(64 days)
Prosthetic replacement with this device (Aequalis PerFORM+ glenoid component and humeral component) may be indicated to relieve severe pain or significant disability caused by:
- · Degenerative pathologies: arthrosis, rheumatoid arthrosis, post traumatic arthrosis
- · Primary and secondary necrosis of the humeral head
- · Displaced 4-part upper humeral fracture
- · Humeral head fracture
- · Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
- · Revision surgery when other treatments or devices have failed
- The Aequalis PerFORM+ glenoids are intended for cemented use only.
The Aequalis monobloc stem is for cemented use
The Aequalis Press-Fit is for uncemented use
The Aequalis PerFORM+ Shoulder System is a modular system consisting of a metaphyseal humeral stem component, anatomic humeral heads and glenoid for a total shoulder athroplasty. Surgical instruments are designed to facilitate proper implantation of the system.
The provided text describes a 510(k) premarket notification for the "Aequalis PerFORM+ Shoulder System." This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for meeting specific acceptance criteria related to AI/software performance.
Therefore, the requested information regarding acceptance criteria and studies (especially those related to AI/software performance, such as sample size, ground truth, expert involvement, MRMC studies, or standalone algorithm performance) is not applicable or cannot be extracted from this document, as it pertains to a traditional orthopedic implant rather than an AI/software-based medical device.
The "studies" mentioned are non-clinical performance data for the physical device, mainly mechanical and biocompatibility testing.
Here's a breakdown of the information that can be extracted or clarified as "not applicable" based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Validation and / or Verification Method | Acceptance Value / Criteria | Results |
|---|---|---|
| Loosening Test | No Loosening detected at completion of test. | Acceptable |
| Shear testing | Comparable to the predicate device design. | Acceptable |
| Tensile (pull out) testing | Comparable to the predicate device design. | Acceptable |
| Endotoxin | $\le 20\ EU / device$ | Acceptable |
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to mechanical and biocompatibility tests of the physical shoulder implant components, not a dataset for an AI/software. No information on the number of samples for these tests or data provenance is provided beyond the "results" column being "Acceptable."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/software (e.g., expert consensus on medical images) is not relevant to the non-clinical performance tests of an orthopedic implant.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept is for resolving discrepancies in expert labeling of data, which is not part of the described testing.
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 physical shoulder implant, not an AI diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical shoulder implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the non-clinical tests performed. The "ground truth" for mechanical testing is based on engineering standards and measurements, and for endotoxin, it's a quantitative lab result compared to a threshold.
8. The sample size for the training set: Not applicable. This is not an AI/software device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document is for a traditional medical device (shoulder implant) and therefore lacks the information requested about AI/software performance studies and related aspects.
§ 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.”