(198 days)
The GLUCOLAB™ Diabetes Monitoring System and EOCENE™ System is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings., including physician's office laboratories and point of care sites . The GLUCQLAB™ System and EOCENE'M System is not to be used for diagnosis, screening of diabetes or for neonatal use. The GLUCOLAB™ System and EOCENE™ System are for testing outside the body (in vitro diagnostic use only).
Testing sites include the traditional fingertip testing along with alternate site testing on the forearm, upper arm, palm, calf and thigh.
GlucoLab™ control is used with GlucoLab™ Brand System to check that the meter and test strips are working together as a system and that you are performing the test correctly
Data transmitted by the Eocene™ system is available online for you or your designed healthcare professionals to review within the Eocene Secure website. To register your Eocene™ cradle for use with the Eocene systems, contact the dealer you purchased your device from or visit www.eocenesystems.com for more information. For best results. follow the daily testing frequency prescribed by your and upload your data at least once a week or as indicated by your provider.
The Eocene™ system may be used with GlucoLab™ or Eclipse™ Diabetes Monitoring Systems.
This Eocene™ System is used with the GLUCOLAB™ Diabetes Monitoring System. It is composed of the Eocene cradle, DC 5V Adaptor, and phone line.
It allows to use the phone line to upload GlucoLab™ data to a database server.
This document describes the Eocene™ Glucose Telecommunication system, an accessory device that allows the GLUCOLAB™ Diabetes Monitoring System to upload data via a phone line to a database server. It is important to note that the primary glucose monitoring system itself (GLUCOLAB™) is described as operating under the same technological characteristics as its predicate device (K051285). The Eocene™ system's function is specifically data transmission, not the direct measurement of glucose.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance Study
The acceptance criteria are implicitly defined by the "pre-determined Pass/Fail criteria" for various tests. The device's performance is reported as meeting these criteria.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Requirement Specifications | Passed all tests based on pre-determined Pass/Fail criteria. |
| Product Requirement Specifications | Passed all tests based on pre-determined Pass/Fail criteria. |
| User Interface Requirement Specifications | Passed all tests based on pre-determined Pass/Fail criteria. |
| Functionality | Established |
| Reliability | Established |
Study Details:
This submission focuses on the Eocene™ Glucose Telecommunication system, which is a data transmission accessory for a blood glucose monitoring system. The study described is non-clinical verification and validation of this accessory, rather than a clinical efficacy study of a glucose meter itself.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of patients or glucose readings. The "test set" refers to the verification and validation activities conducted on the Eocene™ system itself, likely involving various software and hardware tests.
- Data Provenance: Not applicable in the context of clinical patient data. The testing was conducted internally by the manufacturer (Infopia Co.,ltd.) and is described as "non-clinical."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context would relate to the correct functioning of the telecommunication system, not clinical interpretations. The "Pass/Fail criteria" for the software, product, and user interface specifications would have been established by the manufacturer's engineering and quality teams.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used for clinical endpoints requiring expert consensus. The non-clinical testing of the Eocene™ system would follow standard engineering verification and validation protocols with internal review.
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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. This is not an AI-assisted diagnostic device, nor does it involve human "readers" interpreting cases. The Eocene™ system is a data telecommunication accessory.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The "Performance Data" section describes "Verification, validation and testing activities... to establish the performance, functionality and reliability characteristics of the Eocene 100 Glucose Telecommunication." This non-clinical testing evaluates the device's ability to transmit data according to its specifications, which is an "algorithm only" or system-only performance assessment in a controlled environment. Human interaction would be in operating the system and reviewing test results, but not in interpreting patient data in a clinical context.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the Eocene™ system refers to its ability to correctly and reliably transmit data. This would be established by comparing the transmitted data against the original data from the GlucoLab™ system to ensure integrity and accuracy of transmission. It's essentially a functional validation to ensure data is transferred without corruption.
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The sample size for the training set:
- Not applicable. As a non-clinical data transmission device, there would not be a "training set" in the sense of machine learning or AI models. Development would involve iterative testing and refinement, but not a distinct training set for an algorithm.
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How the ground truth for the training set was established:
- Not applicable for the reasons mentioned 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.