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The Fenning-Pappas, Modular Knee Bearing is intended for reconstruction or revision of painful and/or severely disabled knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis, in knees having coirectable mity, and viable or reconstructable ligaments. valgus or var ..

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I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for a medical device called "Fenning-Pappas, Modular Knee Bearing", indicating it has been found substantially equivalent to a legally marketed predicate device.

The letter discusses regulatory classifications, general controls, and other administrative information related to marketing the device. It also includes the "Indications for Use" for the device, but it does not detail any performance metrics, study results, or acceptance criteria.

Thus, I cannot provide the requested table and information as it is not present in the given text.

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The BUECHEL-PAPPAS (B-P) Fixed Bearing New Jersey (NJ) Total Knee Replacement System is intended for the reconstruction of painful and/or severely disabled knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis. Additionally, it is intended for Subjects with severe arthritis (e.g. Posttraumatic, rheumatoid or osteoarthritis.). with sufficient bone stock (i.e. cortical bone present to support the platform of the components) and ligamentous support (i.e. intact medial and lateral collateral ligaments) to allow stable, anatomical positioning of components and supporting tissue structures, who are skellatly mature and have not responded to conservative treatment (i.e. injections, therapy, etc.). Porous components and textured components are intended for cemented use.

Buechel-Pappas (B-P) Fixed Bearing New Jersey Total Knee Replacement System

I am sorry. I cannot provide the information you are requesting. The document you provided is a 510(k) clearance letter for a medical device (Buechel-Pappas (B-P) Fixed Bearing New Jersey Total Knee Replacement System). This type of document confirms that the FDA has found the device to be substantially equivalent to a legally marketed predicate device.

It does not contain details about acceptance criteria, specific performance studies, sample sizes, expert qualifications, or comparative effectiveness studies as described in your request. These details would typically be found in the more comprehensive 510(k) submission itself, which is not publicly available in this format, or in associated scientific literature or clinical trial reports for the device.

Therefore, I cannot extract the information to fill out the table or answer the subsequent questions.

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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.

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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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The BUECHEL-PAPPAS™ Modular Salvage Shoulder Replacement System is intended for the reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis, rheumatiod arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis; for use in the absence of a functionally sufficient rotator cuff as well as where the proximal humerus is insufficient to support a standard angled humeral prosthesis. Biocoat® porous coated components are intended for cemented use.

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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth.

The document is a 510(k) clearance letter from the FDA for the "Buechel-Pappas Modular Salvage Shoulder Replacement System," and an "Indications For Use" statement for the device. It indicates that the device has been determined to be substantially equivalent to devices marketed prior to May 28, 1976. This type of regulatory document does not typically contain the detailed technical study information you are requesting.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device