(178 days)
Intended use for the Flowmate LTE is for Pulmonary Function Testing (measuring a person's ability to move air into and out of their lungs). The volume and flow rates measured for the entire effort and then reported as numerical results with a printout of the effort if selected.
Flow sensing pneumotach and base that measures differential pressure as air passes through it (the same principle as the Flowmate, PC Flow +, Renaissance, and Flash devices)
Compact design molded from high impact UL rated ABS plastic. rechargeable Ni-Cad batteries for portable operation,
Automatic calculations of test results, and best test selection based on ATS criteria
Testing capabilities include; FVC, FEV1, FEV3, FEV1/FVC%, FEF.2-1.2, FEF25-75%, FEF75-85, PEF, FEF50, FIVC, FEF50/FIF50, PIF, MVV, Methacholine Challenge, and Lung Age
Testing Capabilities: Capacity 10 Liters
Volume Accuracy +/- 3% Max. Flow Rate +/- 16 L/s
Back Pressure Less than 1.5 cm H2O
Population Predicted Normals included: Composite Knudson Crapo (ITS) ECCS HSU
Customization allows user to change report format, input temperature and barometric readings, and select printer driver for printer being used
Reports printed on standard 8 1/2 " x 11" paper
Field calibration with a 1 to 9 Liter calibration syringe
Cross-contamination control via external filter system
Here's an analysis of the provided text regarding the acceptance criteria and study for the Flowmate LTE device:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Volume Accuracy | +/- 3% |
| Max. Flow Rate | +/- 16 L/s |
| Back Pressure | Less than 1.5 cm H2O |
| FVC Accuracy | Exceeded ATS recommendations at 23 out of 24 waveforms. At waveform #17 (which exceeds the device's 15-second recording limit), accuracy was -1.8% at the 15-second mark, which is within ATS recommendations. |
| FEV1 Accuracy | Exceeded ATS recommendations at 23 out of 24 waveforms. |
| FEF 25-75 Accuracy | Exceeded ATS recommendations at 23 out of 24 waveforms. |
| PEF Accuracy | Exceeded ATS recommendations at 23 out of 24 waveforms. |
| MVV Accuracy | Acceptable results compared with ATS criteria for accuracy and precision to delivered values. |
Study Information
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Waveform Performance Testing: 24 waveforms were used.
- MVV Testing: A 2-liter volume at flow rates from 40 to 245 L/M was used. The number of specific tests or readings performed is not specified, but it refers to a range of flow rates.
- Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. The testing appears to be laboratory-based performance testing rather than human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth for the test set (waveforms and MVV) was established based on "ATS recommendations" and "delivered values" from a 2-liter calibration syringe. No human experts are mentioned as directly establishing the ground truth for these performance tests.
4. Adjudication method for the test set:
- Not applicable, as the ground truth was based on pre-defined standards (ATS recommendations) and objective measurements from a calibration syringe, not on human interpretation requiring adjudication.
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, a multi-reader multi-case comparative effectiveness study was not done. This device is a diagnostic spirometer, which directly measures physiological parameters, not an AI-powered image analysis or diagnostic support tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance testing described for the Flowmate LTE is a standalone performance study. The device's measurements (volume, flow rates) are directly compared against established standards (ATS recommendations) and known delivered values (from a calibration syringe). There is no "human-in-the-loop" aspect to the performance evaluation itself, though the device is intended for human use.
7. The type of ground truth used:
- The ground truth used was based on expert consensus standards (ATS recommendations for FVC, FEV1, FEF 25-75, PEF, MVV accuracy and precision) and objective measurements from a calibrated device (a 1 to 9 Liter calibration syringe for field calibration, and a 2-liter volume for MVV testing).
8. The sample size for the training set:
- The document does not describe a "training set" in the context of machine learning or AI. This device appears to be a hardware-based medical device with integrated software for calculations, not a learning-based algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set for a machine learning algorithm.
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"Dedicated to Improving the Quality of Life"
510(k) SUMMARY
Submitted by: New VED Inc. d.b.a. Spirometrics Medical Equipment Co. 415 Rodman Road Auburn, ME 04210 207-784-0906, Fax 207-784-1481
Contact Person: Donald Henton, Official Correspondent Date Prepared: October 10, 1995
- � Classification Name: Diagnostic Spirometer
- Common or Usual Name: Diagnostic or Screening Spirometer �
- Proprietary Name: Flowmate LTE �
- Establishment Registration Number: 1720605 �
- Classification: Diagnostic Spirometers have been classified as Class II devices. �
- Performance Standard: None applicable �
Spirometrics has been marketing a flow sensing pneumotach with its models Flowmate and PC Flow + . The proposed product is substantially equivalent to the Flowmate 2500 premarket notification number K863953/A, and PC Flow + 3350 premarket notification number K900673 both manufactured by Spirometrics, the Renaissance from Puritan Bennett premarket notification number K911143, and the Flash Portable Spirometry System from Tamarac Systems Corporation premarket notification number unkown.
For a description of the device see Exhibit 1.
Description of the device:
- � Flow sensing pneumotach and base that measures differential pressure as air passes through it (the same principle as the Flowmate, PC Flow +, Renaissance, and Flash devices)
- � Compact design molded from high impact UL rated ABS plastic. rechargeable Ni-Cad batteries for portable operation,
- � Automatic calculations of test results, and best test selection based on ATS criteria
510(k) SUMMARY
510(k) SUMMARY
{1}------------------------------------------------
- Testing capabilities include; FVC, FEV1, FEV3, FEV1/FVC%, FEF.2-1.2, � FEF25-75%, FEF75-85, PEF, FEF50, FIVC, FEF50/FIF50, PIF, MVV, Methacholine Challenge, and Lung Age
- Testing Capabilities: Capacity 10 Liters �
Volume Accuracy +/- 3% Max. Flow Rate +/- 16 L/s
Back Pressure Less than 1.5 cm H2O
- Population Predicted Normals included: Composite �
Knudson Crapo (ITS) ECCS
HSU
- Customization allows user to change report format, input temperature and � barometric readings, and select printer driver for printer being used
- � Reports printed on standard 8 1/2 " x 11" paper
- Field calibration with a 1 to 9 Liter calibration syringe �
- Cross-contamination control via external filter system �
Intended use for the Flowmate LTE is for Pulmonary Function Testing (measuring a person's ability to move air into and out of their lungs). The volume and flow rates measured for the entire effort and then reported as numerical results with a printout of the effort if selected.
Waveform performance testing showed that the Flowmate LTE exceeded the ATS recommendations for FVC. FEV1. FEF 25-75 and PEF accuracy at all of the 24 waveforms except #17. Waveform #17 takes over 20 seconds to complete. The Flowmate LTE accumulates volume for up to 15 seconds the same as the Flowmate 2500. Therefore, some of Waveform #17's volume was produced after the Flowmate LTE stopped recording data from the effort, which accounts for the variation between the actual delivered volume and the measured volume (See Exhibit 2). Taking the volume at the 15 second mark generated by waveform #17 (5.662 Liters) the accuracy is within the ATS recommendation at - 1.8%.
MVV testing used a 2 Liter volume at flow/rates from 40 to 245 L/M also showed acceptable results compared with the ATS criteria for accuracy and precision to the delivered values (See Exhibit 3).
Our conclusion is that the Flowmate LTE is substantially equivalent to the predicate device the Flowmate. It is also substantially equivalent to the PC Flow +. Renaissance, and Flash Portable Spirometry System.
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§ 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).