The Capitello-Condylar Total Elbow Prosthesis is indicated for arthroplasty of the elbow in patients suffering from rheumatoid arthritis with intractable elbow pain, limited motion, and radiographically identifiable destruction, with relative preservation of bony stock. It is also indicated for use in certain older posttraumatic or osteoarthritic patients where a relatively low activity level is anticipated. This device is intended for cemented use.

Device Description

The Captiello-Condylar Total Elbow Prosthesis is an elbow replacement which relies on existing soft tissue structures such as the medial collateral ligament and triceps tendon for support and stability. The Humeral component is composed of cobalt-chromium-molybdenum (Co-Cr-Mo) alloy and has an intramedullary stem for fixation. The Ulnar component is composed of Co-Cr-Mo, with an articulating surface of ultra-high molecular weight polyethylene (UHMWPE). The device is designed to rely on soft tissue structures to support and absorb the forces which would otherwise be transmitted to the prosthesis, cement, or bone. The device is intended for use with bone cement.

AI/ML Overview

The provided text describes a 510(k) submission for the Capitello-Condylar Total Elbow Prosthesis. Under a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a predicate (already legally marketed) device, rather than proving efficacy through clinical trials with specific acceptance criteria in the same way a device seeking de novo authorization or PMA does. Therefore, the device does not have explicit acceptance criteria or a study designed to meet them in the traditional sense.

Instead, the "acceptance criteria" for a 510(k) are met by demonstrating that the new device is as safe and effective as a predicate device. This is primarily done through comparison of design, materials, manufacturing, function, and sometimes, performance testing.

Here's an analysis of the provided text in relation to your questions:

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

Acceptance Criteria (for substantial equivalence to predicate)	Reported Device Performance (compared to predicate)
Intended Use: Same as predicate device (Pre-Amendment Capitello-Condylar Elbow System)	The Capitello-Condylar Total Elbow Prosthesis has the same intended use.
Materials: Similar to predicate device, specifically UHMWPE for some components.	Modifications to UHMWPE are not a significant change to safety/effectiveness. Extensive evaluation showed calcium stearate-free UHMWPE meets/exceeds specifications.
Design: Similar to predicate device.	Substantially equivalent in design.
Manufacturing: Similar to predicate device.	Substantially equivalent in manufacturing.
Function: Similar to predicate device.	Substantially equivalent in function. Device relies on existing soft tissue structures for support and stability, similar to the predicate.
Mechanical Properties: New materials perform equivalently or better than predicate materials.	Results of both mechanical property and device function testing show that the material performs as well as or better than the UHMWPE currently being used (in the predicate).

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable in the context of clinical testing for establishing efficacy or safety against pre-defined clinical acceptance criteria. The "test set" here refers to the materials testing.
Data Provenance: The device testing summary mentions "extensive evaluation testing" of the calcium stearate-free UHMWPE. This likely refers to in vitro mechanical and material property testing, not in vivo clinical data from patients. No information is provided regarding the specific origin of these test results (e.g., country of origin). It's typically conducted in a laboratory setting.
Retrospective or Prospective: Not applicable as there are no clinical studies described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The "test set" refers to material and mechanical property testing, where the "ground truth" is typically established by engineering standards, specifications, and laboratory measurements, not by expert clinical consensus.

4. Adjudication method for the test set

Not applicable. No clinical test set or adjudication process is described.

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

No. This device is a passive implantable prosthesis (an elbow replacement), not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies are not relevant.

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

No. This device is a passive implantable prosthesis.

7. The type of ground truth used

For material properties: Engineering specifications, material standards, and benchmark performance of the predicate device's materials.
For design/function: Comparison against the design and known function of the legally marketed predicate device, likely supported by engineering analysis.

8. The sample size for the training set

Not applicable. This device is a passive implantable prosthesis. There is no training set as would be used for machine learning algorithms.

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

Not applicable. There is no training set. The "ground truth" for the device's substantial equivalence largely relies on comparing its characteristics to the well-established "truth" (safety and effectiveness) of the predicate device.

Summary

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6 1998 NOV

K98314/

510K Summarv Capitello-Condylar Total Elbow Prosthesis November 2, 1998

1. Submitter

Johnson & Johnson Professional, Inc. 325 Paramount Drive Ravnham, MA 02767 Deana Boushell, Regulatory Affairs Specialist, (508) 828-3107

Device Name 2.

Proprietary Name:	Capitello-Condylar Total Elbow Prosthesis
Common Name:	Elbow Prosthesis
Classification Name:	Elbow joint metal/polymer semi-constrained cemented prosthesis
Regulatory Class:	Class II, per CFR § 888.3160

3. Intended Use

4. Device Description

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5. Predicate Device Comparison

The Capitello-Condylar Total Elbow Prosthesis is substantially equivalent in terms of intended use, materials, design, manufacturing, and function to the Pre-Amendment Capitello-Condylar Elbow System. Modifications to the UHMWPE used in the manufacture of some of the system components do not represent a significant change to the safety and effectiveness of the device.

Device Testing Summary 6.

Extensive evaluation testing of the calcium stearate free UHMWPE indicates that the material meets or exceeds all current specifications for the material. In addition, results of both mechanical property and device function testing show that the material performs as well as or better than the UHMWPE currently being used.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 6 1998

Deana M. Boushell, RAC Regulatory Affairs Specialist Johnson & Johnson Professional, Inc. 325 Paramount Drive 02767-0350 Raynham, Massachusetts

Re: K983141 Capitello-Condylar Total Elbow Prosthesis Regulatory Class: II Product Code: JDB September 4, 1998 Dated: Received: September 8, 1998

Dear Ms. Boushell:

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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 - Deana M. Boushell, RAC

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 requlation (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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K783/41

Capitello-Codylar Total Elbow Prosthesis INDICATIONS FOR USE

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

Sign-Off)
Division of General Restorative Devices L983141

法

S Prescription Use (Per 21 CFR §801.109)

510(k) Number

Over-the-Counter Use _No

(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.