(232 days)
The Heliox Low Flow Sentry Blender is designed to provide a continuous heliox/oxygen qas mixture to infant, pediatric, and adult patients. It is intended as a device to mix an 79% Helium / 21% Oxygen gas source with a 100% oxygen gas source to provide low flow mixtures containing 20% to 100% oxygen with the balance of the gas being Helium for patients who are spontaneously breathing. It is a medical device intended for use by qualified, trained personnel, under the direction of a physician, in institutional environments where the delivery and monitoring of helium/oxygen mixture is required.
The helium/oxygen and oxygen blender/monitor combines a precision helium/oxygen (79%/21%) and oxygen mixing valve with an integral battery operated oxygen concentration analyzer and user adjustable alarms.
Here's a breakdown of the acceptance criteria and study information for the Heliox Low Flow Sentry Blender, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document lists performance requirements and indicates that the device met these requirements. No specific quantitative acceptance values are given for most criteria, only a "Pass" status. The table below paraphrases the descriptions as presented in the document.
| Acceptance Criteria (Description) | Reported Device Performance |
|---|---|
| Dimensional Envelope | Pass |
| Weight | Pass |
| Interface (gas inlets and outlets) | Pass |
| Nominal Supply Pressure | Pass |
| Normal Operating Pressure | Pass |
| Environmental Withstand | Pass |
| % O2 Control | Pass |
| Flow Characteristics | Pass |
| Blender Safety Features | Pass |
| Monitor Display | Pass |
| Oxygen Range, Resolution, & Accuracy | Pass |
| Low O2 Alarm Set point | Pass |
| High O2 Alarm Set point | Pass |
| "%" Flashing during calibration | Pass |
| Locked Indicator | Pass |
| Attach Sensor | Pass |
| Low Battery Indicator | Pass |
| On/Off Switch (Monitor Controls) | Pass |
| Lock/Unlock Switch (Monitor Controls) | Pass |
| Calibrate Button (Monitor Controls) | Pass |
| High Set Button (Monitor Controls) | Pass |
| Low Set Button (Monitor Controls) | Pass |
| Alarm Silence Button (Monitor Controls) | Pass |
| Hi O2 Concentration (Alarm/Alert Indications) | Pass |
| Low O2 Concentration (Alarm/Alert Indications) | Pass |
| Alarm Silence (Alarm/Alert Indications) | Pass |
| Alarm Loudness (Alarm/Alert Indications) | Pass |
| Monitor Power Source | Pass (Specified by Manufacturer) |
| Oxygen Sensor | Pass (Specified by Manufacturer) |
| Oxygen Blender Performance | Pass |
| Monitor/Analyzer Performance | Pass |
| Display, Controls, Alarms | Pass |
| System Accuracy | Pass |
| Labeling | Pass |
| Shipping Container | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 4 units were used for the majority of verification tests.
- Data Provenance: Not explicitly stated, but given it's a 510(k) submission for a medical device by Cardinal Health 207, Inc., in Yorba Linda, CA, the testing likely occurred internally or by a contracted lab within the United States. The document describes "Non-clinical Testing," implying laboratory or engineering tests rather than clinical human data. The testing is retrospective in relation to the submission date.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The tests appear to be objective engineering/performance verification tests against predefined specifications (ER3348 sections). There's no mention of human experts establishing "ground truth" in the context of diagnostic interpretation, as this is a device for blending gases, not an imaging or diagnostic AI.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. The testing described is performance verification of a device against specifications, not a diagnostic task requiring adjudication of human performance or expert consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not performed or mentioned. This type of study is relevant for diagnostic AI tools that assist human readers (e.g., radiologists). The Heliox Low Flow Sentry Blender is a physical device for gas blending and monitoring, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. The device itself is a standalone blender, but the "standalone performance" term usually refers to the performance of an AI algorithm without human involvement in a diagnostic or interpretive task. The "performance testing" described in the document is effectively a standalone test of the device's technical specifications.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests was defined by the device's own performance requirements and specifications as outlined in "ER3348" (Verification Test Protocol Reference Number) and potentially other internal design history files (e.g., "Sentry Blender DHF" for Environmental Withstand). For example, "Oxygen Range, Resolution, & Accuracy" would have specific numerical targets against which the device's output was measured.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. This device is a mechanical/electronic medical device, not an AI model 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 this type of device.
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).