Search Results

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."

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 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.

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