(143 days)
The Precision Medical, Inc. Heliox Blender Oxygen System is intended to deliver blended Helium and oxygen in a hospital setting. Oxygen concentrations can be dialed in from 20% to 100% for heliox tank mixtures of 20% oxygen / 80% helium, and 30% to 100% for heliox tank mixtures of 30% oxygen / 70% helium.
The blender is not intended as a life supporting device.
The Precision Medical, Inc. Heliox/oxygen blender is a restricted medical device intended for use by qualified and trained personnel under the direction of a physician in institutional environments where delivery of Heliox/oxygen mixtures are required.
The provided 510(k) summary for the Precision Medical, Inc. HeliO2 Blender does not contain a study that proves the device meets specific acceptance criteria in the way described in your request.
This document is a premarket notification (510(k)) submission to the FDA. For this type of device (a medical gas blender), "proving acceptance criteria" typically involves demonstrating substantial equivalence to a predicate device, as well as meeting recognized performance standards for medical gas blenders. The submission focuses on comparison to a predicate device and outlines the device's technical specifications and intended use, rather than presenting a performance study with detailed acceptance criteria and results against those criteria.
Here's an breakdown of the information available and what is not present, based on your request:
1. Table of acceptance criteria and the reported device performance
The document provides a table comparing the Heliox/oxygen blender to its predicate (air/oxygen blender) for various specifications. These specifications act as de facto acceptance criteria for functional performance, largely demonstrating equivalence or improvement compared to the predicate.
| Feature | Acceptance Criteria (Predicate Performance) | Reported Device Performance (HeliO2 Blender) |
|---|---|---|
| Oxygen % Range | 21 to 100% | 20 to 100% (for 20/80 Heliox) and 30 to 100% (for 30/70 Heliox) |
| Accuracy | ± 3% of full scale | ± 3% of full scale |
| Supply Pressure | 30-75 psi air + O2 must be within 10 psi | 30-75 psi Heliox + O2 must be within 10 psi of each other |
| Max Flow (High Flow) | ≥ 120 lpm @60% setting at 50psi inlet | ≥ 120 lpm @60% setting at 50psi inlet pressures |
| Pressure Drop (High Flow) | ≤ 6 psi at 50 psi inlet and 40 lpm flow | ≤ 3 psi at inlet pressures from 30-90 psi and at 30lpm flow rate at 60% FiO2 (This shows an improvement compared to the predicate's 6 psi) |
| Alarm/Bypass Reset | When inlet gas pressure differential ≤ 6 psi | When inlet gas pressure differential is ≤ 6 psi |
| Alarm intensity | ≥80 db at 1 foot | ≥80 db at 1 foot |
| Operating temperature | 59°F to 104°F | 59°F to 104°F |
| Max Flow (Low Flow) | ≥ 30 lpm @60% setting at 50psi inlet | ≥ 30 lpm @60% setting at 50psi inlet pressures |
| Pressure Drop (Low Flow) | ≤ 6 psi at 50 psi inlet and 10 lpm flow | ≤ 2 psi at 30-90 psi inlet pressure and 10 lpm flow Rate at 60%FiO2 (This shows an improvement compared to the predicate's 6 psi) |
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 summary. For a medical device like a blender, "test set" would typically refer to the various configurations and conditions under which the device was tested (e.g., different flow rates, oxygen percentages, inlet pressures, gas mixtures). The document only states the specifications; it does not detail the testing methodology, number of test runs, or data provenance.
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 is not applicable and not provided for this type of device. "Ground truth" established by experts, especially clinical experts, is relevant for AI/diagnostic devices where human interpretation is involved. For a mechanical medical gas blender, performance is measured against engineering specifications, not expert consensus on an image or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not provided. Adjudication methods are used in studies where there is subjective assessment or disagreement, typically in diagnostic or imaging trials. Performance of a medical gas blender is measured objectively using calibrated instruments.
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 is not applicable and not provided. MRMC studies are used for evaluating diagnostic systems where human readers interpret medical cases, often with and without AI assistance. This device is a mechanical blender, not a diagnostic tool requiring human interpretation of cases.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable and not provided. "Standalone" performance testing relates to AI algorithms. This device is a mechanical blender and does not involve algorithms in the sense of AI. Its performance is inherent to its mechanical design and operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" for its performance would be objective engineering measurements from calibrated test equipment, adhering to relevant standards for medical gas blenders (e.g., flow meters, oxygen analyzers, pressure gauges). This is implied by the listed specifications but not explicitly detailed as "ground truth" in the provided text.
8. The sample size for the training set
This is not applicable and not provided. "Training set" refers to data used to train AI models. This device is a mechanical product, not an AI system.
9. How the ground truth for the training set was established
This is not applicable and not provided for the same reason as point 8.
In summary:
The provided 510(k) summary focuses on demonstrating substantial equivalence of the HeliO2 Blender to a predicate oxygen blender through a comparison of their technical specifications and intended use. It does not present a "study" in the typical clinical or AI sense, but rather relies on the device meeting established engineering performance criteria consistent with or better than the predicate device. The detailed methodological aspects of a performance study (like sample size for test sets, expert involvement, adjudication, or training sets) are not included in this type of regulatory submission for a mechanical 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).