(288 days)
The Ventura anesthesia gas delivery machine is designed to deliver a combination of medical gases and volatile anesthetic agents to a breathing system.
The DRE Ventura anesthetic machine is a constant flow anesthesia gas delivery system intended for human use. The intended use for the Ventura anesthesia gas delivery machine is for the application of continuous flow anesthesia in a hospital. office based anesthesia settings, induction room or operating room. The units are intended to provide concentrations and flows of anesthesia gases and vapors into a patient breathing system. The anesthesia machine is designed for use by suitably qualified practitioners only. The basic device is commonly referred to as an anesthesia trolley. The Ventura is fitted with facilities to deliver 3 gases – oxygen, nitrous oxide or air. Up to 4 'E' size cylinders can be fitted along with pipeline supplies for all gases. It has a number of drawers for storage. In order to make the unit fully functional, the Ventura can be fitted with FDA cleared equipment, such as: Anesthetic agent vaporizer, specifically Selectatec compatible designs, Carbon dioxide absorber, Gas scavenging system, Ventilator of the complete standalone type. The Ventura has an anti-hypoxic device is built into the oxygen gas control system to enable a safe supply anesthetic gases under varying flow conditions.
The provided text describes a 510(k) summary for the DRE Ventura anesthetic machine, which is a traditional medical device, not an AI/ML-driven one. Therefore, the questions regarding acceptance criteria and studies that prove the device meets these criteria are framed in the context of substantial equivalence to a predicate device, rather than the performance metrics typically associated with AI/ML systems.
Here's an analysis based on the provided text, while acknowledging the limitations for AI-specific questions:
1. A table of acceptance criteria and the reported device performance
For a traditional medical device like the DRE Ventura, acceptance criteria are typically met by demonstrating substantial equivalence to a legally marketed predicate device and compliance with relevant performance standards. The document outlines a comparison to the predicate device (Penlon Prima K061102) across various features and ultimately states that the DRE Ventura met all requirements and standards.
| Acceptance Criteria Category | DRE Ventura Reported Performance |
|---|---|
| Indications for Use | Designed to deliver a combination of medical gases and volatile anesthetic agents to a breathing system. (Equivalent to predicate) |
| Environment of Use | Locations where an anesthesia delivery device may be required. (Equivalent to predicate) |
| Patient Population | Adult. Not indicated for pediatric populations. (Equivalent to predicate) |
| Design and Technology | Equivalent design and features; identical technology to the predicate. |
| Performance and Specifications | Equivalent specifications of performance as the predicate. |
| Compliance with Standards | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-13, ISO 7767, ASTM F1208-89, ISO 8835-2:2007, ASTM F1343-02, ISO 8835-3:2007, ISO 8835-4:2004, ASTM F1101-90, ISO 8835-5:2004, ISO 5356-1:2004, ASTM F1850-00(2005), ISO 21647:2004+Cor 1:2005. (Many equivalent to predicate) |
| Materials | Identical to the predicate. |
| Functional Attributes | Met all requirements. |
| Performance Tolerances | Met all requirements. |
| Environmental Conditions | Met all requirements. |
| Compatibility with Specified Devices | Met all requirements. |
| Gas Flow and Oxygen Measurement Accuracy | Met performance requirements in compliance with BS EN 60601-2-13:2006, ASTM F1850-00(2005), ISO 21647:2004+Cor 1:2005. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "bench tests" were performed. However, it does not specify any sample size for the test set (e.g., number of machines tested, number of measurement cycles). As this is a physical device rather than an AI/ML system, "data provenance" in the sense of patient data is not applicable. The testing would have been conducted on the device itself under controlled laboratory conditions, likely in the US (where DRE Medical, Inc. is based and seeking FDA clearance).
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)
This is not applicable to the DRE Ventura. The "ground truth" for a device like this is defined by engineering specifications and compliance with established performance standards (e.g., gas flow rates, oxygen concentration accuracy, alarm functionality). These are typically verified by engineers and technicians with expertise in medical device testing and relevant standards, not clinical "experts" establishing ground truth for diagnostic classifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to the DRE Ventura. Adjudication methods like 2+1 or 3+1 are used in studies where human readers independently interpret data, and discrepancies are resolved. For physical device performance testing, the results are typically quantitative measurements against predefined thresholds, not subjective interpretations requiring adjudication.
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 to the DRE Ventura as it is not an AI-assisted device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to the DRE Ventura as it is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the DRE Ventura is based on:
- Engineering Specifications: The device's design and manufacturing specifications.
- Performance Standards: Compliance with recognized national and international standards for anesthesia machines (e.g., ASTM, ISO, IEC). These standards define acceptable ranges for various parameters like gas flow, pressure, oxygen concentration, and safety features.
- Functional Verification: Testing that proves the device functions as intended (e.g., anti-hypoxic device activates at correct oxygen levels).
8. The sample size for the training set
This is not applicable as the DRE Ventura is a traditional medical device, not an AI/ML-driven device that undergoes a "training" phase with data.
9. How the ground truth for the training set was established
This is not applicable as the DRE Ventura is a traditional medical device and does not have a "training set" in the context of AI/ML. The "ground truth" (i.e., correct operating parameters and safety features) for such a device is established through engineering design, regulatory standards, and rigorous bench testing against those established criteria.
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).