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The SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) is composed of the SuperCheck Plus Multi Test Strips and SuperCheck Plus Multi Blood Glucose Meter and is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from fingertips or forearm, or in venous whole blood. The Super Check Plus Multi Blood Glucose Monitoring System(Model 5228-M) is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancets.

The SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) 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 SuperCheck Plus Multi Test Strips are for use with the SuperCheck Plus Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from fingertips or forearm, or in venous whole blood.

The SuperCheck Plus Multi Control Solutions are for use with the SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) as a quality control check to verify that the meter and test strips are working together properly.

The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or forearm. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended to be used by a single person and should not be shared. The SuperCheck Plus Blood Glucose Monitoring System(Model for self-testing outside the body(in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) 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 in not changing rapidly).

The SuperCheck Plus Test Strips are for use with the SuperCheck Plus Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or forearm.

The SuperCheck Plus Control Solutions are for use with the SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) as a quality control check to verify that the meter and test strips are working together properly.

The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) (also applicable to: SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M)) is a product kit consisting of a blood glucose meter, test strips, control solutions, a lancing device, lancets, and instructions for use.

The data download functionality is optionally available and sold separately. To perform a test, when a small drop of blood is applied to the end of the test strip, glucose reacts with the reagents on the test strip, producing an electrical current that is proportional to the blood glucose concentration. The glucose concentration is calculated by the glucose meter and is based on the electrical current measured. The quantitative glucose concentration (in mg/dL or mmol/L) is displayed on the display screen.

Here's an analysis of the acceptance criteria and supporting studies for the SuperCheck Plus Blood Glucose Monitoring System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for accuracy are not explicitly stated in a single consolidated table in the document, but rather described in the text, referencing ISO 15197 for precision and generally implying agreement with a reference method (YSI 2300) for overall system accuracy. The document states that the system "met the acceptance criteria" without detailing the specific criteria for system accuracy (e.g., percentage within a certain range). For precision, ISO 15197 is mentioned, which typically has performance targets based on CV (Coefficient of Variation) or absolute differences. I will infer based on the stated performance.

2. Sample Sizes Used for the Test Set and Data Provenance

• Precision/Reproducibility (Test Set):
  • Repeatability Precision: 5 whole blood concentrations were tested. The number of replicates per concentration is not specified, but typically this involves multiple measurements (e.g., 10-20 replicates). The document doesn't specify if the samples were from a particular country. It's an in-vitro lab study.
  • Intermediate Precision: 3 levels of control solutions, 3 lots of test strips, and 10 meters were tested for 10 days. This is an in-vitro lab study.
• Linearity (Test Set): 11 concentration levels of capillary whole blood samples (spiked). No specific provenance mentioned, assumed to be laboratory-prepared samples.
• Operating Temperature and Humidity Study: Not specified, assumed to be laboratory test samples.
• Analytical Specificity: Not specified, assumed to be laboratory test samples.
• Hematocrit Study: 9 hematocrit levels at 3 spiked target glucose concentrations. Not specified, assumed to be laboratory test samples.
• Altitude Study: Venous blood samples spiked to 3 glucose concentrations. Performed at 33 ft and 10,744 ft. Not specified, assumed to be laboratory test samples.
• Sample Volume Study: Blood samples spiked to 3 glucose concentrations, tested from 0.5µL to 3.0µL. Not specified, assumed to be laboratory test samples.
• System Accuracy Study (Clinical Test Set): A total of 151 subjects were recruited. The document does not specify the country of origin, but it is a "clinical" study, implying prospective participant recruitment.
• User Performance Study (Clinical Test Set): 129 participants. The document implies these were lay users who could read English, suggesting a prospective recruitment in an English-speaking country, but no specific country is mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• For the System Accuracy Study, the ground truth was established by a reference method, the YSI 2300 glucose analyzer. This is a highly accurate laboratory instrument, and its operation would typically be managed by trained laboratory technicians or clinical chemists. No "experts" in the sense of clinicians or radiologists are involved in establishing this type of ground truth.
• For the User Performance Study, the ground truth for comparison was also likely the YSI 2300 or another laboratory reference method, against which the lay user's results from the device were compared. The "experts" here would be the lab personnel operating the reference method.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for glucose measurements is typically established by objective laboratory reference methods (like the YSI 2300), not through expert consensus or adjudication in the way medical imaging diagnosis might be.

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

No. This type of study (MRMC) is typically done for diagnostic imaging devices where human readers interpret images, sometimes with and without AI assistance, to measure the change in diagnostic accuracy. This document describes a blood glucose monitoring system, which is a quantitative measurement device, not an imaging device. The "User Performance Study" evaluates lay users testing themselves, which is a form of human-in-the-loop performance, but it's not an MRMC study comparing AI vs. no AI assistance for diagnosis.

6. Standalone Performance

Yes, the analytical performance studies (precision, linearity, specificity, hematocrit, altitude, sample volume, meter reliability, EMC/electrical safety) are all forms of standalone performance of the device, without human-in-the-loop interpretation being the primary focus. The "System Accuracy Study" also represents the standalone analytical performance of the device when operated under controlled clinical conditions, comparing its results directly to a gold standard, without focusing on the impact of user interaction beyond the collection and application of the sample.

7. Type of Ground Truth Used

• For most analytical performance studies (precision, linearity, analytical specificity, hematocrit, altitude, system accuracy): Reference method measurements, specifically the YSI 2300 glucose analyzer.
• For meter reliability and EMC/electrical safety: Adherence to engineering specifications and relevant ISO/IEC standards.
• For infection control: Disinfection efficacy testing against a specific pathogen (HBV) and robustness testing of materials.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is a blood glucose meter, which typically operates on electrochemistry principles, not an AI or machine learning algorithm that requires a training set. If there were any internal calibrations or algorithms developed during the device's design, the data used for those would be part of internal R&D and not typically disclosed as a "training set" in this type of regulatory document.

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

As no training set (in the AI/ML sense) is mentioned or implied for this type of device, this question is not strictly applicable. The device's operational parameters would be based on underlying physical and chemical principles, calibrated using known glucose concentrations and validated against reference methods, rather than "trained" on a dataset with established ground truth.

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For single patient use

Easy Plus II Blood Glucose Monitoring System, Model 6276-S

The Easy Plus II Blood Glucose Monitoring System Model 6276-S is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger and the forearm. The Easy Plus II Blood Glucose Monitoring System Model 6276-S is intended to be used by a single person and should not be shared.

The Easy Plus II Blood Glucose Monitoring System Model 6276-S is intended for self-testing outside the body(in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The Easy Plus II Blood Glucose Monitoring System Model 6276-S 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 in not changing rapidly).

The Easy Plus II Test Strips are for use with the Easy Plus II Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the finger and the forearm.

The Easy Plus II Control Solutions are for use with the Easy Plus II Blood Glucose Monitoring System Model 6276-S as a quality control check to verify that the meter and test strips are working together properly.

Smartest Persona II Blood Glucose Monitoring System, Model 6276-S

The Smartest Persona II Blood Glucose Monitoring System Model 6276-S is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger and the forearm. The Smartest Persona II Blood Glucose Monitoring System Model 6276-S is intended to be used by a single person and should not be shared.

The Smartest Persona II Blood Glucose Monitoring System Model 6276-S is intended for self-testing outside the body(in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control. The Smartest Persona II Blood Glucose Monitoring System Model 6276-S 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 in not changing rapidly).

The Smartest Persona II Test Strips are for use with the Smartest Persona II Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the finger and the forearm.

The Smartest Persona II Control Solutions are for use with the Smartest Persona II Blood Glucose Monitoring System Model 6276-S as a quality control check to verify that the meter and test strips are working together properly.

For multiple patient use

Easy Plus II Multi Blood Glucose Monitoring System, Model 6276-M

The Easy Plus II Multi Blood Glucose Monitoring System Model 6276-M is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger and the forearm. The Easy Plus II Multi Blood Glucose Monitoring System Model 6276-M is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a profession healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancets.

The Easy Plus II Multi Blood Glucose Monitoring System Model 6276-M 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 in not changing rapidly).

The Easy Plus II Multi Test Strips are for use with the Easy Plus II Blood Glucose Multi Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the finger and the forearm.

The Easy Plus II Multi Control Solutions are for use with the Easy Plus II Multi Blood Glucose Monitoring System Model 6276-M as a quality control check to verify that the meter and test strips are working together properly.

Smartest Persona II Multi Blood Glucose Monitoring System, Model 6276-M

The Smartest Persona II Multi Blood Glucose Monitoring System Model 6276-M is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger and the forearm. The Smartest Persona II Multi Blood Glucose Monitoring System Model 6276-M is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a profession healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancets.

The Smartest Persona II Multi Blood Glucose Monitoring System Model 6276-M 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 in not changing rapidly).

The Smartest Persona II Multi Test Strips are for use with the Smartest Persona II Blood Glucose Multi Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the finger and the forearm.

The Smartest Persona II Multi Control Solutions are for use with the Smartest Persona II Multi Blood Glucose Monitoring System Model 6276-M as a quality control check to verify that the meter and test strips are working together properly.

The Easy Plus II Blood Glucose Monitoring System, Model 6276-5 (also applicable to: Easy Plus II Multi Blood Glucose Monitoring System, Model 6276-M; Smartest Persona II Blood Glucose Monitoring System, Model 6276-S; Smartest Persona II Multi Blood Glucose Monitoring System, Model 6276-M) is a product kit consisting of a blood glucose meter, test strips, control solutions, a lancing device, lancets, and instructions for use. The data download functionality is optionally available and sold separately.

To perform a test, a glucose test strip is inserted into the top of the device. When a small drop of blood is applied to the end of the test strip, glucose reacts with the reagents on the test strip, producing an electrical current that is proportional to the blood glucose concentration. The glucose concentration is calculated by the glucose meter and is based on the electrical current measured. The quantitative glucose concentration (in mg/dL or mmol/L) is displayed on the display screen.

The provided text is a 510(k) Summary for a blood glucose monitoring system. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data in the format typically used for AI/ML device evaluations.

The submission is for modifications to a previously cleared device, indicating that the core performance (accuracy of glucose measurement) was established by the predicate device (Easy Talk Blood Glucose Monitoring System, Model 6277, K100560). The changes are described as:

• Voice feature change: from talking to non-talking (removal of speaker and software module).
• Housing design modification: for style and market differentiation.

The document explicitly states: "Easy Plus II (6276-S) and Easy Plus II Multi (6276-M) Blood Glucose Monitoring Systems, in all functions and specifications are exactly same as Easy Talk Blood Glucose Monitoring System (Model 6277) except for the talking feature and housing design. The modifications in talking feature and housing design will not affect the intended use of the device, and it will not significantly affect safety or effectiveness." This implies that the performance in terms of glucose measurement accuracy is considered unchanged from the predicate device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness for glucose measurement accuracy is not directly detailed in this document for the new device. The performance studies mentioned focus on the safety aspects related to the modifications (disinfection, robustness, ease of use after modifications).

Below is a breakdown of the information that can be extracted or inferred based on the provided text, and where the information is not available as it relates to the modifications rather than re-evaluating the core performance.

1. Table of Acceptance Criteria and Reported Device Performance

| Criterion | Acceptance Criteria | Reported Device Performance |
| :---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | :-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Disinfection Efficacy | Not explicitly stated (implied to be complete inactivation) | "Clorox® Bleach Germicidal Wipes (EPA Reg No: 67619-12) was validated, demonstrating complete inactivation of live virus for use with the meters." (Specifically for Hepatitis B virus (HBV)). |
| Robustness (Cleaning/Disinfection Cycles) | Not explicitly stated (implied to withstand 3-year use life) | "demonstrated that there was no change in performance or in the external materials of the meters after 11,000 cycles of cleaning and 11,000 cycles of disinfection to simulate the claimed 3 year use life." |
| Lay User Ease of Use and Labeling Comprehension | Not explicitly stated (implied all users should find it "very easy to use" and manuals "easy to use") | "All users answered that Easy Plus II and Smartest Persona II Blood Glucose Monitoring Systems were very easy to use and the user manuals were written to make the devices easy to use." |
| Glucose Measurement Accuracy | Not provided in this document (Performance is claimed to be equivalent to the predicate device K100560) | "in all functions and specifications are exactly same as Easy Talk Blood Glucose Monitoring System (Model 6277)" |

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

• Disinfection Studies: Sample size not specified. Data provenance is a "third party testing service."
• Robustness Studies: Sample size not specified (refers to "the meters").
• Lay User Questionnaire: 20 lay users. Data provenance is likely from the region where the study was conducted (not specified, but the submitter is in Taiwan). The study is prospective in nature for these lay users.
• Glucose Measurement Accuracy: Not applicable to this submission as it relies on the predicate's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Disinfection Studies: A third-party testing service was used. The specific number and qualifications of experts involved in establishing ground truth (i.e., verifying virus inactivation) are not provided.
• Robustness Studies: Not applicable.
• Lay User Questionnaire: The "ground truth" here is the user's subjective experience. No external experts are mentioned as establishing a ground truth for user-friendliness.
• Glucose Measurement Accuracy: Not applicable to this submission. For the predicate device, ground truth for blood glucose accuracy would typically be established by a laboratory reference method, not by experts adjudicating readings.

4. Adjudication Method for the Test Set

• Disinfection Studies: Not explicitly described, but typical for such studies involves laboratory methods to confirm virus inactivation.
• Robustness Studies: Not applicable.
• Lay User Questionnaire: "All users answered" implies a survey or direct questioning, not a formal adjudication process.
• Glucose Measurement Accuracy: Not applicable to this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a blood glucose monitoring system, not an AI/ML diagnostic interpretation tool that would typically involve multiple readers interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not directly applicable in the context of this device. A blood glucose meter functions as a standalone device to measure glucose. Its performance (accuracy) is assessed inherently as a standalone system. The modifications outlined in this submission (voice feature, housing design) do not affect the "algorithm's" core function or performance.

7. The Type of Ground Truth Used

• Disinfection Studies: Laboratory testing for complete inactivation of live virus (e.g., HBV).
• Robustness Studies: Visual inspection and performance testing after cycles of cleaning/disinfection.
• Lay User Questionnaire: User feedback/self-reported ease of use.
• Glucose Measurement Accuracy (Implicit, from predicate): Laboratory reference methods (e.g., YSI analyzer) for blood glucose concentration.

8. The Sample Size for the Training Set

No training set is mentioned or applicable in the context of this 510(k) submission, which describes hardware and minor software modifications to a medical device, not an AI/ML algorithm requiring a distinct training phase.

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

Not applicable, as no training set is mentioned for this submission.

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The SOLUSmobile Blood Glucose Management System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by a single patient with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program, and should not be shared. SOLUSmobile is not intended for the diagnosis of or screening for diabetes mellitus, nor for use in neonates. The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions. This system contains an audible readout function that provides an audible message of test results for users. The SOLUSmobile Blood Glucose Management System uses cellular data transmission to send test results to a cloud server, Telemed-Gluconet.

The SOLUSmobile Blood Glucose Test Strips are to be used with the SOLUSmobile Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood from the finger and the forearm. These test strips are intended for use by a single patient with diabetes mellitus at home and should not be shared.

The SOLUSmobile Control Solutions are for use with SOLUSMobile Meter and Test Strips to check that the meters and test strips are working together properly and that the test is performing correction. A control test that falls within the stated range indicates the user technique is appropriate and the test strip and meter are functioning properly.

The SOLUSmobile (Model 6134) is a product kit consisting of blood glucose meter, test strips, control solutions, a lancing device, lancets, battery charger and charging cable, and instructions for use.

To perform a test, a glucose test strip is inserted into the top of the monitor. When a small drop of blood is applied to the end of the test strip, glucose reacts with the reagents on the test strip, producing an electrical current that is proportional to the blood glucose concentration. The glucose concentration is calculated by the glucose meter and is based on the electrical current measured. The quantitative glucose concentration (in mg/dL or mmol/L) is displayed on the display screen.

An embedded cellular communications module within the SOLUSmobile meter enables automatic wireless data transmission over the Wireless cellular network between the meter and a Central Data Repository (Cloud server).

The test strips, control solutions, lancing device, and lancets are identical to previously cleared devices. The fundamental scientific technology of the SOLUSmobile except the device's communications capabilities remains unchanged from the legally marketed predicate device, SOLO V2 (K093764).

This document describes the SOLUSmobile Blood Glucose Management System (Model 6134), but it does not contain the specific performance study results, acceptance criteria, or most of the other requested details regarding clinical validation of glucose measurement accuracy.

The provided text focuses on:

• Device Description and Intended Use: Explains what the device is, how it works, and its purpose (quantitative measurement of glucose in capillary whole blood for diabetes management).
• Comparison to Predicate Device: Highlights changes from a previous model (SOLO V2), primarily related to wireless data transmission, battery improvements, and minor physical alterations.
• Performance Studies (General): Mentions that disinfection studies were performed to validate cleaning procedures and ensure efficacy against blood-borne pathogens (HBV). It also states robustness studies were conducted to simulate 3 years of use. It broadly refers to "verification and validation testing" to assess changes and demonstrate that "design outputs... meet the predetermined acceptance criteria of the design input requirements."
• Conclusion: States that the device demonstrates "satisfactory performance, is suitable for its intended use, and is substantially equivalent to the predicate device."
• FDA K-Number Letter and Indications for Use: Standard regulatory documents.

Missing Information:

The document explicitly states "Performance Studies" but then only details disinfection and robustness studies, along with a general statement about meeting predetermined acceptance criteria. It does not provide data from studies assessing the accuracy of the glucose measurements themselves (e.g., against laboratory reference methods, or ISO 15197 standards). Therefore, I cannot extract the specific acceptance criteria for glucose accuracy or the reported device performance in those terms.

Without this crucial information, I cannot complete most of the requested table and detailed bullet points.

Based on the available information, here is what can be inferred or stated about the device and its validation, with clear indications of what is missing:

1. Acceptance Criteria and Reported Device Performance

For Glucose Measurement Accuracy:

• Acceptance Criteria for Glucose Measurement: NOT PROVIDED IN THE TEXT. Typically, blood glucose meters are evaluated against standards like ISO 15197, which define accuracy criteria (e.g., a certain percentage of results within ±15% or ±20% of a reference value for different glucose ranges). This document does not state such criteria or present results that meet them.
• Reported Device Performance for Glucose Measurement: NOT PROVIDED IN THE TEXT. The document does not share any data on the accuracy (e.g., bias, precision, percentage agreement with a reference method) of the SOLUSmobile's glucose readings.

For Disinfection Efficacy and Robustness (the only studies detailed):

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

• For Glucose Measurement Accuracy: NOT PROVIDED IN THE TEXT. Sample size (number of subjects, number of blood samples) and data provenance for studies demonstrating glucose measurement accuracy are not mentioned.
• For Disinfection and Robustness Studies: Sample sizes for these specific studies (e.g., number of devices tested for disinfection, number of cycles for robustness) are not precisely stated, though "11,000 cycles" are mentioned for robustness. Data provenance (e.g., country of origin, retrospective/prospective) for these studies is not specified, other than being conducted by "an outside testing service."

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

• For Glucose Measurement Accuracy: NOT PROVIDED IN THE TEXT. Ground truth for glucose accuracy typically involves a highly accurate laboratory reference method (e.g., YSI analyzer), rather than expert consensus. No details on this are provided.
• For Disinfection and Robustness Studies: Not applicable to "experts" for ground truth in the traditional sense; these are laboratory-based tests.

4. Adjudication method for the test set

• For Glucose Measurement Accuracy: NOT PROVIDED IN THE TEXT.
• For Disinfection and Robustness Studies: Not applicable.

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 meter, not an AI-powered diagnostic imaging system requiring human reader interpretation. No MRMC study was done, nor would it be relevant for this type of device.

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

• YES, implicitly. Blood glucose meters inherently operate in a "standalone" fashion (algorithm-only) to measure and display glucose values. The output is directly presented to the user. The document implies this by discussing the meter's function and wireless transmission of results. However, direct "standalone performance" data (like accuracy metrics) are not provided.

7. The type of ground truth used

• For Glucose Measurement Accuracy: NOT PROVIDED IN THE TEXT. For blood glucose meters, the ground truth is typically a highly accurate laboratory reference method (e.g., YSI glucose analyzer) that measures plasma glucose concentration.
• For Disinfection Efficacy: Live virus (HBV) was used.
• For Robustness: Performance of the meter and external materials.

8. The sample size for the training set

• NOT APPLICABLE / NOT PROVIDED IN THE TEXT. This device is not described as using a machine learning algorithm that requires a "training set" in the context of diagnostic pattern recognition. The fundamental technology is electrochemical, detecting glucose concentrations directly.

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

• NOT APPLICABLE / NOT PROVIDED IN THE TEXT. As the device is not described as having an AI-driven "training set" for its core function, this question is not relevant.

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The Smartest™ Glucowise Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program.

It is not intended for the diagnosis or screening for diabetes mellitus.

The Smartest™ Glucowise Blood Glucose Monitoring System has the same intended use as previously cleared for the Smartest™ SuperCheck I Blood Glucose Monitoring System (K091815).

The Smartest™ Glucowise Blood Glucose Monitoring System has done a cleaning and disinfection validation test to comply with "Letter to Manufacturers of Blood Glucose Monitoring Systems Listed with the FDA" dated September, 30th, 2010.

For single patient use

Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S

The Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm. The Smartest™ Glucowise Blood Glucose Monitoring System Model 1 6267-S is intended to be used by a single person and should not be shared.

The Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S 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 Smartest™ Glucowise Test Strips are for use with the Smartest™ Glucowise Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm.

The Smartest™ Glucowise Control Solutions are for use with the Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S as a quality control check to verify that the meter and test strips are working together properly.

For multiple patient use

Smartest™ Glucowise MULTI Blood Glucose Monitoring System, Model 6267-M

The Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm. The Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use, auto-disabling lancets.

The Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M 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 Smartest™ Glucowise MULTI Test Strips are for use with the Smartest™ Glucowise MULTI Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm.

The Smartest™ Glucowise MULTI Control Solutions are for use with the Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M as a quality control check to verify that the meter and test strips are working together properly.

The Smartest™ Glucowise Blood Glucose Monitoring System (Model 6267-S, 6267-M) is a product kit consisting of a blood glucose meter, test strips, control solutions, a lancing device, lancets, and instructions for use. The data download functionality is optionally available and sold separately.

To perform a test, a glucose test strip is inserted into the top of the device. When a small drop of blood is applied to the end of the test strip, glucose reacts with the reagents on the test strip, producing an electrical current that is proportional to the blood glucose concentration. The glucose concentration is calculated by the glucose meter and is based on the electrical current measured.

The quantitative glucose concentration (in mg/dL or mmol/L) is displayed on the display screen.

Here's an analysis of the provided text regarding the Smartest™ Glucowise Blood Glucose Monitoring System, focusing on acceptance criteria, performance, and study details.

Important Note: The provided text is a 510(k) summary for a Special 510(k) submission. A Special 510(k) is used when a modification to an already cleared device does not significantly alter its safety or effectiveness. In this case, the modification was the removal of a "talking feature." Therefore, the submission primarily focuses on demonstrating that this change does not negatively impact the device's original performance, rather than conducting a full de novo performance study for the original device. This means much of the detailed performance data and study specifics (like sample sizes for training/test sets, expert qualifications, etc.) for the glucose measurement function itself are likely contained within the predicate device's (K091815) original submission, which is not included here. This document leverages the previous clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a Special 510(k) and the primary modification is the removal of a talking feature, the document does not explicitly state new, specific acceptance criteria for glucose measurement performance. Instead, it asserts that the device's performance remains equivalent to the predicate device (Smartest™ SuperCheck 1, K091815), which was already cleared by the FDA.

Therefore, the "reported device performance" is essentially that the Smartest™ Glucowise system retains the performance characteristics of the Smartest™ SuperCheck 1, as the modification (removing the talking feature) is stated to "not affect the intended use of the device, and it will not significantly affect safety or effectiveness."

To understand the actual numerical acceptance criteria for glucose measurement accuracy, one would need to refer to the original K091815 submission for the predicate device.

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

The provided document does not specify a sample size for a test set related to the glucose measurement accuracy for the Smartest™ Glucowise device. This is because the submission is a "Special 510(k)" relying on the equivalence to a previously cleared device where only a non-performance-affecting modification (removal of a talking feature) was made.

The document states: "Biotest Medical Corp. has conducted a risk analysis and has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device... meet the design input requirements." This suggests internal testing was done to confirm the removal of the talking feature did not inadvertently introduce new risks or affect existing functionalities. However, no details on test set sizes or data provenance for these specific "verification and validation activities" are provided in the summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For a glucose monitoring system, "ground truth" for blood glucose levels is typically established using laboratory reference methods (e.g., YSI glucose analyzer), not expert consensus in the traditional sense of medical imaging or diagnosis. Since this is a Special 510(k), explicit details on expert involvement (beyond internal validation engineers) are not expected for this specific modification.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods are typically relevant for studies where human interpretation of data (e.g., medical images) is involved and multiple experts' opinions need to be reconciled. For a blood glucose meter, the "ground truth" is typically a quantitative laboratory measurement.

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

No, an MRMC comparative effectiveness study was not done for this submission. MRMC studies are generally applicable to interpretive tasks where human readers' performance is being evaluated, often with and without AI assistance. This device is a blood glucose meter, which provides a quantitative reading, not an interpretive one involving human readers for diagnosis.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This document does not describe a standalone performance study in the context of an "algorithm only" as typically discussed for AI/ML devices. The device is a standalone glucose measurement system. Its performance is evaluated by comparing its readings to a reference method, not by assessing an algorithm's performance in isolation from the hardware.

The entire device is the "standalone" measurement system, and its performance for glucose measurement would have been established and cleared in the predicate device's submission (K091815). The current submission leverages that prior clearance.

7. Type of Ground Truth Used

Based on the nature of a blood glucose monitoring system, the ground truth for glucose measurements would typically be established using a laboratory reference method (e.g., YSI glucose analyzer) that provides highly accurate and precise glucose concentration values. This document does not explicitly state the ground truth method, but it is implied by the "quantitative measurement of glucose."

8. Sample Size for the Training Set

This information is not provided in the document. The device is a traditional electrochemical blood glucose meter, not a machine learning model that requires a "training set" in the common understanding of AI/ML. Its operational parameters are determined through calibration and manufacturing processes, not by training on a large dataset in the AI sense.

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

As noted above, the concept of a "training set" as it applies to AI/ML devices is not relevant here. The device uses established chemical principles to measure glucose. Therefore, there is no "ground truth for the training set" to be established in the context of machine learning.

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The Easy Talk Blood Glucose Monitoring System, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus, nor for use with neonates.

The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.

This system contains a speaking function that provides audible test results for users with low vision.

The Easy Talk Blood Glucose Monitoring System, consists of a blood glucose meter, test strips, control solutions, lancing device, and commercially available lancets. The meter has a bilingual speaking feature that provides audible test results for users with low vision. The forearm may be used as an alternate site for capillary blood.

The provided text describes a 510(k) submission for the "Easy Talk Blood Glucose Monitoring System". While it mentions "clinical performance study" and "test results showed substantial equivalence", it does not provide specific acceptance criteria or detailed results of a study that proves the device meets those criteria in a quantitative manner that would allow for the tables and specific details requested.

Here's an analysis based on the available information:

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

• No specific quantitative acceptance criteria are provided in the document. Blood glucose monitoring systems typically have accuracy criteria based on ISO standards (e.g., ISO 15197) or FDA guidance, which define acceptable percentages of readings within certain deviation limits from a reference method. These are not present in this summary.
• No reported device performance metrics (e.g., accuracy percentages, bias, precision) are provided. The document only states "The test results showed substantial equivalence."

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.
• Data Provenance: Not specified, other than the submitter's address being in Taiwan. It's unclear if the study was conducted there or elsewhere. It is implied to be prospective as it's a "clinical performance study" for validation purposes.

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. For blood glucose monitors, the ground truth is typically established by laboratory reference methods (e.g., YSI analyzer) rather than expert consensus on images or interpretations. The document does not mention how ground truth was established, but it would almost certainly be a chemical laboratory method.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human interpretation of medical images or data is involved and discrepancies need to be resolved. This is not relevant for a blood glucose monitoring system where ground truth is established by an objective chemical measurement.

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 study was done. This type of study is for evaluating human performance (e.g., radiologists) with or without AI assistance, typically for image interpretation. This device is a standalone blood glucose meter and does not involve AI for human readers.

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

• Yes, a standalone performance study was done. The entire "Clinical Tests" section refers to the performance of the device itself ("Easy Talk Blood Glucose Monitoring System") in terms of usability and accuracy, without human-in-the-loop interaction beyond operating the device. The device is designed to provide a direct measurement; it's not an AI assisting a human.

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

• Inferred Ground Truth: While not explicitly stated, for blood glucose monitoring systems, the ground truth for accuracy studies is typically established by comparing the device's readings to those obtained from a central laboratory reference method (e.g., a YSI analyzer or similar highly accurate laboratory instrument) using venous blood samples.

8. The sample size for the training set:

• Not applicable / Not specified. Blood glucose monitoring systems, especially of this generation, do not typically use "training sets" in the machine learning sense. Their algorithms are based on established electrochemical principles, requiring calibration and validation, but not a "training set" of patient data for a machine learning model. If any internal calibration or algorithm refinement occurred using data, it's not described as a "training set".

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

• Not applicable. As explained in point 8, the concept of a "training set" with established ground truth in the context of machine learning is not described or indicated for this device.

In summary: The provided 510(k) summary is very high-level regarding performance studies. It asserts that "extensive verification, validation and testing activities" were performed and the device "passed all of the tests based on pre-determined Pass/Fail criteria," and "The test results showed substantial equivalence" to a predicate device. However, it lacks the specific quantitative data, acceptance criteria, sample sizes, and methodological details required to fully address your request in a structured scientific manner. Such detailed information would typically be found in the full submission, not in the summary document.

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The Smartest Persona Blood Glucose Monitoring System, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus, nor for use with neonates.

The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.

This system contains a speaking function that provides audible test results for users with low vision.

The Smartest Persona Blood Glucose Monitoring System consists of a blood glucose meter, test strips, control solutions, lancing device, and commercially available lancets. The meter has a bilingual speaking feature that provides audible test results for users with low vision. The forearm may be used as an alternate site for capillary blood.

The provided text is a 510(k) summary for the Smartest Persona Blood Glucose Monitoring System. It describes the device, its intended use, comparison to a predicate device, and the conclusion that it is substantially equivalent. However, it does not include detailed information regarding acceptance criteria, specific performance study results, sample sizes for test or training sets, ground truth establishment, or expert involvement as requested in the prompt.

Therefore, I cannot populate the requested information from the provided text. The document states that "Biotest Medical Corp. has conducted a risk analysis and has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements," but it does not elaborate on what those requirements or the results of those activities were.

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The SoloV2TM Blood Glucose Monitoring System, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus, nor for use with neonates.

The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.

This system contains a speaking function that provides audible test results for users with low vision.

The SoloV2TM Blood Glucose Monitoring System consists of a blood glucose meter, test strips, control solutions, lancing device, and commercially available lancets. The meter has a bilingual speaking feature that provides audible test results for users with low vision. The forearm may be used as an alternate site for capillary blood.

The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets said criteria. The document is a 510(k) summary for a blood glucose monitoring system, primarily focused on demonstrating substantial equivalence to a predicate device.

Here's a breakdown of the information that is and is not present, based on your request:

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

• Not present. The document states that Biotest Medical Corp. "has conducted a risk analysis and has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements." However, it does not detail what those acceptance criteria were (e.g., accuracy standards like ISO 15197) or present specific performance data.

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

• Not present. The document mentions "Performance Studies" in a very general way, but does not provide any specifics about sample sizes, study design (retrospective/prospective), 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):

• Not applicable/Not present. This type of information is typically relevant for studies involving subjective assessment (e.g., image interpretation), where expert consensus establishes ground truth. For a blood glucose monitoring system, the "ground truth" would typically be established by a laboratory reference method, not by expert consensus interpreting images. The document does not describe how ground truth was established for any performance studies.

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

• Not applicable/Not present. Similar to point 3, adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert interpretations, which is not relevant for a blood glucose meter's performance assessment.

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/Not present. MRMC studies are used to evaluate the impact of AI on human reader performance, particularly in diagnostic imaging. This device is a blood glucose monitoring system and does not involve AI assistance for human readers in the way an imaging AI would.

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

• Not applicable/Not present. While the device itself is a "standalone" system for measuring glucose, the concept of "standalone (algorithm only without human-in-the-loop performance)" is usually applied to AI algorithms that process data independently. This device is a physical diagnostic tool; its performance is inherently a standalone measurement. The document does not describe any specific "algorithm-only" performance study in the context of AI.

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

• Not explicitly stated, but inferred to be a laboratory reference method. For blood glucose meters, the ground truth is typically a highly accurate laboratory reference method (e.g., hexokinase method). The document does not explicitly state this, but it's the standard for such devices.

8. The sample size for the training set:

• Not applicable/Not present. This device is not described as involving machine learning or AI models that require a "training set" in the conventional sense. Its performance is based on its electrochemical measurement technology.

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

• Not applicable/Not present. As there's no mention of a training set for an AI/ML model, this information is not provided.

In summary:

The provided 510(k) summary for the SoloV2™ Blood Glucose Monitoring System focuses on demonstrating substantial equivalence to a predicate device (SuperCheck 1 Blood Glucose Monitoring System) by listing modifications and asserting that "necessary verification and validation activities" were performed. It does not include detailed performance data, specific acceptance criteria, or study methodologies that would address most of your requested points, which are more typically found in documents for AI/ML-based medical devices or more comprehensive clinical study reports.

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The SuperCheck 1 Blood Glucose Monitoring System, Model 6268, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. The SuperCheck 1 Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor for use with neonates.

The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.

This system contains a speaking function that provides audible test results for users with low vision.

The SuperCheck 1 Blood Glucose Monitoring System, Model 6268 consists of a blood glucose meter, blood glucose test strips, control solutions, the lancing device, and lancets. The meter also comes with a speaking function that provides audible test results for users with low vision. The SuperCheck 1 Model 6268 allows the forearm to be used as an alternate site. User performance testing was conducted to support an over-the-counter indication.

Here's a summary of the acceptance criteria and study information for the SuperCheck 1 Blood Glucose Monitoring System, Model 6268, based on the provided 510(k) summary:

Please note: The provided document is a 510(k) summary, which often provides a high-level overview of performance studies without detailing every specific acceptance criterion or the exhaustive data from the studies themselves. Therefore, some requested information (like specific numerical acceptance criteria or full study details) is not explicitly present in the provided text. I will extract what is available.

1. Table of Acceptance Criteria and Reported Device Performance

Missing specific quantitative acceptance criteria: The 510(k) summary does not list specific numerical accuracy or precision acceptance criteria (e.g., % within ±15% of reference, ISO standards for blood glucose meters). It only states that the performance was "satisfactory" and "meets its intended use."

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

• Sample Size: Not explicitly stated. The document mentions "The performance... was studied in the laboratory and in clinical settings by healthcare professionals and lay users," but does not provide specific numbers for participants or conducted tests.
• Data Provenance: Not explicitly stated. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the submitter's address in Taiwan, it's possible that at least some studies were conducted there, but this is not confirmed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not provided in the 510(k) summary. For blood glucose monitoring systems, ground truth is typically established using a highly accurate reference method (e.g., a laboratory analyzer), rather than expert consensus on images or interpretations.

4. Adjudication Method for the Test Set

• This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving expert review of medical images or records to establish a consensus ground truth. For a blood glucose meter, ground truth is established by a reference laboratory method, not expert adjudication in this manner.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. An MRMC comparative effectiveness study was not done. This type of study typically applies to diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is measured. For a blood glucose meter, the performance is standalone, measuring the device's accuracy against a reference standard.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, a standalone performance study was done. The performance studies described in the summary ("in the laboratory and in clinical settings") relate to the device's ability to accurately measure blood glucose levels by itself. The results are compared directly to a reference method (though the reference method isn't specified in this summary). This is the primary mode of evaluation for a blood glucose monitoring system.

7. The Type of Ground Truth Used

• While not explicitly stated in detail, the ground truth for blood glucose monitoring systems is invariably established by a highly accurate laboratory reference method (e.g., YSI analyzer, hexokinase method). This is the standard practice for evaluating the accuracy of blood glucose meters. It is not expert consensus, pathology, or outcomes data in this context.

8. The Sample Size for the Training Set

• This information is not provided. The 510(k) summary focuses on the performance studies (testing data). Details about the training set size for the device's internal algorithms (e.g., for calibration) are not typically included in these summaries unless they are part of a novel machine learning component that requires extensive training data.

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

• This information is not provided. Similar to question 8, the details of how any internal algorithms were trained or calibrated, and how their ground truth was established, are not included in this high-level 510(k) summary. It's likely that if a reference method was used for validation (testing), a similar or identical method would have been used for calibration/training.

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