(110 days)
The Nitronox® Scavenger Plus is intended to control the vacuum flowrate for scavenging of waste analgesic gas.
The Nitronox® Scavenger Plus (Scavenger Plus) is used within a nitrous oxide/oxygen conscious sedation system to allow removal of waste analgesic gases through a connected vacuum source. The device is used during a dental or medical procedure in a healthcare facility environment. The device is not intended to be used for general anesthesia. The Scavenger Plus is operated by a licensed healthcare professional during conscious sedation of a patient.
The Scavenger Plus connects the exhalation line of the patient's breathing circuit to vacuum tubing from the vacuum source and controls the vacuum flowrate (i.e., scavenging flowrate). The rate at which the gas is removed (i.e., scavenged) is specified by the Scavenger Plus, which uses a control knob and reservoir bag to limit the amount of vacuum applied to the exhalation line of the breathing circuit.
The document provided is a 510(k) Premarket Notification from the FDA for a medical device called the "Nitronox® Scavenger Plus." This type of submission aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device, rather than proving its absolute safety and efficacy through extensive clinical trials.
The document discusses non-clinical performance data and states that clinical investigation was not required because safety and efficacy were supported by non-clinical testing. Therefore, the information typically associated with a study proving a device meets acceptance criteria for an AI/ML medical device (such as those involving test sets, training sets, expert adjudication, MRMC studies, and detailed ground truth establishment) is not present in this document.
The acceptance criteria described in the document relate to engineering and operational performance of a physical gas-scavenging apparatus, not an AI/ML algorithm.
Here's a breakdown of the relevant information provided, adapted to the questions where possible, and noting where information is absent due to the nature of the device and submission:
Acceptance Criteria and Reported Device Performance
The document describes performance criteria primarily related to pressure limits for gas scavenging.
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Under normal operating conditions (75 L/min flow through the inlet), the pressure shall not exceed 3.0 cm H2O. (This is a standard from ISO 80601-2-13, Section 201.103.1.1.1) | Under normal operating conditions (75 L/min flow through the inlet), the pressure did not exceed 3.0 cm H2O. | The device met this ISO standard. |
| Functional, operational, and performance characteristics (general) | The Scavenger Plus met all of the acceptance criteria for functional, operational, and performance characteristics. | Demonstrated through performance bench testing. |
Study Details (as inferable from the document, with many points being N/A for this type of device/submission)
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Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This device is a physical gas scavenging apparatus, not an AI/ML algorithm that processes data. Testing was likely done on physical units of the device under controlled conditions. The number of samples/units tested is not specified but would be part of standard engineering verification.
- Data Provenance: Not applicable in the context of "data" for an AI model. This refers to bench testing performed on the physical device. The location of testing is not specified, but it would be part of the manufacturer's quality system. The testing would be "prospective" in the sense that it was conducted specifically for this submission.
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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 usually relates to engineering specifications and physical measurements, rather than expert interpretation of complex data (like medical images). Compliance with standards like ISO 80601-2-13 is verified directly through measurement.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is relevant for studies involving human interpretation or subjective assessments. Performance testing for this device is based on objective measurements against engineering specifications.
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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 is not an AI-assisted device. MRMC studies are used to evaluate diagnostic imaging devices or AI algorithms that assist human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-only device. It's a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering specifications and objective physical measurements: The "ground truth" for this device's performance is whether its physical output (e.g., pressure) meets predefined engineering and regulatory standards (e.g., ISO 80601-2-13).
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. No training set for an AI/ML model.
In summary, the provided document details a 510(k) submission for a physical medical device. The "acceptance criteria" and "proof" primarily revolve around bench testing demonstrating compliance with established engineering standards and functional specifications, rather than complex data-driven analyses characteristic of AI/ML device evaluations. The FDA determined that the non-clinical testing was sufficient to establish substantial equivalence to a predicate device, thus no clinical trials were deemed necessary.
§ 868.5430 Gas-scavenging apparatus.
(a)
Identification. A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system.(b)
Classification. Class II (performance standards).