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The LOCATOR Angled Abutment is indicated for the attachment of full or partial, fixed and removable restorations retained by endosseous implants to restore masticatory function for the patient.

The LOCATOR Angled Abutment consists of various height abutments with identical attachment features compared to LOCATOR Abutments of the LOCATOR Implant Attachment System, cleared in K072878. The LOCATOR Angled Abutment will be used with the accessories of the LOCATOR Implant Attachment System (retention inserts, denture attachment housing, and ancillary processing parts) and LOCATOR FIXED Attachment System (fixed inserts, denture attachment housing) for the attachment of a restoration. The LOCATOR Angled Abutment interfacing features are provided at a 15 degree angle to allow for angle correction, substantially equivalent to the predicate device of K233587. The LOCATOR Angled Abutments are manufactured from titanium (Ti-6Al-4V) and are titanium nitride (TiN) coated, identical to the predicate device.

This document (K243272) is a 510(k) premarket notification for a dental device, the LOCATOR Angled Abutment. It is important to note that this document does not describe the performance of software or an AI device. Instead, it describes a mechanical dental implant component and its substantial equivalence to previously cleared predicates.

Therefore, many of the requested categories related to AI/software performance criteria, expert adjudication, MRMC studies, ground truth establishment for AI/ML, and training set information are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding the acceptance criteria (in terms of performance testing for a mechanical device) and how the device meets them:

1. Table of Acceptance Criteria (for a mechanical device) and Reported Device Performance:

Study Details (for a mechanical device):

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

   • Specific quantitative sample sizes for each mechanical test (e.g., number of abutments fatigued, number of coatings tested) are not detailed in this summary.
   • The data provenance is from non-clinical performance testing conducted by the manufacturer, Zest Anchors, LLC. This is typically internal laboratory testing.
   • The nature of the tests (fatigue, coating, packaging, functional fit) indicates this is prospective testing performed specifically to support this regulatory submission. Country of origin for data is not specified but is implicitly from the manufacturer's testing facilities (likely USA, given the submission location).

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 "ground truth" for a mechanical device is established through objective engineering measurements and standardized performance tests (e.g., ISO, ASTM standards), not by human expert consensus on interpretations. The "experts" involved would be qualified engineers and technicians performing the tests.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth from multiple human readers/experts in AI/medical image analysis. For mechanical device testing, the results are objectively measured and compared against predefined performance specifications.

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 device is a mechanical dental abutment, not an AI or software product. Therefore, no MRMC study involving human readers and AI assistance was conducted or is relevant.

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

   • Not applicable. This device is a mechanical abutment, not an algorithm.

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

   • The "ground truth" for this device's performance is based on established engineering principles, material science specifications, and adherence to international standards (e.g., ISO 14801, ASTM F1044, ASTM F1147, ISO 10993). Functional fit was verified against OEM implant specifications through direct testing.

8. The sample size for the training set:

   • Not applicable. This is a mechanical device, not a machine learning model. There is no "training set."

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

   • Not applicable. As above, no training set exists for this type of device.

In summary, the provided document explicitly states that the submission aims to demonstrate substantial equivalence of the new LOCATOR Angled Abutment variations to existing predicate devices. This is achieved by showing that the new abutments share the same intended use, principles of operation, materials, manufacturing processes, and fundamental design, and they meet the same functional and performance characteristics through non-clinical testing. The "acceptance criteria" here refer to the successful completion and passing of these engineering and material performance tests against established standards.

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

The purpose of this submission is to add to the S.I.N. Dental Implant System components cleared in K170392 and K170398. This submission adds the following components to the S.I.N. Dental Implant System:

Tryon CM Conical implants, Tryon CM Cylindrical implants, Tryon CM Cylindrical Body and Conical Apex implants, and Strong SW implants, each with a Morse taper connection and the identical acidetched endosseous surface cleared in in K170392;

Strong SW Plus implants with a Morse taper connection and an endosseous surface produced by acidetching followed by application of a hydroxyapatite coating (HA™M) identical to the coating cleared in K170392:

conventional angled abutments and healing caps with a Morse taper connection that are compatible with the Strong SW CM implant line cleared in K170392;

conventional angled abutments and healing caps with a Morse taper connection that are compatible with the subject device Tryon CM implant lines, the subject device Strong SW/Plus implant lines, and the Unitite implant line cleared in K17039;

healing caps with a Morse taper connection that are compatible with the Unitite Compact implant line and the Unitite Slim implant line cleared in K170392;

healing caps with an external hex (HE) or internal hex (HI) connection that are compatible with the Strong SW HE, the Tryon HE implant lines, and the Strong SW HI implant lines, cleared in K170398;

abutment screws for use with the angled abutments or healing caps.

This document is a 510(k) summary for the S.I.N. Dental Implant System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving a device meets specific acceptance criteria through a standalone study with defined performance metrics.

However, the document does contain information about performance data used to support the substantial equivalence claim. Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria in a structured table with corresponding device performance metrics. Instead, it lists various non-clinical tests conducted and states that these tests demonstrate substantial equivalence to predicate devices, implying these tests met the necessary standards for such a claim.

Based on the "Performance Data" section (Page 6), the following can be inferred as the type of performance evaluation conducted:

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