(88 days)
The BUECHEL-PAPPAS™ Humeral Head Resurfacing Shoulder Component is intended for the reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis and rheumatoid arthritis. For proper function of this device, the humeral head and neck must be of sufficient bone stock to support the loads on it. Also, the presence of an intact or reconstructable rotator cuff is important for proper functioning and dislocation resistance. Biocoat® porous coated components are intended for cemented use only.
Not Found
Based on the provided document, the device in question is the Buechel-Pappas™ Humeral Head Resurfacing Component. This document is a 510(k) clearance letter from the FDA, meaning it primarily focuses on establishing "substantial equivalence" to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics for a novel AI device.
Therefore, the information requested in your prompt regarding acceptance criteria, performance tables, sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, and standalone performance for an AI-powered device cannot be extracted from this document. This is a pre-AI era medical device clearance.
The document states: "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..."
Essentially, this document describes a traditional medical device (a humeral head resurfacing component) and its clearance based on substantial equivalence, not an AI/ML device requiring the specific types of studies you've outlined.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 1999
Mr. John Pappas Regulatory Affairs Endotec 20 Valley Street South Orange, New Jersey 07079
Re: K992394
Trade Name: Buechel-Pappas™ Humeral Head Resurfacing Component Regulatory Class: II Product Code: HSD Dated: July 16, 1999 Received: July 19, 1999
Dear Mr. Pappas:
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 requirement, as set forth in the Quality System Regulation (OS) 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 - Mr. John Pappas
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) 594-4659. 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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
K992394 510(k) Number (if known):
Device Name: BUECHEL-PAPPAS™ Humeral Head Resurfacing Component
Indications For Use:
The BUECHEL-PAPPAS™ Humeral Head Resurfacing Shoulder Component is intended for the reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis and rheumatoid arthritis. For proper function of this device, the humeral head and neck must be of sufficient bone stock to support the loads on it. Also, the presence of an intact or reconstructable rotator cuff is important for proper functioning and dislocation resistance. Biocoat® porous coated components are intended for cemented use only.
Contraindications
The device is contraindicated for use with forms of post-traumatic arthritis, rotator cuff dysfunction, humeral head avascular necrosis, failed, previous prosthesis, or congenital dysplasia.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Division of General Restorative Devices 510(k) Number K492394
Prescription Use
OR
Over-The-Counter Use
20 Valley Street South Orange, NJ 07079 Tel. 973 762 0095 Fax. 973 762 2279
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.