(80 days)
The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
The proposed Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere represents a modification of the predicate Exactech Equinoxe Reverse Shoulder 46x25mm Glenosphere cleared in K063569. Both the predicate and proposed devices have the same intended use, general design features and basic fundamental scientific technology. The only difference between the predicate and the proposed device are the following dimensional modifications:
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- Reduced Lateral Offset The proposed glenosphere has a lateral offset of 21mm, which is 4mm shorter than the predicate 46x25mm glenosphere.
These modifications are proposed to provide another glenosphere option to the existing glenospheres cleared in K063569.
- Reduced Lateral Offset The proposed glenosphere has a lateral offset of 21mm, which is 4mm shorter than the predicate 46x25mm glenosphere.
This document discusses a 510(k) premarket notification for the "Exactech® Equinoxe® Reverse Shoulder 46x21mm Glenosphere." This is a medical device, specifically a component of a shoulder prosthesis. The document is a letter from the FDA to Exactech, Inc., indicating that the device has been found substantially equivalent to a legally marketed predicate device.
The "device" in question is not an AI/ML powered device, but a physical medical implant. Therefore, most of the requested information regarding AI/ML study design, such as sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, or MRMC studies, is not applicable. The provided text describes engineering tests performed to demonstrate substantial equivalence for this physical product.
Here's an analysis based on the provided text, addressing the relevant sections of your request:
1. A table of acceptance criteria and the reported device performance.
Since this is a physical medical device and not an AI/ML algorithm, the "acceptance criteria" are related to mechanical performance and the "reported device performance" are the results of engineering analyses demonstrating equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Demonstrated mechanical equivalence to predicate device for glenoid loosening, cyclic fatigue, deltoid abductor moment arms, and range of motion. | Engineering analyses (Glenoid Loosening and Cyclic Fatigue Testing, Analysis Of Deltoid Abductor Moment Arms, Range of Motion Analysis) were conducted and results demonstrated substantial equivalence to the cleared predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective).
This question is not applicable as the submission is for a physical medical device. The "test set" here refers to the actual physical devices or components tested in engineering analyses, not a dataset for an AI/ML model. The document does not specify the number of physical components tested in the engineering analyses. Data provenance in this context would refer to the testing facility and procedures, which are not detailed.
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).
This question is not applicable. "Ground truth" in the context of physical device testing would refer to established engineering standards and methodologies, not expert consensus on medical images or patient outcomes. The engineering analyses are likely performed by qualified engineers following established protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set.
This question is not applicable. Adjudication methods like 2+1 are used for resolving disagreements among human reviewers of cases, typically in clinical studies or for establishing ground truth for AI/ML. Engineering tests typically follow standardized protocols, and results are measured objectively, not through adjudication.
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.
This question is not applicable. An MRMC study is relevant for evaluating the clinical utility of an AI/ML-powered diagnostic or assistive tool. This device is a physical shoulder implant, and no AI component is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
This question is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
This question is not applicable for a physical device in the AI/ML sense. The "ground truth" for the engineering tests would be established engineering principles, material science properties, and established benchmarks for mechanical performance of similar medical implants.
8. The sample size for the training set.
This question is not applicable. There is no AI/ML model being trained for this physical device.
9. How the ground truth for the training set was established.
This question is not applicable. There is no AI/ML model being trained for this physical device.
Summary of what can be gleaned about the "study" (engineering analyses) for the device:
- Device: Exactech® Equinoxe® Reverse Shoulder 46x21mm Glenosphere (a physical shoulder implant component).
- Purpose of "Study": To demonstrate substantial equivalence of the new 46x21mm glenosphere to a predicate 46x25mm glenosphere, primarily due to a dimensional modification (reduced lateral offset).
- Methodology: "Engineering analyses" were conducted.
- Glenoid Loosening and Cyclic Fatigue Testing
- Analysis Of Deltoid Abductor Moment Arms
- Range of Motion Analysis
- Conclusion: The engineering studies demonstrated substantial equivalence to the predicate device.
- Data Provenance: Not specified in terms of country or retrospective/prospective, but implies laboratory-based engineering testing.
In essence, the document details the regulatory approval process for a physical medical device based on engineering tests, not an AI/ML algorithm or software.
§ 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.”