(62 days)
The CLEVER CHEK Auto-Code Voice Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The alternative site testing in the CLEVER CHEK Auto-Code Voice Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.
CLEVER CHEK Auto-Code Voice Blood Glucose Monitoring System
This looks like a 510(k) clearance letter for a blood glucose monitoring system, not a study report. Therefore, much of the requested information about acceptance criteria and study details for an AI/ML device is not directly available in these documents.
However, I can extract the general indication for use which implies the functional requirements of the device and how it is expected to perform, and then discuss what kind of studies would typically be done for such a device to meet acceptance criteria, even if the specifics aren't here.
Based on the provided document, the following information can be extracted or reasonably inferred:
The document describes the CLEVER CHEK Auto-Code Voice Blood Glucose Monitoring System, intended for quantitative measurement of glucose in fresh capillary whole blood.
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly list acceptance criteria or reported device performance in a table format. For blood glucose monitoring systems, performance is typically assessed against accuracy standards. A common standard is ISO 15197 for in vitro diagnostic test systems, which typically requires a certain percentage of results to fall within specific accuracy ranges when compared to a laboratory reference method.
- Inferred Performance Requirement (based on device type): The device is intended for "quantitative measurement of glucose." This implies accuracy and precision.
- Typical Acceptance Criteria (based on similar devices, not from this document):
- For glucose concentrations < 75 mg/dL (4.2 mmol/L), at least 95% of results must be within ±15 mg/dL (±0.83 mmol/L) of the reference measurement.
- For glucose concentrations ≥ 75 mg/dL (4.2 mmol/L), at least 95% of results must be within ±20% of the reference measurement.
The document does not provide the reported device performance against such criteria. This information would typically be in the 510(k) summary or the full submission, not the clearance letter itself.
Regarding the speaking functionality: The document states, "This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons." The acceptance criteria for this would likely involve user studies demonstrating the clarity, accuracy, and usability of the voice prompts for the target user group. Again, no specific study details are in this document.
2. Sample size used for the test set and the data provenance
The document does not provide details on the sample size or data provenance for any test set. For a blood glucose meter, the test set would typically involve human subjects whose blood glucose levels are measured by both the device under test and a laboratory reference method.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available in the provided document. For blood glucose meters, the "ground truth" is typically established by a highly accurate laboratory reference method (e.g., YSI analyzer) operated by trained laboratory personnel, rather than interpretation by clinical experts.
4. Adjudication method for the test set
This information is not available in the provided document. As noted above, for blood glucose meters, ground truth is usually established by a single, high-precision laboratory reference method, so traditional adjudication methods among clinical experts are not typically relevant here.
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
Not applicable. This device is a blood glucose meter, not an AI/ML-based diagnostic imaging system or similar. There are no "human readers" interpreting medical images or complex data in the context of this device. Its function is to quantitatively measure glucose.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is inherently a standalone device in its primary function – it measures blood glucose and displays the result. The "algorithm" is the biochemical reaction on the test strip and the meter's internal calculation to convert electrical signal to glucose concentration. It provides a numerical output without requiring human interpretation of raw data. The speaking functionality is an enhancement but doesn't change the standalone nature of the primary measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For blood glucose meters, the ground truth is typically established using a laboratory reference method known for its high accuracy and precision, such as a YSI glucose analyzer.
8. The sample size for the training set
The document does not provide information on the sample size for a training set. While the internal algorithms of a blood glucose meter are developed and calibrated, the concept of a "training set" as understood in AI/ML is not directly applicable in the same way. Calibration data would be used, but specific "training set" details are not provided.
9. How the ground truth for the training set was established
Similar to point 8, the document does not provide details on how "ground truth" was established for a training set. For the calibration of a blood glucose meter, the device is typically tested against various known concentration levels of glucose solutions and compared to results from a laboratory reference method to establish its calibration curve and ensure accurate readings across the physiological range.
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 8 2008
TaiDoc Technology Corp. c/o Yuhua Chen Specialist Regulatory Affairs 6F, No. 127, Wugong 2nd Road Wugu Township, Taipei County China (Taiwan) 248
Re: K081144
Trade Name: CLEVER CHEK Auto-Code Voice Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System. Regulatory Class: Class II Product Codes: NBW, CGA, JJX Dated: June 4, 2008 Received: June 5. 2008
Dear Yuhua Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, perroits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Officer of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number:
Device Name: CLEVER CHEK Auto-Code Voice Blood Glucose Monitoring System
Indication For Use:
The CLEVER CHEK Auto-Code Voice Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The alternative site testing in the CLEVER CHEK Auto-Code Voice Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.
Prescription Use (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use X . (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benson
Division Siañ-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081144
§ 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.