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The MY01 Continuous Compartmental Pressure Monitor is intended for real-time and continuous measurement of compartmental pressures. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome. The trend arrows displayed are meant for qualitative purposes only and are not intended to have any clinical significance. The MY01 Mobile Application is an optional application intended for storing and displaying identical pressure values from the MY01 Continuous Compartmental Pressure Monitor device. The data is for informational purposes only and is not intended to be used for diagnosis of any nature or active patient monitoring.

The MY01 Continuous Compartmental Pressure Monitor (MY01 device) is a device for measuring real-time and continuous compartmental pressured compartmental pressures should always be used along with the current standard of care as an aid in the diagnosis of compartment syndrome. The device is supplied sterile for single patient use and intended to be used for 18 hours, it contains two major components that are referred to as the Introducer (plastic housing and 17- gauge stainless-steel needle) and the Pressure Monitor. The Pressure Monitor consists of a capacitive Micro-Electro-Mechanical System (MEMS) pressure sensor, which allows for the measurement of intracompartmental pressure relative to a secondary atmospheric pressure sensor.It is embedded on a flexible PCB circuit, which extends via a lead-wire to a rigid PCB circuit within the Pressure Monitor. The Introducer allows for placement of the pressure sensor into muscle compartments. The Pressure Monitor continuously outputs pressure values on the LCD screen and can be attached on the patient's skin using the provided adhesive strip on the underside. MY01 device uses wireless communication over BLE to transmit data to an optional, nongeneric compatible accessory mobile application, which is also developed by MY01 Inc. for data logging and archival purposes and both cleared under Traditional 510(k), K202635. The MY01 Mobile Application cleared under K202635 is a Non-Device MDDS as per FDA guidance documents "Policy for Device Software Functions and Mobile Medical Applications" and "Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices" (both issued on September 27, 2019) and is therefore not subject to FDA regulatory requirements applicable to devices.

The provided text describes a 510(k) premarket notification for a medical device called the MY01 Continuous Compartmental Pressure Monitor. The submission is for a modification to an existing cleared device (K202635), specifically the addition of a graphing feature to its accessory mobile application.

Therefore, the study focuses on validating the added graphing feature of the mobile application and its impact on the overall system, rather than proving the core performance of the pressure monitor itself, which was established by the predicate device.

Here's an analysis of the acceptance criteria and the study, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in a table format for the modified device's performance. Instead, it states that the device successfully "PASSED all verification and validation testing, demonstrating the effectiveness of risk mitigations and providing a high level of assurance that the subject MY01 device fulfills design input requirements and meets established performance criteria for the intended use."

The primary focus of this 510(k) is to demonstrate that the modification (graphing feature in the mobile app) does not introduce new safety or effectiveness concerns and maintains substantial equivalence to the predicate device.

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

The document does not specify a "test set" in the traditional sense of a clinical or retrospective dataset with a specific sample size of patients or measurements. The submission pertains to software verification and validation testing of the modified mobile application and its integration with the hardware.

• Sample Size: Not applicable in terms of patient/case samples for performance evaluation of a diagnostic or predictive algorithm. The testing would involve simulated data, unit tests, integration tests, and system-level tests for the software.
• Data Provenance: Not applicable as it's not a clinical study on patient data. The focus is on software functions and risk analysis.

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

This information is not provided in the document. Given that the submission primarily concerns a software modification (graphing feature) and system integration, it's unlikely that external medical experts were used to establish "ground truth" for a test set in the way they would be for a diagnostic AI. Internal software quality assurance and medical device specialists within MY01 Inc. would be responsible for verifying the software's functionality and adherence to design specifications.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable to the type of testing described (software verification and validation for a functional change). Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where multiple human readers assess cases and a consensus or tie-breaker mechanism is needed for ground truth establishment.

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, an MRMC comparative effectiveness study was not done. The submission is for a modification to a medical device's accessory mobile application, specifically adding a graphing feature. It does not involve an AI algorithm intended to assist human readers in making diagnoses or interpretations in a comparative effectiveness setting. The graphing feature is explicitly stated to be "for informational purposes only" and "not intended for active patient monitoring or diagnosis."

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

No, a standalone algorithm performance study was not done in the context of diagnostic or predictive capabilities. The MY01 Continuous Compartmental Pressure Monitor is a measurement device that provides "real-time and continuous measurement of compartmental pressures." The mobile application is an "optional application intended for storing and displaying identical pressure values" and the graphing feature is "for informational purposes only". There is no mention of a standalone algorithm for diagnosis or prediction.

7. The Type of Ground Truth Used

The concept of "ground truth" as pathology, expert consensus, or outcomes data is not applicable in this context. The study is a software verification and validation effort. The "ground truth" for the added graphing feature would be:

• Software Design Specifications: Ensuring the graph accurately displays the pressure data transmitted from the device according to its design.
• Data Integrity: Verifying that the data displayed graphically is identical to the raw pressure values.
• Risk Analysis Outcomes: Demonstrating that the graphing feature introduces no new or unmitigated risks.

8. The Sample Size for the Training Set

This information is not applicable. The MY01 Continuous Compartmental Pressure Monitor and its mobile application are not described as using machine learning or AI algorithms that require a "training set" of data in the sense of supervised learning. The device measures physical pressure, and the app displays that measurement.

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

This information is not applicable as there is no mention of a training set or machine learning algorithms requiring a ground truth for training.

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