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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 D R Burton iPEP Therapy System or vPEP is intended for use as a Positive Expiratory Pressure (PEP) by patients capable of generating an exhalation flow of 10 lpm for 3-4 seconds and an Incentive Spirometer as an inspiratory, deep breathing positive exerciser.

Intended for single-patient, multi-use.

iPEP System for hospital and clinical settings vPEP for hospital, clinical, and home care setting

D R Burton Healthcare as indicated above proposes to offer 2 devices which we will refer to as the:

• iPEP (integrated Incentive spirometer with PEP) system and ●
• . vPEP which is a standalone PEP therapy device

iPEP system

• Volumetric Incentive Spirometer up to 4000 cc
• Oscillatory PEP module (cartridge) ●

The design of the iPEP system permits the PEP cartridge to be removed and used as an independent PEP device, which we refer to as the Pocket PEP.

In order to use the Pocket PEP the iPEP system includes a separate mouthpiece, carrying / storage case and dust cover which are needed when one wants to use the PEP cartridge independent of the iPEP systems (Pocket PEP).

When the PEP cartridge is removed from the iPEP system, one can insert a cover where the PEP cartridge has been removed to allow the incentive spirometer to be used one its own.

vPEP

• The vPEP is the standalone device that is pre-assembled and is not intended to be used in the iPEP ● System. The vPEP incorporates the identical internal components of the PEP cartridge of the iPEP system.

The provided document is a 510(k) Summary for the D R Burton iPEP System and vPEP, which are devices intended for Positive Expiratory Pressure (PEP) therapy and as Incentive Spirometers. The study described is a non-clinical bench testing and usability study, focused on demonstrating substantial equivalence to predicate devices. There is no clinical study described.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents two comparison tables (Table 1 for PEP function, Table 2 for Incentive Spirometer function) comparing the proposed device against its predicates. The acceptance criteria for the proposed device are implicitly set by its performance falling within a certain range (e.g., 15%) of the predicate devices' performance.

Note on "Criteria within 15%": This phrase appears in Table 1 for Frequency and Amplitude/Pressure, suggesting that the proposed device's performance metrics were expected to be within 15% of the predicate device's values. The reported values for the iPEP and vPEP appear to meet this implicit criterion.

Additional Bench Testing:

• Aging, Simulated Life (cleaning), Drop Testing, Cleaning: Performed with pre- and post-exposure evaluation.
• Biocompatibility Materials: Cytotoxicity, sensitization, and irritation testing for materials with limited duration (

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