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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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