(37 days)
The Gopher Gold catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents.
The Gopher Gold catheter is a 3F catheter that is compatible with standard 0.014" guidewires and 6F guide catheters. The Gopher Gold is a single-lumen catheter with a working length of 135 cm with printed positioning marks at 95 cm and 105 cm. The Gopher Gold catheter is packaged in a dispenser coil and is sealed within a single sterile barrier pouch. The Gopher Gold catheter is sterilized by ethylene oxide and intended for single use.
The provided document is a 510(k) Premarket Notification for a medical device called the Gopher Gold Catheter. It focuses on establishing substantial equivalence to a predicate device based on design, materials, and intended use. The document does not contain any information regarding specific acceptance criteria, performance studies (clinical or non-clinical that would generate performance metrics), sample sizes for testing, expert involvement, adjudication methods, or ground truth establishment for AI/ML device evaluation.
It explicitly states: "Technological differences in design and materials have been qualified through biomaterial assessments and other design verification testing, the results of which did not raise any new safety or performance questions." This indicates that the evaluation was primarily around material compatibility and design verification, not performance metrics based on clinical outcomes or a rigorous statistical study.
Therefore, I cannot populate the requested table or provide answers to most of your questions based on the input provided. The questions you've asked are typically relevant for AI/ML-driven medical devices, which require extensive performance validation against a defined ground truth using statistical methods. This document describes a traditional medical device (a catheter) where the 510(k) pathway often relies on substantial equivalence to a predicate device rather than novel performance claims from studies.
Here's what can be extracted/inferred from the document, with caveats:
- A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as performance metrics. The implicit acceptance criterion is "substantial equivalence" to the predicate device (K070372 Gopher catheter). This means its intended use, technological characteristics, and safety/effectiveness profile should be comparable to the predicate.
- Reported Device Performance: No quantitative performance metrics are reported in the document. The document states that "biomaterial assessments and other design verification testing" were performed, and these "did not raise any new safety or performance questions." This is a qualitative statement of comparability, not a report of specific performance values.
| Acceptance Criteria (Implicit) | Reported Device Performance (Qualitative) |
|---|---|
| Substantial Equivalence to Predicate Device (Gopher Catheter K070372) in terms of intended use, technological characteristics, and safety/effectiveness. | Biomaterial assessments and design verification testing conducted. Results did not raise any new safety or performance questions compared to the predicate. |
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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 Applicable / Not Provided. The document does not describe a "test set" in the context of performance metrics or data-driven evaluation. The "testing" mentioned refers to design verification and biomaterial assessment, which are typically bench or in-vitro tests, not studies with patient data.
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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. No ground truth establishment is described, as the evaluation focused on physical properties and design comparability rather than diagnostic or clinical performance assessed against a consensus of experts.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided. No such method is mentioned.
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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. This is not an AI/ML device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/ML device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Not Provided. The evaluation was against engineering specifications, material standards, and comparability to a predicate device, not, for example, expert diagnosis of a disease.
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The sample size for the training set:
- Not Applicable / Not Provided. This is not an AI/ML device.
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How the ground truth for the training set was established:
- Not Applicable / Not Provided. This is not an AI/ML device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).