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510(k) Data Aggregation
(195 days)
VASSALLO GT 018 Floppy
This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.
The VASSALLO GT 018 Peripheral Guide Wire in this submission is a steerable guide wire with a maximum diameter of 0.018" (0.45mm) and available in lengths of 190cm and 300cm. The device has a solid core with a hydrophilic coated coil-type distal end. The coil is partly or entirely radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy. The core shaft surface is coated with Polytetrafluoroethylene (PTFE). About 2cm of the distal end can be shaped. A detachable extension wire (hereafter "extension wire") is available to connect with the proximal end of the quide wire with a length of less than 300 cm. A Torque device is included in the same package.
The provided document describes the VASSALLO GT 018 Floppy peripheral guide wire. It does not describe an AI/ML powered device, but rather a medical device that facilitates the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. Therefore, many of the requested elements for AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this submission.
However, I can provide information based on the non-clinical testing performed for the device.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "The in vitro bench tests demonstrated that the VASSALLO GT 018 met all acceptance criteria and performed similarly to the predicate and reference devices." However, specific quantitative acceptance criteria and their corresponding reported device performance values are not detailed in this document. The document only lists the types of tests performed.
| Test Category | Acceptance Criteria (General Description) | Reported Device Performance (General Description) | Specific Quantitative Data Provided? |
|---|---|---|---|
| Dimensional Verification | Device dimensions meet specifications | Met all acceptance criteria | No |
| Visual Inspection | Device free from defects | Met all acceptance criteria | No |
| Tensile Strength / Tip Pull | Adequate tensile strength and tip integrity | Met all acceptance criteria | No |
| Torque Strength | Adequate torque strength | Met all acceptance criteria | No |
| Torqueability | Device can be torqued effectively | Met all acceptance criteria | No |
| Coating Adhesion/Integrity | Coating remains intact and adheres | Met all acceptance criteria | No |
| Particulate | Minimal particulate matter | Met all acceptance criteria | No |
| Catheter Compatibility / Lubricity | Compatible with catheters and lubricious | Met all acceptance criteria | No |
| Corrosion Resistance | Resists corrosion | Met all acceptance criteria | No |
| Kink Resistance | Resists kinking | Met all acceptance criteria | No |
| Tip Flexibility | Adequate tip flexibility | Met all acceptance criteria | No |
| Radiopacity | Visible under fluoroscopy | Met all acceptance criteria | No |
| Biocompatibility Tests (Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis, Partial Thromboplastin Time, In Vivo Thromboresistance, SC5b-9 Complement Activation) | Biocompatible with human tissue and blood | Determined to be biocompatible | No |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each non-clinical bench test. The data provenance is not explicitly stated in terms of country of origin for the testing, but the applicant company, FILMECC CO., LTD., is based in Japan. These would be considered prospective tests conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device and the tests are non-clinical bench tests (e.g., tensile strength, corrosion resistance). "Ground truth" in the context of expert consensus is not relevant here; the tests have objective physical or chemical measurements.
4. Adjudication method for the test set
Not applicable, as this refers to expert review processes for complex diagnostic outputs, not physical device performance tests.
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 not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an AI/ML algorithm.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" is established by standard engineering and biocompatibility testing protocols and specifications. For example, for "Tensile Strength," the ground truth would be a pre-defined range of acceptable tensile forces according to relevant standards for guide wires. For biocompatibility, the ground truth is the absence of cytotoxicity, irritation, etc., according to recognized international standards (e.g., ISO 10993).
8. The sample size for the training set
Not applicable. This device does not involve machine learning and therefore has no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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