(63 days)
The Turbo Elite is intended for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
The Turbo-Elite Atherectomy Catheter is a laser atherectomy catheter constructed of multiple optical fibers arranged circumferentially around a guidewire lumen (0.014 and 0.018, presently). Turbo Elite Laser Catheters are available in Over the Wire (OTW) and Rapid Exchange (RX) configurations. The proposed catalog additions are over-the-wire (OTW) 0.035" guidewire compatible with crossing profiles of 2.3mm and 2.5mm.
The laser catheter is connected to the Spectranetics CVX-300 Excimer Laser System by means of an optical coupler and tail-tubing.
The Turbo Elite, OTW catheters include a luer adapter located at the proximal end of the usable length facilitates the use of the laser catheter over the appropriate sized guidewire.
The provided document is a 510(k) summary for the Spectranetics 0.035" compatible, 2.3mm and 2.5mm TurboElite Atherectomy Catheters. It is not a study report that details specific acceptance criteria and the results of a clinical or analytical study in the way typically expected for AI/ML device evaluations.
Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K071227) by showing that the new devices have comparable intended use, patient population, mode of operation, materials, packaging, biocompatibility, sterilization, and shelf-life. The "studies" mentioned are primarily device integrity testing to support this claim of substantial equivalence.
Therefore, many of the requested items (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, ground truth types) are not applicable or cannot be extracted from this specific document, as it describes a different type of regulatory submission.
Here's an analysis based on the information provided, highlighting what is available and what is not:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Preamble: The primary acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to the predicate device (K071227). This means showing that the new devices are as safe, as effective, and perform substantially equivalent to the predicate. | The document concludes that the 0.035" compatible 2.3mm and 2.5mm Turbo Elite Laser Atherectomy Catheters "are as safe, as effective, and perform substantially equivalent to the predicate device" based on the summary of studies. |
| Specific Performance Requirements (Inferred from "Summary of Studies"): These are not explicit quantitative "acceptance criteria" with numerical thresholds, but rather categories of testing performed to support substantial equivalence. | |
| Visual Inspection and Dimensional Testing met specified requirements. | Met specified requirements. |
| In vitro Liquid Leak Pressure Testing met specified requirements. | Met specified requirements. |
| Tensile Strength met specified requirements. | Met specified requirements. |
| In vitro Track Testing met specified requirements. | Met specified requirements. |
| Laser testing met specified requirements. | Met specified requirements. |
| Accelerated age testing met specified requirements. | Met specified requirements. |
Study Proving Device Meets Acceptance Criteria:
The "study" proving the device meets the acceptance criteria is the device integrity testing (listed above) performed by Spectranetics. The purpose of these tests was to support the claim of substantial equivalence to the predicate device (K071227). The conclusion states that "All device integrity tests...met the specified requirements," leading to the determination of substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: This document does not provide specific sample sizes (e.g., number of catheters, number of tests for each category) for the device integrity testing. This information is typically found in detailed test reports, not a 510(k) summary.
- Data Provenance: Not specified. The studies are described as "device integrity testing" and "in vitro," implying laboratory-based testing rather than clinical data from human subjects or specific geographical regions.
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)
- Not Applicable. This submission is for a medical device (catheter) and relies on engineering and performance testing, not on expert adjudication of diagnostic images or clinical assessments to establish "ground truth" in the context of an AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this type of adjudication is relevant for studies involving human interpretation (e.g., radiology reads) and is not part of the device integrity testing described here.
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
- No. An MRMC study was not done. This study is focused on the physical and performance characteristics of a catheter, not the comparative effectiveness of human readers, with or without AI assistance, in a diagnostic context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device (catheter), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context refers to the specified requirements or design specifications for the device's physical and functional performance (e.g., dimensional tolerances, leak pressure limits, tensile strength minimums, laser output parameters). The device integrity tests were conducted to verify that the manufactured devices met these engineering specifications.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of this device's regulatory submission. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not applicable.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).