(453 days)
The TysonBio AC100 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 or palm. The TysonBio AC100 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The TysonBio AC100 Blood Glucose Monitoring System 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 TysonBio AC100 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The TysonBio AC100 contains a voice function but this function is not intended for users with impaired vision. The TysonBio AC100 Test Strips are for use with the TysonBio AC100 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The TysonBio AC100 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, or forearm. The TysonBio AC100 Pro 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 single-use lancing devices. The TysonBio AC100 Pro Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The TysonBio AC100 Pro contains a voice function but this function is not intended for users with impaired vision. The TysonBio AC100 Pro Blood Glucose Test Strips are for use with the TysonBio AC100 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The TysonBio AC200 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 or palm. The TysonBio AC200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The TysonBio AC200 Blood Glucose Monitoring System 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 TysonBio AC200 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The TysonBio AC200 Test Strips are for use with the TysonBio AC200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The TysonBio AC200 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, or forearm. The TysonBio AC200 Pro 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 single-use lancing devices. The TysonBio AC200 Pro Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The TysonBio AC200 Pro Blood Glucose Test Strips are for use with the TysonBio AC200 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The TysonBio AC100/AC100 Pro Blood Glucose Monitoring System and the TysonBio AC200/AC200 Pro Blood Glucose Monitoring System is an amperometric biosensor, It is adopted for its ease of use, its ability to process accurate results utilizing only a small volume of blood, and its quick response time. The TysonBio AC100/AC100 Pro Blood Glucose Monitoring System and the TysonBio AC200/AC200 Pro Blood Glucose Monitoring System consist of three main products: the meter, Test Strips and Control Solutions. Use only TysonBio AC100/AC100 Pro Test Strips for TysonBio AC100/AC100 Pro Blood Glucose Monitoring Systems, TysonBio AC200/AC200 Pro Test Strips for TysonBio AC200/AC200 Pro Blood Glucose Monitoring Systems, and use i TysonBio AC100/AC100 Pro Control Solutions for TysonBio AC100/AC100 Pro Blood Glucose Monitoring Systems, TysonBio AC200/AC200 Pro Control Solutions for TysonBio AC200/AC200 Pro Blood Glucose Monitoring Systems to perform quality checks.
The provided text describes the TysonBio AC100/AC200 Blood Glucose Monitoring Systems and their substantial equivalence to a predicate device, the Easy Step Blood Glucose Monitoring System (K090629). However, it does not explicitly state specific acceptance criteria (e.g., accuracy percentages within certain glucose ranges) or detailed performance metrics against those criteria. The document only broadly states that "The studies showed substantially equivalent performance with the current Easy Step Blood Glucose Monitoring System." and "Evaluations...were studied in the laboratory and in a clinical setting using persons with diabetes. The results were compared to results from the currently marketed Easy Step Blood Glucose Monitoring System and to a laboratory method."
Therefore, based on the provided text, I cannot complete all sections of your request with specific numbers.
Here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated in the provided text.) | "Substantially equivalent performance with the current Easy Step Blood Glucose Monitoring System." |
| (Likely involved accuracy metrics within glucose ranges, as is standard for BGMs, but specific percentages are not given.) | Compared favorably to a laboratory method and the predicate device. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The document mentions "a clinical setting using persons with diabetes" but doesn't provide the number of participants.
- Data Provenance: Not explicitly stated. The sponsor information indicates Tyson Bioresearch, Inc. is in Taiwan, but it doesn't specify where the clinical evaluation was conducted. The study appears to be prospective due to the nature of clinical evaluations for new medical devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Number of Experts: Not applicable or not stated. For blood glucose monitoring systems, the "ground truth" is typically established by a reference laboratory method (e.g., YSI analyzer) rather than expert consensus on images or clinical assessments.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This method is typically used for image-based or qualitative assessments where multiple human readers might disagree. For blood glucose measurements, the reference method provides a quantitative 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
- MRMC Study: No. This is not relevant for a blood glucose monitoring system, which is a standalone diagnostic device. The study evaluates the device's accuracy against a reference method and a predicate device, not its impact on human reader performance.
- Effect Size of Human Readers with AI: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes. The performance evaluation was for the device itself (meter and test strips) in measuring glucose. This is by nature a standalone performance evaluation, comparing its results to a laboratory reference method. The "human-in-the-loop" aspect for a blood glucose monitor primarily refers to the user taking the sample and operating the device, but the measurement mechanism is automated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: A "laboratory method" was used, often a highly accurate and precise analytical instrument like a YSI Glucose Analyzer, which serves as the reference standard for glucose concentration.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/not stated. Blood glucose monitoring systems are typically developed through engineering and chemical optimization, and then validated. They don't typically involve "training sets" in the same way machine learning algorithms do. While there would have been internal R&D and calibration data, it's not described as a "training set" in this context.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable. As mentioned above, the concept of a "training set" with established ground truth is not directly relevant to the described development and validation of this type of medical device in the same way it would be for an AI/ML device. The device's calibration and accuracy are established through comparison to precise laboratory methods during development and validation.
§ 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.