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The CATALYSTEM Femoral Stems are intended for total and partial hip arthroplasty in skeletally mature patients for the following indications:

Hip components are indicated for individuals undergoing primary surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip.

The CATALYSTEM Femoral Stems are intended for use without bone cement.

The purpose of this Special 510(k) is to notify the FDA of Smith & Nephew's intent to market the CATALYSTEM Femoral Stems with additional femoral head compatibility. The CATALYSTEM Femoral Stems were previously cleared by the FDA under K240381.

The CATALYSTEM Femoral Stems consists of femoral stem implants intended for primary in skeletally mature patients. The CATALYSTEM Femoral Stems are provided sterile to the user via gamma irradiation.

The subject CATALYSTEM Femoral Stems are comprised of two variants: CATALYSTEM Collared and CATALYSTEM Collarless. Both variants are available in standard and high neck offset options.

The CATALYSTEM Femoral Stems are intended to be used with Smith & Nephew femoral heads and acetabular components for total hip arthroplasty and hip hemiarthroplasty.

This document is a 510(k) clearance letter for the CATALYSTEM Femoral Stems. It primarily addresses the regulatory approval process rather than detailing a study proving the device meets specific acceptance criteria in the context of an AI/software device.

The provided text does not contain information related to AI/software device performance or studies proving such a device meets acceptance criteria. It describes a medical device (femoral stems for hip replacement) and its regulatory clearance based on substantial equivalence to a predicate device.

Specifically, it states:

• "No clinical tests were performed to support safety and efficacy of the subject device."
• Bench testing was performed for mechanical properties (e.g., fatigue, range of motion, impingement), which are relevant to orthopedic implants, not AI performance.
• The clearance is a "Special 510(k)" primarily for "additional femoral head compatibility."

Therefore, I cannot extract the requested information about acceptance criteria and a study proving an AI device meets them from this document. The concepts of ground truth, expert adjudication, MRMC studies, standalone performance, training sets, and test sets are not applicable to the information provided in this 510(k) clearance letter for a mechanical implant.

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The CATALYSTEM Femoral Stems are intended for total and partial hip arthroplasty in skeletally mature patients for the following indications:

Hip components are indicated for individuals undergoing primary surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip.

The CATALYSTEM Femoral Stems are intended for use without bone cement.

The purpose of this Traditional 510(k) is to notify the FDA of our intent to market the Smith & Nephew CATALYSTEM Femoral Stems. The CATALYSTEM Femoral Stems consists of femoral stem implants intended for primary hip arthroplasty in skeletally mature patients. The CATALYSTEM Femoral Stems are provided sterile to the user via gamma irradiation.

The subject CATALYSTEM Femoral Stems are comprised of two variants: CATALYSTEM Collared and CATALYSTEM Collarless. Both variants are available in standard and high neck offset options. The CATALYSTEM Femoral Stems are non-cemented femoral hip stems manufactured from forged titanium alloy and feature a CP-Ti and HA coating.

The CATALYSTEM Femoral Stems are intended to be used with Smith & Nephew femoral heads and acetabular components for total hip arthroplasty and hip hemiarthroplasty.

This document is a 510(k) summary for the CATALYSTEM Femoral Stems. It describes a medical device, specifically hip joint components, and outlines the testing and analyses conducted to demonstrate its substantial equivalence to previously marketed devices. This type of submission does not typically involve AI/ML components or studies on diagnostic performance, but rather focuses on mechanical integrity, materials, and biocompatibility.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not applicable in the context of this device and submission type. The device is a physical implant, not a diagnostic software or AI product.

However, I can provide the acceptance criteria and a summary of the studies that prove the device meets these criteria based on the non-clinical testing performed, as described in the document.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each mechanical or material test. These tests typically involve a defined number of samples according to the specific ASTM or ISO standard being followed. Data provenance is implied to be from Smith & Nephew's internal testing labs or contracted testing facilities, as these are non-clinical (laboratory) studies. The data is prospective in the sense that the tests were conducted specifically to support this 510(k) submission.

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

This is not applicable. For mechanical and material testing of implants, "ground truth" is established by the specifications defined in recognized national and international standards (e.g., ISO, ASTM). The "experts" are the engineers and material scientists conducting and interpreting these standardized tests, whose qualifications are inherent in their ability to perform such tests according to regulatory requirements. No clinical expert consensus is involved in establishing the "truth" for these non-clinical tests.

4. Adjudication method for the test set

Not applicable. Mechanical and material tests follow defined methodologies in their respective standards. The results are quantitative and directly measured against pre-defined acceptance criteria, not subject to subjective adjudication.

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

Not applicable, as this is not an AI/ML-driven diagnostic device.

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

Not applicable, as this is not an AI/ML-driven diagnostic device.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is based on:

• Engineering specifications and design requirements: Derived from the predicate devices and industry best practices.
• Recognized national and international standards: Such as ISO (e.g., ISO 7206, ISO 21535, ISO 10993, ISO 13779) and ASTM (e.g., ASTM F2996, ASTM F1147, ASTM F1044, ASTM F1160, ASTM F2182, ASTM F2052, ASTM F2213, ASTM F2119). These standards define acceptable performance metrics for medical devices of this type.

8. The sample size for the training set

Not applicable, as this is not an AI/ML-driven diagnostic device.

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

Not applicable, as this is not an AI/ML-driven diagnostic device.

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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.

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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 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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Catalyst Bone Void Filler is indicated for filling bone voids or defects of the skeletal system (i.e., the posterolateral spine, intervertebral disc space, extremities, and pelvis) that are not intrinsic to the stability of the bony structure. These osseous defects may be surqically created or as a result of traumatic injury to the bone. Catalyst Bone Void Filler is a bone graft putty that is resorbed and replaced with bone during the healing process. Catalyst Bone Void Filler must be used with morselized autograft bone at a ratio of 1:1 by volume in the posterolateral spine. When used in intervertebral body fusion procedures, Catalyst Bone Void Filler must be used with morselized autograft bone at a ratio of 1:1 by volume with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler. OssDsign Catalyst contains 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel. The final, finished OssDsign Catalyst is 30 wt% granules and 70 wt% polymer gel. The high surface area porous granules have been designed to deliver consistent and rapid bone ingrowth, remodeling, and cellmediated resorption during the bone healing process. The aqueous polymer gel phase binds the highly porous granules into a moldable, pliable formulation which enables OssDsign Catalyst to be implanted directly from the packaging without any further gelation, mixing or graft setting time. OssDsign Catalyst is provided sterile to the end user in 1 cc, 2.5 cc, 5 cc, and 10 cc syringe volumes.

OssDsign Catalyst is identical to the currently marketed product Osteo3 ZP Putty (K193075). The cleared Osteo3 ZP Putty was launched in the USA in October 2021 and marketed under the name OssDsign Catalyst.

Here's a breakdown of the acceptance criteria and supporting study details based on the provided FDA 510(k) summary for the Catalyst Bone Void Filler.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a detailed clinical study demonstrating the device's standalone performance against specific acceptance criteria. The performance testing summarized supports the claim of substantial equivalence. Therefore, the "acceptance criteria" here are inferred from the types of non-clinical testing performed and the comparison to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document primarily relies on non-clinical testing and refers to data from the prior clearance (K193075) of an identical device.

• Sample Size: Specific sample sizes for each non-clinical test (e.g., sterilization, biocompatibility, mechanical testing) are not detailed in this summary. It states "non-clinical testing data were submitted" for K193075.
• Data Provenance: The data provenance is from non-clinical (laboratory and animal) studies conducted in support of the original device clearance (K193075). The specific countries where these tests were performed are not mentioned. The studies were retrospective in the context of this 510(k) submission, as they were conducted for a prior clearance.

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

This information is not provided in the 510(k) summary. Given that it's primarily non-clinical testing and comparison to predicates, the concept of "experts establishing ground truth for a test set" in the context of clinical reads (like a radiologist for imaging devices) doesn't directly apply in the same way. The "ground truth" for non-clinical tests is established by the methods, standards, and results of those tests.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods like "2+1" typically apply to human interpretation of data (e.g., medical images) where discrepancies need resolution. The testing described here is primarily non-clinical compliance and performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done as described in this 510(k) summary. This type of study would compare human performance with and without AI assistance, which is not relevant for a bone void filler device in this context. The document focuses on demonstrating substantial equivalence through non-clinical data and comparison of device characteristics.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to the Catalyst Bone Void Filler. This device is a bone void filler, not an algorithm or AI-powered diagnostic/therapeutic tool. Therefore, "standalone algorithm performance" is not a relevant concept here.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the device's characteristics and equivalence was established through:

• Non-clinical test results: Chemical composition analysis, physical properties testing, sterility testing, pyrogenicity, bacterial endotoxin, shelf life, biocompatibility studies.
• Animal testing: Specifically, mechanical performance in a posterolateral spine fusion animal model for the reference device (K193075).
• Comparison to predicate devices: The "ground truth" for substantial equivalence heavily relies on demonstrating that the Catalyst Bone Void Filler's characteristics and performance are comparable to (or identical to, in the case of K193075) legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a physical medical implant, not an AI algorithm that requires a "training set."

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

This information is not applicable/not provided for the same reason as #8.

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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.

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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 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.

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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 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).

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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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