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The Rotarex™ Atherectomy System is intended for use as an atherectomy device and to break up and remove thrombus from native peripheral arteries or peripheral arteries fitted with stents, stent grafts or native or artificial bypasses.

The Rotarex™ Atherectomy System is made up of a single use Rotarex™ Atherectomy Catheter Set and the Drive System, consisting of the control unit, motor and foot switch. The Rotarex™ Atherectomy Catheter Set is composed of multiple components, including the Rotarex™ Atherectomy Catheter, guidewire, collecting bag, and sterile drape. Rotarex™ Atherectomy Catheters are over-the-wire, single use, percutaneous devices for the removal of atheromatic plaque and thrombi in native arteries fitted with stents, stent grafts or native or artificial bypasses. The catheters are latex and phthalate free, and consist of a flexible outer covering, a rotating head, and a rotating helix which runs the length of the catheter. A lumen for the passage of the supplied quidewire runs the entire length of the helix and through the head of the catheter. The catheter head is made up of two overlying metal cylinders, with two side openings. The outer cylinder is connected to the rotating helix, and the inner cylinder to the catheter shaft. The helix and the catheter head rotate at approximately 40.000-60.000 rpm depending on the model, by means of a gear box in the catheter housing and a motor contained within the catheter handle driven by the Drive System. The rotating outer cylinder is fitted with abrading facets at its foremost tip.

The provided text is a 510(k) premarket notification for the Rotarex™ Atherectomy System. This document explicitly states that no changes have been made to the subject Rotarex™ Atherectomy System itself. The purpose of this submission is to obtain FDA clearance related to proposed revisions to the existing Rotarex™ Atherectomy System instructions for use (IFU) to clarify and emphasize procedural steps to reduce the risk of catheter breakage events.

Given this, the document clearly states:

"As no changes are being made to the Rotarex™ Atherectomy System associated with this 510(k) notice, no new performance testing was conducted on the subject device."

Therefore, the Acceptance Criteria and Device Performance information you requested, related to new testing proving the device meets acceptance criteria, cannot be extracted from this document because such testing was not performed for this specific 510(k) submission.

This document describes a regulatory filing for an IFU update for an already cleared and existing device. It does not contain information about the original performance data, acceptance criteria, or studies used to clear the initial device.

In summary, none of the requested information (performance table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, training set details) can be provided based on the text you supplied, as the document explicitly states no new performance testing was conducted.

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The Rotarex™ Atherectomy System is intended for use as an atherectomy device and to break up and remove thrombus from native peripheral arteries or peripheral arteries fitted with stents, stent grafts or native or artificial bypasses.

The Rotarex™ Atherectomy System is made up of a single use Rotarex™ Atherectomy Catheter Set and the Drive System, consisting of the control unit, motor and foot switch. The Rotarex™ Atherectomy Catheter Set is composed of multiple components, including the Rotarex™ Atherectomy Catheter, guidewire, collecting bag, and sterile drape. Rotarex™ Atherectomy Catheters are over-the-wire, single use, percutaneous devices for the removal of atheromatic plaque and thrombi in native arteries fitted with stents, stent grafts or native or artificial bypasses. The catheters are latex and phthalate free, and consist of a flexible outer covering, a rotating head, and a rotating helix which runs the length of the catheter. A lumen for the passage of the supplied guidewire runs the entire length of the helix and through the head of the catheter. The catheter head is made up of two overlying metal cylinders, with two side openings. The outer cylinder is connected to the rotating helix, and the inner cylinder to the catheter shaft. The helix and the catheter head rotate at approximately 40,000-60,000 rpm depending on the model, by means of a gear box in the catheter housing and a motor contained within the catheter handle driven by the Drive System. The rotating outer cylinder is fitted with abrading facets at its foremost tip. The Rotarex™ Atherectomy System Guidewires are 0.018" and are included with each Rotarex™ Atherectomy Catheter Set. These guidewires consist of a Nitinol core and a PTFE coating with a 9.5cm hydrophilic distal coating and a 4 cm angled flex tip. All components within the Rotarex™ Atherectomy Catheter Sets are supplied sterile for single use only. The method of sterilization is ethylene oxide.

This document is a 510(k) Summary for the Rotarex™ Atherectomy System. It describes the device, its intended use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence.

Here's the breakdown of the requested information based on the provided text:

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

The document does not provide a specific table of quantitative acceptance criteria with corresponding performance metrics. Instead, it states overall conclusions:

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

The document mentions "in vitro tests" and "Clinical Literature Review."

• In vitro tests:
  • Sample size: Not specified.
  • Data provenance: Not specified, but generally in vitro tests are laboratory-controlled and do not have country of origin in the same way clinical data does. The tests were performed "using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures."
• Clinical Literature Review:
  • Sample size: Not specified, as it's a review of existing literature, not a new study with a defined sample size. It refers to "a significant body of medical literature."
  • Data provenance: Not specified in terms of country of origin or retrospective/prospective nature. Clinical literature usually encompasses both retrospective analyses and prospective studies from various global locations.

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)

This information is not provided in the document. The document describes a literature review and in vitro testing, neither of which typically involves experts establishing ground truth for a test set in the way an AI algorithm test might.

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

This information is not provided in the document. The document describes laboratory testing and a literature review, not a study that would involve expert adjudication of a test set.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. This document focuses on demonstrating substantial equivalence of a physical medical device (atherectomy system), not a diagnostic AI tool. The "clinical literature" review examined the safety and efficacy of the device itself compared to other treatments, not the improvement of human readers with AI assistance.

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

This question is not applicable as the Rotarex™ Atherectomy System is a physical interventional medical device, not an AI algorithm. Therefore, no standalone algorithm performance was assessed.

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

• For in vitro tests: The "ground truth" would be established by the physical and chemical properties of the materials tested, the design specifications, and the quantifiable outcomes of the specific tests (e.g., heat generation measurements, absence of emboli in collected fluid).
• For Clinical Literature Review: The "ground truth" comes from the aggregated findings of published clinical studies, which typically rely on clinical outcomes data (e.g., patency rates, complication rates, re-intervention rates) and potentially expert diagnoses within those studies.

8. The sample size for the training set

This information is not applicable. The Rotarex™ Atherectomy System is a physical medical device, not an AI algorithm that requires a training set.

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

This information is not applicable, as it's not an AI algorithm with a training set.

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