(22 days)
For use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices.
The modified Hybrid Endopore Implant also are identical to the predicates, except for the addition of three selftapping threads in the coronal region of the implant. The dimensions of the modified Hybrid Endopore Implant, 9.5 mm and 11 mm in length x 4.0 mm diameter; and 7.5 mm and 9.5 mm in length x 5.0 mm diameter, are very similar to the dimensions of previously cleared Endopore implants.
The provided text describes a 510(k) premarket notification for a dental implant system. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive performance data or clinical study results in the manner requested.
Therefore, much of the information asked for, particularly regarding acceptance criteria, specific study design, sample sizes, ground truth establishment, and expert involvement, is not available in this submission. This document is a regulatory filing, not a detailed scientific report of a clinical trial.
However, based on the information provided, here's what can be inferred:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of performance metrics. The implicit acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device.
- Reported Device Performance: Not provided empirically. The document states that the "minor modification to the surface of the Endopore Implant does not alter its indications for use or its fundamental scientific technology." This is the core "performance" claim in a 510(k) for a modified device – that its performance is equivalent to the predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (Endopore® Endosseous Dental Implant System in 4.1 mm diameter (K926354), 5.0 mm diameter (K971196), and 5 mm long x 5.0 mm diameter (K032140)) | The modified Hybrid Endopore Implant is considered "substantially equivalent" to the predicate devices. |
| Does not alter indications for use or fundamental scientific technology | The minor modification (addition of three self-tapping threads) does not alter its indications for use or fundamental scientific technology. |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable/not provided. This 510(k) submission does not detail a study involving a test set of data. It relies on the substantial equivalence to previously cleared devices.
- Data provenance: Not applicable/not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable/not provided. No test set requiring expert ground truth is described.
- Qualifications of experts: Not applicable/not provided.
4. Adjudication method for the test set
- Adjudication method: Not applicable/not provided. No test set requiring adjudication 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
- MRMC study: No. This device is a dental implant, not an AI-powered diagnostic tool. Such a study would not be relevant.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: No. This device is a physical dental implant, not an algorithm.
7. The type of ground truth used
- Type of ground truth: Not applicable/not provided. No ground truth is established in this filing; it's a comparison to predicate devices and their known clinical performance.
8. The sample size for the training set
- Sample size: Not applicable/not provided. This submission is about a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- How ground truth was established: Not applicable/not provided for the reasons stated above.
§ 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.