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The Strive™ Dual Zone PFM is a monitoring device that measures Peak Expiratory Flow (PEF) generated by the patient during a forced exhalation maneuver. The device will monitor the PEF of patients whose doses of medication are dependent upon a measured obstruction in PEF.

The Strive™ Peak Flow Meter is designed for children five years or older and adults. The intended environments for use include home, hospitals and clinics.

The Strive™ Dual Zone Peak Flow Meter (PFM) is a hand-held monitoring device that measures Peak Expiratory Flow (PEF) generated by the patient during a forced exhalation mancuver. It can be used to objectively measure PEF by tracking day-to-day changes in breathing patterns.

The Strive™ PFM meets the Standards of Spirometry, 2005 revision, for portable peak flow meters as established by the American Thoracic Society and also meets ISO23747, First edition 2007-07-15, for Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans. The Strive™ PFM and product insert meets the educational guidelines recommended by the National Asthma Educational Prevention Program (NAEPP) of the National Institutes of Health.

The Strive™ PFM has two scale ranges to make the device suitable for both pediatric (+5 yrs) and adult patients who use a peak flow meter as part of their treatment program for respiratory conditions. A range selector is used to select the scale that best fits the patient's needs as determined by a healthcare provider. The device incorporates the NAEPP three zone color codes. The color-coded zone indicators on the side of the device adjust to define the patient's red, yellow and green zones. They can be readjusted as recommended by a healthcare provider.

The provided text describes a 510(k) summary for the Strive™ Dual Zone Peak Flow Meter (PFM). It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific acceptance criteria through clinical trials. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance and AI-specific metrics is not available in the provided document.

However, based on the non-clinical testing sections, we can infer the acceptance criteria for performance and the type of evaluation conducted.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document describes non-clinical performance and functional testing against established standards (ATS, ISO 23747). It does not mention a "test set" in the context of clinical data or patient samples. The testing would have involved physical units of the Strive™ Dual Zone PFM and potentially simulated exhalation profiles, as per the standards. Specific sample sizes of devices or simulated breath cycles for these non-clinical tests are not provided in this summary. There is no data provenance in terms of country of origin or retrospective/prospective for clinical data, as no clinical study was performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical expert-based ground truth was established for a "test set" as no clinical study was conducted. The "ground truth" for the non-clinical tests would be the specifications and requirements defined by the ATS and ISO standards.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication 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 physical medical device (peak flow meter) and does not involve AI or human readers for diagnostic interpretation. Therefore, no MRMC study or AI-assisted improvement analysis was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device and does not involve an algorithm for standalone performance evaluation in the context of AI. Its "standalone performance" is its accuracy and reliability in measuring PEF, which was evaluated against the ATS and ISO standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical and functional testing, the "ground truth" was established by recognized industry and medical standards: the American Thoracic Society (ATS) Standard of Spirometry: 2005 and ISO 23747 International Standard. These standards define the acceptable range of accuracy and performance for peak flow meters.

8. The sample size for the training set

Not applicable. This device is a physical medical device and does not involve machine learning or AI models, so there is no training set in that context.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for AI/machine learning, this question is not relevant.

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The TruPeak® Peak Flow Meter (PFM) is a portable monitoring device that measures the peak expiratory flow (PEF) generated by a patient during a forced exhalation maneuver. This measurement is useful in detecting changes that could signal a worsening of symptoms or an improvement in breathing function for people with respiratory conditions such as Asthma and emphysema. This device is packaged and labeled so it can be used as a screening device in a hospital or other clinical setting. Labeling is also included for the use of the device if dispensed by a health care provider to a patient for personal use.

The TruPeak® Peak Flow Meter (PFM) is a portable monitoring device that measures the peak expiratory flow (PEF) generated by a patient during a forced exhalation maneuver.

The provided document is a 510(k) premarket notification letter for the TRUPEAK Peak Flow Meter. It is a regulatory approval document from the FDA and does not contain the detailed study information or acceptance criteria requested in the prompt.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses regulatory classifications, general controls, and compliance requirements, but it does not include performance data, study design, or ground truth establishment.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
6. If a standalone study was done: Not mentioned.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned (as this is a medical device, not an AI/ML model, training sets are not typically applicable in the same way).
9. How the ground truth for the training set was established: Not mentioned.

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The TruZone™ Peak Flow Meter (PFM) is a portable monitoring device that measures the peak expiratory flow (PEF) generated by a patient during a forced exhalation maneuver. This measurement is useful in detecting changes in airways that could signal a worsening of symptoms or an improvement in breathing function for people with respiratory conditions such as Asthma and emphysema.

This device is packaged and labeled so it can be used as a screening device in a hospital or other clinical setting. Labeling is also included for the use of the device if dispensed by a health care provider to a patient for personal use.

The TruZone™ Peak Flow Meter (PFM) is a portable monitoring device that measures the peak expiratory flow (PEF) generated by a patient during a forced exhalation maneuver.

I am sorry, but the provided text does not contain the information requested regarding acceptance criteria or a study that proves the device meets those criteria for the "TrueZone Peak Flow Meter™".

The document is a 510(k) clearance letter from the FDA, which indicates that the device has been found substantially equivalent to a legally marketed predicate device. It confirms the device's classification, product code, and indications for use. However, it does not detail the specific performance acceptance criteria used in the substantial equivalence determination or provide a summary of any study demonstrating the device's performance against such criteria.

Therefore, I cannot populate the table or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

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Collapsible Holding Chamber used as an accessory to administer meter dose inhalers to patients being mechanically ventilated.

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I'm sorry, but this document is a 510(k) clearance letter for a medical device (AeroVent II™ CHC Collapsible Holding Chamber), not a study report. It does not contain information about acceptance criteria, device performance, study design, or expert ground truth as requested in your prompt. This document primarily states that the device has been found substantially equivalent to legally marketed predicate devices for its stated indications for use.

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Portable monitoring device which measures the peak expiratory flow (PEF) generated by the patient during a forced exhalation maneuver. This measurement is useful in detecting changes in airways that could signal a worsening of symptoms or an improvement in breathing function for people with respiratory conditions such as Asthma or emphysema.

TruZone™ Peak Flow Meter

The provided text is an FDA 510(k) clearance letter for the TruZone™ Peak Flow Meter. It describes the device and its indications for use, but it does not contain a detailed study report or acceptance criteria for the device's performance. The letter itself states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than a presentation of new performance data against specific acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided document. I can, however, extract the device name and indications for use.

Device Name: TruZone™ Peak Flow Meter

Indications for Use: Portable monitoring device which measures the peak expiratory flow (PEF) generated by the patient during a forced exhalation maneuver. This measurement is useful in detecting changes in airways that could signal a worsening of symptoms or an improvement in breathing function for people with respiratory conditions such as Asthma or emphysema.

Missing Information (Not available in the provided text):

1. A table of acceptance criteria and the reported device performance: This information is not present in the FDA clearance letter. Such data would typically be found in a separate study report or a detailed section of the 510(k) submission itself.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
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 as this is a peak flow meter, not an AI-assisted diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical measurement device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
8. The sample size for the training set: Not applicable, as this is a physical measurement device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

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The AeroGear Asthma Action Kit is a product containing the AeroChamber Aerosol Holding Chamber, a TruZone Peak Flow Meter, and educational materials used in an asthma management program. This kit is intended to be marketed to hospitals, outpatient clinics and physicians.

The provided text does not contain information about acceptance criteria, device performance, a study conducted to prove the device meets acceptance criteria, sample sizes, data provenance, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.

The document is a 510(k) summary for a medical device (AeroGear Asthma Action Kit) submitted in 1997. It describes the device, its components (which are previously cleared devices), and its intended marketing audience. It does not include any performance data or a study design.

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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

Study Details (Applicable to mechanical devices)

1. 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.

2. 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.

3. 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.

4. 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."

5. 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.

6. 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.

7. The sample size for the training set:

   • N/A. This is a mechanical device, not a machine learning model. There is no "training set."

8. 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.

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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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Not Found.

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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The Truzone 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. forced As this 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 the maximum displacement position of the piston at maneuver is terminated. This position the after 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 the addition of a separate package of Colorione tapes as an accessory to the TruZone Peak Flow Meter. The essence of the modification to this 510 (k) is adding the package for sale to aforementioned accessory physicians.

This K955262 submission is for a medical device called the TruZone Peak Flow Meter. However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The submission primarily focuses on:

• Identification of the device: TruZone Peak Flow Meter.
• Description of its function: A simple mechanical device that measures Peak Expiratory Flow Rate (PEFR).
• Comparison to a legally marketed predicate device: TruZone Peak Flow Meter (K926307).
• The nature of the current modification: The addition of a separate package of Colorzone tapes as an accessory.

Therefore, I cannot provide a table of acceptance criteria or details about a study as requested, because that information is not present in the given text. The provided text is a 510(k) summary, which often focuses on device description and substantial equivalence to a predicate device, rather than detailed performance study results and acceptance criteria.

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