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ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

The ASAHI® PTCA Guide Wire ASAHI Gladius Mongo consists of a one-piece core wire and a distal coil assembly. The coil assembly consists of an inner coil and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of the ASAHI® PTCA Guide Wire ASAHI Mongo. The coil and distal portion of the quide wire are coated with polyurethane and then covered with hydrophilic coating. The proximal portion of the guide wire is coated with PTFE only. The ASAHI® PTCA Guide Wire ASAHI Mongo is available in various lengths. The shorter length device is designed for use with a commercially available ASAHI INTECC extension, wire.

The provided text describes the 510(k) premarket notification for the "ASAHI® PTCA Guide Wire ASAHI Gladius Mongo 14 and ASAHI Gladius Mongo 14 ES." This document pertains to a medical device (a guide wire), not an AI algorithm or a diagnostic tool. Therefore, the questions regarding acceptance criteria and studies for an AI/ML powered device, specifically those requiring information on human readers, ground truth establishment for AI training/test sets, and expert adjudication, are not applicable to this document.

The document focuses on demonstrating substantial equivalence of the new guide wire to a legally marketed predicate device (ASAHI® Fielder XT-A). It primarily relies on non-clinical testing/performance data to show that the new device functions as intended and has a similar safety and effectiveness profile.

Here's a breakdown of the relevant information provided, responding to the spirit of the request where applicable to a traditional medical device:

1. A table of acceptance criteria and the reported device performance:

The document lists the following non-clinical tests performed, implying that internal acceptance criteria were met. However, the specific quantitative acceptance criteria and the exact reported performance results (e.g., specific tensile strength values or torque strength ranges) are not detailed within this public summary. The statement is qualitative: "met all acceptance criteria and performed similarly to the predicate device."

Regarding the other questions, they are not directly applicable to this type of device submission:

• 2. Sample sized used for the test set and the data provenance: This refers to data for an AI model. For this physical device, "sample size" would refer to the number of devices tested for each non-clinical test. This specific number is not provided in the summary. Data provenance is not relevant for a physical device's bench testing.
• 3. Number of experts used to establish the ground truth... and qualifications: This is for AI performance evaluation. Not applicable.
• 4. Adjudication method... for the test set: This is for AI performance evaluation. Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: This is for AI performance evaluation. Not applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is for AI algorithm performance. Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This is for AI ground truth. For this device, "ground truth" would be established by validated test methods and engineering specifications.
• 8. The sample size for the training set: This is for AI model training. Not applicable.
• 9. How the ground truth for the training set was established: This is for AI model training. Not applicable.

In summary, the provided document is a 510(k) summary for a physical medical device (a guide wire), and the questions posed are primarily designed for the evaluation of AI/ML-powered medical devices. Therefore, most of the specific details requested regarding AI acceptance criteria, ground truth, and study design are not found within this document. The core of this submission is demonstrating substantial equivalence through a comparison of technological characteristics and non-clinical bench testing.

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ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

The ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 consists of a core wire and a coil assembly. The coil assembly consists of an inner coil, safety wire. and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of ASAHI® PTCA Guide Wire: ASAHI SUOH® 03. The distal portion of the guidewire has a hydrophilic coating, and the proximal portion of the guidewire is coated with PTFE. The ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 is available in various lengths and tip shapes. The shorter length device is designed for use with a commercially available Asahi Intecc extension wire.

The provided document is a 510(k) Summary for a medical device (Asahi PTCA Guide Wire Asahi SUOH 03) and focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML medical device. Therefore, the information typically requested in an AI/ML context regarding acceptance criteria and study details (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable or present in this document.

The document outlines the device's technical specifications and compares them to predicate devices, along with non-clinical performance testing to ensure safety and effectiveness.

Here's a breakdown of the non-clinical performance data and acceptance criteria as presented in the document, which primarily revolve around engineering and material properties, rather than diagnostic accuracy or AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the device "met all acceptance criteria" and "performed similarly to the predicate devices" for the listed tests. Specific numerical values for the criteria or performance are not provided in this summary but would have been part of the full 510(k) submission.

Regarding the AI/ML specific questions (2-9):

This document is for a conventional medical device (a guide wire), not an AI/ML-driven device. Therefore, the following information is not applicable and cannot be extracted from the provided text:

2. Sample size used for the test set and data provenance: Not applicable. The "test set" here refers to physical guide wire samples for bench testing, not a dataset for an AI model.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. Ground truth for an AI model is not relevant to guide wire physical testing.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and effect size: Not applicable. This type of study is for evaluating human performance with/without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used: Not applicable. The "ground truth" for a guide wire's performance is its physical properties meeting engineering standards.
8. The sample size for the training set: Not applicable. There is no AI model to train.
9. How the ground truth for the training set was established: Not applicable.

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This product 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 Astato XS 40 Peripheral Guide Wire in this submission has a coil-type distal end. The coil is radiopaque to facilitate selection of the blood vessel and confirmation of the position of the quide wire's distal end by fluoroscopy. The core shaft surface is coated with Polytetrafluoroethylene (PTFE). The distal end is coated with a hydrophilic coating. The ASAHI Astato XS 40 guide wires in this submission have an overall length range of 200 to 300 cm and a nominal outer diameter of 0.36 mm.

This document is a 510(k) Summary for a medical device called the "ASAHI Astato XS 40" guide wire. It details the device's characteristics and its comparison to predicate devices to demonstrate substantial equivalence, rather than a study designed to meet specific acceptance criteria for AI performance.

Therefore, the requested information points regarding AI acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to this document as it describes a traditional medical device (guide wire) and not an AI/ML-driven device.

However, I can extract the acceptance criteria and performance data for the physical device as described in the document.

1. A table of acceptance criteria and the reported device performance

The document states that "The in vitro bench tests demonstrated that the ASAHI Astato XS 40 met all acceptance criteria and performed similarly to the predicate devices." While specific numeric acceptance criteria are not provided, the following tests were performed:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "in vitro bench tests" but does not specify sample sizes or data provenance.

3. 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)

This information is not applicable as this is not an AI/ML device requiring expert-established ground truth. The tests performed are engineering-based performance tests for a physical device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as this is not an AI/ML device requiring adjudication of results.

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

This information is not applicable as this is not an AI/ML device.

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

This information is not applicable as this is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable as the "ground truth" for a physical device like a guide wire would be established by physical measurements and engineering standards, not typical "ground truth" as understood in AI/ML performance evaluation.

8. The sample size for the training set

This information is not applicable as this is not an AI/ML device.

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

This information is not applicable as this is not an AI/ML device.

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