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GPS® Angled Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. These abutments are designed to only receive a fabricated multi-unit bridge or overdenture. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

GPS® Angled Abutments are designed to be used in conjunction with dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. The proposed GPS® Angled Abutments are intended to provide extra prosthetic options currently unavailable to the clinician. The proposed abutments are intended to complement the cleared systems listed in Table 2 below. The proposed abutments have the same compatible implant interface specific to each implant system and platform size. The GPS® Angled abutments have the same coronal GPS Angled Top for all proposed GPS® Angled abutments. The GPS top has a superior outer radius at its coronal region that is identical to the primary predicate GoDirect implants (K090234 - Spectra System Dental Implants 2008). The proposed GPS® Angled abutments are a two-piece design having an identical lower piece with same interface features and angles as the reference predicate InterActive screw receiving angled abutments with a ball top (K130572 - InterActive/SwishPlus2 Implant System).

The provided text describes the 510(k) summary for the GPS® Angled Abutments, detailing their substantial equivalence to predicate devices. Here's a breakdown of the requested information:

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

The document does not explicitly state acceptance criteria in a quantitative format for specific performance metrics (e.g., "Must pass X N of force"). Instead, it confirms that the device meets the "equivalent or higher load" than the primary predicate device when tested according to FDA and ISO standards. The general acceptance criteria are:

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

• Sample Size: The document indicates that testing was performed on "the worst case abutment testing" (InterActive® /SwishActive GPS® Angled Abutment, 3.0 mm Platform) and "the proposed Angled GPS Abutments, primary predicate GoDirect implant and compatible comfort caps." However, it does not provide specific numerical sample sizes (e.g., how many abutments were tested for fatigue).
• Data Provenance: The studies are non-clinical performance data, likely conducted by Implant Direct Sybron Manufacturing, LLC which is located in Thousand Oaks, California, USA. The data is retrospective in the sense that it's generated for a regulatory submission rather than a prospective clinical trial. There's no mention of country of origin of data beyond the company's location.

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 section is not applicable as the document describes non-clinical performance data (mechanical, sterilization, biocompatibility testing) rather than a study requiring expert-established ground truth like image analysis or disease diagnosis.

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

This section is not applicable for the same reason as point 3.

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 section is not applicable. The document describes a medical device (dental abutment), not an AI diagnostic tool that would involve human readers or AI assistance.

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

This section is not applicable for the same reason as point 5.

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

As mentioned in point 3, the studies are non-clinical performance evaluations. The "ground truth" for these tests are universally accepted scientific and engineering standards:

• Mechanical Testing: ISO 14801 standards for fatigue, and static compression tests. The ground truth is the physical failure or endurance limit of the material under applied forces.
• Sterilization: Sterility assurance level (SAL) of 10-6, as per AAMI/ANSI/ISO 17665-1 and ANSVAAMI ST79. The ground truth is the measurable absence of viable microorganisms.
• Biocompatibility: ISO 10993-5 standards for biological evaluation of medical devices. The ground truth is the measurable absence of toxic reaction from the devices.

8. The sample size for the training set

This section is not applicable. The device is a physical medical implant, not an algorithm that requires a training set.

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

This section is not applicable for the same reason as point 8.

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