(84 days)
The Zero-Click™ Data Management System is intended for use in the home and professional settings to aid people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the AgaMatrix's Liberty™ Blood Glucose Monitoring System. The Zero-Click™ Data Management System allows users to download Blood glucose reading automatically from the meter to the PC without clicking a button.
The Zero-Click™ Data Management System is an optional data management software accessory for use with the AgaMatrix's Liberty "M Blood Glucose Monitoring System. The Zero-Click™ Data Management System allows the transfer of data from the AgaMatrix's Liberty™ Blood Glucose meter to a personal computer for enhanced data management capability. The Zero-Click1131 Data Management System eliminates the need for manual data logs and provides enhance glucose reading trends and statistics. Using the unique Zero-Click™ USB cable, glucose readings are automatically downloaded from the Liberty™ Meter to a PC without pressing a button.
The provided document describes the AgaMatrix Zero-Click™ Blood Glucose Management System and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, or information typically found in a clinical performance study for an AI/ML medical device.
The document states:
- "System testing was performed with the Zero-ClickTM Data Management System to ensure the optional accessory is equivalent to a currently marketed device (FreeStyle'™ Connect Data Management System)."
- "These tests consisted of system, hardware, software, and electrical safety (EMC, EMI, and ESD) and clinical user study which consisted of lay users with diabetes and Health Care Professionals (HCPs) to demonstrate the ease of operating the Zero-Click Data Management Software as intended."
- "Software verification and validation testing demonstrated that the Zero-Click™ Data Management System meets the performance requirements for the intended use of the optional accessory device and the resultant modification has not affected safety of effectiveness."
Based on the provided text, I cannot extract the information required for your request in the format you specified, as the document focuses on regulatory submission and stating that testing was done, rather than providing the detailed results and methodology of a clinical AI/ML performance study.
Therefore, many sections of your request will be marked as "Not provided in the document."
Here's the breakdown based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document | "Software verification and validation testing demonstrated that the Zero-Click™ Data Management System meets the performance requirements for the intended use of the optional accessory device and the resultant modification has not affected safety of effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not provided in the document. The document mentions "clinical user study which consisted of lay users with diabetes and Health Care Professionals (HCPs)" but does not specify the number of participants.
- Data Provenance: Not provided in the document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable, as the device is a data management software, not an AI/ML diagnostic tool that establishes ground truth on medical images or signals. The "clinical user study" involved "lay users with diabetes and Health Care Professionals (HCPs)" to demonstrate ease of operation, not to establish ground truth for an algorithm's diagnostic performance.
- Qualifications of Experts: Not specifically provided for ground truth establishment. HCPs were involved in the user study to evaluate ease of operation.
4. Adjudication Method for the Test Set
- Adjudication Method: Not provided in the document. Not applicable in the context of this device's function (data management software).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: Not applicable/Not provided in the document. This is a data management software, not a diagnostic AI that would typically be evaluated in an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable/Not provided in the document. The device's primary function is to transfer and manage data, not to perform independent diagnostic or analytical functions in a standalone fashion. Its effectiveness is tied to its integration with the blood glucose monitoring system and user interaction.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable. The "clinical user study" focused on ease of operation and meeting performance requirements for data management, not on establishing a diagnostic ground truth.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable/Not provided in the document. This is a data management software, and the concept of "training set" in the context of AI/ML algorithms is not relevant to the described verification and validation.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable/Not provided in the document for the reasons stated above.
§ 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.