(90 days)
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The TruZone Peak Flow Meter is a simple mechanical device that responds to and indicates the Peak Expiratory Flow Rate (PEFR) generated by the user during a forced exhalation maneuver.
inlet of the device is placed into the user's The mouth after which the maximum rate at exhalation is attempted from nearly full lungs. As this forced exhalation commences an internal piston extends ત્વ spring as reaction to an internal pressure spike. An indicator is pushed by the moving piston and remains at the maximum displacement position of the piston after the maneuver is terminated. This position corresponds to the PEFR and is quantified in liters per minute by reading a scale next to the indicator. piston displacement function is logarithmic The thereby providing greater resolution of scale at lower PEFR readings.
The TruZone Peak Flow Meter is identical in form and function to the TruZone Peak Flow Meter as described in its 510(k) #926307 except for changes in component dimensions necessary for the performance of the device to conform to the November 1994 ATS Standards update.
Here's a breakdown of the requested information based on the provided text for K963089:
Important Note: The provided document is a 510(k) summary for a mechanical medical device (Peak Flow Meter), not a software or AI-powered device. Therefore, many of the requested criteria (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable or directly addressed in the context of a mechanical device submission.
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to November 1994 ATS Standards Update (for PEFR measurement accuracy) | Not explicitly quantified in this summary, but the device is stated to conform to these standards. "changes in component dimensions necessary for the performance of the device to conform to the November 1994 ATS Standards update." |
| Functionality consistent with previous TruZone Peak Flow Meters | "The TruZone Peak Flow Meter is identical in form and function to the TruZone Peak Flow Meter as described in its 510(k) #926307" |
| Accurate indication of Peak Expiratory Flow Rate (PEFR) | "responds to and indicates the Peak Expiratory Flow Rate (PEFR)" |
| Logarithmic piston displacement for greater resolution at lower PEFR readings | "piston displacement function is logarithmic thereby providing greater resolution of scale at lower PEFR readings." |
Study Details (Applicable to mechanical devices)
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Sample size used for the test set and the data provenance:
- Not Applicable (N/A) / Not provided in this summary. For a mechanical device, testing typically involves bench testing against reference standards or physical models, not patient data in the way AI models are evaluated.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A / Not provided. The "ground truth" for a mechanical peak flow meter would be derived from calibrated instruments or national/international standards (like ATS), not expert human interpretation.
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Adjudication method for the test set:
- N/A / Not provided. Adjudication methods like 2+1 or 3+1 are relevant for subjective interpretations, often in image analysis. Mechanical device performance is assessed objectively.
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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. This is a mechanical device, not an AI or diagnostic imaging device that would involve human "readers."
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is a mechanical device. The concept of "standalone algorithm" does not apply. The device's performance is inherently "standalone" in its mechanical operation.
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The type of ground truth used:
- Implied Regulatory/Standard Performance: The ground truth for confirming the device's accuracy would be derived from the November 1994 ATS Standards update. This standard specifies how peak flow meters should perform and the acceptable ranges of error. The device was modified to conform to these standards.
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The sample size for the training set:
- N/A. This is a mechanical device, not a machine learning model. There is no "training set."
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How the ground truth for the training set was established:
- N/A. This is a mechanical device. There is no "training set" or ground truth for it in the context of machine learning. The design parameters were likely established through engineering principles and compliance with the ATS standards.
Summary of the Study Proving Acceptance Criteria:
The provided 510(k) summary for the TruZone Peak Flow Meter indicates that the device was modified to meet the November 1994 ATS Standards update. The previous versions of the device were cleared under 510(k) #926307 and #955262, and the current device is "identical in form and function" to the previously cleared device, except for component dimension changes made specifically to achieve compliance with the updated ATS standards.
While explicit testing data (e.g., number of units tested, specific accuracy percentages) is not detailed in this high-level summary, the claim of "conform[ing] to the November 1994 ATS Standards update" serves as the primary evidence that the device meets its acceptance criteria. For mechanical devices, compliance with such recognized national or international standards is a common method of demonstrating safety and effectiveness. The "study" here is implicitly the engineering and testing effort undertaken to ensure the device's performance aligns with these standards.
§ 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).