(53 days)
The MY01 Continuous Compartmental Pressure Monitor is used for real-time and continuous measurement of the muscle compartment pressure. The measured muscle compartment pressure can be used as an aid in diagnosis of Compartment Syndrome (Acute and Chronic). The MY01 Mobile Application intended for storing and displaying identical pressure values from the MY01 Continuous Compartmental Pressure Monitor device and calculating critical muscle perfusion pressure utilizing diastolic pressure manual entry by the physician. Diagnosis should always be made in conjunction with clinical assessments.
The MY01 Continuous Compartmental Pressure Monitor (MY01 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 intra-compartmental 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 to the patient's skin using the provided adhesive strip on the underside. MY01 device uses wireless communication over BLE to transmit muscle pressure data to a nongeneric, compatible accessory, the MY01 Mobile Application, which is also developed by MY01, Inc..
The MY01 Mobile Application, cleared under K210525 is intended for storing and displaying pressure values from the MY01 Continuous Compartmental Pressure Monitor. Authenticated users of the MY01 Mobile Application can securely connect to a MY01 device the transmission of pressure data via an encrypted BLE link. The pressure values can be displayed as seen on the MY01 device or as a graph that is updated in real-time. The MY01 Mobile Application does not analyze or interpret pressure data on the MY01 device. The application is not able to control any functions or configuration of the MY01 device. The current pressure data measurement is displayed on the application and forwarded via an encrypted network link to a MY01 Application Server (cloud-based server) for data logging and archival purposes. The displayed and recorded pressure data is intended for informational purposes only and is not to be used for active-patient monitoring or diagnostic purposes.
The modification that necessitated this submission entails the addition of a feature to the MY01 Mobile Application (cleared under K210525) that allows for calculation of perfusion pressure utilizing diastolic pressure manual entry by the physician.
The provided text is an FDA 510(k) summary for the MY01 Continuous Compartmental Pressure Monitor. It focuses on demonstrating substantial equivalence to a predicate device, particularly regarding a software modification to the MY01 Mobile Application that allows for the calculation of perfusion pressure.
However, the provided text does not contain the specific information requested about acceptance criteria and the study that proves the device meets those criteria for the AI/Software component (the perfusion pressure calculation).
The document mentions:
- "Software Verification and Validation Testing" in accordance with IEC 62304 and FDA guidance.
- It states that the device "successfully PASSED all verification and validation testing."
- It refers to "Functional and performance verification and validation testing with the added feature" being carried out successfully.
But it does not provide details such as:
- A table of acceptance criteria and reported device performance for the perfusion pressure calculation. While the method of calculation (Diastolic Pressure - Muscle Pressure) is stated, the performance criteria (e.g., accuracy, reliability) and test results are not presented.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on explaining what the modification is, that it does not alter the core device or its primary function, and that standard software validation processes were followed. The perfusion pressure calculation is described as a "simple subtraction algorithm" performed on a server, and its output is for "informational purposes only" and "not to be used for active-patient monitoring or diagnostic purposes" but rather for "retrospective analysis." This statement suggests that the FDA may not have required extensive clinical validation for this specific calculative feature given its non-diagnostic, informational role.
In summary, based only on the provided text, I cannot provide the requested detailed information about acceptance criteria and the proof of meeting them for the perfusion pressure calculation feature. The document confirms that general software verification and validation were performed and passed, but it does not elaborate on specific performance metrics or study designs for this particular calculation.
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