(315 days)
Impact Universal Single-Limb Ventilator Circuit is intended for use in conjunction with ventilators having a single-limb circuit interface. The ventilator circuits are used as a means by which to transfer breathing gases from a ventilator to a patient (inhalation) and from a patient to atmosphere (exhalation). The device is intended for use with adults and medium to large pediatric patients.
The Impact, Universal Single-Limb, Portable Ventilator Circuit is comprised of disposable connectors, tubing and exhalation valve.
The provided text describes the Impact, Universal Single-Limb, Portable Ventilator Circuit and its substantial equivalence to a predicate device. However, it does not contain information about "acceptance criteria" and "device performance" in the format of a table with numerical values, nor does it detail a study that explicitly demonstrates the device meets specific acceptance criteria in the way typically found for AI/ML-based medical devices.
The document focuses on demonstrating substantial equivalence for a physical medical device (a ventilator circuit). This involves showing that the new device has the same intended use and performance attributes as a legally marketed predicate device. The performance attributes are evaluated through biological qualification safety tests and industry-recognized test methods.
Therefore, many of the requested elements for an AI/ML device study are not applicable or not present in this document. I will extract the information that is available and indicate where the requested information is not provided.
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with numerical performance metrics for the device. Instead, it refers to general compliance with safety and performance standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Safety | Evaluated through biological qualification safety tests as outlined in: ISO 10993 Part 1 "Biological Evaluation of Medical Devices"ISO 10993 Part 5 "Tests for in vitro cytotoxicity"ISO 10993 Part 12 "Sample Preparation and Reference Materials"USP 25 "Biological Reactivity Tests, in vivo -Classification of Plastics"21 CFR 177.1350 "Ethylene-Vinyl Acetate Copolymers" |
| Functional Performance | Tested in accordance with industry recognized test methods contained in ASTM F-1100, Table 2, and found to be acceptable for its intended use. Performance attributes are stated to be the same as the predicate device (Allegiance Healthcare Corporation, Catalog Number 1755, Airlife™ Universal Portable Volume Ventilator Circuit). |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data for an AI/ML device. The testing described involves material and functional performance of the device itself, not a dataset for an algorithm. Therefore, information on sample size for a test set, country of origin, or retrospective/prospective nature is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" for a physical device's performance is typically established through adherence to engineering specifications and performance standards, not expert consensus on data.
4. Adjudication method for the test set
Not applicable. There is no "test set" or adjudication process described as would be relevant for an AI/ML device's output.
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 device is a physical ventilator circuit, not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies and human reader improvement with AI are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used
The "ground truth" equivalent for this device is based on compliance with established international and national standards for medical device materials and functional performance. This includes:
- Biological qualification safety tests (ISO 10993, USP 25, 21 CFR 177.1350)
- Industry-recognized test methods (ASTM F-1100, Table 2)
- Demonstration of performance attributes being the same as the predicate device.
8. The sample size for the training set
Not applicable. This device does not have a "training set" as it is not an AI/ML model.
9. How the ground truth for the training set was established
Not applicable.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).