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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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The Noris LONGY and LONGY-N implants are indicated for splinted restorations in the maxilla, utilizing a minimum of two implants to support fixed or removable prosthetic devices with partially or fully edentulous upper jaws, and may be suitable for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The procedure can be accomplished in a one-stage or two-stage surgical operation.

The subject dental implant devices are single use devices, provided sterile by Gamma Radiation, made of Titanium alloy Ti-6Al-4V ELI (ASTM F136). The LONGY Implants and LONGY-N Implants bare internal hex connection, diameters of 3.75 and 4.0mm and lengths of 18, 20, 22 and 25 mm. The Noris LONGY and LONGY-N implants are indicated for splinted restorations in the maxilla, utilizing a minimum of two implants to support fixed or removable prosthetic devices in patients with partially or fully edentulous upper jaws, and may be suitable for immediate loading when good primary stability is achieved. The procedure can be accomplished in a one-stage surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

LONGY and LONGY-N dental implants are compatible with FDA cleared Noris Medical Ltd. Internal Hex platform abutments and superstructures only intended for multiple-unit loading, provided that they do not exceed an angulation of 30° (≤30).

The provided text is a 510(k) Premarket Notification from Noris Medical Ltd. for their LONGY Implant and LONGY-N Implant. It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving a device meets specific acceptance criteria through a study involving AI or human reader performance.

Therefore, the document does not contain the information required to answer the prompt's request for acceptance criteria and a study proving device performance against those criteria, especially in the context of AI assistance or human reader improvement.

The document details the following:

• Device Name: LONGY Implant and LONGY-N Implant
• Regulation Number/Name: 21 CFR 872.3640 (Endosseous Dental Implant)
• Regulatory Class: Class II
• Product Code: DZE
• Indications for Use: Splinted restorations in the maxilla, utilizing a minimum of two implants to support fixed or removable prosthetic devices in patients with partially or fully edentulous upper jaws, suitable for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Can be accomplished in a one-stage or two-stage surgical operation.
• Predicate Devices: Neodent Implant System - GM Helix LG ® (K190958 - Primary), Noris Medical Ltd. - TUFF (K140440 - Reference), Neodent Implant System - Zygoma GM (K190718 - Reference), Noris Medical Ltd. - Zygomatic Implants (K151909 - Reference), Noris Medical Ltd. - MBI Dental Implant System (K153043 - Reference).
• Device Description: Single-use, sterile (Gamma Radiation), made of Titanium alloy Ti-6Al-4V ELI (ASTM F136), internal hex connection, diameters of 3.75 and 4.0mm, lengths of 18, 20, 22, and 25 mm.
• Performance Data: Fatigue tests per ISO 14801, biocompatibility, sterilization validation, shelf-life testing, mechanical testing, and MRI review. These tests are to demonstrate substantial equivalence, not to establish performance against specific clinical acceptance criteria in a user-performance or AI-assisted context.

Missing Information (as per the prompt's requirements):

1. A table of acceptance criteria and the reported device performance: Not provided in the context of clinical endpoints or user performance. The performance data discussed (fatigue, biocompatibility, etc.) are for device safety and mechanical integrity, not for clinical diagnostic or treatment performance against specific numerical acceptance criteria.
2. Sample size used for the test set and the data provenance: No test set is described for evaluating AI or human reader performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no AI/human reader study is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. This document is about a physical dental implant, not AI software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the presented data (which is about implant mechanical and material properties).
8. The sample size for the training set: Not applicable (no AI/machine learning model discussed).
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a dental implant, focusing on its physical and material properties to demonstrate substantial equivalence for market clearance. It does not contain information related to AI or human-in-the-loop studies, nor does it define acceptance criteria in the manner requested by the prompt for such studies.

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Noris Medical Ltd. Conical Platform Dental Implants System is intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function.

Noris Medical Ltd. Conical platform Dental Implants diameter 3.25 are intended to replace lateral incisor in Maxilla and/or a central or lateral incisor in the mandible for supporting prosthetic devices that may aid in restoring the patient's chewing function.

The procedure can be accomplished in a one-stage surgical operation. All impants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The subject dental implant devices are single use devices, provided sterile by Gamma Radiation, made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The UniCon and Tuff Unicon Implants are designed with conical connection comprises of cone and internal hex connection, diameters of 3.25, 3.5, 3.75 and 4.2 mm and lengths of 8, 10, 11.5, 13, 16 and 18 mm. Both Implants are designed with three thread zones, the Tuff UniCon with lower V-shape thread zone and UniCon with sharp buttress threads enables self-tapping. The middle zone square type thread of Tuff UniCon and wide edge buttress of UniCon is used for compressing cancellous bone. The micro threads on the upper zone enables less pressure on the crestal bone. The subject devices undergo RBM (Resorbable Blasting Media) surface treatment and color anodization within its connection for the purpose of color coding. It is indicated to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. The Implants Diameter Ø3.25 are intended to replace lateral incisor in maxilla and/or a central or lateral incisor in the mandible for supporting prosthetic devices that may aid in restoring the patient's chewing function.

Healing Caps are Titanium devices mounted onto the dental implant before the soft tissue is sutured around the implant and are intended to protect the implant bore. The Subject Healing Cap with the conical connection fits the UniCon and Tuff Unicon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The Healing Cap provided with 4.3mm, 4.8mm and 5.2mm Diameter and 4.5mm, 5.5mm, 6.5m, 7.5mm, 8.5mm External Body Height. The subject device undergoes color anodization.

The Subject Abutments (temporary, straight, angular and screw retained) with the conical connection fits the UniCon and Tuff UniCon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The subject device undergoes color anodization. The abutments are provided in different types and dimensions.

Multi-Unit Straight/Angular Screw Retained abutment are intended to function in the mandible or maxilla to support multiple-unit temporary or permanent restorations on Noris dental implants. The Subject Abutments with the conical connection fits the UniCon and Tuff UniCon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The subject device undergoes color anodization.

The abutment screw is intended to fasten the abutment to a dental implant. The Subject Abutments screw with the conical connection fits the UniCon and Tuff Unicon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The Abutments screw provided with 2mm Diameter and 7.3 mm Length. The subject device undergoes color anodization.

Cover screw- Healing Caps and Cover Screws are Titanium devices mounted onto the dental implant before the soft tissue is sutured in place around the implant and which are intended to protect the implant bore. The Subject Cover screw with the conical connection fits the UniCon and Tuff Unicon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The cover screws are provided with 3.2mm, 3.5mm Diameters and 4.9 mm Length. The subject device undergoes color anodization.

Based on the provided FDA 510(k) summary for the "Conical Platform Dental Implants System," here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Important Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. This is different from a PMA (Premarket Approval) application, which requires clinical efficacy and safety studies. Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to non-clinical performance testing and comparisons to predicate devices, rather than a full-scale clinical trial with human subjects. The document primarily focuses on physical and material characteristics and demonstrates equivalence through engineering analyses rather than clinical outcomes with an AI component.

The request asks for information that is more typical of a software as a medical device (SaMD) or AI/ML device approval, such as "number of experts," "adjudication method," "MRMC study," and "training set ground truth." However, this document describes a dental implant system, which is a physical device, and does not mention any AI/ML components. Therefore, many of the requested points related to AI/ML device evaluation are not applicable or cannot be found in this submission. I will address the points that are applicable to this type of device and note where information is not present in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this physical device are primarily based on demonstrating substantial equivalence to predicate devices in terms of design, materials, indications for use, and performance testing (specifically fatigue).

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

Since this is a physical device and the primary evidence provided is non-clinical performance data (fatigue testing, material characterization, etc.) rather than a clinical study with a "test set" of patients, the concept of a sample size for a test set and data provenance (country, retrospective/prospective) as it applies to AI/ML or clinical trial data isn't directly applicable here in the same way.

• Sample Size for Testing: The document states that "Fatigue tests per ISO 14801 were performed to determine the fatigue strength for UniCon implants." ISO 14801 specifies the number of samples for fatigue testing (typically 6-12 samples per group, depending on the desired confidence and methodology), but the exact number used is not explicitly stated in this summary. Other tests (biocompatibility, reprocessing, pyrogen, MRI review) were leveraged or based on scientific rationale, meaning new physical samples were likely not tested for these aspects as equivalence to previously cleared devices was the basis.
• Data Provenance: Not applicable in the context of a clinical test set for a physical device where the primary evaluation is non-clinical. The company is Noris Medical Ltd., located in Nesher, Israel.

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

This question is highly relevant for AI/ML devices where "ground truth" often involves expert annotation or consensus. For this physical dental implant device, ground truth is established through:

• International Standards: e.g., ISO 14801 for fatigue testing, ASTM F136 for material specifications. These standards define the "ground truth" for material properties and mechanical performance.
• Regulatory Guidance: e.g., FDA Guidance for MRI safety, USP for pyrogen limits. These guidances define the acceptable methodology and results.
• Predicate Device Characteristics: The comparison of technological characteristics to predicate devices (K140440, K142260, K130462) establishes the "ground truth" for substantial equivalence.

There is no mention of human experts defining "ground truth" in the way it's done for diagnostic image interpretation by multiple radiologists. The expertise lies within the material science, mechanical engineering, and regulatory compliance teams that designed the device and conducted/evaluated the non-clinical tests.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or subjective assessment of a test set that would require an adjudication method like 2+1 or 3+1. Performance is measured against objective engineering standards and direct comparison of physical/material characteristics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is specific to diagnostic imaging devices, particularly those involving human interpretation of medical images, often assisted by AI. This document pertains to a physical dental implant system and therefore, this type of study was not conducted or required. No AI assistance or human reader improvement is mentioned.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable. This device is a physical dental implant system and does not involve an algorithm or AI component.

7. The Type of Ground Truth Used

The "ground truth" for this device application is primarily based on:

• Engineering Standards: Specific material properties, mechanical performance (e.g., fatigue strength as per ISO 14801), and dimensional tolerances.
• Predicate Device Characteristics: The established safety and effectiveness of the chosen predicate devices serve as the benchmark for demonstrating substantial equivalence for the new device's indications for use, materials, and design.
• Leveraged Data: For biocompatibility, reprocessing sterilization, and pyrogen limits, the "ground truth" is that the material, manufacturing, and surface treatments are identical to previously cleared devices (K151909 and K140440), therefore their established safety and performance data (ground truth) is directly applicable.

No pathology reports or patient outcomes data as "ground truth" are mentioned in this 510(k) summary, as it relies on non-clinical data for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML component described, so there isn't a "training set" in the context of machine learning.

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

Not applicable, as there is no AI/ML component or training set described.

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Indications for Use for Zygoma-S GM Implant:

Zygomatic implants are indicated for intraoral surgical procedures in the zygoma region in cases of severe maxilla bone resorption, to restore the patient's chewing function and aesthetics. Zygomatic Implants may be used in one or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load.

Indications for Use for GM Mini Conical Abutment 52° and 45°:

Product indicated for surgical procedures in zygomatic bones, making possible the rehabilitation with screw-retained abutments over the implant, thus restoring the chewing function. It may be used in one- or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load. Multiple rehabilitations may be splinted rigidly.

Indications for Use for Coping for Removable Prosthesis:

The product, when used with non-zygomatic implants, 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 multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with approprate occlusal loading. Multiple tooth applications may be rigidly splinted. When used with zygomatic implants, the product is indicated for surgical procedure only in upper jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used in two-stage procedures (delayed loading protocol) and for multiple unit restorations. Multiple rehabilitations may be splinted rigidly.

The subject devices implants are single use devices, provided sterile by Gamma Radiation, made of commercially pure Titanium grade 4 (ASTM F67). The Zygomatic Implant is a long implant with a nominal diameter of 3.50 and 3.75mm, conical apex with rounded tip, 3 helical chambers, trapezoidal thread and GM prosthetic interface. The cervical portion in both models has Ø 4.3 mm. The length varies from 30 to 55 mm. Zygomatic Implants are intended to provide support for a fixed prosthesis in patients with severe atrophy in the maxillary region. They are extra-long to allow bone anchorage in the zygomatic bone. The subject implants consider the Zygoma Anatomy-Guided approach (ZAGA) for planning the surgical steps, being indicated for extrasinus and extra maxillary installation technique (ZAGA-4).

The subject abutments are single use devices, provided sterile by Ethylene Oxide, made of Titanium alloy (Tl6Al4V-ELI). They are intermediate prosthetic components angled at 52 and 45 degrees with gingiva heights 1.5 and 2.5 mm, to be installed on the implant, offering a structure to support the screw-retained multiple prosthesis. The abutments present GM prosthetic interface and are available in the anti-rotational form in the implant to abutment interface, and rotational form in the abutment to prosthesis interface, presenting different transmucosal heights.

The subject coping is single use device, provided sterile by Ethylene Oxide, made of titanium alloy (Ti6Al4V-ELI). It presents a NEO torque interface for torque application. The subject device has diameter 4.80 mm and total height 4.60 mm. They are indicated for removable prostheses with fitting over Mini Conical Abutment installed in the maxilla or mandible and can be used in partial removable prostheses or over dentures. They are compatible with all previously cleared GM Mini Conical abutments.

The provided document is a 510(k) premarket notification for a medical device (Neodent Implant System - GM Zygomatic Implant System). It focuses on demonstrating substantial equivalence to predicate devices through comparisons of indications for use, technological characteristics, and performance data, primarily bench testing, sterilization validation, shelf life validation, and biocompatibility.

Crucially, this document does not contain information about an AI/ML algorithm or a study validating its performance, nor does it detail acceptance criteria for software or AI/ML components. The product being cleared is a set of dental implants and abutments. Therefore, I cannot extract the acceptance criteria and study details for an AI-powered device as requested.

The document discusses performance data in the context of the physical dental implants and abutments, which includes:

• Performance Testing – Bench: Dynamic fatigue testing (ISO 14801), insertion tests, torsion tests, and microscopic analysis of the implant body.
• Surface treatment: Discussion of the NeoPoros surface.
• MR Compatibility testing: Assessment of safety in MRI environments.
• Sterilization validation: Conformance to ISO standards for Gamma Irradiation (implants) and Ethylene Oxide (abutments).
• Shelf Life validation: Based on packaging integrity and physical stability.
• Biocompatibility: Testing per ISO 10993 standards.
• Clinical data: A review of published literature on zygomatic implants, including survival rates and observed complications (not a specific clinical study conducted for this device clearance).

If you are looking for information regarding acceptance criteria and study data for an AI/ML medical device, this document does not provide it, as it pertains to a different type of medical device.

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Noris Medical Dental Implants System is intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. The procedure can be accomplished in a one-stage or two-stage surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Noris Medical Dental Implants are tapered internal hex 2.1. implants, designed to enable easy insertion while supporting excellent initial stability. The variable thread design enables self-tapping, thus providing solutions for a variety of bone conditions. Noris Medical multi-design features offer a solution for immediate placement and immediate loading. The implantation procedure can be accomplished in a one-stage or two-stage surgical operation. Packaging has been designed for quick identification and easy opening. The scope of this submission is Noris Medical Cortical Implant as part of the Noris Medical dental Implants system identical platform. Cortical implants are able to undergo immediate loading when good primary stability is achieved and with appropriate occlusal loading. The Cortical system can be used in extraction sites for immediate implantation. Cortical implant is available in different sizes to suit relevant implantation site. Made of titanium alloy Ti 6Al 4V ELI.

Here's an analysis of the acceptance criteria and the study that proves the Noris Medical Dental Implants System - Cortical meets those criteria, based on the provided FDA 510(k) summary:

Overview

The provided document is a 510(k) Summary for the Noris Medical Dental Implants System - Cortical. The core purpose of a 510(k) submission is to demonstrate that a new medical device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective. In this case, the clinical test section details a study that supports the safety and effectiveness of the implant with respect to a specific performance criterion: marginal bone loss. The non-clinical tests (biocompatibility, sterilization, performance testing) also contribute to demonstrating substantial equivalence but are not the focus of a comparative clinical performance criterion for this device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 40 Noris cortical implants were placed in 19 patients. The document states "The sample population was statistically derived as n=38" which is a bit ambiguous; it likely refers to the minimum required sample size for the study to achieve statistical significance, with 40 implants actually being tested.
• Data Provenance:
  • Country of Origin: Israel ("Israeli private clinic").
  • Retrospective or Prospective: Retrospective clinical study.

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

The document does not specify the number of experts or their qualifications for establishing ground truth (specifically, measuring crestal bone height/loss). Measurements were taken from panoramic radiographs and CT scans. It's common in such retrospective studies that image analysis is performed by the researchers or a trained technician, often validated by a clinician. However, this detail is not provided.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. Since it's a retrospective study, it's possible that data was collected and analyzed by a single party or an unadjudicated team.

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

• Was it done?: No. This study is an observational clinical study assessing the performance of the Noris Medical Dental Implants System - Cortical in a real-world setting, focusing on marginal bone loss and survival rate. It does not involve human readers comparing AI-assisted vs. non-AI-assisted diagnosis or treatment.
• Effect size of improvement with AI vs. without AI assistance: Not applicable, as this was not an AI-assisted MCMC study.

6. Standalone (Algorithm-Only) Performance Study

• Was it done?: No. This device is an endosseous dental implant, a physical medical device, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance (e.g., marginal bone loss) is an inherent characteristic of the physical implant itself when used in patients.

7. Type of Ground Truth Used

• Clinical Outcomes/Measurements: The ground truth for the clinical study was established through quantitative measurements of crestal bone height and subsequent calculation of marginal bone loss from panoramic radiographs taken at baseline and follow-up intervals (e.g., 6, 12, 24, and up to 33 months). Implant survival (100%) was also a key outcome.
• Note: The document mentions "Adjudication method (e.g. 2+1, 3+1, none) for the test set" in the prompt template, which implies a study where human readers interpret data. In this clinical study, measurements are taken directly from images or clinical observation, not through a diagnostic interpretation process that requires expert consensus adjudication in the same way an AI diagnostic algorithm might.

8. Sample Size for the Training Set

• Not applicable. This report describes a physical medical device (dental implant), not a machine learning or AI algorithm that requires a training set. The clinical study described served as a test/validation set for the device's performance in humans.

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

• Not applicable. See point 8.

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Southern Implants Zygomatic System Standard implants, Zygan (narrow apex) implants, and Oncology implants are intended to be implanted in the upper jaw arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

This submission includes fully threaded and partially threaded root-form dental implants and mating abutments designed for placement into the zygomatic bone. All implants are provided with an external hexagon abutment interface angled 55° at the head of the implants are provided in three designs: Standard implant, fully threaded, diameter 4.3 mm (coronal) tapering to 3.8 mm (apical), in lengths of 30 mm and 57.5 mm; Zygan implant, partially threaded, diameter 4.3 mm (coronal) tapering to 3.4 mm (apical), in lengths from 30 mm to 57.5 mm; and Oncology implant, partially threaded diameter 4.3 mm (coronal) tapering to 3.8 mm (apical), in lengths from 30 mm to 47. 5 mm.

This submission includes additional designs of Compact Conical Abutments (gingival heights 2, 3, 4, and 5.5 mm) for use with any of the implants. This submission also includes a Titanium Cylinder Abutment, for use with the Compact Conical Abutments, with a collar (gingival) height of 5 mm, and a prosthetic platform diameter of 3.4 mm. All subject device abutments are for support of screw-retained overdenture prosthetic restorations.

All subject device implants are manufactured from unalloyed titanium conforming to ASTM F67. The threaded portions of the implants have the identical aluminum oxide grit-blasted surface as the implants cleared in K093562. The subject device Compact Conical Abutments are manufactured from titanium alloy conforming to ASTM F136. The subject device Titanium Cylinder Abutment is manufactured from unalloyed titanium conforming to ASTM F67. All of the subject device components are manufactured in the same facilities using the same manufacturing processes as used for the previously cleared predicate devices in K093562 and K070841.

Based on the provided text, the document is a 510(k) Premarket Notification for the Southern Implants Zygomatic Implant System. This document does not describe a study involving an AI/Machine Learning device. Instead, it proves the substantial equivalence of a dental implant system to previously cleared predicate devices through non-clinical performance data and comparison of technological characteristics.

Therefore, many of the requested criteria related to AI/ML device studies (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment) are not applicable to this document.

However, I can extract information related to the acceptance criteria and the study (referred to as performance data) that proves the dental implant device meets those criteria.

Here's a breakdown of the relevant information from the document:

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

The document doesn't present a formal table of acceptance criteria with corresponding performance numbers in the way an AI/ML study would. Instead, substantial equivalence is demonstrated through:

• Identical intended use: The Zygomatic Implant System is intended to support fixed or removable dental prostheses in patients with partially or fully edentulous maxillae, identical to the predicate device.
• Similar technological characteristics: Comparisons are made regarding design, dimensions (platform diameter, implant diameter, implant lengths, threaded lengths, connection angle), abutment design, interface, gingival height, abutment angle, prosthesis attachment, and materials.
• Equivalent non-clinical performance: Biocompatibility, engineering analysis, dimensional analysis, sterilization validation, and dynamic compression-bending testing are the "performance data" used to demonstrate equivalence.

2. Sample sizes used for the test set and the data provenance

• Non-clinical testing: No specific "test set" sample sizes are given for the engineering, dimensional, biocompatibility tests (these often rely on established standards and in-vitro methods).
• Clinical Data (referenced for Oncology implant):
  • Sample Size: 40 implants in 20 subjects.
  • Data Provenance: Retrospective (from a published study: Boyes-Varley JG, et al., 2007). The country of origin is not explicitly stated in this document but the journal International Journal of Prosthodontics is international, and one of the authors for the referenced paper (Boyes-Varley) appears to be associated with South Africa (which is also the manufacturer's location).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as this is a dental implant device approval based on substantial equivalence to existing devices, primarily through non-clinical testing and referencing a retrospective clinical study. "Ground truth" in the AI/ML sense (e.g., expert labels on images) is not relevant here. The "ground truth" for the retrospective clinical study would be observed patient outcomes.

4. Adjudication method for the test set

Not applicable. There's no expert adjudication process mentioned for this type of device.

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 for a physical medical device (dental implant), not an AI/ML diagnostic or assistive tool.

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

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used

For the retrospective clinical data referenced for the Oncology implant:

• Type of Ground Truth: Clinical outcomes data (implant success, soft tissue complications).

For the non-clinical performance data (biocompatibility, mechanical testing, etc.):

• Type of Ground Truth: Compliance with established international standards (e.g., ISO 14801, ISO 17665-1, ISO TS 17665-2, USP 39-NF 34 ) and comparison to the performance of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Not applicable. See point 8.

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