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The Finetest Lite Blood Glucose Monitoring System is comprised of Finetest Lite Blood Glucose meter and Finetest Lite Blood Glucose Testing Strips. It is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, calf and thigh. The Finetest Lite Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Finetest Lite Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The proposed Finetest Lite Blood Glucose Monitoring System consists of a meter, test strips, control solution and a lancing device. This blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in blood by means of an electrical current produced in the test strip and sent to the meter for measurement.

The provided text is related to the FDA 510(k) clearance for the Finetest Lite Blood Glucose Monitoring System. It does not contain information about the acceptance criteria and study proving the device meets those criteria, as typically found in a clinical study report. The document primarily focuses on the regulatory submission, equivalence to a predicate device, and general performance data without specific metrics or detailed study designs.

Therefore, I cannot provide the requested table and detailed information based on the given text. The text only broadly states that "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria." This is insufficient to extract the specific acceptance criteria, reported device performance, sample sizes, ground truth establishment, or other detailed study information.

If such information were available in a more detailed clinical study report or performance evaluation section, I would be able to extract and present it as requested.

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The Finetest lite Smart Blood Glucose Monitoring System is comprised of the Smart meter and the Finetest Lite Smart Blood Glucose Test Strips.

The Finetest Lite Smart Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The Finetest Lite Smart Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

The Finetest Lite Smart Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).

The Finetest Lite Smart Blood Glucose Test Strips are for use with the Finetest Lite Smart Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be fingertins, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.

The Finetest Lite Smart Blood Glucose Monitoring System consists of a meter, test strips, control solution and a lancing device. This blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in blood by means of an electrical current produced in the test strip and sent to the meter for measurement.

The provided text describes the 510(k) premarket notification for the "Finetest Lite Smart Blood Glucose Monitoring System" (K201396). This document is a regulatory approval, not a detailed study report. Therefore, much of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of clinical performance or AI algorithm validation is not present in the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device (Oh'Care Lite Smart Blood Glucose Monitoring System, K182286). It states that "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria." However, it does not provide the specifics of these tests, such as the exact acceptance criteria for accuracy, precision, or the methodology of the studies.

Specifically, the document does not include information on:

• A table of acceptance criteria and reported device performance (in the sense of clinical accuracy metrics).
• Sample sizes used for test sets (other than implicitly, e.g., for disinfection study, but not for glucose measurement accuracy).
• Data provenance (country of origin, retrospective/prospective) for clinical performance tests.
• Number of experts, their qualifications, or adjudication methods for ground truth establishment.
• Whether an MRMC study was done, or related effect sizes.
• Standalone algorithm performance.
• Type of ground truth (e.g., expert consensus, pathology, outcomes data).
• Training set sample size or ground truth establishment for training, as this is a medical device approval, not an AI algorithm approval for which such data would be relevant.

The only specific "study" mentioned is a "Disinfection Study":
"Disinfectant CaviWipes with the EPA registration number of 46781-8 has been validated demonstrating complete inactivation of live virus of use with the meter." This is a validation for cleaning and disinfection, not for glucose measurement accuracy.

Therefore, I cannot fulfill most of your request based on the provided text. The document is a regulatory letter and a 510(k) summary, which typically summarizes the information provided to the FDA for a substantial equivalence determination rather than detailing all the underlying study results.

Summary of what can be extracted from the text (and what is missing):

• Acceptance Criteria & Reported Performance:

  • Acceptance Criteria for Disinfection: "complete inactivation of live virus" (implicitly, when CaviWipes are used).
  • Reported Performance for Disinfection: "demonstrating complete inactivation of live virus".
  • Acceptance Criteria for General Performance: "based on pre-determined Pass/Fail criteria" (details not provided).
  • Reported Performance for General Performance: "The device passed all of the tests" (details not provided).
  • Specific performance metrics for glucose measurement (e.g., accuracy, precision as per ISO 15197 guidelines often used for blood glucose meters) are NOT detailed in this summary.

• Sample size for the test set and data provenance: Not specified for glucose accuracy tests. A "Disinfection Study" is mentioned, but its sample size is not quantified.

• Number of experts and qualifications for ground truth: Not applicable/not provided for this type of device and submission summary.

• Adjudication method for the test set: Not applicable/not provided.

• MRMC comparative effectiveness study: Not mentioned/not applicable for this device type (not an AI-assisted diagnostic imaging task).

• Standalone (algorithm only) performance: Not mentioned/not applicable.

• Type of ground truth: Not specified (presumed to be laboratory reference methods for glucose measurement, but not stated).

• Sample size for the training set: Not applicable (this device is not an AI algorithm that requires a "training set" in the machine learning sense).

• How the ground truth for the training set was established: Not applicable.

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The Oh' Care Lite Smart Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The Oh'Care Lite Smart Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.

The Oh' Care Lite Smart Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).

The Oh'Care Lite Smart Blood Glucose Test Strips are for use with the Oh'Care Lite Smart Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.

The proposed Oh'Care Lite Smart Blood Glucose Monitoring System consists of a meter, test strips, control solution and a lancing device. This blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in blood by means of an electrical current produced in the test strip and sent to the meter for measurement.

The provided text describes the 510(k) submission for the Oh'Care Lite Smart Blood Glucose Monitoring System. However, it does not contain the detailed acceptance criteria, reported device performance (precision, accuracy, etc.), or study results needed to complete most of your requested information. The document primarily focuses on regulatory approval based on substantial equivalence to a predicate device and mentions general performance data without specifics.

Therefore, for many of your points, I can only state that the information is not provided in the given text.

Here's an attempt based on the information available:

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

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 for test set: Not provided in the document.
• Data provenance: Not provided in the 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)

• Not applicable/Provided: For a blood glucose meter, ground truth is typically established using a laboratory reference method (e.g., YSI analyzer), not human experts for interpretation. 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/Provided: Adjudication by human experts is not typically part of the ground truth establishment for a blood glucose meter's analytical performance.

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 monitoring system, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.

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

• Standalone performance was done (implied): The document states "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices" and that "The device passed all of the tests based on pre-determined Pass/Fail criteria." This implies that the device's analytical performance was assessed on its own. Specific results are not detailed.

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

• Implied ground truth: For blood glucose monitoring systems, the ground truth is typically established by laboratory reference methods, such as a YSI glucose analyzer, which provides a highly accurate measurement of glucose concentration in blood samples. This document does not explicitly state the reference method, but it is standard practice.

8. The sample size for the training set

• Not applicable/Provided: This device is a traditional medical device (blood glucose meter) and does not appear to involve machine learning or AI models with distinct "training sets" in the conventional sense. The "training set" concept is typically for AI algorithm development.

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

• Not applicable/Provided: As there's no mention of a training set for an AI model, this question is not relevant.

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