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510(k) Data Aggregation
(291 days)
The ZI blower is a single patient reusable device that provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30 kg) with obstructive sleep apnea.
The Z1 Blower provides the patient with a continuous positive airway pressure (CPAP) flow ranging from 4-20 cmH2O above ambient atmospheric pressure. The device consists of a flow generator and data interfaces. It is intended for home use, and for prescription use only. Treatment settings (e.g., air pressure, ramp) are directed by the physician and can be modified by the physician.
Here's an analysis of the provided 510(k) summary for the Z1 Blower, detailing its acceptance criteria and the study that proves it meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (If explicitly stated or inferred) | Reported Device Performance |
|---|---|---|
| Temperature at Patient Port | < 43 degrees C at Pset = 20 cmH2O | < 43 degrees C at a pressure setting of 20 cmH2O under normal and single fault conditions |
| Pressure Stability (Static Long-term) | Within ± 1.0 cmH2O of set pressure (Pset = 10 cmH2O) (Inferred from reported performance as the criterion) | Within ± 1.0 cmH2O of the set pressure of 10 cmH2O |
| Pressure Accuracy (Short-term Static) | Within ± (0.6 cmH2O + 4% * set pressure) for all pressure settings (Inferred from reported performance as the criterion) | Actual pressure was within ± (0.6 cmH2O + 4% * set pressure) of the set pressure for all pressure settings |
| Dynamic Pressure Stability | Less than the variation of the predicate device for all pressure and breathing rate settings | Peak to peak pressure variation was between 0.6 and 3.1 cmH2O for all pressure and breathing rate settings, and was less than the variation of the predicate device for all pressure and breathing rate settings |
| Maximum Flow Rate | ≥ 75 Liters per minute AND ≥ the maximum flow rate of the predicate device for each pressure setting | ≥ 75 Liters per minute and ≥ the maximum flow rate of the predicate device for each pressure setting |
| Acoustic Noise | < 36 dBA (Inferred from reported performance as the criterion) | < 36dBA |
| Air Leak Detection | Within ± 5 mmH2O of the specified air leak detection thresholds (Inferred from reported performance as the criterion) | Air leaks were detected within +5 mmH20 of the specified air leak detection thresholds |
| Volatile Organic Compounds (VOCs) | No VOCs above 5.0 ug per cubic meter in air output (Inferred from reported performance as the criterion) | No volatile organic compounds were observed in the air output of the device above 5.0 ug per cubic meter |
| Particulate Matter | No particulate matter above 5.0 ug per cubic meter in output air (Inferred from reported performance as the criterion) | No particulate matter was observed in the output air of the device above 5.0 ug per cubic meter |
| Carbon Monoxide/Dioxide Output | Added no carbon monoxide or carbon dioxide to the output air (Inferred from reported performance as the criterion) | The Z1 Blower added no carbon monoxide or carbon dioxide to the output air |
| Ozone Output | ≤ 0.05 ppm (21 CFR 801.415 requirement) | The ozone output of the device met the 21 CFR 801.415 requirement of 0.05 ppm or less |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify sample sizes for any of the performance tests. The data provenance is also not explicitly stated, but the nature of the tests (e.g., temperature, pressure, flow rate, acoustic noise, chemical emissions) indicates these were laboratory-based engineering/performance tests rather than human clinical studies. No information about the country of origin or whether the data was retrospective or prospective is present.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable as the tests described are technical performance measurements of the device itself, not assessments of diagnostic accuracy or clinical outcomes requiring expert interpretation to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as the tests described are objective technical measurements, not evaluations requiring subjective expert consensus or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical data was generated to support a substantial equivalence determination." The studies performed were technical and engineering-based, comparing the device's physical and functional characteristics to established standards and predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable in the context of this device. The Z1 Blower is a hardware device (CPAP system) with integrated software for control and data, not an AI algorithm designed to interpret data or provide diagnostic assistance. The performance tests are for the device's physical operation.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed is based on established engineering specifications, regulatory standards (e.g., ISO, ASTM, IEC, 21 CFR), and the performance characteristics of predicate devices. For example:
- Temperature measurement compared to a maximum safety limit.
- Pressure accuracy and stability compared to defined tolerances.
- Dynamic pressure stability and maximum flow rate compared to predicate device performance.
- Chemical emissions compared to defined limits in regulatory standards.
8. The Sample Size for the Training Set
This information is not applicable. The Z1 Blower is a medical device, not a machine learning model that requires a distinct "training set" for its functionality in the common sense of AI development. Its performance is based on its engineering design and manufacturing, validated through the performance tests mentioned.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as in point 8. The "ground truth" for the device's design and performance validation comes from adherence to engineering principles, scientific measurements, and regulatory standards, rather than a "training set" with associated ground truth as understood in AI/ML.
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