Search Results

FORA ADVANCED GD40 Blood Glucose and ß-Ketone Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger, and for the quantitative measurement of ß-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger. The FORA ADVANCED GD40 is intended for in vitro diagnostic use and is intended for single-patient use as an aid to monitor the effectiveness of a diabetes control program. The system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.

FORA ADVANCED GD40 Blood Glucose Test Strips are for use with the FORA ADVANCED GD40 Blood Glucose and ß-Ketone Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the finger. The FORA ADVANCED GD40 Blood ß-Ketone Test Strips are for use with the FORA ADVANCED GD40 Blood Glucose and ß-Ketone Meter to quantitatively measure ß-ketone in fresh capillary whole blood samples drawn from the finger.

ß-Ketone Control Solutions are intended for use with FORA ADVANCED GD40 Blood Glucose and ß-Ketone Monitoring System to check that the meters and test strips are working together properly and that the test is performing correctly.

FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger, and from venous, and neonatal capillary heelstick whole blood, and for the quantitative measurement of ß-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger, and from venous whole blood. The FORA ADVANCED GD40 pro is intended for in vitro diagnostic use and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices. The system should not be used for the diagnosis of or screening for diabetes.

FORA ADVANCED GD40 pro Blood Glucose Test Strips are for use with the FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, and from venous and neonatal whole blood. The FORA ADVANCED GD40 pro Blood β-Ketone Test Strips are for use with the FORA ADVANCED GD40 pro Blood Glucose and p-Ketone Meter to quantitatively measure fketone in fresh capillary whole blood samples drawn from the fingertips and from venous whole blood.

ß-Ketone Control Solutions are intended for use with FORA ADVANCED GD40 Pro Blood Glucose and ß-Ketone Monitoring System to check that the meters and test strips are working together properly and that the test is performing correctly.

The FORA ADVANCED GD40/GD40 Pro Blood Glucose and ß-Ketone Monitoring System consists of: FORA ADVANCED GD40/GD40 Pro Blood Glucose and ß-Ketone Meter (same as meter cleared under K101509, with addition of ketone testing capability), FORA ADVANCED GD40/GD40 Pro Glucose Test Strips, FORA Glucose Control Solutions (cleared under K093724), FORA ADVANCED GD40/GD40 Pro β-Ketone Test Strips, and ß-Ketone Control Solutions.

The provided document describes the FORA ADVANCED GD40/GD40 Pro Blood Glucose and ß-Ketone Monitoring System. The performance studies for both glucose and ß-ketone measurements are discussed, but specific details regarding the study design, sample sizes, ground truth establishment, or expert involvement are limited.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample sizes for the test set and data provenance:

• Glucose Measurement:
  • For glucose concentrations

Ask a specific question about this device

FORA V10 No Code Blood Glucose Monitoring System, model TD-4244, 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 people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. The meter contains some speaking functions but has not been validated for use by visually impaired users. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

This system is intended to be used by a single patient and should not be shared.

FORA V10 test strips are for use with FORA V10 No Code Blood Glucose meter model TD-4244 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, forearm, upper arm calf and thigh.

The FORA control solutions can only be used with FORA V10 No Code Blood Glucose meter, model TD-4244 and the FORA V10 test strips to check that meter and test strips are working together properly.

The alternative site testing in FORA V10 No Code Blood Glucose Monitoring systems model TD-4244 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 V10 test strips and FORA control solutions with the FORA V10 No Code Blood Glucose Monitoring System, model TD-4244.

Here's an analysis of the provided text regarding the acceptance criteria and study for the FORA V10 No Code Blood Glucose Monitoring System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria in terms of numerical thresholds (e.g., accuracy percentages, precision values) that the device must meet. Instead, the submission for the FORA V10 No Code Blood Glucose Monitoring System, model TD-4244, relies on demonstrating substantial equivalence to a predicate device (FORA V10 Blood Glucose Monitoring System, K093035).

The core of the "performance" claim is that it has the "same performance characteristics as the predicate device" and that "Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA V10 No Code Blood Glucose Monitoring System are equivalent to the predicate device."

Therefore, the implied acceptance criterion is that its performance is equivalent to the predicate. The "reported device performance" is essentially that it is equivalent to the predicate device, which would have had its performance demonstrated in its own 510(k) submission.

Table of (Implied) Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify the sample size used for any test set (accuracy, precision, etc.). It only mentions that the system was "compared to the YSI 2300 Glucose Analyzer in the Accuracy studies."
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).

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

• Number of Experts: This information is not provided in the document.
• Qualifications of Experts: This information is not provided in the document.

4. Adjudication Method for the Test Set

• Adjudication Method: This information is not provided in the document.

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

• MRMC Study Done? No. This device is a blood glucose meter, not an imaging or diagnostic device typically requiring MRMC studies for human reader performance. The "performance characteristics" typically refer to analytical accuracy and precision in comparison to a reference method, rather than human interpretation of results.

6. Standalone (Algorithm Only) Performance

• Standalone Performance Done? Yes, indirectly. The core of the performance evaluation is the device's ability to quantitatively measure glucose, which is its standalone analytical performance. The document states: "The FORA V10 No Code Blood Glucose Monitoring System is compared to the YSI 2300 Glucose Analyzer in the Accuracy studies." This confirms a standalone performance evaluation against a reference standard.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the accuracy studies was established by the YSI 2300 Glucose Analyzer. This is a laboratory reference method widely accepted for determining glucose concentrations. The YSI itself is stated to be "calibrated with NIST (SRM) 917A reference material," confirming a traceable and high-quality reference standard.

8. Sample Size for the Training Set

• Sample Size: The document does not provide information on a training set sample size. This is common for devices like blood glucose meters, as their underlying electrochemical biosensor technology isn't "trained" in the same way a machine learning algorithm is. The "development" and "testing" would involve product development, calibration, and verification/validation, rather than a distinct "training set."

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

• Ground Truth Establishment for Training Set: As there's no mention of a "training set" in the context of an algorithm that learns, this question is not directly applicable. The device's calibration and design would rely on established laboratory methods and reference materials (like the NIST (SRM) 917A) during its development and manufacturing, but not in the sense of a machine learning training process with ground truth labels.

Ask a specific question about this device

The FORA Premium V10 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: palm, forearm, upper-arm, calf and thigh. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. This system is intended to be used by a single person and should not be shared. 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 Premium V10 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

The FORA Premium V10 Test Strips are for use with the FORA Premium V10 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper-arm, calf and thigh.

This meter has some speaking functions but is not intended for use by the visually impaired.

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 test strips and FORA control solutions (cleared under K093724) with the FORA Premium V10 Blood Glucose Monitoring System.

The provided 510(k) summary for the FORA Premium V10 Blood Glucose Monitoring System does not contain detailed information about the acceptance criteria and the study that proves the device meets them in the format requested.

Specifically, it states: "FORA Premium V10 Blood Glucose Monitoring System has the same performance characteristics as the predicate device. A comparison of system accuracy performance demonstrated that the FORA Premium V10 Blood Glucose Monitoring System and the FORA V30 Blood Glucose Monitoring System are substantially equivalent." And also, "Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA Premium V10 Blood Glucose Monitoring System are equivalent to the predicate device."

This indicates that the device's performance was established by demonstrating substantial equivalence to a predicate device (FORA V30 Blood Glucose Monitoring System, K093635), rather than through a detailed, standalone study with specific acceptance criteria and performance metrics presented in this document.

Therefore, most of the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC study, standalone study details, and training set information) is not available in the provided text.

However, based on the information that is present, here's what can be inferred:

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

• Acceptance Criteria: Not explicitly stated in the document for the FORA Premium V10, but implied to be "same performance characteristics as the predicate device" (FORA V30 Blood Glucose Monitoring System). For blood glucose monitors, typical acceptance criteria would involve accuracy standards such as ISO 15197 (which often specifies limits like ±15% or ±20% agreement with a reference method within certain glucose ranges), but these are not cited here.
• Reported Device Performance: The document states that the system "has the same performance characteristics as the predicate device" and that a "comparison of system accuracy performance demonstrated that the FORA Premium V10 Blood Glucose Monitoring System and the FORA V30 Blood Glucose Monitoring System are substantially equivalent." No specific numerical performance metrics are provided for the FORA Premium V10 in this summary.

2. Sample sized used for the test set and the data provenance

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text.

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. The study appears to be a bench-level comparison to a predicate device, rather than a clinical study requiring expert ground truth establishment for a test set.

4. Adjudication method

• Not applicable/not specified in the provided text.

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 is a blood glucose monitoring system, not an imaging device typically evaluated with MRMC studies or AI assistance for human readers.

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

• "Standalone" performance, in the context of a blood glucose meter, refers to the accuracy of the device itself compared to a reference method. The document indicates that "system accuracy performance" was compared to the predicate device. However, no specific data from such a standalone study (if one was performed) is included in this summary.

7. The type of ground truth used

• Not explicitly stated. For blood glucose meters, the "ground truth" (or reference standard) is typically established using a laboratory-grade, highly accurate glucose measurement method (e.g., YSI analyzer) on venous blood samples. The document doesn't detail the method used to compare against the predicate.

8. The sample size for the training set

• Not applicable/not specified in the provided text. As this relies on substantial equivalence to an existing device and a well-established measurement principle (electrochemical biosensor using glucose oxidase), there isn't a "training set" in the machine learning sense.

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

• Not applicable/not specified in the provided text.

Ask a specific question about this device