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To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of compatible stent devices during therapeutic intravascular procedures.

The HI-TORQUE BALANCE MIDDLEWEIGHT™ UNIVERSAL Guide Wire is a steerable guide wire available in a maximum diameter of 0.0137" and in lengths of 190 cm and 300 cm. The distal segment of the guide wire, up to the hypotube, is coated with hydrophilic coating to reduce friction for improved guide wire movement within the catheter. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The proximal core has a maximum diameter of 0.0137". The proximal end of the guide wire is coated with PTFE, which reduces friction of the wire within a catheter. The BMW™ Universal Guide Wire is DOC® extendable in the 190 cm lengths.

The provided text describes a 510(k) summary for the HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire Family. This document focuses on demonstrating substantial equivalence to predicate devices through various bench tests and biocompatibility assessments, rather than presenting a clinical study on human diagnostic performance using an AI algorithm.

Therefore, many of the requested points related to AI, ground truth, expert adjudication, multi-reader multi-case studies, and training/test set sample sizes are not applicable to this submission.

Here's the information that can be extracted from the provided text:

1. Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as a series of "In vitro bench testing" and "Biocompatibility testing." The submission states that these tests "demonstrated that the HI-TORQUE BALANCE MIDDLEWEIGHT™ UNIVERSAL Guide Wire met all acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing program..." This indicates that the tests successfully showed the device's performance aligns with acceptable standards and is comparable to previously cleared devices.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document states "In vitro bench testing... were conducted on the subject device," implying a sample was used, but the specific number is not disclosed.
• Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective). These are lab-based bench tests and biocompatibility tests, not studies involving human patient data.

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

Not applicable. This is not a study assessing diagnostic performance where expert ground truth would be required. The tests are physical and chemical evaluations of the device's properties.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This type of study is typically done for diagnostic imaging devices involving human readers and AI. This submission is for a guide wire, and the testing involved bench and biocompatibility assessments, not MRMC studies.

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

Not applicable. This device does not involve an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the bench tests would be the established engineering specifications and performance characteristics derived from validated test methods, and the performance of the predicate devices. For biocompatibility, it would be the pre-defined safety limits and established biological responses.

8. The Sample Size for the Training Set

Not applicable. This device does not involve an AI algorithm or a training set in that context.

9. How the Ground Truth for the Training Set was Established

Not applicable. This device does not involve an AI algorithm or a training set.

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This HI-TORQUE Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.

The HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire is a steerable guide wire available in a diameter of 0.0140" and in lengths of 190 cm DOC extendable length and a 300 cm exchange length. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The distal segment of the guide wire is coated with a new lubricious coating to improve guide wire movement in the catheter. The proximal end of the guide wire utilizes SMOOTHGLIDE coating technology.

Here's a breakdown of the acceptance criteria and study information for the HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire, based on the provided text:

Acceptance Criteria and Device Performance (Based on provided text)

The provided text does not contain a detailed table of specific acceptance criteria with numerical targets. Instead, it states a general conclusion about meeting acceptance criteria and performance comparability.

Study Details:

1. Sample sizes used for the test set and data provenance:

   • Test Set Sample Size: Not specified in the provided text.
   • Data Provenance: The study was "in vitro bench testing," meaning it was conducted in a laboratory setting, not with human or animal subjects. Therefore, there is no information about country of origin or whether it was retrospective or prospective in the clinical sense.

2. Number of experts used to establish the ground truth for the test set and their qualifications:

   • Not applicable/Not specified. This was an in vitro bench test, not an evaluation relying on expert interpretation of clinical data or images.

3. Adjudication method for the test set:

   • Not applicable/Not specified. This was an in vitro bench test, not a study requiring adjudication of expert opinions.

4. 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:

   • No. This device is a guide wire, not an AI-powered diagnostic or assistive technology. The study was an in vitro bench test.

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

   • Not applicable. This device is a physical medical instrument (guide wire), not an algorithm. The study was an in vitro bench test of its physical properties and functionality.

6. The type of ground truth used:

   • The "ground truth" for this in vitro bench testing would be established engineering specifications, performance standards, and the performance characteristics of the predicate device. The text indicates the device "met the acceptance criteria" and "performed comparable to the predicate device."

7. The sample size for the training set:

   • Not applicable. This was an in vitro bench test of a physical device, not an AI model that requires a training set.

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

   • Not applicable. As noted above, this was not an AI study requiring a training set with established ground truth.

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