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The TRUEbalance Blood Glucose System is intended for the quantitative determination of glucose in human capillary whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and Healthcare Professional in the management of diabetes.

The alternative site (forearm) testing for the TRUEbalance Blood Clucose System can be used only during steady-state blood glucose conditions.

The TRUEbalance Blood Glucose System is not intended for the diagnosis of or screening for diabetes mellitus.

TRUEbalance Blood Glucose System

This document is a 510(k) clearance letter for the TRUEbalance Blood Glucose System. It primarily addresses the FDA's determination of substantial equivalence, and therefore, does not contain the detailed information required to answer your prompt regarding acceptance criteria and a study proving device performance.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act."

The accompanying "Indication for Use" statement (page 2 of the document) describes the intended use of the device but offers no performance data or study details.

Therefore, based solely on the provided text, I cannot extract the information required to populate the table or answer the specific questions about the device's acceptance criteria and the study that proves performance.

To answer your prompt, I would need access to the full 510(k) submission or at least the performance study section of that submission.

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The TRUEresult Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and Healthcare Professional in the management of diabetes. Healthcare Professionals may use the device to test venous whole blood; home-use is limited to capillary whole blood testing. Not for neonatal use.

TRUEresult Blood Glucose Monitoring System

The provided document is an FDA 510(k) clearance letter for the TRUEresult Blood Glucose Monitoring System. It does not contain the acceptance criteria, reported device performance, or details of the study used to establish substantial equivalence.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications based on this document. This letter only states that the device is substantially equivalent to a predicate device for its stated indications for use.

To answer your questions, I would need access to the actual 510(k) submission, which would include the study reports and validation data.

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The TRUE2go Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and Healthcare Professional in the management of diabetes. Healthcare Professionals may use the device to test venous whole blood; home-use is limited to capillary whole blood testing. Not for neonatal use.

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The provided document is a 510(k) FDA clearance letter for the TRUE2go Blood Glucose Monitoring System, and it does not contain the detailed study information needed to answer all aspects of your request. This type of letter confirms the device's substantial equivalence to a predicate device but typically does not include the full study report with explicit acceptance criteria, detailed sample sizes, expert qualifications, or ground truth establishment methods in the way you've outlined for an AI/CAD device.

Blood glucose monitoring systems are generally evaluated based on accuracy against a laboratory reference method, and the acceptance criteria are usually defined by standards like ISO 15197 for in vitro diagnostic medical devices. However, this specific document doesn't provide those details.

Therefore, I cannot provide a complete answer based only on the provided text. I will answer what is inferable from the document and explicitly state what information is missing.

Here's a breakdown of what I can answer and what is missing:

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

• Acceptance Criteria: Not explicitly stated in this document. For blood glucose meters, these typically relate to the accuracy of readings compared to a laboratory reference method (e.g., specific percentages of readings falling within +/- X mg/dL or +/- Y% of the reference).
• Reported Device Performance: Not explicitly stated in this document. The document confirms market clearance based on substantial equivalence, implying performance met regulatory expectations for blood glucose meters, but specific metrics (e.g., mean absolute relative difference, percentage of readings within certain error margins) are not provided.

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: Not specified in this document.
• Data Provenance: Not specified in this document.

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)

• This question is more relevant for diagnostic imaging AI/CAD systems where expert radiologists establish ground truth. For a blood glucose meter, the "ground truth" is typically established by parallel measurements with a highly accurate laboratory reference instrument, not by human expert interpretation. The document does not describe the specific laboratory reference method or setup.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• This is not applicable to a blood glucose monitoring system in the same way it would be for an AI/CAD system relying on expert interpretation. The "adjudication" in this context would be the comparison against the reference method, not a consensus among human interpreters.

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

• No, an MRMC study was not done. This type of study is specific to AI/CAD systems that assist human readers (e.g., radiologists, pathologists). The TRUE2go Blood Glucose Monitoring System is a standalone diagnostic device for quantitative glucose measurement, not an AI assistance tool for human interpretation.

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

• Yes, a standalone performance assessment was done. The TRUE2go Blood Glucose Monitoring System is a standalone device. Its performance is measured by its accuracy in providing a glucose reading. The document doesn't detail the specific study, but a standalone performance evaluation against a reference method is fundamental for such a device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for a blood glucose monitor is typically derived from highly accurate laboratory reference methods (e.g., a YSI glucose analyzer or a hexokinase method performed on venous blood plasma/serum). This document does not specify the exact method used.

8. The sample size for the training set

• Not specified in this document. For a physical device like a blood glucose meter, the concept of a "training set" in the context of machine learning (where this question usually applies) isn't directly relevant in the same way. Performance is typically evaluated through clinical studies.

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

• As above, the concept of a "training set" for a blood glucose meter isn't typically discussed in this context. Device calibration and validation against reference methods are standard, but the document does not detail these processes.

Summary of what is available from the document:

• Device Name: TRUE2go Blood Glucose Monitoring System
• Intended Use: Quantitative determination of glucose in human whole blood (fingerstick or forearm for home use; venous whole blood for healthcare professionals).
• Regulatory Status: Cleared via 510(k) as substantially equivalent to a predicate device.
• Not for neonatal use.
• The device is a standalone diagnostic system, not an AI/CAD system designed to assist human readers.

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TrackRecord Data Management Software is intended for use in the home or in clinical settings, for single or multi-patient use, to assist people with diabetes as well as their healthcare professionals in the review, analysis and evaluation of historical blood glucose test results to support effective diabetes management.

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This document is a 510(k) premarket notification for a software device called "Track Record Data Management Software." It's a regulatory clearance from the FDA, not a scientific study report. Therefore, it does not contain the information requested about acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications for performance evaluation.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the clearance is based on substantial equivalence to an existing device, not necessarily on a new performance study demonstrating the device meets specific acceptance criteria in the way a clinical trial or algorithm validation study would.

Therefore, I cannot provide the requested table and details because they are not present in the provided text.

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The Element Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

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This letter is a 510(k) premarket notification decision from the FDA, not a study report. Therefore, it does not contain the specific details about acceptance criteria, device performance, or study methodology that you are requesting.

The document states that the FDA has reviewed the 510(k) premarket notification for the "Element Blood Glucose Monitoring System" and determined it to be substantially equivalent to legally marketed predicate devices. This determination is based on the information submitted in the 510(k), which would have included performance data, but that data is not detailed in this letter.

To fully answer your questions, you would need to refer to the actual 510(k) submission document (K060793) itself, which is typically a much more extensive report with detailed study results. The letter confirms the device name, regulation number, regulatory class, and product code, as well as its intended use.

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The Sidekick Blood Glucose Test System is intended for the quantitative determination The Glookin' 2100a Diole blood taken from the finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

Sidekick Blood Glucose Test System

This document is a 510(k) clearance letter from the FDA for a blood glucose test system. It does not contain the detailed study information about acceptance criteria and device performance that you requested. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes, data provenance (e.g., country of origin, retrospective/prospective), number of experts, and adjudication methods for a test set.
• Details on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used.
• Sample size for the training set or how its ground truth was established.

This document is a regulatory clearance, not a clinical study report. To get the information you requested, you would typically need to review the submission's associated clinical and analytical studies, which are not included in this letter.

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The TrackEASE Smart System Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

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This document is a 510(k) clearance letter for a blood glucose monitoring system. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Such details would typically be found in the 510(k) summary or the full submission, which are not provided here.

Therefore, I cannot provide the requested information based on the given text.

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The TrueTrack Smart System Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

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The provided text is a 510(k) summary from the FDA for the "TrueTrack Smart System Blood Glucose Monitoring System". While it states that the device is substantially equivalent to a legally marketed predicate device, it does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria.

Specifically, the document does not include any of the following information:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document primarily focuses on the FDA's determination of substantial equivalence based on the provided indications for use and general compliance with regulations. It does not detail the specific performance studies and their results.

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The TrueTrack Smart System Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

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This FDA 510(k) clearance letter details the approval of the TrueTrack Smart System Blood Glucose Monitoring System. However, it does not contain the specific information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The document primarily focuses on the regulatory aspects of the device's clearance, establishing its substantial equivalence to legally marketed predicate devices. It states the indications for use but does not delve into the performance studies used to demonstrate that equivalence.

Therefore, I cannot provide the requested table or answer the other questions based on the provided text. To answer these questions, the actual 510(k) submission document or a summary of the performance studies would be required.

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The TrueTrack Smart System Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

Not Found

The provided document is an FDA 510(k) clearance letter for the TrueTrack Smart System Blood Glucose Monitoring System dated July 11, 2003. This document confirms the device's substantial equivalence to a legally marketed predicate device but does not contain the detailed study information needed to answer the questions about acceptance criteria and device performance.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act." This indicates that the detailed study results and performance data would have been part of the original 510(k) submission, not typically included in the clearance letter itself.

Therefore, I cannot provide the requested information based on the given input. To answer these questions, the actual 510(k) submission document or a summary of its contents would be required.

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