(105 days)
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:
| Acceptance Criterion (Inferred from tests performed) | Reported Device Performance (as stated in document) |
|---|---|
| Device Inspections | Comparable to predicate device |
| Urge Force | Comparable to predicate device |
| Cycle and Life | Comparable to predicate device |
| Cutter Height | Comparable to predicate device |
| Tracking Force | Comparable to predicate device |
| Repeated Cutter Spin Down and Packing | Comparable to predicate device |
| Shaft Torque Tests | Comparable to predicate device |
| Carbide Edge Attachment | Comparable to predicate device |
| DFT Torque and Pressure Tests | Comparable to predicate device |
| Device Tensile Tests | Comparable to predicate device |
| Catheter and Cutter Driver Interaction | Comparable to predicate device |
| Embolization | Comparable to predicate device |
| Cut Mass Per Pass (Tissue Removal Rate) | Comparable to predicate device |
| Tissue Removal Cycles | Comparable to predicate device |
| Package Integrity | Comparable to predicate device |
| Biocompatibility | Comparable to predicate device |
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.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).