(175 days)
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.
- 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.
- 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.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Accuracy of Data Measured | "In all cases the CODR meet the specified performance criteria" |
| Data Transmission / Collection Accuracy | "In all cases the CODR meet the specified performance criteria" |
| EMC / EMI | "In all cases the CODR meet the specified performance criteria" |
| Mechanical and Environmental Testing | "In all cases the CODR meet the specified performance criteria" |
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
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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.
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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.
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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.
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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. 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.
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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.
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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.
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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."
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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.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).