(190 days)
The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in percutaneous interventions in native coronary arteries with total occlusions.
The Safe-Cross™ Radio Frequency (RF) Total Occlusion (TO) Crossing System consists of a the following:
- 0.014" Safe-Cross RF Crossing Wire -- Straight and Angled Tip (with Torquer) .
- Safe-Steer™ Optical Coherence Reflectometry (OCR) Unit with . Display Monitor
- Safe-Cross RF Generator with Footswitch and Interface Cable .
The Safe-Cross RF Crossing Wire is similar to the prodicate guidewire in construction and intended use. The proximal end of the Crossing Wire is connected to a Y-Site hub that houses the optic fiber connector and the RF connector. The optical connector is connected to the OCR Unit to allow the medical practitioner to visualize structures within the vessel for navigation purposes. The RF connector is connected to the RF Generator. This allows the medical practitioner to provide discrete RF energy to the distal tip to assist in moving the wire tip through the occlusion in the vessel.
The RF Crossing Wire is packaged in a Tyvek® sealed plastic tray. The packaged RF Crossing Wire is sterilized by ethylene oxide gas. The packaged RF Crossing Wire is provided "STERILE" and Non-pyrogenic, and is intended for single use only.
The provided text describes the Safe-Cross Radio Frequency Total Occlusion Crossing System, a medical device, and its regulatory submission. It mentions human clinical studies were conducted to verify the device's safety and performance, but it does not provide specific acceptance criteria or detailed results of those studies in a quantifiable manner.
Therefore, I cannot populate the table or answer all of your questions directly from the provided text.
However, I can extract the information that is present and indicate where information is missing.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Quantitative) | Reported Device Performance (Quantitative) |
|---|---|
| Not specified in document | Not specified in document |
| (e.g., Specific success rate for crossing occlusions, rate of adverse events within defined limits) | "the device performs as intended and does not involve unacceptable risk to the patient" |
Note: The document only states a general conclusion that the device performs as intended and does not pose unacceptable risks, but it does not provide the specific numerical acceptance criteria (e.g., "successful crossing of occlusion in X% of cases") or the achieved performance metrics (e.g., "successful crossing in Y% of cases").
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only states "Human clinical studies have been conduct to verify the safety and performance characteristics of the Safe-Cross System."
- Data Provenance: Prospective human clinical studies. The country of origin is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. The document does not detail how the outcomes of the clinical studies were assessed or by whom.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- MRMC Study Done?: Not applicable. This device is a guidewire system, not an imaging or diagnostic AI requiring human reader comparison. The "clinical studies" mentioned are likely efficacy and safety trials demonstrating the device's ability to cross occlusions.
- Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Study Done?: Not applicable in the context of an "algorithm only" study. This is a physical medical device (guidewire system) operated by a human, not a standalone AI algorithm. The device's performance inherently involves human interaction.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for performance and safety would be established through clinical outcomes observed during the human clinical studies, likely including successful occlusion crossing, procedural success rates, and the incidence of adverse events, as assessed by the treating physicians and study investigators.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI algorithm that requires a "training set" in the machine learning sense. The development and testing would involve bench testing and animal studies prior to human clinical trials.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable as there is no "training set" in the AI sense. For the development and pre-clinical stages, "ground truth" for design and performance would be established through engineering specifications, bench testing results (e.g., force required to cross simulated occlusions, RF power output, durability), and animal study observations (e.g., successful crossing in animal models, tissue effects). These would typically be compared against predetermined design requirements and safety parameters.
§ 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.