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The Precision Xtra Advanced Diabetes Management System is intended for in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose and/or ketone in fresh capillary whole blood. The Precision Xtra System is for home (lay user) or professional use.

The Precision Xtra System may also be used for the quantitative measurement of glucose in venous, arterial, or neonatal whole blood and ketone in venous blood, provided the sample is used within 30 minutes after collection.

The Precision™ Xtra™ Advanced Diabetes Management System for Blood Glucose and Ketone Testing utilizes amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose (or Beta-Hydroxybutyrate ketone) present in the sample, providing a quantitative measure of glucose (or ketone) in whole blood and control solutions.

The provided text describes the regulatory submission for the Precision™ Xtra™ Advanced Diabetes Management System but does not contain the detailed performance study results, acceptance criteria, or specific data about ground truth determination, reader studies, or sample sizes for testing and training sets.

The document states that "The studies demonstrated that lay users can obtain blood glucose and ketone results that are substantially equivalent to the current methods for blood glucose and ketone measurements," and "Results of laboratory and clinical testing demonstrate that the performance of the Precision Xtra Advanced Diabetes Management System... is acceptable and comparable to the performance of the previously mentioned predicate devices." However, it does not present the raw data, statistical analysis, or predefined acceptance criteria.

Therefore, many of the requested fields cannot be filled directly from this document.

Here's a breakdown of what can be inferred or explicitly stated from the provided text, and what is missing:

Acceptance Criteria and Device Performance (Based on Inferred Information)

The document implies that the acceptance criteria are met if the device demonstrates "substantial equivalence" to the predicate devices for blood glucose and ketone measurements in both laboratory and clinical settings, for both healthcare professionals and lay users. Specific numerical acceptance criteria are not provided.

Study Details

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

   • Sample Size: Not specified.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies were conducted in "laboratory and clinical settings" but no further detail is provided.

2. 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. The "ground truth" for the device's performance seems to be established by comparing its results to "current methods for blood glucose and ketone measurements," which include predicate devices. There's no mention of independent expert adjudication for establishing ground truth in the context of diagnostic interpretation.

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

   • Not applicable in the context of this device type (blood glucose/ketone meter) as there isn't a complex diagnostic image or clinical case requiring expert adjudication in the traditional sense. The comparison is against established laboratory methods or predicate devices.

4. 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 not an AI-assisted diagnostic imaging device. The "readers" are the users of the device (lay users and healthcare professionals) obtaining direct measurements. The study did compare "trained operators and lay users" to show they "obtain equivalent whole blood glucose and ketone results," but this is not an MRMC study comparing AI assistance.

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

   • The device inherently produces a quantitative measurement, which is its standalone performance. The "human-in-the-loop" refers to the user operating the device and interpreting the numerical output. The studies included both laboratory testing (likely more controlled, akin to standalone) and clinical settings with users, demonstrating the device's ability to provide measurements directly.

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

   • The ground truth was established by comparison to results from "current methods for blood glucose and ketone measurements," specifically the listed predicate devices (Precision QID, Precision G, GDS Stat-Site Meter, Sigma Diagnostics β-Hydroxybutyrate Procedure No. 310-UV). These are established, validated methods for measuring glucose and ketones.

7. The sample size for the training set:

   • Not applicable as this is not an algorithm-based device that undergoes a "training" phase in the machine learning sense. The device's performance is based on its biosensor technology and calibration.

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

   • Not applicable for the same reason as point 7.

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The Precision G Plus Point of Care Management System for Blood Glucose is intended for the in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Precision. G Plus Point of Care Management System is for home (lay user) or professional use.

The product may also be used by healthcare professionals for the quantitative measurement of glucose in venous, arterial or neonatal whole blood, provided the sample is used within 30 minutes.

The Precision·G Plus Point of Care Management System for Blood Glucose Testing utilizes amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose present in the sample providing a quantitative measure of glucose in whole blood and control solutions.

The provided text is a summary of a 510(k) premarket notification for a medical device (a blood glucose testing system). It doesn't contain detailed information about specific acceptance criteria or a dedicated study report with performance metrics. Rather, it states that performance studies were conducted and the device met substantial equivalence.

Therefore, many of the requested fields cannot be filled directly from the provided text. However, based on the general information available in a 510(k) summary for a blood glucose monitor, I can infer what common acceptance criteria and study designs are for such devices and how the provided text aligns with that.

Here's an attempt to answer your questions based on the available information and general knowledge of blood glucose meter submissions:

Acceptance Criteria and Study for K987303: Precision·G Plus Point of Care Management System for Blood Glucose Testing

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state the specific acceptance criteria (e.g., ISO 15197 accuracy limits such as "X% of results within ±Y mg/dL" or "X% within ±Z%"). It generally states that the device demonstrated "substantially equivalent" results and "acceptable" performance when compared to predicate devices and current methods.

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

• Sample Size: Not specified in the provided text. For blood glucose meters, clinical studies typically involve hundreds of samples from patients (capillary, venous, arterial, neonatal, as per intended use) to cover the analytical range and demonstrate accuracy.
• Data Provenance: The studies were conducted "in the laboratory and in clinical settings." The country of origin is not specified, but given the submitter's address in Massachusetts, USA, it's highly probable the studies were conducted in the US. The studies are prospective, as they involved "user[s]" obtaining results in these settings.

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

• Number of Experts: Not specified.
• Qualifications: "Healthcare professionals" were involved in the clinical settings, implying medical professionals qualified to perform blood draws and potentially operate reference laboratory instruments. The "current methods for blood glucose measurement" (likely laboratory-based glucose analyzers, sometimes referred to as "gold standard" or "reference" methods) would have established the ground truth. These reference methods are themselves operated by trained laboratory personnel.

4. Adjudication Method for the Test Set:

Not explicitly mentioned. For blood glucose meters, adjudication (in the context of expert consensus) is less common for establishing the primary glucose value, as a reference laboratory method provides the quantitative "ground truth." Any discrepancies would typically be resolved by investigation into sample handling, instrument malfunction, or procedural errors, rather than expert consensus on the glucose value itself.

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

• Was one done? Not explicitly mentioned. MRMC studies are more common for imaging devices where human interpretation is a primary component. For a blood glucose meter, the focus is on the device's accuracy in providing a quantitative result, not on human interpretation of complex data. The "lay user" and "professional" studies evaluate the usability and performance of different user types, which has some overlap with reader variability, but it's not typically described as an MRMC comparative effectiveness study in the same way an imaging or diagnostic AI product would be.
• Effect size of human readers with vs. without AI assistance: Not applicable, as this is not an AI-assisted diagnostic imaging or interpretation device.

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

• Was one done? Yes, implicitly. The core performance of the device's "amperometric biosensor technology to generate a current" and subsequent calculation is a standalone function. The "laboratory" studies would likely represent a standalone assessment of the device's analytical performance against a reference method, without necessarily accounting for all human-in-the-loop variables that are tested in clinical settings with different user types. The clinical studies with "healthcare professionals and lay users" then assess the human-in-the-loop performance.

7. Type of Ground Truth Used:

The ground truth was established by "current methods for blood glucose measurement," which typically refers to reference laboratory-based glucose analyzers (e.g., hexokinase method) known for their high accuracy and precision. This is a form of "reference method comparison" or "established analytical standard."

8. Sample Size for the Training Set:

Not applicable/not specified. For an amperometric biosensor system like this, there isn't a "training set" in the machine learning sense. The device's calibration and algorithm are developed through engineering and chemistry principles, and then validated with the test set studies described.

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

Not applicable, as there is no training set in the machine learning context for this type of device. The device's internal calibration parameters would be set during manufacturing based on known glucose standards, not through a "training set" with established ground truth in the AI sense.

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The Precision A1c Home HbA1c Sample Collection Kit is intended to be a home-use or office-use device for the collection of a capillary blood sample on a blood sample collection card for in vitro diagnostic laboratory evaluation of the amount of HbA1c (glycosylated hemoglobin). This collection device will be used to monitor long-term blood glucose control in patients with diabetes mellitus.

The Precision Alc sample collection device will be marketed over-the-counter. This kit is not indicated for the diagnosis of diabetes mellitus.

The Precision A1c Home HbA1c Sample Collection Kit contains the materials necessary to collect a capillary blood sample from a finger-stick to a piece of filter paper and mail it to a clinical laboratory for the determination of percent hemoglobin A1c (also known as glycohemoglobin or glycosylated hemoglobin).

The Precision A1c sample collection kit contains a lancet, patient information sheet, instruction sheet, alcohol pad, gauze pad, bandage, pre-paid mailing envelope, and a blood sample collection card (inside a zip-locked foil pouch containing a desiccant).

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance for Precision A1c™ Home HbA1c Sample Collection Kit (K983253)

The key performance criteria for the Precision A1c™ Home HbA1c Sample Collection Kit are based on the correlation and agreement of HbA1c results obtained from samples collected with the kit compared to whole blood samples. The study assessed the performance of the device when used by both trained operators and lay users.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria values (e.g., "correlation coefficient must be > 0.95"). However, the language of the conclusion, stating "Results indicate excellent correlation... and equivalent results," strongly implies that the observed performance values were considered acceptable. Based on the data presented and the concluding remarks, the implied acceptance criteria would generally be a correlation coefficient close to 1.000, a slope close to 1.000, and a y-intercept close to 0.0, along with low bias and Sy.x values.

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The Precision QID Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. For home or professional use with the Precision QID Blood Glucose Sensor. Compatible with the MediSense 2 Card and Pen Blood Glucose Sensors, and the Companion 2 Card and Pen Blood Glucose Sensors.

The product may also be used by healthcare professionals for the quantitative measurement of glucose in venous, arterial, or neonate whole blood, provided the sample is used within 30 minutes of collection.

The Precision G Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh whole capillary blood. The Precision G Blood Glucose Testing System is intended for home or professional use.

The Precision QID and Precision G Blood Glucose Test Strips are identical in test strip design. Both test strips utilize amperometric biosensor technology to quantitatively measure glucose in whole blood and control solutions. The Precision QID Blood Glucose Test Strips are for use with the Precision QID Blood Glucose Testing System and are also compatible with the MediSense 2 Card and Pen Blood Glucose Testing Systems. The Precision G Blood Glucose Test Strip is only for use with the Precision G Blood Glucose Testing System.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Precision QID® and Precision G Blood Glucose Test Strips:

Overview

The provided document is a 510(k) Summary of Safety and Effectiveness for the Precision QID® and Precision G Blood Glucose Test Strip. It seeks substantial equivalence to previously cleared predicate devices. The primary focus of the performance studies is to demonstrate that the new device is "substantially equivalent" to existing methods for blood glucose measurement.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" in the format typically seen with accuracy or precision targets (e.g., "95% of results within ±X% of reference"). Instead, the acceptance criterion is implicitly framed within the context of substantial equivalence to predicate devices. The reported device performance is qualitative:

"Results of laboratory and clinical testing demonstrate that the performance of the Precision QID and Precision G Blood Glucose Test Strip when used according to the intended use stated above is acceptable and comparable to the performance of the predicate devices..." |

Study Details

1. Sample Size used for the test set and the data provenance:

   • The document states that the performance was studied "in the laboratory and in clinical settings by healthcare professionals and lay users."
   • Specific sample sizes are NOT provided.
   • Data Provenance: Not explicitly stated, but clinical settings by "healthcare professionals and lay users" suggests data was collected from human subjects, likely in the US where the submission originated. It is a prospective study as it's evaluating the performance of the new device.

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

   • Not applicable for this type of device. For blood glucose meters, the "ground truth" or reference method is typically an established laboratory-based glucose analyzer, not expert consensus on image interpretation. The document doesn't specify the reference method used, but it would almost certainly be a highly accurate lab instrument.

3. Adjudication method for the test set:

   • Not applicable. Adjudication is typically used to resolve discrepancies among human readers or to establish ground truth in subjective assessments (e.g., image interpretation). This is a quantitative measurement device (blood glucose), where performance is compared directly to a reference method, not an adjudicated human reading.

4. 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. This is a standalone diagnostic device for measuring blood glucose, not an AI-assisted interpretation tool for human readers. Therefore, an MRMC study is not relevant.

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

   • Yes, in essence. The evaluation described is of the device itself (the test strip and its associated meter system) against a reference method. While human users (healthcare professionals and lay users) operate the device, the performance being assessed is the quantitative output of the device, which is a "standalone" measurement by the instrument based on its internal algorithm/chemistry. The study is assessing the device's ability to accurately measure glucose, independent of human interpretation of complex data.

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

   • The document implies that the ground truth was established by "current methods for blood glucose measurement," which almost certainly refers to a laboratory reference method (e.g., a glucose analyzer like a YSI analyzer), known for its high accuracy and precision.

7. The sample size for the training set:

   • Not explicitly stated and not directly applicable in the AI/machine learning sense. This device is based on amperometric biosensor technology, which relies on chemical reactions and electrochemical detection, not a machine learning model that requires a "training set" in the computational sense. While the device's development and calibration would involve extensive testing and refinement with many samples, this isn't referred to as a "training set" in the context of this 510(k) summary.

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

   • Not applicable for a "training set" in the AI/ML sense. For the development and calibration of such a biosensor, the "ground truth" for establishing the device's performance characteristics (e.g., sensitivity, linearity, accuracy) would be established using precisely measured glucose solutions and/or blood samples analyzed by highly accurate laboratory reference methods.

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The Precision G Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh whole blood. The Precision G Blood Glucose Testing System is intended for home or professional use. The product may also be used by healthcare professionals for quantitative measurement of glucose in venous or arterial whole blood, provided the sample is used within 15 minutes.

The Precision G Blood Glucose Testing System utilizes amperometric biosensor technology to quantitatively measure glucose in whole blood and control solutions. A drop of whole blood or control solution is applied to the target area of the test strip and the assay is automatically initiated. A countdown begins and glucose oxidase catalyzes the oxidation of glucose to produce gluconic acid. During the reaction, electrons are transferred by an electrochemical mediator to the electrode surface, generating a current that is measured by the Precision G Sensor. The size of the current is proportional to the amount of glucose present in the sample, thus giving an accurate reading of glucose concentration after 20 seconds.

Here's an analysis of the provided text, focusing on acceptance criteria and study information for the Precision G Blood Glucose Testing System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state pre-defined acceptance criteria (e.g., "The correlation coefficient must be > 0.95"). Instead, it presents the results of performance studies and then draws a conclusion based on those results. The conclusion acts as a post-hoc assessment of whether the performance is deemed acceptable.

Therefore, the table below presents the reported device performance, and the "Acceptance Criteria" column reflects what was concluded to be acceptable based on the reported values.

Conclusion from the document: "The correlation coefficients and slopes obtained were close to 1.000 and y-intercepts close to 0 mg/dL indicating good correlation of the MediSense Precision G Blood Glucose Testing System to the reference analyzer when testing was conducted by trained operators and lay users. In addition, equivalent results were achieved by Lay Users and Trained Operators using the Precision G Blood Glucose Testing System."

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

• Sample Size for Test Set: N = 200 for each comparison (Lay User vs. YSI, Trained Operator vs. YSI, Trained Operator vs. Lay User).
• Data Provenance: The document does not explicitly state the country of origin. It describes "Accuracy Performance... versus the YSI," implying a controlled laboratory or clinical setting. The term "Accuracy Performance... when used by lay users" suggests that some of the data might have been collected from non-clinical environments, but this is not fully clear. It is a prospective study as it involves the "performance information on clinical accuracy" of the device in comparison to a reference.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. However, the ground truth is established by a "reference analyzer" (YSI), which likely refers to a laboratory-grade glucose analyzer, suggesting that the results from this analyzer are considered the gold standard, not the interpretation of human experts in this context.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth is established by a reference analyzer (YSI), which typically provides objective quantitative measurements, not subjective interpretations requiring adjudication.

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

• MRMC Study: No, this is not an MRMC study. This study assesses the accuracy of a blood glucose testing system against a reference laboratory method (YSI) and compares performance between trained operators and lay users. It does not involve AI assistance for human readers.
• Effect Size of AI Improvement: Not applicable, as there is no AI component or human reader assistance being evaluated in this context.

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

• Standalone Performance: Yes, the device itself provides a quantitative reading ("quantitatively measure glucose"). Although human operators (trained and lay users) interact with the device to obtain the sample and initiate the test, the "device performance" or "system performance" against the YSI can be considered a standalone assessment of the device's accuracy in producing glucose concentration values. The comparison between trained operator and lay user performance also assesses the robustness of the standalone device, given varying operator proficiency.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for glucose measurements is established by a reference analyzer, specifically the "YSI." This implies a highly accurate and validated laboratory method for determining blood glucose concentration.

8. The Sample Size for the Training Set

• Sample Size for Training Set: The document does not provide information about a separate training set. The "Performance Studies" described appear to be validation or testing studies only. For a medical device like a blood glucose meter, the "training" usually refers to the internal development and calibration data, which is not typically disclosed in a summary of safety and effectiveness.

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

• How Ground Truth for Training Set Was Established: Not mentioned in the provided text, as no explicit training set is discussed.

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The Precision QID Blood Glucose Test Strips are intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. For home or professional use with the Precision QID Blood Glucose Sensor. Compatible with the MediSense 2 Card and Pen Blood Glucose Sensors, and the Companion 2 Card and Pen Blood Glucose Sensors.
The product may also be used by healthcare professionals for quantitative measurement of glucose in venous or arterial whole blood, provided the sample is used within 15 minutes.

The Precision QID Blood Glucose Test Strip utilizes amperometric biosensor technology to quantitatively measure glucose in whole blood and control solutions. Insertion of a test strip into the sensor, automatically turns the sensor on. A drop of whole blood or control solution is applied to the target area of the test strip and the assay is automatically initiated. A countdown begins and glucose oxidase catalyzes the oxidation of glucose to produce gluconic acid. During the reaction, electrons are transferred by an electrochemical mediator to the electrode surface, generating a current that is measured by the Precision QID Sensor. The size of the current is proportional to the amount of glucose present in the sample, thus giving an accurate reading of glucose concentration after 20 seconds.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Precision QID™ Blood Glucose Test Strip:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific correlation coefficient, slope, or y-intercept values. Instead, it presents the results of a comparison study and concludes that the performance is "acceptable and comparable" to the predicate device.

However, based on the context of similar medical device submissions for blood glucose meters, common performance metrics are correlation coefficient, slope, and y-intercept when compared to a reference method. We can infer the reported device performance from the provided table.

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

• Sample Sizes:

  • For the study comparing the Precision QID Test Strip using arterial whole blood against an arterial whole blood reference method: N = 320
  • For the study comparing the Precision QID Test Strip using arterial whole blood against an arterial plasma reference method: N = 306
  • For the study comparing the predicate Precision QID Blood Glucose Test Strip using capillary whole blood against a whole blood reference method: N = 311 (These results were reported in a previous 510(k) submission #K945887)

• Data Provenance:

  • The current study (arterial whole blood) was performed "at a university medical center." No specific country of origin is mentioned beyond "university medical center."
  • The study appears to be prospective, as it describes clinical testing being "performed."

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 given text. While it states the study was done at a "university medical center" and compared to "hexokinase reference methods," it doesn't specify if experts were involved in establishing ground truth beyond running the reference method, nor does it detail their qualifications.

4. Adjudication Method for the Test Set

This information is not provided in the given text. Adjudication methods are typically relevant for subjective assessments or when multiple readers are interpreting results, which isn't the primary focus here (it's a quantitative measurement device).

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 comparative effectiveness study was not conducted. This type of study (AI assistance for human readers) is not relevant for this device, which is a blood glucose test strip, a standalone diagnostic tool, not an AI-powered image interpretation or clinical decision support system.

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

Yes, a standalone performance study was done. The study directly assesses the performance of the Precision QID Blood Glucose Test Strip (algorithm + associated hardware to read the strip) against recognized laboratory reference methods (hexokinase). This is essentially the "algorithm only" performance for a quantitative measurement device, as the human-in-the-loop is simply applying the sample and reading the digital result.

7. The Type of Ground Truth Used

The ground truth used was reference laboratory methods:

• Whole blood hexokinase reference method
• Plasma hexokinase reference method

Hexokinase methods are considered highly accurate and are a standard for glucose measurement in clinical laboratories.

8. The Sample Size for the Training Set

This information is not applicable/not provided for this type of device. The Precision QID Blood Glucose Test Strip is based on a chemical reaction (biosensor technology) rather than a machine learning model that requires a training set. The "development" of the device would involve engineering and chemical optimization, not training on a dataset in the way an AI algorithm is trained.

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

As stated above, this question is not applicable as there is no mention or indication of a "training set" in the context of an AI/ML algorithm for this device.

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The ExacTech RSG Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The product is designed for home or professional use.

The ExacTech RSG Blood Glucose Testing System utilizes amperometric biosensor technology to quantitatively measure glucose in whole blood and control solutions. After inserting a test strip into the sensor, a drop of whole blood or control solution is applied to the target area of the test strip and the sensor button is pressed. A countdown begins and glucose oxidase catalyzes the oxidation of glucose to produce gluconic acid. During the reaction, electrons are transferred by an electrochemical mediator to the electrode surface, generating a current that is measured by the ExacTech RSG Sensor. The size of the current is proportional to the amount of glucose present in the sample, thus giving an accurate reading of glucose concentration after 30 seconds.

This document describes the performance of the ExacTech RSG Blood Glucose Testing System compared to the predicate ExacTech Blood Glucose Testing System and a YSI Analyzer. The information provided is for regulatory submission and focuses on equivalence rather than specific acceptance criteria against a fixed benchmark.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with numerical targets for the ExacTech RSG system. Instead, it aims to demonstrate comparability to the predicate device and a YSI Analyzer. The performance metrics presented are for comparison purposes.

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

• Sample Size (Clinical Accuracy Study):
  • Number of subjects: 178
  • Number of measurements (ExacTech RSG): 288
  • Number of measurements (Standard ExacTech): 170 (This discrepancy between subject count and measurements for the standard system is noted, but not explained in the text. It's possible some subjects had fewer measurements with the standard system, or only a subset of measurements were included in this specific summary.)
• Data Provenance: The study was conducted at "three sites" which included "a clinic, physician's office, and clinical research center." The text does not specify the country of origin. The study appears to be prospective as it involved recruiting subjects and collecting fresh capillary whole blood for testing.
• Demographics: 34% male, 66% female, age 9-88 years. Majority were White or Hispanic, with diversity in education and occupation. Two sites had a higher percentage of NIDDM (Non-Insulin Dependent Diabetes Mellitus) and one site had a higher percentage of IDDM (Insulin Dependent Diabetes Mellitus).

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

The ground truth for the clinical accuracy study was established using a YSI Analyzer. This is a laboratory-grade instrument considered a gold standard for glucose measurement, not human experts. Therefore, the question of "number of experts" and "qualifications" doesn't directly apply here in the traditional sense of image interpretation or medical diagnosis.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was an objective measurement from a YSI Analyzer, not a subjective assessment requiring adjudication.

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 not an AI-assisted diagnostic device; it is a blood glucose monitoring system. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" do not apply.

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

Yes, in a way. The performance studies evaluate the device's performance (ExacTech RSG System). While a trained operator performed the test, the focus of the data presented is on the system's accuracy and precision in measuring glucose, which is an automated process once the blood is applied to the strip. The "algorithm" here refers to the internal workings of the amperometric biosensor technology to quantitatively measure glucose.

7. The Type of Ground Truth Used

The ground truth used for the clinical accuracy study was objective measurements from a predicate laboratory-grade instrument (YSI Analyzer). This is considered a highly accurate and reliable method for blood glucose determination.

8. The Sample Size for the Training Set

The document does not mention a separate "training set" in the context of machine learning or AI models. This device relies on established biosensor technology. The "pre-programmed universal calibration information" suggests that this calibration data (which could be considered analogous to a training set for a traditional calibration model) was established internally by the manufacturer, but its specific sample size is not disclosed.

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

As discussed above, a specific "training set" in the AI sense is not described. The device uses "pre-programmed universal calibration information." This calibration would have been established by the manufacturer through rigorous testing of the ExacTech RSG test strips against a reference method (likely a YSI Analyzer or similar laboratory standard) to define the relationship between the electrochemical signal and glucose concentration. Details on the exact process or sample size for this internal calibration are not provided in the summary.

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