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510(k) Data Aggregation
(99 days)
This AccuTrax EPF840device is intended for monitoring PEF and FEV; for patient home and work use. The EPF840 is designed for pediatric to adult patients. The simple device interface provides ease of use for pediatric patients. When the EPF840 is used to watch lung conditions such as asthma, the user should be under the care of a licensed health care professional. A licensed health care professional's advise is required to understand the meaning and importance of the measures reported by the AccuTrax 840, and how to decide on an appropriate treatment plan. This treatment plan will tell you what action to take when there are changes in your PEF/FEV; numbers.
The EPF840 is an electronic PEF/FEV; monitor. It can store PEF/FEV; test results, symptom scoring, and inhaler usage with a time and date stamp. The physician may retrieve data for analysis and trending using a personal computer. The physician may customize color zone indicators to the patient's needs.
Here's a breakdown of the acceptance criteria and study information for the ACCUTRAX EPF840 Electronic Peak Flow Meter, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily compares the ACCUTRAX EPF840 to a predicate device (Vitalograph 2110) against ATS (American Thoracic Society) standards. The acceptance criteria are implicitly the ATS standards for monitoring devices.
| Parameter | Acceptance Criteria (ATS Standard for Monitoring Devices) | ACCUTRAX Model EPF840 Performance | Predicate Device (2110) Performance |
|---|---|---|---|
| Back pressure | < 1.5 cmH2O / Liter / second | < 1.5 cmH2O / Liter / second (complies with ATS standards) | < 1.5 cmH2O / Liter / second (complies with ATS standards) |
| Maximum recorded flow rate | Above ATS standard (implied reference) | 875 L/minute | 999 Liter/minute |
| Maximum recorded volume | Above ATS standard (implied reference) | 8.50 Liter | 9.99 Liter |
| Volume measuring accuracy | $\pm$ 5% or $\pm$ 0.100 L whichever is greater (for monitoring) | $\pm$ 5% or $\pm$ 0.100 L whichever is greater | $\pm$ 3% or $\pm$ 0.050 L whichever is greater (for diagnostic) |
| Flow measuring accuracy | $\pm$ 10% or $\pm$ 24 L/min whichever is greater (for monitoring) | $\pm$ 10% or $\pm$ 24 L/min whichever is greater | $\pm$ 5% or $\pm$ 12 L/min whichever is greater (for diagnostic) |
| Both devices operated within the 10% specification of the ATS standard for peak flow. (This indicates a specific acceptance criteria met.) | Within 10% of ATS standard for peak flow | Operated within 10% specification of ATS standard for peak flow | Operated within 10% specification of ATS standard for peak flow |
| "Both PEF and FEV1 values were well within the required ATS accuracy specifications using the 24 standard waveforms and the 26 flow-time waveforms." | Within required ATS accuracy specifications | Well within required ATS accuracy specifications | (Not explicitly stated for predicate device in this section, but stated to meet ATS recommendations) |
| Inter-device and intra-device variability | Complies with all variability requirements | Complies with all variability requirements | (Not explicitly stated for predicate device in this section) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Description: The device was tested using a "precision waveform generator" and "24 standard waveforms and the 26 flow-time waveforms."
- Sample Size: The number of unique waveform "tests" is explicitly stated as "24 standard waveforms and the 26 flow-time waveforms." This implies 50 distinct waveform tests. An additional test involved "Waveform #24 using a range of scale factors" (0.8, 1.0, 1.2, 1.6, 2.0, 2.4, 2.8, 3.0, 4.0, and 5.7) which would add 10 more tests for both devices.
- Data Provenance: The testing was "at an independent laboratory" and "Performance testing at LDS Hospital (Salt Lake City, UT)". The data is prospective, generated specifically for this regulatory submission. Country of origin for the data is primarily the USA (Salt Lake City, UT).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
No human experts were used to establish ground truth for the test set. The ground truth was established by the "precision waveform generator" which produces known, reproducible PEF and FEV1 values.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was generated by a machine (precision waveform generator), so there was no need for expert 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 MRMC comparative effectiveness study was done, and no AI components are mentioned in the device description. The device is a standalone electronic peak flow meter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The ACCUTRAX EPF840 electronic peak flow meter was tested in isolation against precisely generated waveforms to evaluate its accuracy and repeatability.
7. The Type of Ground Truth Used
The ground truth used was machine-generated reference values from a "precision waveform generator."
8. The Sample Size for the Training Set
No information is provided regarding a training set. This device is a measurement instrument, not a machine learning or AI-based system that would typically require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned or implied for this type of device.
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