(74 days)
The Serranator™ Alto PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, iliofemoral, and popliteal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
The Serranator™ Alto PTA Serration Balloon Catheter is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral vasculature as described in the Indications for Use statement. The Serranator™ has a nylon semi-compliant balloon with four embedded external metal strips, or scoring elements. The scoring elements are designed to create linear, interrupted scoring along the endoluminal surface that occurs during balloon angioplasty.
The given text is a 510(k) Summary for the Serranator™ Alto PTA Serration Balloon Catheter. It describes the device, its intended use, and provides non-clinical testing, biocompatibility, animal, and cadaver study results to support its substantial equivalence to a predicate device.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly provide a table of acceptance criteria alongside the reported device performance in a quantitative manner. Instead, it states that:
- "The non-clinical testing results demonstrated that the Serranator™ met all acceptance criteria." (Page 6)
- "All testing passed the required acceptance criteria and the product is biocompatible for human use." (Page 6)
The tests performed include: Shipping, environmental stresses, Flex/Kink, Peel Strength, Visual Inspection, Particulates, Delivery, Deployment, Retraction, Fatigue, Rated Burst/Compliance, Torsion, Corrosion, Tensile Test of Joints, Lubricious Coating Integrity, and Biocompatibility (following ISO-10993).
While the tests are listed, the specific quantitative acceptance criteria (e.g., "flex strength must be > X Newtons") and the quantitative results for each test are not detailed in this summary. The statement "met all acceptance criteria" is a blanket declaration.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Non-clinical testing: The document mentions "sterile, unaged (Time Zero) and accelerated aged (Time Aged) test samples." No specific sample sizes for these tests are provided. Data provenance is implied to be from the manufacturer's testing facilities (Cagent Vascular).
- Biocompatibility testing: "sterile, finished devices." No specific sample size is provided. Data provenance is implied to be from the manufacturer's testing or contracted labs.
- Animal Studies: "Peripheral vessels in a porcine model were treated with a Serranator™ Alto PTA Serration Balloon Catheter or control, AngioSculpt® PTA Scoring Balloon Catheter." No specific number of animals or vessels is given. The model is porcine. (Prospective study, likely a controlled experiment).
- Cadaver Studies: "Cadaver testing was performed comparing the Serranator™ to the predicate device." No specific number of cadavers or tests is given. (Prospective study).
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 provided in the document. The studies described are primarily technical device performance, biocompatibility, and comparative morphological studies in animal models and cadavers. There is no mention of human expert-established ground truth as would be relevant for an AI/diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as the studies are not clinical trials or diagnostic performance studies requiring adjudication of human expert opinions.
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
There is no mention of an MRMC comparative effectiveness study, nor any evaluation of human readers with or without AI assistance. This device is a physical medical device (balloon catheter), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a physical medical device and not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the animal studies, the "ground truth" or primary endpoints appear to be morphometric measurements (e.g., neointimal areas, thickness, percent stenosis) derived from analyzing treated vessels. These measurements would likely be obtained via histological analysis or imaging post-treatment.
For non-clinical and biocompatibility testing, the "ground truth" is adherence to pre-defined engineering specifications, material properties, and biological safety standards (e.g., ASTM, ISO standards).
8. The sample size for the training set
This is not applicable as the device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).