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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.

AI/ML Overview

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.

Characteristic	Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance (Pulsehaler™)
Indications for Use	Must be same as or similar to predicate (Aerosure, K140772): Improves clearance of secretions, reduces need for postural drainage, facilitates opening of airways, prevents/reverses atelectasis, aids mucus removal. Intended for single patient, adult users in home or hospital.	Same: Improves clearance of secretions, may reduce need for postural drainage, facilitates opening of airways, may be used to prevent or reverse atelectasis, may also be useful in the removal of mucus from the lungs. Intended for single patient, adult users in home or hospital environment.
Intended Use Environment	Must be Hospital and Home Use.	Hospital and Home Use.
Patient Population	Similar to predicate (patients age 21 and above with various lung conditions susceptible to secretion problems/atelectasis).	Adult patients. (Note in comparison table: "Similar to predicate, no specific disease conditions are claimed.")
Oscillation Mechanism	Similar to predicate (Rotating Disk).	Rotating Disc.
PEP Mechanism	Output PEP pressures, vibration frequencies, and amplitudes are equivalent to predicate and reference device.	Flow vs resistance from oscillation mechanism, restricted orifice, and blower. (Note in comparison table: "Subject device generates PEP with a blower, however, output PEP pressures, vibration frequencies and amplitudes are equivalent to those produced by predicate and reference device.")
Operating Modes	Output PEP pressures, vibration frequencies and amplitudes produced at each speed are equivalent to predicate.	Single mode with multiple speeds. (Note in comparison table: "Subject device has multiple speeds. Output PEP pressures, vibration frequencies and amplitudes produced at each speed are equivalent.")
Software Control	Similar to predicate (Yes).	Yes.
Mean Frequency	Within range of predicate (30-52 Hz) and reference (7-22 Hz).	6 Hz to 65 Hz. (Note in comparison table: "Mean frequencies generated by subject device are within the range generated by predicate and reference device.")
Pressure Amplitude	Within range of predicate (2-32 cmH2O) and reference (1-21 cmH2O).	9-23 cmH2O. (Note in comparison table: "Pressure amplitude generated by subject device is within the range generated by predicate and reference device.")
Mean Pressure	Within range of predicate (1-11 cmH2O).	7-10 cmH2O. (Note in comparison table: "Mean pressure generated by subject device is within the range generated by predicate.")
Pressure Limitation	Output pressure during single and multiple faults must be <20 cmH2O.	Based on hardware blower limitations. (Note in comparison table: "Output pressure of blower limited during single and multiple faults to <20cmH2O.")
Power Supply	Similar to predicate (AC Mains connected DC power supply).	AC Mains connected DC power supply, 110~240V 50/60Hz. (Note in comparison table: "Wall power to Base Unit - same as predicate; however, Hand Unit is connected and powered by Base Unit, instead of rechargeable batteries.")
Sterility	Used non-sterile.	Used non-sterile.
Standards Compliance	Compliant with relevant medical device standards shown by predicate (e.g., IEC 60601-1-2, ISO 10993).	ISO 10993; IEC 60601-1-2; IEC 60601-1, IEC 60601-1-6, IEC 60601-1-11, ISO18562. (Note: "Additional applicable standards met.")
Cleaning & Disinfection	Validated cleaning and disinfection methods.	Validation done, involving Cidex.
Shelf/Use Life	Validated shelf and use life.	Shelf Life (6 Months) and Use Life (5 years) Testing completed.
Biocompatibility	Compliant with relevant biocompatibility standards.	Testing including VOC and Particulate Matter 2.5 Micron Testing - External Communicating, tissue / bone / dentin and Surface contact, Mucosal Membrane, permanent contact duration, per ISO 10993 suite and ISO 18562-3:2002.
Functional/Software Testing	Functional and Software validation to Design Input Requirements; Software V&V per FDA guidance.	Functional Testing and Software Validation to Design Input Requirements. Software verification and validation testing conducted, documentation provided as recommended by FDA's Guidance. Software level of concern: moderate.

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 testing and comparison to predicate devices, not typically "test sets" of data for algorithmic performance. The testing involved physical devices. There is no mention of "data provenance" in terms of patient data or clinical images from specific regions or whether it was retrospective/prospective, as this is not a data-driven AI device.

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. There is no "ground truth" establishment in the context of expert review of images or clinical data, as this is a mechanical device submission.

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

Not applicable. There is no adjudication required for this type of non-clinical device test.

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

No. This is not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed or required.

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

Not applicable. This is not an algorithm-only device. Its performance is inherent to its mechanical and software design, tested physically.

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

Not applicable in the context of clinical "ground truth" for diagnostic accuracy. The "ground truth" for this device's performance is its physical measurements (e.g., pressure, frequency) and safety characteristics, confirmed through engineering tests and adherence to recognized standards. For the purpose of substantial equivalence, the "ground truth" is also the performance and characteristics of the legally marketed predicate device.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

Not applicable. See point 8.

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