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The EASYMAX® Tag Self-Monitoring Blood Glucose System is comprised of the EASYMAX® Tag meter and the EASYMAX® Tag test strips. The kit is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn 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 a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

The modified device of EASYMAX® Tag (EM Tag) self-monitoring blood glucose system is derived from the existing device of EasyMax MU glucose meter and the modified device contain the NFC (Near-field communication) function to transfer glucose results to the mobile app. The self-monitoring blood glucose system consists of a blood glucose meter and test strips which are designed, tested, and verified to work together as a system to produce accurate blood glucose test results. The electrochemical principle on the test strip is the reaction of FAD glucose dehydrogenase (FAD-GDH) with blood glucose and a small electrical current generated proportional to the glucose concentration in the blood sample. The meter measures the current and displays the blood glucose result.

The provided text describes a 510(k) premarket notification for the EASYMAX® Tag Self-Monitoring Blood Glucose System, which is an updated version of a previously cleared device. While the document broadly discusses verification and validation activities and risk analysis, it does not provide the specific details required to answer all parts of your request.

Here's what can be extracted and what information is missing:

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

The document states: "The similar V&V testing with similar acceptance criteria as the predicate was performed and the design outputs met pre-determined design inputs was confirmed in the software validation report in this submission."

However, the specific acceptance criteria (e.g., accuracy percentages within certain glucose ranges) and the reported device performance against those criteria are not provided in this summary. These details would typically be found in the actual validation reports (Software Validation Report, Risk Management Report, etc.) which are referenced but not included here.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given 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)

This information is not provided in the given text. Since this is a blood glucose monitoring system, the ground truth would likely be established using a laboratory reference method, not expert consensus in the way it would be for imaging.

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

This information is not provided in the given text.

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 is relevant for devices where human interpretation of medical images or data is involved and the AI assists that interpretation. This device is a self-monitoring blood glucose system which directly provides a numerical measurement to the user. Therefore, an MRMC comparative effectiveness study in the context of human readers improving with AI assistance would not be applicable to this type of device.

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

This device is a standalone system in the sense that it provides a direct measurement. The "algorithm only" aspect would refer to the internal functioning of the meter in conjunction with the test strip. The document indicates that "the design outputs met pre-determined design inputs was confirmed in the software validation report," implying that the standalone performance of the device's measurement function was evaluated. However, specific performance metrics are not provided in this summary.

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

For a blood glucose monitoring system, the ground truth would typically be established by a laboratory reference method for glucose measurement (e.g., using a YSI glucose analyzer). While the document does not explicitly state this, it is standard practice for such devices.

8. The sample size for the training set

This information is not provided in the given text.

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

This information is not provided in the given text. For a blood glucose meter, the ground truth for any training (or calibration) would typically be established using a laboratory reference method.

In summary, the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It briefly mentions that verification and validation activities were performed according to risk analysis and that design outputs met design inputs. However, it does not include the detailed performance data, sample sizes, ground truth establishment specifics, or expert qualifications that would be found in the full validation reports.

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The MDT2 BLE Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from 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 a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

The system consists of the MDT2 BLE meter and the MDT2 BLE test strips. The MDT2 BLE meter only is used with the MDT2 BLE test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.

The modified device of MDT2 BLE glucose meter is derived from the existing device of EM40 glucose meter and the modified device contain the Bluetooth function to transfer glucose results to the mobile app.

The self-monitoring blood glucose system consists of a blood glucose meter and test strips which are designed, tested, and verified to work together as a system to produce accurate blood glucose test results.

The electrochemical principle on the test strip is the reaction of FAD glucose dehydrogenase (FAD-GDH) with blood glucose and a small electrical current generated proportional to the glucose concentration in the blood sample. The meter measures the current and displays the blood glucose result.

The provided text does not contain detailed information about a study proving the device meets acceptance criteria, specifically not in the format requested for a scientific study with sample sizes, expert qualifications, or comparative effectiveness.

However, based on the information provided, here's what can be inferred and presented, focusing on the acceptance criteria as stated in the context of substantial equivalence for a medical device (MDT2 BLE Self-Monitoring Blood Glucose System):

The document indicates that the MDT2 BLE Self-Monitoring Blood Glucose System is considered "substantially equivalent" to its predicate device, the EM40 Self-Monitoring Blood Glucose System (K133389). This implies that the acceptance criteria for the MDT2 BLE system are aligned with those previously met by the EM40 system, particularly since most core functionalities and technologies remain the same.

The modifications to the MDT2 BLE system are primarily related to its physical design, software features (memory mode, measurement mode, reset function, display icons), and the addition of Bluetooth functionality for wireless data transfer. These modifications were subjected to risk analysis and verified/validated.

Given the information, I can construct a table for what could be considered "acceptance criteria" based on the predicate device's performance, and then note that the new device states it meets these as part of its "substantial equivalence" claim.

Acceptance Criteria for MDT2 BLE Self-Monitoring Blood Glucose System and Reported Device Performance

Regarding the specific questions you asked:

1. A table of acceptance criteria and the reported device performance: See the table above. The "acceptance criteria" are implied by the predicate device's specifications, and the "reported device performance" is the claim of "same as predicate" or confirmed equivalence through V&V activities.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document mentions "verification and validation activities" and a "software validation report" but does not specify sample sizes for any test sets used in these activities.
   • Data provenance is not explicitly stated in terms of country of origin or whether studies were retrospective or prospective, beyond the fact that the company is located in Taiwan.

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 information is not provided in the document. The document refers to "risk analysis" and "verification and validation activities" but not to specific expert panels or their qualifications for establishing ground truth derived from clinical studies. Given this is a self-monitoring blood glucose system, ground truth would typically be established against laboratory reference methods.

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

   • This information is not provided.

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 is not applicable to this device. An MRMC study is typically for evaluating diagnostic imaging systems where human readers interpret medical images. This device is a blood glucose monitoring system. Its performance is compared to laboratory reference methods, not human interpretation of images.

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

   • The device is an in-vitro diagnostic device that measures glucose. The "algorithm" here refers to the meter's internal processing of an electrochemical signal into a glucose reading. Its performance is indeed "standalone" in the sense that the meter itself provides the quantitative measurement without human interpretation of the raw signal. The document states "The meter measures the current and displays the blood glucose result." The standalone performance is implicitly claimed through the "substantial equivalence" to the predicate and the verification/validation activities of the new meter's components, including software/firmware changes.

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

   • For blood glucose meters, the ground truth is typically established against laboratory reference methods for glucose measurement (e.g., YSI analyzer). While not explicitly stated here, this is the standard practice for such devices. The document implies verification and validation against established standards and the predicate device, which would have been validated against such ground truth.

8. The sample size for the training set:

   • This information is not provided. The document doesn't detail specific training sets, which is typical for traditional (non-AI/ML) medical devices like blood glucose meters. Even for the software/firmware changes, the term "training set" is not used in this context.

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

   • As no training set is mentioned in the context of AI/ML, this is not applicable. For the device's inherent function, ground truth for calibration and testing is against laboratory reference methods.

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The EasyMax BT Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from 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 a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

The system consists of the EasyMax BT meter and the EasyMax BT test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.

The modified device of EasyMax BT SMBGS is derived from the existing device of EasyMax MU SMBGS with the addition of a Bluetooth dongle on the meter. The system consists of a blood glucose meter and test strips which are designed, tested, and verified to work together as a system to produce accurate blood glucose test results. The system also includes the control solution which is used to check the performance of the system.

The electrochemical principle on the test strip is the reaction of FAD glucose dehydrogenase (FAD-GDH) with blood glucose and a small electrical current generated proportional to the glucose concentration in the blood sample. The meter measures the current and displays the blood glucose result.

The provided text is a 510(k) premarket notification for the EasyMax BT Self-Monitoring Blood Glucose System. It outlines the device's intended use, comparison to a predicate device, and the design control activities undertaken for modifications.

However, the document does not contain specific acceptance criteria tables nor detailed performance study results (accuracy, precision, or clinical performance data) that would typically be used to prove the device meets these criteria. It primarily focuses on the regulatory submission process, risk analysis, and verification/validation activities that address the addition of a Bluetooth dongle and associated software changes, rather than the core accuracy or clinical performance of the blood glucose measurement itself.

The document mentions that "The verification and validate (V&V) activities were conducted based on the impact of the modification and detailed in the EasyMax BT SMBGS risk management report. The similar V&V testing with similar acceptance criteria as the predicate was performed and the design outputs met pre-determined design inputs was confirmed in the software validation report in this submission." This indicates that such data exists in other reports submitted to the FDA, but it is not present in this public summary.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the provided text, nor can I answer questions about sample sizes, expert involvement, adjudication, or specific performance study types like MRMC or standalone studies.

Based only on the provided text, here's what can be inferred or stated:

• 1. A table of acceptance criteria and the reported device performance: Not provided in the document. The document states that "similar V&V testing with similar acceptance criteria as the predicate was performed and the design outputs met pre-determined design inputs was confirmed in the software validation report in this submission." This implies that performance data exists in other, unprovided reports.

• 2. Sample sized used for the test set and the 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: Not applicable or not provided. This device measures glucose, a quantitative value, not interpreted by experts in the typical sense of imaging. The ground truth would be established by a reference laboratory method.

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

• 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 is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone measurement system for glucose. The performance of the blood glucose measurement itself would be a standalone assessment against a reference method. However, the details of such a study are not provided in this document.

• 7. The type of ground truth used: For a blood glucose monitoring system, the ground truth is typically a laboratory reference method (e.g., YSI analyzer) for blood glucose concentration. This is not explicitly stated but is standard for such devices.

• 8. The sample size for the training set: Not applicable. This is not an AI/ML device in the sense of modern deep learning, but rather an electrochemical device. There isn't a "training set" in the common AI/ML context.

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

What the document DOES discuss related to "acceptance criteria" and "proof":

The document focuses on the modifications to an already cleared predicate device (EasyMax MU SMBGS) and the testing done to ensure these modifications did not negatively impact safety or essential performance.

• Acceptance Criteria Mentioned (for specific modifications):

  • Readability Test for Product Name Change: Flesch-Kincaid grade level $\leq$ 8.0 for all inserts.

• "Study that proves the device meets the acceptance criteria" (for modifications):
  The document lists several "Verification and Validation activities" performed due to the addition of the Bluetooth dongle and software changes:

  • Safety Test: IEC 61010-1:2010; IEC61010-2-101:2002
  • EMC Test: IEC 60601-1-2:2014; 61326-1:2001
  • FCC test: FCC Part 15 Subpart B & C
  • Human Factor Test: IEC 62366-1:2015
  • Drop and Vibration Test: ISTA 2A: 2011; IEC60068-2-64: 2008
  • Software Validation Test: IEC 62304:2006; FDA guidance Document "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices."

The document states that "The verification and validate (V&V) activities were conducted based on the impact of the modification and detailed in the EasyMax BT SMBGS risk management report. The similar V&V testing with similar acceptance criteria as the predicate was performed and the design outputs met pre-determined design inputs was confirmed in the software validation report in this submission."

In summary, the provided text serves as a regulatory summary of modifications to a previously cleared device, asserting that necessary testing (including, but not detailed, performance similar to the predicate) has been conducted and documented in other reports to ensure substantial equivalence. It does not contain the detailed clinical or analytical performance study results themselves.

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The EGV1.1 Pro Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.

The system consists of the EGV1.1 Pro meter and the EGV1.1 Pro meter only is used with the EGV1.1 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.

The EGV . I Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from 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 a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

The system consists of the EGV I.I meter and the EGV I.I test strips. The EGV I.I meter only is used with the EGV I.I test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.

Not Found

The provided document is an FDA 510(k) clearance letter for two blood glucose monitoring systems: EGV1.1 Pro Monitoring Blood Glucose System and EGV1.1 Self Monitoring Blood Glucose System. While it states the devices are substantially equivalent to legally marketed predicate devices, it does not contain the detailed acceptance criteria or the study results that demonstrate the device meets those criteria.

FDA 510(k) clearance evaluates substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device. The detailed performance data and acceptance criteria are typically part of the 510(k) submission, which is not fully included here. The provided text primarily focuses on regulatory information, indications for use, and administrative details.

Therefore, I cannot provide the requested information based on the input text alone. The document explicitly avoids detailed technical specifications and performance data.

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The EM40 Pro Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingerip. Testing is done outside use). It is intended for multiple-patient use in professional healthcare schings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of or screening for diabetes mellitus.

The system consists of the EM40 Pro meter and the EM40 Pro meter only is used with the EM40 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.

The EM40 Glucose Control Solution For use with the EM40 Pro Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.

The EM40 Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forcarn. Testing is done outside the body (In Vitro diagnosic use), It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

The system consists of the EM40 meter and the EM40 meter only is used with the EM40 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm,

The EM40 Glucose Control Solution is for use with EM40 Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

The system consists of the EM40 Pro meter and the EM40 Pro meter only is used with the EM40 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.

The system consists of the EM40 meter and the EM40 meter only is used with the EM40 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm,

This document is an FDA 510(k) clearance letter for the EM40 Self-monitoring Blood Glucose System and EM40 Pro Blood Glucose System. While it acknowledges the device's substantial equivalence to predicates and outlines its intended use, it does not contain the specific acceptance criteria, study details, or performance results requested.

Therefore, I cannot provide the information you requested based on the provided text. The document focuses on regulatory approval, not on the detailed technical study results that demonstrate how the device meets specific acceptance criteria.

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The EMV3.1 Pro Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Viro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. The system includes the speaking function but is not intended to be operated by visually impaired users.

The system consists of the EMV3.1 Pro meter and the EMV3.1 Pro test strips. The EMV3.1 Pro meter only is used with the EMV3.1 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.

The EMV3.1 Glucose Control Solution For use with the EMV3.1 Pro Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.

The EMV3.1 Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from 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 a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system includes the speaking function but is not intended to be operated by visually impaired users. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

The system consists of the EMV3.1 meter and the EMV3.1 meter only is used with the EMV3.1 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.

The EMV3.1 Glucose Control Solution For use with EMV3.1 Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

The system consists of the EMV3.1 Pro meter and the EMV3.1 Pro test strips. The EMV3.1 Pro meter only is used with the EMV3.1 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.

The system consists of the EMV3.1 meter and the EMV3.1 meter only is used with the EMV3.1 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.

The provided document is limited to the FDA 510(k) clearance letters and "Indications for Use" statements for the EMV3.1 Self Monitoring Blood Glucose System and EMV3.1 Pro Blood Glucose System.

It does not contain the detailed study information, acceptance criteria tables, or performance metrics that would be necessary to fully answer your request.

Therefore, I cannot provide the specific information regarding:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and data provenance
• Number of experts and their qualifications for ground truth establishment
• Adjudication method
• MRMC comparative effectiveness study results (effect size)
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

What the document does tell us:

• Device Names: EMV3.1 Self Monitoring Blood Glucose System and EMV3.1 Pro Blood Glucose System.
• Purpose: Quantitative measurement of glucose in whole blood.
• Intended Use (EMV3.1 Pro): Professional healthcare settings, venous or fresh capillary whole blood, multiple-patient use, aid to monitor diabetes control. Not for neonates, diagnosis, or screening for diabetes. Not for visually impaired users to operate.
• Intended Use (EMV3.1 Self Monitoring): Home use (OTC), single patient, fresh capillary whole blood from fingertip, palm, or forearm, aid to monitor diabetes control. Not for neonates, diagnosis, or screening for diabetes. Not for visually impaired users to operate. Alternative site testing only during steady-state blood glucose conditions.
• Components: Meter and test strips.
• Control Solution: EMV3.1 Glucose Control Solution for quality control.
• Regulatory Classification: Class II, Product Codes NBW, LFR, JJX.
• 510(k) Number: K133647.

To answer your request, you would need to consult detailed study reports (e.g., from the 510(k) submission materials, if publicly available, or from peer-reviewed publications by the manufacturer).

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The EasyMax MU Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from 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 a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

The EasyMax MU Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.

The system consists of the EasyMax MU meter and the EasyMax MU test strips. The EasyMax MU meter only is used with the EasyMax MU test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.

The system consists of the EasyMax MU Pro meter and the EasyMax MU Pro test strips. The EasyMax MU Pro meter only is used with the EasyMax MU Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.

The provided text from the 510(k) clearance letter and Indications for Use forms for the EasyMax MU and EasyMax MU Pro Self Monitoring Blood Glucose Systems does not contain the detailed information required to answer all parts of your request.

Specifically, the document focuses on regulatory clearance and intended use, but it does not include results from device performance studies, acceptance criteria, sample sizes for test sets, details on ground truth establishment, or information about AI assistance or human reader studies. It's common for these details to be in separate technical documentation submitted to the FDA, not typically summarized in the public-facing clearance letter.

Therefore, I can only address the parts of your request that can be inferred from the provided text.

Here's what can be extracted and what cannot:

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

• Cannot be provided. The document does not specify performance metrics (e.g., accuracy, precision) or acceptance criteria for those metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document does not mention sample sizes for any test sets or data provenance.

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)

• Cannot be provided. The document does not describe how ground truth was established, nor does it mention any experts involved in such a process.

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

• Cannot be provided. The document does not describe any adjudication methods.

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

• Cannot be provided. The EasyMax MU and EasyMax MU Pro systems are Self Monitoring Blood Glucose Systems, meaning they are standalone devices for measuring glucose. They are not AI-assisted imaging devices or diagnostic tools that would involve "human readers" in the sense of interpreting images. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this type of device.

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

• Yes, by nature of the device. While not described as an "algorithm" in a software sense, the blood glucose measurement system inherently operates as a standalone device without human interpretation of the measurement result itself. The device provides a quantitative glucose reading directly. The "performance" being referred to would be the accuracy and precision of the device's quantitative glucose measurement against a reference method. The document implicitly confirms this is a standalone device through its description as "quantitative measurement of glucose."

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

• Inferred: Reference laboratory method. For blood glucose monitoring systems, the "ground truth" or reference standard for comparison is typically a highly accurate laboratory-based glucose analyzer (e.g., hexokinase method). The document doesn't explicitly state this, but it's standard for this type of device.

8. The sample size for the training set

• Cannot be provided. The document does not mention any "training set" or its size. For a blood glucose meter, the "training" (calibration) is typically done during the manufacturing process and verified.

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

• Cannot be provided. As above, no information on a training set or its ground truth establishment is present.

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The EM50 Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood form 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 a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is no the be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

The system consists of the EM50 meter and the EM50 test strips. The EM50 meter only is used with the EM50 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.

The EM50 Glucose Control Solution For use with EM50 Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

The system consists of the EM50 meter and the EM50 test strips. The EM50 meter only is used with the EM50 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm. The EM50 Glucose Control Solution is for use with EM50 Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

The provided document is a 510(k) premarket notification letter from the FDA for a Self-Monitoring Blood Glucose System. This document does not contain any information regarding the acceptance criteria or a study proving the device meets those criteria, especially not in the context of an AI/ML-based medical device.

The document primarily focuses on:

• Regulatory classification: Class II device (Glucose Test System).
• Indications for Use: Quantitative measurement of glucose in fresh capillary whole blood for self-monitoring by diabetics at home.
• General controls and compliance: Registration, labeling, good manufacturing practices, adverse event reporting.
• Contact information for FDA offices.

Therefore, I cannot fulfill your request using the provided text. To answer your questions, I would need a document that describes:

• Performance data and study results for the EM50 Self Monitoring Blood Glucose System.
• Specific acceptance criteria for accuracy, precision, or other performance metrics of the glucose meter.
• Details about the study design, including sample size, data provenance, ground truth establishment, etc.

Since the input text describes a traditional medical device (blood glucose meter) and not an AI/ML system, concepts like "experts for ground truth," "adjudication methods," "MRMC studies," "standalone algorithm performance," and "training set" are not relevant to this document.

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The EME Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from 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 a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

The EME Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.

The system consists of the EME meter and the EME test strips. The EME meter only is used with the EME test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.

The system consists of the EME Pro meter and the EME Pro test strips. The EME Pro meter only is used with the EME Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.

The EME Glucose Control Solution is for use with EME Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

The EME Glucose Control Solution is for use with the EME Pro Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The text provided is a 510(k) clearance letter from the FDA for two devices: EME Self Monitoring Blood Glucose System and EME Pro Self Monitoring Blood Glucose System. It outlines the regulatory classification, indications for use, and general compliance requirements, but it does not detail specific performance studies or acceptance criteria that were met to achieve this clearance.

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The EMV3 Pro Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.

The EMV3 Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

The system consists of the EMV3 Pro meter and the EMV3 Pro test strips. The EMV3 Pro meter only is used with the EMV3 Pro test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip.

The system consists of the EMV3 meter and the EMV3 test strips. The EMV3 meter only is used with the EMV3 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip or forearm.

This document is a 510(k) premarket notification from the FDA, specifically concerning two self-monitoring blood glucose systems: EMV3 Pro and EMV3. It does not contain information about the acceptance criteria or reported device performance in the format requested. The document outlines the indications for use for both devices and confirms their substantial equivalence to legally marketed predicate devices. It provides regulatory information and contact details, but no study details or performance metrics.

Therefore, I cannot provide the requested information based on the provided text.

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