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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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The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System or Univers II Shoulder Arthroplasty System.

The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is porous coated and is intended for cementless use with the addition of screws for fixation.

The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY are indicated for use in anatomic joint replacement(s) when conditions including severe pain or significant disability resulting from degenerative, rheumatic disease, fracture or injury of the glenohumeral joint; non-union humeral head fractures of long duration; avascular necrosis of the humeral head; neoplastic diseases; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

For anatomic joint replacement, the Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY are indicated to be used with the humeral components of the Arthrex II Shoulder Prosthesis System for total shoulder arthroplasty. The UNIVERSAL GLENOID INLAY is intended for use with the UNIVERS REVERS POROUS COATED BASEPLATE.

The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY consists of a porous coated titanium glenoid baseplate and a UHMWPE inlay bearing. The baseplate is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System or Univers II Shoulder Arthroplasty System. The baseplate is centrally anchored by a barbed post with superior and inferior multi-directional screws to ensure optimal fixation. The baseplate and inlay bearing come in three sizes to match anatomical size variations.

For a reversed shoulder application, the baseplate can be paired with the Univers Revers glenosphere.

For an anatomic shoulder application, the baseplate should be paired with the inlay bearing. The inlay bearing is available in two thicknesses (standards and +2mm) and in sizes corresponding to the glenoid baseplate. Pegs on the underside of the inlay bearing snap into corresponding recesses in the baseplate, ensuring a secure attachment to the bearing inlay, while at the same time minimizing angular rotation.

The provided text describes a 510(k) premarket notification for a medical device, the "Arthrex UNIVERS REVERS POROUS COATED BASEPLATE and UNIVERSAL GLENOID INLAY." This document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through comparison of design features, intended uses, and performance testing, rather than an AI-driven system.

Therefore, the information required to populate the fields related to acceptance criteria and ground truth for an AI/ML-based device (e.g., sample size for test/training sets, adjudication methods, expert qualifications, MRMC studies) is not present in this document. This document pertains to a physical orthopedic implant.

Here's what can be extracted regarding performance criteria for this specific device:

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

Missing Information (as pertains to AI/ML device evaluation):

The following points are Not Applicable (N/A) to this document, as it is a 510(k) submission for a physical implant, not an AI/ML diagnostic or therapeutic device:

• Sample sizes used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi reader multi case (MRMC) comparative effectiveness study was done.
• If a standalone (i.e., algorithm only without human-in-the loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

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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. The humeral stem is intended for cementless application while the glenoid baseplate (metal-back or porous) is intended for cementless application with the addition of bone screws for fixation.

The ARROW® Reverse porous glenoid base is used in total reverse shoulder prosthesis and is designed to articulate with the ARROW® Reverse shoulder system (cleared in K112193). The porous glenoid base is used with bone screws for fixation (cleared in K112193). The ARROW® Reverse porous glenoid is intended to be implanted using the dedicated instrumentation supplied by the manufacturer. This instrument set is common for all the configurations of prosthesis: simple humeral prosthesis, total anatomical prosthesis and reverse prosthesis.

This document is a 510(k) Premarket Notification from the FDA regarding the ARROW® Reverse Porous Glenoid. It is a submission for a Class II medical device (shoulder joint prosthesis) and primarily focuses on demonstrating substantial equivalence to existing predicate devices.

This document describes a medical device (shoulder prosthesis), NOT an AI/ML powered device.

Therefore, most of the requested information about acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable here.

Here's a breakdown based on the provided document:

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

Since this is a submission for a physical medical device (shoulder prosthesis) and not an AI/ML powered device, the "acceptance criteria" are related to mechanical and material performance, and "device performance" refers to the results of engineering tests.

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of prostheses tested) for the ASTM standards or LAL testing. These are typically engineering tests performed on a defined number of device units or material samples per the standard's requirements.
• Data Provenance: The tests were conducted by the manufacturer, Fournitures Hospitalières Industrie, based in France. The data would be "prospective" in the sense that the tests were performed specifically for this 510(k) submission on newly manufactured devices or samples.

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

• Not Applicable. This is a physical device submission. "Ground truth" in the context of AI/ML models (e.g., expert annotation of medical images) is not relevant here. Device performance is assessed through standardized mechanical and biological tests. The "experts" would be the engineers and technicians performing and interpreting these standardized tests.

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

• Not Applicable. As above, adjudication methods common in AI/ML performance evaluation (e.g., for reconciling expert disagreements) are not pertinent to the mechanical testing of a medical implant.

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, so MRMC studies and human reader improvement with AI assistance are irrelevant to this submission.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable for AI/ML "ground truth". For a physical device, "ground truth" relates to established engineering principles and the specifications within the ASTM standards. The device is expected to perform in accordance with the established mechanical and material properties defined by these standards.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. There is no "training set" or "ground truth" establishment in the AI/ML sense.

In summary, this document is a regulatory submission for a traditional implantable medical device, demonstrating its substantial equivalence to previously cleared devices through adherence to established material and mechanical performance standards, rather than through AI/machine learning performance metrics.

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