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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 GlutenID Celiac Genetic Health Risk Test uses qualitative genotyping to detect clinically relevant variants in genomic DNA isolated from salva collected from individuals 18 years of age or older with ORAcollect Dx OCD-100 for the purpose of reporting and interpreting Genetic Health Risks (GHR).

The GlutenID Celiac GHR Test is indicated for reporting of one variant associated with the HLA-DQ2.5 haplotype, one variant associated with the HLA-DQ8 haplotype, one variant associated with the HLA-DQ7 haplotype, and three variants associated with the HLA-DQ2.2 haplotype. The report describes if a person has variants linked to haplotypes associated with an increased risk for developing celiac disease, but it does not describe a person's overall risk of developing celiac disease. This report is most relevant for people of European descent.

Not Found

I apologize, but the provided text from the FDA 510(k) clearance letter for the "GlutenID Celiac Genetic Health Risk Test" does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them.

The letter is a formal notification of clearance, confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as:

• The trade name and regulation details.
• General controls provisions and additional controls for Class II/III devices.
• Applicable regulations like Quality System (QS), Medical Device Reporting (MDR), and Unique Device Identification (UDI).
• Contact information for the FDA.
• The Indications for Use statement.

The document does NOT include information on:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, their provenance, or whether they were retrospective/prospective.
• Number of experts, their qualifications, or adjudication methods for ground truth.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was performed or its effect size.
• Whether standalone (algorithm-only) performance was assessed.
• The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for the training set or how its ground truth was established.

This kind of detailed study information is typically found in the 510(k) submission itself, often in a more extensive "Summary of Safety and Effectiveness" or a dedicated study report, which is not part of this specific FDA clearance letter.

Therefore, I cannot fulfill your request based solely on the provided text.

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The GlucoSure ADVANCE Link Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.

The GlucoSure ADVANCE Link Blood Glucose Monitoring System consists of the GlucoSure ADVANCE Link Blood Glucose Meter, GlucoSure ADVANCE Link Blood Glucose Test Strips and Contrex Plus 5 glucose control solution. It is used for testing of blood glucose by self-testers at home. The GlucoSure ADVANCE Link Blood Glucose Test Strips and Contrex Plus 5 glucose control solution are purchased separately. The modified device of GlucoSure ADVANCE Link Blood Glucose Meter is derived from the existing device of BGM014 Blood Glucose Meter and the modified device contain the Bluetooth function to transfer glucose results to the mobile device. The blood glucose test strips and glucose control solution utilized in the GlucoSure ADVANCE Link Blood Glucose Monitoring System are the same as the BGM014 Blood Glucose Test Strips and Contrex Plus 5 Glucose Control Solution, previously cleared in K161299. The meter materials of GlucoSure ADVANCE Link Blood Glucose Meter are the same as the BGM014 Blood Glucose Meter. Therefore, the disinfection performance (robustness of meter to multiple cleanings and disinfections) was previously cleared in K161299.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

Acceptance Criteria and Device Performance

The provided 510(k) summary does not explicitly list a table of quantifiable acceptance criteria with corresponding reported device performance, which is typical for performance claims related to new algorithms or AI-driven devices. Instead, it describes various tests performed to demonstrate substantial equivalence to a predicate device.

However, based on the nature of a Blood Glucose Monitoring System, the primary performance characteristic is system accuracy. While not explicitly a table, the document mentions that a "Usability study confirmed the system accuracy." The common standards for blood glucose meter accuracy are from ISO 15197. Without the full test reports, the specific numerical acceptance criteria and reported performance values related to accuracy are not present in this document.

The document also implies acceptance criteria for:

• Battery Life: The new device must meet an acceptable battery life, which is noted to be decreased from 1000 tests to 750 tests compared to the predicate. The implicit acceptance criterion here would be that 750 tests is still considered acceptable for the intended use.
• Memory Capacity: The new device's memory capacity of 700 test results is a decrease from 1000. Similar to battery life, the implicit acceptance criterion is that 700 results are sufficient.
• EMC and Electrical Safety: The device must comply with relevant Electromagnetic Compatibility and Electrical Safety standards.
• Software Verification and Validation (including cybersecurity): The software must be verified and validated to ensure proper function and data security, especially with the added Bluetooth functionality.
• Disinfection Performance: The meter materials are the same as the predicate, so the disinfection performance must remain acceptable, as it was previously cleared.

Table of Implicit Acceptance Criteria and Reported Performance (based on available information):

Study Details from the Provided Text:

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

   • The document mentions "A Usability study" and "Testing," but does not provide specific sample sizes (e.g., number of patients, number of blood samples) for any test set.
   • The provenance of the data (e.g., country of origin, retrospective or prospective) is not explicitly stated. It's likely prospective for a usability/clinical accuracy study, but this is an inference.

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

   • The document states "A Usability study confirmed the system accuracy." For blood glucose monitoring systems, ground truth is typically established by comparing capillary whole blood glucose readings to laboratory reference methods (e.g., YSI blood glucose analyzer) using venous plasma or serum.
   • The number of experts and their qualifications used to establish ground truth are not specified in this summary.

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

   • No adjudication method is mentioned in the provided text. For blood glucose accuracy studies, adjudication methods (like expert consensus) are typically not directly applicable as the ground truth is established by a quantitative laboratory reference method.

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 MRMC study was mentioned or performed. This device is a Blood Glucose Monitoring System, which does not involve "human readers" or "AI assistance" in the typical diagnostic imaging sense. It's a direct measurement device.

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

   • Yes, implicitly. The "system accuracy" would be a standalone performance measure of the device itself (meter + test strips + algorithm) without requiring a human interpretation component, beyond the user following instructions. The device provides a quantitative number.

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

   • The specific type of ground truth is not explicitly stated in this summary but, in the context of blood glucose monitoring systems, ground truth for accuracy studies is typically established using a laboratory reference method (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer measuring plasma glucose).

7. The sample size for the training set:

   • This device is a measurement system, not a machine learning/AI diagnostic system in the sense that would require a distinct "training set" for an algorithm to learn from data in a traditional ML paradigm. The "algorithm" here refers to the embedded logic for glucose measurement. Therefore, no training set in the typical AI sense is mentioned or implied.

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

   • As there's no mention of a traditional "training set" for an AI algorithm, this point is not applicable based on the provided text. The device's measurement algorithm is likely developed through engineering principles and calibration rather than data-driven machine learning training.

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The GlucoLeader Enhance 2 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 fingertip. The GlucoLeader Enhance 2 Blood Glucose Monitoring System is comprised of the GlucoLeader Enhance 2 Blood Glucose Meter and the GlucoLeader Enhance 2 Blood Glucose Test Strips. The GlucoLeader Enhance 2 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home (over the counter [OTC]) as an aid to monitor the effectiveness of diabetes control. The GlucoLeader Enhance 2 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoLeader Enhance 2 Blood Glucose Monitoring System is not for use in neonates.

The GlucoLeader Enhance 2 Blood Glucose Monitoring System is designed to pursuit the accuracy in blood glucose monitoring to provide with testing. The GlucoLeader Enhance 2 Blood Glucose Monitoring System mainly consists of four parts as below,

• (1) GlucoLeader Enhance 2 Blood Glucose Meter
• GlucoLeader Enhance 2 Blood Glucose Test Strips* (2)
• Glucose Control Solutions (L1, L2)* (3)
• (4) Check Strip*.
• • These products are intended to be used together to get accurate blood glucose test results. They are not included in the kit package, and should be purchased separately.

Display screen size of the meter is 1.73" x 1.7", and weight of the meter is 0.122 lbs (55.2 grams). The GlucoLeader Enhance 2 Blood Glucose Monitoring System is traceable to the NIST (SRM) 917A. The GlucoLeader Enhance Glucose Control Solutions have L1 and L2 levels for optional purchasing.

The GlucoLeader Enhance 2 Blood Glucose Test Strips have been updated with Glucose dehydrogenase-FAD Enzyme, which not only improves the accuracy of measurements, but also increases the HCT interference range up to 10-70%. Also, the required test blood sample volume is reduced to 0.8 µL, and the test reaction time is only 5 seconds.

If the GlucoLeader Enhance 2 Blood Glucose Meter is being operated by a second person who is providing testing assistance to the user, the meter and lancing device should be disinfected prior to use by the second person. Consult your healthcare professional if unusual readings occur.

The provided document is a 510(k) summary for the "GlucoLeader Enhance 2 Blood Glucose Monitoring System". It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and study results for the device's performance.

Specifically, it states: "No new clinical test data was used to support the decision of substantial equivalence." This means that the document does not contain the information requested regarding acceptance criteria and performance studies for the GlucoLeader Enhance 2 Blood Glucose Monitoring System itself. The changes in this new model (color, BLE module) were deemed not to affect the accuracy and effectiveness, thus relying on the predicate device's established performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer questions about sample sizes, data provenance, expert involvement, ground truth establishment, or MRMC studies for this specific device.

If the information about acceptance criteria and performance studies for the predicate device (GlucoLeader Enhance Blood Glucose Monitoring System, K182448) were available, I would be able to answer some of these questions.

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The GlucoSure Link Blood Glucose Monitoring System is comprised of GlucoSure Link Blood Glucose Meter and GlucoSure Link Blood Glucose Test Strips.

The GlucoSure Link Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). This system is intended for self-testing (outside the body, or In Vitro Diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of your diabetes control and should only be used by a single patient and not be shared. It is not intended to be used for the diagnosis or screening of diabetes or for use on neonates.

The GlucoSure Link blood glucose monitoring system consists of the GlucoSure Link meter, GlucoSure Link Blood Glucose Test Strips and Contrex Plus glucose control solution. It is used for testing of blood glucose by self-testers at home. The GlucoSure Link Blood Glucose Test Strips and Contrex Plus glucose control solution are purchased separately.

The modified device of GlucoSure Link glucose meter is derived from the existing device of AutoSure Voice II meter and the modified device contain the Bluetooth function to transfer glucose results to the mobile device and removed the voice Feature.

The glucose test strips and glucose control solution utilized in the GlucoSure Link Blood Glucose Monitoring System are the same as the AutoSure glucose test strips and Contrex Plus Glucose Control Solution, previously cleared in K102037.

The meter materials of GlucoSure Link glucose meter are the same as the AutoSure Voice II meter. Therefore, the disinfection performance (robustness of meter to multiple cleanings and disinfections) was previously cleared in K150396.

The provided text does not contain detailed information about acceptance criteria and the study proving the device meets these criteria in the context of advanced AI-driven medical devices. Instead, it is an FDA 510(k) summary for a blood glucose monitoring system, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel AI algorithm's performance against specific acceptance criteria.

Therefore, I cannot extract the information required by your prompts regarding AI performance metrics, expert consensus, MRMC studies, or training/test set details for an AI model.

However, I can extract information related to the device described in the document, which is a Blood Glucose Monitoring System. Here's what I can provide based on the given text:

Device: GlucoSure Link Blood Glucose Monitoring System

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

The document mentions "linearity, precision, short sample detection, intermittent sampling, sample perturbation, temperature and humidity testing" as non-clinical testing conducted, and "method comparison and user studies for glucose" as clinical testing. It states that "results demonstrate substantial equivalence to the predicate system," but does not provide specific numerical acceptance criteria or performance metrics in a defined table format. For blood glucose monitoring systems, performance is typically evaluated against standards like ISO 15197, which define accuracy criteria (e.g., percentage of results within a certain deviation from a reference method). These specific numerical criteria and the device's performance against them are not detailed in this summary.

The document only broadly states:

• "Method comparison and user studies for glucose were conducted with home users, including evaluation of ease of use and ease of understanding of the user manual. Results demonstrate substantial equivalence to the predicate system."
• "Accuracy at extreme glucose values were also evaluated." (No specific results provided)
• "Clinical and analytical testing demonstrated that the GlucoSure Link Blood Glucose Monitoring System perform in a substantially equivalent manner to that of the predicate."

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

• Test Set Sample Size: Not explicitly stated for either non-clinical or clinical testing. The document generally mentions "method comparison and user studies."
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not explicitly stated. Given that the submitter is Apex Biotechnology Corp. in Hsinchu, Taiwan, and the device is intended for "self-testing (outside the body, or In Vitro Diagnostic use) by people with diabetes at home," the studies would likely involve prospective collection of human blood samples in a clinical setting or by home users. However, the specific location and nature (retrospective/prospective) of the data collection are not detailed.

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

• Not applicable in the context of this device and the type of evaluation described. For blood glucose monitoring systems, the "ground truth" (reference measurement) is typically established using a highly accurate laboratory reference method (e.g., hexokinase or glucose oxidase methods on a spectrophotometer), not human expert review. The document does not mention human experts establishing ground truth.

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

• Not applicable. Adjudication processes (like 2+1 or 3+1 expert consensus) are typically used for subjective interpretations, such as image analysis for AI models. For a quantitative device like a blood glucose meter, the ground truth is a numerical measurement from a reference instrument.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a blood glucose monitoring system, not an AI-driven image analysis or diagnostic tool that assists human readers. Therefore, an MRMC study and
  measurement of human reader improvement with AI assistance are not relevant to this device.

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

• The GlucoSure Link Blood Glucose Monitoring System itself performs the measurement. Its "algorithm" is the measurement methodology. The "standalone performance" is essentially the device's accuracy and precision compared to a reference method, which is generally what "method comparison" studies evaluate. The document indicates these studies were performed, showing "substantial equivalence."

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

• The ground truth for blood glucose measurements is typically established by laboratory reference methods (e.g., using a YSI glucose analyzer) that are highly accurate and precise. The document implies "method comparison" studies were done, which means the device's readings were compared against such a reference method.

8. The sample size for the training set:

• Not explicitly stated. For a blood glucose meter, "training" might refer to the initial development and calibration of the electrochemical system and algorithms. This information is typically part of the device's internal development process and not usually detailed as a "training set" sample size in an FDA 510(k) summary in the way it is for AI models.

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

• Similar to point 8, the "ground truth" for the development and calibration of the device would likely be established using laboratory reference methods to ensure the meter's internal algorithms accurately convert electrochemical signals into glucose readings.

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GlucoSure HT Plus Blood Glucose Monitoring System is intended to quantitatively measure blood glucose in fresh capillary whole blood drawn from fingertips, palm, or forearm. Alternative site testing for glucose test should be performed only during steady-state (when glucose is not changing rapidly). It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use.
The GlucoSure HT Blood Glucose Test Strips are to be used with the GlucoSure HT Plus Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

The GlucoSure HT Plus blood glucose monitoring system consists of the GlucoSure HT Plus meter and GlucoSure HT Test Strips. It is used for testing of blood glucose by self-testers at home.

The provided text describes the 510(k) premarket notification for the GlucoSure HT Plus Blood Glucose Monitoring System, which is a medical device for measuring blood glucose. The information necessary to fully answer your request regarding acceptance criteria and study proving device meets criteria (especially as it pertains to AI/algorithm performance) is not fully detailed in this document, as it focuses on the substantial equivalence to a predicate device for a glucose monitoring system, and not an AI-assisted diagnostic tool in the typical sense this question implies.

However, based on the provided text, I can infer and extract some relevant information as best as possible, particularly regarding the clinical testing and the overall performance evaluation for this type of device.

Key takeaway for AI-related questions: This document describes a blood glucose monitoring system, not an AI-based diagnostic device where radiologists or extensive adjudication methods for image analysis would typically apply. The "algorithm" mentioned refers to the measurement algorithm within the glucose meter, not necessarily a complex AI/ML algorithm for image interpretation.

Here's a breakdown based on the available text:

Acceptance Criteria and Device Performance (Inferred from device type and general FDA requirements for glucose meters):

For a blood glucose monitoring system, the primary acceptance criteria revolve around the accuracy of glucose measurements compared to a reference method. While specific numerical acceptance criteria (e.g., % within 15% range) are not explicitly stated in the provided summary, these are standard for blood glucose meters. The summary states:

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

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

• Sample Size: The document does not explicitly state the specific number of participants or samples used in the "user studies for glucose" (clinical testing) or "analytical testing."
• Data Provenance: The studies were conducted by Apex BioTechnology Corp. No specific country of origin for the data (beyond the applicant's location in Taiwan) is mentioned. The studies appear to be for regulatory submission, implying they are prospective in nature, designed specifically to validate the device.

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

This question is more applicable to diagnostic devices interpreted by human experts (like radiologists for imaging). For a blood glucose monitoring system, the "ground truth" for glucose levels is typically established by laboratory reference methods (e.g., hexokinase method on a clinical chemistry analyzer), not by human experts interpreting data. The text does not mention human experts establishing ground truth for glucose values.

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

Not applicable in the context of a blood glucose monitoring system where ground truth is established by objective laboratory methods. Adjudication methods like 2+1 or 3+1 are used for expert consensus on subjective interpretations (e.g., reviewing medical images).

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 standalone blood glucose meter, not an AI-assisted diagnostic tool that humans (readers) would use to interpret medical cases.

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

The device itself is a "standalone" measurement system. The "algorithm" mentioned (likely the embedded algorithm within the meter that processes the chemical reaction on the test strip to produce a glucose reading) performs without human interpretation in the loop beyond the user performing the test. The "analytical testing" would assess this standalone performance against a reference method.

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

Based on common practices for blood glucose meters, the ground truth would typically be laboratory reference standard glucose measurements obtained from clinical chemistry analyzers (e.g., YSI analyzer, hexokinase method). The document implicitly refers to "analytical testing" which would involve this comparison.

8. The sample size for the training set:

The document does not provide details about a "training set" for an AI model. For traditional medical devices like blood glucose meters, there isn't a "training set" in the machine learning sense. The device's internal algorithm is developed and calibrated, and then its performance is validated through analytical and clinical studies.

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

Not applicable, as there's no mention of an AI/ML training set in the document. The device's measurement algorithm is likely based on electrochemical principles and calibration data rather than a machine learning training process from labeled data.

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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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The GlucoLeader Enhance Blood Glucose Monitoring System is comprised of GlucoLeader Enhance Blood Glucose Meter and GlucoLeader Enhance Blood Glucose Test Strips.

The GlucoLeader Enhance 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 fingertip. The GlucoLeader Enhance Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for selftesting outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GlucoLeader Enhance Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoLeader Enhance Blood Glucose Monitoring System is not for use in neonates.

The GlucoLeader Enhance Blood Glucose Monitoring System is designed to pursuit the accuracy in blood glucose monitoring to provide you with easy and comfortable testing. The GlucoLeader Enhance Blood Glucose Monitoring System mainly consists of four parts as below,

1. GlucoLeader Enhance Blood Glucose Meter

2. GlucoLeader Enhance Blood Glucose Test Strips*

3. GlucoLeader Enhance Glucose Control Solutions (L1-Low glucose level, L2-High glucose level)*

4. GlucoLeader Enhance Check Strip*.

*These products are intended to be used together to get accurate blood glucose test results. They are not included in the kit package, and should be purchased separately.

The meter display screen size of 1.73" x 1.7" is large and easy-to-read, and the meter weight of 0.122 lbs. (55.2 grams) is lightweight and portable for your convenience. The GlucoLeader Enhance Blood Glucose Monitoring System is traceable to the NIST (SRM) 917A. The GlucoLeader Enhance Glucose Control Solutions have L1 and L2 levels for optional purchasing, and L1 is low glucose level and L2 is high glucose level.

The GlucoLeader Enhance Blood Glucose Meter has the latest technology for blood glucose monitoring and is made with quality components. The GlucoLeader Enhance Blood Glucose Test Strips have been updated with Glucose dehydrogenase-FAD Enzyme, which not only improves the accuracy of measurements, but also increases the HCT interference range up to 10-70%. Also, the required test blood sample volume is reduced to 0.8 µL, and the test reaction time is only 5 seconds.

If your GlucoLeader Enhance Blood Glucose Meter is being operated by a second person who is providing testing assistance to the user. the meter and lancing device should be disinfected prior to use by the second person. Consult your healthcare professional if unusual readings occur.

The GlucocLeader Enhance Blood Glucose Monitoring System is a medical device for quantitative measurement of glucose in fresh capillary whole blood samples. It is intended for self-testing by people with diabetes at home.

Here's an analysis of its acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• User Performance Clinical Evaluation:
  • Test Set Sample Size: 360 typical users.
  • Data Provenance: The document does not specify the country of origin, but the submitting company is HMD BioMedical Inc. based in Taiwan. The study is described as a "User performance evaluation" and "clinical evaluation," implying prospective data collection with human participants.
• System Accuracy Evaluation at Extreme Glucose Values:
  • Test Set Sample Size: 100 subjects.
  • Data Provenance: The document does not specify the country of origin. This also appears to be prospectively collected clinical data from human subjects.
• Within-run precision evaluation: 100 samples (for Lot 1, and presumably for Lots 2 and 3 as well, making it 300 samples total across lots). Data provenance is not specified beyond being laboratory-generated.
• Intermediate precision (day-to-day) evaluation: Number of samples not explicitly stated per lot, but given the structure, it likely involves multiple measurements over several days across different glucose levels and lots. Data provenance is not specified beyond being laboratory-generated.
• Other studies (Altitude, Hematocrit, Interference, etc.): Sample sizes are generally not explicitly quantified beyond statements like "five glucose measures at each attitude level" or "3 different levels of glucose concentrations" with "26 endogenous and exogenous substances." These are typically laboratory-based tests.

3. Number of Experts and Qualifications for Ground Truth

• No information provided: The document does not mention the number of experts or their qualifications used to establish ground truth for any of the studies.
• Implied Standard Reference Method: The ground truth for glucose measurements (e.g., in user performance and system accuracy studies) is consistently compared against a "YSI 2300." The YSI 2300 STAT Plus Glucose & Lactate Analyzer is a laboratory reference method widely accepted for accurate glucose measurement. This suggests that the ground truth is established by a highly accurate laboratory instrument, not human experts in the traditional sense of image interpretation.

4. Adjudication Method for the Test Set

• None applicable: For glucose monitoring systems, ground truth is established by a reference laboratory instrument (YSI 2300). There is no "adjudication" between human readers or experts as there would be for image interpretation tasks. The comparison is directly between the device's reading and the YSI's reading.

5. MRMC Comparative Effectiveness Study

• Not Applicable: This type of study (Multi-Reader Multi-Case comparative effectiveness, assessing human reader improvement with/without AI assistance) is typically relevant for interpretative medical tasks (e.g., radiology AI). The GlucoLeader Enhance is a direct measurement device, not an AI or interpretive tool that assists human readers. Therefore, no such study was conducted or is relevant.

6. Standalone Performance

• Yes, standalone performance was done: All listed performance studies (User performance, System Accuracy, Precision, Linearity, Hematocrit, Interference, etc.) evaluate the algorithm/device's performance directly against a reference method (YSI 2300) without human intervention in the measurement interpretation itself. The "User performance clinical evaluation" assesses how typical users operate the device and obtain results, but the accuracy assessment is still the device's output versus the reference.

7. Type of Ground Truth Used

• Reference Laboratory Method / Expert Instrument: The ground truth for glucose concentration measurements is established using the YSI 2300 (likely the YSI 2300 STAT Plus Glucose & Lactate Analyzer), which is a highly accurate and widely accepted laboratory reference instrument for glucose measurement. This falls under the category of a "reference standard" or "expert instrument" rather than direct human expert consensus or pathology data.

8. Sample Size for the Training Set

• Not applicable / Not explicitly stated: For a traditional medical device like a blood glucose monitor, there isn't typically a "training set" in the machine learning sense. The device's performance is based on its electrochemical methodology and calibration, not on a machine learning model trained on a dataset. The document does not provide details on development or calibration data, which might be analogous to a training set for machine learning devices, but it's not discussed in those terms.

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

• Not applicable: As explained above, for this type of device, a "training set" in the machine learning context is not relevant. The device is calibrated during manufacturing using reference standards, but detailed procedures for this are not part of the regulatory submission about performance testing.

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The GLUCOCARD® W onyx Blood Glucose Monitoring System is comprised of GLUCOCARD® W onyx Blood Glucose Meter and disposable GLUCOCARD® W Blood Glucose Test Strips.

The GLUCOCARD® W onyx Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip or palm. Testing is done outside the body (in vitro diagnostic use). It is intended for use at home by persons with diabetes, as an aid in monitoring the effectiveness of a diabetes control program.

The GLUCOCARD® W onyx Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The GLUCOCARD® W onyx Blood Glucose Monitoring System is designed to quantitatively determine glucose concentrations in fresh capillary whole blood samples. The GLUCOCARD® W onyx Blood Glucose Monitoring System consists of a battery-powered GLUCOCARD® W onyx Blood Glucose Meter, disposable GLUCOCARD® W Blood Glucose Test Strips and Assure® Control-Control Solution (Levels 1, 2, and 3). The GLUCOCARD® W onyx Blood Glucose Monitoring System utilizes biosensor technology for the quantitative determination of glucose concentrations in capillary blood samples. Although capillary blood samples are used for measurement, the results displayed on the GLUCOCARD® W onyx Blood Glucose Monitoring System are equivalent to plasma glucose levels.

The biosensor (GLUCOCARD® W Blood Glucose Test Strips) operates on the electrochemical detection of the reaction of glucose with the enzyme glucose oxidase.

Glucose in the blood reacts with the reagent in the test strip, and this produces a small electric current. The strength of this current is proportional to the concentration of glucose in the blood. The meter measures this current and calculates the glucose level in the blood.

The provided text describes the GLUCOCARD® W onyx Blood Glucose Monitoring System but does not contain information about acceptance criteria or specific study results demonstrating that the device meets those criteria.

The document is a 510(k) Summary, which aims to demonstrate substantial equivalence to a predicate device, rather than detailed performance study reports with acceptance criteria and results. While it lists various device features and compares them to the predicate device, it does not include any quantitative performance data, sample sizes for testing, ground truth establishment, or details about comparative effectiveness studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for test sets.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details or effect size.
6. Standalone performance details.
7. Type of ground truth used (beyond implying plasma reference for glucose levels).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily focuses on establishing substantial equivalence by highlighting design and functional similarities to the predicate device (GLUCOCARD® W Blood Glucose Monitoring System) and noting minor differences such as the addition of Bluetooth communication and changes in physical dimensions. It states that both devices "Have the same performance, measurement range, use environment and calibration functions," implying that the performance of the proposed device is expected to be the same as the predicate, which would have undergone performance testing at the time of its own clearance (K170064). However, the details of that performance testing are not included in this summary.

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The GLUCOCARD Shine Express Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The GLUCOCARD Shine Express 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 system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

The GLUCOCARD Shine Blood Glucose Test Strips are for use with the GLUCOCARD Shine Express Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

The GLUCOCARD Shine Connex Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The GLUCOCARD Shine Connex 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 system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

The GLUCOCARD Shine Blood Glucose Test Strips are for use with the GLUCOCARD Shine Connex Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

The GLUCOCARD Shine Connex Blood Glucose Monitoring System consist of a hand held GLUCOCARD Shine Connex Blood Glucose Meter, GLUCOCARD Shine Blood Glucose Test Strip, and GLUCOCARD Shine Glucose Control Solution. The GLUCOCARD Shine Express Blood Glucose Monitoring System consist of a hand held GLUCOCARD Shine Express Blood Glucose Meter, GLUCOCARD Shine Blood Glucose Test Strip, and GLUCOCARD Shine Glucose Control Solution. The two candidate test systems are derived from the same design platform as their predicate device, CareSens N Premier Blood Glucose Monitoring System/CareSens N Premier BT Blood Glucose Monitoring System (K170614). The candidate devices are modified versions of the predicate device to suit the market needs for test systems with Bluetooth and talking features. The GLUCOCARD Shine Connex Blood Glucose Meter is a Bluetooth meter, similar to the CareSens N Premier BT Blood Glucose Meter, whereas the GLUCOCARD Shine Express Blood Glucose Meter is enabled with a talking feature (English and Spanish).

Both candidate devices are used with the GLUCOCARD Shine Blood Glucose Test Strip and GLUCOCARD Shine Glucose Control Solution, which are the same in chemical composition, fundamental scientific technology, intended use and operating principle as with the components of the predicate device, cleared in K170614. The only difference between the test strip & control solution of the candidate device and the ones of the predicate device is the brand name.

This is a medical device application for two blood glucose monitoring systems, GLUCOCARD Shine Connex and GLUCOCARD Shine Express. As such, the acceptance criteria are based on established performance standards for blood glucose meters, primarily ISO 15197:2013 or equivalent.

Here's an analysis of the provided text to fulfill your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for accuracy or precision, nor does it provide specific numerical performance results for the new devices. However, it does refer to "pre-determined Pass/Fail criteria" and concludes that the device passed "all of the tests."

For blood glucose monitoring systems, a common standard for accuracy is ISO 15197:2013, which typically requires:

• For glucose concentrations < 100 mg/dL: 95% of results must be within ±15 mg/dL of the reference method.
• For glucose concentrations ≥ 100 mg/dL: 95% of results must be within ±15% of the reference method.

Given that this is a 510(k) submission and the device is deemed substantially equivalent, it implies that the device met similar, if not identical, criteria to its predicate device (CareSens N Premier BGMS/CareSens N Premier BT BGMS, K170614), which would have needed to meet such standards.

Inferred Table:

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

The document does not explicitly state the sample size for the clinical or analytical test set used for performance evaluation of the GLUCOCARD Shine Connex or GLUCOCARD Shine Express. It only mentions:

• "Verification, validation and testing activities were conducted to establish the performance, functionality and liabilities of the modified devices."
• "The device passed all of the tests based on pre-determined Pass/Fail criteria."

Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

This information is typically not applicable for blood glucose monitoring systems. The "ground truth" for blood glucose measurements is established by a highly accurate laboratory reference method (e.g., YSI analyzer), not by expert consensus. Therefore, no "experts" in the human reviewer sense are used for establishing the ground truth.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable for blood glucose monitoring systems. The ground truth is determined by an objective, quantitative laboratory reference method, not by human adjudication of images or clinical cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What War the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. Blood glucose monitoring systems are standalone diagnostic devices and do not involve human "readers" interpreting results in a way that would necessitate an MRMC study or AI assistance. The device directly provides a numerical glucose value.

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

Yes, the performance evaluation performed for this device is a standalone performance assessment. Blood glucose meters are designed to provide a direct, quantitative glucose measurement without human interpretation or intervention in the measurement process itself. The "device performance" mentioned refers to the accuracy and precision of the meter and test strip system in autonomously measuring glucose.

7. The Type of Ground Truth Used

The ground truth for blood glucose monitoring systems is typically established using a laboratory reference method known for its high accuracy and precision, such as a YSI glucose analyzer, measuring glucose in plasma or whole blood. The document doesn't explicitly name the reference method used but this is the standard practice.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of device performance studies. Blood glucose monitoring systems are not typically developed using machine learning models that require distinct training sets for their primary measurement function. Their performance is validated through analytical and clinical studies.

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

As explained in point 8, a "training set" in the machine learning sense is not applicable here. The ground truth for the validation of the device's accuracy would be established by the laboratory reference method, as described in point 7.

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