(184 days)
The Salter Aire Compressor is an AC-powered, piston type air compressor that generates pressurized air for use with a small volume nebulizer to produce an aerosol. This product is intended to be used primarily by patients in the home care market, although it may also be used by trained hospital staff personnel as well.
The Salter Aire Compressor is a prescription use, non-sterile, durable device.
The Salter Labs Salter Aire Compressor is an AC powered, piston-type compressor that generates pressurized air for a nebulizer. It is designed to be small, light weight and portable. The device is manufactured by Salter Labs to Salter Labs design specifications.
The Salter Aire Compressor will be available in both 115 and 220 VAC models. The units have been designed and built according to applicable requirements of UL 1431 for USA models and IEC 601-1 for European models. All USA versions of the device will be 115VAC.
The Salter Aire Compressor is a prescription device and is designed to be a durable, reusable device that is intended to be used by hospital, clinic and home care markets. It has a 5 year warranty.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Predicate Device Range) | Reported Device Performance (Salter Aire Compressor) |
|---|---|
| Internal Temp: 80.5 to 134.8° F | Internal Temp: 92.3 to 128.5° F |
| Dead Head Pressure: 28 to 40 psi | Dead Head Pressure: 32 to 38.5 psi |
| Flow with Nebulizer: 6.2 to 7.1 LPM | Flow with Nebulizer: 6.7 to 7.5 LPM |
| Free Flow Rate: 7.3 to 12.1 LPM | Free Flow Rate: 11.3 to 12.8 LPM |
| Time to Nebulize 3 cc H2O: 8.5 minutes | Time to Nebulize 3 cc H2O: 8 minutes |
| Operating Life: 5 years | Operating Life: 5 years |
| Over-temperature Protection: Yes | Over-temperature Protection: Yes |
| Portable: Yes | Portable: Yes |
| Case Material: Plastic | Case Material: Plastic |
| Warranty: 1 year | Warranty: 1 year |
| Electromagnetic Compatibility: Conforms to UL 1431 (personal hygiene products) | Electromagnetic Compatibility: Conforms to UL 1431, and IEC 601-1 |
Summary of Device Performance: The Salter Aire Compressor met all design requirements and validation test requirements. Its performance characteristics, including internal temperature, pressure, flow rates, and nebulization time, fell within or outperformed the ranges of the predicate devices. It also met specified criteria for operating life, safety features, portability, and material.
Study Details:
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2. Sample size used for the test set and the data provenance:
- The document implies a comparative performance test was done, but does not specify a sample size for the test set or the number of units tested for the Salter Aire Compressor or the predicate devices.
- Data Provenance: Not explicitly stated, but the comparison involves the Salter Aire Compressor and specified predicate devices ("MIA Sport-Neb Compressor"). The data appears to be from retrospective performance data for the predicate devices and prospective testing for the Salter Aire Compressor to demonstrate equivalence. The testing for the Salter Aire Compressor was conducted by Salter Labs ("Performance characteristics, as tested, are essentially equivalent to predicate devices").
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a compressor, and its performance metrics (temperature, pressure, flow rate, nebulization time) are objective physical measurements. There is no human interpretation or subjective assessment involved that would require experts to establish a "ground truth" in the way it is used for medical image analysis or diagnostic studies.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. As stated above, the performance metrics are objective and directly measurable, not requiring expert adjudication.
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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:
- No. This is not a diagnostic device or an AI-enabled system. Therefore, an MRMC study is not relevant.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit. The performance metrics (internal temperature, dead head pressure, flow rates, nebulization time) were measured directly from the device's function. The results are "algorithm only" in the sense that they represent the device's inherent physical output without human intervention during the measurement process, although humans operate the test equipment. This is effectively a "standalone performance" for a non-AI hardware device.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is established by objective, quantitative measurements of its physical output and characteristics (e.g., temperature, pressure, flow rates) using calibrated instruments and standard test methodologies. This is compared against the known performance data of legally marketed predicate devices.
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8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device. There is no "training set" in the context of an algorithm. Design and engineering principles guide the device's development, not data-driven training.
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9. How the ground truth for the training set was established:
- Not applicable. As there is no training set. The "ground truth" for the device's design and manufacturing is based on established engineering standards and specifications (e.g., UL 1431, IEC 601-1).
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).