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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 Anatomic:
The Tornier Perform Humeral System - Fracture combined with a humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement.
The Tornier Perform Humeral System - Fracture is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, stability, and to relieve pain.
The Tornier Perform Humeral System - Fracture is indicated for use as a replacement of shoulder joints disabled by: • Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral head fracture and displaced 3-or 4-part proximal humeral fractures
· Fracture sequelae

• Revisions where adequate fixation can be achieved and adequate bone stock remains after final reconstruction
  Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients without a suspected material sensitivity to cobalt alloy.
  All components are single use. The fracture stems are intended for cementless use. In cementless use, the fracture stems are intended for use with or without cortical screws. In a total shoulder arthroplasty, the Tornier Perform Humeral System - Fracture is intended to be used with cemented polyethylene glenoid components.

In Reverse:
The Tornier Perform Humeral System - Fracture combined with a reverse insert is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by: • Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures
• Proximal humerus bone defect
· Fracture sequelae
• Revisions where adequate fixation can be achieved and adequate bone stock remains after final reconstruction
The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed fracture stem for patients with a functional deltoid muscle.
All components are single use. The fracture stems are intended for cementless use. In cementless use, the fracture stems are intended for use with or without cortical screws. The Tornier Perform Humeral System – Fracture is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.

The Tornier Perform Humeral System – Fracture is a convertible humeral fracture system for anatomic, reverse, and hemiarthroplasty of the shoulder. The system also allows for conversion from an anatomic to a reverse shoulder prosthesis in the case of revision. The Tornier Perform Humeral System - Fracture is implanted with existing Tornier glenoid systems for total anatomic and reverse shoulder arthroplasty.
The Tornier Perform Humeral System – Fracture includes titanium fracture stems, titanium couplers, titanium spacers and titanium screws. The system is compatible with commercially available Perform humeral heads and reversed inserts. The system also includes reusable instruments used to implant the shoulder prosthesis.

This document is a 510(k) premarket notification for a medical device (Tornier Perform Humeral System - Fracture), not a study evaluating an AI device's performance. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes for AI model training and testing is not applicable.

The document describes the device, its indications for use, and a comparison to predicate devices. It states that no clinical studies were performed to prove the device meets acceptance criteria. Instead, non-clinical performance testing was conducted to demonstrate substantial equivalence to predicate devices.

Here's a breakdown of the information provided in the document as it relates to 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 corresponding performance metrics for a digital health or AI device. The "performance" described refers to the results of non-clinical engineering tests to demonstrate the device's physical properties and compatibility, rather than clinical efficacy or diagnostic accuracy.

Non-clinical Performance Testing Performed:

• Fatigue testing
• Static taper evaluation
• ASTM F543 screw testing
• Evaluations for compatibility with existing components
• Range of motion analysis
• MRI compatibility evaluation
• Biocompatibility, sterilization, cleaning, endotoxin, packaging, shelf life, and distribution assessments (in accordance with recognized consensus standards).

Reported Device Performance:
The document states: "The results of performance testing for the Tornier Perform Humeral System – Fracture support substantial equivalence to the predicate Aequalis Reversed Fracture Shoulder Prosthesis and Aequalis Shoulder Fracture System (K131231)." This implies that the device performed adequately in these non-clinical tests to be considered comparable to the predicate. Specific quantitative results or acceptance thresholds are not detailed in this summary.

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

Not applicable. No clinical test set. The "testing" referred to是在工程实验室进行的非临床性能测试，而不是对临床数据进行的测试。

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. No clinical test set or ground truth established by experts.

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

Not applicable. No clinical test set.

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 implant device, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

Not applicable. This is a medical implant device, not an algorithm.

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

Not applicable. No clinical ground truth was established as no clinical studies were performed. The "ground truth" equivalent for this device would be engineering specifications and standards for its physical and material properties.

8. The sample size for the training set

Not applicable. This is a medical implant device, not an AI model requiring a training set.

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

Not applicable. No training set for an AI model.

In summary: The provided document is an FDA 510(k) clearance letter and its associated Indications for Use and Device Description/Comparison. It describes a medical implant device that demonstrated substantial equivalence through non-clinical performance testing, not through clinical trials or the evaluation of an AI-powered diagnostic/therapeutic tool. Therefore, the questions related to AI device performance evaluation are not relevant to this document.

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The Catalyst R1 Reverse Shoulder System is a reverse total shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:

· Severe arthropathy with a grossly deficient rotator cuff;

• · Previously failed joint replacement with a grossly deficient rotator cuff;
• · Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture,

displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection:

• · Bone defect in proximal humerus;
• Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/ or glenoid:
• · Inflammatory arthritis including rheumatoid arthritis;
• · Correction of functional deformity

The humeral stems are intended for cemented or uncemented applications.

The glenoid baseplate is intended for uncemented use with the addition of screws for fixation.

The Catalyst R1 Reverse Shoulder System is a total shoulder prosthesis designed for use in patients with a non-functional rotator cuff. The articulation of this reverse design is inverted compared to a traditional anatomic total shoulder prosthesis, where the articulating sphere is on the glenoid side of the joint, and the mating insert is fixed into the humeral stem implant.

The humeral implant system consists of humeral stems and polyethylene inserts. The stem implants are manufactured from Ti-6Al-4V ELI conforming to ASTM F136 with a porous structure on the proximal portion. The humeral stems are offered in short and long stem configurations to accommodate varying bone geometries. The humeral articulating inserts are manufactured from UHMWPE conforming to ASTM F648. They have a concave bearing geometry that radially matches the different sized glenospheres and are offered in varying thicknesses to achieve stability of the glenohumeral joint.

The glenoid implant system consists of a central baseplate, glenosphere, fixation components, and locking components. The central baseplate is a circular disc that rests against the glenoid bone and is secured to the bone using up to four peripheral screws and either a central screw or post. The baseplate is manufactured from Ti-6AI-4V ELI conforming to ASTM F136 with a titanium plasma spray on the bone facing surface. The baseplate is offered in standard and augmented configurations. The Co-Cr-Mo glenospheres are manufactured from CoCrMo conforming to ASTM F1537 and are secured to the baseplate by a taper lock, and with an additional locking screw. The fixation components are manufactured from Ti-6Al-4V ELI conforming to ASTM F136.

The provided text describes a medical device submission (K202611) for the Catalyst OrthoScience R1 Reverse Shoulder System. It is a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria through extensive clinical studies.

Therefore, the document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst R1 Reverse Shoulder System to the predicate devices."

This means that a study proving the device meets acceptance criteria as typically understood for new major medical devices (e.g., in terms of clinical outcomes, diagnostic performance, or comparative effectiveness with human readers for AI) was not performed or required for this 510(k) clearance.

Instead, the acceptance criteria for this device are based on demonstrating equivalence to already legally marketed predicate devices through:

• Mechanical and materials testing: Ensuring the device meets relevant ASTM and ISO standards for its intended use.
• Design and intended use similarity: Showing that the new device's design, materials, indications for use, and size ranges are comparable to predicate devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission focused on substantial equivalence and not a de novo clinical trial, the "acceptance criteria" are the demonstration of similarity to predicate devices and performance in non-clinical testing.

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

The Arthrex UNIVERS REVERS MODULAR GLENOID SYSTEM is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The Arthrex UNIVERS REVERS MODULAR GLENOID SYSTEM is porous coated and is intended for cementless use with the addition of screws for fixation.

The Arthrex UNIVERS REVERS MODULAR GLENOID SYSTEM consists of a monoblock baseplate or a modular baseplate; both baseplates are available with either a central screw or central post. The baseplate is designed to be used cementless with peripheral screws and a glenosphere. A humeral insert has been included in this system, to be used with the humeral side of the predicate Univers Revers Shoulder Prosthesis System (K142863).

The UNIVERS REVERS MODULAR GLENOID SYSTEM is comprised of known materials. The baseplates, central screws and posts are comprised of titanium with a BioSync coating, the peripheral screws are titanium and the glenospheres are available in either titanium or cobalt chrome. The humeral inserts are comprised of UHMWPE.

The provided text details a 510(k) premarket notification for a medical device, the Arthrex UNIVERS REVERS MODULAR GLENOID SYSTEM. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device rather than proving safety and effectiveness de novo. Therefore, the information provided focuses on comparative performance, particularly mechanical and material testing, rather than clinical study data from human subjects or AI algorithm performance as might be seen for devices utilizing AI.

Based on the provided text, there is no information regarding acceptance criteria or a study proving an AI device meets acceptance criteria. The document describes a shoulder prosthesis, not an AI device.

However, if we interpret "acceptance criteria" and "study" in the context of this non-AI medical device (shoulder prosthesis), we can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) submission):

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

• Sample Size: The document does not specify the precise number of physical samples used for each mechanical and material test (e.g., how many glenoid components were subjected to rocking horse testing). It refers to tests being "conducted" but not the exact quantity of items.
• Data Provenance: The data comes from non-clinical testing (mechanical and material laboratory tests) performed by the manufacturer, Arthrex Inc. The location of the testing facility is not specified, but the company is based in Naples, Florida, USA. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate equivalence.

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

• This question is not applicable to this type of device. The "ground truth" for a mechanical orthopedic implant is established by engineering standards (e.g., ASTM standards) and validated test methodologies, not by expert human interpretation of results like in an AI imaging study. The tests evaluate physical properties against established benchmarks for similar devices.

4. Adjudication method for the test set:

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for subjective assessments or expert consensus in AI model validation. For mechanical and material testing, the acceptance is based on quantitative measurements meeting predefined criteria from industry 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:

• This question is not applicable. This is a physical medical implant, not an AI-assisted diagnostic tool. Therefore, no MRMC study involving human readers and AI assistance was conducted or would be relevant.

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

• This question is not applicable. This device is a mechanical prosthesis, not an algorithm or software. "Standalone performance" in this context would refer to the purely mechanical performance of the device itself, which is what the mechanical and material tests evaluated.

7. The type of ground truth used:

• The ground truth for this device is based on engineering standards and established performance benchmarks for similar predicate orthopedic implants. Specifically:
  • Mechanical Integrity: Compliance with ASTM standards (F2028, F2009, F543) ensures the device's physical strength, stability, and resistance to wear meet accepted anatomical and functional requirements for shoulder prostheses.
  • Biocompatibility/Material Safety: Compliance with pyrogen limits (EP 2.6.14/USP ) and FDA guidance on plasma sprayed coatings ensures the materials are safe for implantation and do not elicit adverse biological responses.
  • Magnetic Resonance Compatibility: Compliance with ASTM standards (F2182, F2052, F2119) ensures the device is safe for patients undergoing MRI procedures.

8. The sample size for the training set:

• This question is not applicable. There is no "training set" in the context of demonstrating substantial equivalence for a mechanical prosthetic device. The design and manufacturing processes are informed by existing biomechanical knowledge, material science, and the performance of predicate devices, not by a data-driven training process for an algorithm.

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

• This question is not applicable as there is no "training set." The engineering principles and material science knowledge applied in the design and testing of such devices are established through decades of research, manufacturing experience, and regulatory guidance, rather than a specific "ground truth" for a training set.

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