(25 days)
The HI-TORQUE WHISPER Guide Wire is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.
The general guide wire design consists of a stainless steel tapered core with a flexible tip, jacketed by polyurethane on the distal portion of the wire and polytetrafluoroethylene (PTFE) on the proximal portion of the wire. The polyurethane is subsequently covered with a hydrophilic coating to increase lubricity. The guide wires are available with either a straight distal tip that is shapeable, or as a pre-formed 'J' distal tip shaped specifically for accessing the coronary sinus (designated 'CS-J'). The straight tip can be manually shaped to accommodate specific patient anatomy or physician preference; the CS-J shape provides the convenience of an existing 'J' shape without manual shaping.
The HI-TORQUE WHISPER LS, MS/MS CS-J and ES/ES CS-J guide wires with Hydrocoat hydrophilic coating are guide wires with a 0.014" maximum diameter and a length of 190 cm. These wires are constructed with a high tensile (Hyten) stainless steel core wire having a nominal diameter of 0.0128" (LS/MS versions) or 0.0132" (ES versions). The distal segment of each guide wire consists of a series of unique tapers and grinds which reduce the diameter and support at the distal core, thus yielding the desired flexibility and performance characteristics.
The provided text describes a 510(k) premarket notification for a medical device, specifically guide wires. These documents typically focus on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with acceptance criteria and AI performance metrics. Therefore, much of the requested information regarding AI performance, specific acceptance criteria for a study, sample sizes for training/test sets, expert adjudication methods, and MRMC studies is not present in the provided text.
However, based on the available information, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the "results of the verification testing demonstrate that the HI-TORQUE WHISPER LS, MS, ES, MS CS-J, and ES CS-J Guide Wires meet the established acceptance criteria and perform in a manner equivalent to the predicate device."
Without specific numerical or qualitative acceptance criteria defined in the provided text, a table cannot be fully populated. The "reported device performance" is broadly stated as meeting these unspecified criteria and being equivalent to the predicate device. The performance characteristics that were compared include "materials, performance characteristics, sterilization and packaging."
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (as stated in document) |
|---|---|
| (Implicit: Conformity to predicate device's features, performance characteristics, and material properties for safety and effectiveness) | "Meet the established acceptance criteria and perform in a manner equivalent to the predicate device." |
| (Implicit: No new safety or effectiveness issues) | "No new safety or effectiveness issues were raised during the testing program." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "verification testing" but does not specify the sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typically found in a detailed study report, not usually in a 510(k) summary focused on substantial equivalence.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable or not provided. The document describes a medical device (guide wire) and its mechanical/material performance, not an AI or diagnostic tool that relies on expert interpretation for ground truth.
4. Adjudication Method
This information is not applicable or not provided. As above, the context is device performance testing, not diagnostic interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not performed or at least not reported in this 510(k) summary. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The device here is a guide wire, which is a tool used by a physician, not a diagnostic algorithm. Therefore, there's no mention of AI assistance or effect size on human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
This information is not applicable or not provided. The device is a physical medical instrument, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this type of device (a guide wire) would be based on engineering and performance specifications, material science properties, and direct functional testing (e.g., lubricity, flexibility, torque transmission, guidewire trackability, structural integrity after use). The document states that "performance data" and "verification testing" were conducted, implying these types of objective tests. There is no mention of "expert consensus, pathology, or outcomes data" in the context of establishing ground truth for the device's performance.
8. Sample Size for the Training Set
This information is not applicable or not provided. Since this is not an AI/ML device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or not provided. As there is no training set for an AI/ML model, there's no ground truth to establish for it in this context.
§ 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.