(16 days)
The TurboHawk Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The TurboHawk Catheter is NOT intended for use in the coronary, carotid, iliac, or renal vasculature.
The TurboHawk Peripheral Plaque Excision System (TurboHawk Catheter and SilverHawk™ Cutter Driver) is designed for the treatment of de novo and restenotic calcified and non-calcified atherosclerotic lesions located in native peripheral arteries. The TurboHawk Catheter consists of a flexible shaft designed to track over a 0.014" guidewire. At the distal end of the TurboHawk Catheter is a small cutting assembly comprised of a rotating inner cutter contained within a tubular housing. The proximal end of the TurboHawk Catheter contains a connector and cutter positioning lever (thumb switch) designed to fit into the SilverHawk Cutter Driver. The SilverHawk Cutter Driver is a handheld, disposable, battery-driven unit (Catalog No: 02550) which powers the system. The TurboHawk Peripheral Plaque Excision System has two switches: 1) the SilverHawk Cutter Driver main power switch and 2) the TurboHawk Catheter thumb switch. The SilverHawk Cutter Driver main power switch supplies power to the device when turned ON. The TurboHawk Catheter thumb switch activates the drive shaft and engages the cutter when pulled proximally to the ON position. With the cutter engaged, the TurboHawk 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 TurboHawk Catheter thumb switch distally deactivating the drive shaft and disengaging the cutter. The TurboHawk Catheter thumb switch is fully advanced distally to the OFF position in order to pack the excised plaque into the tip. This cutting sequence is repeated as necessary to achieve the desired degree of plaque excision.
The provided document describes the TurboHawk™ Peripheral Plaque Excision System. It is a 510(k) summary for a medical device rather than a study report for an AI/ML device. Therefore, the detailed information about acceptance criteria, study design, expert qualifications, and AI-specific performance metrics (like effect size with AI assistance or standalone algorithm performance) is not applicable or present in this document.
However, based on the information provided, here's what can be extracted and inferred within the context of a medical device submission:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in a table format for specific performance metrics. Instead, it states that "Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence."
The reported device performance is broadly summarized as:
- Performance data: "Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
- Conclusion regarding substantial equivalence: "Based on the identical indications for use, similar technological characteristics, materials and operating principle, and the results from safety and performance testing, the TurboHawk Peripheral Plaque Excision System is considered substantially equivalent to the SilverHawk Peripheral Plaque Excision System (K061188)."
Without specific individual test results and their predefined acceptance values, a detailed table cannot be created.
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 "Bench testing and biocompatibility testing." These types of tests typically do not involve human subject data or clinical trials in the way an AI/ML study would. Therefore, concepts like "test set," "sample size," and "data provenance" related to patient data are not directly applicable here. For bench testing, the "sample size" would refer to the number of devices or components tested, and "provenance" would relate to the manufacturing batch or lot of those samples. This specific information is not provided.
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 applicable. The device is a physical medical instrument (an atherectomy catheter system), not an AI/ML diagnostic tool requiring expert-established ground truth on medical images or patient data. Bench testing and biocompatibility testing involve laboratory measurements and assessments against engineering specifications and biological safety standards, not expert medical opinions on patient cases.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this refers to adjudication of expert opinions, which is not part of the evaluation for this type of device submission.
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 atherectomy system, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as the device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this type of device, the "ground truth" for evaluating its performance would typically involve:
- Engineering specifications: The device is designed to meet certain physical and mechanical properties.
- Material standards: Biocompatibility is assessed against established standards for material safety.
- Functional performance criteria: Bench testing would verify functions like cutting ability, tissue capture, guidewire trackability, and power system operation against predetermined, measurable criteria.
- Predicate device performance: Substantial equivalence relies on demonstrating that the new device performs similarly to a legally marketed predicate device (SilverHawk™ Peripheral Plaque Excision System in this case) under comparable test conditions.
The document states that "Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." This implies the "ground truth" was compliance with established engineering, material, and functional performance benchmarks rather than expert medical diagnoses.
8. The sample size for the training set
Not applicable. This device does not involve machine learning; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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).