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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 Peripheral Guide Wires in this submission have a coil-type distal end or a plastic covered-type distal end. The coil is partly or entirely radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy.

The core shaft surface is coated with Polytetrafluoroethylene (PTFE). About 2cm of the distal end can be shaped. ASAHI INTECC detachable extension wire (hereafter "extension wire") (previously cleared as part of K083145 and K101985) is available to connect with the proximal end of the guide wire with a length of less than 300 cm. The total length of the system after the connection with be 300cm to 400cm. Torque device may be included in the same package.

The ASAHI Peripheral Guide Wires in this submission have an overall length range of 200 to 300 cm and a nominal outer diameter range of 0.36 to 0.45 mm.

This document is a 510(k) summary for ASAHI Peripheral Guide Wires, which includes three models: ASAHI Gladius, ASAHI Halberd, and ASAHI Gaia PV. The purpose of this summary is to demonstrate substantial equivalence to legally marketed predicate devices.

Here's the breakdown of the acceptance criteria and study information provided:

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

The document broadly states that "The in vitro bench tests demonstrated that the ASAHI Peripheral Guide Wire met all acceptance criteria and performed similarly to the predicate devices." However, specific numerical acceptance criteria for each test (e.g., minimum tensile strength in Newtons, or maximum torque strength in N/cm) are not explicitly listed in the provided text. The performance is reported qualitatively as "met all acceptance criteria and performed similarly."

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

The document mentions "Non clinical laboratory testing was performed," which implies a test set. However, the sample size used for the test set is not specified. The data provenance is also not specified beyond being "non clinical laboratory testing." It does not mention the country of origin of the data or whether it was retrospective or prospective, as these are typically not applicable to bench testing of this nature.

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 or provided. For medical devices undergoing bench testing against engineering specifications, ground truth is established by physical measurements and engineering standards, not typically by expert review in the same way it would be for AI model validation in image interpretation, for example.

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

This information is not applicable or provided. Adjudication methods are typically relevant for human review of data, especially in clinical studies or when establishing ground truth for AI model training/testing. For bench testing, the results are typically objectively measured against established engineering specifications.

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 or provided. The device in question is a guide wire, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

This information is not applicable or provided. The device is a physical medical device (a guide wire), not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept for this product.

7. The type of ground truth used:

The ground truth for the bench tests would have been the engineering specifications and performance standards applicable to guide wires. These are based on industry standards, established medical device requirements, and the characteristics of the predicate devices.

8. The sample size for the training set:

This information is not applicable or provided. The document describes a physical medical device undergoing bench testing, not an AI system that requires a "training set."

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

This information is not applicable or provided for the same reason as point 8.

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The HI-TORQUE Guide Wire is intended for general intravascular use to aid in the selective placement of interventional devices and implantable coronary venous leads in the coronary and/or peripheral vasculature during diagnostic and/or therapeutic procedures.

The HI-TORQUE Guide Wires are steerable guide wires available in a nominal diameter of 0.14".

The provided text describes a 510(k) submission for HI-TORQUE Guide Wires, seeking to expand their indications for use. It primarily focuses on demonstrating substantial equivalence to existing devices rather than presenting a novel device requiring extensive performance acceptance criteria and a dedicated study to prove those criteria.

Here's an analysis based on the provided text, addressing your questions where possible:

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

The submission does not explicitly state formal quantitative acceptance criteria for the expanded indication. Instead, it relies on demonstrating equivalence to predicate devices and showing acceptable performance in in vivo animal and human clinical studies for the specific new intended use (placement of coronary venous pace/sense leads).

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

• Animal Study: The sample size is not specified. The text only mentions "Animal studies were conducted." Data provenance is not specified, but typically animal studies for medical devices are conducted in controlled environments.
• Human Clinical Testing Data: The sample size is not specified. The text states, "HI-TORQUE Guide Wires were evaluated in a clinical investigation." The data provenance is not specified, but it was a clinical investigation, implying a prospective study design.

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 provided in the document. Given that this is a 510(k) for an expanded indication and not a de novo device, the focus is on safety and effectiveness as demonstrated through the in vivo studies, rather than a diagnostic device requiring expert interpretation of results to establish ground truth.

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

This information is not provided. As explained above, the nature of this submission (expanded indication for a guide wire) does not typically involve a complex adjudication process for establishing a "ground truth" in the way a diagnostic algorithm might. The evaluation likely focused on procedural success, adverse events, and device performance metrics.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not what the HI-TORQUE Guide Wire is. The device is a physical medical instrument whose performance is assessed through its direct application in procedures.

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

No, a standalone algorithm-only performance study was not done. The HI-TORQUE Guide Wire is a physical medical device, not a software algorithm. Its performance is intrinsically linked to its use by a human operator (e.g., a cardiologist).

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

For the human clinical testing, the "ground truth" would likely be successful placement of the compatible coronary venous pace/sense lead and absence of significant adverse events. This would be determined by the treating physician and potentially confirmed through post-procedure imaging or clinical follow-up (outcomes data related to the procedure's success and safety).

8. The sample size for the training set

The concept of a "training set" is not applicable to this device. Training sets are used in machine learning for AI algorithms. This submission concerns a physical medical device.

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

Not applicable, as there is no training set for a physical medical device.

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The HI-TORQUE STEELCORE™18 Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. It is not intended for use in the cerebral vasculature.

The HI-TORQUE STEELCORE™ 18 Guide Wire is a steerable guide wire with a nominal diameter of 0.018 inches and three lengths: a 130 cm, a 190 cm and a 300 cm exchange length.

The provided text describes the performance testing for the HI-TORQUE STEELCORE™ 18 Guide Wire.

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

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

The document mentions "bench testing" but does not specify the sample size for the test sets used for each test. Furthermore, there is no information provided regarding the country of origin of the data or whether the tests were retrospective or prospective. Given that this is bench testing, it is generally considered prospective, as the tests are conducted for the specific purpose of evaluating the device.

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. The performance data is based on physical bench tests, not on expert interpretations of medical images or data requiring ground truth established by medical professionals.

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

This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, not in physical bench testing.

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. This device is a guide wire, and the study involves bench testing of its physical properties, not an AI-assisted diagnostic or interpretative system.

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

This information is not applicable. This device is a medical instrument, not an algorithm. The "standalone" performance here refers to the device's inherent physical properties as tested in the bench environment, without human interaction during the test itself (though humans operate the testing equipment).

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

The "ground truth" for the bench tests would be the established engineering specifications and performance standards for guide wires, along with comparative data from predicate devices. The tests directly measure physical properties against these predefined criteria.

8. The sample size for the training set:

This information is not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."

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

This information is not applicable, as there is no training set.

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