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The EZ Smart-168 Blood Glucose Test Strips are used with the EZ Smart-168 Blood Glucose Meter for quantitatively measuring glucose (sugar) in fresh capillary whole blood obtained from the fingertip. The EZ Smart-168 Test Strips are for testing outside the body (in vitro diagnostic use). The EZ Smart-168 Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels in persons with diabetes.

Based on an electrochemical biosensor technology and the principle of capillary action, EZ SMART-168 Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and is displayed in 10 seconds, and 28 blood glucose result memory.

The provided 510(k) summary for the EZ SMART-168 Blood Glucose Monitoring System (K052818) does not contain detailed information about specific acceptance criteria and the comprehensive study that proves the device meets them, as requested.

The document primarily focuses on establishing substantial equivalence to a predicate device (EZ SMART Blood Glucose Monitoring System, K040848) based on having the "same working principle and technologies" and "identical" test strips, with only minor changes to meter coding and memory size for convenience.

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

Description of Acceptance Criteria and Study to Prove the Device Meets Acceptance Criteria

The submission states that "Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System: Guidance for Industry and FDA document provided by CDRH/ FDA." However, the details of these tests and their specific acceptance criteria are not included in this summary.

Missing Information:

• Specific quantitative acceptance criteria (e.g., accuracy percentages, bias targets, precision limits).
• Details of the clinical and pre-clinical studies performed.
• The actual results of these studies demonstrating conformance to specific criteria.

Extracted and Inferred Information (with limitations):

1. Table of Acceptance Criteria and Reported Device Performance
This information is NOT present in the provided document.

2. Sample Size Used for the Test Set and Data Provenance
This information is NOT present in the provided document.

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

3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is NOT present in the provided document.

• Since this is a blood glucose monitoring system, the "ground truth" would typically be established by a reference laboratory method (e.g., YSI analyzer) rather than expert consensus on images. Therefore, the concept of "experts" in this context is likely not applicable in the way it would be for imaging diagnostics. The qualifications of lab personnel operating reference instruments are also not provided.

4. Adjudication Method for the Test Set
This information is NOT present in the provided document.

• Given it's a blood glucose device, adjudication methods like 2+1 or 3+1 (common in image interpretation) are not relevant. If there were discrepancies in reference measurements, standard lab protocols for re-testing or averaging would be used, but these details are not supplied.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This information is NOT applicable and NOT present in the provided document.

• MRMC studies are typically for diagnostic imaging devices where human readers interpret images with or without AI assistance. This device is a quantitative blood glucose monitor where human interpretation of results is direct.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This information is mostly inferred but not explicitly detailed.

• Blood glucose meters inherently operate in a "standalone" fashion in terms of generating a numerical result from a sample. The device is designed to measure glucose in whole blood and display the result. The performance data would therefore represent the algorithm's (device's) ability to do this accurately and precisely. The document explicitly states: "EZ SMART-168 Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 10 seconds, and 28 blood glucose result memory." This describes the standalone operation of the device.

7. The Type of Ground Truth Used
This information is NOT explicitly stated in the provided document but can be inferred based on the device type.

• For blood glucose monitoring systems, the ground truth is almost universally established by laboratory reference methods, such as a YSI glucose analyzer or another highly accurate and precise laboratory instrument. This constitutes a form of "outcomes data" or highly reliable direct measurement, against which the device's measurements are compared.

8. The Sample Size for the Training Set
This information is NOT present in the provided document.

• Blood glucose meters, especially older models like this one (2006), typically rely on well-established electrochemical biosensor technology. While a "training set" might be used during the development and calibration of the algorithms within the meter and the manufacturing of test strips, these details are usually proprietary and not included in 510(k) summaries, which focus on clinical performance validation rather than internal algorithm development data.

9. How the Ground Truth for the Training Set Was Established
This information is NOT present in the provided document.

• Similar to the test set, if a training set were explicitly discussed, its ground truth would likely be established by laboratory reference methods.

Conclusion:

The provided 510(k) summary primarily serves to establish substantial equivalence for the EZ SMART-168 Blood Glucose Monitoring System to a predicate device. It confirms the device's intended use and general working principle. However, it lacks the specific details regarding acceptance criteria, study methodologies, sample sizes, and detailed performance data that would be necessary to fully answer the request for a comprehensive description of the device's proven performance against specific criteria. These details would typically be found in more extensive regulatory submissions or in accompanying technical documentation, but they are not part of this summary document.

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The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Meter to measure Glucose (sugar) in the whole blood. The EZ Smart Test strips are for testing outside the body (in vitro diagnostic use). The EZ Smart Blood Glucose Monitoring System is intended for use in the home and in the professional settings to monitor blood glucose levels for better glucose level control among diabetics. The EZ Smart Blood Glucose Monitoring System is indicated for use with capillary whole blood samples drawn from the fingertips and forearm.

The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Meter to measure Glucose (sugar) in whole blood. The EZ Smart Test strips are for testing outside the body (in vitro diagnostic use). The EZ Smart Blood Glucose Monitoring System is intended for use in the home and in the professional settings to monitor blood glucose levels for better glucose level control among diabetics.

The provided text includes a 510(k) summary for the "EZ Smart Blood Glucose Monitoring System," specifically for an additional labeling and indication for alternative site testing. However, it explicitly states that there has been no change to the performance characteristics or fundamental scientific technology of the device system.

Therefore, the document does not contain details about a study to prove new acceptance criteria related to its performance, an MRMC study, or a standalone algorithm performance study. The focus of this 510(k) is solely on labeling changes for alternative site testing.

Here's a breakdown of the information that can be extracted or inferred based on the provided text, and what cannot be found:

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

This information is not provided in the document. The submission focuses on labeling changes, stating "There has been no change to the performance characteristics of the device system." Therefore, no new performance data or acceptance criteria related to a new study are included.

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

This information is not provided as no new performance study was conducted for this 510(k) submission.

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 as no new performance study was conducted.

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

This information is not provided as no new performance study was conducted.

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:

An MRMC study was not done. The device is a "Blood Glucose Monitoring System," which is an instrument for measuring glucose, not an AI-assisted diagnostic tool that would involve human readers.

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

A standalone performance study of an algorithm was not done. This device is a blood glucose monitoring system, not an algorithmic diagnostic tool. The submission explicitly states "There has been no changes to the fundamental scientific technology," implying no new algorithm or AI components.

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

This information is not provided as no new performance study was conducted for this 510(k) submission. For a blood glucose monitoring system, ground truth would typically be established against a laboratory reference method.

8. The sample size for the training set:

This information is not provided as no new performance study was conducted and there is no mention of a "training set" in the context of this device's technology.

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

This information is not provided as no new performance study was conducted and there is no mention of a "training set."

In summary, the provided 510(k) submission focuses solely on updating the labeling for the EZ Smart Blood Glucose Monitoring System to include alternative site testing. It explicitly states that there are no changes to the device's performance characteristics or fundamental scientific technology. Therefore, the document does not contain information about new acceptance criteria, a new study to prove device performance, or details regarding test sets, experts, or ground truth establishment.

Ask a specific question about this device

The EZ Smart Blood Glucose Test Strips are uses with the EZ Smart Meter to measure Glucose (sugar) in whole blood. The EZ Smart Test strips are for testing outside the body (in vitro diagnostic use ). The EZ Smart Blood Glucose Monitoring System is intended for use in the home and in the professional settings to monitor blood glucose levels for better glucose level control among diabetics.

The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Blood Glucose Meter to measure glucose (sugar) in whole blood. The EZ Smart Test Strips are for testing outside the body (in vitro diagnostic use). The EZ Smart Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The document does not contain explicit acceptance criteria in the format of a table with specific numerical targets for accuracy, precision, or other performance metrics. This is often the case for 510(k) submissions where substantial equivalence is demonstrated against a predicate device rather than meeting pre-defined, quantitative acceptance criteria established by a standard or regulatory body for a novel device.

Instead, the document states:
"An evaluation of the EZ Smart was conducted under various conditions including temperature effects, hematocrit levels, sensitivity and linearity, and presence of interferences. The results of the evaluation demonstrate that the EZ Smart is equivalent in performance to the predicate device and suitable for its intended use."

This indicates that the "acceptance criteria" were implied by demonstrating performance "equivalent" to the predicate device (Bayer Elite with Elite Test Strips, K964630 for the meter and K991242 for the test strips). The specific numerical results of these evaluations (e.g., accuracy percentages, bias) are not provided in the submitted text.

Here's a breakdown of the requested information based on the provided text:

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

2. Sample size 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 specified in the provided text.
• Data Provenance: Not specified in the provided text.
• Retrospective or Prospective: 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 (e.g. radiologist with 10 years of experience)

• Not applicable/Not specified. For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods, not by expert consensus in the same way it would be for image interpretation. The document does not mention human experts establishing ground truth.

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

• Not applicable/Not specified. Adjudication methods are typically used for subjective assessments or when multiple human readers interpret data, which is not the primary method for evaluating blood glucose meters.

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

• No MRMC or AI comparative effectiveness study was mentioned. The device is a standalone blood glucose monitoring system, not an AI-assisted diagnostic tool.

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

• Yes, performance evaluations of the EZ Smart Blood Glucose Monitoring System were conducted as a standalone device. The description of "various conditions" (temperature, hematocrit, sensitivity, linearity, interferences) implies direct testing of the device's measurement capabilities.

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

• While not explicitly stated, for blood glucose monitoring systems, ground truth is typically established using laboratory reference methods (e.g., YSI analyzer) which are considered highly accurate for glucose measurement.

8. The sample size for the training set

• Not applicable/Not specified. This is a measurement device, not an AI/machine learning model that requires a distinct "training set." Any internal calibration or development data are not described.

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

• Not applicable/Not specified. As it's not an AI/ML device, the concept of a "training set" and its associated ground truth establishment is not relevant in the context of this 510(k) summary.

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