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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 Exactech Equinoxe Small Reverse Shoulder System is a reverse shoulder system that provides small reverse glenoid plates, small reverse glenospheres, screw components, humeral liners, and surgical instrumentation for use in reverse total shoulder arthroplasty. The modifications proposed by this submission describe minor geometry changes to the predicate Exactech Equinoxe Reverse Shoulder System; these geometry modifications are the entire basis for the proposed Exactech Equinoxe Small Reverse Shoulder System.

This document is a 510(k) premarket notification for a medical device called the "Exactech® Equinoxe® Small Reverse Shoulder System." It describes the device, its intended use, and provides evidence of its substantial equivalence to previously cleared predicate devices.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or categorical format for performance metrics that would typically be expected for a diagnostic or AI-driven device. Instead, the "acceptance criteria" for this implantable device are demonstrated through mechanical and biological testing to show it performs as intended and is substantially equivalent to predicate devices. The "reported device performance" is essentially the successful outcome of these tests.

• Glenoid Plate Fixation Strength
• Glenoid Plate/Glenosphere Fixation Strength
• Range of Motion | - Equinoxe Small Glenoid Plate Fixation Testing: Performed in accordance with ASTM F2028 for Reverse Total Shoulder Arthroplasty. Results indicate adequate fixation strength.
• Equinoxe Small Glenoid Plate/Glenosphere Fixation Testing: Performed in accordance with ASTM F2028 for Reverse Total Shoulder Arthroplasty. Results indicate adequate fixation strength.
• Range of Motion Evaluation: Performed in accordance with ASTM F1378. Results demonstrate appropriate range of motion for the intended application. |
  | Biocompatibility/Sterility:
• Absence of Pyrogens | - Pyrogen Testing: Conducted in accordance with USP , USP , and ANSI/AAMI ST72. Components met recommended limits as per FDA guidance for sterile devices. |
  | Substantial Equivalence:
• Same Indications for Use, Intended Use, Materials, Design Features, and Basic Fundamental Scientific Technology as predicate devices. | - The proposed and predicate devices share: The same Indications for Use, the same intended use, the same materials, the same design features and basic fundamental scientific technology, the same compression screws, glenosphere locking screw, humeral liners, humeral adapter trays, and humeral stem compatibility. |

2. Sample size used for the test set and the data provenance

The document describes non-clinical laboratory testing (mechanical and pyrogen testing) rather than a test set of patient data. Therefore, this information is not applicable in the context of typical AI/diagnostic device studies using patient data. The "sample size" refers to the number of test articles (implants) used in the mechanical and pyrogen tests. The document does not specify exact numbers of test articles, but it does reference specific ASTM and USP standards for these tests, which would dictate appropriate sample sizes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The device is an implantable shoulder system, not a diagnostic or AI-enabled device requiring expert interpretation of results for ground truth establishment. The "ground truth" for this device's performance is established through standardized engineering and biological tests conducted by qualified laboratory personnel following established protocols.

4. Adjudication method for the test set

This information is not applicable as there is no test set in the sense of a collection of patient cases requiring expert adjudication. The "adjudication" of the device's performance is based on meeting the quantitative criteria specified by the referenced ASTM and USP standards during laboratory testing.

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 information is not applicable. This device is an implantable medical device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or would be relevant for this type of device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable. There is no algorithm or AI component in this device, so no standalone algorithm performance study was done.

7. The type of ground truth used

The ground truth used for this device's evaluation is primarily mechanical performance data against industry standards and biological safety data (pyrogenicity). This means:

• Mechanical Ground Truth: Adherence to the specified mechanical properties (e.g., strength, range of motion) as defined by ASTM F2028 and ASTM F1378.
• Biological Ground Truth: Absence of pyrogens within specified limits as defined by USP , USP , and ANSI/AAMI ST72.

8. The sample size for the training set

This information is not applicable. There is no AI component in this device, and thus no training set was used.

9. How the ground truth for the training set was established

This information is not applicable. As there is no training set for an AI/algorithm, no ground truth needed to be established in this context.

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