(336 days)
MADM™ is intended to deliver volatile anesthetic to a patient when placed in either circle or open anesthetic circuits. It vaporizes Isoflurane and Sevoflurane and delivers the vaporized anesthetic agent into the inspiratory limb of the breathing circuit.
MADM™ is also intended to monitor respiratory rate, CO2, and the anesthetic gases Isoflurane and Sevoflurane. It is intended to be connected to a patient breathing circuit for monitoring of patients to whom it is delivering volatile anesthetic gases.
The MADM™ system is a portable vaporizer capable of delivering anesthetic to the inspiratory limb of a breathing circuit. Unlike other in-line vaporizers, MADMTM can be inserted into a circle system where some exhaled anesthetic is rebreathed. The MADM™ system measures the anesthetic concentration of incoming gas and reduces the anesthetic output to ensure the anesthetic concentration of gas delivered to the patient is as set on the dial.
MADM™ includes an internal battery backup capable of powering the device for 20 minutes, and an optional external battery base with hot swappable batteries capable of powering the system for over two hours. Anesthetic is stored in custom single agent anesthetic canisters.
This document is a 510(k) premarket notification summary for the Thornhill Research Inc. MADM™ device. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving acceptance criteria for its performance metrics.
However, based on the provided text, we can extract the following information regarding performance testing and acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the device meets the acceptance criteria of international standards for anesthetic delivery accuracy and gas sensing accuracy. However, specific numerical acceptance criteria (e.g., ±X% accuracy) and the reported performance values are not explicitly provided in this summary. The summary states:
| Performance Metric | Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|---|
| Anesthetic Delivery Accuracy | Meets acceptance criteria of international standards | Demonstrates characteristics substantially equivalent to identified predicates |
| Gas Sensing Accuracy (CO2, Isoflurane, Sevoflurane) | Meets acceptance criteria of international standards | Demonstrates characteristics substantially equivalent to identified predicates |
| Functionality across environmental range | Meets system requirements | Performance testing conducted and results demonstrate meeting system requirements |
| Battery Longevity | Meets system requirements | Testing conducted and results demonstrate meeting system requirements |
| Anesthetic Compatibility | Non-reactivity of components in contact with anesthetic gas | Evaluation demonstrating components were non-reactive to Isoflurane and Sevoflurane |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Performance testing" and "Safety and Performance Testing" but does not specify the sample size for any test sets used. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective nature of the data). This level of detail is typically found in the full test reports, which are not included in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The summary does not mention the use of experts to establish ground truth for a test set. The performance testing described appears to be engineering and laboratory-based testing against established standards and internal system requirements, rather than clinical studies requiring expert consensus on subjective outcomes.
4. Adjudication Method for the Test Set:
Since there is no mention of experts or a "test set" in the context of expert review, no adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as this device is an anesthesia gas machine and monitor, not an interpretive diagnostic imaging or AI-driven system that would typically involve human readers. The document focuses on the device's standalone performance compared to standards and predicates.
6. Standalone Performance:
Yes, a standalone performance evaluation was done. The "Summary of Performance Testing" section details various tests conducted on the MADM™ device by itself to validate its system requirements and compliance with standards. This includes:
- Performance testing across the intended environmental operating range.
- Battery Longevity testing.
- Anesthetic delivery accuracy.
- Disturbance analysis.
- Anesthetic compatibility evaluation.
- Biocompatibility Evaluation.
The conclusion states that the performance characteristics demonstrate substantial equivalence and meet acceptance criteria of international standards.
7. Type of Ground Truth Used:
The ground truth used for the performance testing appears to be based on:
- International standards and regulations: Compliance to AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-13, ISO 80601-2-55.
- System requirements: The device's internal design specifications and functional requirements.
- Physical measurements/instrumentation: For accuracy (anesthetic delivery, gas sensing) and longevity (battery).
- Chemical/material compatibility testing: For anesthetic compatibility.
8. Sample Size for the Training Set:
The concept of a "training set" is typically applicable to machine learning or AI models that learn from data. The MADM™ device, as described, is a physical medical device (vaporizer, monitor) with embedded controls, not an AI system. Therefore, the notion of a "training set" is not relevant in this context, and no information about one is provided.
9. How the Ground Truth for the Training Set Was Established:
As there is no "training set" in the context of this device, this question is not applicable. The device's design and operation are based on engineering principles and validated through testing against established physical and safety standards.
§ 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).