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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:

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

The document does not specify exact sample sizes for each test mentioned. For tests like sterilization, bacterial endotoxin, and shelf life, it generally states "samples" were tested.

• Sterilization: "all subject devices"
• Bacterial Endotoxin: "samples of water used in manufacturing on a weekly basis and on samples from sterilized product on a quarterly basis"
• Shelf Life: "samples after 4 years of real time aging"
• Biocompatibility (PEEK and HA™® coating): Not specified.
• Mechanical Strength: "worst-case constructs" – implies a selection of representatives that challenge the design, but specific numbers are not given.

The data provenance is internal to the manufacturer (S.I.N.-Sistema de Implante Nacional S.A.) via non-clinical testing. While some data is "referenced from K170398 and K170392" or "leveraged from and provided in K170392," these are prior 510(k) submissions for the same manufacturer, indicating a history of internal testing. The tests are non-clinical, so "country of origin" from a clinical data perspective (e.g., patient demographics) is not applicable. The tests are prospective in the sense that they are conducted to evaluate the device, not retrospectively analyzing past clinical outcomes.

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

This information is not applicable as the document describes non-clinical engineering and laboratory testing to establish performance, not expert-based ground truth for clinical evaluation.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes non-clinical engineering and laboratory testing, which typically involves quantitative results against specifications or predicate comparisons, not expert adjudication.

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

No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical data were included in this submission." (Page 6).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable here. The device is a physical dental implant system, not an algorithm or AI system. The performance data presented are for the physical device components in a standalone context (e.g., testing the implant's strength, the coating's biocompatibility).

7. Type of Ground Truth Used

The ground truth used for these non-clinical tests is primarily engineering specifications, recognized standards (e.g., ISO, ASTM), and comparison to predicate device characteristics. For example, sterility is measured against a SAL standard, mechanical strength against ISO 14801, and biocompatibility against ISO 10993 series. The "truth" is whether the device meets these established technical benchmarks or is comparable to a predicate that has previously met them.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical dental implant system, not a machine learning model that requires a training set.

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

This information is not applicable. As stated above, there is no training set for a machine learning model.

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