(260 days)
The TysonBio AC500 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 AC500 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The TysonBio AC500 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 AC500 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 AC500 Test Strips are for use with the TysonBio AC500 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The TysonBio AC500/AC800 Control Solutions is for use on the TysonBio AC500 Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.
The TysonBio AC800 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 AC800 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The TysonBio AC800 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 AC800 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 AC800 contains a voice function but this function is not intended for users with impaired vision.
The TysonBio AC800 Test Strips are for use with the TysonBio AC800 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The TysonBio AC500/AC800 Control Solutions is for use on the TysonBio AC800 Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.
The TysonBio AC500 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 AC500 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, auto-disabling lancing devices.
The TysonBio AC500 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 AC500 Pro Blood Glucose Test Strips are for use with the TysonBio AC500 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm,
The TysonBio AC500/AC800 Control Solutions is for use on the TysonBio AC500 Pro Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.
The TysonBio AC800 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 AC800 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, auto-disabling lancing devices.
The TysonBio AC800 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 AC800 Pro contains a voice function but this function is not intended for users with impaired vision.
The TysonBio AC800 Pro Blood Glucose Test Strips are for use with the TysonBio AC800 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC500/AC800 Control Solutions is for use on the TysonBio AC800 Pro Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.
The TysonBio AC500/AC800 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only TysonBio AC500/AC800 Test Strips and TysonBio AC500/AC800 Control Solution with the TysonBio AC500/AC800 Blood Glucose Monitoring System.
The TysonBio AC500 Pro/AC800 Pro Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only TysonBio AC500 Pro/AC800 Pro Test Strips and TysonBio AC500/AC800 Control Solution with the TysonBio AC500 Pro/AC800 Pro Blood Glucose Monitoring System.
The TysonBio AC500/AC800/AC500 Pro/AC800 Pro Blood Glucose Monitoring System consists of:
a. TysonBio AC500/AC800/AC500 Pro/AC800 Pro Blood Glucose Meter
b. TysonBio AC500/AC800/AC500 Pro/AC800 Pro Test Strips
c. TysonBio AC500/AC800 Control Solution
The provided text is a 510(k) summary for the TysonBio AC500/AC800/AC500 Pro/AC800 Pro Blood Glucose Monitoring Systems. While it establishes the substantial equivalence of the proposed device to a predicate device and states that "The studies demonstrated that the performance of this system meets its intended use," it does not contain specific acceptance criteria, detailed study results, or information about the methodology (like sample sizes, ground truth establishment, or expert involvement) that would be expected for a comprehensive description of acceptance criteria and a study proving device performance in the context of human-in-the-loop AI or standalone imaging algorithms.
The document primarily focuses on:
- Device Description and Intended Use: Explaining what the glucose meters are and what they are used for.
- Predicate Device Comparison: Highlighting similarities and differences with a previously cleared device (TysonBio AC100). The most significant difference noted is the hematocrit range.
- Regulatory Conclusion: Stating that the device is substantially equivalent to the predicate.
Therefore, many of the requested details cannot be extracted from the provided text. The term "acceptance criteria" is not explicitly defined in terms of specific performance thresholds (e.g., accuracy percentages for different glucose ranges). The study mentioned is broadly described as having been conducted "in the laboratory and in clinical settings by healthcare professionals and lay users," but specifics are missing.
Here's an attempt to answer based only on the provided text, with significant acknowledgment of missing information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a numerical table. It only provides a general statement: "The studies demonstrated that the performance of this system meets its intended use."
2. Sample sized 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 specified.
- Data Provenance: Not specified (country of origin, retrospective/prospective). The studies were conducted "in the laboratory and in clinical settings."
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)
Not applicable/Not specified. For a blood glucose monitoring system, the "ground truth" would typically be established by a laboratory reference method (e.g., YSI or hexokinase method) rather than human expert consensus, as is common for imaging AI. The document does not detail how the ground truth reference values were obtained.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiologists) where disagreements in ground truth labeling need resolution. This is not mentioned for this type of device.
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 assisting human readers in diagnostic interpretation. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone algorithm (a blood glucose meter that provides a numerical reading). The "performance characteristic summary" states that the performance was studied "in the laboratory and in clinical settings by healthcare professionals and lay users." This implies that the device's output (glucose reading) was evaluated in these settings, which equates to a standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not explicitly stated. For blood glucose meters, the ground truth is typically established using a highly accurate laboratory reference method (e.g., YSI analyzer, hexokinase method). The document does not specify the method used as the reference.
8. The sample size for the training set
Not applicable/Not specified. This document pertains to a traditional medical device (blood glucose meter) and its submission for regulatory clearance. It does not describe an AI/ML model that would typically have a separate "training set." The performance evaluation mentioned (laboratory and clinical settings) refers to validation of the final device, not the training of an underlying algorithm in the AI/ML sense.
9. How the ground truth for the training set was established
Not applicable. As noted above, this context of "training set" and its ground truth establishment is not relevant to the information provided for this traditional medical device.
§ 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.