(208 days)
The Applied Medical Expandable Vascular Sheath is indicated for percutaneous access to the peripheral vascular system and is designed to assist in the placement and removal of catheters.
The Expandable Vascular Sheath is a sterile single use sheath intended to facilitate the placement and removal of vascular catheters. It is manufactured from polyester filled with Titanium Oxide and Barium. Its shape provides an optimum means of facilitating and removing catheters. The device is supplied sterile and is packaged individually in a trav sealed with a Tyvek® lid.
The provided text describes a 510(k) premarket notification for a medical device called the "Applied Medical Expandable Vascular Sheath." It is a traditional medical device, not an AI/ML-driven diagnostic tool. Therefore, much of the requested information (such as acceptance criteria tables, sample sizes for test sets, expert-established ground truth, MRMC studies, standalone algorithm performance, training set details, etc.) is not applicable to this type of submission.
Here's a breakdown of why and what information can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance:
This information is typically found in detailed design verification and validation documents for traditional medical devices. The 510(k) summary only states that "validation and verification activities were formally controlled and addressed by Applied Medical. The activities included the methods, tests used, and acceptance criteria applied." It does not provide the specific numerical acceptance criteria or performance metrics, as this level of detail is usually reserved for internal company documentation rather than the public 510(k) summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This device is not an AI/ML diagnostic tool that processes data in the way implied by this question. The testing conducted was "bench top testing" comparing it to a predicate device, and "biocompatibility according to ISO 10993-1 requirements." These tests do not involve "data provenance" or "test sets" in the context of data analysis.
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. There is no mention of "experts" establishing a "ground truth" for a "test set" as would be relevant for an AI/ML diagnostic device. The evaluation of this device would involve engineering and materials science experts for bench testing, and potentially medical professionals for clinical evaluations if they were conducted (but are not detailed in this summary for the 510(k) submission).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically used in clinical trials or for establishing ground truth in AI/ML studies where there's potential for disagreement among human readers. This concept does not apply to the bench testing described for this device.
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 not an AI-assisted device, so an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the context of AI/ML. For this device, the "ground truth" would be established by validated test methods (e.g., measuring forces, dimensions, material properties against design specifications, and confirming biocompatibility standards).
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, no training set for this type of device.
Summary of Relevant Information from the Provided Text:
- Acceptance Criteria & Performance: The document states that "validation and verification activities were formally controlled and addressed by Applied Medical. The activities included the methods, tests used, and acceptance criteria applied," and that "bench top testing was conducted and comparisons were made to the predicated device." It also mentions that "The materials used in the device are shown to be biocompatible according to ISO 10993-1 requirements." However, specific quantitative acceptance criteria or detailed performance results are not provided in this 510(k) summary. The primary "performance" reported is its substantial equivalence to the predicate device, implying it meets similar performance characteristics.
- Study That Proves the Device Meets Acceptance Criteria: The study mentioned is "Bench top testing" comparing the device to its predicate (Applied Medical's Expandable Vascular Sheath approved under 510(k) K963886). Additionally, biocompatibility testing was conducted according to ISO 10993-1 requirements. The design control process, risk analysis, and design verification activities were conducted in accordance with internal Applied Medical procedures, 21 CFR § 820.30, EN 1441 standards, ISO 13485, and AAMI/ISO TIR 14971.
In essence, the document confirms that testing was done to ensure the device performs as intended and is safe, but it does not provide the detailed output of those tests or explicit acceptance criteria values, which are typically proprietary and part of a more extensive submission package to the FDA, not the public summary.
§ 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).