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The TruPeak Peak Flow Meter is a simple mechanical that responds to and indicates the Peak device 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 commences an internal piston extends exhalation spring as reaction to an internal pressure spike. An indicator is pushed by the moving piston and remains position of the the maximum displacement piston at maneuver is terminated. This position after the corresponds to the PEFR and is quantified in liters per minute by reading a scale next to the indicator. displacement function is logarithmic The piston thereby providing greater resolution of scale at lower PEFR readings.

This K963095 document describes a medical device, the TruPeak Peak Flow Meter, which is a simple mechanical device used to measure Peak Expiratory Flow Rate (PEFR). However, this document is a 510(k) Summary from 1996 and does not contain the acceptance criteria or details of a study demonstrating device performance as requested.

The 510(k) summary primarily focuses on:

• Identifying the device and its manufacturer.
• Classifying the device.
• Establishing substantial equivalence to a previously cleared device (TruPeak Peak Flow Meter, 510(k) #955234).
• Briefly describing the device's function.
• Noting that the current device is identical to the predicate except for changes in component dimensions to conform to the November 1994 ATS Standards update.

Therefore, I cannot provide the requested information from this document. The document simply states conformity to ATS standards, but does not provide the performance data or the study details.

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The TruPeak 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 a 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. The The piston displacement function is logarithmic thereby providing greater resolution of scale at lower PEFR readings.

The TruPeak Peak Flow Meter is identical in form and function to the TruZone Peak Flow Meter as described in its 510(k) #926307 except for the use of zone management tapes. The essence of the modification to this 510(k) is changes in the device labeling to conform to the "Guidance for labeling Peak Flow Meters for Over the Counter Sale", dated June 1993.

This 510(k) pertains to a mechanical device, a Peak Flow Meter, and not an AI/ML powered device. Hence, the requested information about acceptance criteria and study details for an AI/ML device is not applicable.

Here's why and what information is available:

• Device Type: The "TruPeak Peak Flow Meter" is described as a "simple mechanical device" that measures "Peak Expiratory Flow Rate." It does not involve any algorithms, AI, or machine learning for its operation or interpretation.
• Purpose of Submission: The 510(k) submission is primarily for a modification to device labeling to conform to "Guidance for labeling Peak Flow Meters for Over the Counter Sale," not for a new AI/ML functionality or a study demonstrating AI performance.
• Comparison to Predicate: The document explicitly states, "The TruPeak Peak Flow Meter is identical in form and function to the TruZone Peak Flow Meter as described in its 510(k) #926307 except for the use of zone management tapes." This indicates a substantial equivalence claim based on the predicate device's existing performance, not new studies for AI performance.

Therefore, the following points of your request are not applicable or cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance: Not applicable for an AI device. The general performance of peak flow meters is well-established by regulatory guidance for mechanical devices.
2. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of AI evaluation was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for AI model training or testing was established.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on the mechanical operation and the regulatory compliance of labeling for a predicate device.

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