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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.

1. 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<788>; 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 < 24 hrs)	Materials are the same as the predicate device (K863138), which has a demonstrated history of safe and effective use. Concluded as biocompatible for its intended use.
   Sterilization	ISO 11135:2014 for Ethylene Oxide sterilization (min. SAL of 10-6)	Validated in accordance with ISO 11135:2014 to provide SAL of 10-6.
   Shelf-Life	Not explicitly stated standard, but tests performed on non-aged and accelerated aged samples	Performance ensured throughout the labeled shelf life (24 months).

2. Sample sizes used for the test set and the data provenance:
   The document does not specify exact sample sizes for each test. It mentions "samples" and "accelerated aged samples" but no specific numbers. Data provenance is implied to be internal testing by the manufacturer (Terumo Corporation) based on recognized standards (ISO, ASTM, FDA guidance) and in-house standards. This is for physical device performance, not clinical data or imaging data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable, as there is no "ground truth" related to AI or diagnostic interpretation. The "truth" here is compliance with engineering specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. Adjudication methods are used in consensus building for ground truth in AI/imaging studies.

5. 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:
   Not applicable. This is for evaluating diagnostic performance of AI-assisted human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable, as there is no AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   Not applicable. The "ground truth" for this device is the established engineering and material standards and the performance of the predicate device.

8. The sample size for the training set:
   Not applicable. There is no training set as no AI model is being developed.

9. How the ground truth for the training set was established:
   Not applicable.

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