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For use in the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions can not be crossed with standard guide wires.

Spectranetics' laser atherectorny catheters, including the 2,5 mm Turbo CLiRoath catheter for peripheral use, consist of a bundle of optical fibers, encased within medical grade tubing. The optical fibers conduct ultraviolet laser light (excimer laser light at 308 nm) from a source to the tip of the catheter. The catheter is inserted into a patient's vasculature along the length of a previously inserted medical guidewire, allowing the attending physician to deliver laser energy targeted to a lesion (blockage) in the blood vessel. The 2.5 mm Turbo catheter is designed for "over-the-wire" interventional techniques. Laser energy impinged on a blockage ablates, or debulks, the lesion material re-establishing blood flow within the vessel, and permitting placement of devices used in vascular interventions. The Spectranetics Turbo laser catheter is supplied with a tip diameter of 2.5 mm, appropriate for interventional use in the peripheral vasculature of the leg.

The provided text describes the Spectranetics 2.5 mm Turbo CLiRpath Excimer Laser Catheter and its substantial equivalence to a predicate device. However, it does not explicitly define acceptance criteria in a table format or present a comparative study with numerical performance metrics against those criteria. The study described focuses on safety and performance in a porcine model rather than a detailed, quantitative analysis against pre-defined acceptance criteria for efficacy in humans.

Here's an attempt to extract the relevant information based on the typical content of a 510(k) summary, acknowledging the limitations of the provided document in explicitly defining "acceptance criteria" and "device performance" in a quantitative, human-centric way:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit, quantitative acceptance criteria for efficacy in the manner of a clinical trial. Instead, the "acceptance criteria" are implied by the demonstration of safety and equivalent functionality to a predicate device. The "device performance" is described qualitatively.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a number of animals, but refers to "a porcine model."
• Data Provenance: The study was conducted on a porcine model (animals), making it pre-clinical and prospective (conducted specifically for this submission). The country of origin of the data is not specified, but the company is based in Colorado Springs, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The study was a pre-clinical animal study, and while a GLP (Good Laboratory Practices) compliant protocol was followed, there's no mention of experts establishing a "ground truth" in the diagnostic sense (e.g., radiologists interpreting images). Histological evaluation would typically be performed by veterinary pathologists, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given it was an animal study focused on safety (complications, tissue damage observed histologically) and device functionality, formal adjudication by a panel of experts for diagnostic accuracy (as might be seen in a clinical trial for an imaging device) is unlikely to have been applied in this context.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a medical catheter, not an AI-powered diagnostic tool, so the concept of human readers improving with or without AI assistance is not applicable here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

A standalone performance study of an algorithm was not done. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the animal study was based on:

• Direct observation of complications during the procedure in the porcine model.
• Histological evaluation of harvested arterial segments (pathology) to assess tissue damage.
• Functional assessment of the device's ability to "disrupt occlusive material plaque" and "re-establish blood flow," implicitly compared to the predicate device's known performance.

8. The Sample Size for the Training Set

This information is not applicable as this is a physical medical device, not a machine learning model requiring a training set. The device design and manufacturing processes were likely developed and refined through engineering tests and validation, but these are not "training sets" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

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For use in the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions cannot be crossed with standard guide wires.

Spectranetics laser atherectorny catheters consist of a bundle of optical fibers, encased within medical grade tubing. The optical fibers conduct ultraviolet laser light (excimer laser light at 308 nm) from a source to the tip of the catheter. The catheter is inserted into a patient's vasculature along the length of a previously inserted medical guidewire, allowing the attending physician to deliver laser energy targeted to a lesion (blockage) in the blood vessel. Both over-the-wire and rapid-exchange catheter configurations are available. Laser energy impinged on a blockage ablates, or debulks, the lesion material thus opening the vessel, permitting placement of devices used in vascular interventions.

Spectranetics laser catheters are supplied in several models having tip diameters between 0.9 mm and 2.5 mm, appropriate for interventional use in peripheral arteries. Both over-the-wire and rapid exchange models are available.

Here's a breakdown of the acceptance criteria and study information for the Spectranetics CLiRpath Excimer Laser Catheter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a dedicated table or section. However, it implicitly defines success metrics that can be interpreted as performance targets.

2. Sample Size for the Test Set and Data Provenance:

• Sample Size for Test Set: 47 patients.
• Data Provenance: Retrospective or Prospective: The study is described as "patients were enrolled at investigational sites," which usually implies a prospective clinical study.
• Country of Origin: United States, Germany, and Belgium.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not provide information on the number of experts or their qualifications for establishing ground truth within the clinical study. The "ground truth" for the clinical success metrics (lesion crossing, procedural success, blood flow re-establishment) would have been determined by the treating physicians and potentially confirmed by diagnostic imaging and patient outcomes.

4. Adjudication Method for the Test Set:

The document does not describe a specific adjudication method (e.g., 2+1, 3+1, none) for the clinical study's outcomes. Clinical outcomes are typically assessed by the treating physician and may be reviewed by an independent clinical events committee or core lab, but this detail is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a clinical trial focused on the device's performance in patients, not on comparing human reader performance with and without AI assistance. The CLiRpath is a medical device (laser catheter), not an AI-powered diagnostic tool.

6. Standalone Performance Study:

Yes, a standalone performance study (algorithm only without human-in-the-loop performance) was effectively done. The clinical study evaluated the CLiRpath catheter's performance in isolation as a treatment device, with human operators (physicians) using the device, but not as part of an AI system providing diagnostic or treatment recommendations. The reported metrics (lesion crossing, procedural success, blood flow re-establishment) are direct measurements of the physical device's capabilities when operated by a clinician.

7. Type of Ground Truth Used:

The ground truth for the clinical study was based on:

• Clinical Outcomes Data: Successful crossing of lesions, overall procedural success, and re-establishment of straight-line blood flow to the foot are direct clinical outcomes observed and measured during the procedure and potentially post-procedure.
• Adverse Event Data: Tracking of serious adverse events.

8. Sample Size for the Training Set:

The document does not mention a distinct "training set" for the clinical evaluation. The 47 patients constitute the test set for the performance evaluation of the device in a clinical setting. This is a medical device, not an AI model, so the concept of a "training set" for an algorithm is not applicable in this context.

9. How the Ground Truth for the Training Set Was Established:

As there is no "training set" in the context of an AI algorithm, this question is not applicable to the CLiRpath device's evaluation as described. The "training" for such a device would be the extensive bench testing, qualification, and validation studies (mentioned under "BIOCOMPATIBILITY, STERILIZATION, PACKAGING, AND BENCH TESTING"), which established its adherence to manufacturing and design specifications.

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