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DA01 Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood sample (from the finger and the palm,). The alternate site testing can be only used during steady-state blood glucose monitoring. The DA01 Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates.

The DA01 Blood Glucose Test Strips are used with the DA01 Glucose meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the finger and the palm.

The DiaLife mini is a PC-based software intended for use in the home setting by people with diabetes. It is intended to aid in the review, analysis, and evaluation of patient data to support diabetes management. The DiaLife mini software receives via USB, stores, and uses patient data for display and reporting. It is intended for use as an accessory to DELBio DA01 Blood Glucose Monitoring System.

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The provided text describes a medical device named the "DA01 Blood Glucose Monitoring System" and its regulatory clearance. However, it does not contain the detailed acceptance criteria and the study results as requested by the user.

The document is a 510(k) clearance letter from the FDA, indicating market clearance for the device based on substantial equivalence to existing predicate devices. It outlines the intended use, regulatory classification, and general information about FDA regulations. It does not include specific performance studies or acceptance criteria beyond stating that the device is for "quantitative measurement of glucose level."

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

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DA01 Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood sample (from the finger and the palm). The alternate site testing can be only used during steady-state blood glucose monitoring. The DA01 Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates.

The DA01 Blood Glucose Test Strips are used with the DA01 Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the finger and the palm.

The DA06 Glucose Control Solutions are for use with the DA01 Blood Glucose Test Strips and the DA01 Glucose Meter as a quality control check that the meter and test strip are working together properly, and that the test is performing correctly.

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Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the DA01 Blood Glucose Monitoring System, as best as can be extracted from the given document:

This document is primarily a 510(k) clearance letter from the FDA, and as such, it does not contain detailed information about the acceptance criteria and study results. It confirms that the device has been cleared for marketing based on a determination of substantial equivalence to a predicate device.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's what can be extracted and inferred:

Acceptance Criteria and Device Performance Study for DA01 Blood Glucose Monitoring System

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

Unfortunately, the provided FDA 510(k) clearance letter does not contain the specific acceptance criteria or the reported device performance data from the studies submitted by Delbio Incorporation. These details would typically be found in the original 510(k) submission document itself, not in the clearance letter.

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

• Test Set Sample Size: Not available in this document.
• Data Provenance: Not available in this document. (e.g., country of origin, retrospective/prospective)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not available in this document. For a blood glucose monitoring system, the "ground truth" is typically established by a highly accurate laboratory reference method, not by human expert interpretation in the same way it would be for imaging studies.

4. Adjudication method for the test set

Not applicable/available. As mentioned above, for a glucose meter, adjudication by experts is not the standard method for establishing ground truth.

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 monitor, not an AI-assisted diagnostic imaging system that would involve human readers interpreting cases.

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

This refers to the performance of the device itself (the meter and test strips) in measuring glucose levels. While the clearance implies such studies were done to demonstrate accuracy against a reference method, the details of those standalone performance tests are not provided in this document. The device operates as a standalone measurement tool.

7. The type of ground truth used

For a blood glucose monitoring system, the ground truth would typically be established by a a highly accurate laboratory reference method for glucose measurement (e.g., a YSI analyzer or similar). This document does not explicitly state the reference method used.

8. The sample size for the training set

Not applicable/available. For a hardware device like a blood glucose meter, the concept of a "training set" as understood in machine learning is not directly relevant. Performance is demonstrated through analytical and clinical studies on its accuracy and precision.

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

Not applicable. See point 8.

Summary of what can be gleaned from the document:

• Device Name: DA01 Blood Glucose Monitoring System
• Intended Use: Quantitative measurement of glucose level in fresh capillary whole blood samples (finger and palm) for in vitro diagnostic use, at home, by a single person.
• Purpose: As an aid in monitoring the effectiveness of diabetes control programs.
• Limitations: Not for diagnosis or screening of diabetes, nor for testing neonates. Alternate site testing only during steady-state blood glucose monitoring.
• Regulatory Class: Class II
• What this document does convey: The FDA found the device substantially equivalent to a predicate device, allowing it to be marketed. This determination implies that Delbio Incorporation submitted data (including performance studies) that met FDA requirements for substantial equivalence, but the details of those studies are not in this letter.

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