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This device is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices and to restore the patient's chewing function.
This device is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

The CRYSTAL Implants System implants are post-type endosseous dental implants with design and manufacturing concepts, materials, surgical procedures, and intended uses quite similar to the preamendment device and to others rated substantially equivalent to the preamendment device. This CRYSTAL-SEAL system is most similar to the Crystal and Crystal Plus Implants System which received concurrence of substantial equivalence from the Food and Drug Administration in premarket notification submission K-954432. Like many commercial implants, the CRYSTAL devices are manufactured of high-purity (99+%) titanium, or titanium alloy (ASTM F 136-84 titanium - 6 aluminum - 4 vanadium). CRYSTAL Implants also are available in coated form, either hydroxyapatite or titanium plasma spray.

The provided text is a 510(k) summary for a dental implant system (CRYSTAL and CRYSTAL-SEAL Implants System). It does not contain information about acceptance criteria, device performance metrics, or a study design that would prove the device meets specific performance criteria. This document is focused on establishing substantial equivalence to pre-amendment devices and other already-cleared devices.

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.

Here's what can be inferred and what is explicitly stated concerning the lack of a traditional performance study:

1. Table of acceptance criteria and the reported device performance:

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

• N/A. No formal test set or clinical study specific to the CRYSTAL and CRYSTAL-SEAL Implants System is described in this 510(k) summary. The submission relies on substantial equivalence to predicate devices and general literature on endosseous implants.

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

• N/A. No test set or ground truth establishment process for performance evaluation is described.

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

• N/A. No test set or adjudication method is described.

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:

• N/A. This device is a dental implant, not an AI software or a diagnostic imaging device that would typically involve human readers or MRMC studies.

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

• N/A. This device is a physical medical device (dental implant), not an algorithm or AI system.

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

• N/A. Given the type of submission (510(k) based on substantial equivalence), the "ground truth" for proving safety and effectiveness relies on the long-standing history of similar pre-amendment devices and contemporary legally marketed predicate devices. The document cites literature reviews and a 10-year study (Toronto study by Zarb) on the Branemark implant technique as evidence of safety and effectiveness for endosseous implants in general, not specifically for the CRYSTAL system.

8. The sample size for the training set:

• N/A. No "training set" in the context of an algorithm or AI model is applicable here.

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

• N/A. Not applicable, as there is no training set for an algorithm.

Conclusion regarding the "study that proves the device meets the acceptance criteria":

The provided text does not describe a specific study for the CRYSTAL and CRYSTAL-SEAL Implants System that establishes acceptance criteria and directly proves the device meets them. Instead, the submission relies on the concept of Substantial Equivalence (SE).

The core argument for the device's safety and effectiveness is made by:

• Similarity to pre-amendment devices: Stating that it is "equivalent to devices manufactured and sold before 1976."
• Similarity to currently marketed predicate devices: Explicitly referencing K-954432 (Crystal and Crystal Plus Implants System) and other examples cleared by the FDA (e.g., Bofors Nobelpharma, Core-Vent Corp., etc.).
• General acceptance and literature review: The document includes a "Clinical Discussion and Brief Literature Review" which summarizes that "Endosseous implants...have been proved safe and effective through the years." It references a Medline search, a Consensus Development Conference on Dental Implants (NIH, 1988), and specifically the Toronto 10-year study by Zarb on the Branemark implant technique. This literature supports the general safety and effectiveness of the class of devices, implying that because the CRYSTAL system is substantially equivalent in design, materials, and intended use, it also shares this established safety and effectiveness.

In essence, the "proof" is through demonstrating that the device is fundamentally the same as other devices already proven safe and effective, rather than presenting a de novo study for this specific product.

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This document is a Summary of Safety and Effectiveness Data (SSED) for a dental implant (Endosseous Implant). It does not describe acceptance criteria, nor does it present a study proving a device meets acceptance criteria in the way a modern AI/medical device submission would.

Instead, this SSED (likely from an older 510(k) submission) relies heavily on literature review and substantial equivalence to existing, predicate devices. It argues for safety and effectiveness by demonstrating that:

• The device is an endosseous implant, a class of devices already proven safe and effective through years of clinical usage.
• It uses materials (titanium) and sterilization methods (radiation or ethylene oxide) that are already well-established and used in existing effective devices.
• It involves no new technology or technological questions.
• It cites literature and consensus conferences supporting the safety and effectiveness of endosseous implants generally, particularly the "Branemark implant technique."

Therefore, most of the requested information cannot be extracted from the provided text, as it's not a study documenting specific performance metrics against pre-defined acceptance criteria for the specific device called CRYSTAL and CRYSTAL-PLUS Implants System.

Here's an attempt to answer the questions based on the spirit of the request, highlighting what is and is not present in the provided text:

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

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: Not applicable. No specific test set for this device is described. The "data" comes from a literature review of many existing studies on endosseous implants generally.
• Data Provenance: Not applicable for a specific test set. The literature search produced 579 entries + 60 new review articles, including a special issue on "Proceedings of the Consensus Development Conference on Dental Implants [National Institutes of Health, Bethesda, MD, June 13-15, 1988]". This indicates a broad, likely international, provenance over many years for the general class of devices. It's a review of retrospective and prospective studies conducted by others.

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)

• Number of experts: Not applicable for a specific test set.
• Qualifications of experts: The "Dental Devices Panel" and a "Consensus Development Conference on Dental Implants [National Institutes of Health]" are mentioned, implying expertise from various dental and medical practitioners, researchers, and regulatory bodies, but specific individual qualifications are not detailed.

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

• Adjudication method: Not applicable. No specific test set requiring adjudication for this device is mentioned. The claims are based on consensus from literature reviews and expert panels for the general class of devices.

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

• MRMC study: No. This is a dental implant, not an AI diagnostic device.
• Effect size improvement: Not applicable.

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

• Standalone study: No. This is not an AI algorithm.

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

• Ground Truth: The "ground truth" for the overall safety and effectiveness claims relies on a combination of:
  • Literature consensus: Extensive review of scientific literature.
  • Expert Consensus: Findings from panels and conferences (e.g., NIH Consensus Development Conference, Dental Devices Panel).
  • Clinical Outcomes Data: Referenced studies like the "Toronto 10-year study" by Zarb, which tracked long-term outcomes of endosseous implants.
  • Historical Usage/Precedent: Years of demonstrated safety and effectiveness of the general class of devices.

8. The sample size for the training set

• Training set sample size: Not applicable. This is not an AI device, and no "training set" in the machine learning sense is used. The "training" for the claims comes from the accumulated knowledge base of dental implantology.

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

• Ground truth for training set: Not applicable. There is no training set in the AI sense. The basis for safety and effectiveness is established through the historical body of evidence for endosseous implants, as summarized in the literature review and panel conclusions.

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