The indications for the use of the Osteonics® Solar Shoulder Humeral Bearing Head , in keeping with those of other legally marketed Osteonics® shoulder components, are as follows:
Indications

Aseptic necrosis of the humeral head.
Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
Proximal humeral fracture and/or dislocation.
Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

Device Description

The Osteonics® Solar Shoulder Humeral Bearing Heads are currently marketed devices that are being modified. The modification to the device involves a manufacturing process change in manufacturing of the humeral bearing head from wrought ASTM F-1537 cobalt chromium alloy to cast ASTM F-75 cobalt chromium alloy. Howmedica Osteonics intends to replace the current line of wrought cobalt chromium alloy humeral bearing heads with the subject cast cobalt chromium alloy humeral bearing heads. Minor dimensional changes will accompany the manufacturing process change. When changing from a machining process to a casting process. certain design features (dimensional) must be added to the cast part that is not necessary to the machined part when being manufactured. The internal geometry of the cast part requires draft angles to be placed on all walls of the device that are parallel to the parting line to facilitate the removal of the part from the casting mold. These angles range from approximately 0.5 degrees to 1.5 degrees per side.

AI/ML Overview

This document is a 510(k) premarket notification for a device modification, specifically for the Osteonics® Solar Shoulder Humeral Bearing Head. It primarily addresses the substantial equivalence of the modified device to its predicate device rather than detailing a study that meets specific acceptance criteria in the context of a diagnostic or AI-driven system.

The "Performance Data" section explicitly states: "Engineering Analyses have been performed to demonstrate that mechanical properties of the cast cobalt chromium alloy to be well within the acceptable limits for the subject device." However, the document does not provide the specific acceptance criteria or an in-depth report of these engineering analyses. It also does not involve human readers, AI, or ground truth establishment in the way typically seen in diagnostic device studies.

Therefore, many of the requested categories related to diagnostic studies (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to the information provided in this 510(k) summary.

Here's an attempt to present the available and inferred information in the requested format, with caveats for missing or non-applicable sections:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Mechanical Properties	Not explicitly stated in the document, but implies compliance with relevant ASTM standards for cobalt chromium alloy.	"Mechanical properties of the cast cobalt chromium alloy to be well within the acceptable limits for the subject device." (Based on Engineering Analyses)
Material Equivalence	Change from wrought ASTM F-1537 cobalt chromium alloy to cast ASTM F-75 cobalt chromium alloy must maintain substantial equivalence.	Demonstrated through "Engineering Analyses" and FDA clearance of substantial equivalence.
Dimensional Changes	Minor dimensional changes due to casting process (draft angles 0.5-1.5 degrees per side) must not affect function or substantial equivalence.	Acknowledged, and device deemed substantially equivalent by FDA.
Intended Use	Identical to the unmodified humeral bearing heads and predicate devices.	Stated as identical.
Indications for Use	Maintain existing indications for the predicate device.	Maintained, as listed (Aseptic necrosis, painful joint disease, proximal humeral fracture, revision, clinical management problems).

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

Sample Size for Test Set: Not applicable. This document refers to engineering analyses on materials, not a diagnostic test set with patient data.
Data Provenance: Not applicable. The "data" refers to material properties and engineering analysis results, not patient data from a specific country or retrospective/prospective study.

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

Not applicable. This is not a study requiring expert ground truth for diagnostic accuracy. Engineering analyses were performed by unnamed experts, implicitly with qualifications in materials science and biomechanical engineering.

4. Adjudication Method for the Test Set

Not applicable. There was no test set requiring adjudication in the context of diagnostic accuracy.

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 device is a shoulder prosthesis component, not an AI diagnostic tool or imaging device. Therefore, no MRMC study involving human readers or AI assistance was performed or is relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

Ground Truth: In this context, "ground truth" would refer to the established mechanical and material properties of the alloys and the structural integrity of the component as determined by validated engineering standards (e.g., ASTM F-75, F-1537) and biomechanical testing. The document states "Engineering Analyses have been performed."

8. The Sample Size for the Training Set

Not applicable. No training set was used as this is not an AI/machine learning device.

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

Not applicable. No training set was used.

Summary

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3/15/99

K990598

Special 510(k) - Device Modification Summary of Safety and Effectiveness for the Osteonics® Solar Shoulder Humeral Bearing Head

Submission Information

Name and Address of the Sponsorof the 510(k) Submission:	Howmedica Osteonics Corp.59 Route 17Allendale, NJ 07401-1677
Contact Person:	Marybeth NaughtonRegulatory Affairs Team Member
Date of Summary Preparation:	February 23, 1999
Device Identification
Proprietary Name:	Osteonics® Solar Shoulder HumeralBearing Head
Common Name:	Shoulder Prosthesis
Classification Name and Reference:	Shoulder joint humeral (hemi-shoulder)Metallic uncemented prosthesis21 CFR §888.3690OrShoulder joint metal/polymer semi-constrained cemented prosthesis21 CFR §888.3660

Predicate Device Identification

The modified features of the Osteonics® Solar Shoulder Humeral Bearing Heads are substantially equivalent to features of the following Osteonics® predicate devices, which have been cleared for marketing via the 510(k) process:

· Osteonics® Solar Shoulder Humeral Bearing Head (#K955731)

Device Description

The Osteonics® Solar Shoulder Humeral Bearing Heads are currently marketed devices that are being modified. The modification to the device involves a manufacturing process change in

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manufacturing of the humeral bearing head from wrought ASTM (American Society for Testing and Materials) F-1537 cobalt chromium alloy to cast ASTM F-75 cobalt chromium alloy. Howmedica Osteonics intends to replace the current line of wrought cobalt chromium alloy humeral bearing heads with the subject cast cobalt chromium alloy humeral bearing heads. Minor dimensional changes will accompany the manufacturing process change. When changing from a machining process to a casting process. certain design features (dimensional) must be added to the cast part that is not necessary to the machined part when being manufactured. The internal geometry of the cast part requires draft angles to be placed on all walls of the device that are parallel to the parting line to facilitate the removal of the part from the casting mold. These angles range from approximately 0.5 degrees to 1.5 degrees per side.

Intended Use:

The intended use of the modified humeral bearing heads is identical to that of the unmodified humeral bearing heads. As with the predicate humeral bearing heads, the modified humeral bearing heads are single use devices. They are intended for mating with the Osteonics® Solar Humeral Stems. The Osteonics® Solar Humeral Components are designed to be used in either cemented or cementless applications, as either a hemi-shoulder or a total shoulder component. For use as a total shoulder replacement, the modified and predicate humeral bearing heads may be used in conjunction with any legally marketed Osteonics glenoid component. The indications for the Osteonics® Solar Shoulder Components include:

Aseptic necrosis of the humeral head.
Painful. disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
. Proximal humeral fracture and/or dislocation.
. Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

Performance Data:

Engineering Analyses have been performed to demonstrate that mechanical properties of the cast cobalt chromium alloy to be well within the acceptable limits for the subject device.

Statement of Technological Comparison:

All features of the Osteonics® Solar Shoulder Humeral Bearing Head are unchanged with the exception of 1) the change in materials from wrought ASTM F-1537 cobalt chromium alloy to cast ASTM F-75 cobalt chromium alloy and 2)minor dimensional changes required for the casting procedure.

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Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 1999

Ms. Elizabeth A. Staub Vice President, Quality Assurance/Regulatory Compliance/Clinical Research Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

K990598 Re: Osteonics® Solar Shoulder Humeral Bearing Head Regulatory Class: III Product Codes: KWS and HSD Dated: February 23, 1999 February 24, 1999 Received:

Dear Ms. Staub:

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 able beated in the enoices, 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 aqainst 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. A 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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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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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.qov/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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Page 1 of 1

510(k) Number (if known): KY90598

Device Name: Osteonics® Solar Shoulder Humeral Bearing Head

Indications For Use:

The indications for the use of the Osteonics® Solar Shoulder Humeral Bearing Head , in keeping with those of other legally marketed Osteonics® shoulder components, are as follows:

Indications

Aseptic necrosis of the humeral head. ●
Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, ● rheumatoid arthritis or post-traumatic arthritis.
Proximal humeral fracture and/or dislocation.
Revision of previous unsuccessful total shoulder replacement, resurfacing or other ● procedure.
Clinical management problems where arthrodesis or alternative reconstructive ● techniques are less likely to achieve satisfactory results.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use__

(Optional Format 1-2-96)

Aisellifo
(Division Sign-Off)

Division of General Restorative Devices
510(k) Number K990898

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and 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,” and
(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,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(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 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”