(202 days)
The Inner-Lock Locking Introducer Sheaths are used to facilitate placing a catheter through the skin into a graft. The Inner-Lock dilator is an accessory device, which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath.
The Rex Medical, Inner-Lock Locking Introducer Sheaths, 6F and 7F is a vascular access device consisting of a central lumen, an angled side arm extension and a hemostasis valve. The distal tip contains a retention mechanism that is operated via a control arm on the proximal hub. The device is used in exactly the same manner as the predicate device and other substantially equivalent 510(k) cleared devices.
The provided 510(k) summary for the "Inner-Lock Locking Introducer Sheaths" does not describe acceptance criteria, nor does it detail a study that proves the device meets specific acceptance criteria in the context of an AI/ML device.
This document describes a traditional medical device (vascular access introducer sheaths) and its substantial equivalence to a predicate device based on non-clinical performance and material testing. The concept of acceptance criteria and performance studies in the way you've outlined for AI/ML devices (e.g., sensitivity, specificity, F1-score, MRMC studies, ground truth establishment) is not applicable to this type of submission.
Therefore, I cannot fulfill your request with the provided input. However, I can explain why this information is missing and what kind of information is provided:
Why the requested information is absent:
- Device Type: The "Inner-Lock Locking Introducer Sheaths" is a physical medical device used for vascular access, not an AI/ML software device.
- Regulatory Pathway: This is a 510(k) submission, which relies on demonstrating "substantial equivalence" to a legally marketed predicate device. This typically involves comparing device specifications, materials, and non-clinical performance (physical testing) to ensure safety and effectiveness are comparable. It does not ordinarily involve clinical trials or performance metrics like those for AI/ML diagnostic tools.
- No Clinical Study: The document explicitly states: "Discussion of Clinical Tests Performed: 8. Not applicable, as there are no new indications for use which must be supported by clinical data." This confirms that no clinical study measuring patient outcomes or diagnostic performance was conducted or required for this submission.
What the document does discuss (related to performance assessment):
- Substantial Equivalence: The primary "proof" in this submission is the demonstration of substantial equivalence to predicate devices (K#954234, K#984260: PINNACLE™ R/O or RADIFOCUS® Introducer R/O device, Terumo Medical Corporation).
- Non-Clinical Tests:
- Comparative functional testing: Performed against the predicate device based on ISO 10555-1, ISO 11070, and FDA's Reviewer Guidance for Short-Term and Long-Term Intravascular Catheters.
- Material testing: Included ISO 10993 Biocompatibility Testing.
- Results: "Testing results revealed the subject device to be substantially equivalent to the predicate device."
In summary, for the provided input, the following information cannot be extracted because it is not relevant to this type of medical device and regulatory submission:
- Table of acceptance criteria and reported device performance: Not defined in this context.
- Sample size for test set and data provenance: No clinical test set.
- Number of experts used to establish ground truth: No ground truth establishment in this context.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance (algorithm only): Not applicable, as it's a physical device.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for 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).