(501 days)
HL568 Self-Monitoring Blood Glucose (SMBG) System is self-test medical device and intended for single patient home-use to monitor the blood glucose (B-D-glucose) levels in quantitative measurement from fresh capillary whole blood obtained from the finger tip. It is intended for use outside the body (in vitro diagnostic use) by diabetics at home to measure the glucose concentration for aiding diabetes management. It is not intended for the diagnosis of or screening for diabetes mellitus.
HL568 Self-Monitoring Blood Glucose (SMBG) System is intended to be used by a single person and should not be shared and it is also not intended for use on neonates and should be used with HL568 Blood glucose test strip and HL568 Control Solution.
HL568 Blood glucose test strips are for use with the HL568 Blood glucose meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.
HL568 Control Solutions are for use with the HL568 Blood glucose meter and HL568 Blood glucose test strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The device is capable of transferring the storage data to the connected personal computer (PC) via USB cable. In addition, HL568 Self-Monitoring Blood Glucose System is featured with audio function; it could help the user to know the measured result by hearing but is not intended for visually impaired users.
The HLS68 Self-Monitoring Blood Glucose System is comprised of the HL568 Blood Glucose Meter, HL568 Blood Glucose Test Strip, HL568 Control Solution (2 levels), a lancing device and lancets. All the measured values can be read out in one LCD panel, battery operated and the blood glucose meter is portable. The Subject Device is self-test IVD medical device which is intended for quantitative measurement of blood glucose (B-D-glucose) levels from fresh capillary whole blood obtained from the fingertip and used outside the body only ( in vitro diagnostic use). It is intended for over-the-counter, home use by single patient to measure the glucose concentration for aiding diabetes management.
The test principle based on the electrochemical biosensor technology using glucose oxidase method. Each test strip reacts with glucose in the blood sample to produce a current proportional to the blood glucose level. This reaction is measured by the meter and displayed as the blood glucose result.
The Subject Device is designed to have USB computer interface to allow users make use of their storage memory data more personalized. Users can transfer the readings of their blood glucose meters to the connected personal computer (PC) via USB cable to save and manage their personal data.
Subject Device, HL568 Blood Glucose Meter is featured with an audio function for use to easily and efficiently perform the glucose testing. It provides an auditory aid for the users to know the measured result by hearing and to use the device step by step.
Here's a summary of the acceptance criteria and study information for the HL568 Self-Monitoring Blood Glucose System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the HL568 Self-Monitoring Blood Glucose System is compliant with ISO 15197-2003: In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. While the document doesn't explicitly list the detailed acceptance criteria and specific performance metrics achieved (e.g., mean absolute relative difference percentage), it broadly indicates that "All the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met."
Therefore, for the purpose of this request, the acceptance criteria are considered to be those outlined in ISO 15197-2003. Without the full standard or detailed report, the specific numerical acceptance criteria and the device's precise performance against them cannot be provided in a table. However, the study concludes that these criteria were met.
General Performance Characteristics (Extracted from the "Comparison of Subject Devices and predicate device" table, implying parity with predicate):
| Characteristic | Acceptance Criteria Implied by Predicate (and Met by Subject Device) | Reported Device Performance (Implied as met) |
|---|---|---|
| Detection method | Amperometry: current generated by oxidation of reduced mediator | Same |
| Enzyme | Glucose Oxidase | Same |
| Mediator | Ferricyanide | Same |
| Open Stability | 3 months | Same |
| Sample Type | Capillary whole blood | Same |
| Calibration | Plasma equivalence | Same |
| Test range | 20 - 600 mg/dL | Same |
| Coding Method | Coding by button | Same |
| Altitude limit | >10,000 feet (predicate is 10,000 feet) | 10,335 feet |
| Sample volume | ≥ 1µL | > 1µL |
| Hematocrit Range | 30 - 55% | Same |
| Test time | 5 seconds | 5 seconds (audio function off) |
| Operating Humidity | R.H. ≤ 80% (predicate is 10% to 90%) | R.H. ≤ 80% |
| Day average (reporting) | Including 14, 30-day averages | 7, 14, 28, 60, 90-day average |
2. Sample size used for the test set and the data provenance:
The document mentions compliance with ISO 15197-2003 and other CLSI standards (EP05-A2, EP06-A, EP07-A2, EP09-A2). These standards outline specific requirements for sample sizes in various tests (e.g., precision, linearity, interference, method comparison). However, the specific number of samples used for the test set is not explicitly stated in the provided text.
The data provenance (e.g., country of origin, retrospective or prospective) is also not explicitly stated.
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 in the document. For blood glucose monitoring systems, ground truth is typically established using a laboratory reference method, not expert consensus in the way image analysis or clinical diagnosis might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and therefore not provided in the document, as the ground truth for blood glucose measurements is generally established by a laboratory reference method, not by expert adjudication.
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:
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not typically relevant for a self-monitoring blood glucose system. This device is an automated measurement system, not an AI-assisted diagnostic tool that humans read.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device described is a standalone algorithm/device in the sense that it provides a direct blood glucose measurement without requiring human interpretation of visual data. The performance described (compliance with ISO 15197-2003) refers to the performance of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
While not explicitly stated in detail, for blood glucose monitoring systems, the ground truth is established by a laboratory reference method, typically a central laboratory analyzer that provides highly accurate and precise glucose measurements. This is standard practice for studies complying with ISO 15197. The document mentions compliance with "CLSI/NCCLS EP09-A2: Method Comparison and Bias Estimation Using Patient Samples," which further supports the use of a reference method for comparison.
8. The sample size for the training set:
Blood glucose monitoring systems based on electrochemical biosensor technology, like the HL568, are typically developed and validated using well-established biochemical principles and sensor design, rather than large-scale machine learning training sets in the same way an AI image analysis algorithm would be. Therefore, the concept of a "training set" in the context of machine learning, with a distinct sample size, is not applicable or mentioned for this device. Calibration and initial validation would involve a range of glucose concentrations and interfering substances, but not in the "training set" paradigm.
9. How the ground truth for the training set was established:
As explained above, the concept of a "training set" as it applies to AI/ML is generally not relevant for this type of device. The accuracy of the device is assessed against a laboratory reference method during its development and validation phases.
§ 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.