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

Steri-Oss 3.25 mm Replace Healing Abutment: This device is designed to expand the gingival tissue during the healing phase to maintain the appropriate abutment fit.

Steri-Oss 3.25 mm Replace Abutment: This device is designed to serve as a base for prosthetic devices which restore patient chewing function.

The implants are 3.25 mm in diameter, are 10 to 16 mm in length, and are fabricated from titanium alloy. They are tapered, threaded, and have a superior external hex. The healing screw, healing abutment, and abutment are also fabricated from titanium alloy. Portions of the surface of each of the components are anodized magenta in color.

AI/ML Overview

This looks like a 510(k) summary for a medical device (Steri-Oss 3.25 mm Replace Dental Implant System) seeking substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria based on performance metrics.

Therefore, the requested information elements (acceptance criteria table, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) are not present in the provided text. The document states "Performance Data: Not applicable" which indicates that a detailed performance study as you've requested was not submitted or deemed necessary for this 510(k) clearance due to the nature of the device and its claimed substantial equivalence to existing predicate devices.

The general structure of a 510(k) summary usually involves comparing the new device to a legally marketed predicate device(s) in terms of intended use, technological characteristics, and safety and effectiveness. If the new device is substantially equivalent to a predicate, specific performance acceptance criteria and detailed study results might not be required in the same way as for a novel device undergoing a PMA (Premarket Approval) process.

Based on the provided text, here's what can be extracted:

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

Not applicable. The document states "Performance Data: Not applicable." The submission focuses on demonstrating substantial equivalence to predicate devices based on material, surface characteristics, and sterility, rather than meeting specific performance criteria through a new study.

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

Not applicable. No test set or related performance data is mentioned.

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

Not applicable. No test set or ground truth establishment process is described.

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

Not applicable. No test set or adjudication method 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:

Not applicable. This device is a dental implant system, not an AI-powered diagnostic tool, so an MRMC study is not relevant.

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

Not applicable. This is not an algorithm-based device.

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

Not applicable. No ground truth is established for performance testing. Substantial equivalence is claimed based on comparison to predicate devices.

8. The sample size for the training set:

Not applicable. No training set is mentioned as this is a physical medical device, not a machine learning model.

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

Not applicable. No training set or ground truth establishment is mentioned.

Summary of what is provided regarding comparison:

The document focuses on a comparison to predicate devices to establish substantial equivalence.

Specification/Characteristic	Predicate: Steri-Oss Replace Implant	New Product: Steri-Oss 3.25 mm Replace Dental Implant
Material	Titanium	Same
Surface Characteristics	Color-coded	Same
Sterility	Sterile	Sterile

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.