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The Catalyst F1x 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;

• Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural head and/or glenoid;

· Inflammatory arthritis including rheumatoid arthritis;

· Correction of functional deformity

The Catalyst F1x press-fit stems are intended for cementless press-fit applications.

The Catalyst F1x cemented stems are intended for cemented fixation.

The Catalyst F1x stem is compatible with the implants from the R1 Shoulder Systems.

The Catalyst F1x Shoulder System is intended for use as a replacement of shoulder joints in reverse arthroplasty. The stems can be used in conjunction with the Catalyst R1 Reverse Shoulder humeral articulating poly inserts and glenoid implants for use in reverse shoulder arthroplasty.

This submission for the Catalyst F1x Shoulder System consists of proximal bodies, distal stems, locking screws and spacers. The fracture specific proximal bodies have asymmetric, right- and left-sided finned geometry to provide specific locations to reattach the greater and lesser tuberosities for a stable reconstruction of the proximal humerus. The proximal bodies have a porous titanium structure on the bone engaging regions. The distal stems shall be provided in varying diameters to accommodate varying bone geometries. The distal stems will be offered in press-fit and cemented versions. The press-fit distal stems shall have a tapered, splined proximal geometry with an HA (hydroxyapatite) coating. The cemented stems shall have a smooth stem geometry. The proximal bodies and distal stems shall be secured together using a mechanical taper interface that is supplemented with a locking screw. Spacers shall be provided to offer additional options for restoring the appropriate humeral height.

I am sorry, but the provided text is a 510(k) Premarket Notification letter from the FDA regarding a medical device, the "Catalyst F1x Shoulder System." This document does not contain any information about acceptance criteria or a study that proves a device meets specific acceptance criteria, particularly not for AI/Software as a Medical Device (SaMD) performance.

The document states:

• "Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst F1x Shoulder System to the predicate devices."
• "The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, as the legally marketed predicate identified in this 510(k) Summary."

This indicates that the submission relied on non-clinical testing (like biocompatibility, fatigue testing, etc.) and comparison to predicate devices, rather than a clinical study evaluating AI performance against acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text, as this information is not present.

Ask a specific question about this device

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 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 OrthoScience 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. This submission is to add polyethylene inserts with a modified locking ring to the R1 Reverse Shoulder System. These polyethylene inserts are a design modification of the polyethylene inserts cleared in K202611 and K211991. There are no changes to the articulating interface or overall dimensions of the construct in vivo, the only change is to the locking mechanism. These polyethylene inserts do not replace the standard polyethylene inserts cleared in K202611 and K211991 but are an additional option and are compatible with all components within the Catalyst R1 Reverse Shoulder System.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

Based on the provided FDA 510(k) summary for the Catalyst R1 Reverse Shoulder System, the device is a modification to an existing, previously cleared device. The focus of this specific submission (K232583) is to add polyethylene inserts with a modified locking ring to the existing system. The FDA document focuses on demonstrating substantial equivalence to a predicate device rather than outright performance against specific clinical acceptance criteria in the way a novel diagnostic AI might.

Therefore, the information you've requested regarding acceptance criteria and studies (especially in the context of an AI-powered diagnostic device) is largely not present in this document because this is a medical device clearance, not an AI/diagnostic software clearance. The device is a physical implant, and the testing performed relates to the physical and mechanical properties of the implant, not diagnostic performance.

However, I can extract the relevant information that is available and explain why other requested information is not applicable.

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

For this type of physical implant modification, the "acceptance criteria" are typically related to mechanical performance and demonstrating that the modification does not negatively impact the existing cleared device's safety and effectiveness.

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

This information is not provided in the document. For physical device testing like fatigue and disassembly, sample sizes are typically determined by engineering standards (e.g., ISO, ASTM) and are usually small (e.g., n=3, n=5, n=10 per test condition) prototypes or manufactured samples, not patient data. Data provenance like country of origin or retrospective/prospective is not relevant for this type of non-clinical mechanical testing.

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)

This information is not applicable and therefore not provided. "Ground truth" in the clinical sense (e.g., expert consensus on diagnoses) is not relevant for the mechanical testing of a shoulder implant. The "ground truth" for mechanical testing would be defined by engineering specifications and physical test measurements.

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

This information is not applicable and therefore not provided. Adjudication methods are typically used in clinical studies or expert consensus processes for diagnostic interpretation, not for mechanical testing of physical implants.

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 information is not applicable and therefore not provided. An MRMC study is relevant for evaluating diagnostic software's impact on human readers, not for a physical shoulder implant.

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

This information is not applicable and therefore not provided. Standalone algorithm performance is relevant for AI or diagnostic software. This device is a physical implant.

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

As explained in point 3, clinical "ground truth" is not applicable here. For the non-clinical mechanical performance tests, the "ground truth" is defined by engineering specifications and measurements (e.g., force applied, displacement, cycles to failure, component integrity after testing).

8. The sample size for the training set

This information is not applicable and therefore not provided. "Training set" refers to data used to train AI/machine learning models. This device is a physical implant, not an AI model.

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

This information is not applicable and therefore not provided. As above, "training set" and its "ground truth" are concepts for AI/machine learning, not for physical medical device clearance based on substantial equivalence.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document states:

• Study Type: Non-clinical (benchtop) performance testing.
• Tests Performed: Construct fatigue tests, followed by axial and torsional disassembly tests on the components (specifically the polyethylene inserts with modified locking rings).
• Objective: To demonstrate that the modified locking mechanism does not compromise the mechanical integrity and function of the shoulder system and that the device maintains substantial equivalence to its predicate.
• Conclusion: "The results of these tests indicate that the performance of the Catalyst R1 Reverse Shoulder is adequate for its intended use." And, "The subject device has the same design features, uses the same materials, has the same intended use and indications, has the same size ranges, and the same design intent as the predicate devices. Any noted differences do not raise different questions of safety and effectiveness."

In essence, for this specific 510(k), the "study" was a series of mechanical tests designed to confirm that the design change (modified locking ring) did not negatively impact the device's robust performance, allowing the FDA to determine substantial equivalence. Clinical testing was explicitly stated as "not necessary."

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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 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.

This submission is to add optional sizes of the glenospheres and baseplates to the R1 Reverse Shoulder System. The additional sizes of the glenospheres and baseplates are a design modification of the glenospheres and baseplates cleared in K202611. The glenospheres and baseplates in this submission are not replacing the glenospheres and baseplates cleared in K202611 but are an additional option and are compatible with all components within the Catalyst R1 Reverse Shoulder System.

This document, K223655, is a 510(k) premarket notification for a medical device called the "Catalyst R1 Reverse Shoulder System." The submission seeks to add optional sizes of glenospheres and baseplates to an already cleared system.

Based on the provided text, the device in question is a mechanical implant, not an AI/software-based device that would typically involve a "study that proves the device meets the acceptance criteria" in the sense of accuracy, sensitivity, specificity, and human reader performance. Therefore, a table of acceptance criteria and the study that proves the device meets the acceptance criteria as typically understood for AI-driven diagnostic devices is not applicable here.

Instead, the "acceptance criteria" for this mechanical device relate to demonstrating substantial equivalence to a predicate device through non-clinical performance testing and ensuring no new questions of safety and effectiveness are raised by the design modification.

Here's a breakdown of the relevant information provided, structured to address your points where applicable:

A summary of the acceptance criteria and performance for this type of device, as gleaned from the document, is as follows:

Acceptance Criteria and Reported Device Performance (Non-Clinical/Mechanical Testing Focused):

Addressing your specific points based on the provided text, and highlighting what is not applicable for this type of device submission:

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

   • See the table above. These are derived from the "Performance Data / Non-Clinical Testing" section and the comparison of technologies.

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

   • This section describes mechanical testing, not patient data or a clinical study. Therefore, "sample size" would refer to the number of test articles (e.g., glenospheres or baseplates) that underwent mechanical testing. The document states "Mechanical tests... were completed" but does not specify the number of test articles (i.e., "sample size") used for these mechanical tests.
   • "Data provenance" (country of origin, retrospective/prospective) is not applicable here as it's not a clinical study on human subjects but rather laboratory mechanical testing.

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 the context of mechanical device testing typically refers to adherence to engineering standards (e.g., ASTM standards) and meeting predetermined biomechanical performance benchmarks. It does not involve human expert interpretation of data in the way a diagnostic AI would.

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

   • Not applicable. Adjudication is for resolving discrepancies in human expert interpretation or labeling, which is not part of mechanical device testing.

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 mechanical implant device, not an AI-driven diagnostic tool. MRMC studies are used to assess the impact of AI on human reader performance.

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

   • Not applicable. This is not an algorithm. "Standalone" performance would describe the device's mechanical integrity and function as an implant in a mechanical test environment (e.g., fatigue machine). The document confirms these mechanical tests were done.

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

   • The "ground truth" for this device type is adherence to established engineering and material standards (e.g., ASTM F2028, ASTM F1378) and demonstrating that the mechanical properties of the new components are within acceptable limits and equivalent to the predicate. There is no biological "ground truth" (like pathology or outcomes data) required for this specific filing, as it's a modification to an existing cleared device primarily based on mechanical equivalence.

8. The sample size for the training set:

   • Not applicable. This is a mechanical 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 is involved.

In summary, the K223655 submission for the Catalyst R1 Reverse Shoulder System is a 510(k) for a physical medical device. The "study" that proves it meets acceptance criteria is non-clinical, mechanical performance testing (e.g., fatigue, loosening, disassembly per ASTM standards), aimed at demonstrating substantial equivalence to a previously cleared predicate device. This process differs significantly from the AI/software-validation paradigm your questions are designed for.

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The Catalyst EA Convertible Stemmed Shoulder is intended for use as a replacement of shoulder joints in anatomic or reverse arthroplasty. Should the need arise for a conversion from an anatomic total shoulder to a reverse total shoulder, the humeral stem can remain in place, while the articulating surfaces are exchanged.

The Catalyst EA Convertible Stemmed Shoulder is an anatomic designed total shoulder prosthesis that mates with the Catalyst R1 humeral stems cleared in K202611. This submission adds conversion adapters, locking screw and humeral heads to mate with the previously cleared Catalyst R1 humeral stems. The humeral head components are compatible with previously cleared CSR 3 Peg glenoid components or for articulation with the glenoid cavity of the scapula. When the humeral stem (cleared K202611), adapter and humeral head are mated together, this creates a hemiarthroplasty (product code HSD). When the humeral stem, adapter and humeral head are used in conjunction with the CSR glenoid components (cleared K191811 and K173812), this creates a total shoulder arthroplasty (product code KWS). The adapters and locking screw are manufactured from Ti-6A1-4V ELI conforming to ASTM F136. The humeral components are manufactured from Co-Cr-Mo alloy conforming to ASTM F1537.

The provided document describes a 510(k) premarket notification for the "Catalyst EA Convertible Stemmed Shoulder" device. This is a submission to the FDA to demonstrate substantial equivalence to previously marketed devices, not a study proving the device meets explicit acceptance criteria in the context of a clinical trial or AI performance.

Therefore, many of the requested categories in your prompt are not applicable to this type of regulatory document. Specifically, there is no mention of acceptance criteria related to AI performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies.

However, I can extract the information that is relevant to the non-clinical testing performed for this device.

Acceptance Criteria and Device Performance (Non-Clinical)

Study Details (Non-Clinical)

Your prompt asks for specific details related to AI/clinical studies that are not present in this 510(k) summary. Here's a breakdown of why and what information is available:

1. Sample size used for the test set and the data provenance: Not applicable. This document refers to non-clinical bench testing of a medical implant, not AI or clinical data. The "test set" would refer to the physical prototypes or samples used for mechanical testing. The specific number of samples for each test (e.g., how many constructs for fatigue testing) is not detailed in this summary.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI or diagnostic studies is not relevant here. The "ground truth" for mechanical testing is established by engineering standards and specifications.
3. Adjudication method for the test set: Not applicable. There is no expert review or adjudication process described for the lab-based mechanical tests.
4. 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. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst EA Convertible Stemmed Shoulder to the predicate devices." This is a mechanical implant, not a diagnostic AI device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is not an algorithm or AI device.
6. The type of ground truth used: For the non-clinical testing, the "ground truth" would be established by engineering specifications, material standards (e.g., ASTM F136, ASTM F1537), and predetermined acceptance criteria for mechanical performance (e.g., fatigue life, disassembly forces).
7. The sample size for the training set: Not applicable. No AI training was performed.
8. How the ground truth for the training set was established: Not applicable. No AI training was performed.

Context from the Document:

The document clearly states:

"Non-Clinical Testing: Range of motions analyses, biocompatibility assessment and construct fatigue testing were all conducted. Axial disassembly tests were performed pre-fatigue and post-fatigue testing. The construct fatigue testing demonstrated that the construct of the Catalyst EA Convertible Stemmed Shoulder humeral heads with conversion adapter, met the pre-determined acceptance criterion. All testing has determined that the device is substantially equivalent to the predicate device."

And:

"Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst EA Convertible Stemmed Shoulder to the predicate devices."

This indicates that the FDA cleared this device based solely on non-clinical (i.e., lab/mechanical) testing and comparison to predicate devices, and not on AI performance, clinical trials, or human diagnostic studies.

Ask a specific question about this device

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 Catalyst R1 Reverse Shoulder System was previously cleared per K202611 and modified to add semi-constrained polyethylene inserts per K211991. This submission is to add humeral spacers to the R1 Reverse Shoulder System. The humeral spacers allow for a height extension of the humeral stems cleared in K202611. These humeral spacers are an additional option and are compatible with all components within the Catalyst R1 Reverse Shoulder System.

This looks like a 510(k) summary for a medical device, the Catalyst R1 Reverse Shoulder System, and not a study describing AI/ML performance. Therefore, I cannot provide the requested information about acceptance criteria and studies proving the device meets those criteria, as the information is not present in the provided text.

The document discusses:

• The device's name and classification.
• Its indications for use.
• A comparison to a predicate device for substantial equivalence.
• Non-clinical performance data (construct fatigue tests) but explicitly states "Clinical testing was not necessary to demonstrate substantial equivalence".

There is no mention of:

• A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI/ML.
• Sample sizes for test sets or data provenance.
• Experts used to establish ground truth or their qualifications.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or effect sizes of AI assistance.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Training set sample sizes or how ground truth for training was established.

This document seems to be focused on demonstrating substantial equivalence for a physical implantable device based on its design, materials, intended use, and mechanical performance, rather than evaluating a diagnostic or AI-driven system.

Ask a specific question about this device

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 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.

This submission is to add semi-constrained polyethylene inserts to the R1 Reverse Shoulder System. The semi-constrained polyethylene inserts are a design modification of the polyethylene inserts cleared in K202611. The semi-constrained polyethylene inserts are not replacing the standard polyethylene inserts cleared in K202611 but are an additional option and are compatible with all components within the R1 Reverse Shoulder System.

Unfortunately, the provided document does not contain the information required to answer your request. The document describes a 510(k) premarket notification for a medical device (Catalyst R1 Reverse Shoulder System) and specifically states:

"Clinical testing was not necessary to demonstrate substantial equivalence of the R1 Reverse Shoulder System with semi-constrained polyethylene inserts to the predicate device."

This means that the device's clearance was based on demonstrating substantial equivalence to an already marketed predicate device, rather than on new clinical studies or elaborate performance validations with acceptance criteria and ground truth establishment as would be typical for AI/ML-based medical devices or devices demonstrating novel performance.

Therefore, I cannot provide details on:

1. Acceptance criteria and reported device performance: No specific performance metrics for this device, beyond range of motion analysis (which is stated as "adequate for its intended use" without specific numerical criteria), are presented in the form of a table.
2. Sample size, data provenance, ground truth experts, adjudication, MRMC studies, standalone performance, training set details: These elements are characteristic of studies evaluating the performance of diagnostic algorithms or devices where a "ground truth" needs to be established and compared against device output. Since clinical testing was deemed unnecessary for this particular 510(k) clearance, such studies are not described in the document.

The document focuses on:

• The device description and intended use.
• Comparison to predicate devices, highlighting similarities in design, materials, and indications.
• Non-clinical testing (range of motion analysis).

Ask a specific question about this device

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.

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

Not applicable. No clinical "test set" in the context of device performance or diagnostic accuracy was used. The focus was on non-clinical testing and comparison to predicates.

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

Not applicable. No expert review for ground truth on a clinical test set was required or performed for this 510(k) submission.

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

Not applicable. No clinical test set or adjudication process was described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a shoulder prosthesis, not an AI-assisted diagnostic tool or a device where human reader improvement with AI is relevant.

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

Not applicable. This device is a shoulder prosthesis, not an algorithm.

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

Not applicable in the sense of clinical "ground truth" for diagnostic or predictive accuracy. The "ground truth" for this 510(k) submission is instead the established performance and safety profiles of the legally marketed predicate devices, against which the new device demonstrated substantial equivalence through non-clinical testing.

8. The sample size for the training set

Not applicable. No "training set" in the context of AI or clinical model development was used.

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

Not applicable.

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The Catalyst CSR Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. The Catalyst CSR Shoulder System is intended for use in patients with the following conditions where the humeral head, neck and glenoid vault are of sufficient bone stock and the rotator cuff is intact or reconstructable.

• Osteoarthritis
• Avascular Necrosis
• Rheumatoid Arthritis
• Post-traumatic Arthritis
• Correction of functional deformity

The Catalyst CSR humeral and glenoid implants are intended for cemented use.

The Catalyst CSR Press-Fit humeral implants are intended for uncemented or cemented use.

The Catalyst CSR Shoulder System is a bone preserving total shoulder prosthesis designed for use in patients where the humeral head, neck and glenoid vault are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed.

This submission adds augmented glenoid components to the CSR Shoulder System. The CSR Augmented Glenoids are nearly identical to the previously cleared CSR 3 Peg Glenoids, except that additional material has been added to the fixation surface creating a 10 degree posterior wedge. Like the previously cleared CSR 3 Peg glenoid components, the CSR Augments are manufactured from UHMWPE conforming to ASTM F648. Also like the previously cleared CSR 3 Peg Glenoid components, three sizes of augmented glenoid components are available. The bearing surface has a symmetrical, oval shaped profile allowing use of each component on either the right or the left side. The glenoid component is designed to allow insertion at an angle, in the same orientation as the surgeon's exposure, to reduce the forceful retraction and bone and soft tissue trauma usually required to insert standard glenoid components. Three backside pegs are engineered to provide implant fixation within the dense cortical and subchondral bone.

The CSR Augmented Glenoid components are compatible with previously cleared CSR Press-Fit humeral components.

This document describes a 510(k) premarket notification for the Catalyst OrthoScience CSR Shoulder System, specifically focusing on the addition of augmented glenoid components. This is a medical device submission, and as such, it does not involve the type of AI/ML device performance criteria, studies, or ground truth establishment typically requested in your prompt.

Therefore, many of the requested fields are not applicable to this document. The existing information pertains to the non-clinical testing performed to demonstrate the device's safety and effectiveness for its intended use, rather than a clinical study evaluating diagnostic accuracy or similar AI model performance.

Here's a breakdown based on the provided text, indicating where information is not applicable:

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 applicable for non-clinical testing. The "test set" here refers to physical devices or materials tested.
• Data provenance: Not applicable. The testing is non-clinical/laboratory-based.

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 as typically defined for AI/ML performance evaluation (e.g., expert consensus on images) is not relevant to this type of non-clinical device testing.

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

• Not applicable. This concept is for clinical ground truth establishment, not for non-clinical device testing.

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. This is not an AI/ML device. Clinical testing was explicitly stated as not necessary to demonstrate substantial equivalence.

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

• Not applicable. This is not an AI/ML device.

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

• For the non-clinical tests described:
  • Glenoid stability: Ground truth is defined by the passing criteria of ASTM F2028-14 (a standardized test method).
  • Bacterial Endotoxin Testing: Ground truth is defined by the passing criteria of an endotoxin limit of <1.2 EU/device.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. There is no training set for this type of device.

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The Catalyst CSR Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. The Catalyst CSR Shoulder System is intended for use in patients with the following conditions where the humeral head, neck and glenoid vault are of sufficient bone stock and the rotator cuff is intact or reconstructable.

• Osteoarthritis
• Avascular Necrosis ●
• Rheumatoid Arthritis ●
• Post-traumatic Arthritis
• Correction of functional deformity

The Catalyst CSR humeral and glenoid implants are intended for cemented use.

The Catalyst CSR Press-Fit humeral implants are intended for uncemented or cemented use.

The Catalyst CSR Shoulder System is a bone preserving total shoulder prosthesis designed for use in patients where the humeral head, neck and glenoid vault are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed.

This submission adds Press-Fit Humeral Components to the CSR Shoulder System. The press-fit humeral components have a non-spherical polished surface for articulation with the glenoid component or the glenoid cavity of the scapula. The humeral components incorporate 4 pegs which assist with alignment and provide rotational stability. The four plane geometry of the back side of the humeral component matches four cut surfaces on the humeral head to recreate the geometry and thickness of the removed bone. The CSR Press-Fit Humeral Components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The undersurface of the head and the proximal portion of the alignment pegs are coated with a plasma sprayed coating of CP Ti conforming to ASTM F1580.

The CSR humeral components are compatible with previously cleared CSR 3 Peg glenoid components.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Catalyst CSR Press-Fit Humeral Components:

Summary of Device and Context:

The document is an FDA 510(k) clearance letter and a 510(k) Summary for the Catalyst CSR Press-Fit Humeral Components, which are an addition to the existing Catalyst CSR Shoulder System. This device is a shoulder prosthesis intended for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint, where the humeral head, neck, and glenoid vault have sufficient bone stock, and the rotator cuff is intact or reconstructable. The key new feature here is the "Press-Fit" capability, allowing for uncemented or cemented use, and the device incorporates a plasma sprayed coating of CP Ti. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

Detailed Analysis of Acceptance Criteria and Study Information:

Based on the provided text, the focus is on non-clinical testing to demonstrate substantial equivalence, as clinical testing was deemed unnecessary.

1. Table of Acceptance Criteria and Reported Device Performance:

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

   • Static Shear Testing: The document states "Static shear testing was conducted," but it does not specify the sample size for this test.
   • Bacterial Endotoxin Testing: The document states "Bacterial Endotoxin Testing was performed," but it does not specify the sample size for this test.
   • Data Provenance: The document does not provide information on data provenance (e.g., country of origin, retrospective/prospective). Given these are non-clinical lab tests, it's implied they were conducted in a controlled lab environment by the manufacturer or a contracted lab.

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

   • This question is not applicable as the document describes non-clinical engineering and bench tests, not studies requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set:

   • This question is not applicable for the same reasons as above. No human expert adjudication was involved in the non-clinical tests described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done.
   • The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst CSR Press-Fit Humeral Components to the predicate devices."
   • Therefore, there is no information on human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • This question is not applicable. The device is a physical shoulder implant, not an algorithm or AI system. The testing performed was related to its physical properties and biocompatibility.

7. Type of Ground Truth Used:

   • For the non-clinical tests mentioned:
     • Static Shear Testing: The "ground truth" would be the universally accepted principles of mechanical engineering and material science, measured against a pre-determined acceptance criterion (likely based on established standards for orthopedic implants).
     • Bacterial Endotoxin Testing: The "ground truth" is the predefined acceptable endotoxin limit (<10EU/component or <20EU/device construct), which is based on regulatory standards for medical devices to ensure safety.
     • Torque-out: "Ground truth" from an engineering analysis, likely based on established mechanical principles and data from the predicate device.

8. Sample Size for the Training Set:

   • This question is not applicable. The device is a physical implant, not an AI model requiring a training set. The term "training set" is typically used in the context of machine learning or AI development.

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

   • This question is not applicable for the same reasons as above.

Conclusion:

The FDA clearance for the Catalyst CSR Press-Fit Humeral Components relied on non-clinical testing demonstrating substantial equivalence to predicate devices. The key tests reported were static shear testing and bacterial endotoxin testing, both of which met pre-determined acceptance criteria. Clinical testing, which would involve human performance or outcomes, was explicitly stated as "not necessary." Therefore, many of the questions related to clinical study design, expert involvement, and AI performance are not relevant to this specific clearance document.

Ask a specific question about this device

The Catalyst CSR Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. The Catalyst CSR Shoulder System is intended for use in patients with the following conditions where the humeral head, neck and glenoid vault are of sufficient bone stock and the rotator cuff is intact or reconstructable.

• Osteoarthritis
• Avascular Necrosis
• Rheumatoid Arthritis
• Post-traumatic Arthritis
• Correction of functional deformity
  Both components of the Catalyst CSR Shoulder System are intended for cemented use only.

The Catalyst CSR Shoulder System is a bone preserving total shoulder prosthesis designed for use in patients where the humeral head, neck and glenoid vault are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed.
This submission adds larger, standard (non-spherical) humeral components to the CSR Shoulder System. Like the previously cleared CSR humeral components, the Size H and Size I CSR standard humeral components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. They have a non-spherical polished surface for articulation with the glenoid component or the glenoid cavity of the scapula. The humeral components incorporate 4 pegs which assist with alignment and provide rotational stability. The four plane geometry of the back side of the humeral component matches four cut surfaces on the humeral head to recreate the geometry and thickness of the removed bone.
The CSR humeral components are compatible with previously cleared CSR 3 Peg glenoid components.

The provided text is a 510(k) premarket notification for a medical device called the "Catalyst CSR Shoulder System." This document does not describe acceptance criteria for an AI/ML powered device, nor a study proving a device meets such criteria. Instead, it details the indications for use, device description, and a summary of substantial equivalence for a physical shoulder prosthesis, with non-clinical testing performed on its components.

Therefore, I cannot provide the information requested in your prompt based on the provided text, as it pertains to an entirely different type of medical device submission.

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