(26 days)
The Arstasis 000 Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. The Arstasis006 Access System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
Arstasisone is a device that is comprised of a sheath, anchor mechanism, shaft and handle with control features.
The provided text describes the Arstasisone Access System, a catheter introducer. The information focuses on its regulatory submission for substantial equivalence to a predicate device. There is no information in the provided text about acceptance criteria or a study proving the device meets specific performance criteria in the format requested.
Here's a breakdown of what can be extracted based on your request, and what cannot:
Missing Information:
The provided text does not contain any information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set, data provenance, ground truth experts, or adjudication methods for any study.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human readers with/without AI assistance.
- Standalone algorithm performance.
- Types of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for training sets.
- How ground truth for training sets was established.
Information that can be inferred/extracted about the study (though not presented as a direct acceptance criteria study):
The submission mentions various types of testing and studies conducted to establish substantial equivalence, rather than to specifically meet predefined acceptance criteria in the typical sense of a performance study for a diagnostic AI device.
1. Table of acceptance criteria and the reported device performance:
- Not provided. There is no explicit table of acceptance criteria or quantitative performance metrics within the document.
2. Sample sized used for the test set and the data provenance:
- Test Set Sample Size: "Multiple clinical evaluations were conducted" and "retrospectively studied in a smaller cohort of patients." No specific numbers are given.
- Data Provenance: Not specified (e.g., country of origin). "Clinical investigations" and "animal studies (non GLP) and cadaver assessments" are mentioned.
- Retrospective/Prospective: Clinical investigations are generally prospective, but the long-term safety study was "retrospectively studied."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. The text does not detail how ground truth was established for the clinical evaluations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided.
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:
- No. This device is a physical medical device (catheter introducer), not an AI/diagnostic software. Therefore, an MRMC study or AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated for clinical evaluations. The studies aimed to establish "short term safety and clinical performance" and "long term safety, as well as the ability to access and reaccess." This implies clinical outcomes and observations rather than a singular "ground truth" for a diagnostic task.
8. The sample size for the training set:
- Not applicable/Not provided. This is a physical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. This is a physical device, not an AI algorithm.
Summary of available information related to performance/testing:
The Arstasisone Access System's substantial equivalence was established through a combination of:
- Bench testing: Functionality, deployment and release forces, flexibility, torque loading, tensile, compressive, and torque strengths. (No specific acceptance criteria or results are detailed).
- Biocompatibility testing: Conducted pursuant to ISO-10993-1. (Results reported as "successfully conducted").
- Preliminary animal studies (non GLP) and cadaver assessments: Conducted using prototypes of a similar design.
- Multiple clinical evaluations: Conducted on an earlier device version of similar design. These established short-term safety and performance.
- Retrospective study: On a smaller cohort for long-term safety and reaccess ability.
The overall conclusion is that the "cumulative data provided herein demonstrate that the Arstasis Access System is substantially equivalent to its predicate in providing access to the arterial lumen and facilitating the introduction and placement of devices into the peripheral vasculature and achievement of hemostasis."
§ 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).