(41 days)
The EOCD is intended as a pulse dose delivery device for medical-grade oxygen from portable high-pressure oxygen cylinders. Adult patients requiring supplemental oxygen and using ambulatory oxygen can use the EOCD to extend the use time of a fixed volume oxygen source. This device does not provide alarms and is not intended as life support.
The EOCD is a pulse dose delivery device for medical-grade oxygen from portable high-pressure oxygen cylinders. Adult patients requiring supplemental oxygen and using ambulatory oxygen can use the EOCD to extend the use time of a fixed volume oxygen source. The device does not provide alarms and is not intended as life support. The device includes a built in regulator, valve, control circuitry, and enclosure. The device will be designed to a standard compressed gas cylinder with a CGA 870 style yoke. The EOCD is a device that extends the "use time" from a supply of oxygen. As opposed to continuous delivery of oxygen, the EOCD delivers oxygen only when needed and provides a nominal oxygen conservation ratio of 4 to 1. The EOCD senses inspiration and opens a valve for a short duration of time. When the valve is open, oxygen flows to the patient. The duration the valve is opened is based on the flow setting. The patient can select the continuous mode of operation by manually selecting a continuous flow setting on the rotary switch. The EOCD provides three modes of operation: conserving (pulse) mode, continuous mode, and off mode.
The provided text does not describe any specific acceptance criteria or an associated study that proves the device (EOCD) meets those criteria. Instead, it states that "Performance, environmental, electrical, mechanical and electromagnetic compatibility testing was performed to prove the safety and effectiveness of the EOCD" but does not elaborate on the details, specific criteria, or results of these tests.
The document is a 510(k) premarket notification for a medical device (EOCD), where the manufacturer is seeking to demonstrate substantial equivalence to a predicate device. The core argument for substantial equivalence relies on the device having the "same operating principles and same technology" as the predicate, with the only noted difference being a conservation ratio (4:1 vs. 3:1 for the predicate) which the manufacturer claims has "no effect on safety or effectiveness."
Therefore, I cannot provide the requested information as it is not present in the given text.
Here's a breakdown of why each point cannot be answered:
- A table of acceptance criteria and the reported device performance: Not provided. The text only generally mentions "Performance... testing was performed."
- Sample size used for the test set and the data provenance: Not provided. No details about a specific test set are mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no described test set or ground truth established by experts for performance evaluation.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, no described test set.
- 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. The EOCD is a hardware device for oxygen delivery, not an AI-assisted diagnostic tool involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical oxygen delivery system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided. No specific ground truth for performance evaluation is mentioned.
- The sample size for the training set: Not applicable. The device is a physical product, not a machine learning algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable, as above.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).