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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The Tyson Bio HT100-A 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-A Blood Glucose Monitoring System is comprised of the Tyson Bio HT100-A Blood Glucose Meter and Tyson Bio 50H Blood Glucose Test Strip.

The Tyson Bio HT100-C 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-C Blood Glucose Monitoring System is comprised of the Tyson Bio HT100-C Blood Glucose Meter and Tyson Bio 50H Blood Glucose Test Strip.

The Tyson Bio HT100-A Blood Glucose Monitoring System (with Voice feature) consists of three main components: the meter (with built-in Voice 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 Solution (Control Solutions are the same as K170079) can be used with the Tyson Bio HT100-A Blood Glucose Monitoring System.

The Tyson Bio HT100-C Blood Glucose Monitoring System (with Voice and Bluetooth features) consists of three main components: the meter (with built-in Voice and Bluetooth features), 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 HT100-C Blood Glucose Monitoring System.

The Tyson Bio HT100-A / HT100-C Blood Glucose Monitoring System consists of:

• a. Tyson Bio HT100-A / HT100-C Blood Glucose Meter
• Tyson Bio 50H Test Strips b. (Test Strips are the same as K170079)

The provided text describes the Tyson Bio HT100-A and HT100-C Blood Glucose Monitoring Systems, which are medical devices intended for the quantitative measurement of glucose in fresh capillary whole blood samples. The document is a 510(k) summary submitted to the FDA for premarket notification.

However, the document does not contain information related to acceptance criteria, device performance tables, sample sizes for test or training sets, data provenance, number or qualifications of experts for ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or how training ground truth was established.

The document primarily focuses on:

• Intended Use: For self-testing by people with diabetes at home to monitor diabetes control. Not for diagnosis, screening, or neonatal use.
• Device Description: Consists of a meter (HT100-A with voice, HT100-C with voice and Bluetooth) and test strips.
• Test Principle: Electrochemical biosensor technology using glucose dehydrogenase.
• Predicate Device Comparison: Lists similarities and differences with the predicate device (Tyson Bio HT100, K170079). Similarities include intended use, enzyme, test principle, measuring range, hematocrit range, sample volume, AST, coding, operating temperature/humidity, memory, battery, alarm, buttons, and meter size. Differences are mainly the addition of voice features, slight changes in meter weight, and functional back cover design.
• Conclusion: Claims substantial equivalence to the predicate device.

Since the provided text does not contain the requested information regarding acceptance criteria and study details, it is impossible to populate the table or answer the specific questions about the study design, ground truth, and sample sizes. The document is a regulatory submission for premarket notification, which often summarizes information but does not include the detailed raw data or study methodologies that would be found in a full study report.

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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.

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.

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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.

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The TysonBio MD100 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood samples may be drawn from the fingertip, palm and forearm. The TysonBio MD100 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The TysonBio MD100 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 MD100 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 MD100 Test Strips are for use with the TysonBio MD100 Blood Glucose Meter to quantitatively measure qlucose in venous whole blood sample and fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio MD100 Control Solutions is for use on the TysonBio MD100 Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.

The TysonBio MD100 Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary and venous whole blood samples may be drawn from the fingertip, palm and forearm. The TysonBio MD100 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 auto-disabling, single-use lancing devices. The TysonBio MD100 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 MD100 Pro Blood Glucose Test Strips are for use with the TysonBio MD100 Pro Blood Glucose Meter to quantitatively measure glucose in venous whole blood sample and fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio MD100 Control Solutions is for use on the TysonBio MD100 Pro Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.

The TysonBio MD100 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 MD100 Test Strips and TysonBio MD100 Control Solution with the TysonBio MD100 Blood Glucose Monitoring System.

The TysonBio MD100 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 MD100 Pro Test Strips and TysonBio MD100 Control Solution with the TysonBio MD100 Pro Blood Glucose Monitoring System.

The TysonBio MD100 / MD100 Pro Blood Glucose Monitoring System consists of:
a. TysonBio MD100/MD100 Pro Blood Glucose Meter
b. TysonBio MD100/MD100 Pro Test Strips
TysonBio MD100 Control Solution

The provided text does not contain specific acceptance criteria or an analytical study that proves the device meets those criteria. It is a 510(k) summary document that describes the device, its intended use, and states that performance studies were conducted and the device meets its intended use, but it does not detail these studies or their results in a way that allows for the extraction of the requested information.

Therefore, many of the requested details cannot be provided from this document.

However, based on the information that is present, I can provide the following:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The document states "The performance of TysonBio MD100 / TysonBio MD100 Pro Blood Glucose Monitoring System was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the performance of this system meets its intended use." However, it does not specify what those acceptance criteria were or what the actual reported performance metrics were against those criteria (e.g., accuracy percentages, bias, precision data).

2. Sample Size Used for the Test Set and Data Provenance:

This information is not provided in the document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The document mentions "healthcare professionals" were involved in clinical settings, but does not specify their number or qualifications for establishing ground truth.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

This information is not provided in the document. The device is a blood glucose monitoring system, which typically involves direct use by individuals or healthcare professionals rather than interpretation of medical images by multiple readers. Therefore, an MRMC study is highly unlikely for this type of device.

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

The device is a Blood Glucose Monitoring System, which by its nature is a standalone device that provides direct measurements to the user or healthcare professional. There is no "human-in-the-loop performance" that would be separate from the device's own measurement. So, in essence, the device's performance is its standalone performance. However, the document does not provide the details of this standalone performance.

7. The Type of Ground Truth Used:

The document implies that the ground truth for glucose measurements would be established through a reference method or laboratory analyzer, as is standard for glucose monitoring systems. While not explicitly stated, the phrase "quantitatively measure glucose" and the nature of the device suggest that comparison would be made against a more precise, established glucose measurement method.

8. The Sample Size for the Training Set:

This information is not provided in the document.

9. How the Ground Truth for the Training Set was Established:

This information is not provided in the document.

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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

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.

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The Easy Step / DIACHEX PRO Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The Easy Step / DIACHEX* PRO Blood Glucose Test Strips are for testing outside the body (in vitro . diagnostic use). The Easy Step / DIACHEX* PRO Blood Glucose Monitoring System is intended for use at home (over the counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady-state blood glucose conditions. It is not intended for neonatal testing.

The Easy Step / DIACHEX* PRO Blood Glucose Monitoring System designed by Tyson Bioresearch Inc., an amperometric biosensor, 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. Easy Step / DIACHEX* PRO provide a convenient and safe monitoring system for diabetes health care professionals, hospitals and most importantly, people with diabetes.

The Easy Step / DIACHEX* PRO Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The Easy Step / DIACHEX* PRO Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). When the edge of the test strip is touched to a drop of blood, the test strip draws the blood into the sample chamber and the glucose reading is displayed on the meter after 5 seconds. The test measures glucose from 20 mg/dL (1.1mmol/L) to 600 mg/dL (33.3 mmol/L). The test strip is calibrated to display the equivalent of plasma glucose values to allow the comparison of results with laboratory methods.

This submission pertains to the Easy Step / DIACHEX* PRO Blood Glucose Monitoring System.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are based on the ISO 15197 standard for clinical accuracy.

2. Sample Size Used for the Test Set and Data Provenance

• Clinical Accuracy (Primary Test Set):
  • Sample Size: 129 participants for fingertip testing. 113 participants for alternate site testing (palm and forearm).
  • Data Provenance: The study was an "in-house study" performed by technicians, implying it was conducted by the manufacturer or a contracted lab. The document does not specify the country of origin of the data beyond the manufacturer being in Taiwan. The study appears to be prospective, as it involved collecting samples from participants specifically for this evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The ground truth for the test set was established using a YSI glucose analyzer (likely a YSI 2300 STAT Plus Glucose & Lactate Analyzer or similar laboratory reference method). There is no mention of experts (e.g., radiologists, pathologists) being used to establish the ground truth for this type of glucose monitoring device. The YSI system itself serves as the reference standard.

4. Adjudication Method for the Test Set

Not applicable. For blood glucose monitoring systems, the ground truth is typically a direct measurement from a highly accurate laboratory reference instrument (like the YSI analyzer), rather than a subjective assessment requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not presented. This type of study is usually conducted for imaging devices where human readers interpret results, and the AI's impact on human performance is evaluated. For blood glucose meters, the performance is assessed against a laboratory reference.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was primarily conducted. The "Performance Characteristic Summary" section details the device's accuracy (precision, linearity, clinical accuracy) directly compared to the YSI reference method. The "clinical accuracy" study involved technicians taking readings, but the core evaluation is of the device's measurement against a golden standard.

7. Type of Ground Truth Used

The type of ground truth used was laboratory reference method data, specifically results obtained from a YSI glucose analyzer. This is considered the "gold standard" for glucose measurement in many clinical and research settings.

8. Sample Size for the Training Set

The document does not provide a specific sample size for a "training set." The submission describes performance characteristics of the finalized device. For IVD devices like blood glucose meters, the development process involves internal calibration and validation steps, but a distinct "training set" in the context of machine learning is not typically disclosed in 510(k) summaries, nor is it always applicable in the same way it would be for complex AI algorithms in image analysis.

9. How the Ground Truth for the Training Set Was Established

As mentioned above, information on a distinct "training set" is not provided. For the initial calibration and development of such a device, similar laboratory reference methods (e.g., YSI) would be used to establish the correct response for different glucose concentrations. The chemical formula and enzyme used in the test strip are identical to a previously cleared device (K062829), suggesting that the fundamental detection mechanism, which would have been rigorously characterized, remains unchanged.

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The TysonBio Link Health Management System is an optional software accessory for use with the following models with data management capabilities: a) EZ Smart-608 series meter, b) DIACHEX Series Blood Glucose Meter, and c) DIACHEX+ Series Blood Glucose Meter. When used with one of these meters, TysonBio Link Health Management System transfers data from the device's memory into a computer for enhanced data management.

TysonBio Link Health Management System is intended for use in home and clinical settings to aid people with diabetes and their health care professionals in the review, analysis and evaluation blood glucose test results to support effective diabetes management. It should be noted that the software does not recommend any medical treatment or medication dosage level.

The TysonBio Health Management System software is an optional software accessory for use with TysonBio blood glucose monitors with data management capabilities. When use with one of these meters, TysonBio Link Health Management System software transfers data from the devices records into a computer for enhanced data management. It should be noted that the software does not recommend any medical treatment or medication dosage level.

The TysonBio Link Health Management System is a data management software for blood glucose monitors. The provided 510(k) summary does not contain specific acceptance criteria or a detailed study report with quantitative performance data in the typical sense of a diagnostic device. Instead, the submission relies on demonstrating substantial equivalence to a predicate device through functional comparisons and general software validation.

Here's an analysis of the provided information based on your request, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the submission primarily compares features and functionalities rather than setting quantitative performance thresholds. The acceptance criteria essentially appear to be "functional equivalence" to the predicate device and meeting general software validation principles.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not specify a sample size for a test set in the context of clinical performance or data accuracy. This is a software accessory for data management, not a diagnostic test device itself. The "testing" referred to is software verification and validation.

The "data provenance" (country of origin, retrospective/prospective) for user data or clinical samples is not applicable as no such data is being analyzed for clinical accuracy by the software. The software's function is to transfer and display data from a blood glucose meter.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided and is not applicable to this type of software submission. There is no mention of expert review for establishing ground truth, as the software's role is data handling, not interpretation requiring expert consensus.

4. Adjudication Method

Not applicable. No clinical data requiring adjudication by experts is described as part of the submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not performed or mentioned. This type of study is typically used for diagnostic imaging or interpretation devices where human performance with and without AI assistance is being evaluated. This software is for data management, not interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

While there isn't a "standalone study" in the sense of a diagnostic algorithm evaluating patient data, the software verification and validation testing described is essentially evaluating the algorithm's (software's) performance in isolation against its functional requirements. The statement "Software verification and validation testing demonstrated that the TysonBio Health Management System meets the performance requirements for the intended use of the optional accessory device" indicates this. The performance requirements, in this context, are for accurate data transfer, display, reporting, and adherence to specified functionalities.

7. Type of Ground Truth Used

The "ground truth" for this device would be its functional specifications and software requirements. The testing would verify that the software accurately transfers numeric data (blood glucose readings) from the meter, stores it, and generates reports based on that data, without alteration. The ground truth for individual blood glucose values would originate from the blood glucose meters themselves, which are separate regulated devices. The software's ground truth is about its operation, not the medical accuracy of the data it handles.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML model that requires a training set of data. It is a traditional software application designed for data transfer and management based on explicit programming rules, not learned patterns from data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of software.

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The DIACHEX BASIC / DIACHEX SUPERB / DIACHEX VIGOR Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The DIACHEX BASIC / DIACHEX SUPERB / DIACHEX VIGOR Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). The DIACHEX BASIC / DIACHEX SUPERB / DIACHEX VIGOR Blood Glucose Monitoring System is intended for use at home (over the counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady-state blood glucose conditions. It is not intended for neonatal testing.

Not Found

This letter from the FDA does not contain enough information to complete all sections of your request. It primarily provides a "substantial equivalence" determination based on a 510(k) premarket notification. While it confirms the device's intended use and classification, it does not include detailed study results, acceptance criteria, sample sizes, or ground truth establishment methods. These details are typically found in the actual 510(k) submission document itself, not in the FDA's clearance letter.

Therefore, I can only provide limited information based on the text provided.

Acceptance Criteria and Study Details for Diachex Basic/Superb/Vigor Blood Glucose Monitoring System

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in the provided FDA letter.
• Reported Device Performance: Not explicitly stated in the provided FDA letter.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not specified in the provided FDA letter.
• Data Provenance: Not specified in the provided FDA letter. The device manufacturer is Tyson Bio Research, Inc. in Taiwan, suggesting the studies could have been conducted there, but this is not confirmed. The letter refers to a "premarket notification" which would contain this information.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Not specified in the provided FDA letter.

4. Adjudication Method for the Test Set

• Not specified in the provided FDA letter.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• Not applicable/Not mentioned. Blood glucose monitoring systems typically undergo analytical and clinical performance studies, not MRMC studies in the way medical imaging AI often does.

6. If a Standalone (Algorithm Only) Performance Was Done

• Not applicable/Relevant for a blood glucose monitoring system, as performance relates to the integrated system (meter, strip, blood sample).

7. Type of Ground Truth Used

• Not specified in the provided FDA letter. For blood glucose meters, the ground truth for performance studies is typically established using a reference laboratory method (e.g., YSI instrument) for glucose measurement on the same blood samples.

8. Sample Size for the Training Set

• Not specified in the provided FDA letter.

9. How the Ground Truth for the Training Set Was Established

• Not specified in the provided FDA letter.

Summary of Missing Information:

To answer your request comprehensively, the detailed 510(k) submission (K072854) document would be required. This document typically contains:

• Specific performance claims (e.g., accuracy percentages within certain glucose ranges)
• The clinical study design, including sample sizes, subject demographics, and inclusion/exclusion criteria.
• Comparisons to a reference method (ground truth) and the methodology for establishing that ground truth.
• Statistical analysis and raw data.

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The DIACHEX* DETERMINE / DIACHEX* INFINITY Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The DIACHEX DETERMINE / DIACHEX INFINITY Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). The DIACHEX* DETERMINE / DIACHEX* INFINITY Blood Glucose Monitoring System is intended for use at home (over the counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady-state blood glucose conditions. It is not intended for neonatal testing.

The DIACHEX* DETERMINE / DIACHEX* INFINITY Blood Glucose Monitoring System designed by Tyson Bioresearch Inc., an amperometric biosensor, 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. DIACHEX* DETERMINE / DIACHEX* INFINITY provide a convenient and safe monitoring system for diabetes health care professionals, hospitals and most importantly, people with diabetes. The DIACHEX* DETERMINE / DIACHEX* INFINITY Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and the alternative sites: the palm and the forearm. The DIACHEX* DETERMINE / DIACHEX* INFINITY Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). When the edge of the test strip is touched to a drop of blood, the test strip draws the blood into the sample chamber and the glucose reading is displayed on the meter after 10 seconds. The test measures glucose from 20 mg/dL (1.1mmol/L) to 600 mg/dL (33.3 mmol/L). The test strip is calibrated to display the equivalent of plasma glucose values to allow the comparison of results with laboratory methods.

Here's a breakdown of the acceptance criteria and study information for the DIACHEX* DETERMINE / DIACHEX* INFINITY Blood Glucose Monitoring System:

Acceptance Criteria and Device Performance

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