(121 days)
The LexiPliant™ Dilator Sheath Set is intended for use in patients requiring the percutaneous dilatation of tissue to facilitate the removal of cardiac leads, indwelling catheters, and foreign objects.
The LexiPliant Dilator Sheath Set family consists of an inner and outer polymer sheath that may be used individually or as a set in a telescoping fashion. The inner sheath terminates with beveled tips. The outer sheath terminates with one beveled tip and one blunt tip. The sheaths are designed to dilate tissue while facilitating the removal of cardiac leads, indwelling catheters and foreign objects. The device is introduced at a cardiac pacemaker or defibrillator pocket's implantation site and then advanced over the lead or object that is to be extracted. The rotation and progression of the inner and outer sheaths causes dilation of the tissue binding the lead or object within the vasculature. Upon dilation of the surrounding tissue, the lead or object can be removed by traction.
The provided text is a 510(k) summary for the LexiPliant™ Dilator Sheath Set. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria in a clinical setting. Therefore, many of the requested sections about study design, sample sizes, expert involvement, and ground truth cannot be directly extracted from this document.
Here's an attempt to answer the questions based only on the provided text, with explicit notes about when information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" for the device's performance in a clinical context (e.g., success rate of lead removal). Instead, it lists various engineering and biological tests conducted to demonstrate substantial equivalence to a predicate device.
| Test Category | Test Name | Acceptance Criteria (Not explicitly stated as quantitative targets in the document) | Reported Device Performance (Implied to meet criteria for substantial equivalence) |
|---|---|---|---|
| Design Verification & Validation | Dimensional Verification | Assumed to meet design specifications, similar to predicate. | Subject device "met" requirements, similar to predicate. |
| Tensile | Assumed to meet strength requirements, similar to predicate. | Subject device "met" requirements, similar to predicate. | |
| Cantilever Bend | Assumed to meet flexibility/rigidity requirements, similar to predicate. | Subject device "met" requirements, similar to predicate. | |
| Dilatation | Assumed to achieve effective tissue dilation, similar to predicate. | Subject device "met" requirements, similar to predicate. | |
| Tip Compression | Assumed to withstand compression, similar to predicate. | Subject device "met" requirements, similar to predicate. | |
| Torque Tip | Assumed to provide adequate torque transmission, similar to predicate. | Subject device "met" requirements, similar to predicate. | |
| Sheath Cycle | Assumed to withstand repeated use/stress, similar to predicate. | Subject device "met" requirements, similar to predicate. | |
| Kink Fatigue | Assumed to resist kinking under stress, similar to predicate. | Subject device "met" requirements, similar to predicate. | |
| Radiopacity | Assumed to be visible under fluoroscopy, similar to predicate. | Subject device "met" requirements, similar to predicate. | |
| Sterilization | Product adoption equivalency per AAMI TIR:28-2009 | Assumed to achieve sterility equivalent to recognized standards. | Subject device "met" requirements, similar to predicate. |
| Biocompatibility | Physiochemical | Assumed to be chemically stable and non-toxic. | Subject device "met" requirements, similar to predicate. |
| Cytotoxicity | Assumed to be non-toxic to cells. | Subject device "met" requirements, similar to predicate. | |
| Sensitization | Assumed not to cause allergic reactions. | Subject device "met" requirements, similar to predicate. | |
| Irritation/Intracutaneous Reactivity | Assumed not to cause irritation. | Subject device "met" requirements, similar to predicate. | |
| Acute Systemic Toxicity | Assumed not to cause acute systemic toxic effects. | Subject device "met" requirements, similar to predicate. | |
| C3a and SC5b-9 Complement Activation | Assumed not to cause significant complement activation. | Subject device "met" requirements, similar to predicate. | |
| Indirect and direct Hemolysis | Assumed not to cause red blood cell lysis. | Subject device "met" requirements, similar to predicate. | |
| In Vivo Thromobogenicity-Dog Model | Assumed not to cause excessive clotting in vivo. | Subject device "met" requirements, similar to predicate. | |
| Material Mediated Pyrogenicity | Assumed not to cause fever. | Subject device "met" requirements, similar to predicate. | |
| Genotoxicity – Ames Test | Assumed not to cause genetic mutations. | Subject device "met" requirements, similar to predicate. |
Note: The document states "The results of design verification and validation testing demonstrate that the subject device is as safe and clinically effective as the predicate device" and that the testing results "demonstrated that the subject device is as safe and clinically effective as the predicate device." This implies that the device met the internal acceptance criteria for each test to achieve substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Preclinical and clinical data was not required to demonstrate substantial equivalence."
Therefore, there were no clinical test sets or data provenance as typically understood for a clinical study. The "test set" consists of the physical devices themselves and materials used in the listed engineering and biocompatibility tests. The specific sample sizes for each of these engineering and lab tests are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No experts were used to establish ground truth because there was no clinical study. The testing performed was largely engineering and lab-based, overseen by product developers and quality assurance personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication process as described.
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 device is a physical medical instrument (dilator sheath), not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. For the engineering and biocompatibility tests, the "ground truth" would be the established scientific and engineering principles, test standards (e.g., AAMI TIR:28-2009 for sterilization), and comparison to the predicate device's characteristics, as measured by laboratory equipment and procedures, rather than clinical ground truth from patient data.
8. The sample size for the training set
Not applicable. As there was no AI/algorithm, there was no training set.
9. How the ground truth for the training set was established
Not applicable. As there was no AI/algorithm, there was no training set or ground truth for it.
§ 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).