(18 days)
The Equinoxe™ Shoulder System is indicated to relieve pain and restore function in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
Clinical indications for the PRIMARY (P), LONG/REVISION (L/R) and FRACTURE (F) humeral components are as follows:
rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems
congenital abnormalities in the skeletally mature
primary and secondary necrosis of the humeral head.
humeral head fracture with displacement of the tuberosities
pathologies where arthodesis or resectional arthroplasty of the humeral head are not acceptable
revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved)
displaced three-part and four-part upper humeral fractures
spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases)
revision of failed previous reconstructions when distal anchorage is required
to restore mobility from previous procedures (e.g. previous fusion)
Exactech Equinoxe® Shoulder System. The cemented primary humeral stem, long/revision stem, fracture stem, and both the pegged and keeled glenoids are intended for cemented fixation only. The press-fit stems are intended for press-fit applications but may be used with bone cement if deemed appropriate by the surgeon. The long/revision stem is advised when the distal bone quality is insufficient to adequately anchor the primary stems (typically as a result of mid-humeral fractures). The fracture stem is advised for 3 & 4 part fractures of the proximal humerus. All components are supplied sterile.
The provided text is a 510(k) Summary for the Exactech Equinoxe Shoulder Stem Size Scope Extension. This document does not contain acceptance criteria or study data in the way one would find for an AI/ML device.
This is a submission for a device modification (addition of new size stems and increased lateral offset) to an existing shoulder prosthesis system. The "study" mentioned is "Engineering evaluations," which are typically mechanical tests and analyses to demonstrate that the new sizes and modifications are equivalent in performance to the predicate devices.
Therefore, many of the requested points are not applicable to this type of medical device submission.
Here's a breakdown based on the provided text, indicating where information is not present or not applicable for an AI/ML device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as acceptance criteria in the AI/ML sense. The general acceptance criterion is "substantial equivalence" to predicate devices. | "Engineering evaluations were conducted verifying the proposed Equinoxe Press-Fit Humeral Stems and the Equinoxe Cemented Revision Humeral Long Stems are appropriate for anticipated in vivo use and are substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of clinical trials for AI/ML. The "engineering evaluations" would involve a number of physical samples of the device components being tested for mechanical properties (e.g., strength, fatigue). The specific number of physical samples is not detailed in this summary.
- Data Provenance: Not applicable. These are engineering tests, not clinical data from patients.
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 as understood for AI/ML (e.g., expert labels on medical images) is not relevant for this type of mechanical device evaluation. The "ground truth" here would be the physical properties and performance characteristics determined through engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically for resolving discrepancies in expert labeling or clinical outcomes, not for engineering evaluations.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is specific to AI/ML assistive devices or diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical prosthetic device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's evaluation is based on engineering standards, mechanical testing results, and established performance characteristics of the predicate devices. This demonstrates that the modified stems meet the necessary physical and mechanical requirements for their intended use and are comparable to existing, legally marketed devices.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.