(19 days)
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.
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.
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.
§ 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.”