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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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In an anatomic shoulder configuration, the FX V135™ 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 FX V135™ Shoulder is indicated for primary or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with 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 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 FX V135™ Shoulder Prosthesis is a shoulder replacement system that may be used as a total or hemi shoulder replacement in either an anatomic or a reversed shoulder construct. The new components of the system included in this submission are the FX V135™ Additional Humeral Stems that are added to the system as a line extension of the cementless humeral stems.
The FX V135™ Shoulder Prosthesis is manufactured from Ti-6l-4V ELI alloy conforming to ISO 5832-3 and are available in diameters of 8-16mm in the diaphysis dependent upon the epiphyseal size 32, 36, and 40mm. The longer stems added to the system are available in lengths 120mm, 180mm and 200mm. The proximal portion of the humeral stem has a plasma sprayed commercially pure Titanium (CP-Ti) and Hydroxyapatite (HA) coating. The distal end of the humeral stem is cylindrical and bead blasted with unthreaded screw holes oriented in the medial / lateral direction for optional fixation using cortical bone screws.
The FX V135™ Shoulder Prosthesis incorporates a female taper for attachment of compatible components.
The FX V135™ Shoulder Prosthesis can be used with previously cleared components including a taper adapter, a centered or offset humeral head and a 2 peg or 3 or 4 peg cemented glenoid for use in an anatomic shoulder configuration.
For reverse configuration, the FX V135™ Shoulder Prosthesis can be used with a humeral cup and optional spacer, a centered or eccentric glenosphere with or without a central screw, a qlenoid baseplate (with or without a central screw), optional post extensions and standard (compression) and locking bone screws around the periphery of the baseplate. The previously cleared Humeral Cups mate with the FX V135™ Additional Humeral Stems to complete the reverse configuration.

The provided text is a 510(k) summary for the FX V135™ Shoulder Prosthesis, which is a medical device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing independent performance against a specific set of acceptance criteria through a clinical study.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth, expert opinions, and MRMC studies is not available in this document because the device's clearance relied on non-clinical testing and comparison to existing devices, not a new clinical study with performance benchmarks.

Here's an breakdown of why the requested information cannot be fully provided based on the given text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable: The document does not define specific "acceptance criteria" for clinical performance. Instead, it states that "Construct fatigue testing was completed with test constructs completing all cycles with no failures and taper connections remaining firmly fixed. The results of these tests indicate that the performance of the FX V135™ Shoulder Prosthesis is adequate for its intended use and substantially equivalent to the predicate device." This refers to non-clinical mechanical testing, not clinical outcomes.

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

• Not Applicable (for clinical data): The document explicitly states: "Clinical testing is not necessary to determine substantial equivalence of the FX V135™ Shoulder Prosthesis to the predicate device." Therefore, there is no clinical "test set" with associated sample size or data provenance in this submission. For the non-clinical fatigue testing, specific sample sizes are not provided in this summary.

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

• Not Applicable: No clinical ground truth was established for a test set, as no clinical study was deemed necessary.

4. Adjudication method for the test set:

• Not Applicable: No clinical test set and thus no adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No: The document states that clinical testing was not necessary. Therefore, an MRMC study was not conducted.

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

• Not Applicable: This device is a physical medical implant (shoulder prosthesis), not an AI algorithm. Therefore, "standalone algorithm" performance is not relevant.

7. The type of ground truth used:

• Not Applicable (for clinical ground truth): As no clinical study was conducted, there's no clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for the non-clinical testing would be the engineering specifications and performance standards met by the predicate device and reproduced by the subject device.

8. The sample size for the training set:

• Not Applicable: This is a physical medical device, not an AI model, so there is no "training set."

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

• Not Applicable: As above, no training set.

Summary based on the provided text:

The device, FX V135™ Shoulder Prosthesis, obtained 510(k) clearance by demonstrating "substantial equivalence" to existing predicate devices (FX V135™ Shoulder Prosthesis (K213117), Humelock Reversed® Shoulder (K162455), and Encore Humeral Shoulder Stem (K141990)).

The primary evidence provided in this summary to support this claim comes from non-clinical testing:

• "Range of motion analysis demonstrated comparability to the predicate device."
• "Construct fatigue testing was completed with test constructs completing all cycles with no failures and taper connections remaining firmly fixed."

The conclusion is that these non-clinical tests indicate the performance is "adequate for its intended use and substantially equivalent to the predicate device." The document explicitly states, "Clinical testing is not necessary to determine substantial equivalence of the FX V135™ Shoulder Prosthesis to the predicate device."

Therefore, the device meets its "acceptance criteria" (which are performance benchmarks derived from the predicate device and established through non-clinical testing) by demonstrating comparable range of motion and successful completion of fatigue testing without failures or loosening. This approach leverages the pre-existing FDA clearance of the predicate devices.

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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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In an anatomic shoulder configuration, the FX V135 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 FX V135 Shoulder is indicated for primary or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with 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 FX V135 Cementless Shoulder is intended for cementless use only. 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 FX V135 Shoulder Prosthesis is a shoulder replacement system that may be used as a total or hemi shoulder replacement in either an anatomic or a reversed shoulder construct. The new components of this system include the FX V135 cementless humeral stems, the new Humeral Cup 135/145° and a new humeral spacer on the reverse configuration, and on the anatomic configuration, the new humeral stem and new humeral heads.

The Humeral Stem of the FX V135 Shoulder Prosthesis is manufactured from Ti-6AI-4V ELI alloy conforming to ISO 5832-3 and is available in diameters of 10-20mm in the diaphysis dependent upon the epiphyseal size 32, 36, or 40mm. All have a length of 70mm. The distal end of the humeral stem is quadrangular and bead blasted. The proximal portion of the humeral stem has a plasma sprayed commercially pure Titanium (CP-Ti) and Hydroxyapatite (HA) coating.

The FX V135 Humeral Stems incorporate a female taper for attachment of compatible components.

The new FX V135 Humeral Head is available in two versions and are manufactured from CoCrMo alloy conforming to ISO 5832-12. The new FX V135 Humeral Cup 135/145° is available in three sizes, Ø32, Ø36 and Ø40mm. Each size is available in two versions, standard and stability. Each version is available in three heights: +3mm, +6mm; and is compatible with all sizes of FX V135 Humeral Stems. The FX V135 Humeral Cup 135/145º is pre-assembled, one-piece component manufactured from ultra high molecular weight polyethylene (UHMWPE) conforming to ISO5834-2 and Ti-6AI-4V ELI alloy conforming to ISO 5832-3. The new Humeral Cup 135/145° may be used with the new Humeral Spacer +9mm to increase the cup offset.

The FX V135 Humeral Stems can be used with previously cleared components including a taper adapter, a centered or offset humeral head and a 2 peg or 3 or 4 peg cemented glenoid for use in an anatomical shoulder configuration.

For reverse configuration, the FX V135 Humeral Stem can be used with a humeral cup and optional spacer, a centered or eccentric glenosphere with or without a central screw, a glenoid baseplate (with or without a central screw), optional post extensions and standard (compression) or locking bone screws around the periphery of the baseplate. The previously cleared Humeral Cups or the subject Humeral Cup 135/145° mate with the FX V135 Humeral Stem to complete the reverse configuration.

The provided text does not contain information about acceptance criteria for an AI/ML powered device, nor does it describe a study proving such a device meets acceptance criteria.

The document is a 510(k) premarket notification for a FX V135 Shoulder Prosthesis, which is a medical implant (a shoulder replacement system), not an AI/ML powered device. The document details the device description, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Specifically, under the heading "Non-Clinical Testing", it states:
"Range of motion analysis demonstrated substantial equivalence to predicate device. Construct fatigue testing was completed with test constructs completing all cycles with no failures and taper connections remaining firmly fixed. The results of these tests indicate that the performance of the FX V135 Shoulder Prosthesis is adequate for its intended use and substantially equivalent to the predicate device."

And under "Clinical Testing":
"Clinical testing was not necessary to determine substantial equivalence of the FX V135 to the predicate device."

This indicates that the evaluation was based on non-clinical (mechanical) testing for a physical implant, not an AI/ML algorithm. Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for an AI/ML device from this document.

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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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The Easytech® Anatomical Shoulder System is in total shoulder repacement to treat a severely painf il and/or disabled joint resulting from osteoarthritis.

The humeral stemless of the Easytech® Anatomical Shoulder is intended for cementless use only. The glencid components of the Easytech® Anatomical Shoulder System are intended for cemented use only.

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

The Easytech® Anatomical Shoulder is an anatomical shoulder prothesis designed for use in patients with a functional rotator cuff. The Easytech® humeral stemless (Anchor base) is used with a connector, a centered or offset humeral head, and a glenoid for use in an anatomical shoulder configuration.

This system is designed to articulate with a glenoid component for total shoulder arthroplasty. Subject of this submission is the cementless, stemless Humeral Anchor base that is part of the Easytech® Anatomical Shoulder System. The compatible components to complete the system have been cleared previously in K111097, K123814, and K163669.

The Easytech® Anchor base is a stemless prosthesis. The cementless Anchor base is available in diameters of 30 to 38 mm. The Anchor base has a main central post with striaes. In the periphery of the Anchor base, five retentives striaes are positioned to help with the primary fixation. The undersurface of the Anchor base, including the central post and retentive striaes, has a plasma sprayed CPTitanium and Hydroxyapatite coating without the superior surface and the female taper. The Anchor base incorporates a female taper for attachment of compatible components. This component is manufactured in Ti-6AI-4V ELI allov conforming to ISO 5832-3.

The Anchor base can be used with a straight taper connector or a centered spacer manufactured from Ti-6Al-4V ELI alloy conforming to ISO 5832-3, a centered or offset humeral head manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12 and a 2 pegs or 3 or 4 pegs cemented glenoid manufactured from ultra high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2 for use in an anatomical shoulder configuration.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

• Adjusted Constant Score >54 AND improved from baseline >10
• No migration or subsidence
• No radiolucencies of the humeral or glenoid components
• Implant integrity maintained
• No revision surgery
• No serious adverse device event | 91.7% (with a lower two-sided 90% confidence bound of 87.3%).
  This is compared to a performance goal for the predicate device of 92.3% and a reference margin of 10%. The lower bound (87.3%) being greater than (92.3% - 10% = 82.3%) indicated success. |
  | Adjusted Constant Score Improvement: Clinically significant improvement in Adjusted Constant Score from preoperative baseline. | Average Month 24+ Adjusted Constant Score: 99.14 (SD 18.73).
  Clinically significant improvement (p

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When used in the Humelock II Cemented Shoulder System: The Humelock II Cemented Shoulder System is indicated for use in total and hemishoulder replacement to treat:

1. Proximal humeral fractures
2. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
3. 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).

The humeral stem and glenoid components of the Humelock II Cemented Shoulder System are intended for cemented use only.

TiN coated Heads are not intended for hemi-shoulder arthroplasty

When used with 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).

TiN coated Heads are not intended for hemi-shoulder arthroplasty.

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 TiN Coated Humeral Head is a new component for Humelock II total shoulder replacement systems. The TiN Coated Humeral Head has a titanium nitride (TiN) coating, which is applied to the predicate humeral heads made of cobalt chromium molybdenum (CoCr). Compatible components for use with the TiN coated humeral heads to complete the total shoulder replacement construct are the same as those previously cleared compatible components for use with the CoCr humeral heads in the respective predicate devices, including the primary predicate (K123814) and K163669 for the Humeris Shoulder System.

This document is a 510(k) Premarket Notification from the FDA regarding a TiN Coated Humeral Head. It does not describe a study that proves a device meets acceptance criteria for an AI/ML medical device. Instead, it details the substantial equivalence determination for a physical orthopedic implant.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size, expert ground truth, MRMC study, standalone performance, training set details) because this document does not pertain to an AI/ML medical device and does not contain information about a study proving an algorithm's performance.

The document states:

• "Clinical testing was not necessary to determine substantial equivalence of the TiN Coated Humeral Head to the predicate devices." (Page 7)
• The determination is based on the device being "identical to the primary predicate with the only modification of added TiN coating" and a review of "risk analysis, design controls, biocompatibility, wear properties of the TiN coating, and verification and validation activities to demonstrate that the TiN coating does not increase risk and does not raise new questions of safety and effectiveness." (Page 7)

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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 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 System 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 hemishoulder 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.q. 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 Humelock TiN Coated Glenosphere is a new component for Humelock II, Humelock Reversed, and Humeris reversed total shoulder replacement systems. The Humelock TiN Coated Glenosphere has a titanium nitride (TiN) coating, which is applied to the predicate glenosphere made of cobalt chromium molybdenum (CoCr). Compatible components for use with the Humelock TiN Coated Glenosphere to complete the reversed total shoulder replacement construct are the same as those previously cleared compatible components for use with the CoCr glenospheres in the primary predicate device, K150488 and are also components in K162455 for the Humelock Reversed Shoulder System and K163669 for the Humeris Shoulder, when used for a reverse shoulder construct.

This document describes the Humelock TiN Coated Glenosphere, a new component for shoulder replacement systems. Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for specific tests. The document mentions "wear testing" and "biocompatibility testing" but doesn't provide the number of devices or samples used for these non-clinical tests.
• Data Provenance: All testing mentioned is non-clinical (e.g., in-vitro, material characterization, animal studies). There is no patient data involved in this submission.

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

• This is not applicable as the evaluation relies solely on non-clinical testing and substantial equivalence to previously cleared devices and a reference device. There are no "ground truth" labels established by human experts on a clinical test set.

4. Adjudication Method for the Test Set

• This is not applicable as there is no clinical test set requiring human adjudication.

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 comparative effectiveness study was not done. This submission is for a physical medical device (implant component) and does not involve AI or human readers.

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

• No, a standalone algorithm performance study was not done. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" in this context is established through objective scientific methods and standards for material characterization, mechanical testing, and biocompatibility, as well as the established safety and effectiveness profiles of the predicate and reference devices. For instance, biocompatibility is evaluated against ISO standards, and mechanical wear is measured.

8. The Sample Size for the Training Set

• This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• This is not applicable as there is no training set.

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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.

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 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.

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 athroplasty 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 Humeral Cup Stability and the Humeral Cup 135 / 145° Stability are components that are added to the Humelock II Reversible Shoulder System, the Humelock Reverse Shoulder and Humeris Shoulder, when used as a reverse shoulder replacement. The Humeral Cup and the Humeral Cup 135 / 145°. Mobility and Standard, were previously cleared for use in the U.S. in the Humelock II Reversible Shoulder System (K150488), and included as compatible components in the Humelock Reversed Shoulder System (K162455) and the Humeris Shoulder (K163669), when used for a reversed total shoulder construct. The 32mm Glenosphere and Cups were added to the reverse shoulder systems in K192206. These reverse total shoulder systems are used in patients with a non-functional rotator cuff and have an inverted articulation such that the ball of the articulation is on the glenoid side and the mating humeral cup is part of the humeral side of the construct, which includes either a cemented or cementless humeral stem. Depending on the humeral stem used, the humeral cup may be fixed to the humeral stem using a 135 / 145° Reverse Adapter. All mating components specific to each system are described in the respective cleared 510(k) submissions.

The predicate humeral cups, the Humeral Cup and the Humeral Cup 135 / 145°, are onepiece constructs consisting of a pre-assembled Ti-6Al-4V allov shell (ISO 5832-3) and a UHMWPE insert (ISO 5834-1 and ISO 5834-2). Both humeral cups are available in 32mm, 36mm and 40mm to articulate with the glenosphere of the same size (K150488) and come in heights of +3mm, +6mm, and +9mm.

The predicate humeral cups vary in depth providing different amounts of constraint and articulation. This submission is for the Stability variant of the Humelock Reverse Humeral Cup and 135 / 145° Humelock Reverse Humeral Cup and is a component added to the Humelock II Reversible Shoulder System (K150488), Humelock Reversed Shoulder System (K162455) and the Humeris Shoulder (K163669), when used for a reversed total shoulder construct.

The provided text is a 510(k) premarket notification for a medical device: Humeral Cup Stability & Humeral Cup 135/145° Stability. This document is a regulatory filing, not a study report. Therefore, it does not contain the detailed information typically found in a study proving a device meets acceptance criteria.

Specifically, the document states: "Clinical testing was not necessary to determine substantial equivalence of the Humeral Cup Stability to the predicate devices." This indicates that the FDA's substantial equivalence determination for this device was based on non-clinical testing and comparison to predicate devices, rather than a clinical study with acceptance criteria, human subjects, ground truth establishment, or multi-reader studies.

Therefore, I cannot provide the requested information, such as a table of acceptance criteria and reported device performance based on a human study, sample sizes for test sets, data provenance, number of experts, adjudication methods, or MRMC study details, because such a study was not conducted or presented in this regulatory filing.

The document focuses on demonstrating substantial equivalence to existing legally marketed devices (predicates) through:

• Comparison of Indications for Use: The new device's intended uses are compared to those of the predicate devices.
• Comparison of Fundamental Scientific Technology: The underlying principles and mechanisms are deemed similar.
• Material, Function, Manufacturing Processes, Shelf Life, Sterilization, Packaging, Instructions for Use, and Surgical Technique: These aspects are compared and shown to be similar or identical.
• Non-Clinical Testing: The document mentions mechanical testing to ASTM F2028-2017 and range of motion analysis, demonstrating that the device performs similarly to predicate devices and does not raise new questions of safety and effectiveness.

In summary, the provided document is a regulatory submission for premarket clearance via the 510(k) pathway, not a detailed report of a clinical study or a study designed to prove acceptance criteria through human performance data.

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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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