(46 days)
The Anatomica All-Poly Glenoid component is intended use in treatment of the following:
- Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
- Omarthrosis.
- Rheumatoid arthritis.
- Revision of shoulder prosthesis.
- Traumatology: the only cone to be used in traumatological indications is the traumatology cone.
The Anatomica Glenoid component is manufactured from ultra-high molecular weight polyethylene. It features a bone saving convex back surface with four threaded anchorage pegs to ensure stability. The three peripheral anchorage pegs are fitted with x-ray markers to allow for radiographic evaluation. The component is available in three sizes.
This document describes a medical device, the Sulzer Orthopedics Anatomica Glenoid Component, and its substantial equivalence to other legally marketed devices, rather than a study proving acceptance criteria for a new AI/ML device. Therefore, the requested information components are not directly applicable.
However, I can extract information related to the device's performance based on the provided text, which mentions general testing activities for medical devices.
Acceptance Criteria and Study for Sulzer Orthopedics Anatomica Glenoid Component
Based on the provided text, the device is a conventional medical implant, not an AI/ML device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets acceptance criteria" in the context of AI/ML performance metrics (like accuracy, sensitivity, specificity, etc.) are not directly applicable.
Instead, for this type of medical device, "acceptance criteria" generally refer to meeting regulatory requirements for safety and effectiveness, and "studies" involve demonstrating substantial equivalence to a predicate device and undergoing mechanical testing.
Here's an interpretation of the available information:
1. Table of Acceptance Criteria and the Reported Device Performance (as far as applicable):
| Acceptance Criteria (Interpreted for a medical implant) | Reported Device Performance |
|---|---|
| Biocompatibility and Material Safety: | Manufactured from ultra-high molecular weight polyethylene. (Implies material suitability) |
| Mechanical Stability and Durability: | "Static and Dynamic Testing indicated that the device would survive physiologic loading." |
| Substantial Equivalence to Predicate Devices: | Determined to be "substantially equivalent" to several named predicate devices. |
| Intended Indications for Use: | Met the stated specific diagnostic indications for cemented use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable for a mechanical implant. The document refers to "Static and Dynamic Testing" which would involve prototypes or manufactured components, not a "test set" of patient data in the AI/ML sense. Data provenance regarding patient cases is not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. "Ground truth" in the context of patient data for AI/ML validation is not relevant for this type of device. The mechanical testing would be evaluated against engineering specifications and industry standards by qualified engineers or experts in biomechanics, but the number and qualifications are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This refers to human review of AI/ML outputs, which is not relevant for a mechanical device.
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 pertains to studies evaluating AI assistance for human interpretation, which is not relevant for the Sulzer Orthopedics Anatomica Glenoid Component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This refers to AI algorithm performance without human intervention, which is not relevant for this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the AI/ML sense. For a mechanical implant, "ground truth" might be considered the successful mechanical performance against engineering standards and the clinical outcomes for the predicate devices to which it demonstrated substantial equivalence.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" or "ground truth for a training set" as this is not an AI/ML device.
Summary based on the document:
The Sulzer Orthopedics Anatomica Glenoid Component's acceptance relies on:
- Substantial Equivalence: Demonstrated similarity in intended use, design, materials, and technological characteristics to legally marketed predicate devices.
- Mechanical Testing: "Static and Dynamic Testing" confirmed the device's ability to "survive physiologic loading," implying it met internal or industry-standard performance criteria for mechanical integrity.
- Regulatory Compliance: Conformance with 21 CFR 807 and general controls provisions of the Federal Food, Drug, and Cosmetic Act.
§ 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.”