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Aequalis Shoulder System (excluding Acqualis Shoulder Fracture System): Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by: Degenerative pathologies : arthrosis, rheumatoid arthritis, post-traumatic arthrosis. Primary and secondary necrosis of the humeral head Displaced 4-part upper humeral fracture Humeral head fracture Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable Revision surgery when other treatments or devices have failed. Aequalis Shoulder Fracture System Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures. Revision surgery when other treatments or devices have failed.

The labeling for the Aequalis Shoulder Fracture System and Aequalis Shoulder System is being modified to indicate that, when used as total shoulder prostheses, the Aequalis Shoulder Fracture System humeral stems, Aequalis Shoulder System humeral stems and Aequalis humeral heads are compatible with the Affiniti pegged glenoid components in addition to the Aequalis glenoid components that have been previously cleared for use with these systems. The Affiniti pegged glenoid components are available in sizes 40 - 56.

The provided text is a 510(k) summary for a medical device (Aequalis Shoulder System and Fracture System). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study or even a standalone technical performance study.

Therefore, the document does not contain the information requested about acceptance criteria, device performance, test set details (sample size, provenance, ground truth experts, adjudication), MRMC studies, or standalone algorithm performance.

The reason for this is that the submission states:

"The indications, intended uses, designs, materials and manufacturing methods for the Aequalis Shoulder Fracture System and Aequalis Shoulder System have not changed from those cleared previously in K060209. These systems, with labeling modified to include compatibility with the Affiniti pegged glenoid components, are therefore substantially equivalent to the systems that have been cleared previously."

This indicates that the submission is for a minor modification (compatibility with new glenoid components) to an already cleared device, relying on the substantial equivalence principle rather than new performance testing.

However, I can extract the following information based on the provided text:

• Device Name: Aequalis Shoulder Fracture System and Aequalis Shoulder System
• Device Type: Total shoulder prosthesis (Shoulder joint metal/polymer semi-constrained cemented prosthesis)
• Classification: Class II
• Product Codes: 87 KWS
• Predicate Devices: K994392, K003728, K012212, K032679, K060209 (for Fracture System) and K952928, K980244, K012212, K041339, K043077, K060209, K060988 (for Shoulder System).

In summary, there is no information in the provided document to answer the questions about acceptance criteria and device performance studies because the submission is based on substantial equivalence to predicate devices, not new performance data.

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The Aequalis Reversed Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.

When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to implant a base plate and a sphere of Aequalis Reversed range again, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

The Aequalis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional.

Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition and to recuce or eliminate pain. The Aequalis Reversed Shoulder Prosthesis is intended to accomplish these goals. Its reversed design allows to medialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm.

The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.

The present device modification submission consists in :

• addition of glenoid baseplates and glenoid spheres, .
• addition of polyethylene inserts.

The provided text is a 510(k) premarket notification letter and a summary of safety and effectiveness information for a medical device. It does not contain information about acceptance criteria or a study that proves the device meets those criteria, as typically seen in performance studies for diagnostic or AI-based devices.

The document describes the device, its indications for use, materials, and classification within the FDA's regulatory framework. It primarily focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for certain medical devices. This type of submission does not usually include detailed performance studies with acceptance criteria in the way a clinical trial or AI algorithm validation would.

Therefore, I cannot provide the requested information based on the given text.

To address the specific points you asked for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
2. Sample sized used for the test set and the data provenance: Not applicable/not present. The document is for a physical orthopedic implant, not a diagnostic device that uses a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present.
4. Adjudication method for the test set: Not applicable/not present.
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 device is an orthopedic implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used: Not applicable. For an orthopedic implant, "ground truth" in the context of device performance usually refers to clinical outcomes, wear testing, mechanical properties, etc., which are not detailed in this summary.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

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The Aequalis Reversed Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.

When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to implant a base plate and a sphere of Aequalis Reversed range again, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.

The present device modification submission consists in some additions and changes for metaphyseal screw, glenoid baseplate, glenoid sphere and insert.

Metaphyseal inserts are made of ultra high molecular weight polyethylene (UHMWPE). The base of the glenoid implant is manufactured from Titanium alloy. The sphere is manufactured from Cobalt-Chromium alloy and the screw is manufactured from Titanium alloy.

The hydroxylapatite coating conforms to the ASTM standard F 1185. The coating is performed by BioCoat, Inc. according to their Master File MAF-339.

This is a 510(k) premarket notification for a medical device (Aequalis Reversed Shoulder Prosthesis), not a study report detailing acceptance criteria and performance data. Therefore, the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, etc.) is not available in the provided document.

510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics for the novel device itself.

Here's what can be inferred from the document regarding the device and its regulatory status:

• Device Name: Aequalis Reversed Shoulder Prosthesis
• Intended Use: Restore shoulder joint function and relieve pain for patients with functional deltoid muscle, suffering from arthropathy associated with massive and non-repairable rotator cuff-tear, and for prosthetic revisions with massive and non-repairable rotator cuff-tear. It can also be adapted into a non-reversed hemi-prosthesis if glenoid bone stock is insufficient during primary surgery or revision.
• Predicate Devices: Aequalis Reversed Shoulder Prosthesis (K030941, K041873, K050316), Aequalis Shoulder System (K952928, K012212, K041339, K060209), Delta Shoulder (K021478). This indicates the device is considered substantially equivalent to these devices.
• Regulatory Clearance: The FDA has issued a substantial equivalence determination (K061439) for this device on July 20, 2006, allowing it to be marketed.

The document does NOT contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance for a study proving acceptance criteria.
3. Number or qualifications of experts used to establish ground truth for a test set.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
6. Information about a standalone (algorithm only) performance study.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How the ground truth for a training set was established.

This document is a regulatory approval letter based on substantial equivalence, not a clinical trial report.

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AEQUALIS Shoulder Range (except AEQUALIS for Fracture): Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by: - Degenerative pathologies : arthrosis, rheumatoid arthritis, post-traumatic arthrosis. i Primary and secondary necrosis of the humeral head - Displaced 4-part upper humera! fracture । - Humeral head fracture । - Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable - Revision surgery when other treatments or devices have failed. - AEQUALIS for Fracture: Traumatic or pathologic conditions of the shoulder resulting in fracture of the Fraumatio of painting of joing humeral head fracture and displaced 3-or 4-part proximal humeral fractures. Revision surgery when other treatments or devices have failed.

Total-Shoulder System and Hemi-Shoulder System. Shoulder joint metal/polymer semi-constrained cemented prosthesis.

This document is a 510(k) premarket notification for a medical device (AEQUALIS Shoulder Fracture System, AEQUALIS Shoulder System). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/software as a medical device.

The provided text is a regulatory filing for a physical medical device (shoulder prosthesis), focusing on establishing substantial equivalence to previously marketed predicate devices. It lists indications for use, device classification, and administrative details for FDA approval.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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