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The Turbo-Power Laser Atherectomy Catheter is indicated for laser atherectomy of de novo restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA).

The 2.0mm and 2.3mm Turbo-Power Laser Atherectomy Catheters are laser atherectomy devices designed for use with the CVX-300™ Excimer Laser System. The 2.0mm and 2.3mmTurbo-Power Laser Atherectomy Catheters are sterile, single use, prescription only devices used for peripheral atherectomy. The 2.0mm and 2.3mm Turbo-Power Laser Atherectomy Catheters are used to ablate lesions with reference vessel diameters of ≥3.0mm. 2.0mm and 2.3mm Turbo-Power Laser Atherectomy Catheters are comprised of 2 subassemblies: 1. Catheter Subassembly 2. Motor Drive Unit (MDU) Subassembly The working length of the Turbo Power Laser Atherectomy Catheter is constructed of multiple optical fibers arranged eccentrically around a 0.018" (0.46 mm) guidewirecompatible lumen. The PTFE quidewire lumen tip is attached to a stainless steel torque wire which is connected to the MDU at the proximal end of the working length. The multifiber laser catheter transmits ultraviolet energy from the Spectranetics CVX-300 Excimer Laser System through the tip of the laser to an obstruction in the patient's artery. The outer surface of the laser catheter working length is hydrophilic-coated, and the distal tip of the catheter contains a radiopaque marker band for in situ visibility. The ultraviolet energy transmitted from the CVX-300 laser system is used to photoablate multiple morphology lesions which mav be comprised of atheroma, fibrosis, calcium, and thrombus, thus recanalizing diseased vessels. Photoablation is the process by which energy photons cause molecular bond disruption at the cellular level without thermal damage to surrounding tissue.

The provided text is a 510(k) summary for the Spectranetics Turbo-Power Laser Atherectomy Catheters. The document states that "New clinical data was not required to demonstrate substantial equivalence," and much of the testing was "leveraged from the predicate Turbo-Power (2.3mm)" and summarized within this submission (which is not fully provided). Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, and ground truth establishment for a new study are not available in the provided text because a new extensive clinical study for this specific 510(k) was not conducted.

However, based on the information provided, here's what can be inferred or directly stated:

1. A table of acceptance criteria and the reported device performance

The document lists types of performance data collected but does not provide specific acceptance criteria or quantitative performance results in a table format.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not specified for any new testing. Much of the data was leveraged from predicate devices. For pre-clinical GLP studies, the sample size is not disclosed.
• Data Provenance: Not specified for any new testing. The phrase "pre-clinical GLP studies" suggests controlled laboratory or animal studies, not human clinical trials.

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, as new clinical data requiring expert-established ground truth was not explicitly detailed or required. The testing involved "Design Verification and Validation Testing" and "Pre-clinical GLP studies," which typically don't involve expert ground truth in the same way clinical imaging studies do.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as new clinical data requiring adjudication was not explicitly mentioned or required.

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 MRMC study was mentioned. This device is a physical medical device (laser atherectomy catheter), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable to a physical medical device like a laser atherectomy catheter. The device itself performs the intended function, often with human operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the pre-clinical GLP studies, the ground truth would likely be based on direct observations, measurements of tissue effects, and safety endpoints within the experimental setup, rather than expert consensus on diagnostic images or pathology. The document does not provide details.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for this physical device.

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