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Vyntus Walk is a mobile medical application which is intended to be used on a mobile platform to collect and collate sequential pulse oximetry data during six minute walk tests (6MWT). Pulse oximetry data are collected from an external pulse oximeter, using Bluetooth connection. The mobile platform has access to a host computer with SQL database (SentrySuite) via a wireless network for further data evaluation and diagnosis. Patients as young as 4 years of age and older can be tested providing they can cooperate with the test instructions. Measurements are performed under the direction of a physician in a hospital environment, physician's office or similar setting (professional healthcare facilities).

The Vyntus Walk is a tablet based software mobile application that collects and collates pulse oximeter data from an external pulse oximeter during a 6 Minute Walk Test and remotely transmits to the SentrySuite for access to physicians for diagnosis purposes. Vyntus WALK includes wearable, wireless sensors connected to a tablet PC running Android Operating System with a workflow driven 6MWT application. Vyntus WALK integrates seamlessly in today's mobile healthcare environment through the new Sentry CIS™ service landscape for central data management and reporting.

The provided document describes the Vyntus Walk, a mobile medical application designed for collecting and collating pulse oximetry data during Six Minute Walk Tests (6MWT). The document includes a 510(k) summary, which outlines the device's characteristics, intended use, and comparison to a predicate device (SpiroPro K092324). It also summarizes testing performed to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" with numerical thresholds for performance metrics. Instead, it refers to passing applicable tests and standards and demonstrating substantial equivalence to the predicate device. The performance characteristics of the Vyntus Walk and how they relate to the Nonin Oximeter (which it connects to) are listed.

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

• Sample Size for Clinical Test Set: 16 healthy subjects.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the clinical test was performed in September 2014, making it prospective in relation to the submission date.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical test. It only states that the 6MWT was performed "according to ATS criteria," implying standard clinical practice, but not involving independent expert adjudication for ground truth.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method for the clinical test set. The focus was on the direct measurement and recording of data by the Vyntus Walk compared to an external pulse oximeter (Nonin) and the overall successful operation of the device during the ATS-compliant 6MWT.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance:

No, an MRMC comparative effectiveness study was not done. The Vyntus Walk is a data collection and collation tool, not an AI-driven interpretive device that assists human readers in making diagnoses. It facilitates the 6MWT by integrating external pulse oximeter data into a mobile platform.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The document does not specifically describe a "standalone" performance test in the context of an algorithm's diagnostic accuracy. The Vyntus Walk's primary function is as a data collection and display tool for an external oximeter. Its performance evaluation focuses on its ability to accurately collect, collate, and transmit data from the Nonin oximeter. The accuracy of the SpO2 and Heart Rate measurements themselves relies on the connected Nonin Oximeter. The "Accuracy Testing" mentioned was bench testing comparing the proposed device with the predicate device, likely focusing on data handling and display, rather than inherent measurement accuracy as a standalone sensor. The clinical test confirmed the device operated as intended and collected data during a 6MWT successfully.

7. The Type of Ground Truth Used:

For the clinical testing, the ground truth was essentially the real-time physiological data (Heart Rate and SpO2) from an external pulse oximeter (Nonin) during a 6MWT performed according to ATS criteria, and the proper collection and display of this data by the Vyntus Walk. There is no mention of a separate "ground truth" established by experts or pathology for the data itself, as the device is a data handler.

8. The Sample Size for the Training Set:

The document does not provide any information about a training set size. The Vyntus Walk is described as a "mobile medical application," and while software typically undergoes development and internal testing, there's no mention of a "training set" in the context of machine learning or AI algorithm development for a diagnostic task.

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

As no training set is discussed or implied for an AI algorithm, there is no information on how ground truth for a training set was established.

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