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

The Steri-Oss Replace Titanium Implant System is designed to serve as support for prosthetic devices to restore patient chewing function. Natural dentition is composed of a root (subgingival) and a crown (supragingival). Designs in existence are intended to mimic this structure to aid the patient in restoring natural masticatory function. The implant is designed to serve as the root of the artificial tooth and the abutment/prosthetic is designed to serve as the crown. The implants are 4.3, 5.0 or 6.0 mm in diameter, from 10 - 16 mm in length and are composed of titanium. They are tapered, threaded and have a hexed superior surface. The Replace Titanium Implant System utilizes color coding.

AI/ML Overview

This document, a 510(k) summary for the Steri-Oss Replace Titanium Implant System, lacks the specific details required to fully address your request. This type of submission, especially from 1997, typically focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance data from clinical studies with detailed acceptance criteria.

Here's an analysis based on the provided text, highlighting what is and is not present:

Key Takeaway: The document explicitly states "Performance Data: Not applicable." This indicates that the submission did not include studies with acceptance criteria in the way you're asking. The basis for clearance was likely a comparison of material and superficial characteristics to a predicate device already on the market.

Here's a breakdown of the requested information, noting where it's absent:

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

Not Provided. The document states "Performance Data: Not applicable." This means there are no reported device performance metrics against predefined acceptance criteria for the Replace Titanium Implant System in this submission. The substantial equivalence argument is based on material and surface characteristics being similar to the predicate, not on a clinical performance study with statistical endpoints.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective).

Not Provided. Since no performance data is applicable, there's no test set, sample size, or data provenance mentioned related to clinical performance.

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).

Not Provided. This is relevant for studies where expert review is used to establish ground truth (e.g., image analysis, clinical outcome assessment). Since no such performance studies are mentioned, this information is absent.

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

Not Provided. As no test set performance studies are described, there's no mention of an adjudication method.

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.

Not Provided. These types of studies are typically for AI/software devices. This document describes a physical medical device (dental implant).

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

Not Provided. This is also relevant for AI/software devices. This document describes a physical medical device.

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

Not Provided. No ground truth for performance assessment is mentioned, as no performance studies are described.

8. The sample size for the training set.

Not Provided. This is relevant for AI/machine learning models. This document describes a physical medical device.

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

Not Provided. This is also relevant for AI/machine learning models. This document describes a physical medical device.

Summary of Device and Claim:

Device: Steri-Oss Replace Titanium Implant System (Endosseous implant).
Intended Use: To restore masticatory function in edentulous and/or partially edentulous patients.
Mechanism: Functions as the root of an artificial tooth, supporting prosthetic devices.
Key Characteristics: 4.3, 5.0, or 6.0 mm diameter; 10-16 mm length; tapered, threaded, hexed superior surface; titanium composition; color-coded.
Predicate Device: Steri-Oss Titanium Implants, Healing Screws, Healing Abutments, and Abutments.
Substantial Equivalence Claim: Based on material (Titanium) and sterility being the same as the predicate. The only difference noted is the "Surface characteristics" being "Non-color coded" for the predicate versus "Color coded" for the Steri-Oss device, which is presented as a minor difference not impacting safety or effectiveness.

In conclusion, this 510(k) summary provides very limited information regarding clinical performance studies or acceptance criteria because the submission strategy was based on demonstrating equivalence to an already marketed device rather than providing new performance data.

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.