(153 days)
This device is a self-tapping titanium threaded screw indicated for intra-bony and inter-radicular transitional applications, to permit immediate splinting stability and ongoing fixation of new or existing crown & bridge installations, for full or partial edentulism, and employing minimally invasive surgical intervention.
Representative applications include the following:
- t Temporary (transitional) supports for fixed or removable implant-supported prostheses while conventional implants are integrating .
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- Stabilizing interim prostheses in graft sites and guided tissue regeneration applications to avoid iatrogenic damage to healing grafts, membranes Ox integrating implants.
- 本 Introductory system for nervous or apprehensive potential implant patients, offering a simple methodology for testing out the actual "feel" of boneanchored implants, without the major committment to final restorations; or as an interim system for medically compromised, handicapped or terminally ill patients to enhance their comfort by maintaining a reasonable level of speech, mastication & general well-being, at modest cost levels.
Self-capping citanium threaded screw, 1.8mm in width by 14,17,19,&22mm lengchs
The provided text is a premarket notification summary (510(k)) for a dental implant, not a study describing acceptance criteria and device performance in the way typically seen for diagnostic or AI-driven medical devices. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance metrics against specific acceptance criteria.
Therefore, many of the requested categories (e.g., specific acceptance criteria, sample sizes for test and training sets, expert qualifications, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of document.
However, I can provide available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Dentatus MIIE Anchor Post) in terms of: | Device is a self-tapping titanium threaded screw comparable in biocompatible titanium materials, manufacture, sterilization methods, and intended applications to the predicate. |
| - Biocompatible materials | Comparable biocompatible titanium materials. |
| - Manufacture | Comparable manufacture. |
| - Sterilization methods | Comparable sterilization methods. |
| - Intended applications | Comparable intended applications. |
| Safety and efficacy (survival) | Demonstrated consistent quality and quantity of survival over 20 years. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a "test set" in the context of typical device performance evaluations. The clinical data is based on a "twenty year prospective clinical study." The exact number of patients or implants is not provided.
- Data Provenance: The study "commencing in 1976 by Sendax & associates" suggests the data is prospective and collected over a long period. The country of origin is not explicitly stated but "Sendax MDIC Management, Inc." and "New York, N.Y." might imply US-based data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The study appears to be a clinical outcome study, not one requiring expert consensus for a ground truth label in the diagnostic sense.
4. Adjudication method for the test set:
- Not applicable as the study type does not involve a "test set" requiring adjudication in this manner.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a dental implant, not an AI-driven diagnostic tool. No MRMC study was performed, and human readers are not involved in its "performance."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device (dental implant), not an algorithm.
7. The type of ground truth used:
- The "ground truth" implicitly refers to the clinical outcomes of the dental implants, specifically their "survival" over 20 years, confirming safety and efficacy.
8. The sample size for the training set:
- Not applicable. This is not a machine learning model. The clinical data constitutes the "study data" rather than a "training set."
9. How the ground truth for the training set was established:
- Not applicable. The ground truth (clinical survival) was established through direct observation and follow-up in the "twenty year prospective clinical study."
§ 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.