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The Asahi 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 Asahi Guide Wire Extension (Asahi Extension Wire) accessory is used to elongate the working length of compatible Asahi PTCA and Peripheral extendable wires. The stainless-steel Asahi Guide Wire Extension (Asahi Extension Wire) has an outer stainlood clour round of 165cm. Its distal end bears a prefermed elastic connecting tube. The product is specially designed to use with Asahi PTCA and elastio connooting table wires. This product is a non-invasive medical device, and it is not contact with tissue and body fluids.

The provided text describes a 510(k) summary for the Asahi Guide Wire Extension 165cm and its substantial equivalence to a predicate device. This device is a medical accessory and not an AI/ML powered device. Therefore, many of the requested fields related to AI/ML device studies (such as MRMC studies, ground truth establishment for training sets, number of experts for ground truth, etc.) are not applicable.

However, I can extract the information relevant to the device's performance testing and acceptance criteria as described in the summary.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" values in the common format of "must exceed X" or "must be less than Y". Instead, it states that the device "meets all predetermined performance criteria" and performs "as intended" based on the results of the bench testing. For a non-AI medical device like this, substantial equivalence is often demonstrated by showing that the new device performs comparably to the predicate device in relevant tests.

2. Sample Size Used for the Test Set and Data Provenance

The document describes "in vitro bench testing" for the performance data.

• Sample Size: Not specified. The document only mentions that evaluations were "conducted on the subject device - Asahi Guide Wire Extension accessory/Asahi Guide Wire Extension 165cm."
• Data Provenance: In vitro bench testing, meaning conducted in a laboratory setting, not from human patients or a specific country of origin in relation to clinical data. The study is a prospective bench test for the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a physical medical device, not an AI/ML device requiring expert ground truth for image or data interpretation. Performance was assessed through objective bench tests.

4. Adjudication Method for the Test Set

Not applicable. This is a physical medical device. The performance was assessed through objective bench testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical medical device, not an AI/ML device, so no MRMC study was performed.

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

Not applicable. This is a physical medical device, not an AI/ML algorithm.

7. The type of ground truth used

For this device, the "ground truth" is established by direct measurement and observation of the device's physical properties and mechanical performance during various bench tests (joint strength, tensile strength, kink resistance) against predetermined engineering specifications and comparison to the predicate device.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML device that requires a training set.

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

Not applicable. This is a physical medical device, not an AI/ML device.

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