(89 days)
To be used in nitrous oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen gases with a maximum nitrous oxide concentration of 70%.
The Accutron Digital Ultra Analgesia Gas Machine precisely meters oxygen and nitrous oxide medical gases for conscious sedation of patients in dental offices and hospitals. With the device, the attending physician or dentist is able to set both the percentage of nitrous oxide and the total flow to a desired level of sedation and flow. The Digital Ultra Analgesia Gas Machine has been designed with built in safety features that prevent the level of oxygen gas from falling below 30% of total flow, mechanical features that prevent the mix-up of gases, and fail-safe features to prevent the flow of nitrous oxide in the absence of oxygen gas.
The provided text describes a 510(k) premarket notification for the Accutron Digital Ultra Analgesia Gas Machine. This type of submission is for medical devices, not for AI/ML-based diagnostic or prognostic algorithms. Therefore, much of the requested information regarding acceptance criteria, study details, expert involvement, and AI performance metrics is not applicable to this document.
The document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on safety and effectiveness, primarily through compliance with recognized voluntary standards and good manufacturing practices. It does not contain information about studies proving the device meets specific performance criteria in the way an AI algorithm would be evaluated.
Here's an attempt to answer the questions based only on the provided text, noting its limitations for AI-specific queries:
1-5, 7-9: Not Applicable (N/A) for this device and document type.
This submission is for a medical device (analgesia gas machine) that is not an AI/ML diagnostic or prognostic algorithm. Therefore, the concepts of acceptance criteria for AI performance, clinical study design for AI efficacy, expert ground truth adjudication for AI, MRMC studies, standalone algorithm performance, training set details, and ground truth establishment for AI are not applicable to this 510(k) submission.
The "acceptance criteria" for this device are implicitly tied to compliance with the listed voluntary standards and the demonstration of substantial equivalence to predicate devices in terms of safety and intended use. The "study" proving it meets these "criteria" is the documentation provided to the FDA demonstrating this compliance and equivalence, which is reviewed by the FDA.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is Not Applicable as the device is a physical gas machine, not an algorithm.
Summary of Device and Regulatory Submission:
The Accutron Digital Ultra Analgesia Gas Machine meters oxygen and nitrous oxide for conscious sedation. Key safety features include preventing oxygen from falling below 30% of total flow, mechanical prevention of gas mix-ups, and fail-safe features to stop nitrous oxide flow without oxygen.
The 510(k) submission (K052335) seeks to demonstrate substantial equivalence to predicate devices (K970163: Technical Medical Products Model 20 Alpha MX / Model 30 Ultra PC by Accutron Inc.; K945722: Matrx MDM, RA by Matrx Medical, Inc.). This equivalence is supported by adherence to various voluntary standards:
- EN 60601-1 / IEC 60601-1: "Medical Electrical Equipment - Part 1 : General Requirements for Safety"
- EN 60601-1-2 / IEC 60601-1-2: "Medical electrical equipment -- Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests"
- ISO 5356-1: "Anesthetic and respiratory equipment -- conical connectors"
- ASTM F1054-01: "Standard specification for conical fittings"
- CGA C-9:1988: "Standard color marking of compressed gas containers for medical use"
- CGA V-5:2000: "Diameter-Index Safety System (non-interchangeable low-pressure connections for medical gas applications)"
- ADA Recommendations: Designed to meet recommendations of the American Dental Association.
The "study" referenced in the prompt (though not a clinical study in the AI sense) is the comprehensive product design and risk management program, which aimed to eliminate or mitigate known health hazards, ensuring the device is "safe and effective when used as instructed by knowledgeable and trained personnel, and is substantially equivalent to the legally marketed predicate devices."
The FDA's review of the 510(k) documentation determined substantial equivalence, allowing the device to be marketed.
§ 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).