(53 days)
The Precision Medical, Inc. Blender Oxygen System is intended to deliver blended air and oxygen in a Hospital setting. Oxygen concentrations can be dialed in from 21% to 100%. The blender is not intended as a life supporting device.
The Precision Medical, Inc. Air and 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 air/oxygen mixtures is required.
The provided text describes the Precision Medical, Inc. Blender, an oxygen blender, and its substantial equivalence to a predicate device (Bio-Med Blender). The document explicitly lays out performance specifications for the device and a summary of performance testing.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device Specification) | Reported Device Performance (Precision Medical, Inc. Blender) |
|---|---|---|
| Oxygen % Range | 21 to 100% | 21 to 100% |
| Accuracy | ± 3% of full scale | ± 3% of full scale |
| Supply Pressure | 30-75 psi air + O2 must be within 10 psi of each other | 30-75 psi air + O2 must be within 10 psi of each other |
| Max Flow (High Flow) | ≥ 120 lpm @60% setting at 50psi inlet pressures | ≥ 120 lpm @60% setting at 50psi inlet pressures |
| Pressure Drop (High Flow) | ≤ 6 psi at 50 psi inlet pressure and 40 lpm flow | ≤ 6 psi at 50 psi inlet pressure and 40 lpm flow |
| Max Flow (Low Flow) | ≥ 30 lpm @60% setting at 50psi inlet pressures | ≥ 30 lpm @60% setting at 50psi inlet pressures |
| Pressure Drop (Low Flow) | ≤ 6 psi at 50 psi inlet pressure and 10 lpm flow | ≤ 6 psi at 50 psi inlet pressure and 10 lpm flow |
| Alarm/Bypass Reset | When inlet gas pressure differential is ≤ 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° to 104°F | 59°F to 104°F |
| Dimensions | H 3 ½ "x W 2 ¼" D 2 ⅞ " | H 3 ½ " W 2 ¼ " 5 ¼ " |
| Weight | 2 ¼ lbs | 2 ¼ lbs |
The "Reported Device Performance" column directly reflects the specifications of the Precision Medical, Inc. Blender, which are stated to be equivalent to the predicate device. The document affirms that "The Precision Medical, Inc. Blender will successfully pass tests in the following areas; Mechanical / Climatic Device Performance."
2. Sample size used for the test set and the data provenance
The document states, "The Precision Medical, Inc. Blender will successfully pass tests in the following areas; Mechanical / Climatic Device Performance." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information is typically detailed in technical reports that would accompany such a submission but is not present in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device is an oxygen blender, which is a mechanical device, not a diagnostic or AI-driven system that requires expert interpretation for ground truth establishment. Therefore, this section is not applicable. The performance is measured against established physical and mechanical parameters.
4. Adjudication method for the test set
As this is a mechanical device, performance is evaluated against defined physical and operational specifications using measurement tools, not through human interpretation or adjudication. Therefore, an adjudication method is not applicable.
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 device is an oxygen blender, not an AI-assisted diagnostic or interpretive tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is related to AI/algorithm performance. The Precision Medical, Inc. Blender is a purely mechanical device. Therefore, this is not applicable.
7. The type of ground truth used
For the Precision Medical, Inc. Blender, the "ground truth" for performance evaluation is based on defined engineering specifications and measurable physical/mechanical parameters (e.g., oxygen concentration, flow rates, pressure differentials, alarm intensity, temperature range). These are objective measurements rather than subjective expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This device is not an AI/machine learning system that requires a "training set." Its design and performance are based on engineering principles and physical testing. Therefore, this is not applicable.
9. How the ground truth for the training set was established
As there is no training set for this mechanical device, this is not applicable.
§ 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).