(131 days)
The Arthrex VaultLock Glenoid is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatic disease, or injury of the glenohumeral joint: non-union humeral head fractures of long duration: irreducible 2- and 4- part proximal humeral fractures: avascular necrosis of the humeral head; or, other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.
The glenoid components are designed fixation in the joint and must only be used with an appropriate bone cement.
The Arthrex VaultLock Glenoid is a UHMWPE glenoid designed to be used with the existing Univers II Shoulder Prosthesis system (K071032). The proposed Arthrex VaultLock Glenoid has an identical spherical articulating surface as that of the previously cleared glenoids and is available in 4 nominal sizes.
This document is a 510(k) Pre-Market Notification for the Arthrex VaultLock Glenoid, a medical device. This document describes a medical device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details for AI/ML performance, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable here.
The document contains information about the device's performance testing, which serves a similar role to "acceptance criteria" but in the context of device equivalence rather than AI/ML model performance.
Here's the relevant information extracted from the document regarding the device's performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test / Acceptance Criteria | Reported Device Performance |
|---|---|
| Bacterial Endotoxin Testing | Performed per EP 2.6.14/USP |
| Rocking Horse Stability | Preclinical testing performed per ASTM F2028 |
Explanation of Performance:
- Bacterial Endotoxin Testing: This test ensures that the device is free from harmful levels of bacterial endotoxins, which are a safety concern for implanted devices. The performance indicates that the device met the standards specified in European Pharmacopoeia (EP 2.6.14) and United States Pharmacopeia (USP ).
- Rocking Horse Stability: This test, performed according to ASTM F2028, assesses the mechanical stability of the glenoid component within the joint under simulated loading conditions. This is crucial for evaluating its long-term performance and resistance to loosening once implanted.
2. Sample size used for the test set and the data provenance: Not applicable. This is a physical medical device, not an AI/ML diagnostic system. The "test set" here refers to physical devices undergoing testing, not a dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert consensus are concepts typically applied to AI/ML model evaluation of data, not to the physical testing of a medical implant. The design and testing standards (e.g., ASTM) are established by groups of experts in biomaterials and orthopedics, but this is a different context.
4. Adjudication method for the test set: Not applicable as this is a physical device testing, not an AI/ML evaluation.
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 document pertains to a physical shoulder prosthesis, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a physical device. For device performance, the "ground truth" is defined by the objective physical and chemical properties measured against established standards (e.g., freedom from endotoxins, mechanical stability under load).
8. The sample size for the training set: Not applicable. There is no AI/ML training set mentioned.
9. How the ground truth for the training set was established: Not applicable. There is no AI/ML training set mentioned.
Summary of Device Equivalence:
The document concludes that the Arthrex VaultLock Glenoid is "substantially equivalent to the predicate devices in which the basic design features and intended uses are the same. Any differences between the Arthrex VaultLock Glenoid and the predicates are considered minor and do not raise questions concerning safety and effectiveness." This substantial equivalence is based on the device's design, intended use, and the successful completion of the described performance tests.
§ 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.”