(86 days)
The MCT-Diabetes™ software serves as an interface between the software in personal glucose monitoring devices and a general purpose health management database to assist in the review, analysis and evaluation of blood glucose test results. MCT Diabetes is designed for home use and professional healthcare settings.
MCT-Diabetes software serves as an interface between the software in personal glucose monitoring devices and a general purpose health management database to assist in the review, analysis and evaluation of blood glucose test results. MCT-Diabetes is designed for home use and professional healthcare scttings. It is an accessory device to most manufactured models homc-use blood glucose monitors, including glucose monitoring devices by Roche Diagnostics, Bayer, BD, Johnson & Johnson, Abbott, and Nova Biomedical. The list of supported devices is located at www.mycareteam.com.
The purpose of the electronic diabetes management system is to help the user manage their own blood sugar information to better regulate diabetes treatments and control blood glucose. The MCT-Diabetes system holds a convenience function, as the user can upload blood glucose data from a variety of currently marketed blood glucose monitors into one location for viewing.
Finally, after the user transmits and stores blood glucose data to the secure database, the MCT-Diabetes system allows family members and/or hcalthcare professionals who have permission from the primary user and a password to view and monitor the user's data and reports. Four different types of chart displays are available, and the user selects the time period and the type of output. The subject can view their blood glucose information over time and can compare to previous time periods, to help the subject better manage their disease over time. The subject can also enter and track other health-rclated information such as body weight, blood pressure, and level of exercise.
The MCT-Diabetes device is an Internet-based software device that has physical requirements common to most home personal computers users (Pentium 4 microprocessor or greater, 256Mb of RAM memory, 10Gb secondary storage, Microsoft Internet Explorer v6.0 or later, etc.). The MCT-Diabetes device is a sccure device and meets or exceeds HIPAA Guidelines for data and patient security.
Here's a breakdown of the acceptance criteria and study information for the MCT-Diabetes™ device, based on the provided 510(k) summary:
Please note: This 510(k) summary focuses on software verification and validation and usability testing to demonstrate substantial equivalence to a predicate device, rather than a clinical performance study measuring diagnostic accuracy. Therefore, many standard acceptance criteria and study aspects related to diagnostic performance (like sensitivity, specificity, or AI-assisted improvement) are not applicable or not detailed in this document.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Software Functionality | Not explicitly stated as acceptance criteria, but implied through verification and validation. The software should perform its intended function as an interface to retrieve, store, and display blood glucose data from various monitors. | "Software verification and validation testing were conducted in compliance with FDA Quality System Guidelines." The device was considered a "Moderate level of concern," suggesting it met established V&V protocols for this risk level. The outcome of these tests is not explicitly quantified but is stated to support substantial equivalence. |
| Usability | The device should be usable by its target audience (home users and healthcare professionals) to effectively manage blood glucose information. This implies ease of use, clarity of information, and ability to perform intended tasks. Specifically, adherence to ISO 15197:2003 (which often includes usability aspects for blood glucose monitoring systems). | Two surveys conducted by the American Diabetes Association (ADA) (independent of MyCareTeam Inc) assessed usability. |
| - First Survey: Used for initial system improvements. "the vast majority of responses were positive." | ||
| - Second Survey: "revealed positive outcomes regarding the user interaction with the device and its operation." | ||
| Overall: "The overall results from user testing demonstrate that the MCT-Diabetes performs according to its intended use and reliably transmits blood glucose data in a way that is understandable to the user and fits the Intended Use of the device." User testing was conducted in accordance with ISO 15197:2003. | ||
| Security/Compliance | Meet or exceed HIPAA Guidelines for data and patient security. | "The MCT-Diabetes device is a secure device and meets or exceeds HIPAA Guidelines for data and patient security." (No specific audit reports or metrics are provided in this summary). |
| Compatibility | Act as an interface for "most manufactured models home-use blood glucose monitors" from specified brands (Roche Diagnostics, Bayer, BD, Johnson & Johnson, Abbott, and Nova Biomedical). | The device description implies this capability, stating it is an "accessory device to most manufactured models home-use blood glucose monitors." The list of supported devices is located at www.mycareteam.com. The 510(k) doesn't specify testing details or acceptance criteria for compatibility across all these devices within the summary itself. |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for the usability surveys. It refers to "Two surveys" and "the first survey respondents" and "the second survey."
- Data Provenance: The usability surveys were conducted by the American Diabetes Association (ADA) "independent of MyCareTeam Inc." This suggests a prospective, independent data collection, though the country of origin isn't explicitly stated, it's implied to be within the US given the ADA's role.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) summary. The device is a data management software, not a diagnostic device requiring expert interpretation of medical images or data to establish a ground truth for diagnostic accuracy. The "ground truth" here is user experience and software functionality, assessed via user surveys and software testing, not expert consensus on medical findings.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving multiple expert readers. Here, the "test set" refers to usability survey responses and software verification/validation results, which are not adjudicated in that manner. The ADA independently tabulated the survey results.
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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. This device is not an AI-powered diagnostic tool; it's a data management and display software. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "standalone performance" of the software was assessed through "Software verification and validation testing." These tests would ensure the software's algorithms correctly process, store, and display information as programmed, without direct human intervention in the data processing itself, though the overall system relies on human users entering and viewing data. It's a "standalone" software in the sense it performs its core functions independently of direct human oversight of its internal computations. However, it's not a standalone diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Software Verification and Validation: The ground truth is implied to be the software requirements and design specifications. The software is tested against these predefined functional and non-functional requirements to ensure it performs as intended.
- For Usability Testing: The "ground truth" is user feedback (positive or negative outcomes regarding interaction and operation) and adherence to usability standards (ISO 15197:2003). There isn't a medical "ground truth" like pathology for this type of device.
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The sample size for the training set:
- Not applicable. The MCT-Diabetes™ is not described as an AI/ML-driven device that learns from a "training set" of data. It's software that performs pre-programmed functions for data management and display.
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How the ground truth for the training set was established:
- Not applicable. As there is no described training set for an AI/ML model.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.