(127 days)
The St. Jude Medical™ CPS Direct™, MediGuide Enabled™ slittable 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. The CPS Direct™, MediGuide Enabled™ slittable outer guide catheter are used with the MediGuide System to enable real-time tip positioning and navigation. The MediGuide system is indicated for use as an adjunct to fluoroscopy. In addition, the CPS Direct™, MediGuide Enabled™ slittable outer guide catheters can work with inner catheters as a system.
The St. Jude Medical CPS DirectTM, MediGuide EnabledTM outer catheter is made from PEBAX and reinforced with a stainless steel braid. The shaft has progressively decreasing durometers of PEBAX form the proximal to the distal end with a soft, atraumatic distal tip. The distal end is embedded with a sensor coil to enable device tip projection onto the MediGuideTM system and tungsten stripes for fluoroscopic visibility. The hub contains an integrated hemostasis valve and a molded slit channel. The hub contains a sideport with extension tubing for contrast delivery, aspiration or saline flush using a 3-way stopcock. In addition, the hub contains a port for the connector cable.
This document describes the CPS Direct™ MediGuide Enabled™ Slittable Outer Guide Catheter Models DS2M041, DS2M042, DS2M043, DS2M044 and its performance testing. This is a medical device, and the provided text does not contain information related to AI/ML software or studies that would typically include the requested details about acceptance criteria, data sets, expert involvement, or comparative effectiveness studies in the context of an AI/ML algorithm.
Therefore, I cannot provide an answer that directly addresses most of your specific numbered requests (1, 2, 3, 4, 5, 6, 7, 8, 9) because they are designed for evaluating AI/ML models.
However, I can extract the relevant information about the performance testing of this medical device as described in the document.
Here's a summary of the available information regarding the device's performance testing:
Device: CPS Direct™ MediGuide Enabled™ Slittable Outer Guide Catheter Models DS2M041, DS2M042, DS2M043, DS2M044
1. A table of acceptance criteria and the reported device performance:
The document lists the types of performance testing conducted, but it does not provide specific numerical acceptance criteria or quantitative performance results for each test. It states that the device "met all specified design and performance specifications."
| Test Category | Reported Device Performance |
|---|---|
| Package Integrity | Met all specified design and performance specifications |
| Seal Strength | Met all specified design and performance specifications |
| Saline and Aspiration Leak Testing | Met all specified design and performance specifications |
| Visual Inspection | Met all specified design and performance specifications |
| Dimensional Testing | Met all specified design and performance specifications |
| Kink Testing | Met all specified design and performance specifications |
| Compatibility Testing | Met all specified design and performance specifications |
| Electrical Integrity | Met all specified design and performance specifications |
| Tensile Testing | Met all specified design and performance specifications |
| Rotation Capacity | Met all specified design and performance specifications |
| Torque Testing | Met all specified design and performance specifications |
| Slit Force | Met all specified design and performance specifications |
| Flex Testing | Met all specified design and performance specifications |
| Radiopacity Testing | Met all specified design and performance specifications |
| Polarity | Met all specified design and performance specifications |
| Static Accuracy | Met all specified design and performance specifications |
| Biocompatibility | Met all specified design and performance specifications |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the performance tests. It also does not discuss data provenance in terms of country of origin or retrospective/prospective for this type of device testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided for this type of medical device performance testing, which focuses on physical and functional characteristics rather than diagnostic accuracy based on expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided for this type of medical device performance 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 information is not applicable. The device is a physical catheter, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical catheter, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance testing of a physical medical device, the "ground truth" is typically defined by engineering specifications, material properties, and established industry standards for performance (e.g., specific tensile strength, leak rate limits, etc.). The document does not detail how these "specifications" were established, but it implies they exist as a benchmark for the tests.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set" as this is not an AI/ML device.
Additional Information from the document:
- Type of Study: Product verification (non-clinical) to confirm design requirements and applicable industry standards.
- Conclusion: St. Jude Medical considers the device equivalent to predicate devices based on similarities in design, technological characteristics, principle of operation, materials, and indications for use. Performance testing demonstrated that differences do not adversely affect safety and effectiveness.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).