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The Liberty™ Blood Glucose Monitoring System is intended to quantitatively measure blood glucose levels, also known as blood sugar, from fresh capillary whole blood samples taken from the fingertips, palm, or forearm. The Liberty, TM Test Strips are for in vitro diagnostic (outside of the body) use only. The Liberty™ System is not intended for use with neonates.

AgaMatrix Liberty " Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip, palm, or forearm. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for use with neonates.

AgaMatrix Liberty™ Blood Glucose Meter is intended for use with AgaMatrix Liberty™ Blood Glucose Test Strips for the quantitative measurement of glucose in frearians courty whole blood. Testing sdone outside the body (in viro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveress of diabetes control.

AgaMatrix Liberty " Blood Glucose Test Strips are intended for use with AgaMatrix Liberty™ Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effective of por diabetes control.

AgaMatix Liberty™ Control Solutions are intended for use with the AgaMarix Libery™ Meter and AgaMatix Liberty™ Test Stri results.

The AgaMatrix Liberty™ Blood Glucose Monitoring System includes a meter with batteries, compact carrying casc, quick start guide, reference guide, owner's booklet, and warranty/registration card. Test Strips, Lancing device, Lancets, and Control Solution are purchased separately.

It is intended for over-the-counter home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by healthcare professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument.

The provided 510(k) summary for the AgaMatrix Liberty™ Blood Glucose Monitoring System (K063409) does not contain detailed information regarding the specific acceptance criteria and the comprehensive study results as typically expected for device validation.

Instead, it states that the device complies with certain ISO and IEC standards, which imply conformance to established performance requirements. However, the specific numerical acceptance criteria (e.g., accuracy percentages, precision limits) and the detailed results of studies demonstrating compliance are not explicitly provided in the given text.

Based on the provided document, here's what can be extracted and what information is missing:

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

This information is not explicitly stated in the provided text. The document refers to compliance with ISO 15197:2003, which sets performance requirements for blood glucose monitoring systems for self-testing. However, the specific numerical criteria (e.g., accuracy within a certain percentage of a reference method) and the device's measured performance against those criteria are not listed.

2. Sample size used for the test set and the data provenance:

This information is not explicitly stated in the provided text. The document mentions "Testing" but does not detail the sample sizes for patient samples or control samples, nor their country of origin or whether the data was retrospective or prospective.

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

This information is not explicitly stated in the provided text. For blood glucose monitoring systems, "ground truth" is typically established by laboratory reference methods, not by expert consensus on visual assessment.

4. Adjudication method for the test set:

This information is not applicable/not explicitly stated in the context of a blood glucose monitoring system's performance testing. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation) where multiple readers provide their opinion. For quantitative measurements like blood glucose, accuracy is determined by comparison to a reference method.

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:

This information is not applicable. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device that involves human readers interpreting cases.

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

This information is not explicitly stated but is implicitly the primary mode of operation for a blood glucose meter. The "device performance" would inherently be its standalone performance, as it provides a direct measurement rather than an interpretation to a human.

7. The type of ground truth used:

This is not explicitly stated, but for blood glucose monitoring systems, the ground truth is universally established by laboratory reference methods (e.g., YSI analyzer). The document mentions "in vitro diagnostic (outside of the body) use only," which confirms the nature of the testing.

8. The sample size for the training set:

This information is not applicable/not explicitly stated. "Training set" refers to data used to develop and train machine learning models. A blood glucose monitoring system, based on electrochemical principles, does not typically involve a "training set" in the machine learning sense. Its performance is based on its sensor technology and calibration, not learned patterns from a dataset.

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

This information is not applicable for the reasons stated in point 8.

Summary of available and missing information:

To get the specific acceptance criteria and detailed study results, one would typically need to refer to a more detailed clinical study report or the full submission documentation to the FDA, which is not provided in this 510(k) summary. The summary focuses on establishing substantial equivalence based on identical technological characteristics and compliance with general standards.

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AgaMatrix LibertyTM Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip and palm of the hand. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

AgaMatrix Liberty™ Blood Glucose Meter is intended for use with AgaMatrix Liberty™ Blood Glucose Test Strips for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip and palm of the hand. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

AgaMatrix Liberty™ Blood Glucose Test Strips are intended for use with AgaMatrix Liberty™ Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip and palm of the hand. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

AgaMatrix Liberty™ Control Solutions are intended for use with the AgaMatrix Liberty™ Meter and AgaMatrix Liberty™ Test Strips as a quality control check to verify the accura results.

The AgaMatrix Liberty™ Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, quick start guide, reference guide, owner's booklet, and warranty/ registration card. Test Strips, Lancing device, Lancets, and Control Solution are purchased separately.

It is intended for over-the-counter home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by healthcare professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument.

The provided text describes the AgaMatrix Liberty™ Blood Glucose Monitoring System and its 510(k) submission, confirming its substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria or the specific study data that definitively proves the device meets those criteria.

The document mentions compliance with ISO 15197:2003, which sets requirements for blood glucose monitoring systems for self-testing. This ISO standard would contain the acceptance criteria for accuracy, but the document itself does not explicitly list these criteria or the specific performance metrics achieved by the AgaMatrix Liberty™ system against them.

Therefore, the requested information in the prompt cannot be fully extracted from the provided text.

Here's what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in the document. The document refers to compliance with ISO 15197:2003, which would define these criteria, but the specific numerical targets for accuracy (e.g., within X% or Y mg/dL of a reference method) are not provided.
• Reported Device Performance: Not explicitly stated in the document in numerical terms that can be directly compared to acceptance criteria. The document states "The new device contains additional features compared to the predicate device. These additional features include faster test time, smaller sample size, and better accuracy." and "The system performs as intended and raises no new safety of effectiveness issues." While "better accuracy" is mentioned, no quantitative data is given.

Missing Information (based on the provided text):

2. Sample size used for the test set and the data provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned, as no specific clinical study details are provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.

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 device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable in the context of typical AI performance studies. This is a point-of-care diagnostic device. Its performance is inherent to 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 by a laboratory reference method (e.g., a YSI analyzer).

8. The sample size for the training set: Not mentioned.

9. How the ground truth for the training set was established: Not mentioned.

Summary of what can be extracted:

The device is the AgaMatrix Liberty™ Blood Glucose Monitoring System. It gained 510(k) clearance by demonstrating substantial equivalence to the Ascensia Contour Blood Glucose Monitoring System (K023657). The manufacturer certifies compliance with ISO 15197:2003, which is the relevant standard for blood glucose monitoring systems' accuracy. However, the specific data from the studies (sample sizes, detailed accuracy metrics, ground truth methods, etc.) are not included in this 510(k) summary document.

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The Liberty™ Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use in the home by persons with diabetes as an aid to monitor the effectiveness of diabetes control.

The Liberty™ Blood Glucose Monitoring System consists of the following elements: test strips; a battery operated, portable, compact meter; and a control solution.
Instrument Operating Principle: photometric
Reagent Test Principle: glucose oxydase
The Liberty™ System is based on photometric biosensor technology. The test strip is first inserted into the meter and the meter is switched on by pressing the "ON" button. A code number will appear on the display that should match the code on the vial of strips. An icon showing a flashing drop near the end of a test strip will appear on the display to prompt the user to apply a drop of blood. When a drop of blood is applied to the top of the strip at the mesh-filled target area, it flows into the membrane and starts the measurement. This is indicated on the display by a moving bar. After approximately 30 seconds, a glucose reading is displayed on the meter. The reading is stored in the meter memory with a date and time.
The Liberty™ System uses a photometric test strip that includes glucose oxidase to generate a color reaction that is proportional to the concentration of glucose in the sample.

I am sorry, but the provided text does not contain sufficient detail to fully address all parts of your request regarding acceptance criteria and a study proving device performance as it pertains to AI/ML devices. The document seems to be a 510(k) summary for a blood glucose monitoring system, and the information provided is typical for such a submission for a non-AI/ML device.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides performance characteristics for the Liberty™ System and compares them to a predicate device (Accu-Chek Simplicity). Since this is not an AI/ML device, the acceptance criteria are not explicitly stated in terms of model performance metrics (like sensitivity, specificity, AUC). Instead, the performance is reported as correlation and precision data against a laboratory reference method.

Note: The "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device, which met FDA requirements. The specific numeric thresholds for acceptance are not explicitly listed but are demonstrated through the provided results being comparable to or better than the predicate for the given metrics.

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

• Capillary blood study: N = 116 patients
• Consumer study: N = 116 different patients
• Provenance: The document does not explicitly state the country of origin. It indicates it's a "clinical study" and "consumer study," which implies prospective data collection, but this is not explicitly stated. It does not mention retrospective data.

3. Number of Experts and Qualifications for Ground Truth:

This information is typically not relevant or included for blood glucose monitoring systems. The "ground truth" for glucose measurements is established by a highly accurate laboratory reference method (Yellow Springs Instrument (YSI) and HemoCue), not by human expert consensus or radiologists.

4. Adjudication Method for the Test Set:

Not applicable for this type of device. Glucose measurement is an objective quantitative biochemical reading, not a subjective interpretation requiring adjudication.

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

Not applicable. This is a standalone diagnostic device, not an AI-assisted interpretation system for human readers.

6. Standalone Performance Study:

Yes, a standalone study was conducted. The performance data presented in the table (Capillary blood study and Consumer study) represents the performance of the Liberty™ System (algorithm/device only) against a laboratory reference method.

7. Type of Ground Truth Used:

The ground truth used was a laboratory reference method, specifically the Yellow Springs Instrument (YSI) and HemoCue, which are highly accurate established methods for measuring glucose in blood.

8. Sample Size for the Training Set:

The document does not mention a "training set" in the context of machine learning. For traditional medical devices like this, the device's development involves engineering and calibration, not an AI training set. Performance is evaluated through analytical and clinical studies on defined sample sizes.

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

As there is no mention of a "training set" in the AI/ML sense, this question is not applicable. The device relies on photometric biosensor technology and glucose oxidase chemistry, not a trained AI model.

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