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510(k) Data Aggregation
(273 days)
The device is a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The Vitalograph Pneumotrac is a desktop spirometer designed for lung function testing for use on adults and pediatrics, 5 years and older, in a variety of environments such as hospital wards, health centers and private homes under the supervision of a healthcare provider.
The intended use of the Vitalograph Pneumotrac desktop spirometer, which connects to Vitalograph Model 7000 Spirotrac software, ref 510(k) K141546, shall provide a USB-powered desktop spirometer for creating, adding and recalling subjects and performing Spirometry testing on those subjects to aid in the measuring the effect of lung disease on pulmonary function. Spirometry is in the simple assessment of respiratory function through the measurement of dynamic lung volumes. Its primary functions are; 1. Standalone spirometric measures using single breath or multiple-breath testing techniques, display and record lung volumes and flow rates (including FVC, MVV, VC) and it's subdivisions, Display a single subject's demographic data entered by the user. 2. Produce reports In a clinical setting, the measurements obtained from a lung function test form part of the various findings of a physician in the detection, diagnosis and monitoring of chest diseases.
The Vitalograph Model 6800 Pneumotrac is a diagnostic spirometer. The device was studied through validation bench testing against several international standards to demonstrate its performance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Volume Range | 0-10 Liters (Predicate) | 0-10 Liters |
| Max Flow Range | 0-16 Liters/second (Predicate) | 0-16 Liters/second |
| Back Pressure | <= 0.1 kPa/L/s (Predicate) | < 0.1 kPa/L/s |
| Accuracy FEV1 | +/- 3% (Predicate) | +/- 3% |
| Accuracy FEV6 | +/- 3% (Predicate) | +/- 3% |
| Accuracy PEF | +/- 5% (Predicate) | +/- 5% |
| Operating Temp | 10-40°C (At least 17-37°C required per ATS 2005) | 10-40°C (At least 17-37°C required per ATS 2005) |
| Storage Temp | 0-50°C (Predicate) | 0-50°C |
| Humidity | 10-95% relative humidity (Predicate) | 10-95% relative humidity |
| Performance Standards | ATS ERS 2005, ISO 23747:2009 for PEF, EN ISO 26782:2009, ISO 10993-1 Fourth Edition | ATS ERS 2005, ISO 23747:2009 for PEF, EN ISO 26782:2009, ISO 10993-1 Fourth Edition |
| Compliance | IEC / EN 60601 (EN 60601-1-1 and EN 60601-1-2) | IEC / EN 60601 (EN 60601-1-1 and EN 60601-1-2) |
| Biocompatibility | All materials previously cleared | All materials previously cleared in K100687 & K925085 |
| Connectivity/Communication | Validation with Vitalograph Model 7000 Spirotrac software to maintain integrity and successful download/storage | Validation with Model 7000 Spirotrac (K141546) performed and deemed satisfactory |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size of a "test set" for data provenance in terms of patient data. The study primarily involved validation bench testing against international performance standards. This implies controlled laboratory testing rather than a clinical study with patient data. Therefore, the data provenance would be from laboratory experiments rather than patient data from a specific country or collected retrospectively/prospectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the described study is a series of bench tests against engineering standards, not a study involving human interpretation of data where "ground truth" would be established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the study did not involve expert adjudication of results. The performance was assessed against predefined numerical and technical standards.
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:
This is not applicable. The device is a spirometer, which measures physiological parameters. It is not an AI-assisted diagnostic tool that would be evaluated in a MRMC study involving human readers and AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a measurement instrument. The "standalone" performance was assessed through bench testing against international standards (ISO, ATS/ERS). This is the functional equivalent of standalone performance for such a device, ensuring its accuracy and precision in measuring respiratory parameters independent of human interpretation during the measurement process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the bench tests, the "ground truth" was established by the international performance standards themselves (e.g., ISO 26782, ATS/ERS 2005, ISO 23747) which define acceptable ranges and accuracy for spirometry measurements. These standards are developed through scientific consensus and extensive validation.
8. The sample size for the training set:
This is not applicable as the device is not an AI/machine learning algorithm requiring a training set in the conventional sense. Its functionality is based on established physiological measurement principles.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as point 8.
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