(71 days)
The BMW Guide Wire is intended for general intravascular use to aid in the selective placement of interventional devices, such as catheters, in the coronary, peripheral and visceral vasculature during diagnostic and/or therapeutic procedures.
The BMW Guide Wire is a steerable guide wire available in a nominal diameter of 0.14" in two lengths: a 190 centimeter extendible length (extendible to 335cm using the DOC® Guide Wire Extension) and a 300-centimeter exchange length.
The provided text describes a 510(k) summary for the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire. This document focuses on demonstrating substantial equivalence to a predicate device for a labeling modification, rather than evaluating a new device's performance against specific acceptance criteria in a detailed clinical study.
Therefore, the requested information regarding acceptance criteria, reported performance, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details cannot be fully extracted as such information is not typically part of a 510(k) submission for a labeling change on a pre-existing device.
However, I can provide the limited information that is present regarding testing:
Key Takeaways from the Provided Text:
- Focus: The 510(k) is primarily for a labeling modification to change the indications for use of an already marketed device (ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire, K971815).
- No Changes to Device: There are "no changes to the design, materials, manufacturing process, packaging process, sterilization process, or shelf life of the subject device." This significantly reduces the scope of required testing compared to a new device.
- Substantial Equivalence: The primary goal is to show substantial equivalence to the MicroVena Niner Nitinol Guide Wire (K952860) for the modified indication and to the existing BMW Guide Wire (K971815) for all other aspects.
Information Extracted from the Text:
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A table of acceptance criteria and the reported device performance:
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Acceptance Criteria: The text does not explicitly state quantitative acceptance criteria for the device performance in the context of this 510(k) submission. The acceptance was primarily based on demonstrating substantial equivalence to predicate devices and the results of a single animal study.
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Reported Device Performance:
Performance Metric Reported Performance Performance in Coronary Vein (In Vivo Animal Study) "acceptable within the coronary vein when used with a compatible lead system." Design, Materials, Manufacturing, Packaging, Sterilization, Shelf Life Stated to be identical to the currently marketed BMW Guide Wire (K971815). Intended Use Equivalence Equivalent to MicroVena Niner Nitinol Guide Wire (K952860) for intended use.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size: The text mentions "An animal study was conducted," but does not specify the number of animals (sample size) used.
- Data Provenance: The study was an "In Vivo Testing" and "animal study." No specific country of origin is mentioned for the study. It is a prospective study as it was conducted to evaluate performance.
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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):
- This information is not provided in the text. The animal study results are reported as "acceptable," implying an evaluation by experts, but their number and qualifications are not detailed.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the text.
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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:
- No, an MRMC comparative effectiveness study was not done. This device is a guide wire, not an AI-assisted diagnostic tool, so such a study would not be applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is a physical medical instrument (guide wire), not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the animal study appears to be a clinical assessment of acceptability based on the performance of the guide wire within the coronary vein, likely by veterinary or medical experts involved in the study. Details are not provided on whether this included specific pathological findings or long-term outcomes for the animals.
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The sample size for the training set:
- This question is not applicable as this is a physical medical device and not an AI/machine learning algorithm that requires a training set.
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How the ground truth for the training set was established:
- This question is not applicable as this is a physical medical device and not an AI/machine learning algorithm that requires a training set.
§ 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.