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The D R Burton® OxyPAP™ device is indicated for the treatment and prevention of atelectasis. It also has the ability to provide supplemental oxygen when used with compressed oxygen. It includes the option of a pressure manometer. The device is for patients (ages 5 years and above) who are capable of following directions for positive airway pressure (PAP) therapy.

Normal use of the D R Burton OxyPAP™ should not be more than 24 hours total combined time.

The environment of use is for hospital and clinical setting.

The OxyPAP device is a handheld respiratory therapy device that creates a positive airway pressure. The OxyPAP device is intended to be used by pediatric (ages 5 years and above) and adult patients in the hospital environment, under the supervision of a healthcare professional. The OxyPAP device is a single patient use device.

The provided text describes the D R Burton OxyPAP device, its indications for use, and a comparison to predicate and reference devices for a 510(k) submission. However, this document does not contain any information about acceptance criteria, a specific study proving the device meets these criteria, or details regarding AI/algorithm performance and ground truth establishment.

The document is a US FDA 510(k) clearance letter and summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a dedicated standalone study. The "Performance" and "Non-clinical Comparative Performance" sections primarily describe comparative testing to show similarity to existing devices.

Therefore, I cannot fulfill all parts of your request based on the provided text. I will explain what information is present and what is missing.

Summary of what can be extracted from the document:

• Device Name: D R Burton OxyPAP
• Device Type: Incentive Spirometer, Positive Airway Pressure (PAP) Therapy Device
• Indications for Use: Treatment and prevention of atelectasis; ability to provide supplemental oxygen when used with compressed oxygen. For patients (ages 5 years and above) capable of following directions for PAP therapy. Normal use not more than 24 hours total combined time. Environment of use: hospital and clinical setting.
• Predicate Device: K991300 – DHD Healthcare Corp. – Boeing, Positive Airway Pressure (PAP) Therapy Device
• Reference Devices: K173819 – Trudell VersaPAP™ Device; K040991 – Ambu Disposable Pressure Manometer

Missing/Not Applicable Information based on the prompt's requirements:

The document focuses on substantial equivalence for a medical device that is not an AI/ML powered device. As such, information typically associated with AI/ML device validation studies (like distinct acceptance criteria for algorithm performance, expert review for ground truth, MRMC studies, training/test set details, etc.) is not present and not applicable to this type of device submission.

Specifically, the following sections of your request cannot be answered from the provided text:

• 1. A table of acceptance criteria and the reported device performance: The document presents comparative performance data (e.g., Mean PEEP, Mean Peak Expiratory Pressure), but these are comparisons to predicate/reference devices, not explicit acceptance criteria for a standalone study performance. There are no clear quantitative acceptance criteria stated for the D R Burton OxyPAP itself beyond being "substantially equivalent" to the predicate.
• 2. Sample size used for the test set and the data provenance: Not applicable as this is a physical device, not an algorithm being tested on a data set. The "bench testing" mentioned includes performance testing and drop testing, but no "sample size" in the context of data points.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like this is established through engineering and clinical performance testing, not expert review of AI outputs.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for an AI-assisted workflow, which is not the case here.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
• 7. The type of ground truth used: For a physical device, "ground truth" would refer to measured physical properties or clinical outcomes. The document discusses "Biocompatibility" (material certification to a legally marketed device) and "Bench Testing" (comparative performance, drop testing, effects of aging). These are the "truths" for this device.
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable.

Information that is present (though not in the requested format for AI/ML devices):

• Device Performance Reported (Comparative, not against specific acceptance criteria):
  • Proposed OxyPAP:
    • Mean PEEP (cmH2O) @800 ml TV: 2.81 @ 5 Lpm, 12 @ 10 Lpm, 12.75 @ 15 Lpm
    • Mean Peak Expiratory Pressure (cmH2O) @800 ml TV: 15 Lpm / 15 cmH2O; 20 (400 TV) / 21 (800 TV)
    • Mean Inspiratory Pressure (cmH2O) @800 ml TV: -0.7 @ 5 Lpm, -4.7 @ 10 Lpm, -3.46 @ 15 Lpm
    • Mean Expiratory Pressure (cm H2O) @ 800 ml TV: 3.1 @ 5 Lpm, 12.1 @ 10 Lpm, 13 @ 15 Lpm
  • Predicate DHD EzPAP (for comparison):
    • Mean PEEP (cmH2O) @800 ml TV: 2 @ 5 Lpm, 8 @ 10 Lpm, 16 @ 15 Lpm
    • Mean Peak Expiratory Pressure (cmH2O) @800 ml TV: 15 Lpm / 15 cmH2O; 22 (400 TV) / 26 (800 TV)
    • Mean Expiratory Pressure (cm H2O) @ 800 ml TV: 5 @ 5 Lpm, 11 @ 10 Lpm, 20 @ 15 Lpm

The core conclusion of the document is that "Based upon the comparative performance testing we have demonstrated that the proposed device compared to the predicate and reference devices can be found to be substantially equivalent." This is the primary "acceptance criterion" for a 510(k) submission of this nature.

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The Aerobika* Oscillating Positive Expiratory Pressure device intended for use as a Positive Expiratory Pressure (PEP) device. The Aerobika* Oscillating PEP device may also be used simultaneously with nebulized aerosol drug delivery. The device is intended to be used by patients capable of generating an exhalation flow of 10 lpm for 3 – 4 seconds.

The Aerobika* OPEP with Manometer device combines Positive Expiratory Pressure (PEP) with oscillations upon exhalation with visual feedback relative to the patient's expiratory pressure. The device is mechanically driven using only the energy from the patient's exhaled breath. Upon exhalation, a portion of the patient's exhaled breath is routed through the manometer device and exits through it. While the manometer is pressurized by the patient's exhaled breath, an indicator contained within the manometer housing indicates the patient's exhaled pressure. The manometer adapter consists of plastic components constructed of polypropylene material, and the manometer is a purchased component to TMI, and is previously cleared under K040991.

This document, a 510(k) Premarket Notification for the Aerobika* OPEP with Manometer, describes non-clinical testing performed to establish substantial equivalence to a predicate device. It does not contain information about clinical studies with human participants. Therefore, many of the requested details about acceptance criteria for clinical performance, ground truth, expert adjudication, or MRMC studies are not applicable or available in this document.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document details several non-clinical tests performed. While explicit "acceptance criteria" are not numerically stated in a table format, the narrative indicates that the device "meets specifications and performs comparably to the predicate Aerobika* OPEP device." The performance reported is that the device did meet these specifications.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes non-clinical laboratory testing. Specific sample sizes for each mechanical or environmental test are not provided in this summary. The data provenance is Trudell Medical International, located in London, ON, Canada, conducting design verification and validation activities. The studies are prospective in nature as they are conducted for the purpose of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This document describes non-clinical mechanical and material testing, not diagnostic or clinical performance requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This document describes non-clinical mechanical and material testing, not diagnostic or clinical performance requiring 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

Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study was conducted.

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

Not applicable. This device is a mechanical OPEP device, not an algorithm. The "standalone" performance refers to the device's inherent mechanical function. The non-clinical testing evaluates this.

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

For the non-clinical tests, the "ground truth" is established by engineering specifications, recognized standards (like ISO 10993-1:2009 for materials), and the performance characteristics of the legally marketed predicate device (Aerobika* OPEP device, K123400).

8. The sample size for the training set

Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for a mechanical device.

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To provide visual indication of a patient's airway pressure during ventilation. It may be attached to the manometer port or proximal port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP mask, or CPAP circuits.

For patients that the clinician desires to monitor or measure airway or circuit pressure.

Home, Physician office, Hospital, Sub-acute Institutions, Emergency services or anywhere measurement of airway pressure is desired.

The Westmed disposable pressure manometer is a means of providing visual indication of patient airway pressure during ventilation.

The device consists of:

• 1. Clear housing with a printed pressure scale
• 2. A float with indicator and
• 3. Spring

It functions by reacting to the positive present in the ventilation device. When pressure is in the device the float moves up or down to indicate the pressure of the system. This manometer displays the pressure in the "circuit". The proposed design incorporates a calibrated spring, which has demonstrated reasonable accuracy over the expected clinical pressure range -0-60 cm H2O. The performance characteristics are that the measured pressures are accurate to:

• • 3 cm H2O up to 60 cm H2O
    It is a single patient, disposable, packaged non-sterile device.

Here's a breakdown of the acceptance criteria and study information for the Disposable Pressure Manometer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The predicate device K003497 had different accuracy criteria:

• ± 1 cm H₂O from 0-10 cm H₂O
• ± 2 cm H₂O from 10-40 cm H₂O
• ± 3 cm H₂O above 40 cm H₂O
  The proposed device set its own accuracy criteria, consistent with reference devices (K040991 Ambu, K954486 Mercury Medical) for a wider pressure range.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document states that "All samples met the pass/fail criteria" for Accuracy and Repeatability, Aging, Mechanical, Environmental, and Positional Orientation tests. It also mentions "Samples were dropped," "Samples which had real-time aging and samples in accelerated aging were pressurized," and "Each sample was tested multiple times." However, the exact number of samples (N) used for the test set is not explicitly stated in the provided text.
• Data Provenance: Not specified, but likely from in-house testing by Westmed, Inc. No mention of geographical origin or whether it's retrospective or prospective is made.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. This device is a measurement tool (manometer), and ground truth for its performance is established by comparison to a calibrated standard (digital manometer), not expert interpretation.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Ground truth for a physical measurement device's accuracy and performance is typically determined against established calibration standards and engineering specifications, not human adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. This is a physical medical device (disposable pressure manometer) used for objective measurement, not an AI or diagnostic imaging device that requires human interpretation. Therefore, an MRMC comparative effectiveness study is not relevant.
• Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done: Yes, in essence. The documented "Non-Clinical Testing Summary" details the performance of the Westmed DPM device itself, including its accuracy, repeatability, and resilience to aging, mechanical stress, environmental conditions, and positional changes. This testing is performed on the device without a human in the loop, directly measuring its output against a digital manometer.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the device's accuracy and repeatability was established by comparison with a digital manometer (implicitly, a calibrated standard). The "Summary: Accuracy and Repeatability" section states: "Samples were pressurized across the range and confirmed with the digital manometer."

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set. Its functionality is based on mechanical principles (spring and float), not learned patterns.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

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