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The ReFORM Peripheral Catheter System is intended for use in atherectomy of the peripheral vasculature. The catheter is not intended for use in the coronary or carotid vasculature.

The ReFORM Peripheral Catheter System consists of two major components which are packaged separately but used together during atherectomy procedures. The two components are the ReFORM Peripheral Catheter and the ReFORM Cutter Driver.

The ReFORM Peripheral Catheter is comprised of a long, low-profile shaft at the end of which is a small mechanical cutter. The catheter is a monorail design which allows a single operator to insert and remove the device from the patient while maintaining guidewire position. A Cutter Driver controls the actuation of the cutting element. Excision of atheroma from the vessel is accomplished by a small spinning cylindrical blade contained within a cylindrical housing. Once the catheter is tracked to the target lesion, the tip is deflected, moving the cutter against the lesion. As the cutting blade spins, the device is advanced through the lesion, "shaving" plaque from the vessel wall. As the tissue is cut, it enters the device through a small opening just distal to the blade and is captured in the catheter tip and removed from the patient.

ReFORM Peripheral Catheters consist of a braided drive shaft inside a Pebax/Nylon outer shaft, connecting to the cylindrical cutter and cylindrical cutter housing. The soft, flexible tip also provides an area for tissue collection. At the end of each cutting pass, the cutter advances into the soft tip "packing" tissue into the nosecone. The cutter housing is radiopaque due to plating with platinum which allows it to serve as an angiographic marker for easy positioning of the cutter blade within the lesion. ReFORM Peripheral Catheter System configurations covered under the subject 510(k) Premarket Notification include 7 F and 8 F sheath compatible diameter catheters in lengths of 135 cm and110 cm respectively.

The provided 510(k) summary for the ReFORM™ Peripheral Catheter System (K024243) focuses on demonstrating substantial equivalence to a predicate device, the Simpson Peripheral Atherocath. This type of submission relies heavily on comparisons of intended use, technological characteristics, and non-clinical performance data, rather than detailed acceptance criteria and standalone clinical studies with specific performance metrics as might be found in a De Novo or PMA submission for a novel device.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, ground truth establishment methods, expert qualifications, and MRMC studies is not explicitly available or applicable in the provided document. The submission's approach is to establish equivalence through a lack of significant differences that would raise new questions of safety or effectiveness.

Here's an analysis based on the available information:

Acceptance Criteria and Study for ReFORM™ Peripheral Catheter System (K024243)

The provided submission is a 510(k) premarket notification, which seeks to demonstrate "substantial equivalence" to a legally marketed predicate device. In this context, "acceptance criteria" are interpreted as showing that the new device is as safe and effective as the predicate, without raising new questions of safety or effectiveness. The "study" largely consists of non-clinical performance testing and a comparison of technological characteristics to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary relying on substantial equivalence, specific numeric acceptance criteria for performance metrics are not explicitly stated in the provided text in the way they might be for a novel device with defined performance endpoints. Instead, acceptance is implied by demonstrating that the device performs comparably to the predicate or meets established standards for devices of its type.

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

• Test Set Sample Size: Not specified in the summary for any specific performance tests. The document broadly states "Performance testing... has been performed and presented in the body of this 510(k)." For the "human clinical study safety data," the sample size is also not specified.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be prospective in nature, as they involve testing a new device and animal studies, "human clinical study safety data" implies a controlled study.

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

This information is not applicable or provided in the context of this 510(k) submission. Ground truth establishment by experts is typically relevant for diagnostic devices or AI algorithms where subjective interpretation is involved. For a mechanical atherectomy catheter, performance is assessed through engineering tests and clinical safety data, not expert consensus on images or clinical classifications.

4. Adjudication Method for the Test Set

This is not applicable or provided. Adjudication methods (like 2+1 or 3+1) are typically used in studies involving expert interpretation of data (e.g., imaging studies) to resolve disagreements and establish ground truth.

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

This is not applicable. An atherectomy catheter is a therapeutic/interventional device, not a diagnostic imaging device or an AI-powered tool that assists human readers. Therefore, an MRMC study is not relevant to its evaluation.

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

This is not applicable. The device is a physical, mechanical catheter, not an algorithm.

7. The Type of Ground Truth Used

For a mechanical device, "ground truth" typically refers to objective measurements or observations from engineering tests and clinical outcomes.

• Engineering/Performance Data: Measurement of device attributes (e.g., cutting efficiency, material properties, dimensions, force resistance, tissue collection).
• Biocompatibility: Established by testing against ISO standards or similar benchmarks.
• Clinical Safety Data: Observation of adverse events, device malfunctions, and patient outcomes in animal studies and a human clinical safety study. The details of what specifically constituted "ground truth" (e.g., histology of treated vessels, specific adverse event rates) are not provided in the summary.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is a mechanical medical device, not a machine learning model.

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

This is not applicable for the reasons stated above.

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