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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.

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The Clinical Oxygen Dose Recorder (CODR) Model 300-CR records heart rate and oxygen saturation data provided by a Pulse oximeter; flow and pressure data from the oxygen delivery system; and measures breath rate and inhale/exhale ratio (1:E ratio) by monitoring the flow in the oxygen delivery tubing. Data is presented to enable the clinician to view the effects of the oxygen device's delivery performance on a patient in different ambulatory settings, i.e., rest and exercise. It is not to be used as a diagnostic tool.

The CODR is intended to be used by trained clinicians in the hospital, clinical or home care environments.

For the patient population the CODR will have the same indications for use as the oxygen source to which it is attached.

The Inspired Technologies Clinical Oxygen Dose Recorder (CODR) Model 300 CR is a portable data gathering and information display system which is intended to be used as an adjunct to commercially available pulse oximetry and oxygen delivery systems to enable the clinician to record and view the gathered data together.

The CODR records heart rate and oxygen saturation data provided by a cleared Pulse Oximetry system, flow and pressure data from the oxygen delivery system, and tracks breath rate and inhale/exhale ratio (I:E ratio) by monitoring the flow in the oxygen delivery tubing. The CODR displays this data in real time to enable the clinician to view the effects of the oxygen device's delivery performance on a patient as they rest and exercise. It is not to be used as a diagnostic tool. The CODR is intended to be used by trained clinicians in the hospital, clinical or home care environments.

The CODR consists of two components; (1) an interface module and (2) PC based data display software.

1. The interface module is a portable, battery powered module which is in line with Oxygen Source and is used to connect various oxygen sources, including LOX portables, standard oxygen cylinders, and oxygen concentrators. Standard, commercially available, single or dual lumen nasal cannula can be used with the interface module. The CODR interface module also has capability of connecting a Pulse Oximeter. The interface module is designed to be worn by the patient during evaluation of the system. It is approximately 6" X 4" X 2" deep and contains the pressure and flow sensors, a connector for the pulse oximeter, and a Secure Digital (SD) card slot for use in data recording. The interface module is powered by four AA batteries. Either alkaline or rechargeable batteries can be used.
2. The PC based data display software

Here's a breakdown of the acceptance criteria and the study information derived from the provided text for the CODR Model 300-CR:

Acceptance Criteria and Reported Device Performance

The provided document describes the device's performance testing generally, focusing on meeting "specified performance criteria" rather than presenting a detailed table of specific quantitative acceptance criteria and their corresponding results. The "specified performance criteria" are not explicitly defined with numerical targets in this summary.

Note: The document only states that the device "meet the specified performance criteria" but does not detail what those specific criteria were (e.g., "±X% accuracy for heart rate").

Study Information

1. Sample size used for the test set and the data provenance:

   • The document does not specify the sample size (number of patients or data points) used for the performance tests.
   • The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned. The testing is described as "Performance and verification / validation testing," implying prospective testing conducted specifically for regulatory submission, but no details are given.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided. The study appears to be a technical performance evaluation of the device's measurement capabilities against an assumed reference, rather than a clinical study requiring expert ground truth for interpretation of patient data.

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

   • This information is not provided. Given the nature of the device (a data recorder), the primary "ground truth" would likely be from calibrated measurement instruments, not human adjudication of subjective findings.

4. 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. A MRMC comparative effectiveness study was not done. This device is a data recording and display system, not an AI-powered diagnostic or assistive tool. It's intended to present data to clinicians, not to interpret or assist in interpretation in an "AI vs. human" context.

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

   • Yes, implicitly. The "Accuracy of data measured" and "Data transmission / collection accuracy" tests would constitute standalone performance evaluations, as they assess the device's ability to accurately record and transmit data independent of a clinician's interpretation. The device's primary function is as a standalone data recorder.

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

   • The document does not explicitly state the type of ground truth. However, for "Accuracy of data measured," the ground truth would typically be derived from calibrated reference instruments that are considered the gold standard for measuring heart rate, oxygen saturation, flow, and pressure. Similarly, for "Data transmission / collection accuracy," the ground truth would be the original data intended for transmission/collection.

7. The sample size for the training set:

   • This information is not applicable or provided. The CODR Model 300-CR is described as a data gathering and display system using sensors, not a device employing machine learning or AI that would require a "training set."

8. How the ground truth for the training set was established:

   • This information is not applicable or provided, as the device does not use a training set for machine learning.

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