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For in vitro diagnostic use with the CARESIDE Analyzer to measure LDH activity from anti-coagulated whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with certain liver diseases, heart diseases, and tumors of the lung, kidneys, and liver.

CARESIDE LDH cartridges are used with the CARESIDE, Inc. CARESIDE Analyzer to measure LDH activity in anti-coagulated whole blood, serum or plasma specimens. The CARESIDE LDH cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of serum or plasma to a dry film to initiate the measurement of LDH activity. The patented film cartridge contains all reagents necessary to measure LDH activity.

Here's a breakdown of the acceptance criteria and the study information for the CARESIDE LDH device, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Information

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

   • The document does not explicitly state the sample size for the test set used for the performance characteristics reported (Detection Limit, Reportable Range, Recovery, Linearity, Interference, Precision, Relative Accuracy).
   • The document does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) for the test set. It can be inferred that the testing was performed by the manufacturer, CARESIDE, Inc., prior to submission.

2. 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 document. The performance characteristics seem to be based on laboratory measurements against reference instruments or calibrated standards rather than expert consensus on diagnostic images or clinical outcomes.

3. Adjudication method for the test set:

   • This information is not applicable or provided. The performance assessment for this in vitro diagnostic device does not involve adjudication by multiple experts in the way clinical diagnostic imaging studies might.

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 comparative effectiveness study was done. This device is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

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

   • Yes, the reported performance characteristics (Detection Limit, Reportable Range, Recovery, Linearity, Interference, Precision, Relative Accuracy) likely represent the standalone performance of the CARESIDE LDH system (cartridge + analyzer) as an in vitro diagnostic test. There is no human-in-the-loop component in the analytical measurement itself; the analyzer quantifies LDH activity.

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

   • The ground truth for the analytical performance appears to be established through:
     • Reference Methods/Instruments: For relative accuracy, it was compared to a "BM/Hitachi 902" analyzer.
     • Calibrated Standards: Linearity and recovery assays typically use samples with known, precisely measured concentrations.
     • Controlled Samples: Interference studies use samples spiked with known interferents at specific concentrations.

7. The sample size for the training set:

   • The document does not directly mention a "training set" in the context of an AI/algorithm. For an in vitro diagnostic device like this, method development and calibration would be performed using various samples, but these are not typically referred to as a "training set" in the machine learning sense. The device uses lot-specific standard curves, which are established during manufacturing.

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

   • Not applicable as there isn't a "training set" for an AI algorithm. For the device's internal calibration, the instrument uses "lot-specific standard curve" information, which is "bar-coded on each cartridge." This implies that during the manufacturing of each batch (lot) of cartridges, their performance is characterized against known standards to create a unique calibration curve that ensures accurate readings for that specific lot.

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For in vitro diagnostic use with the CARESIDE Analyzer to quantitatively measure GGT from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.

CARESIDE® GGT cartridges are used with the CARESIDE Analyze® to measure GGT activity in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE GGT cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of GGT activity. The patented film cartridge contains all reagents necessary to measure GGT activity.

Each CARESIDE® GGT cartridge consists of a GGT-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the anti-coagulated whole blood, serum. or plasma specimen into the cartridge sample well, closes the lid and inserts the cartridge into the CARESIDE Analyzer.

Once loaded, the CARESIDE Analyzer scans the cartridge barcode, brings the cartridge and the contained specimen to 37℃, and spins the cartridge to move the sample from the sample deposition well into the cartridge channels and chambers. As the cartridge continues to spin, the blood cells are separated from the plasma/serum and the cells accumulate in the separation well. Approximately 8.5 microliters of plasma (or serum, as applicable) remain in the metering passage. Any excess sample flows into an overflow well.

The plasma (or serum, as applicable) is automatically dispensed onto the multi-layer reagent film. The spreading and substrate layer distributes the GGT containing specimen uniformly. The GGT in the specimen reacts with the substrate L-y-glutamyl-p-nitroanilide to release p-nitroaniline resulting in a change in film color. The rate of change of color intensity, as measured by the amount of reflected light at 425 nanometers, directly relates to the specimen GGT activity.

As the cartridges spin, photodiodes measure reflectance of light emitted by wavelengthspecific light emitting diodes (LEDs) over a fixed time period. The instrument uses the reflectance measurements and the lot-specific standard curve to calculate GGT activity.

Here's an analysis of the acceptance criteria and study information for the CARESIDE® GGT device, based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the CARESIDE® GGT is "substantially equivalent in principle, intended use, and clinical performance to the currently marketed Vitros slides for the quantitative measurement of GGT on the Vitros DTSC 60 II." This broad statement acts as the overarching acceptance criterion, with the detailed performance characteristics providing the evidence for this claim. The differences (e.g., direct whole blood specimen, no accurate pipetting required, no reagent pre-warming required for CARESIDE® GGT) are presented as differences rather than failures of acceptance, implying they are either improvements or clinically insignificant for the intended use.

Study Details

1. Sample size used for the test set:

   • The document does not explicitly state the sample size (number of patient samples) used for the comparison studies (accuracy, precision, method comparison, interference, specimen type evaluation).
   • Data provenance: Not explicitly stated, but clinical data is implied for "Method Comparison" and "Specimen Types & Anticoagulants" by comparing against other analyzers and evaluating different sample types. Given the context of a 510(k) summary, it's highly likely to be prospective testing for the CARESIDE device.

2. 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 document. For an in vitro diagnostic device measuring an analyte (GGT), the "ground truth" is typically established by reference laboratory methods or a predicate device.

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

   • This is not applicable for this type of in vitro diagnostic device study. Adjudication methods like 2+1 or 3+1 are typically used in imaging or clinical trials involving subjective expert interpretation to resolve discrepancies. For quantitative laboratory tests, the "ground truth" is typically a quantitative value from a reference method or predicate device, not subject to subjective expert interpretation requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • This is not applicable. The CARESIDE® GGT is an in vitro diagnostic device to measure GGT activity, not an AI-assisted diagnostic tool requiring human interpretation. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant.

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

   • Yes, the performance characteristics (accuracy, precision, linearity, interference, method comparison) are inherently "standalone" in that they describe the performance of the CARESIDE® GGT device and analyzer system directly, without requiring human-in-the-loop performance assessment to determine the GGT value. The device provides a quantitative result.

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

   • The "ground truth" for the CARESIDE® GGT performance evaluation is established by:
     • Reference laboratory methods: For the "Method Comparison," it states "CARESIDE = 1.00 (BM/Hitachi 902 GGT) + 0.91 U/L, r= 1.00", indicating a comparison against a commercially available clinical chemistry analyzer (BM/Hitachi 902 GGT), which serves as a reference or predicate method.
     • Known concentrations: For "Accuracy" (mean recovery 101%) and "Linearity" (by dilution), the ground truth would be known concentrations of GGT in control materials or diluted samples.
     • Predicate device comparison: The overall claim of substantial equivalence to the Vitros GGT DT Slides implies that the Vitros system values served as a de facto "ground truth" or comparator for aspects of clinical performance.

7. The sample size for the training set:

   • The document does not specify a separate "training set" or its sample size. For an IVD device like this, the calibration data (bar-coded on each cartridge) effectively serves as the "training" for the device to interpret raw signals into GGT activity. However, this is distinct from statistical machine learning model training sets.

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

   • As above, explicitly defined "training set" in a machine learning sense is not described. However, for the calibration of the device, the ground truth would have been established using calibrators with known GGT concentrations, typically verified against reference methods. The document mentions "Calibration information bar-coded on each cartridge. Calibration information may change with each lot." This indicates that each lot is calibrated, likely against reference standards, to ensure accurate GGT measurement.

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For in vitro diagnostic use with the CARESIDE Analyzer to quantitatively measure ALT from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of patients with certain types of liver and heart disease.

CARESIDE ALT cartridges are used with the CARESIDE, Inc. CARESIDE Analyzer to measure ALT activity in anti-coagulated whole blood, plasma, or serum specimens. The CARESIDE® ALT cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of sample to a dry film to initiate the measurement of ALT activity. The patented film cartridge contains all reagents necessary to measure ALT activity.

Each CARESIDE ALT cartridge consists of an ALT-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the specimen into the cartridge sample well, closes the lid and inserts the cartridge into the CARESIDE Analyzer.

Once loaded, the CARESIDE Analyzer scans the cartridge barcode, brings the cartridge and the contained specimen to 37℃, and spins the cartridge to move the sample from the sample well into the cartridge channels and chambers. Approximately 8.5 microliters of sample remains in the metering passage. Any excess sample flows into an overflow well.

The sample is automatically dispensed onto the multi-layer reagent film. The spreading and substrate layer uniformly distributes the specimen. As the specimen passes through the spreading and substrate layer, ALT in the specimen catalyzes the reaction of L-aspartate and a-ketotglutaric acid to form pyruvic acid and L-glutamic acid (see Test Reaction Sequence). The pyruvic acid is converted to acetyl phosphoric acid, CO2 and hydrogen peroxide in the reaction layer. Peroxidase in the reaction layer then catalyzes the oxidation of a diaryliminidazole leuco dye by hydrogen peroxide to form a green dye. The rate of change of intensity of the color as measured by the amount of reflected light at 655 directly relates to the amount of ALT activity in the specimen.

The provided document describes the CARESIDE® ALT test system, an in vitro diagnostic device for quantitatively measuring Alanine Aminotransferase (ALT) activity. The submission is a 510(k) premarket notification, aiming to demonstrate substantial equivalence to a predicate device, not to establish new performance criteria. Therefore, the document does not contain an "acceptance criteria" table in the traditional sense of a new clinical trial setting with predefined endpoints that need to be met for device approval. Instead, it presents a comparison of the CARESIDE ALT's performance characteristics against those of the predicate device (Vitros ALT DT Slides) to show "substantial equivalence."

Here's the information extracted and organized based on your request, focusing on the comparative performance data provided:

1. Table of Acceptance Criteria (Comparative Performance) and Reported Device Performance

As this is a 510(k) submission showing substantial equivalence, there are no explicitly stated "acceptance criteria" for a new device's clinical performance. Instead, the performance of the CARESIDE ALT is compared to the predicate device and the new device's performance is presented. The implicit "acceptance criterion" is that the CARESIDE ALT performs "as well as or better than" the predicate device.

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

The document does not explicitly state the sample size used for the "test set" (i.e., the number of patient samples or specimens used for the accuracy, precision, linearity, method comparison, and interference studies). It also does not specify the country of origin of the data or whether the study was retrospective or prospective.

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

This type of information (experts, qualifications, etc.) is typically associated with studies involving human interpretation (e.g., image analysis, diagnoses). The CARESIDE ALT is an in vitro diagnostic device for quantitative chemical measurement. Its "ground truth" would be established by reference methods or laboratory-grade analyzers. Therefore, this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are relevant to studies where human readers interpret and classify data, and discrepancies need resolution. This is not applicable to a quantitative in vitro diagnostic device where measurements are compared to reference methods or statistical thresholds for performance.

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

This section is not applicable. The CARESIDE ALT is an in vitro diagnostic device for measuring a chemical analyte, not an AI-powered diagnostic system requiring human interpretation or assistance.

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

The performance data presented (accuracy, precision, method comparison, linearity, interference) describes the standalone performance of the CARESIDE ALT device, as it is an automated quantitative measurement system that does not involve human interpretation for its primary function.

7. The Type of Ground Truth Used

The "ground truth" for the performance characteristics appears to be established using:

• Reference Method Comparisons: For accuracy and method comparison, the CARESIDE ALT measurements were compared against results from other established analytical methods, such as the "BM/Hitachi 902" analyzer and a "NADH/NAD coupled reduction of pyruvate by lactate dehydrogenase" reference method. The predicate device also refers to the "IFCC, 1978" method.
• Known Concentrations/Spiked Samples: For linearity, "linearity by mixing" was employed, suggesting known concentrations were used. Interference studies involved adding known concentrations of potential interfering substances.
• Statistical Analysis: Precision is determined through statistical analysis of replicate measurements.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This device is a chemical assay, and its development would typically involve optimization and validation runs rather than a distinct "training set" in the computational sense. The document focuses on demonstrating the final product's performance.

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

As no "training set" in the AI/ML sense is mentioned, this question is not applicable to the information provided. The development of a chemical assay involves extensive R&D, optimization using laboratory standards, and clinical validation using patient samples, but these are not typically categorized as "training sets" with associated "ground truth establishment" in the way an AI algorithm would be described.

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The CARESIDE Triglyceride cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE Analyzer to quantitatively measure the concentration of triglycerides in anti-coagulated whole blood, plasma or serum. This product is indicated for use in the diagnosis and treatment of patients with primary or secondary hyperlipidemias. Hyperlipidemias may result from liver obstruction, diseases involving lipid metabolism, or various endocrine disorders. Triglyceride results are used together by the CARESIDE Analyzer with total cholesterol and HDL-cholesterol results to calculate LDL-cholesterol levels.

CARESIDE Trighceride cartridges are used with the CARESIDE Analyzer to measure triglyceride concentration in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE Triglyceride cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of triglyceride concentration. The patented film cartridge contains all reagents necessary to measure triglyceride concentration. Each CARESIDE Triglyceride cartridge consists of a triglyceride-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the anticoagulated whole blood, serum, or plasma specimen into the cartridge Sample Well, closes the lid and inserts the cartridge into the CARESIDE Analyzer. Once loaded, the CARESIDE Analyzer scans the cartridge barcode, brings the cartridge and the contained specimen to 37℃, and spins the cartridge to move the sample from the sample deposition well into the cartridge channels and chambers. As the cartridge continues to spin, the blood cells are separated from the plasma/serum and the cells accumulate in the separation well. Approximately 8.5 microliters of plasma (or serum, as applicable) remain in the metering passage. Any excess sample flows into an overflow well. The plasma (or serum, as applicable) is automatically dispensed onto the multi-layer The triglyceride-containing specimen is distributed uniformly by the reagent film. spreading layer. The sample then passes through a reflection layer and into the reaction layer. Finally, the reaction mixture is pulled through the reaction layer by a suction layer where the NTB chromogen is converted into a purple formazan dye. As the cartridge spins, a photodiode measures film reflectance of light emitted from a wavelength-specific light emitting diode (LED) at a lixed time. The instrument uses the reflectance measurements and the lot-specific standard curve to calculate triglyceride concentration.

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

CARESIDE Triglyceride Premarket Notification (K020488)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by comparing the CARESIDE Triglyceride device's performance characteristics against its predicate device (Vitros TRIG DT Slides) and general analytical standards. The document doesn't explicitly state "acceptance criteria" as a separate section, but rather presents performance characteristics of both devices side-by-side. The key areas of comparison are:

Study Proving Device Meets Acceptance Criteria:

The document describes a comparative performance characteristics study, though the details are somewhat summarized rather than a full protocol.

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

• Sample Size: Not explicitly stated for each characteristic. For "Precision," a single sample concentration (146 mg/dL) is mentioned as tested. For "Method Comparison," the slope and intercept are provided, indicating a regression analysis was performed on a set of samples, but the number of samples is not stated. Similarly, for "Interference" and "Specimen Types & Anticoagulants," various conditions were tested, but specific sample numbers (n) are not given.
• Data Provenance: Not explicitly stated. Given that it's a premarket notification for a US market, it's highly likely the data was generated in a lab environment (prospective testing) but the country of origin of the samples themselves is not specified.

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

• Not Applicable. This is an in vitro diagnostic device for measuring a biochemical analyte (triglycerides). The "ground truth" for the test set would be established by a well-characterized reference measurement method (e.g., an assay on a high-precision clinical chemistry analyzer like the BM/Hitachi 902, or a gas chromatography-mass spectrometry method if available at the time for direct comparison). It does not involve human expert interpretation of images or clinical cases.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is a quantitative chemical assay, there is no human adjudication process involved in establishing the "ground truth" or comparing results. The comparisons are statistical and analytical.

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

• No. An MRMC study is relevant for diagnostic imaging or interpretation tasks where human readers make subjective assessments (e.g., radiologists reading scans). This device is an automated in vitro diagnostic assay, so MRMC studies are not applicable.

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

• Yes. The entire performance characteristic section (Section IV.C. "Comparative Performance Characteristics") is effectively a standalone performance evaluation of the CARESIDE Triglyceride system (cartridge + Analyzer). The device is designed to be an automated measurement device, and the reported accuracy, precision, linearity, and method comparison data reflect its standalone performance. The document highlights features like "accurate pipetting not required" and "reagent pre-warming not required," which further emphasize its automated, standalone nature.

7. The Type of Ground Truth Used:

• For Method Comparison, the ground truth was established by another well-accepted clinical chemistry analyzer, specifically the "BM/Hitachi 902." The comparison yielded the equation: CARESIDE = 0.98 (BM/Hitachi 902) + 2.92 mg/dL. This indicates the BM/Hitachi 902 served as the reference or comparative "ground truth" for evaluating the CARESIDE device's quantitative accuracy.
• For Accuracy (Recovery), the ground truth would be the known concentration of triglycerides in spiked samples or certified reference materials, where the device's measured value is compared to the expected true value.
• For Precision, the ground truth is the statistical property of repeatability and reproducibility, typically assessed by running samples multiple times to determine the variability (CV%).
• For Linearity, the ground truth is derived from preparing samples with known serially diluted or mixed concentrations and ensuring the device's readings are proportional to these known values.

8. The Sample Size for the Training Set:

• Not applicable / Not explicitly stated for this type of device. Clinical chemistry devices like this typically undergo extensive analytical validation (accuracy, precision, linearity, interference) using characterized samples. While there's an internal "lot-specific standard curve" mentioned for calibration, this isn't a "training set" in the machine learning sense. The device's underlying chemistry and optical detection principles are well-established. The development process would involve optimizing reagents and calibration, but the specific term "training set" with a defined sample size as used in AI/ML is not relevant here.

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

• Not applicable for a "training set" in the AI/ML sense. For the calibration curves that the instrument uses, "ground truth" is established through carefully characterized calibrator materials with known triglyceride concentrations, measured by highly accurate reference methods. The device then generates a standard curve based on these calibrators to convert raw reflectance data into triglyceride concentrations.

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For in vitro diagnostic use with the CARESIDE Analyzer™ to measure direct bilirubin from whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with hepatic, hemolytic hematologic, and metabolic diseases, including hepatitis and gall bladder blockage.

CARESIDE™ Direct Bilirubin cartridges are used with the CARESIDE Analyzer™ to measure direct bilirubin in whole blood, plasma or serum specimens. The CARESIDE™ Direct Bilirubin cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of plasma or serum to a dry film to initiate the measurement of direct bilirubin. The film cartidge (patent pending) contains all reagents necessary to measure direct bilirubin. Each CARESIDE™ Direct Bilirubin cartridge consists of a direct bilirubin-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the specimen into the cartridge Sample Well, closes the lid and inserts the cartridge into the CARESIDE Analyzer™. Once loaded, the CARESIDE Analyzer™ scans the cartridge barcode, brings the cartridge and the contained specimen to 37℃, and spins the cartridge to move the sample from the Sample Well into the cartridge channels and chambers. 8.5 microliters of sample remains in the metering passage. Any excess sample flows into an overflow well. The 8.5 microliters of sample is automatically dispensed onto the multi-layer reagent film. The spreading layer distributes the specimen uniformly before it passes through to the absorption layer. The color intensity of the resulting bluish dye, as measured by the amount of reflected light at 570 nanometers, directly relates to the direct bilirubin concentration of the specimen.

Here's a breakdown of the acceptance criteria and the study details for the CARESIDE™ Direct Bilirubin device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied through the comparison with the predicate device and the stated performance characteristics.

Notes on Acceptance Criteria:

• The document doesn't explicitly state "acceptance criteria" but rather presents a comparative performance table against a legally marketed predicate device. The underlying assumption is that the CARESIDE™ device must perform as well as or better than the predicate for these parameters to be considered substantially equivalent.
• For "Reportable Range," the CARESIDE™ device has a slightly lower upper limit (16 mg/dL vs 20 mg/dL) but this is still within clinically relevant ranges and the overall performance is deemed equivalent.
• For "Precision," the CARESIDE™ device demonstrates better precision (3.1% vs 8.7% CV).

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only provides the performance characteristics determined from studies.

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

This information is not provided in the document. The type of device (in vitro diagnostic for bilirubin) suggests that the ground truth would likely be established through a reference method or laboratory standard, rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the "test set" and "ground truth establishment" would refer to analytical performance studies, not human expert interpretation of images or other subjective data.

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

This information is not applicable/provided. The CARESIDE™ Direct Bilirubin is an in vitro diagnostic device, operating independently to measure a biomarker. It does not involve human readers interpreting output that would be assisted by AI.

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

The entire study described is essentially a standalone (algorithm only) performance assessment, as the device directly measures bilirubin concentration without requiring human subjective interpretation during the measurement process. The device's performance characteristics (detection limit, reportable range, accuracy, precision, linearity, interference) are all measures of its standalone analytical capability.

7. Type of Ground Truth Used

The ground truth for this type of in vitro diagnostic device would be established by:

• Method Comparison: Comparing the CARESIDE™ device's results against a well-established, legally marketed predicate device (BM/Hitachi 902 Direct Bilirubin) or a recognized reference method. The document states:
  • "CARESIDETM = 0.99 (BM/Hitachi 902 Direct Bilirubin) + 0.019 mg/dL, r = 0.997"
• Reference Standards/Calibrators: For accuracy, linearity, and detection limits, the performance would be verified against known concentrations of bilirubin in control materials or calibrators.

8. Sample Size for the Training Set

This information is not provided in the document. For an in vitro diagnostic device like this, "training set" doesn't typically apply in the same way it would for an AI/machine learning algorithm that learns from data. Device development involves establishing reagent formulations, reaction kinetics, and optical measurement parameters, which are validated through analytical studies.

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

Since a "training set" in the machine learning sense is not applicable here, the question of how its ground truth was established is also not applicable. The underlying chemical reactions and spectrophotometric measurements are based on established scientific principles. The "calibration information bar-coded on each cartridge" and the "lot-specific standard curve" mentioned in the device description imply that internal reference materials and procedures are used to establish the device's measurement accuracy for each manufacturing lot.

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The CARESIDE Analyzer is an in vitro diagnostic instrument intended for the measurement of various clinical chemistry analytes in human whole blood, plasma, or serum. For in vitro diagnostic use. For point of care use.

The CARESIDE Analyzer is a compact chemistry instrument that performs multiple discrete analyses on human whole blood, plasma, or serum samples. The CARESDIDE Analyzer is semi-automated: the only operator steps are the addition of the sample to the test cartridge and the insertion of the dosed cartridge into the instrument. The CARESIDE Analyzer automatically warms, separates, meters, dispenses, and incubates the sample before reading the signal and calculating results. The CARESIDE Analyzer is intended only for use with CARESIDE test cartridges. The instrument is controlled through a touch-screen interface. Results are displayed on the interface screen. Results can also be downloaded on to a 3-1/2 inch diskette or to a computer via a RS-232 port. The CARESIDE Analyzer accepts up to 6 test cartridges from a single patient at the same time.

The provided text describes the CARESIDE™ Analyzer, an in vitro diagnostic instrument for measuring clinical chemistry analytes. The document focuses on establishing substantial equivalence to predicate devices for regulatory clearance (510(k)), rather than presenting a detailed study proving performance against explicit acceptance criteria.

However, based on the information provided, we can infer the approach taken for performance evaluation and how "acceptance criteria" are implied through comparison with a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in the format requested (e.g., "Accuracy must be within X% of reference method"). Instead, it relies on demonstrating substantial equivalence to an existing legally marketed predicate device (the Vitros DT 60/DTSC/DTE II Module and their own previously cleared CARESIDE Analyzer for lab use).

For each analyte the CARESIDE Analyzer measures, its performance would have been compared to the predicate device. The general "acceptance criteria" for regulatory clearance in this context are that the new device's performance is equivalent or better than the predicate device for its intended use, without raising new questions of safety or effectiveness.

While specific percentage differences or statistical thresholds are not given in this summary, the "Comparative Performance Characteristics" section states: "The clinical data provided demonstrate that the CARESIDE Analyzer... performs equivalently or better than the other legally marketed predicate device." This implies that for each analyte, the observed agreement, correlation, bias, and precision met the FDA's criteria for substantial equivalence when compared to existing devices.

To illustrate how such a table would be structured if explicit criteria were available, and how the performance statement translates, let's use a hypothetical example for a single analyte (e.g., Glucose) and infer the comparison:

The document points out that details for each individual test's 510(k) submission would contain the specific performance data ("see individual test 510k submissions").

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

The provided 510(k) summary does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "clinical data provided" without further detail. This information would typically be found in the specific validation studies submitted with each individual test cartridge's 510(k).

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

Given that this is a clinical chemistry analyzer, the "ground truth" for the test set would typically be established by comparison to a recognized reference method or a predicate device, as opposed to expert consensus on images or clinical assessments. Therefore, the concept of "number of experts" and "qualifications of those experts" for establishing ground truth is not directly applicable in the same way it would be for, say, an AI-powered diagnostic imaging device.

For a clinical chemistry analyzer, consistency and agreement with a predicate device or a gold standard laboratory method are the primary measures of ground truth. The "experts" involved would be clinical chemists, laboratory scientists, or medical technologists who perform the reference measurements and analyze the results. Their qualifications would include relevant certifications and experience in clinical laboratory testing.

4. Adjudication Method for the Test Set

As the ground truth is established by quantitative comparison to reference methods or a predicate device, an "adjudication method" in the sense of a committee resolving disagreements (e.g., 2+1, 3+1) is not typically used for clinical chemistry results. The differences between the new device and the reference/predicate would be analyzed statistically to determine agreement, bias, and correlation.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. MRMC studies are typically used to evaluate the impact of a diagnostic aid (e.g., an AI algorithm) on human reader performance, particularly in fields like radiology or pathology where human interpretation is central. The CARESIDE Analyzer is a standalone instrument that provides quantitative measurements, not an aid designed to improve human reader performance in interpreting complex data.

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

Yes, the information provided describes the performance of the CARESIDE Analyzer as a standalone device. The instrument performs the measurement and calculation of results directly from the sample without human interpretation of raw signals. The comparison in the submission (as inferred) is between the measurements obtained by the CARESIDE Analyzer and those obtained by predicate devices or reference methods.

7. The Type of Ground Truth Used

The ground truth used for validating the CARESIDE Analyzer's performance would primarily be:

• Reference Methods: Measurements obtained from established, accurate laboratory methods (e.g., spectrophotometry, chromatography, highly accurate ion-selective electrodes) in a qualified clinical laboratory.
• Predicate Device Data: Performance data obtained from the legally marketed predicate device (Vitros DT 60/DTSC/DTE II Module and the CARESIDE Analyzer for lab use) on the same samples.

The document states that the individual test (analyte) cartridges were subject to separate 510(k) submissions, and those submissions would contain the detailed ground truth information for each specific analyte.

8. The Sample Size for the Training Set

The document does not specify the sample size for the training set. The CARESIDE Analyzer is factory-calibrated, and lot-specific calibration coefficients are provided via barcodes on the cartridges. This implies that extensive calibration and characterization data (which could be considered a form of "training data" for the internal algorithms/calibration curves) were collected by the manufacturer during development and manufacturing. However, the exact sample sizes for this internal development and calibration are not disclosed in this regulatory summary.

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

The ground truth for establishing the factory calibration (which is analogous to the "training set" for the device's inherent algorithms) would typically involve:

• Certified Reference Materials (CRMs) or Standard Solutions: Samples with known, highly accurate concentrations of analytes.
• Split Sample Analysis: Running samples on both the CARESIDE system and established reference methods (or predicate devices) in a robust laboratory setting to generate the dose-response curves and calibration coefficients.
• Statistical Modeling: Using the data from CRMs and split samples to derive the polynomial equations that convert raw reflectance/potentiometry signals into analyte concentrations.

The document mentions that "The observed reflectance (ODr) is adjusted by inputting it into the equation. The patient result is calculated from the adjusted ODr using the polynomial describing the master dose - response curve." This "master dose-response curve" and its associated polynomial are derived from this extensive calibration process using samples with established ground truth. This process ensures the instrument correctly interprets its raw signals into clinically meaningful concentrations across its analytical measuring range.

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For in vitro diagnostic use with the CARESIDE Analyzer™ to measure total CO2 from anticoagulated whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with respiratory and metabolic disorders associated with acid-base imbalance.

CARESIDE™ CO2 cartridges are used with the CARESIDE Analyzer™ to measure total CO2 in whole blood, serum or plasma specimens. The CARESIDE™ CO2 cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of serum or plasma to a dry film to initiate the measurement of total CO2 The film cartridge (patent pending) contains all reagents necessary to measure total CO2.

Here's a breakdown of the acceptance criteria and study information for the CARESIDE™ CO2 device, based on the provided text:

CARESIDE™ CO2 Device: Acceptance Criteria and Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states, "The nonclinical and clinical data provided demonstrate that the CARESIDE™ CO2 product is as safe, effective, and performs as well as or better than the legally marketed predicate device." This indicates that the predicate's performance served as the "acceptance criteria" for demonstrating substantial equivalence.

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

• Sample Size: Not explicitly stated for the "clinical data" or "method comparison" studies.
• Data Provenance: Not explicitly stated (e.g., country of origin). The document refers to "nonclinical and clinical data provided," implying internal studies by CARESIDE, Inc. It does not indicate if 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 document. The document describes an in vitro diagnostic device for quantitative measurement, and ground truth would typically be established by laboratory reference methods rather than expert consensus for individual results.

4. Adjudication Method for the Test Set

• This information is not provided. Given it's a quantitative diagnostic device, adjudication methods like 2+1 or 3+1 are not typically applicable. The comparison is against established laboratory methods.

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

• No, an MRMC study was not done. This type of study is for evaluating human performance, often with AI assistance, in interpreting medical images or data. The CARESIDE™ CO2 device is an automated in vitro diagnostic device, not one requiring human interpretation in this manner.

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

• Yes, this was a standalone performance study. The CARESIDE™ CO2 cartridge, used with the CARESIDE Analyzer™, is an automated system designed to quantitatively measure total CO2 without human intervention in the measurement process itself, beyond sample loading. The performance characteristics (accuracy, precision, linearity, method comparison, interference) reported are indicative of the device's standalone performance.

7. The Type of Ground Truth Used

• The ground truth for the method comparison and accuracy studies would have been established by comparing the CARESIDE™ CO2 results against a legally marketed predicate device (Vitros CO2 DT Slides) or other established reference methods in a clinical laboratory setting. The "Method comparison" section directly compares the CARESIDE™ results to the Vitros CO2 DT, indicating the Vitros results served as a comparative ground truth.

8. The Sample Size for the Training Set

• The document does not specify a separate "training set" sample size. For in vitro diagnostic devices, method validation studies typically encompass "development" or "internal validation" phases which are analogous to a training set, but explicit sample sizes for these are rarely detailed in 510(k) summaries. The reported performance data would generally come from a separate "test set" after method development is complete.

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

• As a quantitative diagnostic test, the "ground truth" during any developmental or training phase would typically be established against existing, well-established reference methods or predicate devices in a laboratory. The document does not describe the specific process for establishing ground truth during initial development or "training" phases, if any specific "training set" was used for the algorithm. The fundamental principle is that the device is calibrated and its performance evaluated against established, accurate measurements of CO2.

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For in vitro diagnostic use with the CARESIDE Analyzer™ to quantitatively measure magnesium from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of patients with hypomagnesemia or hypermagnesmia. It is intended professional laboratory use: not for point of care or physician office laboratory use.

CARESIDE™ Mg cartridges are used with the CARESIDE, Inc. CARESIDE Analyzer™ to measure magnesium in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE™ Mg cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of plasma or serum to a dry film to initiate the measurement of magnesium concentration. The film cartridge (patent pending) contains all reagents necessary to measure magnesium concentration.

Here's a breakdown of the acceptance criteria and study information for the CARESIDE™ Mg, based on the provided text:

CARESIDE™ Mg Acceptance Criteria and Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Notes on Acceptance Criteria:

• Implicit Nature: The acceptance criteria are largely implied by the claim of substantial equivalence to the predicate device (Vitros Mg DT Slides). The studies are designed to demonstrate that the CARESIDE™ Mg performs "as well as or better than" the predicate.
• Specific Values: For detection limit and reportable range, the acceptance criteria are a direct match to the predicate. For precision, the CARESIDE™ Mg is slightly higher (4.3% vs 3.6%), but is presented as acceptable. For method comparison, high correlation coefficients (r=0.99) demonstrate agreement with established methods.
• Interference Test: The CARESIDE™ Mg tested against a broader range of interferents than the predicate, demonstrating non-inferiority or superiority in this aspect.

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

• Sample Size: The document does not explicitly state the specific number of samples for each test (accuracy, precision, method comparison, linearity, interference).
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). This information is typically detailed in the full study report, not necessarily in a 510(k) summary.

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

• Not Applicable: This device is an in vitro diagnostic (IVD) for quantitative measurement of magnesium. The ground truth for such devices is established through reference methods, calibrated instruments, and known sample concentrations, not human expert consensus like in image interpretation tasks.

4. Adjudication method for the test set:

• Not Applicable: Given that the ground truth is established by objective laboratory methods, there is no need for human adjudication for the test set measurements.

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

• Not Applicable: This is an in vitro diagnostic device, not an AI-powered diagnostic imaging tool that would involve human readers.

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

• Yes, this is a standalone device/algorithm. The CARESIDE™ Mg cartridge, in conjunction with the CARESIDE Analyzer™, is designed to quantitatively measure magnesium without human intervention in the result generation beyond operating the analyzer. The comparative performance characteristics (Accuracy, Precision, Method Comparison, Linearity, Interference) are all measures of the algorithm's standalone performance.

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

• The ground truth for the CARESIDE™ Mg performance evaluation is established through:
  • Reference methods: Primarily indicated by the method comparison against the Hitachi 902/BMD and Vitros DT 60 II systems, which serve as established, accepted methods for magnesium measurement.
  • Known concentrations: For tests like linearity and interference, samples with precisely known magnesium levels or known concentrations of interfering substances would be used.

8. The sample size for the training set:

• Not Applicable: This document describes an in vitro diagnostic device that uses enzymatic reactions and reflectometry, not a machine learning model that requires a "training set" in the conventional sense. The "lot-specific standard curve" mentioned in the device description serves a similar purpose to calibration in traditional analytical chemistry, which is distinct from large-scale data-driven machine learning training.

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

• Not Applicable: As there is no "training set" in the machine learning sense, this question is not relevant. The device relies on chemical principles and a calibrated measurement system. The "standard curve" for each lot of cartridges is established using reference materials with known magnesium concentrations (though the details of this process are not provided in this summary).

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