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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 Ti Base abutments or Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.

The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes dental implants, abutments, and prosthetic components cleared previously in various submissions. The previously cleared abutments and prosthetic components are compatible with a variety of original equipment manufacturer (OEM) dental implants as well as DESS Dental Smart Solutions dental implants.

This submission adds various abutments to the DESS and OEM implant lines as summarized on the following pages in Table 1 Summary of Subject Device Abutment Designs, and Table 2 Summary of Subject Device Abutment Sizes.

The subject device abutment designs include Cover Screws, Healing Abutments, Temporary Abutments, Ti Base Abutments, AURUM Base Abutments (Ti Base abutments with a screw channel design that allows easier instrument access to the abutment screw), CoCr Base Abutments, Pre-Milled Blank Abutments, Multi-Unit Abutments (straight and angled), DESSLoc Abutments (Locator-type abutments), and abutment screws.

This document is a 510(k) summary for the DESS Dental Smart Solutions, a line of endosseous dental implant abutments. It details the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, the device itself is a physical medical device (dental implant abutments and associated components), not a software or AI-driven system. Therefore, the questions related to AI acceptance criteria, training/test sets, expert adjudication, MRMC studies, and ground truth establishment for AI would not be directly applicable to this product as described.

The document focuses on establishing substantial equivalence to previously cleared predicate devices through:

• Identical Intended Use: The device is intended for "functional and esthetic rehabilitation of the edentulous mandible or maxilla" by providing support for prosthetic restorations, which is the same as the predicate devices.
• Similar Technological Characteristics: The device utilizes similar designs, materials (Ti-6Al-4V, Co-Cr-Mo alloy), manufacturing processes, and sterilization methods as its predicates.
• Performance Data: Non-clinical testing (mechanical testing per ISO 14801, MR environment assessment) and comparison to existing data from predicate devices are used to demonstrate safety and effectiveness.

Therefore, many of the requested elements for describing AI acceptance criteria and studies are not present or applicable in this document.

However, I can extract information relevant to the device's performance assessment and criteria for its type of submission.

Here's an attempt to answer the questions based solely on the provided text, acknowledging that the nature of the device (a physical implant component) means many AI-specific questions will be answered as "Not Applicable" (N/A):

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

The document does not explicitly state quantifiable "acceptance criteria" in a table format with corresponding "reported device performance" metrics for this specific 510(k) submission. Instead, it relies on demonstrating substantial equivalence to existing predicate devices.

The underlying "acceptance criteria" for demonstrating substantial equivalence for this device type are primarily through:

• Mechanical Testing (ISO 14801): This is a critical performance standard for dental implants and abutments. The document states that mechanical testing was "conducted according to ISO 14801 to support the performance." The acceptance criteria would be successful completion of these tests, demonstrating the device's mechanical strength and fatigue resistance are comparable to or better than predicate devices. The reported performance is simply that the tests supported the performance.
• Material Conformance: Materials must conform to specific ASTM standards (e.g., ASTM F136 for Ti-6Al-4V, ASTM F1537 for Co-Cr-Mo). The reported performance is that the materials conform to these standards.
• Biocompatibility: While not detailed in this excerpt, the mention of "biocompatibility" in relation to predicates implies conformance to relevant biocompatibility standards (e.g., ISO 10993 series). The reported performance is that it is compatible.
• Sterilization Validation: Demonstrated sterility assurance level (SAL) of 10⁻⁶ via validated methods (moist heat or gamma irradiation). The reported performance is that validation was performed and met this SAL.
• Dimensional Compatibility: The abutments must fit the corresponding OEM implants correctly. The reported performance is that reverse engineering dimensional analysis confirmed compatibility.

Due to the nature of the document being a 510(k) summary focusing on substantial equivalence rather than a full study report, specific numerical performance results for the device tests are not provided in this text.

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

• Sample Size for Mechanical Testing: The document states "mechanical testing conducted according to ISO 14801." For such tests, ISO 14801 typically specifies minimum sample sizes (e.g., 10-11 samples for static strength, typically more for fatigue). The exact number of samples used for this specific submission is not explicitly stated, but it would have followed the standard's requirements.
• Data Provenance: The mechanical testing and material analyses are assumed to be "non-clinical data submitted or referenced" by the manufacturer, Terrats Medical SL, based in Barcelona, Spain. The "reverse engineering dimensional analysis" was done by Terrats Medical SL or through contractual agreement. This is prospective testing performed to support the 510(k). The document itself does not specify the country of origin for the underlying OEM implant data used for reverse engineering, although the OEM companies are listed (e.g., Astra Tech AB, BioHorizons).

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

N/A. This is a physical device. Ground truth, in the context of AI, refers to validated labels for data used to train and test an algorithm. For a physical device, performance is evaluated through engineering and biocompatibility testing against defined standards. There are no "experts" establishing ground truth in the AI sense. Testing would be performed by qualified engineers and technicians.

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

N/A. Adjudication methods are typically used in clinical studies involving interpretation (e.g., by radiologists) to resolve discrepancies. This document describes non-clinical performance testing of a physical 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

N/A. This product is a dental implant abutment, not an AI software intended to assist human readers.

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

N/A. This is a physical device, not an algorithm.

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

N/A. For engineering tests of physical devices, the "ground truth" is typically derived from established engineering principles, international standards (e.g., ISO 14801 for mechanical properties, ASTM for materials), and the physical properties of the materials and designs themselves. There isn't "expert consensus" or "pathology" in the AI or clinical trials sense.

8. The sample size for the training set

N/A. This is a physical device; there's no "training set" in the machine learning sense. The device is manufactured based on established engineering designs and material specifications.

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

N/A. No training set for AI. For device manufacturing, the "ground truth" for design and production parameters comes from established engineering best practices, prior successful device designs (predicate devices), and adherence to quality systems regulations (21 CFR Part 820).

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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 Bases or Blanks are to be sent to a Terrats Medical validated milling center for manufacture.

The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes abutments cleared previously in K170588, K173908, K191986, K203464, K212577, and K212628. This submission adds various abutments to eight (8) OEM implant lines from Keystone Dental, Inc., having three (3) implant-abutment connections (Internal TiLobe, Internal Conical). The subject device abutment designs include Multi Unit Abutments (straight and angled 17° and 30°), Ti Base abutments, and Premilled Blank Abutments. Abutments are provided with the appropriate abutment screw (if applicable) for attachment to the corresponding implant, and the appropriate prosthetic screw (if applicable) for attachment of a screw-retained prosthesis. All abutments and screws are provided non-sterile.

The provided text is a 510(k) Summary for a dental device (DESS Dental Smart Solutions abutments). It focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through engineering specifications, material composition, and non-clinical performance data for mechanical integrity and biocompatibility.

Crucially, this document does not describe an AI/ML-driven device or study parameters related to AI/ML performance. Therefore, most of the requested information (related to AI acceptance criteria, training/test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI) cannot be extracted from this text.

The document details the physical characteristics, intended use, and mechanical testing of dental abutments, which are physical components used in dental implants. There is no mention of algorithms, artificial intelligence, machine learning, or any form of image analysis or diagnostic support that would involve such technologies.

Therefore, I can only provide information related to the device itself and its non-clinical testing, not an AI/ML study.

Here's what can be extracted from the document:

1. A table of acceptance criteria and the reported device performance (for non-AI device):

The document discusses "performance data" in the context of non-clinical analyses, referencing compliance with various ISO standards and published literature. The acceptance criteria are implied by adherence to these standards and the demonstration of substantial equivalence.

Regarding the AI-specific questions (2-9), the document provides no relevant information.

• 2. Sample sized used for the test set and the data provenance: Not an AI device.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI device.
• 4. Adjudication method for the test set: Not an AI device.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not an AI device.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not an AI device.
• 7. The type of ground truth used: Not an AI device (ground truth concepts apply to AI/diagnostic performance, not mechanical devices). For this device, "ground truth" would be the measured physical properties and clinical use case defined by dental/medical standards.
• 8. The sample size for the training set: Not an AI device.
• 9. How the ground truth for the training set was established: Not an AI device.

Summary of Device and its "Study":

The device is a set of dental implant abutments. The "study" described is a non-clinical bench testing and engineering analysis to demonstrate the physical and material characteristics of the abutments and their substantial equivalence to previously cleared devices. It involves:

• Material composition analysis: Ensuring materials meet ASTM standards (Ti-6Al-4V ELI).
• Biocompatibility testing: Referenced from previous 510(k) submissions.
• Sterilization validation: Referenced from previous 510(k) submissions.
• MR environment compatibility analysis: Based on scientific rationale and published literature.
• Mechanical testing: Static compression and compression fatigue testing performed in conformance with ISO 14801 on worst-case configurations of the Multi Unit Angled Abutments and compatible implants.

This document clearly states: "No clinical data were included in this submission." This reinforces that the review process for this particular device is based on technical specifications and non-clinical performance, not clinical trials or AI/ML performance evaluations.

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KDG Abutments are pre-manufactured prosthetic components for direct connection to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

The KDG-Osteon Precision Milled Suprastructure is indicated for attachment to KDG Abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The KDG-Osteon Precision Milled Suprastructure is intended for attachment to a minimum of two (2) abutments.

Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cemented.

The purpose of this submission is the marketing clearance for KDG Abutments which comprises endosseous rootform dental abutments, abutment screws, and other associated components for single-unit, and overdenture restorations. The Subject device abutment components introduce 30° post correction angle multi-unit abutments compatible with the sponsor's previously cleared implants.

The Keystone family of abutments are compatible with the Keystone implants which have a hex-lobe internal connection. The Paltop family of abutments are compatible with the Paltop implants which have hex-wall internal connection.

The KDG-Osteon Precision Milled Suprastructure is an overdenture bar which is compatible with the Subject device abutments. The overdenture bar is dental restorative device that is intended for screw-retained attachment to dental abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring their chewing function. The KDG-Osteon Precision Milled Suprastructure is fabricated by means of CAD/CAM technology and is used to facilitate the attachment of both fixed and removable prostheses.

The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's impression. The suprastructure is manufactured in biocompatible Titanium alloy with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical, within our premises. The abutment-born Suprastructure is only indicated for straight placement and is not to exceed the maximum angulation of the connected multi-unit abutments.

KDG-Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence categorized as type B.

The Subject device abutments, abutment screws, and bar suprastructure are fabricated from Ti-6Al-4V ELI titanium alloy (Grade 23) which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

All Subject device components are one-time use device components are provided sterile and sterilized by gamma irradiation except for the Single-Unit and Multi-Unit copings, the KDG-Osteon Precision Milled Suprastructure and all replacement screws which are provided non-sterile. Devices provided as non-sterile are sterilized by steam.

The provided document is a 510(k) Premarket Notification from the FDA to Keystone Dental Inc. regarding their KDG Abutments. This document primarily focuses on establishing substantial equivalence to predicate devices based on indications for use and technological characteristics, supported by non-clinical performance data.

Crucially, this document does NOT contain information related to a study that proves the device meets specific acceptance criteria for AI/ML performance, nor does it describe a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or the establishment of ground truth for training or test sets in the context of an AI-powered device.

The acceptance criteria mentioned in the document refer to the performance of dental abutments in the context of mechanical testing (fatigue testing per ISO 14801:2016) and biocompatibility, not the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and studies related to AI/ML performance based on the input text. The information in the document pertains to traditional medical device clearance.

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The XL Dental Implant System is intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications. This XL implant system provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

This submission includes threaded root-form dental implants with large diameter for use in the molar region. The implants are provided in diameters of 7, 8 and 9mm and lengths of 7, 9 and 11mm. This submission also includes mating components: Cover screws; Healing Abutments in varying diameters and cuff heights; Titanium Cylinder abutments for temporary restorations; Titanium Abutments in varying diameters and cuff heights for permanent restorations; and the abutment screw.

The XL implants are manufactured from titanium alloy conforming to ASTM F136. The implants have a is grit blasted, acid etched (SLA) surface. The Cover Screw, Abutments and Abutment Screw are manufactured from titanium alloy conforming to ASTM F136.

The provided text is a 510(k) Premarket Notification from the FDA for the Keystone Dental XL Dental Implant System. It discusses the device's administrative information, indications for use, device description, performance data, and a comparison to legally marketed predicate devices to demonstrate substantial equivalence.

However, it does not contain the specific information requested regarding acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML medical device.

The document details non-clinical performance data for physical characteristics of the dental implant (sterilization validation, biocompatibility, bacterial endotoxin testing, modified surface analysis), and relies on established standards (ISO, ASTM, FDA guidances) and substantial equivalence to predicate medical devices for these aspects. There is no mention of an "algorithm" or "AI assistance" in this document.

Therefore, I cannot extract the requested information as it is not present in the provided text. The device being reviewed is a physical implant, not an AI/ML-based diagnostic or therapeutic tool.

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MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit, cement-retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants:

Keystone Dental Implant Line Platform Diameter (mm) Body Diameter (mm) Genesis 3.8, 4.5, 5.5, 6.5 3.8, 4.5, 5.5, 6.5 PrimaConnex® 1.0 (Straight) 3.5, 4.1, 5.0 3.3, 4.0, 5.0 PrimaConnex® 1.0 (Tapered) 3.5, 4.1, 5.0 3.5, 4.1, 5.0

All digitally designed custom abutments for use with MIST IC abutments are to be sent to an Imagine Milling Technologies validated milling center for manufacture.

MIST IC abutments include three abutment designs, MIST IC S-LINK, and MIST IC S-LINK, and MIST IC PREFIT, having connections compatible with three Keystone Dental implant systems. Subject device are provided in three interface connection diameters (SD (3.5 mm), RD (4.1 mm) and WD (5.0 mm)). All subject device abutments have the same connection type to the compatible Keystone Dental implants cleared in K101545 and K051614. Corresponding compatible implant platform diameters range from 3.5 mm to 6.5 mm. Corresponding compatible implant body diameters range from 3.3 mm. All sizes of the compatible Keystone Dental implants have one of the three interface connection sizes (SD, RD, and WD).

All subject device L-LINK and S-LINK abutments are two-piece abutments to be used as a base when fabricating a CAD/CAM customized restoration where the superstructure produced will compose the second part of the twopiece abutment; the assembly becoming a final finished medical device after cementation on the subject device abutment. The zirconia superstructure will be fabricated using a CAD/CAM process. MIST IC S-LINK has a cut out in the post to accommodate a restoration with an angled screw channel when clinically necessary. MIST IC PREFTT abutments are titanium cylindrical abutments designed for patient specific abutment fabrication using a CAD/CAM process. All patient-specific abutment fabrication on the order of the clinician.

Design parameters for the L-LINK zirconia superstructure are: minimum wall thickness -0.5 mm; minimum post height for single-unit restoration - 4.0 mm; maximum gingival height - 5.0 mm; and maximum angle - 20°.

Design parameters for the S-LINK zirconia superstructure are: minimum wall thickness - 0.7 mm; minimum post height for single-unit restoration - 4.0 mm; maximum gingival height - 5.0 mm; and maximum angle - 20°.

Design parameters for the PREFIT patient specific abutment are: minimum wall thickness - 0.5 mm; minimum post height for single-unit restoration - 4.0 mm; maximum gingival height - 5.0 mm; and maximum angle - 30°.

All subject device components (abutments and abutment screws) are made of titanium alloy conforming to ASTM F136. Zirconia superstructures for subject device abutments are made of Y-TZP conforming to ISO 13356.

All subject device components are provided non-sterile, and are intended to be end-user sterilized.

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Straumann® BLX Implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX Implants can be placed with immediate function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment components.

Straumann® Closure Caps and Healing Abutments are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and to shape, maintain and stabilize the soft tissue during the healing process. Closure caps and healing abutments should be used only with suitable implant connections. Straumann Closure Caps and Healing Abutments have a maximum duration of usage of 6 months.

Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. Final abutments may be placed into occlusion when the implant is fully osseointegrated. BLX Temporary Abutments have a maximum duration of usage of 180 days.

Straumann® Variobase® prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (crowns) can be cemented onto the Straumann® Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

The Straumann BLX Implants are fully tapered implants manufactured utilizing the Roxolid material and are finished with SLActive® surface. The connection is identified as conical fitting with Torx style engaging feature. The prosthetic platforms are identified as RB (Regular Base) and WB (Wide Base). The implants with a RB platform have a "small top/head", and implants with WB platform have a "large top/head", whereas the internal connection is identical for both platform and all the implant diameters and lengths.

The closure cap and healing abutments are manufactured from Titanium Grade 4, per ISO 5832-2 and ISO 5832-11, and are anodized signal violet for the parts compatible with the RB platform and brown for the parts compatible with the WB platform for identification purposes. Closure caps are screwed into the implant to protect the inner configuration and shoulder of the implant during the healing phase in cases of submerged (submucosal) healing. Healing abutments are screwed into the implant to protect the inner configuration in cases of transmucosal healing and are placed out of occlusion.

The temporary abutments are manufactured from TAN and are anodized signal violet (RB platform) and brown (WB platform) for identification purposes. The temporary abutments are fixed in the implant with a basal screw which is also manufactured from TAN. The basal screw will be delivered with the temporary abutment.

BLX Variobase abutments is a two-piece abutment ultimately composed by three components: Variobase™ Abutment (Ti-base), Prosthetic restoration (coping and/or crown), and Basal Screw. The BLX Variobase Abutments are manufactured and are delivered with the corresponding basal screw. The prosthetic restoration (crowns) can be cemented onto the Variobase prosthetic components.

Basal screws are used to seat the temporary abutments and the BLX Variobase Abutments to the dental implant, and can be also be used during lab procedures to fix lab prosthetic parts on implant analogs. There is one basal screw for the RB platform and one for the WB platform. They have identical designs and differ only in color-coding (signal violet and brown) to ease the handling. They are provided along the abutments but they are also provided as standalone screws. The BLX basal screws are manufactured from TAN.

This document describes the Straumann® BLX Implant System, a dental implant system, and its various components. The information provided is for a 510(k) premarket notification to the FDA. The goal is to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than setting and meeting specific, quantitative acceptance criteria for novel performance. Instead, the "acceptance criteria" are implied by successful comparative testing and adherence to existing standards and guidance documents. The "reported device performance" is the outcome of these tests.

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ATLANTIS™ ISUS Implant Suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

ATLANTIS™ ISUS Implant Suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems:

Implants:
Biomet 3i Certain 3.25, 4/3 - Prevail 3/4/3, 4/3
Biomet 3i Certain 4.0, 5/4 – Prevail 4/5/4. 5/4
Biomet 3i Certain 5.0, XP 4/5 - Prevail 5/6/5, 6/5
Biomet 3i Certain 6.0, XP 5/6
BioHorizons Internal/Tapered 3.5, 4.5, 5.7
Camlog Screw-line Implant 3.3
Camlog Screw-line / Root-line Implant 3.8, 4.3, 5.0, 6.0
DENTSPLY Implants XiVE S 3.0, S 3.4, S 3.8, S 4.5, S 5.5
DENTSPLY Implants OsseoSpeed™ TX 3.0, 3.5/4.0, 4.5/5.0
DENTSPLY Implants Osseospeed™ Profile TX 4.5/5.0
DENTSPLY Implants Osseospeed™ EV 3.0, 3.6, 4.2, 4.8, 5.4
DENTSPLY Implants Osseospeed™ Profile EV 4.2, 4.8
Keystone Dental PrimaConnex SD 3.3/3.5
Keystone Dental PrimaConnex RD 4.0/4.1
Keystone Dental PrimaConnex WD 5.0
Keystone Dental Genesis 3.8, 4.5, 5.5/6.5
Nobel Biocare NobelActive NP 3.5 - RP 4.3, 5.0
Nobel Biocare NobelReplace NP-3.5 - RP 4.3 - WP 5.0 – 6.0
Straumann Bone Level 3.3 NC - 4.1, 4.8 NC
Straumann Standard Plus 3.5 NN
Straumann Standard / Standard Plus 4.8 RN – 4.8 WN
Zimmer Dental Tapered Screw Vent S-V 3.5/S-V 3.3, 3.7 / S-V 4.5/ S-V 4.5
Zimmer Dental Tapered Screw Vent 5.7

Abutments:
Biomet 3i Low Profile Abutment
DENTSPLY Implants ATIS Uni Abutment EV
DENTSPLY Implants ATIS UniAbutment 20°, ATIS UniAbutment 45°
DENTSPLY Implants ATIS Angled Abutment EV
DENTSPLY Implants ATIS Angled Abutment 20°
DENTSPLY Implants ANKYLOS Balance Base Narrow D4.2, Balance Base D5.5
DENTSPLY Implants XiVE MP 3.4, MP 3.8, MP 4.5, MP 5.5
DENTSPLY Implants XiVE TG 3.4, TG 3.8, TG 4.5
Nobel Biocare Multi-Unit Abutment RP
Straumann Bone Level Multi-Base Angled Abutment
Straumann Bone Level Multi-Base Abutment D3.5, D4.5
Straumann RN Abutment Level, WN Abutment Level
Straumann Screw-Retained Abutment 3.5, 4.6
Zimmer Dental Tapered Abutment

The ATLANTIS™ ISUS Implant Suprastructures include new implant and abutment interfaces of the predicate ISUS Implant Suprastructures, cleared in K122424.

The ATLANTIS™ ISUS Implant Suprastructures are patient-specific restorative devices that are intended to be attached to dental implants or abutments to facilitate prosthetic restoration in the treatment of partially and totally edentulous patients. The design of the subject device is derived from patient dental models and completed by DENTSPLY technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of the ATLANTIS™ ISUS suprastructures are fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device.

The subject ATLANTIS™ ISUS Implant Suprastructures are available in the same design types as cleared for the predicate ISUS Implant Suprastructures in K122424:

1. Bar Intended as a fixed supporting structure for a removable dental prosthesis.
2. Bridge Intended for direct veneering using dental ceramics or resin composites resulting in a fixed, screw-retained prosthesis.
3. Hybrid Intended as a fixed denture framework.

Screws are available for all compatible implant and abutments systems to screw the ATLANTIS™ ISUS Implant Suprastructures into the implant or onto the abutment.

In addition to the introduction of the new interfaces of the ATLANTIS™ ISUS Implant Suprastructures, the product reference names of the compatible interfaces are adjusted in the indications for use for the currently marketed ATLANTIS™ ISUS Implant Suprastructures to better reflect the original manufacturer's product description.

The provided document describes a 510(k) premarket notification for a medical device, specifically the ATLANTIS™ ISUS Implant Suprastructures. This type of submission aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the information provided focuses on demonstrating substantial equivalence through non-clinical testing and comparison to existing devices, rather than a clinical study establishing acceptance criteria in the traditional sense of AI performance metrics like sensitivity, specificity, or AUC.

Based on the document, here's a breakdown of the requested information:

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

Since this is a 510(k) for a dental implant component, the "acceptance criteria" are related to mechanical and material equivalence to predicate devices, and "device performance" refers to its ability to meet these engineering standards. There are no performance metrics like sensitivity or specificity.

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 or not provided in the context of an AI device. This document is for a physical medical device (dental suprastructures). The testing performed is non-clinical, involving mechanical and dimensional analysis of device components themselves, rather than testing on a "test set" of patient 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 or not provided. "Ground truth" in the context of an AI device, established by experts, is not relevant here as this is a physical medical device. The "ground truth" for this device's performance would be the universally accepted engineering standards for dental prosthetics and the demonstrable properties of the materials and design.

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

This information is not applicable or not provided. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI studies. The testing described is non-clinical performance data (mechanical design analysis, dimensional analysis, static and dynamic compression-bending testing).

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 or not provided. This is not an AI device, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

This information is not applicable or not provided. This is not an algorithm-only device.

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

The "ground truth" here is the established engineering standards for dental prosthetics. This includes:

• Mechanical standards: ISO 14801 Dentistry -- Implants -- Dynamic fatigue test for endosseous dental implants.
• Material standards: Properties of CPTi, CoCr, Ti-6Al-4V ELI, Ti-6Al-7Nb (as listed for abutment and screw materials).
• Biocompatibility: Demonstrated equivalence to the predicate device (K122424) which had prior biocompatibility testing.
• Design principles: Comparison to existing, legally marketed predicate devices to establish substantial equivalence in intended use and fundamental technology.

8. The sample size for the training set

This information is not applicable or not provided. As this is a physical device submission, there is no "training set" in the context of machine learning. The device's design is "derived from patient dental models and completed by DENTSPLY technicians using computer-assisted design (CAD) according to the clinician's prescription," and then fabricated using computer-assisted manufacturing (CAM).

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

This information is not applicable or not provided. There is no machine learning training set for this device. The "ground truth" for the CAD/CAM design process would be the clinician's prescription and the patient's dental models, which guide the creation of the patient-specific device.

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The TRI® Dental Implant System is intended for placement in the bone of the maxillary or mandibular arch for the rehabilitation of edentulous and partially edentulous patients. TRI® Dental Implant System allows for one and two-stage surgical procedures. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading.

TRI Dental Implant System 6.5 mm implants are intended for delayed loading only.

The TRI-Narrow and TRI-Vent implants are root form endosseous dental implants. They are available with two collar options, blasted or machined. TRI-Narrow is available in one implant diameter (3.3 mm) and three lengths (11.5, 13, and 16 mm). TRI-Narrow abutments include all abutment options with the exception of the Gingiva Former and the angled Screw Retained Abutment.

TRI-Vent is available in three implant diameters (3.75, 4.1 and 4.7 mm) and six lengths (6.5, 8, 10, 11.5, 13, and 16 mm). Only the 4.1 mm and 4.7 mm diameter implant bodies are available in the 6.5 mm length. All three TRI-Vent implant diameters have the same platform diameter (3.5 mm). TRI-Vent abutments include Healing Collar, Straight Temporary PEEK Abutment, Straight and 20° Angled Abutments, Straight and 30° Angled Screw Retained Abutment, PEEK Gingiva Former, Straight and 15° Angled Contoured Abutment, Gold-castable Abutment, Screw- retained Abutment, Ball Abutment, and applicable abutment fixation screws.

The TRI-Octa implants are root form endosseous dental implants. They have a pink, transgingival collar. TRI-Octa is available in three implant diameters (3.75, 4.1 and 4.7 mm) and six lengths (6.5, 8, 10, 11.5, 13, and 16 mm). Only the 4.1 mm and 4.7 mm diameter implant bodies are available in the 6.5 mm length. All three TRI-Octa implant diameters have the same platform diameter (4.8 mm). TRI-Octa abutments include Healing Collar, Straight PEEK Temporary Abutment, Straight and 20° Angled Abutments, Straight Screw Retained Abutment, Ball Abutment, and applicable abutment fixation screws.

Here's a breakdown of the acceptance criteria and study information for the TRI® Dental Implant System, based on the provided text:

Preamble: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to existing legally marketed devices. It typically describes non-clinical testing performed to show that the new device performs as safely and effectively as predicates, rather than extensive clinical efficacy studies with specific acceptance criteria in the clinical sense. Therefore, the "acceptance criteria" here refer more to the performance standards the device was tested against to prove equivalence, particularly in mechanical and biological compatibility. Clinical outcomes data (e.g., success rates in patients) often come from post-market surveillance or larger clinical trials not detailed in a 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Study Information:

2. Sample size used for the test set and the data provenance:

   • The document does not explicitly state sample sizes for each non-clinical test (e.g., number of implants tested for fatigue). It only mentions that "Non-clinical testing data submitted, referenced, or relied upon" was provided.
   • Data provenance: Not specified (e.g., country of origin, retrospective/prospective). Given it's non-clinical lab testing against ISO standards, it would be prospective data generated for the submission.

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

   • Not applicable in this context. The "ground truth" for non-clinical performance data is defined by the technical specifications outlined in the ISO standards themselves (e.g., a specific fatigue load, or a cytotoxicity response in a cell culture). There isn't typically expert consensus to establish a "ground truth" for these types of engineering and biocompatibility tests.

4. Adjudication method for the test set:

   • Not applicable as this is non-clinical testing against ISO standards, not a study involving human readers or clinical adjudication.

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 document describes a dental implant system, not an AI-powered diagnostic device. No MRMC studies were conducted or reported.

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

   • Not applicable. This is a physical medical device (dental implant), not an algorithm.

7. The type of ground truth used:

   • For non-clinical testing: The "ground truth" is defined by the physical, chemical, and biological properties and performance metrics specified in the referenced ISO standards (e.g., mechanical strength requirements, cytotoxicity levels, sterility assurance levels). It's based on established scientific and engineering criteria.
   • For demonstrating equivalence: The ultimate "ground truth" for the 510(k) process is the safety and effectiveness of the legally marketed predicate devices.

8. The sample size for the training set:

   • Not applicable. This is a physical medical device, not a machine learning algorithm requiring a "training set."

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

   • Not applicable, for the same reason as above.

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