(178 days)
The CRICKET™ is intended to be used as a steering mechanism for guidewires. The opposite end of the CRICKET™ has a shaping bar which allows for shaping the distal tip of guidewires (revised February 13, 1996)
The CRICKET™ is intended to be used as a steering mechanism for guidewires. The opposite end of the CRICKET™ has a shaping bar which allows for shaping the distal tip of guidewires (revised February 13, 1996)
This document is a 510(k) summary for a medical device called the "CRICKET™ Multipurpose Steering Device and Tip Shaper." It is a premarket notification to the FDA to demonstrate that the device is as safe and effective as a legally marketed predicate device.
The provided text does not contain the acceptance criteria or the details of a study that proves the device meets acceptance criteria in the format requested.
Here's why and what information is available:
1. A table of acceptance criteria and the reported device performance:
- Not present. The document states "All current MICROVENA guidewires were successfully shaped with the CRICKET™ and the guidewires successfully passed visual, functional and tensile strength tests." However, it does not define specific quantitative acceptance criteria for "successfully shaped," "visual," "functional," or "tensile strength tests." For example, it doesn't say "tensile strength must be > X Newtons" or "no visible damage greater than Y mm."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not present. The document mentions "All current MICROVENA guidewires" but does not specify the number or type of guidewires tested. There is no information on data provenance (country, retrospective/prospective).
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/Not present. This device is a mechanical tool (a steering device and tip shaper for guidewires), not an AI or diagnostic imaging device that requires expert ground truth for interpretation. The "ground truth" would be objective physical measurements and functional performance, not expert consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not present. Adjudication methods are typically used in studies involving subjective interpretation, like reading medical images. This is a mechanical device test.
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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Implied objective testing. The ground truth would be based on "visual, functional and tensile strength tests" of the guidewires after shaping. These are objective measures rather than subjective expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
- Not applicable/Not present. This device is not an AI model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device.
What the document does tell us about the "study":
The document describes "Functional/Safety Testing" where:
- Device Tested: CRICKET™ Multipurpose Steering Device and Tip Shaper.
- Purpose: To demonstrate that the device successfully shapes guidewires and that the shaped guidewires maintain their integrity.
- Method: "All current MICROVENA guidewires were successfully shaped with the CRICKET™."
- Evaluations: The shaped guidewires "successfully passed visual, functional and tensile strength tests."
- Conclusion: The testing led to the conclusion that the CRICKET™ is "substantially equivalent to the predicate devices based on intended use and the results of functional testing." This implies the performance was at least as good as the predicate devices, though no specific benchmarks are given.
In summary, the provided 510(k) summary is for a physical medical device and therefore does not contain the information typically associated with studies for AI/diagnostic devices as requested in your prompt. It focuses on functional and safety testing to establish substantial equivalence, without detailing specific quantitative acceptance criteria or study design elements like sample sizes or ground truth establishment relevant to AI/diagnostic performance.
§ 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.