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Pulsehaler™ is indicated for use as a Positive Expiratory Pressure (PEP) Device.

• The use of Pulsehaler™ improves clearance of secretions .
• The use of Pulsehaler™ may reduce the need for postural drainage ●
• Pulsehaler™ facilitates opening of airways in patients ●
• Pulsehaler™ may be used to prevent or reverse atelectasis ●
• Pulsehaler™ mav also be useful in the removal of mucus from the lungs ●

Pulsehaler™ is intended for single patient, adult users in a home or hospital environment.

Pulsehaler™ is a non-invasive handheld treatment device used daily by the patient to promote airway opening and secretion clearance by vibrating the airways at a variety of different frequencies. It consists of Base Unit with an LCD touch screen that provides a pressure source, and a Hand Unit with a rotating disc that periodically interrupts the pressure source to deliver pressure pulsations to the patient. These components are connected by an air hose and an electrical power and data cable.

While sitting in a relaxed position, the patient holds the Hand Unit and breathes normally through its mouthpiece. A steady flow of pressurized air is delivered to the Hand Unit component by the Base Unit and enters the air inlet of the Hand Unit. The pressurized air passes along the internal airflow duct of the Hand Unit through an air filter until it reaches the rotating disc. When it rotates the disc interrupts the continuous flow of air from the Base Unit and then releases the flow in pulses at a rate corresponding to the rotation speed. The rotation speed of the disc is determined by the software using a pre-set protocol.

The exhalation port is restricted in size, which together with the positive pressure generated by the Base Unit, induces PEP.

The patient is treated with the device for 20 minutes at a time, up to three times a day according to the prescribing physician's instructions. During each 20-minute treatment, Pulsehaler™ delivers pulses varying from 5 to 50 pulses per second. The patient may use the User Interface to pause the treatment at any time or resume after a pause.

Pulsehaler™ is intended for single adult patient, multiple reuse, at home or in a healthcare facility and is non-sterile. The instructions for use contain cleaning and high-level disinfection instructions that involve the use of Cidex.

Expected Use Life of the device is 5 years and Shelf Life is 6 Months.

The provided document is a 510(k) premarket notification for the Pulsehaler™ device, which is a Positive Expiratory Pressure (PEP) Device. The document details the device, its indications for use, and a comparison to predicate and reference devices to establish substantial equivalence.

Based on the provided text, the Acceptance Criteria and the Study that proves the device meets the Acceptance Criteria are primarily focused on non-clinical testing and comparison to predicate devices, rather than a clinical study with human subjects, especially not a multi-reader, multi-case (MRMC) comparative effectiveness study of an AI-powered device. The device is a mechanical PEP device, not an AI-powered diagnostic or therapeutic device that would typically involve AI-specific performance metrics like sensitivity, specificity, or AUC, or human reader improvement studies.

Therefore, the requested information regarding AI device acceptance criteria, MRMC studies, ground truth establishment for AI models, and training/test set sizes for AI data are not applicable to this specific submission. The submission relies on demonstrating substantial equivalence to a legally marketed predicate device (K140772) through technical and functional comparisons, and non-clinical testing.

Here's an attempt to answer the questions based only on the provided document, noting the limitations of the document for an AI-focused query:

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

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for performance in the way one might see for an AI device (e.g., "Sensitivity must be >X%"). Instead, the device's "performance" is demonstrated by its functional characteristics being similar or equivalent to its predicate device. The document summarizes non-clinical testing and then provides a comparison table.

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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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