(433 days)
The Precision Medical Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining. The concentrator is intended for use in the home or hospital institutional environment.
Precision Medical, Inc. Concentrator is a medical device that produces concentrated oxygen from room air. The concentrator uses a molecular sieve and a pressure differential absorption process to concentrate oxygen from air.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study conducted to prove the device meets those criteria:
Acceptance Criteria and Device Performance
| Specifications | Acceptance Criteria | Reported Device Performance | ISO 8359:1996 Clause | Meets The Requirement |
|---|---|---|---|---|
| Oxygen % | 93% ±3% | 93% ±3% | 8.1, 50.4, 50.5 | Meets requirements |
| Liter flow | 0.5 to 5.0 liters per minute | 0.5 to 5.0 liters per minute | 8.1, 50.6, 50.5 | Meets requirements |
| Flow accuracy | 10% or ±200ml (comparison to predicate shows this is the acceptance spec) | 10% or ±200ml | 8.1, 50.3 | Meets requirements |
| Operating temperature | 55 to 90 °F | 55 to 90 °F | 7-42.3 | Meets requirements |
| Storage temperature | -30 to 140 °F (based on reported performance of Precision Medical) | -30 to 140 °F | 60601-1 Section 10.1 | Meets requirements |
| Humidity | Up to 95% noncondensing | Up to 95% noncondensing | 60601-1 Section 10.1 | Meets requirements |
| Power requirements (Voltage) | 120 vac ±10% | 120 vac ±10% | Meets requirements | |
| Power requirements (Wattage) | 450w | 450w | Meets requirements | |
| Power requirements (Frequency) | 60 HZ | 60 HZ | Meets requirements | |
| Power alarm | LED and audible | LED and audible | Meets requirements | |
| O2 concentration Alarm | LED and audible | LED and audible | Meets requirements | |
| Warm up time | ≤ 10 minutes | ≤ 10 minutes | 8.1, 50.4 | Meets requirements |
| Dimensions | 29 inches x 15 inches x 10 inches | 29 inches x 15 inches x 10 inches | na | |
| Weight | ≤ 36 lbs. (based on reported performance of Precision Medical) | ≤ 36 lbs. | na | |
| Sound level | 53.3 dBA (based on reported performance of Precision Medical) | 53.3 dBA | 4.6, 26.1 | Meets requirements |
| Outlet pressure | 5.0 psi (based on reported performance of Precision Medical) | 5.0 psi | 8.1, 50.8 | Meets requirements |
| Back pressure | 1.0 psi (based on reported performance of Precision Medical) | 1.0 psi | 8.1, 50.7 | Meets requirements |
| Outlet gas temp | Max above ambient 0.5 °F or 0.3 °C | Max above ambient 0.5 °F or 0.3 °C | 7, 42.3 | Meets requirements |
Note: For "Flow accuracy," "Storage temperature," "Weight," "Sound level," "Outlet pressure," and "Back pressure," the acceptance criteria were inferred from the reported performance of the Precision Medical device, as the table presents them as if the Precision Medical performance is the criteria for meeting the requirement within its own column.
Study Information
Based on the provided text, the study focuses on technical performance testing rather than a clinical study involving human subjects or expert assessment of data.
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Sample size used for the test set and the data provenance:
- The document does not specify a "sample size" in terms of cases or patients for a test set. The tests described are for the device itself (e.g., mechanical, climatic, life test, alarm testing).
- Data Provenance: Not applicable in the context of clinical data provenance. The data comes from internal testing of the Precision Medical, Inc. Oxygen Concentrator. It is a prospective study in the sense that the tests were specifically conducted on the manufactured device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for this device is based on objective measurements against engineering specifications and regulatory standards (like ISO 8359:1996 and 60601-1). No human "experts" are establishing a subjective "ground truth" for interpretation of data in the way radiologists establish ground truth for medical images. The measurements themselves are the ground truth.
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Adjudication method for the test set:
- Not applicable. This is not a study involving human interpretation or subjective assessments that would require an adjudication method. The device's performance is objectively measured.
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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 MRMC comparative effectiveness study was done. This document describes the technical performance testing of a medical device (oxygen concentrator), not an AI-powered diagnostic or assistive tool for human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The entire performance evaluation reported is a "standalone" evaluation of the device itself (the oxygen concentrator). There is no "algorithm" in the sense of AI being evaluated here, but the device's functional performance criteria are tested without human intervention impacting its core operation.
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The type of ground truth used:
- The ground truth is based on engineering specifications, objective measurements, and compliance with recognized standards (e.g., ISO 8359:1996, 60601-1 Section 10.1). For example, oxygen percentage is measured and compared to the 93% ±3% specification.
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The sample size for the training set:
- Not applicable. This is a medical device (oxygen concentrator) whose performance is evaluated against physical and functional specifications. It does not involve machine learning or a "training set" for an algorithm.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned or implied for this device's evaluation.
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).