(98 days)
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:
| Acceptance Criteria Category | Actual Acceptance Criterion (Implicit/Explicit for Device Equivalence) | Reported Device Performance and Evidence from Document |
|---|---|---|
| Overall Substantial Equivalence | The device must be substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, principles of operation, materials, safety, and effectiveness. Any differences should not raise new questions of safety or effectiveness. | "The St Jude Medical CPS Excel MediGuide Enabled guidewire has a similar intended use and the same fundamental scientific technology as the predicate devices." |
| "All technological characteristics of CPS Excel MediGuide Enabled guidewire kit are substantially equivalent to the predicate devices including packaging, biocompatibility, sterilization, and labeling." | ||
| "Where differences exist... performance testing demonstrated that these differences do not adversely affect the safety and effectiveness of the subject device." | ||
| "St Jude Medical considers the CPS Excel MediGuide Enabled guidewire kit to be equivalent to the predicate devices listed above." | ||
| Intended Use | Must be similar to predicate devices. | "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. The MediGuide system is intended for use as an adjunct to fluoroscopy." (Similar to predicate devices, though specific predicate intended uses are not detailed in this excerpt) |
| Fundamental Scientific Technology | Must be the same or similar to predicate devices. | "The St Jude Medical CPS Excel MediGuide Enabled guidewire has a similar intended use and the same fundamental scientific technology as the predicate devices." |
| Technological Characteristics | Must be substantially equivalent to predicate devices (packaging, biocompatibility, sterilization, labeling). | "All technological characteristics of CPS Excel MediGuide Enabled guidewire kit are substantially equivalent to the predicate devices including packaging, biocompatibility, sterilization, and labeling." |
| Safety and Effectiveness (where differences exist) | If there are differences from predicate devices, performance testing must demonstrate that these differences do not adversely affect the safety and effectiveness of the device. (Specific benchmarks for safety/effectiveness are not provided in this public summary, but would be part of the full 510(k) submission). | "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." (No specific performance data or metrics are provided in this summary, only the statement that testing was done and met the criteria). |
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:
- 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.
- 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.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 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.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.