(31 days)
The Precious Plus Guide Catheter is intended for use in coronary artery applications and is designed to provide a pathway through which medical instruments, such as balloon catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.
The Precious plus guide catheter consists of a tube, a proximal hub, and protector for the joint portion of the first 2 components. The surface of inner lumen of the shaft is coated with PTFE to enhance lubricity. The outer surface of the product is coated with Silicone oil.
This document, a 510(k) Pre-Market Notification for the Precious Plus Guide Catheter, describes the device and its intended use, and argues for its substantial equivalence to predicate devices, but does not contain detailed acceptance criteria or a study proving that the device meets those criteria.
Therefore, many of your requested fields cannot be filled from the provided text.
Here is an attempt to answer as much as possible:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state specific acceptance criteria (e.g., minimum tensile strength, maximum friction coefficient) with corresponding reported values. It broadly states that "mechanical and functional bench testing that demonstrates that the Precious plus guide catheter performs as intended" and that "Bench testing demonstrates that the device functions as intended."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any test set or the provenance of any data (country of origin, retrospective/prospective). It only mentions "bench testing."
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. This device is a physical medical instrument, not an AI or diagnostic imaging device that typically requires expert-established ground truth for performance evaluation in the way you describe.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device and performance evaluation.
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 or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "performance data" section states: "This 510(k) notice includes mechanical and functional bench testing that demonstrates that the Precious plus guide catheter performs as intended." This implies standalone testing of the device itself (without human-in-the-loop, as it's a catheter, not an AI algorithm) was conducted. However, no specific details of this testing are provided beyond this general statement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For physical medical devices like this, "ground truth" typically refers to established engineering standards, material specifications, and functional requirements. For example, a "ground truth" might be that the catheter must withstand a certain pressure without leaking, or have a specific surface lubricity. The document implies compliance with these types of standards through "mechanical and functional bench testing," but does not explicitly detail them or how they were established.
8. The sample size for the training set
Not applicable. This is not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI model.
Summary of available information:
The document focuses on establishing substantial equivalence to predicate devices based on:
- Identical indications for use.
- Similar materials with a long history of biocompatibility.
- Equivalence in dimensional specifications to predicate devices.
- General statements about "mechanical and functional bench testing" demonstrating the device performs as intended.
- Biocompatibility testing on the actual device.
The 510(k) process primarily relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than comprehensive, detailed clinical studies with specific acceptance criteria and outcome measurements as might be seen for novel therapeutic drugs or AI diagnostic tools. For a Class II device like a guide catheter, bench testing and material equivalence are often central to the submission.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).