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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 Guidant RAPIDO™ Cut- Away™ Guiding Catheter is intended to access the coronary venous system, and may be used as a dualcatheter assembly. The catheter serves as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads, introduced into the coronary venous system.

The RAPIDO Cut-Away Guiding Catheter is similar to the approved RAPIDO Guiding Catheter. The Cut-Away Catheter is comprised of a flexible shaft, lucr (hub) and a soft tip. The catheter shaft is comprised of an inner liner of polytetrafluoroethylene (PTFE), an outer layer of radiopaque polyether block amide (PEBAX), with a reinforcing layer of 304V stainless steel braid sandwiched between the two. A blue PEBAX luer (sometimes referred to as a "hub") is attached to the proximal end of the shaft using a cyanoacrylate adhesive. A silicone coating is applied to the exterior of the shaft to improve device lubricity. The distal end of the catheter is formed into a variety of shapes as needed to access differing areas of the anatomy.

The provided document describes a 510(k) summary for the RAPIDO™ Cut-Away™ Guiding Catheter. This type of regulatory submission establishes substantial equivalence to a predicate device, rather than providing detailed clinical study data with specific acceptance criteria as might be found for a novel device or one requiring a PMA.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment are not explicitly present in the provided text. The document focuses on demonstrating substantial equivalence through technological characteristics and performance testing in comparison to a predicate.

However, I can extract and infer some information based on the typical content of a 510(k) and the statements made.

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

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

• Sample Size for Test Set: Not specified. The document mentions "testing" but does not provide details on the number of catheters or tests performed.
• Data Provenance: Not explicitly stated, but typically, performance testing for 510(k) submissions is conducted by the manufacturer (Guidant Corporation) in a controlled laboratory environment. It is retrospective in the sense that the data is generated to demonstrate equivalence of a new design to an existing one. No information on country of origin of data (e.g., patient data) is relevant or provided, as this is a device performance test, not a clinical trial with human subjects.

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

• This is not applicable/not provided. The "ground truth" for this type of device (a guiding catheter) is typically established through engineering specifications, material testing, and functional performance benchmarks rather than expert consensus on medical images or clinical outcomes. The performance is compared to the predicate device, not against an "expert ground truth" in a diagnostic sense.

4. Adjudication method for the test set

• This is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where there might be disagreement in expert interpretation. For a medical device like a catheter, performance is assessed against engineering and functional specifications, not subjective interpretations requiring 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

• This is not applicable. The RAPIDO™ Cut-Away™ Guiding Catheter is not an AI-powered diagnostic device, nor is it a device that enhances human reader performance in interpreting medical cases. Therefore, an MRMC study and AI-related effect sizes are irrelevant to this submission.

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

• This is not applicable. This is a physical medical device (catheter), not an algorithm or software.

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

• The "ground truth" for this submission would be engineering specifications, material properties, and functional performance benchmarks that the predicate device (RAPIDO Guiding Catheter, K021455) was designed and cleared to meet. The new device is then tested to confirm it meets these same implicit standards.

8. The sample size for the training set

• Not applicable/not provided. This is a physical medical device, not a machine learning algorithm, so there is no concept of a "training set" in this context.

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

• Not applicable. As stated above, there is no training set for this device.

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