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The indications for use of the FMD Peripheral Guide Wires F-14 and F-18 :

The FMD Peripheral Guide Wires are intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The indications for use of the FMD Guide Wire Extension F-14 EXT :

The FMD Guide Wire Extension accessory is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure.

The FMD Peripheral Guide Wires F-14 and F-18 are designed to facilitate the placement of interventional peripheral devices such as dilating balloon catheters, stent delivery systems and other peripheral artery diagnostic or therapeutic devices. The guide wires are available in nominal diameters of 0.014 (F-14) and 0.018 (F-18) inches and nominal lengths from 190cm to 300cm. The F-14 and F-18 guide wires with a length of less than 300 cm are compatible exclusively with the FMD Guide Wire Extension F-14 EXT, which can extend the guide wire length allowing for exchange of Over-The-Wire systems. The guide wires are composed of a stainless-steel core wire and a stainless steel and platinum nickel coil assembly on the distal end of the device. The coil assembly is soldered to the core. The Pt-Ni radiopaque coil allows for visualization while using fluoroscopy. The proximal portion is coated with PTFE. The distal section is coated with hydrophilic coating. All wires are available in a straight tip configuration.

The FMD Guide Wire Extension F-14 EXT is composed of a stainless steel core wire coated with PTFE. It has an outer diameter of 0.014" (0.36 mm) and a length of 165cm. Its distal end contains a connecting hypotube that is compatible with guide wires less than 300cm of both the F-14 and F-18 series.

Attachment of the FMD Guide Wire Extension F-14 EXT to FMD's extendable guide wire creates an extended guide wire that can be used to exchange out a percutaneous transluminal angioplasty (PTA) catheter without removing the original guide wire from the artery. When the exchange is complete, the FMD Guide Wire Extension F-14 EXT can be detached, and the original guide wire can be used in a conventional manner.

This document describes the premarket notification for the FMD Peripheral Guide Wires F-14 and F-18, and the FMD Guide Wire Extension F-14 EXT. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's an analysis based on your request:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria alongside performance data in a detailed quantitative manner. Instead, it broadly states that "The in vitro bench tests demonstrated that the FMD Peripheral Guide Wires F-14 and F-18 met all acceptance criteria and performed similarly to the predicate and reference devices." and for the biocompatibility tests, it indicates "The following biocompatibility tests were completed".

Here's a summary based on the listed tests:

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each non-clinical bench test. The data provenance is from non-clinical laboratory testing performed on the FMD Peripheral Guide Wires F-14 and F-18 and FMD Guide Wire Extension F-14 EXT. The country of origin of the data is not explicitly stated, but the applicant and contact information are for FMD Co., Ltd. located in Japan. All data would be considered prospective as it's generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the study described is a series of non-clinical bench tests and biocompatibility tests, not a clinical study involving human data or expert review of images for ground truth. The "ground truth" for these tests would be the established scientific and engineering principles and standards for medical device performance.

4. Adjudication method for the test set

This information is not applicable as the described study involves non-clinical bench testing and biocompatibility assessments, not a clinical trial requiring adjudication of patient outcomes or expert consensus. Decisions would be based on quantitative measurements and established pass/fail criteria for each test.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes the premarket notification for physical guide wires and guide wire extensions, which are mechanical devices, not AI-powered software or diagnostic tools that would involve human readers or AI assistance. The document explicitly states "Clinical evaluation was not required for this device."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance study of an algorithm was not done. This submission is for mechanical medical devices, not an algorithm or AI.

7. The type of ground truth used

The ground truth used for this submission is based on established engineering principles, international and national standards (e.g., ISO, ASTM), and the performance characteristics of legally marketed predicate devices. For biocompatibility, the ground truth is based on the results of validated in vitro and in vivo toxicology tests as per relevant standards (e.g., ISO 10993 series).

8. The sample size for the training set

This information is not applicable. The submission is for physical medical devices and does not involve an AI algorithm or a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

This information is not applicable, as there is no "training set" in the context of an AI algorithm described in this submission.

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The Asahi Regalia XS 1.0 Peripheral Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The Asahi Regalia XS 1.0 Peripheral Guide Wire is steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm length. The extension wire is connected to the end of the guide wire outside the body. The wire is constructed from a stainless steel core wire. The core wire and coil are soldered. The distal tip of the guide wire has a radiopaque tip to achieve visibility, and is made flexible to bend easily at the vessel curve. There is polyurethane coating covered with hydrophilic coating applied to the distal section of the guide wire. The proximal section of this guide wire is coated with PTFE.

This document is a 510(k) summary for the Asahi Regalia XS 1.0 Peripheral Guide Wire. It asserts substantial equivalence to predicate devices, and therefore, does not contain information about acceptance criteria or a study proving the device meets new acceptance criteria.

The submission states: "This submission represents a change to the existing product labeling. Additional performance testing is not applicable." This indicates that no new performance studies were conducted for this specific 510(k) submission.

Therefore, the requested information cannot be filled from the provided text.

Here's how I would answer based only on the provided text, indicating what information is not available:

Acceptance Criteria and Device Performance Study for Asahi Regalia XS 1.0 Peripheral Guide Wire

Based on the provided 510(k) summary, the sponsor (Asahi Intecc Co., Ltd.) states that additional performance testing is not applicable for this submission, as it represents a change to existing product labeling. The device's substantial equivalence is asserted based on similarities in materials and dimensional specifications to already cleared predicate devices. Therefore, there are no specific, new acceptance criteria or a study described within this document that proves the device meets such criteria.

The document emphasizes substantial equivalence rather than presenting new performance data.

1. Table of Acceptance Criteria and Reported Device Performance:

   • Acceptance Criteria: Not specified as no new performance testing was conducted.
   • Reported Device Performance: Not reported as no new performance testing was conducted beyond asserting equivalence to predicate devices based on material and dimensional characteristics.

2. Sample size used for the test set and the data provenance: Not applicable. No new test set and data provenance for performance evaluation are described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new ground truth establishment for a test set is described.

4. Adjudication method for the test set: Not applicable. No test set requiring adjudication is described.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable. This device is a guide wire, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (guide wire), not an algorithm.

7. The type of ground truth used: Not applicable. No new ground truth for performance evaluation is described. The basis for clearance is substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable. No training set is described.

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