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In an anatomic shoulder configuration, the Humeris Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:

• A severely painful and/or disabled joint resulting from osteoarthritis or o rheumatoid arthritis;
• . Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).

In a reverse shoulder configuration, the Humeris Shoulder is indicated for primary or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The humeral stem of the Humeris Cementless Shoulder is intended for cementless use only. The humeral stem of the Humeris Cemented Shoulder is intended for cemented use only.

The glenoid components of the Humeris Shoulder System are intended for cemented use only. The glenoid baseplate component is intended for cementless use with the addition of screws for fixation.

The Humeris® 135 Shoulder System adds new components to the previously cleared Humeris Shoulder System (K163669). The additional new components are humeral cups eccentric symmetric and a Humeris humeral spacer, which provide a 135 degree angle for articulation with the previously cleared glenospheres and humeral cups (K150488 Humelock II® Reversible Shoulder System and K162455 Humelock Reversed® Shoulder System) when used in a reverse shoulder construct.

The Humeris Shoulder System can be used in either an anatomic or a reverse configuration and includes both cementless and cemented variants of the humeral stems.

The Humeris Cementless Humeral Stem is manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 with a plasma sprayed commercially pure Titanium (CP Ti) and hydroxyapatite (HA) coating at the distal end.

The Humeris Cemented Humeral Stem is also manufactured from Ti-6Al-4V allov conforming to ISO 5832-2 with a trapezoidal a polished surface at the distal end.

This document, K222936, is an FDA 510(k) Premarket Notification for the Humeris® 135 Shoulder System. It asserts substantial equivalence to a previously cleared predicate device rather than presenting a de novo study with novel performance criteria. Therefore, the traditional concept of "acceptance criteria" for a new device's performance, as would be found in a clinical trial or a study designed to prove a device meets specific accuracy or efficacy thresholds, is not directly applicable to this submission.

Instead, the acceptance criteria here are focused on demonstrating substantial equivalence to a predicate device. This means the device performs at least as safely and effectively as the predicate, without raising new questions of safety or effectiveness. The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical testing presented to support this claim of substantial equivalence.

Based on the provided text, here's a breakdown of the information requested, framed within the context of a 510(k) submission for substantial equivalence:

Acceptance Criteria and Device Performance (in the context of Substantial Equivalence)

The acceptance criteria for a 510(k) device like the Humeris® 135 Shoulder System are primarily met by demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use, fundamental technological characteristics, and similar performance to the predicate, or that any differences do not raise new questions of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not specify a numerical sample size for the "Range of motion analysis" or "Construct fatigue testing." These types of tests typically involve a defined number of test articles (e.g., specific numbers of implants subjected to fatigue cycling) rather than patient samples.
• Data Provenance: The testing described (Range of motion analysis, Construct fatigue testing) is non-clinical/bench testing. It is conducted in a controlled laboratory environment, not on human subjects. Therefore, provenance like country of origin for patient data or retrospective/prospective status is not applicable.

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

• This is a 510(k) submission primarily relying on bench testing and comparison to a predicate device. The concept of "ground truth" established by experts for a test set (e.g., for diagnostic accuracy) is not applicable here.
• The determination of substantial equivalence is made by the FDA based on the submission and relevant regulations. Design engineers, materials scientists, and biomechanical engineers would have conducted and interpreted the non-clinical tests.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or outcomes, where human expert consensus is needed to establish ground truth or evaluate performance. This submission relies on non-clinical engineering tests.

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 medical device (shoulder prosthesis) with no AI component or interpretative function. Therefore, MRMC studies are not relevant.

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

• Not applicable. This is a surgical implant, not an algorithm or diagnostic imaging device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• For the non-clinical testing, the "ground truth" is defined by established engineering and material science standards, specifications, and test methodologies (e.g., ISO standards, ASTM standards). The "truth" is whether the device meets predefined mechanical performance thresholds (e.g., completing a certain number of fatigue cycles without failure, demonstrating comparable range of motion as determined by engineering analysis).

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable, as this is not an AI/ML device requiring a training set.

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When used in the Humelock II Reversible Shoulder System: The Humelock II Reversible Shoulder is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The humeral stems are intended for cemented or cementless use. The metaglene baseplate is intended for cementless use with the addition of screws for fixation.

When used in the Humelock Reversed Shoulder System:

The Humelock Reversed Shoulder is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable cuff tear.

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

During primary or revision surgery, if the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or the glenoid bone fractures during the procedure, a taper adapter can be used to convert the Humelock Reversed Shoulder to an anatomic hemi-shoulder prosthesis.

The humeral stem of the Humelock Reversed Cemented Shoulder Prothesis is intended for cemented use only. The humeral stem of the Humelock Reversed Cementless Shoulder Prothesis is lockable with two cortical bone screws and is intended for cementless use only. An optional anti-rotational spoiler can be used with either the cementless or the cemented stems.

The glenoid baseplate and post extension are intended for cementless use with the addition of screws for fixation.

When used in the Humeris Shoulder System:

In an anatomic shoulder configuration, the Humeris Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:

• A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;

• Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).

In a reverse shoulder configuration, the Humeris Shoulder is indicated for primary or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The humeral stem of the Humeris Cementless Shoulder is intended for cementless use only. The humeral stem of the Humeris Cemented Shoulder is intended for cemented use only. The glenoid components of the Humeris Shoulder System are intended for cemented use only. The glenoid baseplate component is intended for cementless use with the addition of screws for fixation.

The Glenoid Baseplate with Screw is a new component added to the Humelock II® Reversible Shoulder System, Humelock Reversed® Shoulder System, and Humeris® Shoulder System, when used for a reverse shoulder construct. Compatible components for use with the Glenoid Baseplate with Screw are the same as those previously cleared compatible components for use as a component in the primary predicate device, K150488, K162455 Humelock Reversed Shoulder System and K163669 Humeris Shoulder System, when used for a reverse shoulder construct.

This FDA 510(k) clearance document for the "Glenoid Baseplate with Screw" does not describe a study that involves software, AI, or human readers, or that uses acceptance criteria based on metrics like sensitivity, specificity, or AUC.

Instead, this document is for a medical device (a shoulder implant component). The "acceptance criteria" and "device performance" discussed relate to mechanical testing of the implant, not diagnostic or predictive performance.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details, because this type of information is simply not present in this document.

Here's what I can extract related to the mentioned "acceptance criteria" which is limited to mechanical performance:

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

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

• Sample Size for Test Set: Not specified. Standard mechanical testing typically uses a specific number of samples for each test, but the exact number is not detailed here.
• Data Provenance: Not explicitly stated, but the manufacturer is FX Solutions in Viriat, France (01440). It's reasonable to infer the testing was conducted by or for the manufacturer, potentially in France or a certified testing facility elsewhere. The testing is non-clinical, meaning it's conducted in a lab setting, not on patient data.

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):

Not applicable. "Ground truth" in this context would refer to the mechanical properties of the device as defined by a standard. Experts are typically involved in setting the standard and performing the tests, but no specific number or qualifications are mentioned as this isn't a diagnostic performance study.

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

Not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, not for mechanical testing of a physical device.

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:

No, an MRMC study was not done. This document is for a physical medical implant, not an AI device or software.

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

Not applicable. This document is for a physical medical implant, not an algorithm.

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

The "ground truth" for the device's mechanical performance is based on the specifications outlined in the ISO 6475-1 standard for torque properties.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI or machine learning device.

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

Not applicable as there is no training set.

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