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The St. Jude Medical CPS Aim™ Inner Catheter is designed for intracardiac access of the coronary sinus and subselection of the venous system of the heart, and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical devices, including guidewires. In addition, the inner catheters can work with outer guide catheters as a system.

The inner catheter is an introducer that shall be used to primarily subsclect a coronary sinus vein branch in the venous system. The CPS Aim730 Inner Catheters will have eight different curve configurations. The catheters will have a working length of 71 cm, are radiopaque, and have a flexible distal tip. The inner diameter of the catheter is lined with polytetrafluoroethylene (PTFF) to ensure additional lubricity. The catheters function as an inner catheter and can work with an outer guide catheter as a system.

Here's an analysis of the provided information regarding the acceptance criteria and study for the CPS Aim™ Inner Catheter:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K053217) is a 510(k) premarket notification summary. For this type of submission, especially for a Class II device like the CPS Aim™ Inner Catheter, the regulatory pathway relies on demonstrating "substantial equivalence" to a legally marketed predicate device rather than establishing completely new performance criteria through extensive clinical trials with explicit acceptance metrics.

Therefore, the document does not contain a table of explicit acceptance criteria with specific numerical targets (e.g., sensitivity, specificity, accuracy) or reported device performance in the way one might expect for an AI/diagnostic device.

Instead, the acceptance criteria are implicit in the demonstration of equivalence to predicate devices, which means:

• Similar technological characteristics: The device uses similar technology, intended uses, functions, materials, and method of operation.
• Meeting general design and performance specifications: The device underwent verification testing to ensure it meets its own internal design and performance specifications.
• Biocompatibility: Materials are biocompatible.
• Sterilization validation: The sterilization process is validated.

The "reported device performance" is essentially that it "met all specified design and performance specifications" and was found to be "substantially equivalent" to the predicate devices.

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

The document does not report on a "test set" in the context of clinical data or patient imaging. The studies mentioned are primarily engineering-based device comparison testing, mechanical testing, functional testing, and biocompatibility testing.

Therefore, information on:

• Sample size used for a test set
• Data provenance (country of origin, retrospective/prospective)

...is not applicable or not provided in this 510(k) summary, as it's not a study that involved clinical data in the form of patient populations or images.

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

Given that this is a catheter and the studies described are device comparison testing, mechanical, functional, and biocompatibility testing, the concept of "experts used to establish ground truth" (e.g., radiologists interpreting images) for a clinical test set is not applicable. The "ground truth" for these tests would be established by engineering standards, industry best practices, and laboratory measurements.

4. Adjudication Method for the Test Set

As there is no clinical "test set" in the conventional sense involving patient data or interpretations by human experts, there is no adjudication method provided or applicable.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a physical catheter, not an AI or diagnostic imaging system that would involve human readers interpreting output from an AI.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the verification and device comparison testing described would have been established through:

• Engineering specifications and design documents: For mechanical and functional testing, the "ground truth" is whether the device meets its pre-defined specifications (e.g., dimensions, flexibility, tensile strength, flow rates).
• Established laboratory protocols and standards: For biocompatibility and sterilization, the "ground truth" is adherence to recognized ISO standards and validated testing methodologies.
• Predicate device characteristics: For device comparison, the "ground truth" refers to the known characteristics and performance of the legally marketed predicate devices, which the new device aims to be substantially equivalent to.

8. The Sample Size for the Training Set

There is no "training set" in the context of machine learning or AI described in this document. The studies performed are engineering verification and validation, not model training.

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

Since there is no training set for an AI/algorithm, the concept of establishing ground truth for it is not applicable.

In Summary:

The provided document (K053217) pertains to a 510(k) premarket notification for a physical medical device (an inner catheter). The regulatory approval is based on demonstrating "substantial equivalence" to existing predicate devices through engineering, material, and performance testing, rather than clinical studies with explicit statistical acceptance criteria, ground truth established by experts, or AI performance metrics. Therefore, many of the requested details related to "acceptance criteria" and "studies" as they apply to AI or diagnostic imaging devices are not present or applicable to this submission.

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The St. Jude Medical Slittable Direct™ Outer Guide Catheter is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical devices, including implantable left heart leads and delivery tools, and support of fluids where minimizing blood loss is essential. In addition, the outer guide catheters can work with inner catheters as a system.

The outer catheter is an introducer that is used to cannulate the Coronary Sinus (CS). The CPS Direct SL outer catheter will have 7 different curves configurations. The catheters will be available in 47 and 54cm working lengths and are radiopaque. The inner diameter of the sheath shall be PTFE lined and to ensure additional lubricity the inside and outside surfaces of the sheath shall be coated with a lubricious coating. The sheath shall have a proximal split away hub which interfaces with the hemostasis valve. The catheter functions as an outer catheter and can work with an inner guide catheter as a system.

This document describes a 510(k) premarket notification for the "CPS Direct™ SL Outer Catheter," a medical device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving novel clinical effectiveness through extensive studies involving human subjects or AI algorithms. As such, many of the requested categories for AI-driven device studies are not applicable or cannot be extracted from the provided text.

Here is the information that can be extracted, acknowledging the limitations for a traditional medical device submission:

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

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

The document mentions "Device comparison testing" and "Verification... which included mechanical, functional and biocompatibility testing." However, it does not specify sample sizes for these tests, nor the data provenance (e.g., country of origin, retrospective/prospective). These would typically be detailed in underlying test reports, not usually summarized in a 510(k) notification in this manner unless it's a clinical study. This is a medical device, not an AI or software device that processes data in the typical sense this question implies.

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 question is not applicable to the type of device and submission described. The "ground truth" for this catheter's performance is established through engineering and biological testing (mechanical, functional, biocompatibility) against established specifications and predicate device equivalence, not through expert review of data like in an AI diagnostic device.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or evaluations where expert consensus on outcomes or interpretations is required, typically for diagnostic or prognostic devices. This submission involves technical 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

This question is not applicable. This is a physical medical device (catheter), not an AI system. Therefore, no MRMC study, human reader improvement with AI, or effect size related to AI assistance would be performed or reported for this device.

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

This question is not applicable. This is a physical medical device, not an algorithm or AI system.

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

The "ground truth" for this device's performance, in the context of the described studies, would be based on:

• Engineering specifications and standards: For mechanical and functional testing.
• Established biocompatibility standards: For biocompatibility testing.
• Validated sterilization methods: For sterilization validation.
• Performance of predicate devices: As a benchmark for "substantial equivalence."

It is not based on expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or AI-driven devices.

8. The sample size for the training set

This question is not applicable. This device does not involve a "training set" as it is not an AI or machine learning model.

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

This question is not applicable. As there is no training set, there is no ground truth, as defined for AI models, that needs to be established for it.

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