The Herbert Ulnar Head Prosthesis System is indicated for ulnar head and stem replacement necessitated by: 1) Failed operative procedures such as Darrach, Bowers, or Sauve-Kapandji, 2) Primary osteoarthritis, 3) Post -traumatic osteoarthritis as a result of radial fractures, TFCC tears, ulnar impingement, 4) Rheumatoid arthritis, and 5) Tumors.

Device Description

The Herbert Ulnar Head Prosthesis System consists of an intramedullary ulnar stem made of titanium, a Co/Cr or Zirconia ulnar head, and a surgical instrumentation set.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Herbert Ulnar Head Prosthesis System." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo clinical study with specific acceptance criteria and performance metrics against those criteria. Therefore, much of the requested information regarding detailed acceptance criteria and a study proving device performance in the context of AI/software device evaluation is not directly applicable to this document.

However, I can extract the relevant information from the document to address as many of your points as possible within the context of a 510(k) submission for a physical medical device.

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

For a 510(k) for a physical implant, "acceptance criteria" are typically related to meeting recognized standards and demonstrating equivalence to a predicate device in terms of design, materials, and intended use. Performance is demonstrated through comparison with the predicate and compliance with these standards.

Acceptance Criterion (Implicit)	Reported Device Performance
Material Compliance: Use of biocompatible and historically safe materials that meet recognized standards.	The device uses an intramedullary ulnar stem made of titanium, a Co/Cr or Zirconia ulnar head. These materials have "a long history of safe usage in medical devices." The device complies with the following standards for materials: - ISO 5832-2:1999 (Unalloyed Titanium) - ISO 5832-3:1996 (Wrought titanium 6-aluminium 4-vanadium alloy) - ISO 5832-12:1996 (Wrought cobalt-chromium-molybdenum alloy) - ISO 7153-1:1991/Amd. 1:1999 (Surgical instruments Metallic materials - Stainless steel) - ASTM F899 95 (Stainless Steel Billet, Bar and Wire for Surgical Instruments) - ASTM F138 97 (Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants)
Sterilization Process Compliance: Ensure the sterilization method meets recognized standards.	The device complies with: - AAMI/ANSI/ ISO 11134:1993 (Sterilization of health care products - industrial moist heat sterilization) - AAMI/ANSI ST46:2002 (Steam Sterilization and Sterility Assurance in Health Care Facilities)
Technological Equivalence to Predicate Device: Demonstrate that the design and features are substantially equivalent to a legally marketed predicate device.	An "8-point comparison of technological characteristics" was performed between the Herbert Ulnar Head Prosthesis System and the predicate device (uHead Ulnar Implant System, K010786). The devices were found to be substantially equivalent based on this comparison.
Intended Use Equivalence: Ensure the indications for use are the same or subset of the predicate device.	The indications for use match the predicate: for ulnar head and stem replacement necessitated by: 1) Failed operative procedures (Darrach, Bowers, Sauve-Kapandji), 2) Primary osteoarthritis, 3) Post-traumatic osteoarthritis, 4) Rheumatoid arthritis, and 5) Tumors.
Manufacturing Standards: Adherence to good manufacturing practices.	The device "will be manufactured per specifications using good manufacturing practices that ensure the device is safe and effective for its intended use."

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

This information is not applicable to this 510(k) submission. A test set in the context of device performance studies (like for AI/software) was not used. The clearance is based on comparison to a predicate device and adherence to recognized standards for materials and manufacturing.

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. There was no "test set" and thus no ground truth established by experts in the sense of a clinical performance study for this type of device submission.

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

Not applicable. No test set requiring adjudication was used.

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 for a physical prosthetic implant, not an AI/software medical device.

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

Not applicable. This is for a physical prosthetic implant, not an AI/software medical device.

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

Not applicable. For this 510(k), the "ground truth" for clearance is the established performance and safety of the legally marketed predicate device and the recognized standards for materials and manufacturing, not a clinical ground truth established for a test set.

8. The sample size for the training set

Not applicable. This is for a physical prosthetic implant, not an AI/software medical device that uses a training set.

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

Not applicable. This is for a physical prosthetic implant, not an AI/software medical device that uses a training set.

Summary

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DEC 2 7 2004 Summary of Safety and Effectiveness for the Herbert Ulnar Head Prosthesis System

submitted by OrthoSurgical Implants, Inc. 12244 SW 130 St Miami, FL 33186 Phone: (305) 969-4545

Contact Person:	Ricardo Schoening
Device Trade Name:	Herbert Ulnar Head Prosthesis System
Common Name:	Ulnar Head Prosthesis
Classification Name:	Wrist joint ulnar (hemi-wrist) polymer prosthesis per 21 CFR §888.3810

Identification of a Legally Marketed Predicate Device

The OrthoSurgical Implants, Inc. Herbert Ulnar Head Prosthesis System is substantially equivalent to uHead Ulnar Implant System that is legally marketed and distributed by Avanta Orthopaedics, Inc. pursuant to premarket notification K010786.

Device Description

The Herbert Ulnar Head Prosthesis System consists of an intramedullary ulnar stem made of titanium, a Co/Cr or Zirconia ulnar head, and a surgical instrumentation set.

Intended Use

Summary of Technological Characteristics

An 8-point comparison of technological characteristics of the OrthoSurgical Implants, Inc. Herbert Ulnar Head Prosthesis System and the predicate devices was performed. The devices were found to be substantially equivalent.

Summary of Performance Data

The OrthoSurgical Implants, Inc. Herbert Ulnar Head Prosthesis System complies with the requirements of listed FDA Recognized Consensus Standards.

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ISO 5832-2:1999, Implants for Surgery Metallic Materials Part 2: . Unalloved Titanium
ISO 5832-3:1996, Implants for Surgery Metallic materials Part 3: . Wrought titanium 6-aluminium 4-vanadium alloy
ISO 5832-12:1996, Implants for Surgery Metallic materials Part 12: . Wrought cobalt-chromium-molybdenum alloy
ISO 7153-1:1991/Amd. 1:1999, Surgical instruments Metallic materials . - Part 1: Stainless steel
ASTM F899 95, Standard Specification for Stainless Steel Billet, Bar . and Wire for Surgical Instruments
ASTM F138 97, Standard Specification for Wrought 18 Chromium-14 . Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
AAMI/ANSI/ ISO 11134:1993, Sterilization of health care products Re-. quirements for validation and routine control-industrial moist heat sterilization.
. AAMI/ANSI ST46:2002, Steam Sterilization and Sterility Assurance in Health Care Facilities

The OrthoSurgical Implants, Inc. Herbert Ulnar Head Prosthesis System is substantially equivalent to the uHead Ulnar Implant System that is legally marketed and distributed by Avanta Orthopaedics, Inc. This has been demonstrated through a 8-point technological comparison of features.

The blood and tissue contact materials used to fabricate the Herbert Ulnar Head Prosthesis System have a long history of safe usage in medical devices. Because the OrthoSurgical Implants, Inc. Herbert Ulnar Head Prosthesis System meets the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device. The Herbert Ulnar Head Prosthesis System will be manufactured per specifications using good manufacturing practices that ensure the device is safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized eagle-like symbol with three swooping lines forming the body and wings. The seal is black and white and appears to be of an official government entity.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 27 2004

Stuckenbrock Medizintechnik GmbH C/o Mr. Al Weisenborn OrthoSurgical Implants, Inc. 12244 SW 130 Street Miami, Florida 33186

Re: K042902

Trade/Device Name: Herbert Ulnar Head Prosthesis System Regulation Number: 21 CFR 888.3810 Regulation Name: Wrist joint ulnar (hemi-wrist) polymer prosthesis Regulatory Class: II Product Code: KXE Dated: September 27, 2004 Received: October 20, 2004

Dear Mr. Weisenborn:

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. Al Weisenborn

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 (240) 276-0120. 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 yours,

Alan Webb

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

Enclosure

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Indications for Use - Indications for

Page 1 of 1

KO42905 510(k) Number (if known):

Device Name: Herbert Ulnar Head Prosthesis System

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)

Division of General, Restorative and Neurological Devices

5110(k) Number K042602 Page 1 of 1

Regulation Number and Section

§ 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.

(a)
Identification. A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.(b)
Classification. Class II.