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The St. Jude Medical CPS Excel™ MediGuide Enabled™Guidewire is intended for use with the MediGuide™ System to enable real-time tip positioning and navigation within the coronary and peripheral vasculature (such as to facilitate left heart lead implantation). The MediGuide system is intended for use as an adjunct to fluoroscopy.

The Connector accessory is a flexible, insulated cable that is used to connect the CPS Excel™ MediGuide Enabled " guidewire to the MediGuide Technology. The guidewire is inserted into the connector until it bottoms out. Once the guidewire cannot be pushed any further, the nut on the connector end is tightened to fixate the guidewire in the connector. Inside the molded connector housing is a printed circuit board (PCB) which is wrapped with magnetic shielding. The PCB has contact slots that connect with the electrical contacts of the guidewire for electrical functionality. The other end of the MediGuide guidewire connector is a ODU-compatible connector that connects to the MediGuide Technology catheter connect box.

The provided text is a 510(k) Summary for a medical device (CPS Excel™ MediGuide Enabled™ Guidewire and accessories). It states that this submission is a "special 510(K) to gain clearance" for the device, and that there are "no design changes to the Guidewire Models DS2M027, and DS2M029." It also states that the "Connector accessory DS2M033 have only undergone minimal design changes to connect directly to the MediGuide technology as compared to the predicate."

This type of submission often focuses on demonstrating that the modified device remains substantially equivalent to a previously cleared predicate device, rather than performing a new, extensive clinical study to establish new performance criteria. It relies heavily on non-clinical testing and comparison to the predicate.

Therefore, many of the typical acceptance criteria and study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithmic performance) that would be present for a novel AI/software device are not applicable or available in this document because the submission focuses on demonstrating equivalence through non-clinical testing and minimal design changes.

The document does not describe a study in the sense of a large-scale clinical trial with human subjects for novel performance claims. Instead, it describes non-clinical verification and validation testing to ensure the modified device meets its design and performance specifications and remains substantially equivalent to the predicate.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the requested information is not applicable:

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

The document does not provide a table of precise acceptance criteria with specific numerical thresholds and corresponding reported device performance values in a format typical for new performance claims. Instead, it lists the types of non-clinical tests performed and states that they were "Successful completion of all verification and validation activities...demonstrated that the candidate devices meet their predetermined design and performance specifications and that the products are substantially equivalent to the predicate devices."

The acceptance criterion for each test would generally be that the device successfully passes the specified test according to the guiding standard. The reported device performance is implicitly that it passed these tests.

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. The tests performed are non-clinical, mechanical, and integrity tests, not studies involving patient data or clinical datasets.

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. The tests are non-clinical and do not involve expert interpretation of medical data to establish ground truth.

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

This information is not applicable. The tests are non-clinical and do not involve expert adjudication of medical data.

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. This is a medical device for real-time tip positioning and navigation, not an AI-assisted diagnostic tool for human readers. No MRMC study was mentioned or performed for this specific 510(k) submission.

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

The device is a guidewire and connector, intended for use with the MediGuide™ System to enable real-time tip positioning and navigation. It is not an algorithm or AI product that would have a standalone performance study in the context typically described (e.g., for diagnostic algorithms). Its "performance" relates to its structural integrity, electrical functionality, and ability to connect to the MediGuide system.

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

For the non-clinical tests described, the "ground truth" is typically defined by the specifications and requirements outlined in the referenced ASTM, ISO, and ANSI/AAMI standards. For example, for a bubble leak test, the "ground truth" is the absence of bubbles under specified conditions. For dimensional testing, it's meeting the specified dimensions. There is no expert consensus, pathology, or outcomes data involved in these non-clinical tests.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device (guidewire and connector), 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, as there is no training set for this type of device.

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The St. Jude Medical CPS Excel™ MediGuide Enabled™Guidewire is intended for use with the MediGuide™ System to enable real-time tip positioning and navigation within the coronary and peripheral vasculature (such as to facilitate left heart lead implantation). The MediGuide system is intended for use as an adjunct to fluoroscopy

The St. Jude Medical CPS Excel ™ , MediGuide Enabled ™ guidewire is a MediGuide enabled guidewire with a hydrophilic coating. The CPS Excel, MediGuide Enabled guidewire contains a magnetic sensor allowing it to be visualized using the MediGuide system

This document is a 510(k) summary for a medical device called the "CPS Excel™ MediGuide Enabled™ Guidewire and accessories." It does not describe a study involving algorithms, AI, or human readers, but rather a traditional medical device (a guidewire) seeking FDA clearance based on substantial equivalence to existing predicate devices.

Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/algorithm performance cannot be extracted from this document.

However, I can provide the information that is present, interpreted for a traditional medical device:

Acceptance Criteria and Device Performance (for a traditional medical device)

The document asserts "substantial equivalence" as the primary acceptance criteria. For traditional medical devices seeking 510(k) clearance, the "acceptance criteria" are generally that the device is as safe and effective as a legally marketed predicate device, and any differences do not raise new questions of safety or effectiveness.

Key statements:

• "Where differences exist between the subject device and the predicate devices performance testing demonstrated that these differences do not adversely affect the safety and effectiveness of the subject device."
• "This conclusion is based upon the device similarities in design, technological characteristics, principles of operation, materials and indications for use."

Table of Acceptance Criteria and Reported Device Performance:

Regarding the specific questions about an AI/algorithm study:

As stated previously, this document is about a physical guidewire. Therefore, the following information is not applicable or available from the provided text:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, no "test set" in the AI sense. The "performance testing" referred to for the guidewire would be mechanical, chemical, and biological, not based on data sets of images or algorithms.
2. 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.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Safety and effectiveness for a guidewire would be demonstrated through various tests (e.g., tensile strength, kink resistance, pushability, torqueability, biocompatibility, sterility) and potentially animal or bench testing relevant to its physiological environment and mechanism of action, compared against predicate devices.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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