(54 days)
The ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire is a steerable wire intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of equipment such as atherectomy and compatible stent devices during other diagnostic and therapeutic intravascular procedures.
The ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire is a steerable guide wire intended to facilitate placement of balloon dilatation catheters during Percutaneous Transluminal Coronary Angioplasty (PTCA) and Percutaneous Transluminal Angioplasty (PTA). The wire is also intended to facilitate the placement of equipment, such as atherectomy and compatible stent devices, during other diagnostic and therapeutic intravascular procedures. It is not intended for use in the cerebral vasculature.
The proximal and distal portions of the guide wire are constructed from a core assembly. A series of tapers and flats, which reduce the diameter of the core wire distally, yields the desired tip flexibility. The ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire is coated with Microglide® from 40cm to 3cm back from the distal tip, while the remaining portion is coated with polytetrafluoroethylene (PTFE). Both coatings are intended to reduce friction for improved movement of the wire within the catheter.
The design of the new ACS BALANCE MIDDLEWEIGHT" Guide Wire is constructed from a stainless steel core wire. Like the predicate 0.014" HI-TORQUE BALANCE® guide wire, the new guide wire design includes a series of tapers and flats which reduce the diameter of the core wire distally, yielding the desired tip flexibility. Unlike the 0.014" HI-TORQUE BALANCE® Guide Wire, the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ wire diameters and tapers along the length of the distal portion of the guide wire have been modified to yield the desired support over the distal 30 centimeters of the wire.
The provided document is a 510(k) summary for a medical device (guide wire) submitted in 1997. It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence. However, it does not contain the specific acceptance criteria, study details, and performance metrics typically found in recent AI/ML device submissions.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions related to sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone performance, as this information is not present in the given text.
The document focuses on demonstrating substantial equivalence based on materials, design, functional properties, and packaging compared to previously approved guide wires, as well as bench and animal testing results that show "adequate" or "performs as well as or better than" the predicate devices.
Here's a breakdown of what is available based on your request, and what is absent:
1. Table of acceptance criteria and the reported device performance:
- Absent. The document describes testing performed (tensile strength, torsional strength, rotational accuracy, tip flexibility) and states the device "has adequate" or "acceptable" performance, but it does not provide specific numerical acceptance criteria or quantitative performance results in a table format.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Absent. The "In vivo Testing" section mentions "An animal study was completed," but does not specify the number of animals (sample size), species, or any other details about the study design or data provenance beyond it being an animal study.
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 / Absent. This type of ground truth establishment by human experts is typically relevant for interpretative devices (e.g., AI for image analysis). For a guide wire, performance is typically assessed through physical and functional tests, not by expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Absent. See point 3.
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 a physical medical device, not an AI/ML-based diagnostic or interpretative device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the bench testing, the "ground truth" would be the engineering specifications and established test methodologies for guide wires.
- For the in vivo animal study, the "ground truth" was a comparison of its performance against a predicate guide wire in specific procedures, implicitly using direct observation of physical function as the basis of comparison ("performs as well as or better than the ACS Hi-Torque Floppy Xtra Support® Guide Wire").
8. The sample size for the training set:
- Not applicable / Absent. This device is a physical product and does not involve AI/ML models that require a "training set."
9. How the ground truth for the training set was established:
- Not applicable / Absent. See point 8.
Summary of available information regarding studies and acceptance criteria (from the text):
Study Types Performed:
- Bench Testing:
- Tensile strengths (distal tip and hypotube junction) - demonstrated "adequate tensile strength."
- Torsional strength (distal tip and hypotube junction) - showed "adequate torsional tip strength."
- Rotational accuracy - showed "adequate torque response."
- Tip flexibility - demonstrated "acceptable tip flexibility."
- In vivo Testing (Animal Study):
- Purpose: To evaluate and compare the performance of the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire to a predicate device (ACS Hi-Torque Floppy Xtra Support® Guide Wire, K913353).
- Context: Used in combination with specific devices (Johnson and Johnson (JJIS) Stent Delivery System, DVI AtheroCath-GTO Atherectomy Catheter, and CVIS UltraCrossIntravascular ultrasound catheter).
- Results: "performs as well as or better than the ACS Hi-Torque Floppy Xtra Support® Guide Wire in the majority of the performance parameters."
- Biocompatibility:
- Relied on data from the predicate 0.014" HI-TORQUE BALANCE® Guide Wire due to identical materials, demonstrating biocompatibility for short-term use.
Data Provenance (limited):
- Bench testing is typically conducted in a lab setting.
- In vivo testing was an "animal study." No country of origin is specified.
- Biocompatibility data was from a predicate device.
Acceptance Criteria (as implied by outcomes):
The acceptance criteria are not explicitly stated with quantitative thresholds, but are indicated by qualitative statements of performance:
- "adequate tensile strength"
- "adequate torsional tip strength"
- "adequate torque response"
- "acceptable tip flexibility"
- "performs as well as or better than" the predicate device in the animal study.
- Biocompatibility "demonstrate[d]" for short-term use.
This document serves as a substantial equivalence submission, which typically relies on comparisons to already approved devices and demonstrating that the new device does not raise new questions of safety or effectiveness. The level of detail on specific performance metrics and study designs is less compared to what might be expected from a pre-market approval application (PMA) or a submission for a novel device, especially one incorporating AI/ML.
§ 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.