restorations when necessary, and enabling the transition to final restoration components once osseointegration is complete. Healing abutments are used after osseointegration, once the cover screw is removed, to make a natural soft tissue shape before setting up prosthetics. The Hex-type Couple Abutment is designed to mate with the internal hex cavity of the endosseous implant and is fixed to the implant via an abutment screw. The Hex-type Couple Abutment is a transgingival component, which serves as the support for the artificial tooth or other prosthetic.

The provided FDA 510(k) clearance letter for the HEXIM Implant and Samwon General Abutments is for a medical device that includes physical implants and abutments, not an AI or software-based medical device. Therefore, the information typically associated with acceptance criteria and a study proving an AI device meets those criteria (such as sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment, and training set details) is not applicable to this document.

This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through comparisons of:

• Intended Use and Indications for Use
• Technological Characteristics (material, design, dimensions, sterilization, surface treatment, connection type, principle of operation)
• Performance Testing (bench testing, biocompatibility, sterilization validation)

The "study" that proves the device meets acceptance criteria in this context is the non-clinical performance testing and the demonstration of substantial equivalence to legally marketed predicate devices, rather than a clinical trial or AI model validation study.

Here's a breakdown of the relevant information provided in the document concerning how the device meets its "acceptance criteria" (understood as demonstrating substantial equivalence and safety/effectiveness):

1. A table of acceptance criteria and the reported device performance

The document does not present explicit "acceptance criteria" in a tabulated form with specific numerical targets typical for AI model performance (e.g., AUC > X, Sensitivity > Y). Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices and adherence to relevant industry standards and guidance documents. The "reported device performance" is demonstrated through various tests and comparisons:

• Surface Treatment: SLA (Similar to predicate, same as reference; justified differences do not affect substantial equivalence).
• Sterilization: Gamma irradiation (Same as reference, predicate not specified).
• Connection Type: Internal Hex (Same as both predicate and reference).
• Fixture Body Diameter/Length: Differ slightly but fall within predicate/reference ranges or justified as not affecting safety/efficacy.
• Bottom Cavity: Presence/absence compared and justification provided. |
  | Technological Characteristics Equivalence (Samwon General Abutments) | - Material: Ti-6Al-4V ELI of ASTM F136 (Same as predicate/reference).
• Surface Treatment: None (Same as predicate; justified difference from reference).
• Sterilization: End User (Steam) (Same as predicate/reference where specified).
• Connection Type: Threaded/Internal Hex (Same or similar, justified).
• Dimensions (Diameter, Length, G/H, Post Height): Differ but fall within predicate/reference ranges or justified as not affecting safety/efficacy; mechanical testing confirms suitability. |
  | Biocompatibility | Tested in accordance with ISO 10993 series for various biological endpoints (cytotoxicity, irritation, sensitization, systemic toxicity, implantation effects, chemical characterization). Results implicitly met acceptance criteria as they support substantial equivalence. |
  | Sterilization Validation | For HEXIM Implants (sterile): ISO 11137 series.
  For Abutments (non-sterile, end-user steam): ANSI/AAMI ST79:2017 & ISO 17665 series. LAL bacterial endotoxin testing also performed. Results implicitly met acceptance criteria. |
  | Shelf-Life | Established via accelerated aging per ASTM F1980-2021 at 5 years for HEXIM Implants. |
  | Mechanical Performance (Bench Testing) | - Fatigue Testing: Performed per ISO 14801:2007 using worst-case geometries. Results met criteria.
• Implant-to-Abutment Compatibility: Determined through mechanical testing. Results implicitly met criteria.
• Surface Analysis (SLA): Chemical and visual analysis performed to ensure no blasting particles/chemicals remain. Results implicitly met criteria. |
  | MRI Safety | Non-clinical worst-case MRI review performed using scientific rationale and published literature, addressing magnetically induced displacement force and torque. Justified as safe. |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as this is a medical device clearance for physical implants and abutments, not an AI/software device. The "test set" here refers to physical samples used in bench testing.

• Sample Size: Not explicitly stated for each bench test (e.g., number of implants for fatigue testing). The tests were performed on "representative final manufactured samples."
• Data Provenance: Not applicable. Tests are conducted in a lab environment (e.g., ISO-certified labs for mechanical and biocompatibility testing).
• Retrospective or Prospective: Not applicable. Bench testing is a controlled, experimental process, not typically classified as retrospective or prospective clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. Ground truth establishment by experts pertains to diagnostic AI models. For physical implants, "ground truth" is established through physical and chemical measurements against engineering specifications and international standards, and results are interpreted by engineers and scientists.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are relevant for human interpretation of data, typically in diagnostic studies for AI. For bench testing, results are objective measurements against defined standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. MRMC studies are for evaluating diagnostic performance, particularly with AI assistance. This submission is for physical dental implants and abutments.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. Standalone performance refers to AI algorithm performance. This is a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, the "ground truth" for demonstrating safety and effectiveness includes:

• Engineering Specifications: Design drawings, material specifications (e.g., ASTM F67, ASTM F136).
• International Standards: ISO 14801 (fatigue), ISO 10993 series (biocompatibility), ISO 11137 / ANSI/AAMI ST79 / ISO 17665 series (sterilization).
• FDA Guidance Documents: "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."
• Pre-market Review Precedents (Predicate Devices): The performance and safety profile of the legally marketed predicate devices (K111889, K190641, K221866, K222792) serve as the established "ground truth" for substantial equivalence.

8. The sample size for the training set

This information is not applicable. There is no "training set" for physical medical devices in the context of AI/machine learning.

9. How the ground truth for the training set was established

This information is not applicable. There is no "training set" for physical medical devices that requires ground truth establishment in the AI sense. The design and manufacturing processes follow established engineering principles and quality systems (21 CFR Part 820), which ensure the product meets its intended specifications.

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URIS Long Implant & Abutments are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

URIS Long Implants are dental implants made of Unalloyed Titanium, grade 4 (ASTM F67) intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The surface is SLA (Sandblasted, Large grit and Acid etched) treated and is provided sterile.

URIS OMNI Long Implants consist of two implant lines, the OMNI Straight and the OMNI Tapered. The OMNI Straight implant features straight walls, with smaller threads at the coronal end and larger threads at the apical end. The OMNI Tapered implant has a tapered wall with a single-thread design.

Both implant lines have two platform sizes, Narrow (Ø 3.5 mm) and Regular (Ø 4.0 – Ø 4.5 mm).

Both implant lines share the following diameters and lengths:

URIS OMNI Long Implants are compatible with the following abutments:

• Cover Screw (K172100)
• Healing Abutments (K172100)
• Multi-Unit Straight Abutment (K200817)
• Multi-Unit Angled Abutment (K200817)
• Multi-Unit Healing Cap (K200817)
• Multi-Unit Ti Cylinder (K200817)
• Multi-Unit Temporary Cylinder (K200817)
• Multi-Unit Base (K200817)
• Multi-Unit Cylinder Screw (K200817)
• AOT Base (K231874)
• AOT Temporary (K231874)
• AOT Straight Abutment (K243255)
• AOT Angled Abutment (K243255)
• Multi-Unit Base (K243255)
• Multi-Unit Base Screw (K243255)
• Multi-Unit Temporary Abutment (K243255)
• AOT Direct Screw (K243255)
• AOT Plus Direct Screw (K243255)
• Multi-Unit Direct Screw (K243255)

The abutments are provided non-sterile. All non-sterile products must be sterilized by the end user prior to use.

The AOT Angled Abutment, Multi-Unit Base, and Multi-Unit Temporary Abutment are packaged with their corresponding screw(s).

For convenience, the Multi-Unit Base and Multi-Unit Temporary Abutment are each supplied with two screws included in the package.

The abutments are designed for use with the two implant types submitted in this application. They are also compatible with the implants included in the K172100 URIS OMNI Implant system (Narrow: Ø3.5 mm, lengths 8.5–14.5 mm / Regular: Ø4.0–Ø6.5 mm, lengths 7.0–14.5 mm).

The AOT Straight and AOT Angled Abutments are compatible with the Base and Temporary Abutments included in this submission, as well as those previously cleared under K231874.

The provided FDA 510(k) clearance letter for URIS Long Implant & Abutments does not contain information about acceptance criteria and study proving device performance as typically expected for AI/ML-driven medical devices. This submission is for a traditional dental implant system, and the clearance is based on substantial equivalence to predicate devices through non-clinical testing, primarily focusing on mechanical, material, and biocompatibility properties.

Therefore, many of the requested elements regarding acceptance criteria for device performance (e.g., sensitivity, specificity, AUC), study design (sample size, data provenance, ground truth establishment, expert adjudication), and AI/ML-specific study types (MRMC, standalone performance) are not applicable to this submission.

However, I can extract the information relevant to the type of device and submission, specifically the non-clinical acceptance criteria and the tests performed to meet them.

Acceptance Criteria and Supporting Study for URIS Long Implant & Abutments

As this FDA 510(k) pertains to a traditional dental implant and abutment system (URIS Long Implant & Abutments, K243255), and not an AI/ML device, the acceptance criteria and study details are focused on non-clinical performance, primarily demonstrating mechanical integrity, material compatibility, and safety through established engineering and biological standards, rather than diagnostic accuracy metrics.

The clearance is largely based on demonstrating substantial equivalence to previously cleared predicate devices through a series of non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this device (dental implants), the "performance" is demonstrated through engineering and biocompatibility testing rather than diagnostic accuracy. The acceptance criteria are implicitly meeting the requirements of the cited ISO and USP standards. The document doesn't provide specific quantitative "pass/fail" values for each test, but rather states that the device "met the criteria of the standards."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated in terms of a "test set" as one would expect for an AI/ML device. The "sample size" would refer to the number of physical dental implants/abutments subjected to each non-clinical test (e.g., number of units for fatigue testing, number of samples for biocompatibility). These numbers are not detailed in the summary but would be standard for regulatory testing required by the ISO/ASTM standards cited (e.g., minimum of 5-10 samples for fatigue per condition).
• Data Provenance: Not applicable in the context of patient data for diagnostic accuracy. The "data" originated from laboratory testing of the manufactured dental implants and abutments.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable: This clearance is based on non-clinical engineering and biological safety tests (e.g., fatigue strength, sterility, biocompatibility), not on the interpretation of medical images or patient data requiring expert consensus or ground truth establishment by clinical experts like radiologists.

4. Adjudication Method for the Test Set

• Not Applicable: As there is no human interpretation of data for diagnostic purposes, there's no need for an adjudication process. Test results are objective measurements (e.g., force at failure, sterility present/absent).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not Performed / Not Applicable: MRMC studies are specific to evaluating diagnostic devices, particularly those involving human readers and AI assistance. This device is a physical dental implant, not a diagnostic AI tool.

6. Standalone (Algorithm Only) Performance Study

• Not Performed / Not Applicable: This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

• Engineering/Material Standards and Biological Safety Standards: The "ground truth" for this device's performance is established by the specified ISO and ASTM standards (e.g., ISO 14801 for fatigue testing, ISO 10993-1 for biocompatibility). These standards define acceptable performance limits for mechanical properties and biological responses.

8. Sample Size for the Training Set

• Not Applicable: This device is not an AI/ML algorithm that requires a training set. Its design and manufacturing are based on established engineering principles and materials science.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable: As there is no training set for an AI/ML algorithm, this question is not relevant.

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