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The FreedomFlow™ Orbital Circumferential Atherectomy System is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

The FreedomFlow™ Orbital Circumferential Atherectomy System is a flexible over-the-wire rotational device used to ablate atherosclerotic plaque from arterial blood vessels within the body. The FreedomFlow™ Orbital Circumferential Atherectomy System is used together with a compatible introducer sheath and 0.014-inch diameter x 300 cm (minimum length) atherectomy guidewire. The driveshaft is introduced into the patient's vasculature by traditional minimally invasive techniques. The FreedomFlow™ User Handle is available in model numbers that are listed below with vessel size ranges.

The FreedomFlow Orbital Circumferential Atherectomy System - Electric (FreedomFlow™) includes an integrated driveshaft with multiple abrasive spheres on a rotating driveshaft. The abrasive spheres are eccentrically mounted onto the driveshaft so that when the driveshaft is rotated, they move outward due to centrifugal force. These abrasive spheres are spaced along the driveshaft in a spiral configuration to optimize plaque modification within a vessel while still maintaining flexibility for treating tortuous arterial anatomy. The User Handle includes two rotational speeds: low speed at 50,000 revolutions per minute (RPM) and high speed at 76,000 RPM.

The FreedomFlow Orbital Circumferential Atherectomy System - Electric (FreedomFlow™) is powered by Cardio Flow Power Supply H7001, which is a hospital-grade portable, reusable component. H7001 provides DC power to rotate the FreedomFlow™ driveshaft. H7001 also provides DC power to a saline pump integrated into the FreedomFlow™ User Handle. During operation the saline pump delivers saline to the distal tip of the driveshaft.

The FreedomFlow™ orbital atherectomy User Handle is supplied single patient use, sterile. The package contents include the following items.

• FreedomFlow™ orbital atherectomy User Handle with integrated electric motor and saline pump
• Saline infusion tubing set

I'm sorry, but your request cannot be fulfilled. The provided document is an FDA 510(k) clearance letter for a medical device (FreedomFlow™ Orbital Circumferential Atherectomy System), not for an AI/ML-driven medical device.

The document describes the physical characteristics of an atherectomy system, its intended use, and bench testing to demonstrate its mechanical and performance characteristics (like plaque removal efficiency, tensile strength, rotational speed, etc.). It does not involve any AI/ML components, nor does it describe a study involving human readers, ground truth establishment by experts, or MRMC studies, which are typical for validating AI/ML-driven medical devices.

Therefore, I cannot extract the information required to describe acceptance criteria and a study proving an AI/ML device meets those criteria from this non-AI/ML medical device submission.

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The FreedomFlow™ Orbital Circumferential Atherectomy System is indicated for use as a therapy in patients with occlusive atherosclerotic disease in peripheral arteries. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

The FreedomFlow™ Orbital Circumferential Atherectomy System is a flexible over-the-wire rotational device used to ablate atherosclerotic plaque from peripheral arterial blood vessels within the body. The FreedomFlow™ System consists of three components: User Handle with integrated driveshaft, Tubing Set, and Power Supply. The User Handle with the integrated driveshaft is sterile, single use, and disposable. The User Handle provides the operator interface to control driveshaft rotation (with two speed options) and translation within the vessel. The User Handle also incorporates a guidewire mechanical clamp. The User Handle controls the saline fluid flow down the driveshaft catheter. The User Handle utilizes firmware and hardware to perform these functions. The Tubing Set is sterile, single use, and disposable. The Tubing Set connects a user provided sterile saline supply to the User Handle. The Tubing Set is connected by the operator to the User Handle. The Power Supply is a medical grade AC powered transformer, supplying DC electrical energy to the User Handle. The power supply is reusable.

This looks like a 510(k) summary for a medical device called the "FreedomFlow™ Orbital Circumferential Atherectomy System". This document focuses on demonstrating substantial equivalence of a modified device to a previously cleared predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the way one might for a novel AI/software device.

The premise of a 510(k) is that if a new device is shown to be substantially equivalent to a legally marketed predicate device, it does not require a new Pre-Market Approval (PMA) application. Substantial equivalence is often established by demonstrating that the device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Therefore, the requested information about acceptance criteria, study design parameters (sample size, data provenance, expert adjudication, MRMC, standalone performance, training set details), which are common for AI/software device submissions, are largely not applicable in the context of this specific 510(k) submission.

Here's a breakdown of why this information is largely absent and what is provided:

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

• Acceptance Criteria/Performance: This document does not provide a table of acceptance criteria and reported device performance in the form typically expected for AI/software evaluations (e.g., sensitivity, specificity, AUC). Instead, it establishes "substantial equivalence" to predicate devices. The "performance" being evaluated here relates to the manufacturing process change (soldering to welding) and a pump head change. The document states: "There are no performances differences incurred as a result of this change." and "Testing verifies all pump related specifications."
• Table of Comparison (from the document): The document includes a large table on pages 6-7 comparing the subject devices (H6001 & H6004 with changes) to predicate devices (H6001 [K231538] & H6004 [K233483]). This table highlights that all key characteristics, including Product Code, Classification, Intended Use, Indications for Use, Mechanism of Operation, System Components, Driveshaft Variations, Rotational Speed, Saline flow rate, Shelf life, Sterility, etc., are "Same." The core acceptance criterion for this 510(k) is demonstrating that these characteristics remain equivalent despite the manufacturing changes.

2. Sample size used for the test set and the data provenance:

• Not Applicable in this context: The document does not describe a "test set" in the sense of a clinical or image dataset for an AI algorithm. The evaluations conducted are likely engineering bench tests, biocompatibility tests, and potentially functional tests related to the manufacturing processes. Details on sample sizes for these types of tests are not typically included in the 510(k) summary provided to the public.
• Data Provenance: Not applicable as there isn't a "data set" originating from specific countries or clinical studies as would be for an AI device. The data provenance would be internal engineering and manufacturing quality control data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable: There is no "ground truth" established by experts in this context. The evaluation is against engineering specifications and the established performance of the predicate device.

4. Adjudication method for the test set:

• Not Applicable: There is no "adjudication method" as this is not a subjective diagnostic or interpretative task.

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:

• Not Applicable: This device is a physical medical device (atherectomy system) and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is completely irrelevant.

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

• Not Applicable: This is a physical atherectomy system; it is not an algorithm.

7. The type of ground truth used:

• Ground Truth: In the context of this 510(k), the "ground truth" for the device's performance is its adherence to engineering specifications, functional requirements, and safety standards, which are themselves benchmarked against the predicate device. For example, biocompatibility testing would be compared against ISO standards, and functional tests (like rotational speed, saline flow) would be compared against their defined operational parameters.

8. The sample size for the training set:

• Not Applicable: There is no "training set" as this is not an AI/ML device.

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

• Not Applicable: There is no "training set."

In summary:

This 510(k) pertains to a manufacturing process change and a component change for a physical medical device (Atherectomy System). The regulatory submission demonstrates substantial equivalence to existing predicate devices by showing that these changes do not alter the intended use, indications for use, or fundamental technological characteristics, and do not raise new questions of safety or effectiveness. The detailed study parameters typically associated with AI/software device evaluation are not relevant to this type of submission.

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The FreedomFlow™ Orbital Circumferential Atherectomy System is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

The FreedomFlow™ Orbital Circumferential Atherectomy System (H6004 5Fr 3-Sphere) is a flexible over-the-wire rotational device used to ablate atherosclerotic plaque from peripheral arterial blood vessels within the body. The FreedomFlow™ System consists of three components: User Handle with integrated driveshaft, Tubing Set, and Power Supply. The User Handle with the integrated driveshaft is sterile, single use, and disposable. The User Handle provides the operator interface to control driveshaft rotation (with two speed options) and translation within the vessel. The User Handle also incorporates a guidewire mechanical clamp. The User Handle controls the saline fluid flow down the driveshaft catheter. The User Handle utilizes firmware and hardware to perform these functions. The Tubing Set is sterile, single use, and disposable. The Tubing Set connects a user provided sterile saline supply to the User Handle. The Tubing Set is connected by the operator to the User Handle. The Power Supply is a medical grade AC powered transformer, supplying DC electrical energy to the User Handle. The power supply is reusable.

The provided text describes a medical device, the FreedomFlow™ Orbital Circumferential Atherectomy System (H6004 5Fr 3-Sphere), and its substantial equivalence determination by the FDA. However, the document does not contain the level of detail requested regarding acceptance criteria and the specifics of a study proving a device meets these criteria in the context of an AI/human-in-the-loop system.

The "study" mentioned in this document refers to performance testing for a mechanical medical device, specifically:

• Dimensional Analysis Testing
• Orbit Characterization Testing (effectiveness of sanding technology, lumen diameter vs. speed vs. time, plaque removal efficiency)
• Simulated Life Test
• Torque Stall and Loaded Start Test
• Joint Tensile Test
• Joint Torque Test
• Particulate Analysis Comparison Test
• Electric System Human Cadaver Pre-Clinical Test

There is no indication that this device incorporates AI or sophisticated software that would necessitate human-in-the-loop performance studies, expert ground truth adjudication, or metrics like sensitivity, specificity, or AUC, which are typically associated with AI-powered diagnostic or assistive devices.

Therefore, I cannot provide the requested information in the format of the questions because the document describes a mechanical atherectomy system, not a device whose performance is measured in the ways implied by the prompt's questions (e.g., AI assistance, expert readers, ground truth establishment for AI training/testing).

If the prompt intended for me to infer or create a hypothetical scenario for an AI-powered atherectomy system, I would need additional context or a different document. Based only on the provided text, the questions are not applicable to the described device and its testing.

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The FreedomFlow™ Orbital Circumferential Atherectomy System is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

The FreedomFlow™ Orbital Circumferential Atherectomy System is a flexible over-the-wire rotational device used to ablate atherosclerotic plaque from peripheral arterial blood vessels within the body. The FreedomFlow™ System consists of three components: User Handle with integrated driveshaft, Tubing Set, and Power Supply.

The User Handle with the integrated driveshaft is sterile, single use, and disposable. Both 5 Fr and 6 Fr variations of the User Handle are available. The User Handle provides the operator interface to control driveshaft rotation (with two speed options) and translation within the vessel. The User Handle also incorporates a guidewire mechanical clamp. The User Handle controls the saline fluid flow down the driveshaft catheter. The User Handle utilizes firmware and hardware to perform these functions. The Tubing Set is sterile, single use, and disposable. The Tubing Set connects a user provided sterile saline supply to the User Handle. The Tubing Set is connected by the operator to the User Handle. The Power Supply is a medical grade AC powered transformer, supplying DC electrical energy to the User Handle. The power supply is reusable.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

2. Sample sizes used for the test set and the data provenance

• FAST II Study (Primary Clinical Study):
  • The exact sample size isn't explicitly stated for this part, but it refers to "patients with symptomatic peripheral arterial disease (PAD) of the lower extremities."
  • Provenance: Prospective, multi-center, single-arm, open-label clinical study. No specific country of origin is mentioned, but "multi-center" implies multiple locations.
• Supplemental Analysis (Matched Comparison):
  • FAST II Cohort: The same patient cohort from the FAST II study.
  • PVI Registry Cohort: Real-world evidence obtained from the Vascular Quality Initiative (VQI) Peripheral Vascular Intervention (PVI) registry. This cohort was refined using propensity scoring to identify a control group with well-balanced baseline covariates.
  • Provenance: This involves data from a prospective clinical study (FAST II) and retrospective registry data (VQI PVI). The "real-world evidence" suggests a broader, likely multi-national or U.S.-based, data source.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• For the "raw data (i.e., arteriographic images) from the cohort registry and the FAST II study," an independent angiographic core-laboratory was used for blinded analysis.
• The number and specific qualifications of experts within this core-laboratory are not explicitly detailed in the provided text.

4. Adjudication method for the test set

• For the supplemental effectiveness analysis, the "raw data (i.e., arteriographic images)" were "randomized for blinded analysis by an independent angiographic core-laboratory." This implies a blinded, independent review process. The specific number of readers or a 2+1, 3+1 method is not stated, but the "core-laboratory" typically suggests a robust, structured review process.

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 comparative effectiveness study involving human readers with and without AI assistance was not mentioned or performed. This submission is for an atherectomy system (a physical medical device) and its associated firmware, not a diagnostic AI system designed to assist human readers in interpreting images.

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

• No, this is not applicable. The FreedomFlow Orbital Circumferential Atherectomy System is a physical medical device. While it includes firmware (software), the studies described evaluate the device's clinical and non-clinical performance, not the standalone performance of an algorithm that generates an interpretation or diagnosis without human interaction.

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

• Clinical Outcomes Data: The primary safety endpoint (freedom from MAE) and primary effectiveness endpoints (technical success, Post Atherectomy Stenosis) are based on direct clinical outcomes measured in patients.
• Expert Adjudication: For the effectiveness endpoint, residual diameter stenosis was determined by an "independent angiographic core-laboratory," which implies expert consensus based on angiographic images.

8. The sample size for the training set

• Not applicable/Not provided. This information pertains to machine learning models. The studies described are evaluating a physical medical device, not training a machine learning model for diagnostic or predictive purposes where a distinct training set would be required for the evaluation itself. The "propensity scoring" used in the supplemental analysis to "refine" and "identify a control cohort" from the PVI registry is a statistical matching technique, not a machine learning training process in the sense of an algorithm.

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

• Not applicable/Not provided. As there is no described training set for a machine learning model in this context, the method for establishing its ground truth is not relevant here.

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The Cardio Flow Peripheral Guide Wire is intended for temporary placement in peripheral vasculature the placement and exchange of diagnostic and therapeutic devices during percutaneous intravascular procedures. This guidewire device is intended for peripheral vascular use only.

The Cardio Flow Peripheral Guide Wire (Guidewire), Model GW1001 is a 304V stainless steel mandrel guidewire with a fixed distal spring coil. The distal coil is radiopaque to fluoroscopy. The coil is medium-stiffness in load-force and the distal end is coated in hydrophobic silicone to facilitate tracking. The Guidewire has a maximum outer diameter of 0.36 mm (0.014-inch). The GW1001 Guidewire has overall nominal length of 325 cm.

The Cardio Flow Peripheral Guide Wire (Model GW1001) underwent several non-clinical performance tests to demonstrate substantial equivalence to its predicate device, the Asahi Astato XS 20 Guide Wire (K103057).

Here's the breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes bench evaluations and non-clinical performance tests. This implies that physical samples of the Cardio Flow Peripheral Guide Wire were tested in a laboratory setting.

• Sample Size: Not explicitly stated for each individual test. However, it is standard practice for such tests to use a statistically significant number of samples to ensure robust results.
• Data Provenance: The tests were conducted internally by or on behalf of Cardio Flow, Inc., likely at their facilities or a contracted testing lab, following established international and FDA-recognized standards. There is no mention of country of origin for test data, but the company is based in Mahtomedi, MN, USA. The data is prospective for the device under review.

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

Not applicable. This was a physical device performance study, not a study requiring expert clinical assessment for ground truth. The "ground truth" for these tests is defined by the objective performance criteria specified in the referenced standards (e.g., ISO, ASTM, FDA guidance).

4. Adjudication Method for the Test Set

Not applicable, as this was a physical device performance study, not a clinical study involving human judgment that would require adjudication.

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

Not applicable. This device is a medical guidewire, not a diagnostic AI system that evaluates medical images or data. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical guidewire, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this type of device performance testing is established by objective engineering and performance specifications defined in recognized national and international standards (e.g., ISO, ASTM) and FDA guidance documents. These standards dictate acceptable ranges, thresholds, or qualitative outcomes (e.g., "Pass/Fail") for various physical and material properties.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML 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 a physical medical device.

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