(63 days)
Catheter stylets provide internal reinforcement to aid in catheter placement. When used with the Sherlock 3CG® Tip Confirmation System (TCS), the Sherlock 3CG® TPS Stylet also provides the placer rapid feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection.
Bard Access Systems, Inc.'s Sherlock 3CG® Tip Positioning System (TPS) Stylet is a sterile, single use device 0.49 mm (0.019 in) outer diameter x 78.5 cm, made of specially-formulated materials designed to aid in the placement of specific Bard catheters, as well as any open-ended, non-valved, polyurethane, peripherally inserted central catheters (PICCs) that meet the dimensional specifications of the stylet. The Sherlock 3CG® TPS Stylet is designed to work with catheters containing a minimum lumen diameter of 0.51mm (0.020 in). The stylet provides internal reinforcement to aid in catheter placement. The Sherlock 3CG® TPS Stylet may be used with the Sherlock 3CG® Tip Confirmation System (TCS) to provide catheter tip placement information during the procedure.
The provided document is a 510(k) summary for the Sherlock 3CG® Tip Positioning System (TPS) Stylet. It outlines the intended use, technological characteristics, and safety and performance tests. However, it does not contain the detailed acceptance criteria and study results in the format requested.
The document indicates that "Verification and validation tests have been performed in accordance with Design Controls as per 21 CFR §820.30" and that "The subject devices met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate devices." However, it does not explicitly state what those predetermined acceptance criteria were, nor does it provide specific reported device performance metrics against them.
Therefore, I cannot populate the table or answer most of your detailed questions directly from the provided text.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that the devices met predetermined acceptance criteria, but it does not list these criteria or specific performance values. Instead, it lists technical standards and guidance documents (e.g., BS/EN/ISO 10555-1: 1997, ISO 594-2: 1998, AAMI/ANSI/ISO 11135-1:2007) that were used to determine appropriate methods for evaluating performance. It also mentions risk management according to ISO 14971:2012.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document mentions "Verification and validation tests" but provides no details on sample size, data provenance, or whether the study was retrospective or 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/Cannot be provided. This device is a stylet for a catheter tip positioning system, which uses passive magnets and cardiac electrical signal detection for feedback on catheter tip location. The ground truth for such a device would likely involve direct physical measurement or imaging confirmation (e.g., X-ray) of the catheter tip, not expert review of images for diagnosis. The document does not describe the establishment of a ground truth by experts in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Cannot be provided. As above, the nature of the device and the information provided do not suggest an adjudication method for a test set, which is typically relevant for interpretative tasks often involving human expert readers.
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
- Cannot be provided. The document does not mention an MRMC study. This device is an accessory to a positioning system, which is a tool to aid in placement, not an AI for interpretation that would typically require an MRMC study to evaluate reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be directly answered. The device is described as a "stylet" that "provides the placer rapid feedback." This implies it works with human-in-the-loop (the placer). The document doesn't detail the performance of the "Sherlock 3CG® Tip Confirmation System (TCS)" itself, only the stylet which is an accessory to it. The stylet's function is to provide internal reinforcement and, when used with the TCS, enables the system to provide tip location feedback.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be determined from the text. The document does not specify how the accuracy of the catheter tip location detected by the Sherlock 3CG® TCS (when used with the stylet) was validated or what "ground truth" method was employed for this validation.
8. The sample size for the training set
- Not applicable/Cannot be provided. As this is not an AI/machine learning device in the context of image interpretation or diagnosis (it's a physical medical device accessory), the concept of a "training set" is not relevant in the sense of data used to train an algorithm.
9. How the ground truth for the training set was established
- Not applicable/Cannot be provided. For the same reason as above.
In summary, the provided document is a regulatory submission summary focusing on the equivalence of the device to a predicate based on technological characteristics and general safety/performance testing protocols. It does not contain the detailed study results or acceptance criteria in the requested format.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”