(15 days)
The Arstasis®16 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 Arstasis 000 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 a medical device, the "Arstasisone Access System," and its submission for 510(k) clearance. However, the document primarily focuses on regulatory approval and substantial equivalence to a predicate device, rather than a clinical study designed to establish acceptance criteria for device performance in terms of metrics like sensitivity, specificity, or accuracy.
The information given relates to the safety and performance of the device, not an AI or algorithm's performance. Therefore, many of the requested points regarding AI device criteria, training sets, ground truth establishment, and expert involvement are not applicable to this document.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., success rate for hemostasis, access rate) with specific thresholds as would be found in a clinical trial report with defined endpoints. Instead, the "acceptance criteria" appear to be implicit in demonstrating substantial equivalence to an existing predicate device for safety and effectiveness.
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance (Summary) |
|---|---|
| Premarket Acceptance: Substantial Equivalence to Predicate Device (Arstasisone Access System K100615) regarding: | The cumulative data (including bench testing, animal studies, cadaver assessments, and clinical evaluations) demonstrates that the Arstasis 006 Access System is substantially equivalent to its predicate in providing access to the arterial lumen and facilitating introduction/placement of devices and achievement of hemostasis. |
| - Functionality | Bench testing performed (functionality, torque loading, flexibility, tensile strength of core wire assembly and sheath). Prior bench testing on predicate included deployment forces, flexibility, tensile, compression, and torque loading. |
| - Torque Loading | Covered by bench testing. |
| - Flexibility | Covered by bench testing. |
| - Tensile Strength | Covered by bench testing. |
| - Biocompatibility | Prior testing on predicate included biocompatibility testing pursuant to ISO-10993-1. |
| - Safety (short-term & long-term) | "The short term safety and clinical performance of the device were established." "The long term safety, as well as the ability to access and re-access, was retrospectively studied in a smaller cohort of patients." |
| - Clinical Performance (hemostasis, access) | "The cumulative data provided herein demonstrates that the Arstasis 006 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." |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "Multiple clinical evaluations" and a "smaller cohort of patients" for retrospective long-term safety studies. Specific numerical sample sizes for these clinical evaluations are not provided.
- Data Provenance: The document does not specify the country of origin.
- Retrospective/Prospective: "Multiple clinical evaluations were conducted" (implies prospective or mixed). "The long term safety, as well as the ability to access and re-access, was retrospectively studied in a smaller cohort of patients."
Given that this is a medical device (catheter introducer) and not an AI algorithm, the concept of a "test set" in the context of machine learning performance metrics is not directly applicable. The "test set" here refers to the patients involved in the clinical evaluations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. For a medical device like this, "ground truth" would typically refer to clinical outcomes (e.g., successful hemostasis, complication rates), which are observed directly or documented by clinicians, rather than established by expert consensus on interpretations of data.
4. Adjudication Method for the Test Set
This information is not provided. Clinical outcomes are generally observed and recorded, rather than adjudicated in the same way imaging interpretations might be.
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 document describes a physical medical device (catheter introducer), not an AI algorithm for interpretation or assistance. Therefore, an MRMC study related to AI performance is not relevant.
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 a software algorithm.
7. The Type of Ground Truth Used
Based on the nature of the device and the statements:
- Clinical Outcomes: The "ground truth" for the clinical evaluations would be actual patient outcomes, such as successful hemostasis, ability to access/re-access the vasculature, and safety events (complications). The short-term and long-term safety and clinical performance were established through these evaluations.
8. The Sample Size for the Training Set
Not Applicable. This document describes a physical medical device, not an AI algorithm that requires a training set. The "training" for such a device would involve bench testing, animal studies, and cadaver assessments to refine the device design.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As per point 8, there's no "training set" in the AI sense. However, the "ground truth" for the development of the device was established through:
- Bench Testing: Evaluation against engineering specifications and performance standards (e.g., torque, tensile strength).
- Animal Studies (non-GLP): Observation of device function and biological response in animal models.
- Cadaver Assessments: Evaluation of device performance in human cadavers.
These methods served to inform and refine the device design prior to human trials.
§ 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).