(84 days)
The Locking Stylet 2 is intended for use during the percutaneous removal of cardiac leads, indwelling catheters and other foreign objects having a central lumen.
The Locking Stylet 2 is used during the percutaneous removal of cardiac leads, indwelling catheters and other foreign objects having a central lumen. The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the Locking Stylet 2 is provided by their established history of use in medical product manufacturing by COOK Vascular™ Incorporated.
The provided text is a 510(k) Premarket Notification for the "Locking Stylet 2". It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain details about specific acceptance criteria, performance studies, or clinical trial data in the way you've outlined.
Therefore, most of the requested information cannot be extracted directly from this document.
Here's what can be gathered based on the available information:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not define specific acceptance criteria or report performance metrics from a study against such criteria. The submission is a 510(k) for substantial equivalence, not a clinical trial report.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. No test set or study data is mentioned.
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)
- Cannot be provided. No ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. No adjudication method is described.
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. This information is not relevant to a device like a locking stylet, which is a physical instrument, not an AI-powered diagnostic tool. The document describes a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not applicable to a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. No ground truth establishment is described.
8. The sample size for the training set
- Cannot be provided. No training set is mentioned as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established
- Cannot be provided. No training set or ground truth establishment is mentioned.
Summary based on the document:
The 510(k) summary states that the Locking Stylet 2 is "similar to the predicate Locking Wire Guide Stylet that is currently marketed with respect to intended use, material composition, and method of operation." It also mentions "Reasonable assurance of biocompatibility of the materials comprising the Locking Stylet 2 is provided by their established history of use in medical product manufacturing by COOK Vascular™ Incorporated." The basis for substantial equivalence relies on these similarities and the manufacturing processes. The document does not contain data from performance studies or clinical trials to demonstrate specific acceptance criteria.
§ 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.