(80 days)
The SCIMED Sceptor and Sceptor Exchange PTCA Guide Wires are intended to facilitate the placement and enchange of PTCA balloon catheters and other therapeutic devices during angioplasty. The devices are provided sterile and intended for one procedure only.
The Sceptor and Sceptor Exchange Guide Wires utilize common biocompatible materials and are constructed in a similar manner as currently marketed devices. The one piece stainless steel core wire has a PTFE (gray or black) coated proximal section and a tapered distal section. The distal section is surrounded by a Pebax® sleeve and platinum spring coil. The spring tip and polymer sleeve are coated with XTRA™ (silicone) coating.
This 510(k) notification describes a modification to an existing medical device (SCIMED Sceptor and Sceptor Exchange PTCA Guide Wires) by changing the proximal coating material. The notification primarily focuses on demonstrating substantial equivalence to currently marketed devices through non-clinical testing of the new coating adherence.
Based on the provided text, a comprehensive acceptance criteria and study description as typically defined for AI/ML device performance is not applicable or available. This is because the submission is for a physical medical device (guide wire), not a software-based AI/ML diagnostic or prognostic tool. Therefore, many of the requested elements (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not relevant to this type of device submission.
Here's a breakdown of what can be extracted and what is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Minimum requirements for teflon coating adherence | "Test results verified that the Sceptor and Sceptor Exchange Guide Wires met the minimum requirements and are adequate for their intended use." |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable: This refers to in-vitro testing of material properties, not a clinical test set with patient data. The document does not specify the number of guide wires tested for coating adherence, nor the exact nature of the "test results" (e.g., how many tests were performed, on how many samples).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable: Ground truth, in the context of AI/ML, refers to a definitively correct answer for a diagnostic or prognostic task, typically established by human experts or pathology. For a physical device's material performance, there isn't "ground truth" in this sense. The "ground truth" is simply the physical properties of the material being tested against established engineering specifications.
4. Adjudication Method for the Test Set
- Not Applicable: Adjudication methods (e.g., 2+1) are used to resolve disagreements among human annotators or diagnosticians establishing ground truth for AI/ML models. This is not relevant to in-vitro material testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: This is a physical device, not an AI/ML algorithm that assists human readers. Therefore, an MRMC study is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No: This is a physical device, not an algorithm. Standalone performance is not applicable.
7. The Type of Ground Truth Used
- Not Applicable (in the AI/ML sense): The "ground truth" for the material testing would be the pre-defined engineering specifications or performance standards for teflon coating adherence.
8. The Sample Size for the Training Set
- Not Applicable: There is no "training set" in the context of a physical device's material properties testing as described here. This concept is relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no training set, this question is not relevant.
Summary based on the document:
The provided text details a 510(k) submission for a modification to a PTCA guide wire. The core of the safety and effectiveness summary relies on non-clinical in-vitro testing of a new proximal coating (PTFE) to demonstrate that the modified device remains substantially equivalent to existing, legally marketed predicate devices. The "study" mentioned is the "testing and evaluation of the guide wires included teflon coating adherence." The acceptance criteria were "minimum requirements" for this adherence, which the device "met." No human-in-the-loop studies, AI/ML training, or complex ground truth establishment methods are described or relevant to this type of device submission.
§ 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.