(399 days)
The EpiFaith CV is intended for use in central venous catheter placement procedure, which is designed to facilitate guidewire-assisted catheter placement and is compatible with guidewires ranging from 0.025"(0.64mm) to 0.038"(0.96mm) along with their appropriate introducer needles. The device provides a visual cue when it hits a vessel with >50mmHg of pressure. The EpiFaith CV will be sold sterile individually packaged, and as part of a sterile kit. Neonates and infants shall be excluded from the intended population.
The EpiFaith CV is a syringe with spring loaded piston, which can provide a high/low blood pressure signal when introducer needle tip entry to the blood vessel. Based on the principle of blood pressure differences in different blood vessel, the piston will simultaneously move backward when the pressure increase occurs due to the high blood pressure in the syringe barrel. The moving of the piston can provide a visual signal to indicate the high/low blood pressure as well as verify the introducer needle tip placement in the blood vessel.
The provided text describes the 510(k) submission for the EpiFaith CV device, which is a medical device intended for use in central venous catheter placement procedures. The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe a study involving an AI algorithm, human readers, or image analysis. Instead, it details bench testing for physical and material properties of a medical device.
Therefore, I cannot provide the requested information about acceptance criteria for an AI device, sample sizes for a test set, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as the document does not contain this type of information.
The document discusses "acceptance criteria" in the context of the non-clinical bench tests performed on the EpiFaith CV device to ensure its physical and material properties meet predetermined standards. These are not acceptance criteria for an AI system's performance metrics like sensitivity, specificity, or AUC.
Here's a breakdown of what the document does provide, in a format that relates to your request, but acknowledging the difference in context:
1. A table of acceptance criteria and the reported device performance:
The document lists various non-clinical tests performed on the EpiFaith CV device. The "acceptance criteria" are implied by the "Pass" results for each test. The reported "device performance" is simply that the device passed these tests, indicating it met the implicit criteria for acceptable functioning and safety.
| Test | Acceptance Criteria (Implied by "Pass" result) | Reported Device Performance |
|---|---|---|
| Cytotoxicity | Meets ISO 10993-5:2009 standards | Pass |
| Sensitization | Meets ISO 10993-10:2010 standards | Pass |
| Irritation or intracutaneous reactivity | Meets ISO 10993-10:2010 standards | Pass |
| Acute systemic toxicity | Meets ISO 10993-11:2017 standards | Pass |
| Material-medicated pyrogenicity | Meets USP standards | Pass |
| Hemocompatibility | Meets ISO 10993-4:2017 & ASTM F756 standards | Pass |
| Endotoxin | Meets USP & USP standards | Pass |
| Sterility test | Meets ISO 11737-2:2019 standards | Pass |
| Seal strength test | Meets ASTM F88 standards | Pass |
| Bubble leak test | Meets ASTM F2096 standards | Pass |
| Negative pressure leakage | Meets Flat Medical internal protocol | Pass |
| Positive pressure leakage | Meets Flat Medical internal protocol | Pass |
| Auto-aspirating mechanism | Meets Flat Medical internal protocol | Pass |
| Positive pressure indication | Meets Flat Medical internal protocol | Pass |
| Resistance of passing guidewire | Meets Flat Medical internal protocol | Pass |
| Fatigue tests of latches | Meets Flat Medical internal protocol | Pass |
| Fluid leakage - Positive pressure liquid leakage | Meets ISO 80369-7:2016 & ISO 80369-20:2015 | Pass |
| Sub-atmospheric pressure air leakage | Meets ISO 80369-7:2016 & ISO 80369-20:2015 | Pass |
| Stress cracking | Meets ISO 80369-7:2016 & ISO 80369-20:2015 | Pass |
| Resistance to separation from axial load | Meets ISO 80369-7:2016 & ISO 80369-20:2015 | Pass |
2. Sample sized used for the test set and the data provenance:
The document describes non-clinical bench testing. It does not specify "sample sizes" in the context of patient data or test sets for an AI algorithm. The tests were performed on physical units of the EpiFaith CV device. The data provenance is internal to Flat Medical Co., Ltd. through their internal protocols and compliance with various ISO and ASTM standards. The study is a non-clinical bench study, not a retrospective or prospective clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the provided document. Ground truth as typically defined for AI models (e.g., expert annotations on medical images) is not relevant here. The "ground truth" equivalent for this device is whether it physically functions as designed and meets specified safety and performance standards, as evaluated by engineers and technicians during bench testing according to established protocols and standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is for expert review of data, not for bench testing of a physical device.
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 document is about a physical medical device (catheter guide wire accessory), not an AI system designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" in this context is established engineering and safety standards (e.g., ISO, ASTM, USP) and the manufacturer's internal protocols. The device either passes or fails these pre-defined physical and material performance criteria.
8. The sample size for the training set:
Not applicable. There is no AI training set mentioned.
9. How the ground truth for the training set was established:
Not applicable. There is no AI training set.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.