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The TightRail Mechanical Dilator Sheaths are intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters and foreign objects.

The TightRail Mechanical Dilator Sheaths are mechanical, intra-operative devices consist of a proximal handle drive mechanism with a distal dilation catheter. The sheaths are packaged with an outer support sheath. The dilator sheath is advanced, withdrawn and rotated about the lead, catheter or foreign object to be removed. Actuating the trigger on the proximal handle activates a rotary dilation mechanism sheathed at the distal terminus of the catheter. Rotation of the inner shaft is translated to axial actuation of the dilation mechanism via a cam path contained within the distal components. Actuation of the distal dilation mechanism causes dilation of tissue and fibrous attachments surrounding the object targeted for removal thereby facilitating removal of said object. The diameter sizes range from 9 French (F) to 13 F. The nominal effective length of the TightRail is 47.5 cm.

The provided text describes a 510(k) summary for the "TightRail™ Mechanical Dilator Sheath Set." This premarket notification asserts that the device is substantially equivalent to a legally marketed predicate device, focusing on design verification and validation testing rather than presenting formal acceptance criteria with specific performance metrics.

Here's an analysis of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria or specific performance metrics in a tabular format as would be typical for independent studies. Instead, it lists various "Design Verification and Validation Testing" categories, implying that the device was tested to "meet all specifications" and "demonstrated that the subject device is as safe and clinically effective as the predicate device."

• No explicit table of acceptance criteria or quantitative performance is provided in the document. The acceptance is based on demonstrating substantial equivalence to a predicate device through a series of verification and validation tests.

Study Details:

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

   • Test Set Sample Size: Not explicitly stated. The "Simulated Use Bench Top" test would have involved a certain number of devices or iterations, but the specific sample size is not detailed for any of the listed tests.
   • Data Provenance: The tests are described as "Design Verification and Validation Testing" and "Simulated Use Bench Top," implying in-house laboratory testing. There is no mention of country of origin for data or whether it was retrospective or prospective in a clinical sense. These are engineering and performance tests, not clinical data from patients.

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

   • Not applicable. This is not a study involving expert assessment of medical images or patient outcomes to establish ground truth. The "ground truth" for these engineering tests would be the established performance specifications for the device itself and comparison to the predicate.
   • "Physician Simulated Use" is mentioned, which implies input from physicians, but the number or specific qualifications are not detailed, nor is it a method for establishing "ground truth" in the typical sense of a diagnostic study.

3. Adjudication method for the test set:

   • Not applicable. This is not a clinical study involving human readers or interpretation where adjudication methods (like 2+1 or 3+1) would be used. The tests described are engineering and performance validation tests.

4. 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. This is a medical device for percutaneous dilation, not a diagnostic imaging AI device. Therefore, MRMC studies and AI-assisted human reader improvement are not relevant to this submission.

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

   • No. This is a mechanical medical device, not a software algorithm.

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

   • For the engineering and performance testing, the "ground truth" would be established engineering specifications, industry standards (e.g., AAMI TIR:28-2009 for sterilization), and the performance characteristics of the legally marketed predicate device. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these tests.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable, as there is no training set for this type of device.

Summary of Device Acceptance Criteria and Study:

The acceptance criteria for the TightRail Mechanical Dilator Sheath Set were met through a series of Design Verification and Validation Tests. These tests aimed to demonstrate that the device met all its specifications and was substantially equivalent to the predicate device (Cook® Medical Evolution® Mechanical Dilator Sheath Set, K061000).

The types of tests conducted included:

• Dimensional Verification
• Axial Loading of Tip Assembly and Outer Sheath
• Tensile and Torsional Testing on the Tri-Coil
• Simulated Use Bench Top
• Radiopacity
• Corrosion Resistance
• Physician Simulated Use
• Simulated Distribution (Shipping and Environmental Conditioning)
• Shelf Life Verification Testing (6 months, including Dimensional Verification, Axial Loading, Simulated Use Bench Top, Package Integrity)
• Sterilization (Product adoption equivalency per AAMI TIR:28-2009)
• Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, C3a and SC5b-9 Complement Activation, Direct Hemolysis, Indirect Hemolysis, In Vivo Thrombogenicity-Ovine Model, Genotoxicity Ames Test, Material Mediated Pyrogenicity)

The submission explicitly states, "Preclinical and clinical data were not required to demonstrate substantial equivalence. The design characteristics of the subject device are similar to the predicate. The design verification and validation test results demonstrated that the subject device is as safe and clinically effective as the predicate device." This confirms that the acceptance of this device was based purely on non-clinical, engineering, and laboratory performance testing, establishing equivalence to a previously cleared device.

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