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The Model 9100 PFT/DICO is a pulmonary function testing device which uses Morgan Scientific's ComPAS2 software to measure subject respiratory parameters including FVC, SVC, MVV, CPF, RMS, SNIP, DLCO, MBN2 and SBN2.

The device is PC-based and designed for lung function testing on adults and pediatrics, 6 years and older, in a variety of professional healthcare environments e.g., primary care, hospitals, pharmaceutical research centers and physicians' offices.

The Model 9100 PFT/DICO is intended for the assessment of respiratory function through the measurement of dynamic lung volumes i.e., spirometry and other lung functions i.e., diffusing capacity.

The Model 9100 PFT/DICO is composed of various sensors and valves with associated low level firmware. The firmware interfaces with the Morgan Scientific's ComPAS2 software (K213872) that resides on an on-board computer. The Model 9100 also provides for user input and present resulting data on an integral display.

The ComPAS2 software controls valves and reads unprocessed data from the sensors in the Model 9100then determines respiratory parameters including FVC, SVC, MVV, CPF, RMS (MIP and MEP), SNIP, DLCO, MBN2 and SBN2. The Model 9100 PFT/DICO firmware does not determine any respiratory parameters.

The ComPAS2 software uses flow and volume from the Vitalograph pneumotachograph spirometer to display the flow and volume information measured directly from patient effort. ComPAS2 also utilizes gas analyzer readings from the Model 9100 patient test benchmark to display dilution lung volume data and single / multi breath diffusion data measured directly from patient effort. This information is then provided in a report format.

The provided text describes the regulatory clearance of the Vitalograph Model 9100 PFT/DICO, a pulmonary function testing device, and its substantial equivalence to a predicate device. However, it does not contain information about a study proving the device meets acceptance criteria related to a machine learning or AI model's performance.

The document outlines performance testing conducted for the device's electrical, mechanical, and biocompatibility aspects, as well as software verification and validation. It explicitly states that the device uses "Morgan Scientific's ComPAS2 software to measure subject respiratory parameters," but there's no indication that this software includes an AI or machine learning component that would require a study with human-in-the-loop performance, expert ground truthing, or MRMC studies typically associated with AI/ML medical devices.

Therefore, many of the requested details about acceptance criteria for an AI model's performance and associated study specifics (sample size for test/training, number of experts, adjudication, MRMC, standalone performance, ground truth type) cannot be extracted from this document.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and principles of operation, supported by standard bench testing and software validation.

Here's an attempt to answer the request based only on the provided text, highlighting the absence of AI/ML-specific details:

Device: Vitalograph Model 9100 PFT/DICO

Study Type: This document describes a 510(k) premarket notification for substantial equivalence, supported by bench testing, software verification/validation, and compliance with various standards. It is not an AI/ML performance study. The "study that proves the device meets the acceptance criteria" refers to the entire body of evidence submitted for 510(k) clearance, rather than a specific AI model's performance study.

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

The document defines performance specifications and states that testing supported the safety and performance, implying these specifications were met. The specific "acceptance criteria" for the overall device's performance are embedded in the compliance with standards and the "similar" comparisons to predicate/reference devices.

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