(263 days)
The Spirovit SP-2 / PneumoCheck ® II can be used to measure the following spirometric parameters within the Healthcare Facility:
Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1), FEV 1.0 / FVC, FEF 0.2-1.2, FEF 25-75%, FEF 75-85%, PEF, FEF 25%, FEF 50%, FEF 75%, FIVC, FIV 1.0, FIV 1.0 / FIVC, PIF, FIF 50%, SVC, ERV, IRV, TV, MVV, MV, RR, TV, in patients 6 years of age or older.
Not Found
Here's an analysis of the provided text regarding the acceptance criteria and study for the SPIROVIT SP-2 / PneumoCheck® II device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not outline specific numerical acceptance criteria for the spirometric parameters measured by the device. Instead, it relies on demonstrating equivalence to a predicate device and compliance with established standards. The reported "performance" for the new device is largely asserted as being "the same" as the predicate device or having passed relevant electrical and software standards.
| Feature / Criteria | Predicate Device (SP-250) "Acceptance" | SPIROVIT SP-2 / PneumoCheck® II Reported Performance |
|---|---|---|
| Dimensions | ||
| Flow Sensor | 7.5 cm | 85x190x27 mm |
| Handle | 10 cm | n.a. (not applicable, implies no separate handle) |
| Mouthpiece | Disposable | Same (Disposable) |
| Weight | 180 g | 275 g |
| Environmental Conditions | ||
| Operating Temp. | +10° - 40° C | Same |
| Storage Temp. | -10° - +50° C | Same |
| Relative Humidity | 25% - 95% (non-condensing) | Same |
| Electrical Safety / EMC | ||
| ESD (Functional) | Below 4 kV (Open Air) | Same |
| ESD (No damage) | Below 8 kV (Open Air) | Same |
| Radiated Emissions | Less than 30 dB Microvolts | Same |
| Radiated Immunity | 3 Volts per meter | Same |
| Data Communication | RS-232 interface | IrDA |
| Spirometry Standards | Not explicitly stated for predicate in comparison table, but ATS compliance is mentioned for new device. | ATS Spirometry Statement 1994 (All tests passed) |
| Electrical Safety Standards | Not explicitly stated for predicate in comparison table. | IEC 601-1-1 (All tests passed) |
| EMC Standards | Not explicitly stated for predicate in comparison table. | IEC 601-1-2 (All tests passed) |
| Software Quality Standards | Not explicitly stated for predicate in comparison table. | IEC 601-1-4 (All tests passed) |
Discussion of Differences: The document explicitly states, "None of the above differences (1, 2 or 3) can be considered as safety relevant differences," and concludes that the submitted device is "as safe and effective as the Predicate (SP-250) device."
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states "B2 Clinical Tests n.a." (not applicable). This indicates that no clinical test set was used to validate the performance of the device against specific spirometric parameters in a patient population. The device's performance is demonstrated through compliance with standards and comparison to the predicate device's specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical test set with ground truth established by experts was performed. The "ground truth" for the device's technical specifications and compliance was established through rigorous testing against international and industry standards (ATS, IEC).
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was performed.
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
Not applicable. This device is a spirometer, a medical measurement device, not an AI-powered diagnostic imaging or interpretation tool.Therefore, no MRMC study or AI assistance comparison was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable in the context of AI. The device itself is a standalone measurement system. Its performance relies on its hardware and software implementing spirometry standards correctly, rather than an AI algorithm's standalone performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests:
- Technical Specifications: The ground truth for device dimensions, weight, environmental conditions, and data communication was the design specifications of the device itself and its predicate.
- Electrical Safety and EMC: The ground truth was the requirements and test methodologies specified in IEC 601-1-1, IEC 601-1-2.
- Software Quality: The ground truth was the requirements and guidelines from IEC 601-1-4 and the "reviewer guidance for computer controlled medical devices undergoing 510(k) review."
- Spirometry Performance: The implicit ground truth for accurate spirometric measurements is the ATS Spirometry Statement (November 11th, 1994). The document states that the device was tested to be in accordance with this standard and "All tests are passed."
8. The Sample Size for the Training Set
Not applicable, as this device does not involve machine learning or AI models that require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).