(113 days)
The Turbo-Power is indicated for laser atherectomy of de novo and restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Pecutaneous Transluminal Angioplasty (PTA).
The Turbo-Power (2.0mm) Laser Atherectomy Catheter is a laser atherectomy device designed for use with the CVX-300™ Excimer Laser System. The Turbo-Power (2.0mm) Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy.
The Turbo-Power (2.0mm) is used to ablate lesions with reference vessel diameters of ≥3.0mm. Turbo-Power (2.0mm) Laser Atherectomy Catheter is comprised of 2 subassemblies:
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- Catheter Subassembly
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- Motor Drive Unit (MDU) Subassembly
The working length of the Turbo Power Laser Atherectomy Catheter is constructed of multiple optical fibers arranged eccentrically around a 0.018" (0.46 mm) guidewirecompatible lumen. The PTFE quidewire lumen tip is attached to a stainless steel torque wire which is connected to the MDU at the proximal end of the working length. The multifiber laser catheter transmits ultraviolet energy from the Spectranetics CVX-300 Excimer Laser System through the tip of the laser to an obstruction in the patient's artery. The outer surface of the laser catheter working length is hydrophilic-coated, and the distal tip of the catheter contains a radiopaque marker band for in situ visibility. The ultraviolet energy transmitted from the CVX-300 laser system is used to photoablate multiple morphology lesions which mav be comprised of atheroma, fibrosis, calcium, and thrombus, thus recanalizing diseased vessels. Photoablation is the process by which energy photons cause molecular bond disruption at the cellular level without thermal damage to surrounding tissue.
The provided document is a 510(k) summary for the Spectranetics Turbo-Power (2.0mm) Laser Atherectomy Catheter. It describes the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or detailed results of a study proving the device meets those criteria, nor does it include information about sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.
The document mentions that various tests were conducted to validate and verify that the subject device met all acceptance criteria, as required by the risk analysis. These tests included:
- Design Verification and Validation Testing: Simulated Use Testing, Functional Testing, Physical Testing, Laser Testing.
- Sterilization: Product adoption equivalency per AAMI TIR:28-2009.
- Biocompatibility: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Direct Hemolysis, Indirect Hemolysis, In Vivo Thrombogenicity-Ovine Model, Genotoxicity - Ames Test, Material Mediated Pyrogenicity.
- Pre-clinical Data: A pre-clinical GLP study was conducted to compare usability and procedural safety of the Turbo-Power (2.0mm) and Turbo-Power (2.3) laser catheters.
The document does not provide the specific acceptance criteria for these tests or the reported performance values against those criteria in a table format. It only states that the device "met all acceptance criteria." It also explicitly states that new clinical data was not required to demonstrate substantial equivalence, which means there isn't a human-in-the-loop or standalone study with clinical outcomes described here.
Therefore, many of the requested details cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that testing was performed and the device "met all acceptance criteria," but it does not specify what those criteria were or the actual performance results in a quantifiable manner.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document mentions "Simulated Use Testing," "Functional Testing," "Physical Testing," "Laser Testing," and a "pre-clinical GLP study." However, it does not specify sample sizes for any of these tests or the data provenance (e.g., retrospective/prospective, country of origin). The pre-clinical study involved an "Ovine Model," indicating animal 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)
- Not applicable/Cannot be provided. This question typically applies to studies involving human interpretation or clinical endpoints. The document describes engineering, biocompatibility, and animal (ovine model) studies. It does not mention any studies where human experts established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Cannot be provided. Similar to point 3, this is relevant for studies involving human assessment or interpretation, which are not detailed here.
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. The document explicitly states "New clinical data was not required to demonstrate substantial equivalence." An MRMC study would fall under clinical data. This device is a physical catheter, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical catheter, not an algorithm or AI system. Its performance is evaluated through engineering, biocompatibility, and pre-clinical animal studies, not standalone algorithmic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be fully specified. For the engineering tests, ground truth would likely refer to engineering specifications and performance benchmarks. For the biocompatibility tests, it would be established standards (e.g., ISO standards for cytotoxicity, sensitization). For the pre-clinical GLP study using an ovine model, ground truth would have been based on observations and measurements from the animal subjects related to usability and procedural safety as defined by the study protocol.
8. The sample size for the training set
- Not applicable. The document describes a medical device (catheter), not an AI system that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. Same as point 8.
§ 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).