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The Equinoxe Shoulder System is indicated for use 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.

• The cemented primary humeral stem, long/revision stem, fracture stems, and all Equinoxe glenoids are intended for cemented fixation.
• The press-fit humeral stems are intended for press-fit applications but may be used with bone cement at the discretion the surgeon.
• The reverse humeral components are intended to be used in cemented applications or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
• Humeral Heads are intended for use in cemented and press-fit applications.

Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:

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 Equinoxe Platform Fracture Stem is indicated for use 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 indicated for cemented use only.

The proposed Equinoxe Activit-E Reverse Humeral Liners are humeral liners intended to be used in reverse total shoulder arthroplasty (rTSA) as a part of the Equinoxe® Shoulder System. The proposed devices are constructed of highly crosslinked UHMWPE containing vitamin E referred to as Activit-E. There are no proposed geometric or compatibility changes as compared to the predicate humeral liner devices cleared in K223833.

The provided document is a 510(k) clearance letter and summary for a medical device, the Equinoxe® Shoulder System. This document focuses on the substantial equivalence of a new version of the device (specifically, the Humeral Liners made from Activit-E material) to a previously cleared predicate device.

The FDA 510(k) clearance process is primarily focused on demonstrating substantial equivalence, not necessarily on proving that a device meets specific "acceptance criteria" in the same way one might for a diagnostic AI algorithm. Therefore, the information typically requested in an acceptance criteria study (like sample sizes for test and training sets, expert qualifications, ground truth establishment for AI, MRMC studies, or standalone algorithm performance) is not directly present in this regulatory submission for a physical orthopedic implant.

However, I will extract the closest available information related to performance and testing, as well as explicitly state where the requested information is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

For this specific medical device (Equinoxe® Shoulder System - Humeral Liners), the "acceptance criteria" are not reported as numerical thresholds like accuracy or sensitivity. Instead, the acceptance criteria are implicitly met by demonstrating that the new device performs "as intended" and is "substantially equivalent" to the predicate device through various non-clinical tests. The performance is assessed by confirming that the new Activit-E material does not negatively impact the mechanical integrity and biological interaction compared to the conventional UHMWPE.

2. Sample Sizes Used for the Test Set and the Data Provenance

This information is typically not included in a 510(k) summary for a physical implant. The "test sets" here refer to the samples of the device components used for mechanical and biological testing.

• Sample Size for Test Set: Not specified in the provided document (e.g., number of liners tested for fatigue, wear). These would be standard engineering test sample sizes as per relevant ASTM/ISO standards.
• Data Provenance: Not specified. Non-clinical bench testing is typically performed in a controlled laboratory environment. Retrospective/prospective data or country of origin are not applicable in the same way as for clinical studies or AI algorithms.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and therefore not provided. For a physical implant like a shoulder system, "ground truth" is established through engineering specifications, material properties, and performance standards, not through expert consensus on interpretations like with medical images.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used for expert review of clinical data (e.g., radiological images) to establish ground truth, which is not relevant for the bench testing of mechanical implants.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This information is not applicable and therefore not provided. MRMC studies are used to assess the impact of a diagnostic aid (e.g., an AI algorithm) on human reader performance, which is not relevant for the clearance of an orthopedic implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This information is not applicable and therefore not provided. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the Equinoxe® Shoulder System Humeral Liners is established through industry-recognized performance standards (ASTM and ISO standards) and engineering specifications. These standards define acceptable limits for wear, fatigue, biocompatibility, and other mechanical and biological properties. Compliance with these standards, along with demonstration of equivalence to the predicate device, forms the basis of the safety and effectiveness claims.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is a physical implant, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and therefore not provided.

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