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The CLIMBER - Partially Coated Guide Wire for Endoscopic Use is designed for endoscopic use. The CLIMBER is used for supporting cannulation or insertion into bile duct strictures and pancreatic duct strictures.

The CLIMBER has a core of titanium nickel alloy coated with polyurethane. The distal tip up to 150 cm is coated again with polyurethane and then is coated with a hydrogel. The remaining 300 cm of the wire is coated with silicone. The wires are 450 cm in length and come in 0.035" diameter. The tip shape is available in straight or angled, shapeable; and straight or angled, non-shapeable.

Here's an analysis of the provided information regarding the CLIMBER - Partially Coated Guide Wire for Endoscopic Use, structured to address your specific questions.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a substantial equivalence determination, not a study with explicit acceptance criteria and corresponding performance metrics for a novel medical device feature or algorithm. Instead, the "acceptance criterion" is implicitly demonstrating that the CLIMBER device performs comparably to existing, legally marketed predicate devices.

• Wire: Nickel-Titanium alloy coated with polyurethane
• Core Wire: single taper
• Wire Diameter: 0.035"
• Wire Length: 450 cm
• Tip Configuration: straight/angled
  A minor difference is noted in "Exterior Coating" (hydrogel/silicone for CLIMBER vs. hydrogel for Terumo 450 cm), which is deemed not to raise new safety/effectiveness issues. |
  | Technology/Principles of Operation | Substantially Equivalent: Both the CLIMBER and the predicate devices are operated manually or by a manual process. |
  | Performance (mechanical and biological properties) | Substantially Equivalent: "The following tests were performed demonstrating the substantial equivalence of the Terumo CLIMBER... to the Microvasive GEENEN ENDOTORQUE™ GUIDE WIRE, the WILSON-COOK® TRACER™ WIRE GUIDE Slip-Coat™ Tip and the Terumo 450 cm Guide Wire for G.I. Use." Specific tests mentioned include:
• Butting Load
• Tip Flexibility Test
• Shaft Flexibility Test
• Memory Retention Test
• Shapeability Test
• Sliding Resistance
• Tensile Strength
• Torque Failure Test
• Torque Transmission Test
• Biocompatibility (passed)
• Sterilization (validated)
• Expiration Dating (24 months established) |
  | Safety (biocompatibility, sterility, residuals, expiration) | Substantially Equivalent:
• Biocompatibility: Blood contacting materials tested in accordance with ISO-10993 and found to be biocompatible.
• Sterilization: Validated according to EN 550 (1994) to SAL of 10^-6. Ethylene oxide residuals within limits.
• Expiration: Established at 24 months. |

Study Proving Acceptance Criteria:

The "study" described is a comparison to predicate devices to demonstrate substantial equivalence, rather than a stand-alone clinical trial. The performance tests listed are a series of bench tests and material characterization tests designed to show that the CLIMBER device performs similarly to or within acceptable limits compared to the predicate devices.

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

• Test Set Sample Size: Not explicitly stated in terms of patient numbers or independent devices. The "tests" listed (e.g., Butting Load, Tip Flexibility Test) imply testing on a sample of the CLIMBER guide wires, but the exact number of units tested for each parameter is not provided.
• Data Provenance: The tests performed are likely bench testing conducted by the manufacturer, Terumo Medical Corporation, in a laboratory setting. There is no indication of patient data, clinical data, or country of origin for such data in the context of this 510(k) submission. It’s a pre-market submission based on physical device characteristics and performance, not clinical outcomes.

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 submission. Ground truth, in the sense of expert consensus on clinical findings, is not established because the evaluation is based on engineering and material performance tests of the device itself, not on diagnostic interpretations or clinical observations. The "ground truth" for these tests would be the established engineering specifications and performance values of the predicate devices or relevant industry standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods are typically used in clinical studies or reader studies where multiple experts interpret data. For a bench test comparing material properties and mechanical performance, the "adjudication" is based on objective measurements against predefined specifications or predicate device performance.

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 is not applicable. This submission is for a physical medical device (a guide wire), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed.

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

This is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this substantial equivalence submission is based on:

• Engineering Specifications and Performance Data of Predicate Devices: The CLIMBER's performance was compared to existing, legally marketed guide wires (Terumo 450 cm Guide Wire, Microvasive GEENEN ENDOTORQUE™, WILSON-COOK® TRACER™). The "ground truth" is that these predicate devices are deemed safe and effective based on their prior clearances and established performance.
• Industry Standards: References to European Standard EN 550 for sterilization and ISO-10993 for biological evaluation indicate adherence to established standards.
• Manufacturer's Internal Specifications: The various bench tests would have target values or ranges derived from internal company standards and/or comparison to predicate devices' known characteristics.

8. The Sample Size for the Training Set

This is not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

This is not applicable as there is no training set for a physical medical device.

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