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The Tyson Bio HS100 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 HS100 Blood Glucose Monitoring System is comprised of the Tyson Bio HS100 Blood Glucose Meter and Tyson Bio 50H Blood Glucose Test Strip.

The Tyson Bio HS100-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 HS100-B Blood Glucose Monitoring System is comprised of the Tyson Bio HS100-B Blood Glucose Meter and Tyson Bio 50H Blood Glucose Test Strip.

The Tyson Bio HS100 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. Tyson Bio 50H Blood Glucose Test Strip (Test Strips are the same as K170079) and Tyson Bio 50H Control Solution (Control Solutions are the same as K170079) can be used with the Tyson Bio HS100 Blood Glucose Monitoring System.

The Tyson Bio HS100-B Blood Glucose Monitoring System consists of three main components: the meter (with Bluetooth feature), test strip, and control solutions. The system has been designed, tested, and proven to work together as a system accurate blood glucose test results. Tyson Bio 50H Blood Glucose Test Strip (Test Strips are the same as K170079) and Tyson Bio 50H Control Solutions (Control Solutions are the same as K170079) can be used with the Tyson Bio HS100-B Blood Glucose Monitoring System.

The Tyson Bio HS100 / HS100-B Blood Glucose Monitoring System consists of:

• Tyson Bio HS100 / HS100-B Blood Glucose Meter
• Tyson Bio 50H Blood Glucose Test Strips (Test Strips are the same as K170079)

The provided document is a 510(k) summary for the Tyson Bio HS100 and HS100-B Blood Glucose Monitoring Systems. It focuses on demonstrating substantial equivalence to a predicate device (Tyson Bio HT100 / HT100-B Blood Glucose Monitoring System, K170079) rather than detailing a specific study to prove new acceptance criteria.

The document indicates that the proposed devices (HS100 and HS100-B) have the same intended use, enzyme, test principle, measuring range, hematocrit range, sample volume, alternative site testing (AST), coding, operating temperature range, operating humidity range, and memory capacity as the predicate devices. The differences highlighted are primarily related to physical design (meter size, button color/position, LCD interface changes) and the removal of the USB transfer function for the HS100 model (and retention of Bluetooth for HS100-B). The key statement is: "The Tyson Bio HS100 and HS100-B Blood Glucose Monitoring Systems are substantially equivalent to the predicate device."

Therefore, the acceptance criteria and study proving their meeting are tied to the substantial equivalence to the predicate device, meaning they perform at least as well as the predicate device which has already met regulatory standards.

Based on the provided text, a direct, new study proving novel acceptance criteria for the proposed device is not detailed. Instead, a comparative analysis against an already cleared predicate device (K170079) is presented to establish substantial equivalence. The document does not contain explicit information about a standalone performance study with detailed acceptance criteria for the new device that would demonstrate its performance independently of the predicate.

However, we can infer some information based on typical blood glucose monitoring system requirements and the provided comparisons:

1. A table of acceptance criteria and the reported device performance:

Since the document asserts substantial equivalence based on the majority of specifications being identical or minor cosmetic/feature changes, the implied acceptance criteria are those met by the predicate device (K170079). The performance characteristics are listed as "similarities" to the predicate.

2. Sample size used for the test set and the data provenance:

The document does not provide details of a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on establishing equivalence to the predicate device, implying that the predicate's performance data is sufficient to support the new device, given the minor, non-performance affecting changes.

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. The document primarily focuses on demonstrating substantial equivalence to a previously cleared device. It does not describe a new clinical study involving expert ground truth determination for the HS100/HS100-B devices.

4. Adjudication method for the test set:

This information is not provided.

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:

This is not applicable. The device is a Blood Glucose Monitoring System, which does not involve human readers interpreting AI outputs like in imaging diagnostics.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The document implicitly affirms that the Tyson Bio HS100 / HS100-B Blood Glucose Monitoring System performs as a standalone device (meter + test strip) by stating its intended use for quantitative measurement of glucose, without mentioning human intervention beyond standard user operation. However, no specific standalone performance study details are provided for the new device, other than asserting its equivalence to a predicate device which already demonstrated such performance.

7. The type of ground truth used:

The document does not describe the specific ground truth used for any new testing of these devices. For blood glucose monitoring systems, the ground truth typically involves a laboratory reference method (e.g., YSI analyzer) for glucose concentration comparison. However, this level of detail is not in the provided summary.

8. The sample size for the training set:

This information is not applicable and not provided. Blood glucose monitoring systems typically do not involve AI/machine learning models that require training sets in the same way as diagnostic imaging algorithms. The performance is based on the electrochemical biosensor technology and calibration.

9. How the ground truth for the training set was established:

This information is not applicable and not provided.

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