Search Results

The FORA G30a Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The alternative site testing in the FORA G30a Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only FORA G30a test strips and control solutions with the FORA G30a Blood Glucose Monitoring System.

The provided text describes a 510(k) summary for the FORA G30a Blood Glucose Monitoring System. However, it does not contain specific acceptance criteria, comprehensive performance data, or detailed study methodology in the way requested by the user's template.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (FORA G30 Blood Glucose Monitoring System, K090187) due to minor modifications (software and labeling changes). It states that the FORA G30a has the "same performance characteristics" and that "A comparison of system accuracy performance demonstrated that the FORA G30a blood glucose monitoring system and the currently marketed FORA G30 Blood Glucose Monitoring System (cleared under K090187) are substantially equivalent."

Therefore, based on the provided text, it's impossible to fill in all the requested information. I can, however, extract the limited information present and point out what is missing.

Here's the breakdown based on the provided text:

Acceptance Criteria and Study Information (Based on provided text)

Summary of what the document does convey:

• Device Name: FORA G30a Blood Glucose Monitoring System
• Intended Use: Quantitative measurement of glucose in fresh capillary whole blood from the finger and alternative sites (palm, forearm, upper-arm, calf, thigh) for use by healthcare professionals and people with diabetes mellitus at home. Not for diagnosis, screening, or neonates.
• Predicate Device: FORA G30 Blood Glucose Monitoring System (K090187)
• Modifications: Software modification in the glucose meter and a corresponding labeling change.
• Performance Claim: Substantial equivalence to the predicate device in performance, with the FORA G30a having the "same performance characteristics." Software verification and validation confirmed this.
• Test Principle: Electrochemical biosensor technology using glucose oxidase.

The provided 510(k) summary is typical for a device demonstrating substantial equivalence based on minor changes to an already cleared predicate device. It relies heavily on the predicate's established performance without reiterating all specific performance criteria and detailed study results, as the expectation is that the minor changes did not alter these characteristics. To get the detailed acceptance criteria and performance data, one would typically need to review the original 510(k) submission for the predicate device (FORA G30, K090187).

Ask a specific question about this device

FORA G31a/TD-4256A is intended for in vitro use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The alternative testing sites in the FORA G31a/TD-4256A Blood Glucose Monitoring system can be used only during steady-state blood glucose conditions.

FORA G31 and TD-4256 Blood Glucose Test Strips are used with the FORA G31a/TD-4256A glucose meter in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the alternative sites specified above.

FORA Control Solutions/Taidoc Control Solutions are intended for use with the FORA G31a/TD-4256A Blood Glucose meter to check that both the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.

FORA G31b/TD-4256B is intended for in vitro use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The alternative testing sites in the FORA G31b/TD-4256B Blood Glucose Monitoring system can be used only during steady-state blood glucose conditions.

FORA G31 and TD-4256 Blood Glucose Test Strips are used with the FORA G31b/TD-4256B glucose meter in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the alternative sites specified above.

FORA Control Solutions/Taidoc Control Solutions are intended for use with the FORA G31b/TD-4256B Blood Glucose meter to check that both the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.

FORA G31a/ TD-4256A Blood glucose monitoring system and FORA G31b/ TD-4256B Blood Glucose Monitoring System consist of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.

The provided text describes the 510(k) summary for the FORA G31a/TD-4256A and FORA G31b/TD-4256B Blood Glucose Monitoring Systems. However, it does not contain the detailed performance study results, acceptance criteria, or most of the specific information requested in the prompt.

The document states: "The performance of FORA G31a/ TD-4256A Blood glucose monitoring system and FORA G31b/ TD-4256B Blood Glucose Monitoring System was studied in the laboratory. The studies demonstrated that the performance of this system meets its intended use." This is a general statement, but no specific data, acceptance criteria, or study design details are provided.

Therefore, I cannot fulfill most of your request from the given text.

Here's a breakdown of what can and cannot be answered based on the provided input:

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

• Cannot be provided. The document states that performance studies were conducted and met the intended use, but it does not specify the acceptance criteria (e.g., accuracy percentages, bias limits) or report the actual 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)

• Cannot be provided. The sample size for the test set and the data provenance are not mentioned in the document. It only states that "studies were conducted in the laboratory."

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)

• Cannot be provided. This information is not present in the document. For a blood glucose monitoring system, the "ground truth" would typically be established by a laboratory reference method, not by experts in the context of diagnostic imaging.

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

• Cannot be provided. Adjudication methods are not applicable nor mentioned for this type of device and study.

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

• Cannot be provided. MRMC studies are typically for diagnostic imaging devices involving human interpretation. This is a blood glucose meter, and no such study is mentioned or relevant.

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

• Cannot be provided directly in the requested format. A blood glucose meter inherently provides a "standalone" reading (the algorithm processes the electrochemical signal to produce a glucose value). However, the document doesn't explicitly describe a study focused on "algorithm only" performance separate from the device's main function.

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

• Inferred based on device type: For blood glucose meters, the ground truth is typically a laboratory reference method (e.g., YSI analyzer). This is not explicitly stated in the document but is standard for such devices.

8. The sample size for the training set

• Cannot be provided. The document does not mention a training set size. Blood glucose meters typically do not involve "training sets" in the same way machine learning algorithms do, as their measurement principle is electrochemical.

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

• Cannot be provided. As a training set isn't explicitly mentioned or relevant in the context of typical blood glucose meter development (compared to ML-based systems), how its ground truth would be established is not discussed.

Summary of available information related to performance:

The document states that the device's performance was studied in the laboratory and that these studies demonstrated the system meets its intended use. However, no specific details about these studies (e.g., number of participants, specific glucose ranges tested, comparison to reference methods, accuracy metrics, or acceptance criteria) are provided. The information focuses on the device description, intended use, and substantial equivalence to a predicate device (FORA G30 Blood Glucose Monitoring System, K090187).

Ask a specific question about this device

The FORA G71a Blood Glucose Monitoring System/TD-4274 Blood Glucose Monitoring System are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The alternative site testing in the FORA G71a Blood Glucose Monitoring System /TD-4274 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only FORA G71a / TD-4274 test strips and control solutions with the FORA G71a Blood Glucose Monitoring System / TD-4274 Blood Glucose Monitoring System.

Here's an analysis of the provided text regarding the acceptance criteria and study for the FORA G71a / TD-4274 Blood Glucose Monitoring System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device. The key performance characteristic mentioned is "system accuracy."

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "A comparison of system accuracy performance demonstrated..." without providing details on the study design.

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

The document does not mention the use of experts to establish ground truth. For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods (e.g., YSI analyzer), rather than expert consensus on images or interpretations.

4. Adjudication Method for the Test Set

As experts are not mentioned in relation to ground truth, an adjudication method is not applicable in this context.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported. This type of study is typically used for imaging interpretation devices where human readers' performance is being evaluated with and without AI assistance. A blood glucose monitor is a standalone diagnostic device.

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

Yes, a standalone performance study in the form of a "system accuracy performance" comparison was conducted. This type of device inherently operates in a "standalone" manner, providing a direct measurement without human interpretation beyond reading the displayed result. The comparison was to a predicate device, implying that the new device's readings were directly compared to those of the predicate device.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used, but for blood glucose monitoring systems, the ground truth is overwhelmingly laboratory reference methods (e.g., YSI glucose analyzer) on blood samples. The term "system accuracy performance" implies a comparison to such a reference method, or at least a comparison to the predicate device which would have been validated against a reference method.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. Glucose meters are typically developed and validated using a series of experiments and comparisons, not usually via a machine learning "training set" in the conventional sense of AI. The "modification in the software of the glucose meter" would have undergone internal development and testing, but not typically a labeled training data set as seen in AI/ML applications.

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

As no training set is described, this information is not applicable and not provided.

Ask a specific question about this device