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The High Retention Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restory function. It is used in fixed hybrid restorations that can be attached with a snap-in system. The High Retention Attachment System is compatible with the following implants: (list of compatible implants and diameters provided in the document).

The High Retention Attachment System is a system that provides rigid connection of fixed, partial, and full arch restorations (fixed/detachable hybrid dentures) to endosseous dental implants. It consists of abutments, attachment housings, inserts and seating and removal tools. The abutments are provided in various cuff heights with the implant and abutment connection specific to the Zest Anchors, LLC or OEM implant. The subject device abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and are TiN (titanium nitride) coated. The High Retention Attachment System is as provided with an abutment (LOCATOR Attachment) and the surgical instrumentation necessary to place the implant. The High Retention Attachment System is designed to accommodate a path of insertion diverqence of up to 20° per implant and no more than 40° of divergence between implants.

This document describes a 510(k) premarket notification for a dental device, the "High Retention Attachment System." It does not contain information about an AI/ML-driven medical device, hence no study details are provided to address the acceptance criteria for such a device. The content is primarily focused on demonstrating substantial equivalence to a predicate device through material, design, and intended use comparisons, rather than performance testing against specific acceptance criteria for an AI algorithm.

Therefore, I cannot provide the requested information from the provided text as it does not pertain to the performance and validation of an AI/ML medical device.

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The High Retention Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restoring masticatory function. It is used in fixed hybrid restorations that can be attached with a snap-in system.

The High Retention Attachment System is a system that provides rigid connection of fixed partial and full arch restorations (fixed/detachable hybrid dentures) to endosseous dental implants. It is designed to accommodate a path of insertion on implants to accommodate a divergence of up to 20° per implant and no more than 40° of divergence between implants. The components are similar to the LOCATOR Implant Anchor Abutment, cleared in K072878; however, the retention and removal of the inserts is similar to that of the LOCATOR F-Tx Attachment System cleared in K151789.

The High Retention Attachment System consists of abutment housings, inserts, laboratory processing tools and seating and removal tools. Abutments, attachment housings and inserts are Class II subject devices (Product Code NHA) and laboratory processing tools and seating and removal tools are Class I accessories (Product Code NDP). The abutments are provided in various cuff heights with the implant/abutment connection specific to the OEM implant. The subject device abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Allov for Surgical Implant Applications (UNS R56401) and are TiN (titanium nitride) coated.

This is a medical device, not an AI/ML device, so the requested information about acceptance criteria, study details, and training data for AI/ML models is not directly applicable.

Here's an analysis based on the provided document, addressing the principles of demonstrating substantial equivalence for a medical device:

The Zest Anchors, LLC "High Retention Attachment System" (K213391) is a Class II medical device (Endosseous Dental Implant Abutment, Product Code NHA). The FDA has determined it is substantially equivalent to legally marketed predicate devices.

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

The document does not explicitly present a table of "acceptance criteria" in the way one might for a specific performance metric of an AI/ML model (e.g., AUC > 0.9). Instead, substantial equivalence is demonstrated by comparing the new device's characteristics and performance to those of legally marketed predicate devices.

The table on page 7 outlines a comparison of the subject device with its primary predicate (K151789, LOCATOR F-Tx Attachment System) and two reference devices (K072878, LOCATOR Implant Anchor Abutment; K200827, LOCATOR R-Tx Attachment System).

Key Performance Demonstrations:

• Sterilization Validation and Biocompatibility Testing: The device undergoes these standard tests for medical devices. The materials and TiN coating are stated to have the "same specifications, processes, and are manufactured in the same facilities" as the predicate F-Tx Attachment System (K151789) and LOCATOR device (K072878). This implies the acceptance criteria for these tests were met as per established standards for similar devices.
• Mechanical Denture Retention Testing: This was a specifically conducted non-clinical test. The reported performance is that "The mechanical testing demonstrated that the retention force of the High Retention Attachment System was greater than retention force of the predicate device K151789." This indicates superior performance in this regard.
• Abutment-Implant Interface Compatibility: Verified through OEM signed abutment drawings, OEM implant drawings, or contractual agreements, and "engineering analysis." No specific performance testing was required due to this established compatibility and demonstrated equivalence to the LOCATOR R-Tx Attachment System (K200827).

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

For the mechanical denture retention testing, the document states tests were conducted, but it does not specify the sample size used for this testing. It is a non-clinical test, so "data provenance" in terms of country of origin or retrospective/prospective is not applicable in the typical sense for patient data. It refers to laboratory/bench testing.

For sterilization validation and biocompatibility testing, these are typically conducted according to international standards (e.g., ISO standards) and involve specific sample sizes and protocols, but these details are not provided in this summary.

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

This question is not applicable as the device is not an AI/ML diagnostic tool that relies on expert interpretation to establish ground truth from patient data. The "ground truth" for this physical device is assessed through engineering specifications, material properties, and mechanical performance tests, not expert clinical interpretation of images or patient outcomes in the context of an AI study.

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

This question is not applicable for the same reasons as point 3. There is no "test set" of clinical cases requiring expert 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

This question is not applicable. The device is a dental implant attachment system, not an AI-assisted diagnostic or treatment planning tool. Therefore, MRMC studies and "human readers improving with AI assistance" are irrelevant.

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

This question is not applicable as there is no algorithm, nor is it an AI/ML device.

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

As explained above, "ground truth" for this device is established through:

• Engineering specifications and drawings: For device design, dimensions, and implant compatibility.
• Material specifications and standards: Conformance to ASTM standards (e.g., ASTM F136 for titanium alloy).
• Laboratory performance testing: Such as mechanical denture retention force testing.
• Biocompatibility and sterilization standards: Demonstrating safety.

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device that requires a training set.

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

This question is not applicable as there is no training set.

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