(88 days)
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA) and compatible stent devices during therapeutic intravascular procedures.
The HI-TORQUE BALANCE UNIVERSALIM Guide Wire is a steerable guide wire available in a maximum diameter of 0.0137" and in lengths of 175 cm, 190 cm and 300 cm. The distal segment of the guide wire, up to the hypotube, is coated with hydrocoat to reduce friction for improved guide wire movement within the catheter. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The proximal core has a maximum diameter of 0.0137". The proximal end of the guide wire is coated with PTFE, which reduces friction of the wire within a catheter. The Balance Universal™ Guide Wire is DOC® extendable in the 175 cm and 190 cm lengths.
The provided text describes a 510(k) summary for the HI-TORQUE BALANCE UNIVERSAL™ Guide Wire. However, it does not contain the detailed performance study information required to answer all the posed questions. The text explicitly states:
"In vitro bench testing performance evaluations demonstrated that the HI-TORQUE BALANCE UNIVERSAL™ Guide Wire met the acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing program and therefore, the HI-TORQUE BALANCE UNIVERSAL™ Guide Wire may be considered substantially equivalent to the predicate devices."
This is a general statement and lacks the specific details about acceptance criteria, the study design, sample sizes, ground truth establishment, or expert involvement that are typically associated with performance studies involving AI or complex medical device efficacy.
Therefore, for many of your questions, the answer will be "Information not provided in the input text."
Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text. The text only states that the device "met the acceptance criteria." | "met the acceptance criteria and performed similarly to the predicate devices." (General statement, no specific metrics provided) |
Study Details
Here's what can and cannot be answered based on the provided text:
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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)
- Not provided in the input text. The text only mentions "In vitro bench testing performance evaluations."
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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)
- Not applicable / Not provided in the input text. The study described is "in vitro bench testing," which would not typically involve human experts establishing ground truth in the way described for clinical or imaging data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided in the input text. This is not relevant for an in vitro bench testing study.
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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. The device is a guide wire, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study or AI-related information is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in essence. The "in vitro bench testing" represents a standalone evaluation of the physical device's performance against pre-defined criteria, without human intervention in the performance measurement itself (though humans design and conduct the tests). However, this is not an "algorithm" in the context of AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated in the input text, but inferred from "in vitro bench testing." The "ground truth" would likely be objective measurements of physical properties (e.g., tensile strength, friction, flexibility, torque transmission, coating integrity) against engineering specifications or established industry standards for guide wires, rather than medical "ground truth" like pathology or clinical outcomes.
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The sample size for the training set
- Not applicable / Not provided in the input text. The concept of a "training set" is typically for machine learning algorithms, which this device is not. For a physical device, manufacturing and process validation would involve numerous samples, but these aren't "training sets" in the AI sense.
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How the ground truth for the training set was established
- Not applicable / Not provided in the input text. (See point 7).
In summary, the provided document is a 510(k) summary for a medical device (a guide wire), not for an AI diagnostic tool. Therefore, many of the questions asked, particularly those related to AI performance, human readers, and clinical data/expert consensus, are not applicable or the information is not present in this type of regulatory submission summary. The "study" described is limited to "in vitro bench testing."
§ 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.