(269 days)
The Tyson Bio HT100 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). 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 monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.
The Tyson Bio HT100 Blood Glucose Monitoring System is comprised of the Tyson Bio HT100 Blood Glucose Meter and Tyson Bio HT100 Blood Glucose Test Strip.
The Tyson Bio HT100-B Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). 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 monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.
The Tyson Bio HT100-B Blood Glucose Monitoring System is comprised of the Tyson Bio HT100-B Blood Glucose Meter and Tyson Bio HT100-B Blood Glucose Test Strip.
The Tyson Bio HT100 Blood Glucose Monitoring System consists of three main components: the meter, test strip, and control solutions. The system has been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only Tyson Bio HT100 Test Strips and Tyson Bio HT100 Control Solution with the Tyson Bio HT100 Blood Glucose Monitoring System.
The Tyson Bio HT100-B Blood Glucose Monitoring System (with Bluetooth feature) consists of three main components: the meter (with built-in Bluetooth), test strip, and control solutions. The system has been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only Tyson Bio HT100-B Test Strips and Tyson Bio HT100-B Control Solution with the Tyson Bio HT100-B Blood Glucose Monitoring System.
The Tyson Bio HT100 / HT100-B Blood Glucose Monitoring System consists of:
- Tyson Bio HT100 / HT100-B Blood Glucose Meter
- Tyson Bio HT100 / HT100-B Test Strips
The Tyson Bio HT100 and HT100-B Blood Glucose Monitoring Systems are intended for the quantitative measurement of glucose in fresh capillary whole blood samples.
Here's an analysis of the acceptance criteria and study data based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (ACCU-CHEK Performa device, K133741) rather than explicitly stating specific numerical acceptance criteria for accuracy. However, it does present linear regression analysis results from a system accuracy study. For blood glucose monitoring systems, common accuracy criteria involve certain percentages of results falling within specific glucose concentration ranges compared to a laboratory reference. Without the explicit mention of these criteria, we can only infer performance based on the regression results.
| Metric (Inferred) | Acceptance Criteria (Implicit for Substantial Equivalence to Predicate) | Reported Device Performance (Tyson Bio HT100, combined three lots) |
|---|---|---|
| Slope of linear regression | Close to 1.000 | 0.9966 |
| Intercept of linear regression | Close to 0.000 | 0.0053 |
| R² (Coefficient of Determination) | Close to 1.000 | 0.9892 |
| 95% Confidence Interval of Slope | Should contain 1.000 | 0.9861 to 1.007 |
| 95% Confidence Interval of Intercept | Should contain 0.000 | -0.7270 to 3.487 |
| User Accuracy | Device meets acceptance criteria (implied by study results) | Met acceptance criteria |
| Ease of Use | Device meets acceptance criteria (implied by study results) | Met acceptance criteria (via participant questionnaire scoring) |
2. Sample Size and Data Provenance for the Test Set:
- System Accuracy Study:
- Sample Size: 127 patients.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "patients," suggesting human subjects. It's a clinical study, implying prospective data collection during the study.
- User Performance Study:
- Sample Size: 121 subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "lay users," suggesting human subjects. It's a clinical study, implying prospective data collection during the study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- For the System Accuracy Study, the ground truth was established by a laboratory instrument: YSI 2300 Plus Glucose Analyzer. This is a common and high-accuracy reference method for glucose measurement. No human experts are explicitly mentioned for establishing this ground truth, as it relies on the calibrated laboratory instrument.
- For the User Performance Study, the ground truth for "user accuracy" would indirectly come from comparing user-obtained results to a reference standard (likely the YSI device or similar, though not explicitly stated for this particular study). No "experts" are mentioned as establishing ground truth in the sense of adjudication for this specific study; rather, it assesses the lay user's ability to operate the device correctly.
4. Adjudication Method for the Test Set:
- The document does not describe an adjudication method (like 2+1, 3+1, or none) for either the system accuracy study or the user performance study.
- For the system accuracy study, the comparison is directly between the test device and the laboratory reference instrument (YSI 2300 Plus Glucose Analyzer), so human adjudication of results is not typically applicable in this context.
- For the user performance study, the focus is on whether users can obtain accurate results by following instructions, rather than on subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human readers interpret medical images with and without AI assistance.
- This device is a blood glucose monitoring system, and the studies performed (system accuracy and user performance) are typical for this type of in-vitro diagnostic device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, a standalone performance assessment was effectively done through the "Method Comparison / System Accuracy Study." In this study, the Tyson Bio HT100 Blood Glucose Monitoring System's readings were directly compared against the YSI 2300 Plus Glucose Analyzer. This represents the algorithm's (and integrated system's) performance without direct human judgment influencing the measurement itself, beyond the initial blood sample collection and device operation.
7. Type of Ground Truth Used:
- For the System Accuracy Study, the ground truth used was laboratory reference measurement (YSI 2300 Plus Glucose Analyzer).
- For the User Performance Study, the ground truth for user accuracy would be a reference measurement obtained during the study (likely using the YSI device or a similar highly accurate method), to which the user's readings are compared. The "ease of use" ground truth would be established by participant questionnaire scoring against predefined criteria.
8. Sample Size for the Training Set:
- The document does not provide information on the sample size for a training set. For these types of devices, particularly with established electrochemical biosensor technology, the development (which might involve 'training' in a broad sense) often relies on extensive in-house testing, calibration, and optimization using many samples and iterations, but these aren't typically documented as a distinct "training set" in the same way machine learning models are. The emphasis in the submission is on validation.
9. How the Ground Truth for the Training Set Was Established:
- Since a specific "training set" is not mentioned or detailed, there is no information provided on how its ground truth was established. The development of the device would have involved calibration and quality control procedures against reference methods, but this is distinct from a formal training set for an AI/ML model.
§ 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.