FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The provided text is a 510(k) premarket notification for a medical device called OSSEOTITE NTTM Certain™ Implants. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical outcomes.

Therefore, many of the requested sections about acceptance criteria, detailed study design, sample sizes for training/test sets, expert qualifications, and specific performance metrics cannot be directly extracted from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug and Cosmetic Act."

This indicates that there are no pre-defined quantitative acceptance criteria against which the device's performance is measured in this submission. The submission relies on demonstrating substantial equivalence to existing legally marketed devices.

Therefore, a table of acceptance criteria and reported device performance, as typically understood in a study proving performance, cannot be generated from this document. The "performance" demonstrated is that the device has "features and functions which are similar to the currently available OSSEOTITE NT Certain Implants and the OSSEOTITE NT Implants."

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

Sample Size for Test Set: Not applicable. The submission is not based on a new performance study with a test set of patient data to validate against specific metrics. It is an equivalence claim to existing devices.
Data Provenance: Not applicable. No new patient data study is described for this submission.

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

Not applicable. There is no described test set requiring ground truth established by experts.

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

Not applicable. There is no described test set requiring adjudication.

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:

No. This submission is for a dental implant (hardware), not an AI-powered diagnostic device. Therefore, an MRMC study is not relevant here.

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

No. This submission is for a dental implant, not an algorithm.

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

Not applicable. The submission is based on demonstrating substantial equivalence to predicate devices, not on proving device performance against a specific ground truth.

8. The sample size for the training set:

Not applicable. No new performance study or algorithm training is described.

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

Not applicable. No new performance study or algorithm training is described.

Summary of what the document does provide regarding safety and effectiveness:

The core of this 510(k) submission is to establish substantial equivalence to predicate devices. The arguments for safety and effectiveness are based on the premise that because the new device's technological characteristics, materials, and intended use are "similar" to or the same as legally marketed predicate devices (OSSEOTITE NT Certain Implants K031475, OSSEOTITE NT Dental Implants K014235, 3i Implants K030614), it can be considered equally safe and effective.

The conclusion states: "The proposed OSSEOTITE NT Certain Implants are substantially equivalent to the legally marketed OSSEOTITE NT Certain Implants and the OSSEOTITE NT Implants." This is the "study" and "proof" presented in this type of submission when explicit performance standards are not established for the device type.

Summary

Regulation Number and Section

§ 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.