(89 days)
KET-1 System: The KET-1 Blood Ketone Monitoring System is intended to quantitatively measure $\beta$ -hydroxybutyrate ( $\beta$ -ketone) in fresh capillary whole blood from fingertips. It should only be used by a single patient and it should not be shared. Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. It is not to be used for diagnosis or screening of diabetes, or for neonatal use. The KET-1 Blood Ketone Monitoring System is comprised of the KET-1 Blood Ketone Meter and KET-1 Blood Ketone Test Strip.
The KET-1 Blood Ketone Monitoring System consists of the KET-1 Blood Ketone Meter, KET-1 Blood Ketone Test Strips, and KET-1 Ketone Control Solutions (Level 1 and Level 2). The system is for self-testing of blood ketone. The KET-1 Blood Ketone Test Strips and KET-1 Ketone Control Solutions are purchased separately.
This document describes the regulatory approval of the KET-1 Blood Ketone Monitoring System. The provided text is a 510(k) summary, which outlines the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics. Instead, it describes general categories of testing and concludes that the device demonstrates substantial equivalence. For quantitative tests like accuracy, it states that "results demonstrate substantial equivalence to the predicate system" without providing specific numbers or ranges for the acceptance criteria.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document mentions an "accuracy study" conducted with "home users using finger capillary whole blood." However, it does not specify the sample size (number of participants or samples) used for this accuracy study or any other mentioned tests (e.g., precision, repeatability, linearity).
- Data Provenance: The device manufacturer is Apex Biotechnology Corp. located in Hsinchu, Taiwan. The location of the clinical study (accuracy study) is not explicitly stated, but it is reasonable to infer it would be in Taiwan or a region where the manufacturer operates or has a testing facility. The data provenance is retrospective in the sense that the studies were completed before the 510(k) submission for regulatory review. However, the accuracy study itself was likely conducted prospectively (data collected specifically for the study) from the home users.
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 a blood ketone monitoring system, ground truth would typically be established by a reference laboratory method (e.g., gas chromatography-mass spectrometry or a highly accurate clinical chemistry analyzer) rather than expert human interpretation of images. The document does not specify details of the ground truth method or the personnel involved.
4. Adjudication method for the test set
This information is not applicable in the context of a blood ketone monitoring system, as it measures a quantitative analyte. Adjudication methods (e.g., 2+1, 3+1) are typically used for qualitative or diagnostic imaging studies where human experts interpret results and disagreements need to be resolved. For a quantitative measurement, the "ground truth" (reference method result) is directly compared to the device's measurement.
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
An MRMC study is not applicable to this device. This type of study is relevant for AI-powered diagnostic imaging devices where human readers (e.g., radiologists) interpret images with and without AI assistance. The KET-1 Blood Ketone Monitoring System is a quantitative point-of-care device that measures a chemical analyte and does not involve human interpretation of complex images or AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The KET-1 Blood Ketone Monitoring System is a standalone device in the sense that it provides a direct quantitative measurement of β-ketone. Its "performance" is its accuracy and precision in measuring blood ketone levels compared to a reference method, rather than a diagnostic algorithm that processes complex data for human review. The documented testing (accuracy, precision, linearity) essentially assesses the standalone performance of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies that the ground truth for the accuracy study was established by a reference method, as is standard for quantitative diagnostic devices. While not explicitly stated, clinical chemistry analyzers or other highly accurate laboratory methods would be used to obtain the "true" β-ketone values against which the KET-1 system's results are compared. It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
The document does not provide any information about a training set. This is likely because the KET-1 Blood Ketone Monitoring System is a pre-calibrated electrochemical device, not an AI/machine learning model that typically requires a large training dataset. The "training" of such a device usually refers to the internal calibration and manufacturing processes, not the statistical training of a data-driven model.
9. How the ground truth for the training set was established
As there is no mention of a training set in the context of an AI/ML model, the establishment of ground truth for a training set is not applicable or described. The device's calibration and internal algorithms would be developed and validated through rigorous engineering and internal testing, using precisely known, manufactured control solutions and spiked samples, rather than a labeled training dataset in the AI sense.
§ 862.1435 Ketones (nonquantitative) test system.
(a)
Identification. A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.