(57 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 peripheral arteries with total occlusions. The device is not to be used in the carotid arteries.
The Safe-Cross Radio Frequency Total Occlusion Crossing System consists of the following:
- 0.014" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool) (275cm Working Length)
- 0.014" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool) (175cm Working Length)
- 0.018" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool) (275cm Working Length)
- 0.035" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer) ◆ (275cm Working Length)
- Safe-Cross RF System Console with Display and Footswitch .
The modified Safe-Cross RF System is similar to the predicate Safe-Cross System. The The modified Bate-Crossing Wire is connected to a Y-Site hub that houses the optic fiber connector and the RF connector. The optical connector is connector is connected to the OCR input on the console to allow the medical practitioner to visualize structures within the mible on the console to anow and more connector is connected to the RF output on the vessel for navigation purposes. al 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 with the Tip Shaping Tool. A Torquer is provided in a separate peel pouch. The packaged RF Crossing Wire is provided "STERILE" (ethylene oxide) and non-pyrogenic, and is intended for single use only.
The provided text describes the Safe-Cross® Radio Frequency Total Occlusion Crossing System (K050916), a catheter guide wire system. The summary focuses on its substantial equivalence to a predicate device and safety testing, rather than a clinical study with detailed acceptance criteria and performance metrics typically seen for AI/ML device evaluations.
Therefore, much of the requested information regarding acceptance criteria, study sizes, expert involvement, and ground truth types for AI performance evaluation is not available in the provided document, as it pertains to a mechanical medical device rather than an AI/ML system.
However, I can extract the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a mechanical device, the "acceptance criteria" are related to safety and performance requirements rather than statistical metrics against a benchmark. The document states:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Biocompatibility testing has been conducted to verify that the materials in the modified 0.014" RF Crossing Wires are safe. |
| Benchtop Performance Characteristics | In vitro bench testing was conducted to evaluate the performance characteristics of the modified RF Crossing Wires. Benchtop performance test results indicate that the modified RF Crossing Wires satisfy safety and performance requirements of the device specifications and do not raise additional safety issues. (Specific metrics of "safety and performance requirements of the device specifications" are not detailed in this summary document.) |
| In Vivo Functionality (System Components) | In vivo animal studies have shown that the components of the system function properly together and satisfy intravascular performance requirements in an animal model. (Specific intravascular performance requirements are not detailed.) |
| Overall Safety and Performance Requirements (Conclusion) | "On the basis of the testing conducted on the modified Safe-Cross System it may be concluded that the device satisfies safety and performance requirements when used in accordance with the Instructions for Use for the indicated patient population. The modified Safe-Cross System is substantially equivalent to the predicate device." (This is a summary conclusion rather than specific criteria and measured performance.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified for biocompatibility, bench testing, or animal studies. The text only mentions "modified 0.014" RF Crossing Wires" for biocompatibility and "an animal model" for in vivo.
- Data Provenance: Not specified (e.g., country of origin). Both bench and animal studies are mentioned as "in vitro" and "in vivo," respectively, but whether they are retrospective or prospective is not stated, though animal studies are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable/Not specified. This information is typically relevant for AI/ML studies where human experts establish ground truth. For this mechanical device, "ground truth" would be the direct measurement of physical properties or biological response in laboratory or animal settings, not expert consensus on interpretations.
4. Adjudication Method for the Test Set:
- Not applicable/Not specified. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert ground truth labeling in AI/ML studies. For device testing involving physical and biological measures, standard scientific protocols for data collection and analysis would be followed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating diagnostic technologies, particularly AI systems, with human readers. The Safe-Cross® system is an interventional device, not a diagnostic one.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical, interventional medical device and does not involve an AI algorithm operating "standalone."
7. The Type of Ground Truth Used:
- Bench Testing: Engineering specifications and physical measurements are the "ground truth" for bench testing.
- Biocompatibility: Standardized biological tests (e.g., cytotoxicity, sensitization, irritation) results compared against acceptance criteria for biological safety.
- Animal Studies: Observed physiological and pathological responses in an animal model—e.g., successful crossing of occlusions, lack of vessel damage, proper system function.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, there is no training set.
§ 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).