(95 days)
The SecurAcath device is indicated for short or long term securement of percutaneous indwelling catheters for intravenous use to the access site by means of a subcutaneous anchor.
The SecurAcath device is a standalone subcutaneous anchoring securement system used to secure the catheter to the access site. The securement is achieved by means of a blunt nitinol anchor deployed into the subcutaneous space at the catheter access site, and the clamping of the catheter shaft between the Base Assembly and Cover of the device.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
The provided document is a 510(k) summary for the SecurAcath medical device, specifically for an update to include new sizes (10F and 12F) and updated product specification testing. It's important to note that this document does not describe a study involving an AI algorithm or human readers analyzing medical images. Instead, it details the performance testing for a physical medical device.
Therefore, many of the requested points related to AI/algorithm performance, such as MRMC studies, ground truth establishment for training sets, and expert qualifications for adjudication, are not applicable to this document.
Here's the information that can be extracted or deduced from the provided text, structured according to your request where applicable, with an explanation of why other points are not relevant:
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states that the device meets product specifications and functions as intended. Specific numerical acceptance criteria are not explicitly listed in this summary, nor are the precise quantitative results ("reported device performance"). The summary states "Test results demonstrate that the device functions as intended" and "In all instances, the subject device functioned as intended and demonstrated equivalent performance to the predicate device."
| Acceptance Criteria (General Description) | Reported Device Performance (Summary) |
|---|---|
| Meets product specifications | Functions as intended |
| Secures catheters to access sites | Able to secure catheters to access sites |
| Functions as intended | Functions as intended |
| Equivalent performance to predicate device | Demonstrated equivalent performance to predicate device |
| Risk analysis in accordance with ISO 14971:2012 | Completed and supported by modifications |
Specific tests performed to demonstrate meeting criteria:
- Dimensional verification
- Joint Tensile Strength
- Base & Cover Interaction
- Hinge performance
- Catheter Securement Performance
- Catheter Interaction
The document doesn't provide the numeric pass/fail criteria for these tests or the quantitative results obtained.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for performance testing (e.g., number of devices tested for dimensional verification, tensile strength, etc.).
The data provenance is from laboratory testing performed by the manufacturer, Interrad Medical Inc. It is not patient data (retrospective or prospective), and thus no country of origin for patient data is applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. The ground truth for a physical device's performance tests (e.g., tensile strength, dimensions) is established by engineering specifications and measurement standards, not by human expert interpretation of images or clinical outcomes.
4. Adjudication Method for the Test Set
This is not applicable. As the tests are for physical device performance against specifications, an adjudication method for conflicting expert opinions is not relevant. The tests likely yield objective measurements.
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
This is not applicable. This document describes performance testing for a physical medical device (catheter securement system), not an AI algorithm. Therefore, no MRMC study, human readers, or AI assistance is involved.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document describes performance testing for a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for these performance tests are the engineering specifications and design requirements for the device. For example, a "Joint Tensile Strength" test would have an engineering specification for the minimum required tensile strength, which serves as the ground truth for that particular test. "Dimensional" tests would compare measured dimensions to specified tolerances.
8. The Sample Size for the Training Set
This is not applicable. There is no AI algorithm being trained, so no training set is relevant.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. As there is no training set, there is no ground truth for it to be established.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”