Search Results

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), 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)

The Equinoxe Reverse Shoulder System is indicated to relieve pain and restore function 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 Equinoxe Platform Fracture Stem is indicated to relieve pain and restore function in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty).

The Equinoxe Platform Fracture Stem is a humeral stem for use in acute fracture of the proximal humerus. The stem is designed to function with the Equinoxe primary shoulder and reverse shoulder components. All components are supplied sterile.

The provided document is a 510(k) premarket notification for a medical device (Exactech® Equinoxe® Platform Fracture Stem). It describes the device's indications for use, its substantial equivalence to predicate devices, and the types of tests performed. However, it does not contain detailed information about acceptance criteria for a specific study, nor does it provide a study that proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity for an AI/algorithm-based device.

The document discusses substantial equivalence for a physical implantable device and focuses on manufacturing, materials, dimensions, and sterilization processes, along with mechanical tests and simulations. These are not typically the types of performance metrics one would report for an AI/algorithm.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving device performance as described in your prompt (which is geared towards AI/algorithm evaluations) from this document.

To directly address your prompt based on the provided text:

1. A table of acceptance criteria and the reported device performance: This table is not present in the document. The document describes the device's intended use and design characteristics but not quantified performance against specific acceptance criteria in the manner of an AI/algorithm's output.

2. Sample size used for the test set and the data provenance: Not applicable/not provided. The "tests" mentioned are mechanical tests, engineering analyses, and simulated surgical implantations (sawbones and cadaver), not a test set of data for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. Ground truth in the context of an AI algorithm is not relevant here.

4. Adjudication method: Not applicable/not provided.

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 is not an AI-assisted device for human "readers."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used: Not applicable/not provided for an algorithm. For the physical device, it implicitly relies on engineering principles, material standards, and clinical outcomes of predicate devices.

8. The sample size for the training set: Not applicable. There is no algorithm training set for this physical device.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is for a traditional medical device (a shoulder stem implant) and does not describe the evaluation of an AI or algorithmic device using performance metrics like accuracy, sensitivity, or specificity.

Ask a specific question about this device