Search Results

The Inspired Technologies 350G Gas Conserver is intended as a delivery device for medial-grade oxygen from high-pressure oxygen cylinders. This is an ambulatory device, which allows patients to ambulate longer than they would with a continuous flow regulator on the same cylinder. The 350G Gas Conserver is intended to be used in the hospital, healthcare facilities, or home care environments.

The Inspired Technologies Model 350G Gas Conserver is designed to extend the use time of oxygen cylinders. It contains an integral pressure regulator with CGA 870 style yoke. The pressure regulator reduces the cylinder pressure to 19 - 25 psig. While the device is normally operated in the conserving mode, there is a continuous flow over-ride switch that allows 2 LPM of oxygen to bypass all valves for delivery to the patient. This continuous flow mode is typically used in the event of low or no battery power. In the conserving mode, the 350G Gas Conserver delivers oxygen to the patient by sensing inhalation via a pressure switch and opening one, two or both control valves for a specified period of time as determined by the microprocessor control algorithm. In the conserving mode, the device uses SmartDose™ technology to accomplish the oxygen savings. SmartDose™ senses the start of inhalation and releases a short "pulsed" dose at the very beginning of the inhalation cycle. The 350G Gas Conserver intended to be used by trained clinicians in the hospital, clinical or home care environments.

This document describes the Inspired Technologies Model 350G Gas Conserver, a device designed to extend the use time of oxygen cylinders via a "SmartDose™" technology.

This device is not an AI/ML device, and therefore the majority of the information requested (AI/ML specific questions) cannot be answered. However, I can still provide the available information regarding its testing and acceptance within the provided text.

Based on the provided text, here's what can be extracted and what cannot be answered:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document mentions "the following tests" were performed, but does not specify sample sizes for any of these tests.

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 information is not applicable as the device is a hardware medical device and the tests performed are primarily engineering and compliance tests, not diagnostic or interpretive tests requiring expert "ground truth" establishment in a clinical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the tests described are technical performance and compliance tests, not clinical evaluations requiring adjudication of subjective interpretations.

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 information is not applicable as the device is a hardware medical device, not an AI/ML diagnostic tool. There is no mention of an MRMC study or human reader assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable in the context of typical AI/ML standalone performance. The device does contain a "microprocessor control algorithm" for the conserving mode, which operates in a standalone manner to deliver oxygen. However, this is a deterministic control algorithm, not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable in the AI/ML sense. For the engineering tests, "ground truth" would be established by validated test equipment and calibration standards (e.g., pressure gauges for verifying pressure regulator, flow meters for dosing, timers for battery life), but these details are not provided.

8. The sample size for the training set

This information is not applicable. The device uses a deterministic control algorithm, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for an AI/ML algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document states that to demonstrate the safety and efficacy of the Model 350G Gas Conserver, "the following tests according to the following standards" were performed:

• Regulatory Compliance Standards:
  • FCC CFR 47 Parts 15B and 18
  • Industry Canada BS EN 55011:2007
  • IEC 60601-1
• Bench and Performance Testing:
  • Low battery voltage tests
  • Battery Life
  • Battery reverse polarity
  • Pressure regulator verification
  • Storage at high and low temperatures
  • Operation at high and low temperatures
  • Cleaning verification
  • IPX1 - Drip proof verification

The FDA's letter states that they have reviewed the premarket notification and "determined the device is substantially equivalent" to legally marketed predicate devices, implying that the submitted test results sufficiently demonstrate that the device meets safety and effectiveness requirements. The specific results of these tests (e.g., actual battery life in hours, exact pressure regulator output values, temperature ranges survived) are not detailed in this summary, but the completion of these tests according to the standards served as the proof of compliance.

Ask a specific question about this device