For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used with bone cement.

Device Description

The Contoured Articular Prosthetic (CAP) consists of two components, a taper post component and an articular component, that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/ prosthetic interface.

The taper post component is manufactured of a Ti-6Al-4V ELI alloy per ASTM F136. The taper post has a tapering distal tip, a full-length cannulation, and a proximal female taper bore. The taper post is available in a 25mm and 30mm length to provide for variation in humeral head size.

The articular component is a dome shaped component manufactured of a Cobalt-Chromium-Molybdenum alloy per ASTM F799 and ASTM F1537. The articular component has a bone contact surface that is coated with a CP Titanium coating and a polished articular bearing surface.

Utilizing the drill guide provided within the CAP instrumentation set, a surgeon is able to define a working axis that is normal to the articular cartilage surface at the site of the defect. After drilling a pilot hole, the taper post is driven into place using the trial cap to ensure that the surface of the articular component will be tangent and congruent to the existing cartilage surface when seated. Using the contact probe instrument corresponding to the implant diameter, offset measurements are taken to define the topography of the patients surrounding articular surface by revolving the probe around a centering shaft coaxial to the working axis of the taper post. With these offset measurements, the surgeon is able to select the articular component from a range of sizes that will allow it to seat flush to the surrounding articular surface. Offset increments in .5mm sizes will allow for an optimal fit to the existing articular cartilage.

A reamer, which matches the articular component internal geometry is used to prepare the site for the prosthetic to be implanted. This allows for a precise fit of the implant to the prepared site and minimizes bone resection, so as to provide minimal impact to any future arthroplasty procedure. The articular component is then impacted to seat the taper interlock between the two components.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called the Contoured Articular Prosthetic (CAP) Humeral Head Resurfacing System. This document focuses on demonstrating substantial equivalence to existing predicate devices rather than providing detailed acceptance criteria and study results for device performance in the way that would typically be seen for a new AI/software device.

Therefore, the requested information elements related to AI device evaluation (such as sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this type of medical device submission.

Here's an attempt to answer the prompt based on the available information, noting the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific quantitative "acceptance criteria" or report detailed "device performance" metrics as would be typically expected for a diagnostic or AI device. Instead, it demonstrates substantial equivalence to predicate devices based on intended use, materials, and application. The "performance" is implicitly tied to meeting the functional requirements of a humeral head resurfacing prosthesis and being similar to legally marketed devices.

Acceptance Criteria (Implicit)	Reported Device Performance (Implicit/Claimed)
Intended Use	Functionally equivalent to predicate devices for reconstruction of painful/disabled shoulder joints due to post-traumatic degenerative disease or avascular necrosis.
Materials	Ti-6Al-4V ELI alloy (taper post) and Cobalt-Chromium-Molybdenum alloy (articular component), coated with CP Titanium. These materials are accepted for orthopedic implants.
Application/Mechanism of Action	Taper interlock system for stable fixation, precise sizing, minimal bone resection, and congruency with existing cartilage. Similar to predicate devices.
Safety Profile	Potential risks are the same as other joint prosthetic devices (e.g., reaction to cement/materials, nerve palsy, embolus, loosening, infection, wear, revision). This implies the device does not introduce new or unmanageable risks compared to predicates.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a physical orthopedic implant. There is no "test set" in the context of an AI algorithm or diagnostic device. The evaluation is based on engineering design, material properties, and comparison to predicate devices, not data analysis of a test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. There is no "ground truth" establishment in the context of a diagnostic test set for this physical implant. The design and manufacturing process adhere to recognized standards and are reviewed for substantial equivalence by the FDA.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" for which adjudication would be required.

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 physical medical implant, not an AI or diagnostic tool that would involve human readers.

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

Not applicable. This is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of a diagnostic dataset. The "ground truth" for the device's safety and effectiveness relies on:

Adherence to established material standards (e.g., ASTM F136, F799, F1537).
Predicate device history of safe and effective use.
Engineering principles and mechanical testing (though specific results are not detailed in this summary, they would be part of the full submission).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for this physical implant.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no "training set" for this physical implant.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" presented in this 510(k) summary is a demonstration of substantial equivalence to legally marketed predicate devices. The core argument is that the Contoured Articular Prosthetic (CAP) Humeral Head Resurfacing System has:

Identical Intended Use: Reconstruction of painful/disabled shoulder joints due to post-traumatic degenerative disease or avascular necrosis, with similar requirements for bone stock and rotator cuff integrity.
Similar Materials: The components are made from Ti-6Al-4V ELI alloy and Cobalt-Chromium-Molybdenum alloy, with a CP Titanium coating – materials commonly used and accepted for orthopedic implants.
Similar Application/Technology: The device's design, including a taper interlock system, drill guide for axis definition, and selection of articular components for optimal fit, is presented as technically similar to predicates. The claims of "minimal bone resection" and flexibility in sizing and fitting are implied to be performance characteristics that align with or improve upon predicate devices.
Established Safety Profile: The potential associated risks are explicitly stated to be the same as those associated with other joint prosthetic devices, implying no new or elevated risks compared to the predicates.

The FDA's letter (K023096) confirms that based on the provided information, the device is "substantially equivalent" to legally marketed predicate devices for its stated indications for use. This determination signifies that the device is as safe and effective as existing legally marketed devices, rather than establishing de novo performance metrics against specific acceptance thresholds as would be done for novel technologies or AI.

Summary

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510(K) Summary of Safety and Effectiveness

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the Contoured Articular Prosthetic (CAP) Humeral Head Resurfacing Prosthesis.

Submitted By:	STD Manufacturing, Inc.1063 Turnpike StreetStoughton, MA 02072(781) 828-4400
Date:	September 16, 2002
Contact Person:	Steven W. EkVP Engineering
Proprietary Name:	Contoured Articular Prosthetic (CAP)Humeral Head Resurfacing System
Common Name:	Hemi-shoulder resurfacing prosthesis
Classification Name:	Prosthesis, Shoulder, Hemi-, Humeral, MetallicOrthopedic21 CFR § 888.3690Class II
Product Code:	HSD

Intended Use:

The Contoured Articular Prosthetic (CAP) System is intended for the reconstruction of painful and/or severly disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used with bone cement.

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023096

p. 2/3

Device Description:

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023096

Substantial Equivalence Information:

The intended use, materials, and application of the candidate device are substantially equivalent to those of the following predicate devices:

Copeland Resurfacing Heads (K003044, K010664) Buechel-Pappas Humeral Head Resurfacing Component (K992394)

Potential risks associated with the candidate device are the same as with other ioint prosthetic devices. These include, but are not limited to:

Reaction to the bone cement .
Reaction to the implant materials .
Nerve palsy ●
Embolus
Implant loosening/ migration
Infection
. Delayed wound healing
Damage to the implants
. Excessive wear
Hematoma .
Need for Revision
Incomplete resolution of symptoms ●

The device is technically easy to implant, and offers the surgeon a high degree of precision and flexibility in sizing and fitting the articular component to the existing anatomy. A minimal amount of bone and articular cartilage resection is also offered by the device.

Additional materials, manufacturing, and performance data to support the safety and effectiveness of the CAP System are provided within this Premarket Notification.

Revised Page 013 (Page 014 Omitted)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 2003

Mr. Steven W. Ek Vice President of Engineering STD Manufacturing, Inc. 1063 Turnpike Street Stoughton, Massachusetts 02072

Re: K023096

Trade/Device Name: Contoured Articular Prosthetic (CAP) Humeral Head Resurfacing System Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder Joint Humeral (hemi-shoulder) Metallic Uncemented Prosthesis Regulatory Class: Class II Product Code: HSD Dated: January 9, 2003 Received: January 10, 2003

Dear Mr. Ek:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Steven W. Ek

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Mark A Millhuser

Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K023096

Device Name: Humeral Head Resurfacing Prosthesis

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109 Over-The Counter Use

(Optional Format 1-2-96)

Mark N. Milligan

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K023096

Regulation Number and Section

§ 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.