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The Glucose2 assay is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the ARCHITECT c System.

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Glucose2 assay is an automated clinical chemistry assay.

Glucose is phosphorylated by hexokinase in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PDH) specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide phosphate (NADP) to its reduced form (NADPH). One micromole of NADPH is produced for each micromole of glucose consumed. The NADPH produced absorbs light at 340 nm and can be detected spectrophotometrically as an increased absorbance.

Methodology: Hexokinase/G6PDH

N/A

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The cobas pro integrated solutions is an IVD device used for the quantitation of clinical chemistry and Ion Selective Electrolyte parameters from various biological fluids.

Glucose HK Gen.3 is an in vitro test for the quantitative determination of glucose in human serum, plasma, urine and CSF on Roche/Hitachi cobas c systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and pancreatic islet cell tumors.

The ISE indirect Na for Gen. 2 is intended for the quantitative determination of sodium in serum, plasma or urine using ion-selective electrodes. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Elecsys TSH immunoassay is intended for the in vitro quantitative determination of thyrotropin in human serum and plasma. Measurements of TSH are used in the diagnosis of thyroid and pituitary disorders. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.

The cobas pro integrated solutions (cobas pro) is a fully automated, random-access, software controlled system intended for in vitro quantitative analysis of analytes in body fluids. It will typically be used in clinical laboratories with large workload. The system consolidates clinical chemistry, homogenous and heterogeneous immunoassays as well as electrolyte testing within one workplace. It consists of a high throughput sample distribution unit (core unit) and different analytical units for ISE (cobas pro ISE analytical unit), clinical chemistry (c 503 analytical unit) and immunoassay (e 801 analytical) testing. The system hardware is comprised of new or previously cleared members of the Roche/Hitachi cobas c or Elecsys families of analyzers. The instrument software is unique to the cobas pro and was developed from previous generations of Roche/Hitachi instrument systems.

Here's a breakdown of the acceptance criteria and study information for the cobas pro integrated solutions device, specifically focusing on the Glucose HK Gen.3, ISE indirect Na for Gen.2, and Elecsys TSH assays.

Preamble: This document describes a Traditional 510(k) Premarket Notification for the cobas pro integrated solutions. The core purpose is to show that previously cleared Glucose, Sodium, and TSH assays, when run on the new cobas pro integrated solutions system, are substantially equivalent to their predicate devices. Therefore, the acceptance criteria and studies presented are largely comparative or validation studies demonstrating consistent performance with previously cleared devices and established analytical standards.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission demonstrating substantial equivalence to pre-existing predicate devices for assays and a new integrated system, the acceptance criteria are generally focused on meeting established performance claims or showing equivalence within acceptable statistical limits. The summary provided focuses on the reported device performance which is then implicitly compared to internal acceptance criteria (often relative to the predicate device or CLSI guidelines).

Note on Acceptance Criteria: The document explicitly states "All samples met the predetermined acceptance criterion" for precision studies. For LoQ, it states "LoQ determined at maximum allowable %TE (total error) of no more than 20% (Glucose and TSH) and 30% (Sodium)." For endogenous interference, it was "recovery of 100±10%". For exogenous interference (common drugs for Elecsys TSH), it was "± 10% of the reference value". For method comparisons, the slope, intercept, and correlation coefficients approaching 1 or 0 respectively, indicate strong agreement, satisfying the intent of substantial equivalence. Specific numerical acceptance criteria are not always stated outright but are implied by the study design and conclusion of meeting criteria.

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

• Glucose HK Gen.3 (Precision):
  • Sample Size: 84 measurements for each control level (PreciControl ClinChem Multi 1 and 2) and 5 human serum samples per application (serum, urine, CSF). So, for repeatability and intermediate precision, 84 measurements for 2 controls + 5 samples, across serum, urine, and CSF applications.
  • Data Provenance: Human serum, plasma, urine, and CSF samples. These were "native, single donors as well as pools." The study was conducted in-house by Roche Diagnostics (implied by the submission).
• ISE indirect Na (Precision):
  • Sample Size: 84 measurements for each control level (PreciControl ClinChem Multi 1 and 2, Liquichek 1 and 2) and 5 human plasma, serum, and urine samples per application. So, for repeatability and intermediate precision, 84 measurements for controls + 5 samples, across Li-Heparin Plasma, Serum, and Urine.
  • Data Provenance: Human Li-Heparin plasma, serum, and urine samples. These were "native, single donors as well as pools." Conducted in-house by Roche Diagnostics.
• Elecsys TSH (Precision):
  • Sample Size: 84 measurements for each control level (PreciControl Universal, PC Thyro Sensitive) and 5 human serum samples.
  • Data Provenance: Human serum samples. These were "native, single donors as well as pools." Conducted in-house by Roche Diagnostics.
• Analytical Sensitivity (LoB, LoD, LoQ) for all assays:
  • Sample Size:
    • LoB: ≥ 60 measurements of analyte-free samples.
    • LoD: 60 measurements (5 low-analyte concentration samples, measured in duplicate over 6 runs, 3 days).
    • LoQ: ≥ 60 measurements per sample type (samples with low analyte concentration measured over 3 to 5 days).
  • Data Provenance: Not explicitly stated for specific blanks or low-concentration samples beyond "analyte-free" or "low-analyte concentration". Conducted in-house by Roche Diagnostics.
• Linearity/Assay Reportable Range:
  • Glucose HK Gen.3: Three high analyte human serum, urine, and CSF samples diluted to 12 levels.
  • ISE indirect Na: Three high analyte human serum, urine, and CSF samples diluted to multiple aliquot concentrations.
  • Elecsys TSH: Three high analyte human serum samples diluted to concentrations covering the measuring range.
  • Data Provenance: Human serum, urine, CSF samples. Conducted in-house by Roche Diagnostics.
• Endogenous Interference:
  • Glucose HK Gen.3: Plasma and urine samples, glucose levels ~79.5 mg/dL and ~116.3 mg/dL.
  • ISE indirect Na: Human plasma, serum, and urine samples. Low (~124 mmol/L) and high (~151 mmol/L) for S/P; low (26.3 mmol/L) and high (188 mmol/L) for urine.
  • Elecsys TSH: Human serum samples with TSH concentrations ~0.462 uIU/mL, ~3.95 µIU/mL, and ~7.54 µIU/mL.
  • Data Provenance: Human samples. Conducted in-house by Roche Diagnostics.
• Exogenous Interference (Drugs):
  • ISE indirect Na: Two sample pools (low and high concentration ISE indirect Na).
  • Elecsys TSH: Two human serum samples (~0.5 uIU/mL and ~8 uIU/mL TSH).
  • Data Provenance: Human samples. Conducted in-house by Roche Diagnostics.
• Analytical Specificity/Cross-Reactivity (Elecsys TSH):
  • Sample Size: Native human serum sample pool.
  • Data Provenance: Human serum samples. Conducted in-house by Roche Diagnostics.
• Method Comparison to Predicate:
  • Glucose HK Gen.3: 74 native human serum samples, 67 native human urine samples, 75 native CSF samples.
  • ISE indirect Na: 120 human Lithium heparin plasma samples (vs cobas c 501 ISE), 118 human Lithium heparin plasma (vs Flame Photometer), 120 human serum (vs cobas c 501 ISE), 120 human serum (vs Flame Photometer), 120 human urine (vs cobas c 501 ISE/Flame Photometer).
  • Elecsys TSH: 138 samples (129 native human serum, 9 diluted human serum samples; single donors and pools).
  • Data Provenance: Native human samples (serum, plasma, urine, CSF), some diluted. Conducted in-house by Roche Diagnostics.
• Sample Matrix Comparison:
  • Glucose HK Gen.3: At least 39 serum/plasma pairs for each anticoagulant type (K2-EDTA, Li-Heparin, NaF/K-Oxalate, NaF/Na2-EDTA, NaF/Citrate/Na2-EDTA, KF/Na2-EDTA plasma tubes) + serum vs. serum tube with separation gel.
  • ISE indirect Na: 50 serum/Li-Heparin plasma pairs.
  • Elecsys TSH: Minimum of 56 serum/plasma pairs for Li-Heparin, K2-EDTA, K3-EDTA plasma tubes. Serum separation tubes from 3 manufacturers, blood from five donors were used.
  • Data Provenance: Native human samples. Conducted in-house by Roche Diagnostics.

3. Number of Experts and Qualifications for Ground Truth

This submission concerns in vitro diagnostic (IVD) devices for quantitative measurements of analytes. For such devices, "ground truth" is typically established by:

• Reference methods (e.g., flame photometry for Sodium reference),

• Previously cleared and validated predicate devices,

• Known concentrations in control materials or spiked samples, or

• The inherent chemical/physical measurement by the device itself (for analytical performance criteria like precision, linearity).

• No human "experts" (like radiologists interpreting images) were used to establish ground truth in the context of these analytical performance studies. The "ground truth" is analytical, derived from established chemical/instrumental methods and reference standards.

4. Adjudication Method for the Test Set

Since this is an IVD device for quantitative measurements and the studies are analytical performance evaluations based on instrumental precision, accuracy, and comparison to established methods or predicate devices, there is no adjudication method (e.g., 2+1, 3+1) involving human experts as would be seen in diagnostic imaging studies. The data points are quantitative measurements from the instruments themselves or reference methods. Statistical analysis (e.g., regression, CVs, SDs) is used to assess performance against pre-defined criteria.

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

No MRMC comparative effectiveness study was done. This type of study, involving multiple human readers interpreting cases with and without AI assistance, is relevant for diagnostic imaging AI algorithms where human interpretation is part of the clinical pathway. This submission is for an in vitro diagnostic (IVD) measurement system, not an AI-powered diagnostic imaging tool that assists human readers. The comparative studies involved comparing the new system's analytical performance against predicate IVD systems or reference methods, not human readers.

6. Standalone Performance Study (Algorithm Only)

The entire non-clinical performance evaluation could be considered analogous to a "standalone" performance study, as it describes the analytical performance of the device itself (the integrated system with its assays) without human intervention in the measurement process. The device provides quantitative results, and these results are directly evaluated for precision, linearity, sensitivity, interference, and agreement with predicate devices or reference methods. There is no "human-in-the-loop" aspect to the core measurement and output of these IVD assays.

7. Type of Ground Truth Used

The ground truth used for these analytical studies consists of:

• Known concentrations: For studies like linearity, analytical sensitivity (LoB, LoD, LoQ), and interference, samples prepared with known concentrations of analytes or interferents serve as the ground truth.
• Reference methods: For method comparison studies, well-established and often independently validated reference methods (e.g., flame photometry for sodium measurement) serve as the ground truth or gold standard for comparison.
• Predicate device results: For demonstrating substantial equivalence, the results obtained from a legally marketed predicate device (which itself has established ground truth capabilities) serve as the comparative ground truth.
• Internal statistical controls: For precision studies, consistent and stable control materials are used, where the expected range or value is the "ground truth" against which repeatability and intermediate precision are measured.

8. Sample Size for the Training Set

This document describes the non-clinical performance evaluation for a 510(k) submission, primarily for demonstrating analytical performance and substantial equivalence. It does not describe the development or training of an AI algorithm based on machine learning, so there is no specific "training set" in the context of AI/ML models. The data presented here are validation data for the analytical performance of the assay and integrated system.

For a traditional IVD device, method development involves internal studies and optimization, but this is distinct from "training data" for a machine learning model. The various studies (precision, linearity, etc.) use samples/replicates as described in point 2.

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

As noted in point 8, there isn't a "training set" in the machine learning sense described in this document. If this were to refer to the developmental studies for the underlying assays (Glucose HK Gen.3, ISE indirect Na, Elecsys TSH, which are previously cleared), their ground truth would have been established during their initial development and validation process using:

• Reference materials: Certified reference materials (CRMs) with known analyte concentrations.
• Clinical samples: Patients samples characterized by confirmed diagnoses or clinical outcomes for intended use populations.
• Comparison to established methods: Correlation with existing, approved methods, often considered the "gold standard."
• Spiking and dilution experiments: Preparing samples with known added amounts of analyte.

These are standard practices in IVD assay development, ensuring the analytical and clinical performance of the individual assays before they are integrated into a new system like the cobas pro integrated solutions.

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Glucose Meter-Check Solution for TaiDoc is intended for in vitro diagnostic use (i.e., for external use only) to assess the performance of blood glucose meters and test strips manufactured by TaiDoc Technology Corporation by healthcare professionals and in the home by people with diabetes mellitus. For In Vitro Diagnostic Use

The control solutions are comprised of buffered aqueous liquid glucose control solution with viscosity modifiers to simulate certain properties of blood on the test strip and colored red to help users see the solution while dispensing onto a test strip. The control solutions are formulated to have performance comparable to those currently manufactured by TaiDoc Technology Corporation. The product is packaged in plastic bottles with dropper tips for dispensing the control solutions for use with test strips. This is a non-hazardous aqueous glucose control solution containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation.

Here's a breakdown of the acceptance criteria and the study details for the Glucose Meter-Check® Solution for TaiDoc, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Glucose Meter-Check Solution are derived from its intended use as a quality control material to assess the performance of TaiDoc blood glucose meters and test strips. The "performance" in this context refers to its ability to consistently produce glucose measurements within specified target ranges when tested on the intended meters and strips.

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

• Sample Size for Analytical Performance Tests (Traceability, Stability, Value Assignment):
  • Closed Bottle Stability: Three lots of equivalent product were used.
  • Stability After Opening: Vials from a single lot were evaluated.
  • Value Assignment: For each lot and level of control solution, 8 samples were measured on 5 meters using three lots of commercially distributed test strips, totaling 120 measurements (8 samples * 5 meters * 3 test strip lots = 120 measurements).
• Data Provenance: The document does not explicitly state the country of origin for the data or if it was retrospective or prospective. However, given that Bionostics, Inc. is located in Devens, MA, USA, and the submission is to the FDA, it is highly probable that the studies were conducted in the USA. The nature of stability studies and value assignment are typically prospective.

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

• Experts and Qualifications: The document does not describe the use of human "experts" to establish ground truth in the traditional sense (e.g., radiologists interpreting images). Instead, the ground truth for glucose concentrations is established through quantitative laboratory methods and traceable calibrators.
  • Traceability of Glucose Concentration: NIST SRM 917 (National Institute of Standards and Technology Standard Reference Material) is used as the reference standard, indicating a highly certified and recognized ground truth.
  • Measurement Devices: YSI 2300 and YSI-supplied calibrators are used, which are standard laboratory instruments for glucose measurement. The expertise lies in the certified nature of these instruments and calibrators, and the adherence to established protocols.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable in the context of this device. The 'ground truth' for glucose concentration is established through instrumental measurement and traceability to reference standards rather than expert consensus requiring adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging or interpretation tasks where human readers' performance is compared with and without AI assistance to assess improved accuracy or efficiency. The Glucose Meter-Check Solution is a quality control material for in vitro diagnostic devices, not an AI diagnostic tool.

6. Standalone Performance Study

• Standalone Performance: Yes, the described analytical performance studies (traceability, stability, value assignment) represent the standalone performance of the control solution. The control solution itself is tested to ensure its glucose concentrations are accurate, stable, and fall within the specified ranges, independent of a human operator's interpretation.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used is primarily traceable laboratory measurements / reference standards.
  • Specifically, glucose concentration is traceable to NIST SRM 917, a highly regarded primary reference standard.
  • Measurements are performed using a YSI 2300 calibrated with N.I.S.T. traceable materials, which acts as the gold standard for glucose measurement in this context.

8. Sample Size for the Training Set

• Training Set Sample Size: The concept of a distinct "training set" for a machine learning algorithm is not directly applicable here, as this device is a chemical control solution, not an AI or algorithm. The "training" in this context refers to the development and formulation of the control solution to have specific characteristics and target ranges. The document states that the control solutions "are formulated to have performance comparable to those currently manufactured by TaiDoc Technology Corporation," implying an iterative development and testing process. However, specific "training set" sample sizes as defined in AI studies are not provided or relevant.

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

• Training Set Ground Truth Establishment: Similar to point 8, the concept of a "training set" and its ground truth is not directly applicable in the AI sense.
  • The "grounding" for the product's development and expected performance is based on the performance characteristics of predicate devices (FORA, TaiDoc Control Solutions) and the functional requirements of the TaiDoc blood glucose monitoring systems.
  • The control solution is "optimized to simulate the response of whole blood on the relevant blood glucose test systems" and is formulated to contain d-glucose, the same analyte detected by the meters. This implies that the 'ground truth' for its development involved understanding the physiological range of glucose, the performance specifications of the TaiDoc meters, and the established ranges of existing control solutions.
  • The "Target Ranges" for the control solution (e.g., Level 1: 60-80 mg/dL) are themselves a form of ground truth established based on clinical relevance (low, normal, high glucose levels) and the measurement capabilities of the TaiDoc meters. These ranges would have been derived from extensive testing during the development of both the meters and the control solutions.

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Glucose Meter-Check Solution Roche ACCU-CHEK is intended to assess the performance of the following Roche ACCU-CHEK blood glucose monitoring systems:

· Roche ACCU-CHEK Nano SmartView® using SmartView® test strips

• · Roche ACCU-CHEK Aviva® and ACCU-CHEK Aviva Combo® using Aviva Plus® test strips
• · Roche ACCU-CHEK Active® using ACCU-CHEK Active test strips
• Roche ACCU-CHEK Compact® and ACCU-CHEK Compact Plus® using ACCU-CHEK Compact test strips.
• · Roche ACCU-CHEK Advantage using Comfort Curve® test strips

Glucose Meter-Check Solution for Roche ACCU-CHEK is intended for use by healthcare professionals and people with diabetes mellitus at home.

For In Vitro Diagnostic Use

Glucose Meter-Check Solution is a single-level, viscosity-adjusted, aqueous liquid glucose control solution. Glucose Meter-Check Solution is intended for use to verify the performance of the Roche ACCU-CHEK brand BGM Systems listed in the package insert at recover glucose values within the interval recommended in ISO 15197:2003 In vitro diagnostic test systems - Requirements for blood glucose monitoring systems for selftesting in managing diabetes mellitus for most meter types (Aviva, SmartView, Advantage), and comparable to solutions currently marketed by Roche for others (Active, Compact). This mid-level glucose concentration will complement the current, low and high glucose concentrations available in quality control products distributed by Roche Diagnostics for these same BGM systems. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a red color to help users see the solution while dispensing onto a test strip.

Glucose Meter-Check Solution is a non-hazardous aqueous solution glucose control solution containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation.

This material consists of viscosity-adjusted, aqueous glucose control solution prepared with a single concentration of D-glucose and has been optimized to simulate the response of whole blood on the Roche ACCU-CHEK blood glucose monitoring systems. The solution contains no hazardous, human or animal derived components. The solution is recognized as a control automatically by the ACCU-CHEK Aviva and Nano SmartView meters to perform consistently as the Roche branded products.

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

Device: Glucose Meter-Check® Solution for Roche ACCU-CHEK

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Value Assignment: For each meter type and for 3 lots of test strips, 8 measurements of the Glucose Meter-Check Solution were taken on each of 5 meters. This results in 120 measurements per meter type (3 lots x 8 measurements/lot x 5 meters/lot).
• Sample Size for Method Comparison/Equivalence: For each meter brand, 2 meters were used. For each meter, 1 measurement of Glucose Meter Check Solution was followed by 1 measurement of the Roche ACCU-CHEK branded control solution. This sequence was repeated until 25 sets of pairs were recorded per meter (25 measurements for the candidate device and 25 for the predicate device, per meter).
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing described appears to be retrospective laboratory testing performed by Bionostics, Inc. to characterize the new control solution and compare it to existing solutions. It is not patient-derived data.

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

N/A. This device is a quality control solution for glucose meters, not a diagnostic algorithm that interprets medical images or patient data. The "ground truth" here refers to the known glucose concentration of the control solution itself and the expected performance ranges of the glucose meters. The "ground truth" for the control solution's glucose level is established through analytical methods (YSI 2300 calibrated with N.I.S.T. 917 traceable materials), not expert interpretation.

4. Adjudication Method for the Test Set

N/A. No human interpretation (such as radiological reads) is involved, so no adjudication method is applicable. The evaluation criteria are quantitative and based on instrument readings.

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

No, an MRMC study was not done. This study pertains to the performance of a quality control solution with blood glucose meters, not an AI-assisted diagnostic tool that involves human readers.

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

Yes, in a sense. The core "performance" of the Glucose Meter-Check Solution is its ability to produce expected glucose values when tested on various blood glucose monitoring systems. The studies evaluated the control solution itself and its interaction with the meters, which are standalone devices. There is no human-in-the-loop aspect for the control solution's function or the meter's measurement.

7. The Type of Ground Truth Used

The ground truth used is analytical measurement of glucose concentration traceable to a recognized standard:

• N.I.S.T. SRM 917 (National Institute of Standards and Technology Standard Reference Material 917)
• Measurements were performed using a YSI 2300 (a glucose analyzer).
• For the meter performance, the "ground truth" is defined by the expected assay ranges provided by Roche for their test strips and the assigned range for the Glucose Meter-Check solution (±15% of the grand mean).

8. The Sample Size for the Training Set

N/A. This is a quality control solution, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML. The device's formulation and performance specifications are developed through R&D and analytical testing, not supervised learning.

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

N/A. As there is no training set for a machine learning model, this question is not applicable.

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Glucose Meter-Check Solution for Bayer is intended to assess the performance of the following Bayer blood glucose test systems:

• Bayer Contour Next blood glucose monitoring systems
• Bayer Breeze 2 blood glucose monitoring systems
• Bayer Contour and Contour TS blood glucose monitoring systems
  Glucose Meter-Check Solution for Bayer is intended for use by healthcare professionals and people with diabetes mellitus at home.
  For In Vitro Diagnostic Use

Glucose Meter-Check Control Solution is a viscosity-adjusted, aqueous liquid glucose control solution containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. Glucose Meter-Check Control Solution is intended for use to verify the performance of the Bayer BGM systems listed in the package insert and is intended for use by healthcare professionals and people with diabetes mellitus at home. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a red color to help users see the solution while dispensing onto a test strip. Glucose Meter-Check Solution is a non-hazardous aqueous solution glucose control solution containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: Glucose Meter-Check® Solution for Bayer

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific numerical sample size for the test set. However, it mentions:

• "a series of measurements" were performed.
• Glucose Meter-Check Solution and mid-level Bayer quality control solution were tested "for each strip/meter type."
• The table "Evaluation of Equivalence of Control Solutions" presents data for various test strip and meter brands (Breeze 2, Contour, Contour TS, Contour Next EZ). Each row represents a "Control Brand" (Bayer's own control, Current Meter-Check, New Meter-Check) with "Pooled Mean," "Pooled SD," "Pooled CV%" implying multiple measurements were pooled for each combination.

Data Provenance:

• The document states: "Current version blood glucose meters, test strips and quality control solutions were purchased through retail outlets for Bayer blood glucose monitoring systems." This suggests the data was collected from commercially available products, likely in the country where the testing was conducted (not specified, but presumably the US where the submission was made).
• The study appears to be prospective as it involved testing the performance of the new device against existing ones.

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

This type of study does not typically involve human experts establishing a "ground truth" in the diagnostic sense (e.g., radiologists interpreting images).

For this device (a quality control solution for blood glucose meters), the ground truth is based on:

• Value assignment ranges: These ranges are established by the test strip manufacturers (Bayer in this case) and Bionostics for their Meter-Check solutions.
• Measurement against reference methods: The document mentions "determined by analysis of glucose on commercial lots of glucose test strips qualified for proper measurement using manufacturer recommended control solution" and "Traceability: N.I.S.T. SRM 917." This indicates a reliance on standardized laboratory methods and reference materials, rather than expert interpretation.

4. Adjudication Method for the Test Set

No explicit adjudication method (like 2+1 or 3+1) is mentioned, as this is not a study relying on human interpretation of subjective data. The assessment is objective, based on whether numerical results fall within predefined ranges.

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

No. An MRMC comparative effectiveness study is designed to evaluate the performance of human readers (e.g., radiologists, pathologists) with and without AI assistance on a set of cases. This study is for a quality control solution used to verify the performance of blood glucose meters, not for an AI algorithm assisting human interpretation. Therefore, it does not involve human readers or assess an effect size of AI assistance.

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

While the device (quality control solution) doesn't have an "algorithm" in the typical AI sense, the performance testing described is analogous to a standalone performance evaluation. The device (control solution) is used directly with blood glucose meters, and its functionality is assessed based on whether the meter/strip system produces results within established ranges when the control solution is used. There is no human intervention required to interpret the control solution's performance; the meter provides a reading, and that reading is objectively compared to the expected range.

7. The Type of Ground Truth Used

The ground truth used is based on:

• Manufacturer-recommended value assignment ranges: These are the expected glucose values for a given meter/test strip/control solution combination.
• Traceability to N.I.S.T. SRM 917: This refers to the National Institute of Standards and Technology Standard Reference Material 917, which is a certified glucose standard, ensuring the accuracy of the glucose concentration.
• YSI analysis: The stability section mentions "percent glucose recovery on YSI," indicating that a YSI (Yellow Springs Instruments) analyzer, a highly accurate laboratory instrument, was used for reference measurements.

This type of ground truth is analogous to analytical reference methods or certified reference materials.

8. The Sample Size for the Training Set

Not applicable. This device is a quality control solution, not an AI algorithm that requires a "training set." The product's performance is driven by its chemical formulation and manufacturing processes, not by machine learning from a dataset.

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

Not applicable, as there is no training set for this type of device.

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Glucose Meter-Check Solution for Infopia is intended for use to verify the performance and correct operation of Infopia blood glucose monitoring test systems utilizing Infopia glucose test strips. Glucose Meter-Check Solution for Infopia is intended for use by healthcare professionals and people with diabetes mellitus at home.

For In Vitro Diagnostic Use

Glucose Meter-Check Solution for Infopia is a buffered aqueous solution with glucose containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. The Glucose Meter-Check Solution is formulated for optimal performance on Infopia glucose meters using Infopia test strips.

This material consists of viscosity-adjusted, aqueous glucose control solution prepared with a single concentration of D-glucose with recovery on the test systems in the range corresponding to Interval 2 of the glucose contration intervals for evalution of intermediate precision in ISO 151972 (96 to 144 mg/dL). This solution has been optimized to simulate the response of whole blood on the blood glucose test systems manufactured by Infopia using Infopia blood glucose test strips. The solution contains no hazardous, human or animal derived components.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Glucose Meter-Check Solution for Infopia:

The submission K113764 is for a control solution, not an AI device, and therefore the majority of the requested information regarding AI device evaluation (such as sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document. This document describes the equivalence of a new control solution to an existing one.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a control solution are typically defined as its ability to produce glucose readings within a specified target range when tested with the intended blood glucose monitoring system. The predicate device's established target range serves as the basis for substantial equivalence.

Note: The new device's target range (88 – 132 mg/dL) falls within the established performance window for glucose concentration intervals for evaluation of intermediate precision in ISO 15197 (96 to 144 mg/dL), and is deemed substantially equivalent to the predicate.

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

This information is not applicable as this is a medical device submission for a control solution, and not an AI device undergoing a performance study with a test set of data. The "tests conducted" section lists stability and response tests, but does not detail sample sizes as would be relevant for an AI model's test set.

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

This information is not applicable. Ground truth, in the context of an AI device, refers to expertly curated data for model comparison. For a control solution, the "truth" is its certified glucose concentration, which is established through analytical chemistry, not expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations, which is not pertinent to the evaluation of a glucose control solution.

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

This information is not applicable. MRMC studies are used to evaluate the impact of AI on human reader performance, which doesn't apply to a control solution.

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

This information is not applicable. There is no algorithm or AI component in this control solution.

7. The Type of Ground Truth Used

For the Glucose Meter-Check Solution, the "ground truth" implicitly refers to the analytical concentration of D-glucose in the buffered aqueous solution, established through chemical manufacturing and quality control processes. This is confirmed by the statement: "Glucose Meter-Check Solution for Infopia is a buffered aqueous solution with glucose..." and its formulation "with a single concentration of D-glucose".

8. The Sample Size for the Training Set

This information is not applicable, as there is no AI model or training set associated with this control solution.

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

This information is not applicable, as there is no AI model or training set associated with this control solution.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria for this control solution primarily focuses on non-clinical tests comparing its characteristics and performance to a legally marketed predicate device (Infopia Control Solution K0572369).

The key aspects of the study demonstrating substantial equivalence include:

• Comparison of Technological Characteristics: A direct comparison table is provided, showing the new device shares fundamental characteristics with the predicate, such as:
  • Name (Infopia Control Solution vs. Glucose Meter-Check Control Solution for Infopia)
  • Number of levels (1, typical fasting glucose)
  • Analytes (glucose)
  • Container (6 mL LDPE vial with dispensing tip and cap)
  • Fill volume (4 mL)
  • Color (red)
  • Matrix (Buffered, aqueous solution of D-Glucose, viscosity modifier, preservatives and other, non-reactive ingredients)
• Target Ranges: The new device's target range (88 – 132 mg/dL) was established and deemed acceptable when compared to the predicate's range (94 – 140 mg/dL). This range is also stated to correspond to Interval 2 of the glucose concentration intervals for the evaluation of intermediate precision in ISO 15197 (96 to 144 mg/dL), implying it meets recognized standards for control solution performance.
• Non-Clinical Performance Tests: The submission states that tests were conducted to verify specific performance requirements:
  • Closed bottle stability (Shelf-life)
  • Stability after opening (Use-life)
  • Transport Stability
  • Test response (This implicitly confirms that the solution provides readings within its specified range on the target glucose meters).

Conclusion drawn from these tests: "Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence." This means the new Glucose Meter-Check Solution for Infopia performs comparably to the predicate control solution, within acceptable parameters, ensuring it can effectively verify the performance of Infopia blood glucose monitoring test systems as intended.

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The ACCU-CHEK Nano SmartView 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 palm. The ACCU-CHEK Nano SmartView Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The ACCU-CHEK Nano SmartView Blood Glucose Monitoring System 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 ACCU-CHEK Nano Smartview Blood Glucose Monitoring System 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 ACCU-CHEK* SmartView Test Strips are for use with the ACCU-CHEK Nano Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.

The ACCU-CHEK® Nano meter was developed to utilize the ACCU-CHEK® Aviva Plus test system's technology and performance characteristics. The ACCU-CHEK® Nano meter designers took the measurement components of the ACCU-CHEK® Aviva Plus system, slightly changed the firmware and hardware supporting the new user interface and housing and embedded/programmed the strip lot code information within the meter so a physical code key or code key port are no longer used.

The ACCU-CHEK ® SmartView test strip is a No Code Freedom 2 Chemistry test strip which shares the same scientific technology as the predicate device, the ACCU-CHEK® Aviva Plus test strips. The instrument's measurement method is not modified as a part of this test strip modification project.

When an ACCU-CHEK® SmartView test strip is inserted into the ACCU-CHEK® Nano meter, a small alternating current (AC) is applied until the application of blood causes a spike in the conductivity to be observed at the measurement and sample-sufficiency electrodes – both are used to assure an adequate sample has been applied.

The instrument then applies a series of AC voltages at four frequencies and reads the AC responses. These carry information about the sample type and environmental temperature; they also allow the system to perform various internal quality checks.

After the AC measures are completed, a small (DC) voltage is applied and current is observed which is proportionate to the glucose. The AC and DC information are then combined to provide a hematocrit and temperature compensated glucose result.

The single-patient use ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System will consist of:

Meter: ACCU-CHEK® Nano Meter Test Strip: ACCU-CHEK® SmartView Test Strip Controls: ACCU-CHEK® SmartView Control Solutions

The provided text describes the ACCU-CHEK Nano SmartView Blood Glucose Monitoring System and its substantial equivalence to a predicate device. However, it does not explicitly detail the acceptance criteria for performance, nor does it present the results of a specific study in the format requested. The document primarily focuses on the device's description, intended use, and a statement of substantial equivalence based on "performance testing."

Therefore, I cannot provide a table of acceptance criteria and reported device performance, information on sample sizes for a test set, ground truth establishment methods, expert qualifications, adjudication methods, or details about MRMC or standalone studies with specific effect sizes from the provided text.

The text does state: "Performance testing on the ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System demonstrated that the device meets the performance requirements for its intended use. The data demonstrates that the test strip is substantially equivalent to the predicate device." This indicates that such testing was conducted and met predefined criteria, but the specific details are not included in this summary.

Based on the provided input, the following information can be extracted:

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

   • Not explicitly provided in the text. The document states that performance testing demonstrated that the device meets the performance requirements for its intended use and that the test strip is substantially equivalent to the predicate device. Specific numerical acceptance criteria and reported performance values are not given.

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

   • Not explicitly provided in the text. The document mentions "Performance testing," but does not specify the sample size or data provenance (e.g., country of origin, retrospective/prospective nature).

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/provided in the text. For a blood glucose monitoring system, the "ground truth" is typically established by comparative measurements against a well-established laboratory reference method, not through expert consensus in the way it would be for image interpretation by clinicians. The text does not detail the specific ground truth method used for performance testing or the involvement of human "experts" in establishing it beyond the use of a reference method.

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

   • Not applicable/provided in the text. Adjudication methods are typically used when multiple human readers interpret data, and their findings need to be reconciled to establish a ground truth or resolve discrepancies. This is not directly relevant to the performance testing of a blood glucose monitoring system, which typically involves comparison to a reference method.

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, an MRMC study was not done (and is not applicable). This device is a blood glucose monitoring system, not an AI-assisted diagnostic tool for human readers. Its purpose is direct measurement.

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

   • Yes, effectively. The performance testing described (though details are absent) would inherently be a standalone evaluation of the device's accuracy in measuring glucose levels against a reference. The device itself is an "algorithm only" type of system in that it measures and reports a value without human interpretation in the loop of the measurement process.

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

   • Implied to be a laboratory reference method. For blood glucose monitoring systems, ground truth is typically established by comparing the device's readings against results from a highly accurate laboratory analyzer (e.g., YSI analyzer) measuring the same blood samples. This is not explicitly stated but is the standard practice for such devices.

8. The sample size for the training set:

   • Not explicitly provided in the text. This document describes a 510(k) submission, which focuses on performance data for substantial equivalence, not the development or training of an algorithm in the machine learning sense. While the device utilizes embedded firmware and hardware, the concept of a "training set" in the context of AI or machine learning is not discussed for this type of device.

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

   • Not applicable/provided in the text. As mentioned above, a "training set" in the context of algorithm development for machine learning is not discussed for this device.

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Glucose Meter-Check Control Solution for NIPRO TRUEresult is intended for use to verify the performance and correct operation of the NIPRO TRUEresult Glucose Test Systems. Glucose Meter-Check Control Solution for NIPRO TRUEresult is intended for use by healthcare professionals and people with diabetes mellitus at home.

Glucose Meter-Check Control Solution for NIPRO TRUEresult is a buffered aqueous solution with glucose containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. The Glucose Meter-Check Control Solution is formulated for optimal performance on NIPRO TRUEresult glucose meters. The product is provided in 2 levels, 1 representing hypoglycemia (low blood glucose) and 2, representing typical fasting blood glucose levels in non-diabetic persons.

The provided text is a 510(k) summary for a medical device called "Glucose Meter-Check Control Solution for NIPRO TRUEresult." This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed acceptance criteria, specific study designs, or performance results in the format requested.

Therefore, I cannot populate the requested tables and sections regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. These details are typically found in more comprehensive study reports or clinical trial data, which are not present in this 510(k) summary.

The document does include the following limited information relevant to non-clinical tests:

Summary of Non-Clinical Tests (b) (1):

• Tests Conducted to Verify Specific Performance Requirements:
  • Closed bottle stability (Shelf-life)
  • Stability after opening (Use-life)
  • Transport Stability
  • Test response

Summary of Clinical Tests (b) (2):

• N/A (No clinical tests submitted with the premarket notification)

Conclusions (b) (3):

• "Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence."

In conclusion, the document's purpose is to demonstrate substantial equivalence, and it does not provide the specific data points needed to fill out the detailed tables and sections you've requested regarding acceptance criteria and performance evaluation studies.

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A.) Glucose Shepherd Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper arm, the calf and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The Glucose Shepherd Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates.

The Glucose Shepherd Blood Glucose Monitoring System consists of the Glucose Shepherd Blood Glucose meter and the Glucose Shepherd Blood Glucose test strips. The Glucose Shepherd Blood Glucose meter is used only with Glucose Shepherd Blood Glucose test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf and the thigh.

The Glucose Shepherd Control Solutions are for use with the Glucose Shepherd Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

B.) Glucose Shepherd Pro Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use). It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper arm, the calf and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The Glucose Shepherd Pro Blood Glucose Monitoring System may be used for multiple patients in a professional healthcare setting. I is intended for use as an aid in monitoring the effectiveness of diabetes control program. This system is only used with single-use, auto-disabling lancing devices. It should not be used for the diagnosis or screening of diabetes, for the testing of neonates, or for testing of arterial blood.

The Glucose Shepherd Pro Blood Glucose Monitoring System consists of the Glucose Shepherd Pro Blood Glucose meter and the Glucose Shepherd Pro Blood Glucose test strips. The Glucose Shepherd Pro Blood Glucose meter is used only with Glucose Shepherd Pro Blood Glucose test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf and the thigh.

The Glucose Shepherd Pro control solutions are for use with the Glucose Shepherd Pro Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

A.) Glucose Shepherd Blood Glucose Monitoring System consists of a blood glucose meter, test strips, control solutions(Level 1, 2 and 3), lancing device, and commercially available sterilized lancets. This system utilizes amperometric method to generate a current. The size of the current is proportional to the amount of glucose presented in the sample, providing a quantitative measure of glucose level in whole blood.

B.) Glucose Shepherd Pro Blood Glucose Monitoring System consists of a blood glucose meter, test strips, control solutions(Level 1, 2 and 3) and single-use lancing devices. This system utilizes amperometric method to generate a current. The size of the current is proportional to the amount of glucose level presented in the sample, providing a quantitative measure of glucose level in whole blood.

This 510(k) summary provides limited information regarding the performance studies. Therefore, a comprehensive description of acceptance criteria and the entire study that proves the device meets those criteria cannot be fully extracted.

However, based on the provided text, here's what can be gathered and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that both the Glucose Shepherd Blood Glucose Monitoring System and the Glucose Shepherd Pro Blood Glucose Monitoring System were studied in laboratory and clinical settings, and these studies "have demonstrated that this system meets the performance requirements of its intended use."

While explicit numerical acceptance criteria are not detailed in this summary, in the context of blood glucose monitoring systems, "performance requirements" typically refer to accuracy standards. For example, ISO 15197 (In vitro diagnostic test systems - Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus) is a commonly referenced standard. A key part of this standard's accuracy requirement is that a certain percentage of results (e.g., 95%) must fall within a defined range of a reference method (e.g., within ±15 mg/dL for glucose concentrations <100 mg/dL and within ±15% for glucose concentrations ≥100 mg/dL).

Given the submission is for a 510(k), the device must demonstrate substantial equivalence to a predicate device. This implies that its performance (including accuracy) is at least as good as, if not better than, the predicate. Therefore, the "reported device performance" is essentially that the device meets relevant accuracy standards and is substantially equivalent to the predicate device.

Since no specific numerical acceptance criteria or detailed performance data are provided in the summary, we can only state the general claim.

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

The document mentions "clinical settings" and "clinical testing results" but does not specify:

• The exact sample size for the test set.
• The country of origin of the data.
• Whether the data was retrospective or prospective.

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

This information is not provided in the 510(k) summary. For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods (e.g., using a YSI glucose analyzer) rather than reliance on human expert consensus, so the concept of "experts establishing ground truth" as it applies to image-based diagnostic systems might not be directly applicable here.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Adjudication methods (like 2+1, 3+1) are typically relevant for studies where human interpretation of data is being assessed, often in imaging or subjective diagnostic tasks. For objective measurements like blood glucose, adjudication would refer to how discrepancies between the device and the reference method or across multiple device measurements were handled, which is not detailed here.

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, an MRMC comparative effectiveness study was not done.
• This type of study is not relevant for a blood glucose monitoring system, which is a quantitative measurement device rather than an AI-driven image interpretation or diagnostic system that assists human readers.

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

• A standalone performance study was done.
• The entire premise of a blood glucose monitoring system is its standalone performance (the meter and test strip system providing a direct quantitative measurement). The document states, "The performance... was studied in the laboratory and in clinical settings. The studies have demonstrated that this system meets the performance requirements of its intended use." This confirms a standalone performance evaluation.

7. The Type of Ground Truth Used

• The ground truth for blood glucose monitoring systems is typically established by a highly accurate laboratory reference method, such as a YSI glucose analyzer. While not explicitly stated in the summary, this is the standard practice for evaluating such devices. The document refers to "laboratory testing results" which would involve comparison against such a reference.

8. The Sample Size for the Training Set

• This information is not provided in the 510(k) summary. For a blood glucose monitoring system based on an amperometric method, the "training set" concept (as used in machine learning) is generally not directly applicable. The device's calibration and algorithm are developed through engineering and chemical principles, then validated through testing. If the question refers to the samples used to establish the initial calibration curve or internal algorithms, that detail is not disclosed.

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

• As mentioned in point 8, the concept of a "training set" for ground truth (in the machine learning sense) is not directly applicable to this type of device. The accuracy of the device's measurement is established through rigorous internal development and external validation against highly precise laboratory reference instruments, which would serve as the "ground truth" for evaluating the system's accuracy. These reference instruments are themselves calibrated and maintained according to strict laboratory standards.

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The Glucose Meter-Check Control Solution for AgaMatrix is intended for use to verify the performance and correct operation of the AgaMatrix blood glucose monitoring test systems utilizing the WaveSense family of blood glucose test strips. Glucose Meter-Check Control Solution for AgaMatrix is intended for use by healthcare professionals and people with diabetes mellitus at home.

Glucose Meter-Check Control Solution for AgaMatrix is a buffered aqueous solution with glucose containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. The Glucose Meter-Check Control Solution is formulated for optimal performance on AgaMatrix glucose meters utilizing the WaveSense family of test strips.

The provided text describes a 510(k) summary for the Glucose Meter-Check Control Solution for AgaMatrix. It details the device's characteristics, intended use, and comparison to a predicate device for substantial equivalence. However, it does not contain detailed information about specific acceptance criteria or the results of a study designed to prove the device meets these criteria.

The document mentions "Tests were conducted to verify specific performance requirements" in section (b)(1) within part {1}, listing categories like "Closed bottle stability (Shelf-life)," "Stability after opening (Use-life)," "Transport Stability," and "Test response." However, it does not provide the actual acceptance criteria for these tests or the reported performance data from these tests.

Therefore, I cannot populate the table or answer most of the specific questions as the required information is not present in the provided text.

Here is a summary of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states that tests were conducted for stability and test response, but it does not specify the acceptance criteria (e.g., "glucose concentration should be within X% of target") or the actual results obtained from these tests.

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

Not available in the provided text. There is no mention of sample sizes or data provenance (country of origin, retrospective/prospective) for any testing.

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

Not applicable/available. This device is a control solution for glucose meters, not an AI/diagnostic imaging device requiring expert ground truth for interpretation of complex data. The "ground truth" for a control solution would typically be its known glucose concentration, established through a traceable analytical method rather than expert consensus on images or clinical cases.

4. Adjudication method for the test set

Not applicable/available. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in diagnostic imaging studies. This is not relevant for a glucose control solution.

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 control solution for glucose meters, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI effect sizes are not relevant.

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

Not applicable. This device is a control solution, not an algorithm.

7. The type of ground truth used

For a control solution, the ground truth would be the known, analytically determined concentration of glucose within the solution. While the document doesn't explicitly state "analytically determined glucose concentration was used as ground truth," this is the standard for such products.

8. The sample size for the training set

Not applicable. This is a control solution, not a machine learning model, so there is no "training set."

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

Not applicable. As there is no training set.

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