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The prostheses from FH Industrie are designed for specific indications such as:

SIMPLE HUMERAL PROSTHESIS

• Humeral head necrosis without injury to the glenoid cavity.
• Extensive humeral head cartilage damage without injury to the glenoid cavity
• Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
• Rheumatoid polyarthritis with thin rotator cuff.
• Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.

TOTAL ANATOMICAL PROSTHESIS (CEMENTED GLENOID IMPLANT WITH 4 PEGS)

• Centred glenohumeral osteoarthritis with functional rotator cuff
• Rheumatoid polyarthritis with functional rotator cuff
• Post-traumatic sequela, functional rotator cuff with glenoid injury.

TOTAL ANATOMICAL PROSTHESIS (POROUS GLENOID IMPLANT)

• Centred glenohumeral osteoarthritis
• Rheumatoid polyarthritis
• Post-traumatic sequela with glenoid injury
• Revision for glenoid loosening
• Glenoid bone loss, where bone graft is needed
• A functional rotator cuff is necessary to use this device

REVERSE PROSTHESIS (METAL-BACK OR POROUS GLENOID IMPLANT)
The ARROW Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device.

For all types of prosthesis, the glenoid baseplate (metal-back or porous) is intended for cementless use with the addition of bone screws for fixation, the humeral short stem (metaphyseal stem) is intended for cementless use. At least 2/3 of the metaphyseal component must be implanted in the proximal humeral bone to allow for adequate humeral component fixation.

The ARROW Humeral Short Stem Humeral System is an extension of humeral stem range of the Arrow prosthesis. The short stem is composed of a metaphyseal part and a cylindrical diaphyseal part. Both components are offered in various sizes to accommodate patient anatomy. This modular stem helps for better adaptation to each patient's anatomy. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3. The metaphysis has fins to provide rotational stability; it has a pure titanium plasma spray coating per ASTM 1580.

This document is a 510(k) Pre-Market Notification from the FDA for the ARROW Short Stem Humeral System. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed study of the device's performance against specific acceptance criteria.

Therefore, many of the requested elements (like acceptance criteria tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth methodologies) are not present in this document because they are typically part of a more extensive clinical or validation study report, not a 510(k) summary.

The document states that performance testing was conducted, but it's focused on mechanical testing, sterilization, packaging, and biocompatibility to demonstrate substantial equivalence, not clinical effectiveness against pre-defined acceptance criteria for a new clinical claim.

I will fill in the requested information based on what is available in the provided text. For categories where the information is not provided, I will explicitly state that.

1. A table of acceptance criteria and the reported device performance

This document does not provide a table of acceptance criteria or reported device performance in the manner of clinical efficacy or diagnostic accuracy. Instead, it states that "The results of all mechanical tests have shown them to be substantially equivalent to the predicate device."

Here's an attempt to extract the relevant tests conducted and the general outcome as described:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described is primarily mechanical and material testing, not clinical studies involving patient data. Therefore, the concepts of "test set" or "data provenance" in a clinical sense do not apply to the reported performance testing.

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)

This information is not provided in the document. The document describes mechanical and material testing for a surgical implant, not a diagnostic device where "ground truth" is typically established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. Adjudication methods are relevant for clinical studies, particularly those involving human interpretation of data, which is not described here.

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 provided in the document. The device is a surgical implant (shoulder prosthesis), not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance metrics are not applicable.

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

This information is not provided in the document. The device is a surgical implant, not an algorithm, so "standalone performance" in this context is not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not provided in the document. For the mechanical and material tests described, the "ground truth" would be the engineering specifications and performance thresholds established by relevant ASTM/ISO standards and internal design requirements, rather than clinical ground truth types like pathology or outcome data.

8. The sample size for the training set

This information is not provided in the document. As this is not an AI/machine learning device, the concept of a "training set" is not applicable.

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

This information is not provided in the document. As this is not an AI/machine learning device, the concept of a "training set" and its associated ground truth is not applicable.

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