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.

AI/ML Overview

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

Performance Metric	Acceptance Criteria	Reported Device Performance
(e.g., Range of Motion)	(e.g., > 100 degrees flexion)	Not provided in the document. The document states "The two systems are equally proficient in allowing normal flexion and extension motion," but doesn't quantify this for either device or provide specific acceptance criteria.
(e.g., Dislocation Rate)	(e.g., < 2%)	Not provided. The document states the Townley System "Resists Dislocation" while the Capitello-Condylar does "No," but no quantitative measure or acceptance criteria are given.
(e.g., Bone Ingrowth/Fixation Strength)	(e.g., Shear strength > X MPa)	Not provided. The document mentions "Cement fixation of the components is required" and the Ulnar Tray stem "aids in fixation," but no metrics or criteria.
(e.g., Wear Rate of UHMWPE insert)	(e.g., < X mg/million cycles)	Not provided. UHMWPE is mentioned as the material for the ulnar insert, but no wear data or acceptance criteria.
(Any other functional or safety outcome)	Not provided	Not provided

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.

Summary

{0}------------------------------------------------

AUG - 8 1996

K955916 510 (k) Summary CLASS III

Submitted Bv: Biopro

17 17th Street Port Huron, MI 48060

Cheryl Warsinske Contact: (810) 982-7777 Fax (810) 982-7794

Device Information:

proprietary name: Townley Total Elbow System common name: Prosthetic, Total Elbow classification name: Prosthetic, Total Elbow

Predicate Device: Capitello- Condylar Total Elbow manufactured by Johnson & Johnson

Device Description:

Intended Use:

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.

Contraindications: Excessive bone loss, Septic arthritis, Periarticular osteomyelitis, and General health problems.

April 9, 1996

{1}------------------------------------------------

510 (k) Summary

Comparison of the Townley Elbow System vs. the Capitello-Condylar System

Image /page/1/Picture/2 description: In the image, a small electronic component is shown against a dark background. The component has a rectangular body with rounded edges, and two wires extend from either side. The wires are thin and metallic, and they appear to be made of copper. The component is likely a resistor or a capacitor, and it is used in electronic circuits to control the flow of electricity.

Image /page/1/Picture/3 description: The image shows a satellite in space. The satellite has a rectangular body with several square panels on its surface. There are two long, thin antennas extending from opposite sides of the satellite. The text in the image includes the words "Caball chromтьт", "Rumara: compens", "Posturse central grem", "for gehemped fixation", "UMPWPE U", and "by tray re".

Photograph of the Townley Elbow

Photograph of the Capitello-Condylar Elbow

Humeral Component	Cobalt Chrome	Sizes Available
Capitello-Condylar	Yes	2
Townley System	Yes	3

Ulnar Tray	Cobalt	Universal Tray(can be used onright or left)	Sizes Available
Capitello-Condylar	Yes	No	4
Townley System	Yes	Yes	2

Ulnar TrayInsert	Snapfits ontoHumeralComponents	UHMWPE	Universal Insert(can be used onright or left)
Capitello-Condyl.	No	Yes	No
Townley System	Yes	Yes	Yes

Total Elbow Joint	NormalFlexion/Extension	Resists Dislocation	Non-constrained inVarus/Valgus
Capitello-Condyl.	Yes	No	No
Townley System	Yes	Yes	Yes

The Townley Total Elbow Replacement ensemble is substantially equivalent to the Capitello-Condylar prosthesis manufactured by Johnson Orthopaedics. The two systems are identical relative to general purpose and concept of elbow replacement as well as the materials used. The only dissimilarity relates to certain details in implant designing that include: l ) allowance for a limited degree of varus/valgus excursion, 2) a modular polyethylene insert, 3) a snap-fitted prosthetic articulation, and 4) the right/left universability of the ulnar component. The two systems are equally proficient in allowing normal flexion and extension motion.

Regulation Number and Section

§ 888.3150 Elbow joint metal/polymer constrained cemented prosthesis.

(a)
Identification. An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,”
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra High Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,”
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(viii) ISO 14630:1997 “Non-active Surgical Implants—General Requirements,”
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,”
(v) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vii) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”