(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.
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Food and Drug Administration 510(k) Notification - Boirab Micro-TORP Prosthesis February 22, 1999
KG90601
510(k) Summary of Safety and Effectiveness
| Trade Name: | Bojrab Micro-TORP Prosthesis |
|---|---|
| Common Name: | Total Ossicular Replacement Prosthesis |
| Classification Name: | Total Ossicular Replacement Prosthesis (§ 874.3495) |
| Official Contact: | Alicia E. FarageSenior Regulatory Affairs SpecialistSmith & Nephew, Inc.ENT Division2925 Appling RoadBartlett, TN 38133 |
| Telephone: | (901) 373-0200 |
| Telefax: | (901) 373-0242 |
| Date Prepared: | February 22, 1999 |
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 These devices have the same indications for use, total reconstruction of the by Xomed. 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.
Differences between the Bojrab Micro-TORP Prosthesis and the predicate devices should not affect the safety or effectiveness.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three flowing lines representing the body and head. The figure is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 1999
Ms. Alicia E. Farage Sr. Regulatory Affairs Specialist Smith & Nephew, Inc. 2925 Appling Road Bartlett, TN 38133
Re: K990601 Trade Name: Bojrab Micro-TORP Prosthesis Regulatory Class: II Product Code: 87 ETA Dated: March 4, 1999 Received: March 5, 1999
Dear Ms. Farage:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Ms. Alicia E. Farage, Sr. Regulatory Affairs Specialist
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Food and Drug Administration 510(k) Notification - Bojrab Micro-TORP Prosthesis February 22, 1999
510(k) Number: Device Name:
- 946601 Bojrab Micro-TORP®
Indications For Use:
- 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 .
(Division Sign-Off) Division of Ophthalmic Devices K99060 510(k) Number ـ
Karen Bohm (for HRS)
Prescription Use
(Per 21 CFR 801.109)
§ 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.