(429 days)
The SD GlucoMentor Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The SD GlucoMentor Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.
The SD GlucoMentor Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The SD GlucoMentor Test Strips are for use with the SD GlucoMentor Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
The SD GlucoMentor multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. The SD GlucoMentor multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The SD GlucoMentor multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The SD GlucoMentor multi Blood Glucose Test Strips are for use with the SD GlucoMentor multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
SD GlucoMentor™ blood glucose system is an Rx/OTC blood glucose monitoring system to be used by professional healthcare personnel or diabetics at home to measure the glucose concentration for aiding diabetes management.
SD GlucoMentor™ blood glucose monitoring system is comprised of the following.
- SD GlucoMentor"M blood glucose meter -
- SD GlucoMentor™ blood glucose test strip -
- -SD Glucose control solution
- -SD Glucose check strip
A drop of blood sample from the finger prick works with glucose oxidase and the mediators in the test strip to make a small electric current proportional to the glucose concentration in the blood. The meter reads the current and displays the blood glucose result equivalent to the current.
The system is a battery-operated portable device and stores 500 test results in memory. The user can search the stored results with three presentations of 7, 14 and 30-day averages of test results stored in memory: normal, pre-meal and post-meal state averages. The system can set the beep, hypo warning. date, time, post-meal alarm. The system can also set the pre-meal and post-meal mark. Test results are displayed with mg/dL unit. A check strip allows the meter to check a problem and the control solution allows the meter and test strip to be checked.
The provided text describes the SD GlucoMentor™ Blood Glucose Monitoring System, but it does not contain detailed acceptance criteria or a study proving that the device meets specific performance criteria in the format requested.
The document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a standalone performance study with detailed acceptance criteria and results.
However, I can extract the information that is present and highlight what is missing based on your request.
Here's a breakdown of the available information and what's not present:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document. The document mentions types of testing performed (e.g., Performance Evaluation, Electromagnetic Compatibility Study (ISO 15197:2003)), but it does not specify the quantitative acceptance criteria (e.g., accuracy percentages, limits of agreement) or the precise reported device performance metrics against those criteria.
2. Sample size used for the test set and the data provenance
The document mentions:
- "A system accuracy evaluation (Method Comparison with Predicate Device) for the SD GlucoLink Blood Glucose Monitoring System was performed according to ISO 15197:2003."
- "A user performance study was performed to demonstrate that lay consumers could obtain accurate results using the SD GlucoLink Blood Glucose Monitoring System. The study was performed using capillary whole blood from fingertip, palm, forearm, and upper arm sample sites."
However, the specific sample sizes for these studies are not provided.
Data provenance (country of origin, retrospective/prospective) is also not specified. Given SD Biosensor, Inc.'s address in Korea, it's possible the studies were conducted there, but this is not stated. The studies appear to be prospective clinical studies based on the descriptions ("performed using capillary whole blood from...").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. For blood glucose monitors, the ground truth is typically established using a reference laboratory method (e.g., YSI analyzer). Certified laboratory personnel would operate such equipment, but they are not "experts" in the sense of clinical reviewers for imaging AI.
4. Adjudication method
This information is not provided. For blood glucose measurements, adjudication methods as described (e.g., 2+1) are not typically applicable. The reference method provides the established true value.
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 MRMC comparative effectiveness study was done. This device is a blood glucose monitoring system, which does not involve "human readers" interpreting medical images or data that an AI would assist with in the traditional sense of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the system accuracy evaluation is a standalone performance test of the device. The "user performance study" then tests the device with human-in-the-loop (lay consumers) to ensure they can obtain accurate results, but the primary measurement is algorithmic. However, the standalone performance metrics are not detailed.
7. The type of ground truth used
The ground truth for blood glucose monitoring systems is typically established using a reference laboratory method, such as a hexokinase-based enzymatic method performed on a YSI analyzer or similar highly accurate laboratory instrument. While not explicitly stated as "YSI," the "system accuracy evaluation (Method Comparison with Predicate Device)" implies comparison against a highly accurate reference.
8. The sample size for the training set
This information is not applicable/not provided. Blood glucose monitoring systems typically rely on established electrochemical principles calibrated during manufacturing; they are generally not "trained" on large datasets in the way a machine learning algorithm for image analysis would be.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the reasons mentioned in point 8.
Summary of Missing and Provided Information:
| Information Requested | Status in Document |
|---|---|
| 1. Acceptance Criteria Table | NOT PROVIDED (only types of tests mentioned) |
| 2. Test Set Sample Size & Data Provenance | NOT PROVIDED (sample sizes) / Limited (provenance - likely prospective, possibly Korea) |
| 3. Ground Truth Experts & Qualifications | NOT APPLICABLE (ground truth usually from lab reference method, not clinical experts for adjudication) |
| 4. Adjudication Method | NOT APPLICABLE (not relevant for blood glucose measurements) |
| 5. MRMC Comparative Effectiveness Study & Effect Size | NOT APPLICABLE (not an AI-assisted interpretation device) |
| 6. Standalone Performance | Yes, implied by "System accuracy evaluation", but metrics not detailed. |
| 7. Type of Ground Truth | Reference laboratory method (implied, not explicitly named, e.g., YSI) |
| 8. Training Set Sample Size | NOT APPLICABLE (not an ML-trained device) |
| 9. How Training Set Ground Truth Established | NOT APPLICABLE (not an ML-trained device) |
This 510(k) summary focuses on demonstrating equivalence to an existing device rather than providing a detailed performance report with specific acceptance criteria and outcome data as might be found in a clinical trial publication.
§ 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.