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This product is indicated for use in patients where enhanced medicated aerosol deposition or lung exercise is recommended by a physician or licensed clinician. This device is intended to be used in the hospital, clinic and home care markets,

The Salter Labs PEP device is designed to be used with the Salter Labs Nebutech Nebulizerseries Mouthpiece as a stand-alone device, or the device may be used in conjunction with the Salter Labs Nebutech Nebulizer and the Salter Labs Aerosol Filter during the nebulization process.

This product is a nebulizer accessory that connects to the exhalation port of the Salter Labs Nebutech Nebulizer mouthpiece and serves to provide a controllable exhalation resustance of from 5 to 20 cm H20 at flow rates ranging from 10 to 55 L/min.

The Salter Labs PEP Device (PEP Device) is a non-sterile, injection molded plastic device that will attach to the exhalation valve of the Salter Labs NebuTech™ Model 8960 & 8660 Nebulizer mouthpiece assembly or to the NebuTech™ mouthpiece placed in line in a 25 to 50 cm flex tube with a one-way valve at the distal opening. In either of these assemblies, the PEP Device will regulate the force and flow of exhalation to provide a specific therapeutic effect. The device is intended to be single patient use and is prescribed by a physician or licensed clinician.

The purpose of the Salter Labs PEP Device is to allow for a variable regulation of exhalation resistance through a selectable set of orifices in order to obtain a resistance at a given flow rate. The restriction of exhalation serves to open closed airways, enhancing aerosol deposition, increasing oxygenation and improving bronchial hygiene.

The Salter Labs PEP Device has a variable exhalation resistance capability. Effective exhalation resistance is determined by rotation of a "handle," located at the top of the device. The handle is connected to a disk that contains a set of predetermined exit ports. The diameter of these ports establishes the resistance to exhalation.

A manometer may be placed on the device port in order for the clinician to determine the correct resistance for each patient. This will also help the patient determine what a proper exhalation force feels like. The patient will be instructed by the clinician on proper breathing techniques and the manometer will be used to assure that exhalation pressure ranges do not exceed 20cm of water pressure, which is considered to be the maximum average therapeutic target value. The prescribing doctor or licensed clinician will determine all appropriate settings and device use and application to meet the particular requirements of his/her patient.

The provided text is a 510(k) summary for the Salter Labs PEP Device. It outlines the device's features, intended use, and comparison to predicate devices, focusing on its physical characteristics and measured back pressure.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" for this device, as implied by the FDA submission, relate to its ability to provide a controllable exhalation resistance within a specific range, and its technological characteristics being substantially equivalent to predicate devices.

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

• Test Set Sample Size: Not explicitly stated as a "sample size" in the conventional sense for human subjects or a large batch of devices. The comparative testing involved one unit of the Salter Labs PEP Device and one unit each of the predicate devices.
• Data Provenance: The data is from "Comparative Test Results at 30 L/min" which is presumably generated by Salter Labs (the submitter) through non-clinical testing. The country of origin for this testing is not specified, but the company is based in Arvin, CA, USA. This is retrospective data in the context of the device's development; the testing was performed to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the given text. The "ground truth" here is objective physical measurements of back pressure, not diagnostic assessments requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. The "test set" involves physical measurements (back pressure at different settings/flow rates) of mechanical devices, not subjective interpretations 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 a mechanical PEP (Positive Expiratory Pressure) device, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of "human readers improving with AI" are irrelevant to this submission. No human interpretation is involved in its function or the assessment of its performance.

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

Not applicable. This device is a purely mechanical product with no software or AI components, so there is no "algorithm only" performance to evaluate. Its performance is its physical function.

7. The Type of Ground Truth Used

The ground truth used for the device's technical specifications (specifically, back pressure) was physical measurement (presumably using a manometer or similar pressure sensor) under controlled flow rate conditions (30 L/min). This is objective, quantitative data.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary of Device-Specific Information from the Text:

The Salter Labs PEP Device is a mechanical respiratory accessory designed to provide variable exhalation resistance for lung exercise and enhanced aerosol deposition. Its performance was primarily evaluated through non-clinical testing focusing on its ability to generate specific back pressures at a given flow rate (30 L/min). The key finding was that it consistently produced back pressures within the intended therapeutic range of 5 to 20 cm H₂O, and that its performance was comparable to existing predicate devices, with the added benefit of an overpressure relief valve. The FDA determined the device to be substantially equivalent based on these characteristics and intended use.

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