(88 days)
The implant is indicated for use in restoring masticatory function in the edentulous and/or partially edentulous patient.
The Steri-Oss implant 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 3.8, 5.0 or 6.0 mm in diameter, from 8 - 18 mm in length and are composed of a titanium body and titanium coating. They are tapered, have a hexed superior surface, and are threaded.
The provided text describes a 510(k) summary for Steri-Oss's "Replace TPS Coated Implants." It primarily focuses on demonstrating substantial equivalence to a predicate device and does not involve a study with acceptance criteria in the typical sense of AI/algorithm performance. The "Performance Data" section explicitly states: "A mathematical justification demonstrates the substantial equivalence of the predicate to the Steri-Oss products." This indicates that the regulatory approval is based on a comparison of device characteristics and design rationale, rather than a clinical study evaluating diagnostic accuracy or a specific performance metric against a defined threshold.
Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance (especially those related to AI or diagnostic accuracy) are not applicable or cannot be extracted from this document.
Here's an attempt to address the request based on the available information:
1. Table of acceptance criteria and the reported device performance
The concept of "acceptance criteria" here is framed around demonstrating substantial equivalence to a predicate device, rather than achieving specific performance metrics in a clinical study. The "performance" is implicitly about matching or being comparable to the predicate's established characteristics and function.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate) | Reported Device Performance (Steri-Oss) |
|---|---|---|
| Material | Titanium | Titanium |
| Diameter (mm) | Range including 3.75 | 3.8, 5.0, 6.0 |
| Length (mm) | Range including 7-20 | 8-18 |
| Geometry | Threaded | Threaded (Same) |
| Sterility | Sterile | Sterile (Same) |
| Function | Support for prosthetic devices to restore chewing function | Designed to serve as support for prosthetic devices to restore patient chewing function |
| Scientific Concepts | Mimic natural dentition structure (root/crown) for masticatory function | Intended to mimic this structure to aid the patient in restoring natural masticatory function; serves as artificial tooth root |
| Intended Use | Restoring masticatory function in edentulous/partially edentulous patients | Restoring masticatory function in the edentulous and/or partially edentulous patient |
| Overall Equivalence | "Substantial equivalence is claimed to Nobelpharma's 3.75 mm implant." | "A mathematical justification demonstrates the substantial equivalence of the predicate to the Steri-Oss products." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable/not provided. The document describes a comparison against a predicate device's specifications, not a clinical trial with a "test set" in the context of diagnostic performance or AI evaluation.
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)
This information is not applicable/not provided. Ground truth in the context of a 510(k) for a medical implant typically refers to established safety and effectiveness of the predicate, or to the inherent design and material properties. There is no mention of an expert panel or ground truth establishment for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. There was no "test set" in the sense of a set of cases 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
This information is not applicable/not provided. This document pertains to a dental implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This document describes a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for regulatory approval in this context is the established safety and effectiveness of the existing predicate device (Nobelpharma's 3.75 mm implant) against which the new device claims substantial equivalence. The characteristics and intended use of the Steri-Oss implant are compared directly to those of the predicate.
8. The sample size for the training set
This information is not applicable/not provided. There is no "training set" in the context of this regulatory submission for a physical medical implant.
9. How the ground truth for the training set was established
This information is not applicable/not provided. There is no "training set." The relevant "ground truth" is the established data and regulatory history of the predicate device.
§ 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.