(33 days)
The Special Orthopaedic Solutions Glenoid Shoulder Component is a single use device intended for cemented fixation within the prepared glenoid fossa of the shoulder. The indications for use of the total shoulder arthroplasty 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. The glenoid components are intended for cemented use only.
The Special Orthopaedic Solutions Glenoid Shoulder Component is designed for use as the glenoid component in a total shoulder arthroplasty. The glenoid is manufactured from ASTM F-648 ultra high molecular weight polyethylene (UHMWPE) and features an xray marking wire on its medial surface manufactured from ASTM F-90 cobalt chromium alloy. The glenoid component will be offered in three sizes 5, 7, & 9 with a 10 degree posterior buildup. Additional size 9 glenoid components both with and without posterior buildup will also be offered with new peg geometry.
This 510(k) summary describes a medical device, the Special Orthopaedic Solutions Glenoid Shoulder Component, which is a prosthetic component for total shoulder arthroplasty. The document compares this new device to a predicate device and relies on engineering analysis and mechanical testing rather than AI/ML performance metrics. Therefore, many of the requested categories related to AI/ML studies are not applicable.
Here's the information based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria and device performance are based on demonstrating equivalence to a predicate device (Osteonics All Polyethylene Glenoid Shoulder Component cleared under K950521) through mechanical testing and engineering analysis. The primary test mentioned is for glenoid loosening.
| Criterion | Acceptance Standard | Reported Device Performance |
|---|---|---|
| Mechanical Equivalence | Must demonstrate equivalence to predicate device in terms of mechanical properties and function. | "Testing has been performed to demonstrate equivalence of the subject device to its predicate device." |
| Glenoid Loosening (Dynamic) | Performance must be comparable to the predicate device, as evaluated by ASTM F2028-08. | "The testing includes dynamic evaluation of glenoid loosening via ASTM F2028-08." (The document implies successful demonstration of equivalence, but exact numerical results are not provided in this summary.) |
| Polyethylene Thickness | Engineering analysis must confirm appropriate thickness, especially with the proposed modifications (posterior buildup and modified peg geometry). | "and an engineering analysis on the polyethylene thickness." (The document implies successful confirmation, but detailed results are not provided in this summary.) |
| Material | Must use ASTM F-648 ultra high molecular weight polyethylene (UHMWPE) for the glenoid and ASTM F-90 cobalt chromium alloy for the x-ray marking wire. | The device is "manufactured from ASTM F-648 ultra high molecular weight polyethylene (UHMWPE)" and features "an x-ray marking wire on its medial surface manufactured from ASTM F-90 cobalt chromium alloy." This meets the material specification. |
| Indications for Use | Must align with the predicate device and standard indications for total shoulder arthroplasty. | The device "has the same indications for and intended use... as the previously cleared Osteonics All Polyethylene Glenoid Shoulder Component cleared under K950521." The listed indications for use are provided in the document. This meets the intended use and indications for use. |
| Operational Principles & Bearing Sizes | Must be the same as the predicate device. | The device "has the same... operational principles, and bearing sizes as the previously cleared Osteonics All Polyethylene Glenoid Shoulder Component cleared under K950521." This meets the operational principles and bearing sizes. |
| Posterior Buildup and Peg Geometry | Must be evaluated to ensure proper function and safety despite modifications. | The device "consists of a rotation to the bearing surface of the implant to increase the posterior thickness to help restore joint alignment. Additional size 9 glenoid components both with and without posterior buildup will also be offered with a modified peg geometry." These modifications were presumably assessed as part of the engineering analysis and dynamic testing. |
Study Information (as applicable to a non-AI/ML medical device submission)
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Sample size used for the test set and the data provenance:
- The document implies mechanical testing was performed in a lab setting, referencing ASTM F2028-08. The specific sample size for this test is not provided in this summary.
- Data Provenance: Not explicitly stated, but standard mechanical testing is typically conducted in a laboratory environment to represent real-world conditions. It's prospective in the sense that physical prototypes are tested.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device relies on mechanical engineering principles and standardized test methods (like ASTM F2028-08), not human expert ground truth for classification.
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Adjudication method for the test set:
- Not applicable. This is a mechanical device, and performance is determined by adherence to engineering specifications and test standards, not through adjudication of expert opinions.
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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 orthopedic implant, not an AI/ML diagnostic or assistive device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical orthopedic implant, not an algorithm. Performance is assessed through mechanical testing.
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The type of ground truth used:
- The "ground truth" here is adherence to established engineering principles, material specifications (ASTM F-648, ASTM F-90), and performance standards outlined in ASTM F2028-08 for dynamic glenoid loosening.
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The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning. Design and material selection are based on established engineering knowledge and previous predicate device experience.
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How the ground truth for the training set was established:
- Not applicable. No "training set" in the ML sense. The design and manufacturing process are based on established engineering standards, materials science, and prior successful designs (predicate device) that serve as a basis for ensuring safety and effectiveness.
§ 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.”