(28 days)
The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:
- A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
- Fracture-dislocations of the proximal humerus where the articular surface is Fracture ansiountine , separated from its blood supply or where the surgeon's severience indicates that alternative methods of treatment are unsatisfactory.
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
Glenoid components are intended for cemented use only.
The DePuy Global™ Crosslink Glenoids are offered in an anchor peg and a fin design. The Crosslink Glenoid anchor peg design consists of sizes: 40mm, 48mm, 48mm, 52mm, 56mm and 56mmXL. The Crosslink Glenoid in the fin design consists of seven sizes: 40mmXS, 40mm, 44mm, 52mm, 52mm, 56mm and 56mmXL. Both the anchor peg and fin designs have a lateral surface that is concave and designed to articulate with the DePuy Global™ line humeral heads indicated for ase in total shoulder arthroplasty. The fixation surface has a central fin or peripheral pegs and is intended to be attached to the glenoid fossa of the scapula with bone cement.
The provided text is a 510(k) premarket notification for a medical device, the DePuy Global™ Shoulder Crosslink Glenoid. This type of document is for demonstrating substantial equivalence to a predicate device, not for proving a device meets acceptance criteria through a study with the detailed structure you've requested.
Therefore, many of the specific details you've asked for, such as acceptance criteria in the context of a performance study, sample sizes for test and training sets, expert qualifications, and adjudication methods for AI performance, are not applicable and not present in this document.
This submission focuses on justifying that the new device (Crosslink Glenoid) is substantially equivalent to existing, legally marketed devices, primarily by demonstrating similar design and intended use, and emphasizing a material difference (highly cross-linked polyethylene) with an additional claim of reduced wear based on shoulder simulator wear studies.
Here's an attempt to answer your questions based only on the provided text, while highlighting what information is missing:
Acceptance Criteria and Study to Prove Device Meets Them
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance (Summary from Section {1}) |
|---|---|
| Design: Same as predicate Glenoid components (K981497, K914000) | Has the same design as predicate Glenoid components. |
| Intended Use: Same as predicate Glenoid components | Has the same intended use as predicate Glenoid components. |
| Indications: Same as predicate Glenoid components | Has the same indications as predicate Glenoid components. |
| Material: Same as predicate Tibial Inserts (K040166) | Made from the same cross-linked polyethylene as predicate Tibial Inserts. |
| Wear Reduction: Expected to show reduced wear compared to Enduron polyethylene. | Shown to have a reduction in wear compared to currently available Enduron polyethylene, based on shoulder simulator wear studies. |
Note: The acceptance criteria here are inferred from the basis of substantial equivalence. They are not explicit, quantitative performance targets as might be found in a clinical trial or a performance study designed to demonstrate specific metrics (e.g., accuracy, sensitivity, specificity for an AI device). The primary acceptance criterion here is "substantial equivalence" to the predicate devices, with an added claim for improved wear.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The "study" mentioned is "shoulder simulator wear studies," which refers to in-vitro mechanical testing, not a human-data-based test set in the context of AI. The number of components tested in these simulator studies is not specified.
- Data Provenance: Not applicable for human data. The "study" is a laboratory-based, in-vitro shoulder simulator wear study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a physical implant, not an diagnostic algorithm requiring expert "ground truth" labels.
4. Adjudication method for the test set:
- Not applicable. This device is a physical implant.
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 not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI device.
7. The type of ground truth used:
- The "ground truth" for the wear reduction claim is based on physical measurements of wear from in-vitro shoulder simulator studies.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI device for this product.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" in the context of an AI device for this product.
§ 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.”