(15 days)
The TightRail and TightRail Mini Rotating 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 and TightRail Mini Rotating Dilator Sheaths are mechanical, intra- operative devices. The devices consist of a proximal handle drive mechanism with a distal dilation catheter. The sheaths are packaged with an optional 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 The dilator sheath is advanced, withdrawn, and rotated about the lead, catheter or foreign object to be removed.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 nominal effective length of the TightRail Mini is 15.5 cm.
The provided text describes a 510(k) premarket notification for the TightRail and TightRail Mini Rotating Dilator Sheaths, focusing on establishing substantial equivalence to previously cleared predicate devices. The information provided does not align with the typical structure of reporting acceptance criteria and a study proving device performance in the context of AI/ML devices or diagnostic accuracy studies. This document pertains to a physical medical device and its mechanical/material performance, not an AI system.
However, interpreting the request in the context of physical medical device validation as presented, here's an attempt to extract relevant information, acknowledging the limitations for your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state acceptance criteria in a strict pass/fail quantifiable manner for each test. Instead, it lists types of tests conducted to ensure safety and effectiveness, and then broadly states that the device "met all specifications" and was "substantially equivalent." Therefore, the table below will generalize the 'acceptance criteria' based on the purpose of each test.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Mechanical/Physical Performance: | |
| Dimensional Verification (Initial & at 24 months) | Met all specifications |
| Tri Coil Tensile Test | Met all specifications |
| Tri Coil Torsional Test | Met all specifications |
| Axial Load Test | Met all specifications |
| Outer Sheath Axial Load Test (Initial & at 24 months) | Met all specifications |
| Rotation Mechanism Functionality (Simulated Use Testing, Initial & at 24 months) | Met all specifications |
| Material/Durability Performance: | |
| Radio-Detectability Test | Met all specifications |
| Corrosion Resistance Test | Met all specifications |
| Package Integrity (at 24 months) | Met all specifications |
| Simulated Distribution (Shipping and Environmental Conditioning) | Met all specifications |
| Sterilization: | |
| Product adoption equivalency per AAMI TIR:28-2009 | Met all specifications |
| Biocompatibility: | |
| Cytotoxicity | Met all specifications |
| Sensitization | Met all specifications |
| Intracutaneous Reactivity | Met all specifications |
| Acute Systemic Toxicity | Met all specifications |
| C3a Complement Activation | Met all specifications |
| SC5b-9 Complement Activation | Met all specifications |
| Direct Hemolysis | Met all specifications |
| Indirect Hemolysis | Met all specifications |
| In Vivo Thrombogenicity-Ovine Model | Met all specifications |
| Genotoxicity - Ames Test | Met all specifications |
| Material Mediated Pyrogenicity | Met all specifications |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for any of the individual tests. The document only lists the types of tests performed.
- Data Provenance: The document does not specify the country of origin for any test data. The tests are "Design Verification and Validation Testing" and "Biocompatibility" tests, which are typically conducted in a laboratory setting by the manufacturer or a contracted lab. It does not mention retrospective or prospective studies in the typical clinical trial sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable in the context of this device and testing. The tests described are primarily engineering, mechanical, and material science evaluations, along with biocompatibility assessments. They do not involve human interpretation of clinical data or images that would require expert consensus for "ground truth."
4. Adjudication method for the test set:
Not applicable. There's no indication of clinical data interpretation requiring adjudication. Performance is assessed against defined engineering and biological standards.
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:
Not applicable. This is a physical medical device (dilator sheath), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. (See point 5).
7. The type of ground truth used:
The "ground truth" for this type of device and its mechanical/biocompatibility testing would be established by:
- Engineering specifications and standards: For dimensional, tensile, torsional, axial, and durability tests.
- International standards (e.g., AAMI TIR:28-2009): For sterilization validation.
- ISO standards for biocompatibility: For cytotoxicity, sensitization, hemolysis, etc.
- Pre-defined pass/fail criteria: Based on the device's intended use and safety profile.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device, so there is no concept of a "training set" in the machine learning sense. The "training" for the device would be its manufacturing process.
9. How the ground truth for the training set was established:
Not applicable. (See point 8).
Summary of what's not in the document but relevant to your questions:
The provided document describes a traditional 510(k) for a physical medical device that facilitates percutaneous dilation. The validation focuses on engineering specifications, material compatibility, and sterilization efficacy to demonstrate substantial equivalence to predicate devices, especially after a change in the drive mechanism for rotation. It does not involve AI/ML technology, diagnostic image interpretation, or clinical efficacy studies that would require expert ground truth, MRMC studies, or training/test sets in the computational sense. The document explicitly states: "Preclinical and clinical data was not required to demonstrate substantial equivalence."
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).