(98 days)
This HI-TORQUE guide wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.
The HI-TORQUE PROGRESS Guide Wire Family is a new family of guide wires. designed to provide improved torque response and crossing while maintaining tactile feedback in stenotic vessels. The subject wire is a core to tip design, where the core material runs through the entire length of the wire. This family of guide wires have a maximum diameter of 0.0140" with a stainless steel core and are provided in 190cm extendable and 300cm exchange lengths. The distal core segment of the PROGRESS is offered in 5 configurations: PROGRESS 40, PROGRESS 80, PROGRESS 120, PROGRESS 140T and PROGRESS 200T. Each configuration is identical in design except for those design features that impact tip stiffness.
The provided text describes a 510(k) summary for the HI-TORQUE PROGRESS Guide Wire Family. It details the device, its intended use, and states that in vitro bench testing was performed to demonstrate substantial equivalence to predicate devices. However, the document does not contain the specific information requested in the prompt regarding acceptance criteria, a detailed study description, sample sizes, ground truth establishment, or expert involvement.
Here's a breakdown of why each requested point cannot be answered from the provided text:
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A table of acceptance criteria and the reported device performance:
- The document states: "In vitro bench testing performance evaluations demonstrated that the HI-TORQUE PROGRESS Guide Wire Family met the acceptance criteria and performed comparable to the matching predicate devices."
- Missing Information: It does not provide the specific acceptance criteria (e.g., tensile strength, kink resistance, pushability thresholds) or the measured performance values for the device against these criteria.
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Sample sized used for the test set and the data provenance:
- The document mentions "in vitro bench testing" but does not specify the sample size (number of guide wires tested) or the provenance of any data (e.g., country of origin, retrospective/prospective).
- Missing Information: No details on sample size or data provenance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is typically relevant for studies involving human judgment (e.g., image interpretation). For a physical medical device like a guide wire, "ground truth" usually refers to objective physical measurements or established engineering standards.
- Missing Information: The document does not describe any expert involvement in establishing a "ground truth" in the context of human interpretation. The "ground truth" for bench testing would typically be the physical properties measured.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication methods are used to resolve disagreements among multiple experts, usually in subjective assessments. Since bench testing is objective and not based on expert interpretation, this concept is not applicable here.
- Missing Information: Not applicable to this type of testing.
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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:
- MRMC studies are typically for diagnostic AI devices where human readers interpret medical images. This device is a physical guide wire, not a diagnostic AI tool.
- Missing Information: No MRMC study was done, as it's not relevant for this device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question pertains to AI algorithms. The HI-TORQUE PROGRESS Guide Wire is a physical medical device.
- Missing Information: Not applicable to this device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For a guide wire, the "ground truth" for bench testing would be the objective physical and mechanical properties measured (e.g., tensile strength, flexibility, lubricity, torque response). These are determined by calibrated instruments and established test methods, not expert consensus, pathology, or outcomes data in the typical sense.
- Missing Information: The document states "in vitro bench testing" which implies objective physical measurements, but it does not explicitly detail the specific ground truth types beyond that.
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The sample size for the training set:
- "Training set" is a concept primarily used in machine learning for AI algorithms. This is a physical medical device.
- Missing Information: Not applicable.
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How the ground truth for the training set was established:
- Again, this relates to AI/machine learning.
- Missing Information: Not applicable.
In summary, the provided 510(k) summary only states that "in vitro bench testing performance evaluations demonstrated that the HI-TORQUE PROGRESS Guide Wire Family met the acceptance criteria and performed comparable to the matching predicate devices." It lacks the detailed study information, specific acceptance criteria, performance data, sample sizes, and other ground truth establishment methods requested in the prompt, as these details are typically found in the full test reports, not the summary document itself.
§ 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.