(85 days)
The kit is indicated for use to assist in fixture placement.
The Steri-Oss kit is designed to assist in fixture placement. The tray is composed of titanium and the instruments are composed of the firstruments are composible for the line of steel.
This document describes a conventional medical device (a surgical kit) and not an AI/ML powered device. As such, most of the requested information regarding acceptance criteria for AI performance metrics, study designs for AI validation, ground truth establishment, expert involvement, and training/test set details are not applicable.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (Steri-Oss) |
|---|---|---|
| Device Function | Designed to assist in fixture placement | Designed to assist in fixture placement |
| Materials | Titanium, Steel, Aluminum (for predicate) | Titanium, Steel, Silicone |
| Sterility | Non-Sterile | Non-Sterile |
| Intended Use | To assist in fixture placement | To assist in fixture placement |
Note: For conventional devices like this, "acceptance criteria" are typically met by demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness. There are no performance metrics like accuracy, sensitivity, or specificity for a surgical kit.
2. Sample size used for the test set and the data provenance: Not applicable. This is a physical surgical kit, not a data-driven device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical kit is not established in this manner.
4. Adjudication method for the test set: Not applicable.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: Not applicable in the context of AI/ML. For this device, "ground truth" would relate to its physical properties meeting design specifications and its ability to function as intended during surgery by a qualified professional.
8. The sample size for the training set: Not applicable. This is a physical surgical kit.
9. How the ground truth for the training set was established: Not applicable.
Study that proves the device meets the acceptance criteria:
The document explicitly states "Performance Data: Not applicable." This indicates that a formal study with statistical data to prove performance metrics (as would be expected for an AI device) was not deemed necessary for this 510(k) submission.
Instead, the "proof" the device meets the acceptance criteria (i.e., is safe and effective) is established through the "Comparison to Predicate." The submission argues that the Steri-Oss Fixture Mount Kit is substantially equivalent to the Nobelpharma's Instrument set for fixture installation (SDIB 101). The comparison highlights:
- Identical Intended Use: Both devices are "designed to assist in fixture placement."
- Similar Materials: The Steri-Oss kit uses Titanium, Steel, and Silicone, while the predicate uses Titanium, Steel, and Aluminum. The change from Aluminum to Silicone is likely considered a minor modification that doesn't raise new questions of safety or effectiveness.
- Same Sterility: Both are non-sterile.
By demonstrating substantial equivalence to a legally marketed predicate device, the manufacturer is asserting that their device meets the necessary safety and effectiveness standards, rather than through a dedicated performance study.
§ 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.