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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 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 Prosthesis is intended for cemented use only. The humeral stem of the Humelock Reversed Cementless Shoulder Prosthesis is lockable with two cortical bone screws and is intended for cementless or 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 and Humeris 135 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 baseplate component is intended for cementless use with addition of screws for fixation.

When used in the FX V135 Shoulder Prosthesis:

In an anatomic shoulder configuration, the FX V135 Shoulder Prosthesis 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 FX V135 Shoulder Prosthesis 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 FX V135 Cementless Shoulder is intended for cementless use only, with optional cortical bone screws for the longer stems. The glenoid components of the FX V135 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 Full Wedge Lateralized and Augmented Baseplates are new components added to the reverse shoulder replacement systems including the Humelock II Reversible Shoulder System, the Reversed (K162455), the Humeris Shoulder (K163669, K222936) and the FX V135 Shoulder Prosthesis (K213117, K223801). The Lateralized baseplate with full wedge augmentation is a modification of the primary predicate half wedge lateralized and augmented baseplates (K210790) and may be used with an asymmetric bone defect when there is no possibility to correct this defect without graft or excessive reaming.

Compatible components for use with the Full Wedge Lateralized and Augmented Baseplates are the same as the compatible components for use in the previously cleared reverse shoulder replacement systems.

This document is a 510(k) Premarket Notification from the FDA regarding orthopedic implants, specifically shoulder joint prostheses. It details the device's indications for use, its classification, and a summary of the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

The request asks for information about the acceptance criteria and a study that proves the device meets these criteria, focusing on aspects typically found in studies for AI/software-driven medical devices. However, this document is for a mechanical orthopedic implant (shoulder baseplates), not an AI or software-driven device. Therefore, many of the requested categories (e.g., number of experts for ground truth, MRMC study, training set ground truth, effect size for human readers) are not applicable to this type of medical device submission.

The "study" in this context refers to non-clinical bench testing to demonstrate mechanical performance, not a study evaluating diagnostic performance of an AI algorithm.

Here's a breakdown of what can be extracted and what is not applicable:

1. Table of acceptance criteria and reported device performance:

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

• Sample size: Not explicitly stated for bench testing, but these typically involve a set number of test samples (e.g., 6-12) based on the specific ASTM standard. The document only mentions "bench testing for glenoid loosening" and "range of motion analysis."
• Data provenance: Not applicable in the sense of patient data. This is mechanical testing done in a lab setting. It is not specified if the testing was performed in the US or another country, but the manufacturer is based in France.
• Retrospective/Prospective: Not applicable for mechanical bench testing.

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

• Not Applicable. Ground truth for mechanical testing is established by engineering specifications and standards (e.g., ASTM). No human experts are used in this context to establish a "ground truth" for diagnostic accuracy.

4. Adjudication method for the test set:

• Not Applicable. This concept applies to human interpretation of data, typically in diagnostic studies. For mechanical testing, the results are quantitative measurements against predefined criteria.

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/software device. No human reader studies were performed.

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

• Not Applicable. This is not an AI/software device.

7. The type of ground truth used:

• For mechanical properties: Established by standardized engineering tests and measurements (e.g., ASTM F2028-17 for glenoid loosening, ASTM F-1378-18 for range of motion). These standards define the methodology and acceptable ranges for performance.

8. The sample size for the training set:

• Not Applicable. This refers to AI model training data. This document is about a physical implant device, not an AI or software device.

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

• Not Applicable. (See point 8)

Summary of Device Performance and Substantial Equivalence:

The document states that the Full Wedge Lateralized and Augmented Baseplates are a modification of previously cleared predicate devices. Substantial equivalence for this device was demonstrated through:

• Non-Clinical Testing:
  • Bench testing for glenoid loosening (ASTM F2028-17) showed the device is substantially equivalent to the primary predicate.
  • Range of motion analysis, based on the same parameters and assumptions as the predicate, demonstrated substantial equivalence and exceeded ASTM F-1378-18.
• Comparison to Predicate Device: The new components are "identical to the primary predicate, half wedge lateralized augmented baseplates, on indications, material, manufacturing, packaging, single use, sterilization, shelf life, biocompatibility, compatible components."

Conclusion: The FDA cleared this device based on non-clinical engineering bench testing that confirmed the modified design performed equivalently to, or better than, the predicate device according to established industry standards. Clinical testing was deemed unnecessary as the changes did not raise new questions of safety or effectiveness.

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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 suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The humeral stems are intended for 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 rotator cuff tear.

The patient's joint must be anatomically 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 Prosthesis is intended for cemented use only. The humeral stem of the Humelock Reversed Cementless is lockable with two cortical bone screws and is intended for cementless use only. An optional anti-rotation spoiler can be used with either the cemented stems.

The clenoid 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 ioint 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 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 Lateralized and Augmented Baseplates are new components for the Humelock II Reversible Shoulder System. They are also components added to the Humelock Reversed (K162455) and Humeris Shoulder (K163669), when used for a reverse construct. The Lateralized Baseplate can be used to increase the offset and as needed the Lateralized baseplate with augmentation has an added wedge and may be used with an asymmetric bone defect when there is no possibility to correct this defect without graft or excessive reaming.

This FDA 510(k) summary describes a device, "Lateralized and Augmented Baseplates," that is a modification of existing shoulder prosthesis components. The review focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies of the new components.

Therefore, the information provided does not fully answer all sections of your request regarding detailed acceptance criteria and a study proving those criteria are met for the new device. However, I can extract the relevant information about the non-clinical testing performed and the general approach to demonstrating equivalence.

Here's a breakdown of the available information based on your request:

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

The document does not provide a formal table of acceptance criteria with specific thresholds for the new Lateralized and Augmented Baseplates. Instead, it refers to prior bench testing conducted for the predicate devices and states that new non-clinical testing for the subject device met acceptance criteria based on those established standards.

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

The document does not explicitly state the sample sizes for the Range of Motion or Glenoid Loosening tests for the new Lateralized and Augmented Baseplates. It refers to "all samples" for the glenoid loosening test without specifying the number.
The data provenance is not explicitly mentioned as country of origin, but the manufacturer is FX Solutions in Viriat, France. The studies are non-clinical (bench testing).

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

Not applicable. This device assessment relies on established engineering standards (ASTM F-1378-18, ASTM F2028) for non-clinical bench testing, not expert-derived ground truth.

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

Not applicable. Adjudication methods are typically for clinical studies involving human interpretation or subjective assessment. This involved objective measurements against engineering standards.

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 medical device (implant), not an AI/software device that would involve human readers or image interpretation.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for non-clinical testing of the Lateralized and Augmented Baseplates was adherence to established engineering standards (ASTM F-1378-18 for Range of Motion and ASTM F2028 for Glenoid Loosening).

8. The sample size for the training set

Not applicable. This device does not involve a training set in the context of AI or machine learning. Its design and performance are based on engineering principles and testing.

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

Not applicable.

Summary of the Study Proving Acceptance Criteria:

The "study" proving the device meets acceptance criteria referred to in this 510(k) is a set of non-clinical bench tests. These tests were performed to demonstrate that the Lateralized and Augmented Baseplates, which are design modifications of previously cleared components, perform similarly to their predicates and meet relevant ASTM standards for mechanical performance.

• Range of Motion (ROM) Analysis: This analysis was conducted based on the same parameters and assumptions as previously submitted ROM analyses for the primary predicate devices. It concluded that the subject device demonstrated substantial equivalence in ROM and "exceeding ASTM F-1378-18."
• Glenoid Loosening Test: Performed according to ASTM F2028. The report states that "all samples ran to 100,000 cycles with no loosening of glenosphere or baseplate," indicating the device met the acceptance criteria for this standard.

The FDA concluded that "Clinical testing was not necessary to determine substantial equivalence of the Lateralized and Augmented Baseplates to the predicate devices," based on the non-clinical testing and assessment of other factors like materials, manufacturing, and indications for use. This means the non-clinical tests were deemed sufficient to support the substantial equivalence claim.

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