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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
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from Literature) |
|---|---|
| Safety: No significant or new adverse effects. | "Endosseous implants... have been proved safe... through the years." "Little or no hard data could be found on the medical risks associated with [dental] implants [in a literature review]." The device uses materials and methods "proved effective by the above summarized years of clinical usage." |
| Effectiveness: Ability to achieve "oral comfort, function, and appearance." | "Endosseous implants... have been proved ... effective through the years." "Zarb completed his report of the detailed Toronto 10-year study by concluding that 'the tried and tested Branemark implant technique has revolutionized the treatment options open to the prosthodontist. For the edentulous patient...the prospect for a lifetime of restored oral comfort, function, and appearance have now become predictable and reliable.' These results are ample evidence of the safety and effectiveness of these endosseous implants." (The CRYSTAL implants are presented as substantially equivalent to these devices). |
| Technological Equivalence: No new technological questions. | "Thus, they involve no new types of technology and no new technological questions." They are "constructed according to methods in the cited substantially equivalent products." |
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that 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, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.