(150 days)
The Augmented VaultLock Glenoid is indicated in replacement(s) when conditions include severe pain or significant disability resulting from degenerative, traumatic 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 appropriate bone cement.
The Augmented VaultLock Glenoid is made of the same materials as the predicate (UHMWPE). The Augmented VaultLock Glenoid is designed with a half-wedge augment. The proposed device has an identical spherical articulating surface as that of the previously cleared glenoids and is available in 4 nominal sizes. The proposed device is a line extension to the Arthrex VaultLock Glenoid cleared under K161108.
This document is a 510(k) premarket notification for the "Augmented VaultLock Glenoid" by Arthrex Inc. It is a medical device, specifically a shoulder prosthesis. The document mainly focuses on proving the substantial equivalence of the new device to existing predicate devices, rather than establishing acceptance criteria and proving performance through a standalone clinical study with specific metrics like sensitivity, specificity, or reader improvement.
Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, and details on training sets for an AI device, are not applicable to this type of submission. This is a submission for a physical medical implant, not an AI or algorithmic diagnostic device.
The "Performance Data" section in the document refers to mechanical testing and biocompatibility testing, which are standard for physical implants, not clinical performance metrics in the way typically discussed for diagnostic algorithms.
Here's an attempt to fill in the table and address the questions based only on the provided text, recognizing that many fields will be "Not Applicable" for this type of device submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (if stated) | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Meets standards requirements (per ASTM F2028) | Demonstrated that the proposed device meets standards requirements (Rocking horse testing) |
| Biocompatibility | Meets pyrogen limit specifications (per ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14) | Bacterial Endotoxin test conducted and meets specifications |
| MRI Safety | N/A (implied to be safe in MR environment) | MRI testing conducted in accordance with FDA guidance and ASTM F2182 |
| Substantial Equivalence | Demonstrates equivalence to predicate device in terms of design features and intended use, with minor differences not raising safety/effectiveness questions. | Conclusion states: "The mechanical testing data demonstrates that the proposed device performance is equivalent to the predicate device for the desired indications. Any differences between the proposed device and the predicate device are considered minor and do not raise questions regarding safety or effectiveness." |
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. This submission describes mechanical and biocompatibility testing for a physical implant, not a clinical test set for an algorithmic device to establish diagnostic performance. The "tests" mentioned are physical and laboratory-based.
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 establishment by experts is relevant for diagnostic algorithms or subjective clinical assessments. This submission focuses on engineering performance (mechanical strength, material safety).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used for reconciling expert opinions in diagnostic studies. This is not a diagnostic study.
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. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. This device is a physical shoulder implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is based on engineering standards (e.g., ASTM F2028 for mechanical testing) and international standards for biocompatibility (e.g., ANSI/AAMI ST72). Compliance with these established industry standards serves as the benchmark for safety and performance in this context.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of an AI/algorithmic device for this physical implant.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" for this physical implant.
§ 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.”