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The Equinoxe Stemless Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment.

Clinical indications for anatomic total shoulder arthroplasty are as follows:

• · Osteoarthritis, osteonecrosis or post-traumatic degenerative problems
• · Congenital abnormalities in the skeletally mature
• · Primary and secondary necrosis of the humeral head
• · Pathologies where arthrodesis or re sectional 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)
• · To restore mobility from previous procedures (e.g. previous fusion)

In the USA, the Equinoxe Stemless Shoulder is only indicated for total shoulder arthroplasty.

The Equinoxe Stemless Shoulder humeral components are indicated for press-fit, uncemented use.

When used in total shoulder arthroplasty, the Equinoxe Stemless Shoulder System is intended to be used with the cemented Equinoxe glenoid components.

The Equinoxe Stemless Humeral Components are intended to be used with Exactech Equinoxe Stemless Humeral Heads and the Equinoxe glenoid components for use in Total Shoulder Arthroplasty. The Exactech glenoid components are indicated for cemented use. The proposed Equinoxe Stemless Humeral Components are additively manufactured from Ti-6Al-4V and have porous regions. The Equinoxe Stemless Humeral Components are available in in three sizes, with lengths between 17mm and 24mm.

This FDA 510(k) K192097 premarket notification is for a medical device called the Exactech® Equinoxe® Stemless Humeral Components. It is an orthopedic implant for shoulder arthroplasty.

It's important to note that this document describes a traditional 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device through engineering analyses and non-clinical testing. It does not involve studies with human subjects, AI algorithms, or deep learning models. Therefore, many of the requested fields (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone AI performance, training set sample size) are not applicable to this type of device submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail numerical sense for each test. Instead, it states that the devices "perform as intended and are substantially equivalent to the identified predicate devices" based on the non-clinical testing. The "reported device performance" is the conclusion that the device passes these tests, thereby demonstrating substantial equivalence.

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

• Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., number of units tested for fatigue). These would typically be determined by relevant ASTM or ISO standards for testing orthopedic implants, but are not detailed in this summary.
• Data Provenance: Not applicable in the context of this device. The "data" comes from engineering and laboratory testing of the physical device components, not from patient data or clinical images. It's not retrospective or prospective in the clinical sense.

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

Not applicable. "Ground truth" in this context is established by physical measurement against engineering specifications and industry standards for material properties, mechanical performance, and sterilization. It doesn't involve clinical experts establishing diagnoses or observations.

4. Adjudication Method for the Test Set

Not applicable. There's no "test set" in the sense of clinical cases requiring adjudication. The tests are physical and chemical 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

Not applicable. This is a physical orthopedic implant, not an AI-powered diagnostic or assistive 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 orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on:

• Established mechanical engineering principles.
• Relevant ASTM/ISO International Standards for orthopedic implants.
• FDA Guidance Documents (e.g., for sterility).
• Material specifications (e.g., for Ti-6Al-4V).
• Functional requirements for shoulder replacement devices.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is a physical implant, not a machine learning model.

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

Not applicable, as there is no training set.

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The Remedy® Shoulder Spacer, which consists of a modular head and stem, is indicated for temporary use (maximum 180 days) as an adjunct to total or hemi-shoulder replacement in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organisms.

The head and stem components are inserted into the glenoidal cavity and humeral medullary canal, respectively, following removal of the existing prosthetic components and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The Remedy® Shoulder Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).

The Remedy® Shoulder Spacer is a sterile, single-use device intended for temporary use (maximum 180 days) as shoulder replacement.

The Remedy® Shoulder Spacer is composed of two components (a head and a stem) that are intended to be used together to form a temporary shoulder spacer; the components are available in a range of sizes.

The device is made of fully formed polymethylmethacrylate (PMMA), which is radioopaque and contains gentamicin. The stem component has also an inner stainless steel reinforcing structure.

The Remedy® Shoulder Spacer provides a functional-mechanical mode of action; it provides patients a temporary implant allowing for a natural range of motion and partial weight-bearing during treatment. It is designed to preserve soft tissue to prevent further complications, such as muscular contraction, and to facilitate the subsequent joint replacement procedure.

This document appears to be a 510(k) Summary for a medical device called the "Remedy® Shoulder Spacer." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study designed to meet specific acceptance criteria in the way one would for an AI/ML powered device.

Therefore, many of the requested categories for AI/ML device studies (like sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document as it describes a physical orthopedic implant, not a software algorithm.

Below is an attempt to map the available information to the closest relevant categories, with explanations for why certain sections are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

As this is not an AI/ML device, the concept of "acceptance criteria" for diagnostic performance metrics (e.g., sensitivity, specificity, AUC) is not present. Instead, the document discusses performance testing designed to demonstrate safe and effective mechanical function and material properties, and equivalence to a predicate device. The "acceptance criteria" would be compliance with relevant standards and demonstration of properties comparable to the predicate.

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

This is not applicable for a physical device 510(k) submission in the context of diagnostic "test sets." The performance data is based on laboratory testing of the device itself and its components, according to established engineering and material science protocols. There is no biological "data" in the sense of patient images or clinical outcomes that would have "provenance."

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

This is not applicable. "Ground truth" in this context refers to a standard of truth for diagnostic or clinical outcome data, which is not evaluated here. The "truth" for device performance is established through physical and chemical testing against engineering standards and comparison to a predicate device.

4. Adjudication method for the test set

This is not applicable. There is no clinical "test set" requiring adjudication by experts.

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 is not applicable as this is not an AI/ML device or a diagnostic device involving "human readers."

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

This is not applicable as this is not an AI/ML device.

7. The type of ground truth used

This is not applicable in the AI/ML sense. The "ground truth" for the device's acceptable performance is defined by:

• Compliance with recognized standards: e.g., ISO for biocompatibility, sterilization standards.
• Engineering and material science principles: for mechanical strength, fatigue, material composition.
• Comparative data to a legally marketed predicate device: demonstrating that the new device is "substantially equivalent" in terms of safety and effectiveness.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device. There is no concept of a "training set" for a physical orthopedic implant.

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

This is not applicable as this is not an AI/ML device.

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