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The I2A Dental Implant System and I2C Dental Implant System are in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The 12A Dental Implant System and J2C Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.

The J2A Dental Implant System and J2C Dental Implant System are internal hexagon type dental implant systems made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of these systems have been treated with R.B.M (Resorbable Blast Media).

The provided document is a 510(k) summary for the J2A Dental Implant System and J2C Dental Implant System. It presents a comparison to predicate devices to establish substantial equivalence, rather than a study proving performance against acceptance criteria in the context of an AI/software as a medical device (SaMD).

Therefore, I cannot extract information related to:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
6. Standalone algorithm performance.
7. Type of ground truth for test set.
8. Sample size for training set.
9. Ground truth establishment for training set.

The document discusses non-clinical testing which was conducted to demonstrate substantial equivalence, but not a study of the device's performance against specific clinical acceptance criteria in the way an AI/SaMD would be evaluated. It states:

Non-Clinical Testing:

• Risk analysis was conducted according to ISO14971 to demonstrate that modifications to the company's own predicate, Hero II Dental Implant System (K121047), are substantially equivalent.
• Modifications evaluated include:
  • Fixture thread design change.
  • Fixture size addition.
  • Coating area expansion for one-piece type abutments.
  • Abutment size addition.
• Additional predicate devices of similar design and dimensions were identified to determine substantial equivalence.
• Based on the risk analysis, the shelf-life, sterilization, biocompatibility, and performance testing of the predicate, Hero II Dental Implant System (K121047), is applicable to the subject device.

Conclusion on Substantial Equivalence:
The document concludes that the J2A Dental Implant system and the J2C Dental Implant system are substantially equivalent to the predicate devices because they:

• Have the same intended use.
• Use the same operating principle.
• Incorporate the same basic design.
• Incorporate the same material and surface treatment.

This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing detailed performance metrics from a clinical study against specific acceptance criteria.

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