(266 days)
The CCS-200 Spirometer is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients who are at least 16 years old, in general practice, specialty physician, industrial, and hospital settings.
The CCS-200 Spirometer System consists of Microsoft Windows based personal computer (PC) software (BUL) and the CCS-200 flow sensing instrument. The BUL software is installed on a desktop or laptop PC to which the CCS-200 flow sensing instrument is connected.
In order to conduct spirometry testing the CCS-200 flow sensing instrument is used in combination with a single-use disposable airway tube with integrated mouthpiece (U-tube).
The flow sensing instrument measures transit time of ultrasound pulses through the air in the U-tube to determine flow velocity and volume. The collected data are transferred to the PC for pulmonary function evaluation and data management. The results of the testing are stored in a database. Reports can be displayed or printed.
Here's a breakdown of the acceptance criteria and the study details for the CCS-200 Spirometer, based on the provided text:
Acceptance Criteria and Device Performance
The core acceptance criteria are based on the American Thoracic Society (ATS) recommendations for accuracy and precision in diagnostic spirometry.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Accuracy and Precision | ATS 1994 "Standardization of Spirometry" recommendations for FVC, FEV1, FEF25-75, and PEF | All results were within the defined ATS acceptance criteria. |
| Electrical Safety | IEC 60601-1 | Conforms to IEC 60601-1 requirements. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | Conforms to IEC 60601-1-2 requirements. |
| Biocompatibility - Cytotoxicity | ISO 10993-5 2009 (MEM elution and neutral red uptake) | All test results met ISO standard requirements. |
| Biocompatibility - Intracutaneous Reactivity | ISO 10993-10 2010 (Intracutaneous injection) | All test results met ISO standard requirements. |
| Biocompatibility - Sensitization | ISO 10993-10 2010 (Kligman maximization) | All test results met ISO standard requirements. |
| Software Verification & Validation | Specified criteria for CCS-200 software | Meets specified criteria. |
Study Information
1. Sample size used for the test set and the data provenance:
- Test set for dynamic wave-form testing: Not explicitly stated how many waveforms were used, but it involved performing standardized waveforms (FVC, FEV1, FEF25-75, PEF) using a mechanical flow-volume simulator (FVS). Data provenance is from mechanical simulation, not human subjects for this part.
- Test set for human testing: Not explicitly stated how many human subjects participated. The text mentions "human testing" as a comparison, implying prospective data collection during the study. Country of origin is not specified.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the ground truth for the primary performance test (dynamic waveform testing) was established by the standardized values provided in the ATS 1994 guidelines, simulating known physiological conditions. For human testing, the "ground truth" would be the physiological output of the humans, measured by both devices for comparison. It does not mention expert consensus for ground truth on this.
3. Adjudication method for the test set:
- Not applicable in the traditional sense. For dynamic waveform testing, the device's output was directly compared to the ATS-defined standard values. For human testing, the CCS-200 results were compared against a predicate device, and both were expected to be within ATS acceptance criteria (implying a comparison to a known standard, not an adjudication between multiple expert opinions).
4. 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 diagnostic spirometer, not an AI-powered image analysis tool or a system designed to assist human readers (e.g., radiologists). No MRMC study was mentioned or relevant to this type of device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the primary performance evaluation was a standalone test. The "Dynamic wave-form testing" using a mechanical flow-volume simulator directly assessed the device's ability to measure spirometry parameters according to ATS standards, without human interpretation in the loop influencing the measurement itself. The software verification and validation also represent standalone algorithm testing.
6. The type of ground truth used:
- For dynamic wave-form testing: Standardized values defined by the American Thoracic Society (ATS) 1994 guidelines. These are established, recognized benchmarks for spirometry performance.
- For biocompatibility: ISO 10993 standard requirements.
- For electrical safety and EMC: IEC 60601 standards.
7. The sample size for the training set:
- Not applicable. This is a medical device for direct measurement, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its "training" or calibration would be part of its manufacturing process and verified by the described bench testing.
8. How the ground truth for the training set was established:
- Not applicable for the same reasons as above.
§ 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).