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The Runthrough NS Extension Wire are used to facilitate the placement of balloon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).

The Runthrough NS is a coil-type guide wire. The main components of the wire include a core wire, a tip coil, a tip coil marker, and surface coating. The core wire is constructed of a Ni/Ti alloy wire and a stainless steel wire joined together. The tip coil marker, a Pt/Ni alloy, is radiopaque. The tip coil has lubricous coating (silicone coating) and/or hydrophilic coating on the surface depending on product code. The shaft is surfacecoated with silicone and PTFE. Tip flexibility can be selected among three types, Extra Floppy, Floppy, and Intermediate, flexibility decreasing in the named order. The wire is also available in a hyper-coating type which is more lubricous than the standard wire. The device may be accompanied by a torque device, inserter, and stylet accessories. An extension wire is available to connect to the proximal end of the 180cm wire when the physician wants to convert from a monorail catheter system to an over the wire system.

The provided text describes a 510(k) summary for the "Runthrough NS Extension Wire," a medical device used to facilitate the placement of balloon dilatation catheters. The document focuses on demonstrating the substantial equivalence of this modified device to a predicate device (Runthrough NS K063695).

Based on the provided information, here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states, "The following verification tests were performed to demonstrate the substantial equivalence of the modified device (Runthrough NS Extension Wire) to the unmodified device (Runthrough NS K063695)." The acceptance criteria are implicitly met if these tests show no new issues of safety or effectiveness and demonstrate substantial equivalence to the predicate device. The detailed quantitative acceptance limits for each test (e.g., specific tensile strength values, dimensional tolerances) are not provided in this summary.

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

The document does not explicitly state the sample sizes for the "Dimensional Inspection," "Tensile strength of tip," and "Extension wire connection strength" tests. These would typically be part of a design verification and validation report, not usually detailed in a 510(k) summary.

Data Provenance: The tests are described as "verification tests" performed to demonstrate substantial equivalence, implying they were conducted by the manufacturer (Terumo Corporation) as part of their design and development process. The data is created by the manufacturer's testing, not from patient data, and is thus prospective in nature in terms of device testing, not clinical data collection.

• Country of Origin of Data: Not explicitly stated, but given the company's address (Elkton, MD, USA), it's likely the testing was conducted in the US or by the manufacturer's global R&D/testing facilities.
• Retrospective or Prospective: Prospective (device testing).

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

This information is not applicable to this type of device submission. The Runthrough NS Extension Wire is a physical medical device (guide wire), not an AI/software device that requires expert consensus for "ground truth" establishment regarding interpretations of data (e.g., medical images). The "ground truth" for this device's performance is objective measurements against engineering specifications and validated test methods.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments, which is not relevant for the engineering performance tests of a guide wire.

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. An MRMC comparative effectiveness study is used to evaluate the performance of AI-assisted diagnostic systems. The Runthrough NS Extension Wire is a physical medical device and does not involve AI or human-in-the-loop performance in diagnostic interpretation.

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

This information is not applicable. This question pertains to AI/software performance. The device is a physical guide wire.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the Runthrough NS Extension Wire is established through:

• Engineering Specifications: Objective measurements (e.g., dimensions, tensile strength, connection strength) are compared against predetermined, specified ranges and values that define acceptable performance.
• Biocompatibility Testing: Results of biological assays and tests in accordance with ISO-10993 standards.
• Sterilization Validation Standards: Compliance with validated sterilization cycles to achieve a specified sterility assurance level (SAL).
• Comparison to Predicate Device Performance: The primary ground for acceptance in a 510(k) is demonstrating "substantial equivalence" to a legally marketed predicate device, meaning the new device performs acceptably and no new safety or effectiveness issues are raised compared to the predicate.

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical medical device, not an AI/machine learning algorithm requiring a "training set."

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

This information is not applicable for the same reasons as #8.

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The Runthrouh NS are used to facilitate placement of balloon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).

The Runthrough NS is a coil-type guide wire. The main components of the wire include a core wire, a tip coil, a tip coil marker, and surface coating. The core wire is constructed of a Ni/Ti alloy wire and a stainless steel wire joined together. The tip coil marker, a Pt/Ni alloy, is radiopaque. The tip coil has lubricous coating (silicone coating) and/or hydrophilic coating on the surface depending on product code. The shaft is surfacecoated with silicone and PTFE. Tip flexibility can be selected among three types, Extra Floppy, Floppy, and Intermediate, flexibility decreasing in the named order. The wire is also available in a hyper-coating type which is more lubricous than the standard wire. The device may be accompanied by a torque device, inserter, and stylet accessories.

The provided 510(k) summary for the Terumo Runthrough NS guide wire describes a device intended to facilitate placement of balloon dilatation catheters. It's important to note that this submission focuses on demonstrating substantial equivalence to a predicate device (Radifocus® Glidewire for Coronary Use with Platinum or Gold Coil, K961445), rather than proving the device meets a set of clinical performance acceptance criteria in the way an AI/software device would.

Therefore, many of the requested categories related to AI performance, such as sample size for training/test sets, ground truth establishment for AI, expert consensus, MRMC studies, and standalone AI performance, are not applicable to this type of device submission. The "acceptance criteria" here are defined by demonstrating equivalence through a series of engineering/physical tests.

Here's the information that can be extracted or inferred from the provided text, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating that the Runthrough NS performs equivalently to the predicate device across a range of physical and mechanical characteristics. The "performance" is reported as "substantial equivalence" based on the results of the verification tests.

The document states: "None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness. Therefore the performance of the modified Runthrough NS is substantially equivalent to the performance of the predicate device..."

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

• Sample Size for Test Set: Not specified in terms of clinical or imaging data. The "test set" refers to physical samples of the device undergoing engineering verification tests. The number of physical units tested for each criterion is not disclosed.
• Data Provenance: Not applicable in the context of clinical data. The performance data comes from internal laboratory testing of the device itself.

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

• Not applicable. Ground truth in the context of AI refers to labels or diagnoses provided by experts. For this medical device, "ground truth" would be the known physical properties and performance of the predicate device, against which the modified device's performance is compared through engineering tests. The "experts" involved would be the engineers and technicians performing and assessing these tests.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to human readers reviewing clinical cases for ground truth establishment. Here, the "adjudication" is based on comparing engineering test results of the new device against established benchmarks or the predicate device's performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a physical medical device like a guide wire.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device is a physical guide wire, not a software algorithm.

7. Type of Ground Truth Used

• For the engineering performance tests, the "ground truth" is implicitly the known and acceptable performance specifications for a guide wire of this type, often derived from prior knowledge of the predicate device and relevant industry standards. For biocompatibility, the ground truth is established by the specified ISO-10993 standards. For sterility, it's defined by ANSI / AAMI / ISO 11135-1994.

8. Sample Size for the Training Set

• Not applicable. This refers to AI/machine learning.

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

• Not applicable. This refers to AI/machine learning.

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