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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 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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