(168 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 is an 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 device is a single-use, sterile, prescription medical device. It consists of two major components: the Introducer (with a plastic housing and 17-gauge stainless-steel needle that allows for placement of a pressure sensor into muscle compartments) and the Pressure Monitor. The Pressure Monitor is a battery-powered, software/firmware controlled component that uses a capacitive Micro-Electro-Mechanical System (MEMS) sensor to measure muscle compartment pressure relative to atmospheric pressure obtained using a second MEMS sensor embedded within the device enclosure. The embedded software/firmware system in the Pressure Monitor handles all processing functions of the MY01 device. Pressure measurements, user notifications, and device status information are displayed on the LCD screen of the Pressure Monitor and stored in non-volatile memory. The MY01 device communicates securely via Bluetooth with the MY01 Mobile Application (the MY01 App) to transmit and display continuously in real time the measured muscle compartment pressure, user notifications and device status information. The muscle compartment pressure is displayed on the MY01 App along with the estimated muscle perfusion pressure that is derived using a manually entered diastolic pressure. The perfusion pressure is calculated using a simple subtraction: Muscle Perfusion Pressure - Muscle Compartment Pressure. The muscle compartment pressure is displayed as real-time numerical values and a continuously updated graph to visualize pressure trends over time. The muscle perfusion pressure is also displayed continuously with a dashed black line, indicating the estimated perfusion pressure based on the latest diastolic pressure entry. The time points of diastolic pressure entries are marked with solid black dots, indicating the calculated perfusion pressure at those specific times. The MY01 App does not analyze or interpret pressure data and it does not control any function or the configuration of the MY01 device. The MY01 App is not intended for active patient monitoring. Optionally, the MY01 App may connect via an encrypted Wi-Fi/Cellular network to the MY01 Application Server (a cloud-based server managed by MY01 Inc.) to transmit the recorded session and pressure data for off-line review, reporting and archival purposes. Registered clinicians using a MY01 device may reviously recorded session data on the MY01 App and may download this data from the cloud server as a comma separated value (.csv) file. The MY01 Application Server is a Non-Device MDDS; it does not modify the device data, does not control the functions or parameters of any medical device, and does not analyze or interpret the device data.
The provided text is a 510(k) summary for the MY01 Continuous Compartmental Pressure Monitor. It describes the device, its intended use, and compares it to a predicate device. However, it explicitly states that clinical testing was not required and therefore does not provide a study to prove the device meets specific acceptance criteria in a clinical setting.
The performance data section (807.92 (b)(1), (b)(3)) focuses on software system verification and validation, cybersecurity, and shelf-life testing, rather than clinical performance measuring against diagnostic accuracy or other clinical endpoints.
Therefore, many of the requested details about acceptance criteria derived from a clinical study, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies cannot be extracted from this document as such studies were not deemed necessary for this 510(k) submission.
Here's the information that can be extracted or inferred based on the provided text, with clarifications where details are missing due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, the "performance data" pertains to engineering and software validation, not clinical performance metrics. The implicit acceptance criteria are that the device modifications (software updates for perfusion pressure display and extended shelf life) do not adversely affect the device's function, safety, or effectiveness compared to the predicate.
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Software System Verification & Validation | Unit-level and functional, system-level (end-to-end) testing of the modified device were successfully conducted in accordance with IEC 62304:2015, 21 CFR 820 (design controls), and FDA guidance following ISO 14971:2019. |
| Cybersecurity Risks | The modified software system was assessed for cybersecurity risks and subjected to vulnerability scanning in accordance with FDA guidance. |
| Shelf-Life Extension (Sterile Device) | Validation by successful completion of sterile package integrity and performance testing using real-time aged devices in accordance with ISO 11607-1:2019. This means the device maintained sterility and functionality for 24 months. |
| Impact of Software/Firmware Changes (v1.8.0 vs. v1.7.0) | "Non-significant changes verified as per IEC 62304:2015. There is no impact on device function, safety or effectiveness." |
| Impact of MY01 Mobile Application Changes (v1.22.0 vs. v1.16.0) | "The software has been updated with the notable functional changes listed below. It includes technical changes for improved user experience and cybersecurity. The changes do not adversely affect device function, safety or effectiveness." This includes new functionality like setting diastolic blood pressure for multiple devices, periodic reminders, and editing previously entered values, all deemed to have "No adverse impact on device safety and effectiveness." Display of perfusion pressure on the app also deemed to have "No adverse impact on device safety and effectiveness," with clinicians able to independently validate results. |
| Diastolic Blood Pressure Range | The change from "0-200 mmHg" to "10-200 mmHg" was noted as "Same, with minor (not clinically significant) change in the acceptable input range." This implies the device functions correctly within the new range. |
2. Sample size used for the test set and data provenance
- Test Set Sample Size: Not applicable/not provided for clinical performance as "Clinical testing was not required to demonstrate substantial equivalence for this device type." The testing mentioned (software, cybersecurity, shelf-life) used other forms of validation, but the "sample size" in a clinical sense is zero.
- Data Provenance: Not applicable for clinical performance. For the engineering tests, no country of origin or retrospective/prospective nature is specified in this summary.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
- Not applicable as clinical testing was not performed. The ground truth for software and shelf-life testing would be established by engineering and quality standards rather than expert clinical consensus.
4. Adjudication method for the test set
- Not applicable as clinical testing was not performed.
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 is not an AI-assisted diagnostic device in the traditional sense that requires human reader comparison studies. It monitors physical parameters and calculates a derived value based on physician input.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device performs continuous pressure measurement and calculation of perfusion pressure based on manual diastolic pressure input. The document states: "The MY01 App does not analyze or interpret pressure data and it does not control any function or the configuration of the MY01 device." and "The MY01 Application Server is a Non-Device MDDS; it does not modify the device data, does not control the functions or parameters of any medical device, and does not analyze or interpret the device data."
- Essentially, the device provides raw and derived numerical data, but the "standalone performance" isn't framed as a diagnostic algorithm. Its accuracy would be in the pressure measurement and calculation, which is implied by the software verification and validation. However, no specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) related to diagnosing Compartment Syndrome are provided because it is an "aid in diagnosis" and "Diagnosis should always be made in conjunction with clinical assessments."
7. The type of ground truth used
- For the engineering and software validation, the 'ground truth' would be the expected output or behavior according to design specifications, industry standards (e.g., IEC 62304, ISO 14971), and regulatory guidance.
- For the shelf-life testing, "real-time aged devices" would be compared against their original specifications for package integrity and performance, with the ground truth being these pre-defined specifications.
- No clinical ground truth (e.g., pathology, outcomes data, expert consensus on Compartment Syndrome diagnosis) was used as clinical testing was not required.
8. The sample size for the training set
- Not applicable/not provided. This device relies on pre-defined algorithms for pressure measurement and calculation, not machine learning models that require a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable (as above).
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