(241 days)
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:
| Acceptance Criteria (Inferred from general performance testing) | Reported Device Performance (Inferred from text) |
|---|---|
| Device sterility and packaging integrity validated to FDA recognized industry standards. | MY01 device successfully met the criteria for maintenance of sterility and packaging integrity. |
| Biological safety evaluated in accordance with ISO 10993-1. | Biological safety of final finished, sterile device was evaluated and found compliant. |
| Electrical safety and performance assessed in compliance with IEC 60601-1 (Ed. 3.1). | Compliant with IEC 60601-1 (Ed. 3.1). |
| EMC assessed in compliance with IEC 60601-1-2 (Ed. 4). | Compliant with IEC 60601-1-2 (Ed. 4) for a Group 1 Class B device. |
| Software verification and validation (moderate level of concern). | Software verification and validation testing were conducted, and documentation provided. |
| Hardware and software device specifications verified for conformity to design input requirements and validated under simulated use conditions. | MY01 device successfully met the criteria for safety of materials and ease of use in a simulated use. |
| Performance testing ensures equivalent level of safety and effectiveness as the predicate device. | Extensive performance testing for the subject device assures that the MY01 device is at least as safe and effective as the previously cleared predicate device. |
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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