(14 days)
The Select Shoulder Curved-back Pegged All-Poly Glenoids, when used with one of the Select Shoulder Humeral Stems and Humeral Heads, are intended only for use with bone cement in cases of total shoulder arthroplasty for treatment of the following:
- Patient conditions, including but not limited to, noninflammatory degenerative joint > 1. disease (NIDJD), e.g., osteoarthritis or post-traumatic arthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- Complex acute fractures, fracture-dislocations of the humeral head, malunion or non-2. union of a small osteoporotic head fragment, chronic, recurrent or acute dislocation with loss of humeral head cartilage, or large impression fractures.
- Those patients with failed previous surgery where pain, deformity, or dysfunction 3. persists.
- Failed previous surgery, including joint reconstruction, internal fixation, nonunion of the 4. humeral neck, arthrodesis or hemiarthroplasty.
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- Cuff tear arthropathy.
- Avascular necrosis or osteonecrosis of the humeral head. 6.
- Tumor resection. 7.
The Curved-back Pegged All-Poly Glenoid is a one piece, polyethylene (ASTM F648) design intended to reproduce the function of the natural glenoid. The design is such that the component may be used in either the right or left shoulder. The implant is cemented into the subchondral bone of the glenoid cavity providing a cement mantle of approximately 1-2 mm.
This design features a curved articulating surface. The component has two grooved pegs bounded by two dovetail cement grooves which provide translational and rotational stability to the implant as well as to enhance cement fixation. The grooves in the pegs also allow the surgeon to intraoperatively trim the length in the glenoid vault is shallow and prevents the full length from being seated. Titanium (ASTM F136) x-ray marker pins are incorporated in the superior aspects of the component to assist in postoperative evaluation. The lateral surface of the glenoid component accommodates the humeral head. The articulating geometry is nonconstrained for greater range of motion and greater translation.
This is a medical device 510(k) summary, not a study describing acceptance criteria and device performance. The provided text describes the product, its intended use, and claims substantial equivalence to other existing devices.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, and ground truthing methods cannot be extracted from this document.
Here's what can be gathered, with caveats:
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Table of acceptance criteria and the reported device performance: This information is not present in the provided text. The document states, "Contact area testing indicates that the Curved-back Pegged All-Poly Glenoids offer adequate contact area at various levels of abduction." This is a qualitative statement of performance, not a quantitative report against specific acceptance criteria.
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Sample size used for the test set and the data provenance: Not applicable. No test set or study of this nature is described. The "contact area testing" mentioned is likely an internal engineering test, not a clinical study with a test set of data.
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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. No clinical study with ground truth established by experts is described.
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Adjudication method for the test set: Not applicable. No test set or adjudication method is described.
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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 document describes a physical medical implant (glenoid prosthesis), not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI-related effectiveness are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No clinical study with a defined ground truth is described.
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The sample size for the training set: Not applicable. This is not an AI or machine learning device requiring a training set.
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How the ground truth for the training set was established: Not applicable, as this is not an AI or machine learning device requiring a training set.
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”