(54 days)
The Glidewire is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.
The Radifocus Glidewire is a guide wire which is designed to fit inside a percutaneous catheter for the purpose of directing a catheter through the blood vessel. It is provided sterile and is intended for single use only. It consists of a Nickel Titanium alloy core wire; a polyurethane coating (containing tungsten) and a hydrophilic polymer coating are applied to the entire wire. There are two shaft configurations: standard and stiff. There are two distal tip shapes: straight and angled, and two types of flexible part lengths of the tip: 3 and 5cm. The Radifocus Glidewire is packaged in a plastic holder that is contained within an individual package. A guide wire inserter is included within the individual package to assist with the insertion of the guide wire into a catheter.
The provided text describes a 510(k) premarket notification for a medical device called the "Radifocus Glidewire". This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials for a novel device.
Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of an AI/Software as a Medical Device (SaMD), as implied by the detailed questions about ground truth, expert adjudication, MRMC studies, and standalone performance, does not directly apply to this document.
The document describes performance testing for a physical medical device (a guide wire) to ensure it meets established engineering and material standards and demonstrates substantial equivalence to a predicate device. It does not involve AI or software development that would require an AI-specific validation study as outlined in your prompt.
Here's a breakdown of why the requested information cannot be extracted from this document, and what is provided:
Why the requested information for AI/SaMD is not applicable/available:
- No AI or Software Component: The Radifocus Glidewire is a physical guide wire. There is no mention of any AI algorithm, software, or digital health component.
- No "Acceptance Criteria" for AI Performance: The "acceptance criteria" discussed in the document relate to physical properties and performance tests of the guide wire (e.g., surface, radiodetectability, fracture test, tensile force, torque strength, biocompatibility, sterilization). These are not AI performance metrics like sensitivity, specificity, AUC, or F-measure.
- No "Ground Truth" for AI/Imaging Data: Since there's no AI interpreting images or patient data, there's no need for establishing ground truth through expert consensus, pathology, or outcomes data, nor for training/test sets sourced from specific countries or collection methodologies (retrospective/prospective).
- No "Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study": This type of study is relevant for evaluating human reader performance with and without AI assistance in interpreting diagnostic images. It's not applicable to a physical guide wire.
- No "Standalone (Algorithm Only) Performance": This refers to the performance of an AI algorithm in isolation. It's not relevant here.
- No "Sample Sizes for Training/Test Sets" or "Adjudication Methods" for AI: These concepts are tied to machine learning model development and validation, which is absent from this submission.
What the document does provide regarding "acceptance criteria" and "proof":
The document details the non-clinical tests performed to demonstrate the device's performance and substantial equivalence to the predicate device.
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A table of acceptance criteria and the reported device performance:
The document provides tables of performance tests based on ISO standards and FDA guidance documents, stating that all samples tested met the standard applicable to each test, and the subject device complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents. It doesn't provide specific numerical values for each test result, but rather a statement of compliance.
Test Standard / Acceptance Criteria (Implicitly Met) Reported Device Performance ISO 11070:2014-based Tests: Surface Section 4.3 of ISO 11070:2014 Met the standard applicable to the test. No new issues of safety and effectiveness were raised. Radiodetectability Section 4.5 of ISO 11070:2014 & ASTM F640-12 Met the standard applicable to the test. Only non-aged sample was tested. Fracture Test Section 8.4 of ISO 11070:2014 Met the standard applicable to the test. No new issues of safety and effectiveness were raised. Flexing Test Section 8.5 of ISO 11070:2014 Met the standard applicable to the test. No new issues of safety and effectiveness were raised. Peak Tensile Force of Guidewire (ISO) Section 8.6 of ISO 11070:2014 Met the standard applicable to the test. No new issues of safety and effectiveness were raised. FDA Guidance & In-house Standard-based Tests: Peak Tensile Force of Guidewire (FDA/In-house) 3.a of Coronary and Cerebrovascular Guidewire Guidance, January 1995 & In-house Standard Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents. Torque Strength 3.b of Coronary and Cerebrovascular Guidewire Guidance, January 1995 & In-house Standard Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents. Torqueability 3.c of Coronary and Cerebrovascular Guidewire Guidance, January 1995 & In-house Standard Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents. Tip Flexibility 3.d of Coronary and Cerebrovascular Guidewire Guidance, January 1995 & In-house Standard Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents. Sliding Resistance/Coating Integrity 3.e of Coronary and Cerebrovascular Guidewire Guidance, January 1995 & In-house Standard Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents. Particulate Evaluation VIII.A.13 of Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010; USP; In-house Standard Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents. Product Dimension In-house Standard Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents. Biocompatibility ISO 10993-1:2009 (Externally Communicating Devices, Circulating blood, Limited Contact
§ 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.