(192 days)
The DuraSheath Introducer Sheath System is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature. The device is also intended to be used within a pediatric population.
The DuraSheath Introducer Sheath System is a sterile, disposable device consisting of (a) a coil reinforced shaft with an atraumatic tip at the distal end; (b) a hemostasis valve with a side port and color coded 3-way stopcock; and (c) a tapered tip dilator with snap-fit hub at the proximal end.
The provided text describes a 510(k) premarket notification for a medical device called the DuraSheath Introducer Sheath System. It details the device's design, materials, indications for use, and a comparison to predicate devices, along with non-clinical performance data.
However, the document does not contain acceptance criteria or study details in the format requested, which typically relates to performance metrics for AI/ML devices or clinical endpoints for studies proving substantial equivalence. Instead, it lists various engineering and biological tests conducted to demonstrate the safety and effectiveness of the device as a whole, rather than specific performance metrics against pre-defined acceptance thresholds for an AI algorithm.
The document mainly focuses on proving the new device is substantially equivalent to existing, legally marketed devices. It details a comprehensive set of non-clinical tests (mechanical, biocompatibility, sterilization, accelerated aging, packaging integrity, simulated use, and usability) to demonstrate this equivalence and the device's safety and effectiveness.
Given the nature of the device (an introducer sheath system, which is a physical medical device, not an AI/ML algorithm or a diagnostic tool with specific performance metrics like sensitivity/specificity), the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI performance, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance is not applicable.
Therefore, I cannot populate the table and answer the specific questions (2-9) about acceptance criteria, test set sample size, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, and training set details because this information is not present in the provided FDA document, as it pertains to a mechanical medical device, not an AI/ML diagnostic or therapeutic device.
The closest information to "acceptance criteria" is the list of standards the device testing conformed to, indicating that meeting these standards served as the "acceptance criteria" for demonstrating safety and effectiveness of a physical medical device. The "study that proves the device meets the acceptance criteria" is the collection of all the non-clinical tests listed in the "PERFORMANCE DATA" section.
Here's what can be extracted from the provided text, recognizing the constraints:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied by Standards/Tests) | Reported Device Performance (Summary from text) |
|---|---|
| Mechanical Integrity & Functionality: | |
| - Sheath/dilator fit | Verified (Internal requirement met) |
| - Sheath pull out strength | Verified (ASTM F2394, ASTM 1929-15, EN 868-5, ISO 11737-2, Internal requirement met) |
| - Sheath kink resistance | Verified (EN 13868:2002 met) |
| - Sheath force at break | Verified (ISO 11070:2014, ISO 10555-1:2013 met) |
| - Sheath creep to break | Verified (ISO 11070:2014, ISO 10555-1:2013 met) |
| - Sheath system insertion force | Verified (Internal requirement met) |
| - Coating integrity (adhesion) | Verified (Internal requirement met) |
| - Coating integrity (particle evaluation) | Verified (AAMI TIR42:2010, ASTM F2394, ISO 8536-4:2010, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, USP 788 met) |
| - Sheath Liquid Leakage | Verified (ISO 11070:2014, ISO 10555-1:2013 met) |
| - Valve Leak Test | Verified (ISO 11070:2014 met) |
| - Dilator hub bond strength | Verified (ISO 11070:2014, ISO 10555-1:2013 met) |
| - Sheath stiffness | Verified (Internal requirement based on ISO 178:2010 met) |
| - Simulated use performance | Verified (Internal requirement met) |
| Biocompatibility: | |
| - Cytotoxicity | Verified (ISO 10993-1, -4, -5, -10, -11, -12 met with BRA) |
| - Thromboresistance | Verified (ISO 10993-1, -4, -5, -10, -11, -12 met with BRA) |
| - Complement activation | Verified (ISO 10993-1, -4, -5, -10, -11, -12 met with BRA) |
| - Hemolysis | Verified (ISO 10993-1, -4, -5, -10, -11, -12 met with BRA) |
| - Pyrogenicity | Verified (ISO 10993-1, -4, -5, -10, -11, -12 met with BRA) |
| - Acute Systemic Toxicity | Verified (ISO 10993-1, -4, -5, -10, -11, -12 met with BRA) |
| - Irritation | Verified (ISO 10993-1, -4, -5, -10, -11, -12 met with BRA) |
| - Sensitization | Verified (ISO 10993-1, -4, -5, -10, -11, -12 met with BRA) |
| Sterility & Shelf-life: | |
| - EO Sterilization Validation | Verified (ISO 11135-1:2007, ISO 10993-7:2008, ISO 11737-1:2006, AAMI TIR28:2009, ANSI/AAMI ST72:2011 met; SAL 10^-6^) |
| - Accelerated aging (3 years shelf life) | Verified (ASTM F1980-16 met, consistent with various performance tests) |
| - Package integrity | Verified (ISO 11607-1:2006, ISTA 2A:2011, ASTM F 1929-12, ASTM F1886:1998, EN 556-1, EN 13868:2002, EN 868-5 Annex D, ISO 11070:1998 met) |
| Usability: | |
| - Usability evaluation | Verified (IEC 62366-1 met) |
| Clinical Performance (European feedback): | |
| - Real-world performance (limited) | Performed comparably with the secondary predicate and other legally marked devices and is safe and effective, with identical performance to the primary predicate. (Feedback from 16 clinical cases in 7 centers in Germany in April and May 2014) |
2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML device. For the mechanical device, the number of units tested for each specific non-clinical test (e.g., how many sheaths were subjected to pull-out testing) is not explicitly stated, although it is implied that sufficient units were tested to meet the requirements of the listed standards. There was feedback from 16 clinical cases in Germany, but this was for European CE certification and not a formal clinical trial for this 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the AI/ML context, does not apply to this mechanical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this physical device is successful performance according to engineering and biocompatibility standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).