(304 days)
The DuraSheath Introducer Sheath System is indicated to be used for introduction of interventional and diagnostic devices into the human vasculature, including but not limited to femoral access via a contralateral approach to access the popliteal and infrapopliteal arteries.
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 distal end of the sheath contains a radiopaque marker. Lubricous coating is applied to the distal end of the sheath. The system is packaged inside a sealed Tyvek pouch.
The DuraSheath Introducer Sheath System is a prescription medical device that is used only in healthcare facilities or hospitals. The device is placed in patients for up to 24 hours.
This document is a 510(k) Premarket Notification from the FDA regarding the DuraSheath Introducer Sheath System. It details the device's indications for use, comparison to predicate devices, and performance data provided for substantial equivalence, but it does not contain the acceptance criteria or a study proving the device meets specific acceptance criteria in the manner you've requested for AI/diagnostic devices.
Instead, this document focuses on demonstrating that the DuraSheath Introducer Sheath System is "substantially equivalent" to legally marketed predicate devices, meaning it performs similarly and raises no new questions of safety or effectiveness. The performance data provided is primarily non-clinical and related to the physical and material properties of the device, rather than diagnostic accuracy or clinical outcomes as would be seen in studies for AI-powered diagnostic tools.
Therefore, many of your requested points cannot be answered based on the provided text.
Here's how the available information relates to your request:
1. Table of acceptance criteria and the reported device performance
N/A. The document does not provide a table of explicit acceptance criteria with numerical targets for clinical performance (e.g., sensitivity, specificity, AUC) or the device's measured performance against those criteria. Instead, it refers to "non-clinical tests" and "performance data" to demonstrate substantial equivalence to predicate devices in terms of safety and effectiveness, rather than meeting specific quantifiable performance benchmarks.
The "performance data" mentioned falls into these categories:
- Mechanical testing: Including tests required under relevant international standards, coating adhesion, particulate testing, and transportation integrity testing. Reported Performance: Performed to verify and validate the design and to demonstrate process capability, with results demonstrating comparable performance to predicates.
- Biocompatibility testing: Full range of tests. Reported Performance: Demonstrated biocompatibility.
- Sterilization Validation Adoption: To confirm sterility of the device upon exposure to the selected sterilization cycle. Reported Performance: Confirmed sterility.
- Accelerated age testing: To confirm product performance and end of shelf life. Reported Performance: Confirmed product performance and end of shelf life.
2. Sample size used for the test set and the data provenance
N/A. The document describes non-clinical engineering and material tests, not tests on patient data sets. Therefore, there is no "test set" in the context of clinical data, sample size, or data provenance (country of origin, retrospective/prospective). These tests are typically conducted in a laboratory setting on manufactured device samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. Since this isn't a diagnostic device and there's no clinical "test set" involving patient data, there's no ground truth established by medical experts in the way that would apply to, for example, an AI image analysis tool.
4. Adjudication method for the test set
N/A. As there is no clinical test set requiring expert adjudication, this is 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
N/A. This device (an introducer sheath system) is a physical medical instrument, not an AI-powered diagnostic tool. Therefore, MRMC studies, human reader improvement with AI, or effect sizes are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This device does not involve an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's evaluation is based on engineering standards, material science, and manufacturing quality control. For example, the ground truth for mechanical testing would be the specified strength or flexibility required by relevant standards, and for biocompatibility, it would be the absence of adverse biological reactions. It's not a clinical "ground truth" derived from patient diagnosis.
8. The sample size for the training set
N/A. The concept of a "training set" applies to machine learning models. This device does not involve AI or machine learning.
9. How the ground truth for the training set was established
N/A. As there is no training set, this is not applicable.
In summary: The provided document is an FDA 510(k) clearance letter and summary for a medical device (an introducer sheath). The evaluation framework for such a device focuses on "substantial equivalence" to existing predicate devices, primarily through non-clinical performance data (mechanical, biocompatibility, sterilization, aging). This is fundamentally different from the evaluation criteria and study types used for AI-powered diagnostic tools, which would involve clinical data, ground truth establishment by experts, and statistical performance metrics.
§ 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).