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The Townley Elbow System contains three components which are intended for single use. Cement fixation of the components is required.

Indications: Osteoarthritis, Rheumatoid arthritis with severe elbow pain and limited joint motion.

Humeral Component: The humeral component of the Townley Total Elbow is manufactured of Cobalt Chrome (ASTM F-799). It is offered in both right and left designs and features a stabilizing intramedullary stem that is angled in five degrees of valgus to accommodate the normal carrying angle of the elbow. The proximal, bone-interfacing, non-articulating side of the body is designed with a squared receptical to accept the similarly remodeled humeral condyles. The articulating surface of the humeral component is contoured to allow a snap-fit with the ulnar component and is extended laterally to articulate with the radial head. It is offered in three sizes: 35mm, 40mm, and 45mm.

Ulnar Insert: The ulnar insert is manufactured of UHMWPE. The insert is designed to snap onto the humeral component and provide a stable joint while retaining multiplanar flexibility. It is offered in two sizes: small and large.

Ulnar Tray: The ulnar tray is manufactured of Cobalt Chrome (ASTM F-799). It features a L-shaped body which provides support for the polyethylene insert as well as a stem that aids in fixation. It is offered in two sizes: small and large.

This document is a 510(k) Summary for the Townley Total Elbow System, submitted by Biopro. It describes a medical device, specifically a prosthetic total elbow, and compares it to a predicate device, the Capitello-Condylar Total Elbow.

Analysis of the Provided Text for Acceptance Criteria and Study Details:

The provided text does not contain any information regarding clinical studies, acceptance criteria, or performance metrics in the way one would typically describe a study proving a device meets acceptance criteria.

Instead, the document is a 510(k) Summary which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device.

The entire "study" in this context is a comparison to a predicate device based on design features, materials, and general function, rather than an independent clinical trial with defined acceptance criteria and performance outcomes.

Therefore, I cannot extract the requested information in the format you provided because the document describes a device comparison for substantial equivalence, not a clinical performance study with acceptance criteria.

Here's how the information would look if the document did contain the requested details, along with an explanation of why it's absent:

Acceptance Criteria and Study for Townley Total Elbow System (Information Not Present in Document)

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. The document does not describe a clinical "test set" or human subject data. The "study" is a comparison of product specifications and features.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No human experts were used to establish "ground truth" for a clinical test set in this document. The comparison is based on engineering specifications and design.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No adjudication method is described as there is no clinical test set.

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 a medical device (prosthesis), not an AI-based diagnostic or assistive technology. Therefore, an MRMC study and AI performance improvement are irrelevant to this document.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable. This is a medical device (prosthesis), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Design Specifications and Material Properties. The "ground truth" in this context is the physical design, dimensions, materials, and stated functional characteristics of the Townley Total Elbow System as compared to the Capitello-Condylar System.

8. The sample size for the training set

• Not Applicable. There is no "training set" described. This is a comparison of two manufactured medical devices, not a machine learning model.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

Summary of Device Comparison (from the provided text, which serves as the "study" for 510(k) purposes):

The document presents a comparison table and narrative to demonstrate substantial equivalence between the Townley Total Elbow System and the predicate Capitello-Condylar Total Elbow.

Key Similarities (indicating substantial equivalence):

• General Purpose and Concept: Both are elbow replacement systems.
• Materials Used: Both use Cobalt Chrome (ASTM F-799) for humeral components and ulnar trays, and UHMWPE for ulnar inserts.
• Normal Flexion/Extension: Both are stated to be "equally proficient in allowing normal flexion and extension motion."

Key Dissimilarities (and how they are argued not to raise new safety/effectiveness concerns):

• Townley System allows for limited varus/valgus excursion: Implies a design innovation without indicating a new risk.
• Townley System has a modular polyethylene insert: A design choice.
• Townley System has a snap-fitted prosthetic articulation: A design choice for stability. The table states the Townley "Resists Dislocation" while the predicate does not, implying an improvement.
• Townley System ulnar component has right/left universality: A design choice for versatility.
• Townley Humeral Component sizes: 3 for Townley vs. 2 for predicate.
• Townley Ulnar Tray sizes: 2 for Townley vs. 4 for predicate.
• Townley Ulnar Tray universality: Yes for Townley vs. No for predicate.
• Townley Ulnar Insert Snapfits: Yes for Townley vs. No for predicate.

Conclusion: The document asserts that despite certain "details in implant designing" being dissimilar, the devices are "substantially equivalent" because they are identical in general purpose, concept, materials, and equally proficient in allowing normal motion. The differences are presented as design enhancements (e.g., resisting dislocation, universality) rather than fundamental shifts requiring extensive clinical trials for new acceptance criteria.

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