(38 days)
For personal monitoring of expiratory-breath function at home under direction of a physician. It measures, logs, and reports events related to respiration and the spirometric values of peak expiratory flow (P.EF), zone and percent of PEF compared to a reference value, timed forced expiratory volumes over 1 second (FEV1) and 6 seconds (FEV6), and the ration of FEV1/FEV6.
KP+ LFM is a model variation of the KoKo Peak KP and KP+ peak flow meters. The KoKo Peak KP+, complete with data-communication accessory and dedicated PC display software, was cleared for over-the-counter sale in 510(k) notification K010009. The LFM is identical to its predicate device-the KP+-physically, technologically, and logically.
This new variation extends some KP+ features-namely, an additional timed flow measurement and extended electronic features. These variations make the LFM a prescription device, rather than an over-the-counter one, like its predicate.
All KP flow meters are personal, electronic, flow meters for measuring the rate at which a person blows through them. Approximately 5x2x1 inches in size, the devices are batterypowered, hand-held, single-user instruments with a mouthpiece removable for cleaning. The meter has a custom liquid-crystal display, one-button operation, and an infrared data port for communicating to a serial port of a PC through an optional data-communication link.
Selecting between the models is done during manufacture by simply setting appropriate flags in the device's memory. This selection can be done during initial calibration at the factory, only. The model is then designated by packaging and labeling.
LFM features include
- Performing all KoKo Peak KP+ features and functions
- Measuring six-second forced expiratory volume (FEV6) by continuing to integrate the breath flow measurement over a 6-s period and displaying the value after a test session
- Displaying the FEV1/FEV6 ratio on meter's front panel after a test session
- Enabling diary logs to be expanded to up to 16 entries from the 5 entries preprogrammed into the KP+
- Enabling options for uploading diary ranges, zone ranges, reference PEF, data-clear command, and alarm-clock settings directly to meter's memory from a PC
The provided 510(k) summary for the KP+ LFM Flow Meter for Spirometry states that no clinical testing or performance study was conducted to establish acceptance criteria or demonstrate device performance, because the device is deemed identical to its predicate device with only enhanced features.
Therefore, many of the requested sections regarding the study design and results cannot be filled from the provided text.
Here's an attempt to answer based on the available information:
Acceptance Criteria and Device Performance Study
The submission states that "Since the device is identical to its predicate device and the added features are simply enhancements or extensions of features already available on the predicate device, no clinical testing was necessary or performed."
Instead, the submission relies on demonstrating substantial equivalence to its predicate device (KoKo Peak KP+, K010009) and compliance with the American Thoracic Society (ATS) standard for spirometry.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present acceptance criteria in a table format with corresponding reported device performance metrics for the KP+ LFM. Instead, it refers to compliance with the ATS standard for spirometry as the benchmark.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) | Source |
|---|---|---|
| Meet or exceed American Thoracic Society (ATS) standard for spirometry (for monitoring devices) | Met or exceeded ATS standard for spirometry | Non-Clinical Performance Data Section |
| Physical, technological, and logical identity to predicate device (KoKo Peak KP+) | Identical to predicate device | Description of Device Section |
| All KoKo Peak KP+ features and functions | Performs all KoKo Peak KP+ features and functions | LFM Features Section |
| Accurate measurement of FEV6 | Measures FEV6 (integrates breath flow over 6s) | LFM Features Section |
| Accurate display of FEV1/FEV6 ratio | Displays FEV1/FEV6 ratio on meter's front panel | LFM Features Section |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable, as no dedicated clinical test set study was performed. The device's performance was evaluated against the ATS standard using an "automatic waveform generator."
- Data Provenance: Not applicable. The "testing to ATS standard was performed successfully in-house" using an "industry-recognized automatic waveform generator." This indicates controlled lab testing, not human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no human expert-established ground truth was used for a test set. The ground truth was established by the ATS standard and verified using an automatic waveform generator.
4. Adjudication method for the test set:
Not applicable, as no human-adjudicated test set was used.
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 flow meter for spirometry, not an AI-assisted diagnostic imaging device for human interpretation. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
The device itself is a standalone measurement device. No clinical study specifically assessing its "standalone" performance on human subjects was conducted or reported in the 510(k) summary beyond the in-house testing against the ATS standard using an automatic waveform generator. This can be considered a form of standalone technical performance verification.
7. The type of ground truth used:
The primary "ground truth" used for performance verification was the American Thoracic Society (ATS) standard for spirometry. This standard defines the expected accuracy and performance characteristics for spirometry devices. Compliance was demonstrated using an "industry-recognized automatic waveform generator," which generates standardized airflow patterns to simulate human breaths.
8. The sample size for the training set:
Not applicable. This device does not appear to utilize machine learning or AI that would require a "training set" in the conventional sense. Its functionality is based on established engineering principles for flow measurement.
9. How the ground truth for the training set was established:
Not applicable, as no training set was used.
§ 868.1860 Peak-flow meter for spirometry.
(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).