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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.

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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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:

1. 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.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. 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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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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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 Continuous Compartmental Pressure Monitor (MY01 device) is a device for measuring real-time and continuous compartmental pressure. The measured 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 17gauge 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.

Modification: The purpose of this submission is an enhancement of the device functionality to include wireless communication over Bluetooth Low Energy (BLE) to transmit data to a compatible mobile application for data logging and archival purposes.

The MY01 mobile application does not analyze of interpret recorded pressure data. It is not intended to aid in diagnosis or monitoring. The application is not able to control any functions or configuration parameters of the MY01 device. Authenticated users of the mobile application can securely connect to a MY01 device and enable the transmission of pressure data via an encrypted BLE link. The current pressure data measurement is displayed on the application and forwarded via an encrypted network link to a cloud-based server (MY01 application server) for data logging and archival purposes.

The provided text is a 510(k) summary for the MY01 Continuous Compartmental Pressure Monitor. This document focuses on demonstrating substantial equivalence to a predicate device, specifically for an enhancement to the device (adding Bluetooth Low Energy connectivity).

Therefore, the document primarily discusses verification and validation (V&V) testing related to the new BLE functionality and general medical device standards, rather than a clinical study proving the core device's diagnostic performance against a ground truth.

Based on the provided text, it is not possible to extract the information requested in your prompt regarding acceptance criteria and a study proving the diagnostic performance of the device.

Here's why and what information can be extracted:

What can be extracted:

• Device Name: MY01 Continuous Compartmental Pressure Monitor
• Purpose of Submission: Enhancement of device functionality to include wireless communication over Bluetooth Low Energy (BLE) for data logging and archival.
• Indicated Use: For real-time and continuous measurement of compartmental pressures as an aid in the diagnosis of compartment syndrome.
• Performance Data (related to the modification):
  • Systematic risk analysis per ISO 14971.
  • Electrical Safety per IEC 60601-1-1.
  • EMC emissions per IEC 60601-1-2/CISPR 11 and 21 CFR 47 Part 15.
  • EMC Immunity per IEC 60601-1-2.
  • Software verification per IEC 62304.
  • Cybersecurity assessment per FDA guidance.
  • Interoperability assessment per FDA guidance.
  • Radio Frequency Wireless Technology in Medical Devices Guidance.
  • Result: The device with BLE connectivity "successfully PASSED all verification and validation testing, demonstrating the effectiveness of risk mitigations and providing a high level of assurance that the MY01 device fulfills design input requirements and meets established performance criteria for the intended use."

What cannot be extracted from this text (and why):

The prompt asks for details about a study that proves the device meets diagnostic performance acceptance criteria. This document is focused on the modification to an already cleared device (K193321). For such modifications that don't change the fundamental technology or indications for use, typically a new, large-scale clinical study re-proving diagnostic accuracy is not required. The 510(k) process for this modification relies on demonstrating that the new feature (BLE) doesn't introduce new risks and that the device remains as safe and effective as the predicate.

Therefore, the following information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance (for diagnostic accuracy): The document lists performance tests (e.g., electrical safety, EMC) but not specific diagnostic accuracy criteria (e.g., sensitivity, specificity, accuracy against a gold standard for compartment syndrome diagnosis).
2. Sample size used for the diagnostic test set and data provenance: No information on a diagnostic clinical study.
3. Number of experts used to establish ground truth for the test set and qualifications: Not applicable, as no diagnostic study is described.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study: Not conducted or reported in this summary. The device aids diagnosis; it's not an AI-driven interpretive tool that assists human readers in the way an MRMC study would evaluate.
6. Standalone (algorithm only) performance: Not applicable. This device provides measurements, not an algorithmic diagnosis.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no diagnostic study is described.
8. Sample size for the training set: Not applicable, as it's not an AI/ML device that requires a training set in the typical sense.
9. How the ground truth for the training set was established: Not applicable.

In summary: The provided 510(k) summary explains how the modification (BLE connectivity) was validated, ensuring it adheres to safety and performance standards for connectivity and electrical properties, but it does not contain details of a study proving the diagnostic performance of the MY01 Continuous Compartmental Pressure Monitor itself. That core performance would have been established during the original K193321 submission.

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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 provide a general pressure direction and are for informational purposes only. Do not rely upon the trend arrows for the diagnosis of compartment syndrome.

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 can be used up to a maximum of 18 hours, at which point a warning message is displayed cautioning the user. It contains two major components that are referred to as the Introducer (plastic housing and 17gauge 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.

The provided text describes the MY01 Continuous Compartmental Pressure Monitor. However, it does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics in numerical terms. The text focuses on the device's substantial equivalence to a predicate device, regulatory compliance, and general performance testing (e.g., sterility, biocompatibility, electrical safety, software validation, human factors).

Therefore, I cannot populate the table with specific acceptance criteria and reported device performance, nor can I provide details on sample sizes, ground truth establishment for test/training sets, or MRMC studies, as this information is not present in the provided document.

Here's a summary of what can be extracted and inferred from the text, noting the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: Numerical or specific performance metrics (e.g., accuracy, precision, bias of pressure measurements, sensitivity, specificity, or error rates for diagnosing compartment syndrome).

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified. The document mentions "simulated use conditions" for hardware/software validation and human factors, but no specific number of cases or patients for a test set validating the diagnostic aid indication.
• Data Provenance: Not applicable, as no clinical study or specific dataset for diagnostic performance is detailed. The performance data focuses on device-specific engineering and safety tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The document does not describe a clinical study with a test set requiring expert-established ground truth for diagnostic performance.

4. Adjudication method for the test set:

• Not applicable. No clinical study with a test set requiring adjudication is described.

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. The MY01 device is a Continuous Compartmental Pressure Monitor, a sensor-based medical device that aids in diagnosis, but it is not an AI/CAD (Computer-Aided Detection/Diagnosis) system that directly interprets medical images or data requiring human-in-the-loop performance measurement. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device as described.

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

• Not applicable in the context of an AI/CAD system. The device itself performs continuous pressure measurements. Its "standalone" performance is assessed through its accuracy and reliability of pressure sensing, which are implied to be part of the "hardware and software device specifications... verified for conformity to design input requirements" and "performance testing." However, specific metrics for this standalone performance (e.g., accuracy against a gold standard pressure transducer) are not provided.

7. The type of ground truth used:

• For engineering and safety tests (sterility, electrical safety, EMC, biocompatibility), the "ground truth" is defined by established international standards (e.g., ISO 14971, ISO 10993-1, IEC 60601-1, IEC 60601-1-2).
• For hardware/software validation and human factors, the ground truth relates to "design input requirements" and "established performance criteria," implying internal specifications and usability guidelines.
• The device's intended use is as an "aid in the diagnosis of compartment syndrome," but the document does not detail a clinical study where its diagnostic accuracy was directly measured against a clinical ground truth (e.g., surgical confirmation of compartment syndrome or expert clinical diagnosis).

8. The sample size for the training set:

• Not applicable. The document describes a medical device, not a machine learning model that requires a training set in the conventional sense. Software verification and validation were performed, but this refers to traditional software engineering testing rather than AI model training.

9. How the ground truth for the training set was established:

• Not applicable, as there is no "training set" for an AI model.

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