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The BD Paradigm Link Blood Glucose Monitor is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

The BD Paradigm Link Blood Glucose Monitor is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertip.

The BD Paradigm Link™ Blood Glucose Monitor is an in-vitro diagnostic device for use in the quantitative measurement of glucose in capillary blood collected from fingertips. The BD Paradigm Link™ is designed to be simple and easy to use. It provides accurate blood glucose test results in 5 second while requiring a very small (0.3 µL) sample.

The BD Paradigm Link™ is also designed for wireless communication with Medtronic MiniMed External Insulin Pumps (511 and higher). When used with Medtronic MiniMed 512 External Insulin Pump, blood glucose test values obtained using the BD Paradigm Link™ can be automatically transmitted to the insulin pump for use in the Bolus Wizard feature of the Medtronic MiniMed 512 External Insulin Pump. Consumers or healthcare practitioners may also use the meter as a communication device to facilitate transfer of information between the pump and a personal computer.

When used with a MiniMed Pump, the BD Paradigm Link Blood Glucose Monitor can automatically telemeter glucose values to the Model 512 Insulin Pump using radio frequency communication. The BD Paradigm Link Blood Glucose Monitor can also serve as a radio frequency interface to allow communication between the MiniMed insulin pump and a personal computer running the appropriate Medtronic MiniMed communications software.

The BD Paradigm Logic™ Blood Glucose Monitor is based on biosensor (glucose oxidase) technology. When blood is applied to the BD Test Strip, reagents on the strip react with the blood and a current is generated. The Paradigm Link™ employs amperometric technology to measure the glucose concentration in the blood sample by measuring the amount of current that is generated and flows through the electrodes on the test strip.

The BD Paradigm Link™ is designed for wireless communication using radiofrequency (RF) technology. The RF telemetry functionality of the Paradigm Link™ allows the meter to automatically telemeter glucose values to a MiniMed pump or to be used as a radio frequency interface to allow communication between a MiniMed insulin pump and a personal computer.

The provided text does not contain specific acceptance criteria or detailed study results, such as statistical performance metrics (e.g., accuracy, precision, sensitivity, specificity, AUC) for the BD Paradigm Link Blood Glucose Monitor. It mentions that "Laboratory and Human Factors studies demonstrate that the BD Paradigm LinkTM performed in an equivalent manner to the predicate devices and is suitable for its intended use" but does not provide the quantitative results of these studies.

Therefore, most of the requested information cannot be extracted from the given document.

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

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

• Acceptance Criteria: Not explicitly stated in the document. For glucose meters, acceptance criteria typically involve accuracy standards (e.g., ISO 15197) stating a certain percentage of readings must be within a defined range of a reference method.
• Reported Device Performance: Not detailed quantitatively. The document only states that the device "performed in an equivalent manner to the predicate devices." No specific accuracy percentages, precision values, or bias measurements are provided.

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: Not mentioned.
• Data Provenance: Not mentioned (e.g., country of origin, retrospective or prospective).

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 not applicable to an in-vitro diagnostic device measuring glucose. Ground truth for such devices is typically established using a highly accurate laboratory reference method (e.g., YSI analyzer), not expert consensus. The document does not specify the reference method used.

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

• Not applicable for a glucose meter study. Adjudication is relevant for studies involving human interpretation of data (e.g., imaging studies), not for direct quantitative measurements against a reference.

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 standalone blood glucose monitor, not an AI system assisting human readers.

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

• Yes, implicitly. The performance of the BD Paradigm Link™ Blood Glucose Monitor is inherently "standalone" as it directly measures glucose concentration. Its stated performance is that of the device itself.

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

• Not explicitly stated, but for a blood glucose monitor, the ground truth would typically be established using a laboratory reference method (e.g., a YSI glucose analyzer) on plasma or whole blood samples.

8. The sample size for the training set

• Not applicable in the context of this device. A "training set" is usually associated with machine learning or AI algorithms. This device uses biosensor (glucose oxidase) and amperometric technology, which are established chemical reaction-based methods, not trained algorithms in the sense of AI.

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

• Not applicable for the same reason as point 8.

Summary of available information:

• Device Name: BD Paradigm Link™ Blood Glucose Monitor
• Intended Use: Quantitative measurement of glucose in capillary whole blood from fingertips, for home use by people with diabetes mellitus to monitor diabetes control. Not for diagnosis/screening of diabetes or use on neonates.
• Technology: Biosensor (glucose oxidase) technology, employing amperometric measurement to determine glucose concentration.
• Performance Claim: Laboratory and Human Factors studies demonstrate that the BD Paradigm Link™ performed in an equivalent manner to predicate devices and is suitable for its intended use.
• Ground Truth: Implied to be a laboratory reference method, though not specified.
• Standalone Performance: Yes (as it's a direct measurement device).

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