(35 days)
Otosclerosis. Congenital fixation of the stapes. When previous remedial surgery has been unsuccessful for the treatment of hearing loss due to otosclerosis, and a significant conductive loss remains with good cochlear reserve. Chronic middle ear disease. Trauma.
The Bojrab Micro-TORP Prosthesis is substantially equivalent to the Black Oval-Top TORP marketed by Smith & Nephew, Inc., ENT Division, and the Schwaber Total implant marketed by Xomed. These devices have the same indications for use, total reconstruction of the ossicular chain that has lost its function due to disease, trauma, or congenital defect. The head of the Bojrab Micro-TORP Prosthesis is made from Hydroxylapatite, a widely accepted material for middle ear reconstruction, as are the heads of the two predicate devices. The Bojrab Micro-TORP Prosthesis and the predicate devices all have trimmable shafts. The Bojrab and Black implant shafts are made from HAPEX and the Schwaber implant shaft is manufactured from FLEX H/A.
The provided text is a 510(k) summary for the Bojrab Micro-TORP Prosthesis, a medical device. It focuses on demonstrating substantial equivalence to existing devices rather than presenting a study with acceptance criteria and performance data in the typical sense of an AI/software device.
Therefore, many of the requested categories for AI-related studies (like sample size, ground truth, expert adjudication, MRMC studies, training set details) are not applicable to this type of medical device submission.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document describes a medical device (a prosthesis) and its substantial equivalence to predicate devices, not an AI or software product. Therefore, there are no specific acceptance criteria or performance metrics in the form of sensitivity, specificity, or other statistical measures typically associated with AI device studies.
The "performance" for this type of device is implicitly that it functions similarly to the predicate devices and is safe and effective for its stated indications for use.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices for safety and effectiveness. | The device is deemed substantially equivalent to the Black Oval-Top TORP and the Schwaber Total implant. |
| Same indications for use as predicate devices. | Same indications for use: total reconstruction of the ossicular chain due to disease, trauma, or congenital defect. |
| Materials used are accepted for middle ear reconstruction. | Head made from Hydroxylapatite (widely accepted). Shaft made from HAPEX (similar to predicate devices). |
| Differences should not affect safety or effectiveness. | Differences between the Bojrab Micro-TORP and predicate devices "should not affect the safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a medical device submission, not a study involving a test set of data for an AI algorithm. The substantial equivalence is based on design, materials, and intended use comparison to existing predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth as typically understood for AI studies (e.g., expert-annotated data) is not relevant here. The "ground truth" for this submission is whether the device design and materials are safe and effective for its intended use, as compared to established predicate devices.
4. Adjudication Method for the Test Set
Not applicable. There is no test set or adjudication process described in this context.
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, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (a prosthesis), not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness of the predicate devices (Black Oval-Top TORP and Schwaber Total implant) and the generally accepted properties of the materials used (Hydroxylapatite and HAPEX) for ossicular replacement prostheses. The FDA's decision relies on this comparison.
8. The Sample Size for the Training Set
Not applicable. There is no training set for an AI algorithm discussed in this document.
9. How the Ground Truth for the Training Set was Established
Not applicable. This document does not describe an AI training set or its ground truth establishment.
§ 874.3495 Total ossicular replacement prosthesis.
(a)
Identification. A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.