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The HawkOne Directional Atherectomy System is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for use in conjunction with the SpiderFX Embolic Protection Device in the treatment of severely calcified lesions. The HawkOne catheter is NOT intended for use in the coronary, carotid, iliac or renal vasculature.

The HawkOne™ directional atherectomy system (HawkOne catheter and cutter driver) is designed for the treatment of de novo and restenotic atherosclerotic calcified and non-calcified lesions located in native peripheral arteries. When treating complex, hard, calcified lesions, pairing the HawkOne catheter with the SpiderFX™ embolic protection device mitigates risk of distal embolization that can be generated when heavily calcified plaque breaks down. For information about the SpiderFX embolic protection device, reference the Instructions for Use provided with the device.

The HawkOne catheter consists of a flexible shaft designed to track with a 0.36 mm (0.014 in) guidewire. At the distal end of the HawkOne catheter there is a small cutting unit comprised of an inner blade that rotates within a tubular housing. The proximal end of the HawkOne catheter contains a connector and cutter positioning lever (thumb switch) designed to fit into the cutter driver. The cutter driver (catalog number H1-14550) is a battery driven, internally powered device, designed to power the HawkOne directional atherectomy catheter.

The HawkOne directional atherectomy system has two switches: 1) the main power switch on the cutter driver and 2) the cutter positioning lever (thumb switch) on the HawkOne catheter. The main power switch on the cutter driver supplies power to the device when turned On. When the thumb switch is pulled proximally to the On position, the HawkOne catheter activates the drive shaft and the cutter. With the cutter engaged, the HawkOne catheter is slowly advanced across the lesion, shaving occlusive material from the artery. The excised tissue is captured and stored in the tip of the device. The cutting process is completed by advancing the HawkOne catheter thumb switch distally, deactivating the drive shaft and disengaging the cutter. When the HawkOne catheter thumb switch is fully advanced distally to the Off position, excised tissue is packed into the tip. This cutting sequence is repeated as necessary to achieve the desired degree of plaque excision.

The provided text describes a 510(k) summary for the Medtronic HawkOne Directional Atherectomy System, focusing on demonstrating substantial equivalence to predicate devices, particularly a smaller 6F version compared to the existing 7F version. The document details bench testing performed, but it does not include information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of clinical performance or human reader studies (MRMC or standalone AI performance). The testing mentioned (bench tests) is for the device's physical and functional characteristics, not for diagnostic or therapeutic efficacy in a clinical setting in relation to established criteria.

Therefore, many of the requested items cannot be answered from the provided text.

Here's a breakdown of what can and cannot be answered:

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

The document lists various bench tests but does not provide specific acceptance criteria or reported performance values for these tests. For instance, it mentions "Cutter Height" but not what the acceptable range for cutter height is, or what was measured.

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

This information is not provided. The testing described is bench testing of the device itself, not clinical testing on patient data.

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 is not applicable as the summary describes bench testing of mechanical properties, not clinical studies requiring expert ground truth.

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

Not applicable.

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 is a medical device for atherectomy, not an AI software intended to assist human readers in diagnosis.

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

Not applicable. This is a physical medical device.

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

For the bench testing, the "ground truth" would be engineering specifications and validated test methods. The document does not explicitly state the specific ground truths but implies that the tests were designed to show comparability to predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable.

Summary of available information related to acceptance criteria and device performance (from bench testing):

The document lists the following bench tests performed to demonstrate substantial equivalence:

Study Proving Device Meets Acceptance Criteria:

The study described is a bench testing program aimed at demonstrating substantial equivalence of the proposed HawkOne 6F Directional Atherectomy System to its predicate and reference devices (HawkOne 7F and TurboHawk). The purpose was to show that, despite changes like a reduced crossing profile, smaller driveshaft, cutter, and tip, and a material supplier change, the device performs comparably.

• Type of Study: Bench testing (non-clinical, engineering/materials testing).
• Purpose: To demonstrate that the technological characteristics and performance criteria of the proposed HawkOne 6F are comparable to the predicate and reference devices.
• Methodology: Various tests listed above were performed using "internal Risk Analysis procedures."

Missing Information: The document explicitly states that the "results from these tests demonstrate that the technological characteristics and performance criteria of the proposed HawkOne 6F devices are comparable to the predicate and reference devices," but it does not provide the specific numerical acceptance criteria or the measured performance values for each test. Instead, it offers a general statement of comparability.

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The HawkOne Directional Atherectomy System is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for use in conjunction with the SpiderFX Embolic Protection Device in the treatment of severely calcified lesions. The HawkOne catheter is NOT intended for use in the coronary, carotid, iliac or renal vasculature.

The HawkOne™ directional atherectomy system (HawkOne catheter and cutter driver) is designed for the treatment of de novo and restenotic atherosclerotic calcified and non-calcified lesions located in native peripheral arteries. When used in complex, hard, calcified lesions, the HawkOne catheter should be paired with the SpiderFX™ embolic protection device to mitigate risk of distal embolization that may be generated by the breakdown of heavily calcified plaque. The HawkOne catheter consists of a flexible shaft designed to track over a 0.014" guidewire. At the distal end of the HawkOne catheter is a small cutting assembly comprised of a rotating inner blade contained within a tubular housing. The proximal end of the HawkOne catheter contains a connector and cutter positioning lever (thumb switch) designed to fit into the cutter driver. The cutter driver (catalog number H1-14550) is a battery driven, internally powered device, designed to power the HawkOne directional atherectomy catheter.

Here's an analysis of the provided text regarding the acceptance criteria and study for the HawkOne Directional Atherectomy System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list acceptance criteria in a quantifiable manner for the HawkOne Directional Atherectomy System. Instead, it states that "bench testing was performed" and the "results from these tests demonstrate that the technological characteristics and performance criteria of the HawkOne Directional Atherectomy System are comparable to the predicate device and that the HawkOne Directional Atherectomy System performs in a manner equivalent to the predicate device currently on the market."

The document lists the types of performance tests conducted, implying these tests were used to assess equivalence to the predicate. Therefore, the "acceptance criteria" can be inferred as meeting or being comparable to the performance of the predicate device (TurboHawk Peripheral Plaque Excision Systems K111723 and K103618) across the following aspects:

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

The document does not specify the sample sizes used for the individual performance tests. It only mentions that "bench testing was performed."

The data provenance is internal and refers to "internal Risk Analysis procedures" and "bench testing." No information is provided about the country of origin of the data or whether it was retrospective or prospective. Given it's bench testing, it's generally a controlled laboratory environment rather than patient data.

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. As the testing appears to be primarily bench/mechanical testing comparing to a predicate, it's unlikely that traditional "ground truth" established by clinical experts (like radiologists for image analysis) was required in the same way. The "ground truth" here would likely be the established performance characteristics of the predicate device.

4. Adjudication Method for the Test Set

This information is not provided.

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 such study was mentioned or performed. The device described is a physical atherectomy system, not an AI or imaging diagnostic tool that would involve human readers.

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

This question is not applicable. The HawkOne Directional Atherectomy System is a medical device, not an algorithm, so the concept of "standalone performance" in the context of AI does not fit. Its performance evaluation would be through its mechanical and functional capabilities.

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

The document implies that the ground truth for the performance tests was the established performance characteristics of the predicate device (TurboHawk Peripheral Plaque Excision Systems). The goal was to demonstrate "comparable" and "equivalent" performance to these existing devices. Clinical outcomes data, pathology, or expert consensus on features are not mentioned as direct ground truth for these bench tests.

8. The sample size for the training set

This information is not applicable. This device is not an AI/ML 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/ML device requiring a training set with established ground truth.

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