Search Results

The Calcium2 assay is used for the quantitation of calcium in human serum, plasma, or urine on the ARCHITECT c System.

Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

The Calcium2 assay is an automated clinical chemistry assay. Arsenazo III dye reacts with calcium in an acid solution to form a blue-purplex. The color developed is measured at 660 nm and is proportional to the calcium concentration in the sample.

Methodology: Arsenazo III

The provided text describes the performance validation of the Calcium2 assay, specifically for its use in quantitating calcium in human serum, plasma, or urine on the ARCHITECT c System. This is a Class II medical device (Calcium test system), regulated under 21 CFR 862.1145, product code CJY.

Here's an analysis based on the request:

Device: Calcium2 assay
Intended Use: Quantitation of calcium in human serum, plasma, or urine on the ARCHITECT c System. Used in the diagnosis and treatment of parathyroid disease, various bone diseases, chronic renal disease, and tetany.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly outline a pre-defined table of "acceptance criteria" against which each test result is measured, as would be common for AI/ML performance studies. Instead, it presents various performance characteristics with their measured values, often referencing CLSI guidelines for the methodology. The "acceptance" can be inferred from the reported values and the conclusion of substantial equivalence. For quantitative assays like this, performance is typically assessed against established industry standards for precision, accuracy, linearity, and interference.

However, we can infer some "acceptance criteria" implicitly from the context of "acceptable performance" and the ranges presented.

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

The provided information is for an in-vitro diagnostic (IVD) test, not an AI/ML model for image analysis. Therefore, the "test set" and "training set" terminology from an AI/ML perspective doesn't directly apply in the same way. Instead, the studies involved various types of samples (controls, panels, human serum/plasma/urine samples) tested under specific experimental designs.

• Precision Studies (Serum & Urine, 20-Day):
  • Sample Size: 80 replicates per sample type (2 controls, 3 human panels) for each of the 3 reagent lot/calibrator lot/instrument combinations in the 20-day study. (e.g., 5 samples * 80 replicates = 400 total data points per combination shown in the table).
  • Data Provenance: Not explicitly stated (e.g., country of origin). The studies are "within-laboratory" meaning they were conducted in a controlled lab setting, likely at the manufacturer's site or a designated testing facility. The nature of these samples (human serum/urine panels) suggests they are likely representative, but the specific collection method or origin (retrospective/prospective collection from patients) is not detailed.
• System Reproducibility Studies (Serum & Urine):
  • Sample Size: 90 replicates per sample type (2 controls, 3 human panels).
  • Data Provenance: Same as above, not explicitly stated.
• Accuracy Study:
  • Sample Size: Not explicitly stated for replicates, but involved 2 concentrations of NIST SRM 956d standard.
  • Data Provenance: NIST standard reference material, a highly controlled and traceable source.
• Lower Limits of Measurement Studies (Serum & Urine):
  • Sample Size: n ≥ 60 replicates for zero-analyte and low-analyte level samples for LoB, LoD, and LoQ determination.
  • Data Provenance: Not explicitly stated.
• Linearity Studies (Serum & Urine):
  • Sample Size: Not explicitly stated how many points were measured across the range, but demonstrated linearity from 2.0 to 24.0 mg/dL.
  • Data Provenance: Not explicitly stated.
• Interference Studies (Serum & Urine):
  • Sample Size: Not explicitly stated how many replicates, but each substance was tested at 2 levels of the analyte.
  • Data Provenance: Not explicitly stated.
• Method Comparison Studies (Serum & Urine):
  • Sample Size: 120 serum samples, 112 urine samples.
  • Data Provenance: Patient samples. Not explicitly stated if retrospective or prospective collection.
• Tube Type Equivalence Study (Serum):
  • Sample Size: Samples from 78 donors.
  • Data Provenance: Donor samples. Not explicitly stated if retrospective or prospective.
• Dilution Verification (Urine):
  • Sample Size: 5 samples prepared with calcium stock. Replicates for dilution recovery and imprecision were performed but the exact number isn't specified beyond "demonstrated acceptable performance."
  • Data Provenance: Prepared samples.

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

This type of IVD device (quantitative chemical assay) relies on objective measurement against a known reference (e.g., NIST standard) or internal validated methods, rather than subjective expert consensus. Therefore, "ground truth" is established through highly controlled laboratory procedures and certified reference materials, not typically through multiple human experts adjudicating results. The "experts" involved are likely laboratory scientists and metrologists operating under strict quality systems (CLSI guidelines, ISO standards).

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

Not applicable for a quantitative chemical assay. Results are objectively measured by the instrument and verified through calibration and quality control. There is no subjective interpretation requiring adjudication.

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

Not applicable. This is an in-vitro diagnostic test, not an AI/ML-driven imaging or diagnostic tool that assists human readers.

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

This is a standalone quantitative assay. The Calcium2 device automatically measures calcium concentration. Human involvement is in sample preparation, loading, and interpreting the numerical output. Its performance is evaluated entirely as an automated system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device's performance validation is established primarily through:

• Reference Materials: For accuracy (e.g., NIST SRM 956d for bias estimation).
• Known Concentrations: For linearity, lower limits of measurement, and dilution verification, samples are prepared with known concentrations of calcium or spiked with calcium.
• Comparative Methods: For method comparisons, the "ground truth" is implicitly the performance of the legally marketed predicate device (Abbott Clinical Chemistry Architect/Aeroset Calcium, K062855), which serves as the comparator.
• Statistical Models/Guidelines: CLSI guidelines (EP05-A3, EP09c, EP17-A2, EP06, EP07, EP34) provide the statistical framework and methodology for validating performance characteristics like precision, linearity, and interference.

8. The Sample Size for the Training Set

Not applicable in the typical AI/ML sense. This is a chemistry assay, not a machine learning model that undergoes a "training" phase with a large dataset. The "training" for such a device involves rigorous engineering, chemical formulation, and calibration development, rather than data-driven model training.

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

As above, "training set" is not a concept for this type of device. The accuracy and reliability of the assay are built into its chemical design, reagent formulation, and instrument calibration process. These processes rely on highly accurate reference standards (like NIST) and established analytical chemistry principles to ensure the device measures calcium correctly across its analytical range.

Ask a specific question about this device

Yumizen C1200 Calcium AS reagent is a diagnostic reagent for quantitative in vitro determination of calcium in human serum, plasma and urine based on colorimetric method, using the clinical chemistry analyzer. Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Yumizen C1200 Creatinine Jaffé reagent is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Not Found

The provided FDA 510(k) summary describes the analytical performance characteristics of the Yumizen C1200 Calcium AS and Yumizen C1200 Creatinine Jaffé reagents when used with the Yumizen C1200 clinical chemistry analyzer. The document focuses on demonstrating substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study designs based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents performance data across several analytical characteristics. For some categories, explicit "acceptance criteria" are mentioned (e.g., CV limits for precision), while for others, the results are presented as factual measurements from the studies conducted.

Yumizen C1200 Calcium AS

• Limit of detection: 0.12 mmol/L (0.48 mg/dL)
• Limit of quantitation: 0.14 mmol/L (0.57 mg/dL)
• Linearity: 0.00 to 4.84 mmol/L (0.00 to 19.40 mg/dL)
• Measuring range: 1.00 - 4.50 mmol/L (4.0 - 18.05 mg/dL)
• Post-dilution: Up to 13.5 mmol/L (54.15 mg/dL)
  Urine:
• Limit of detection: 0.06 mmol/L (0.24 mg/dL)
• Limit of quantitation: 0.16 mmol/L (0.64 mg/dL)
• Linearity: 0.00 to 4.84 mmol/L (0.00 - 18.60 mg/dL)
• Measuring range: 0.16 to 4.5 mmol/L (0.64 - 18.05 mg/dL)
• Post-dilution: Up to 13.5 mmol/L (54.15 mg/dL) |
  | Precision (Serum/Plasma) | Within run (CV limits): 1.2% for low (1.8 mmol/L), middle (2.4 mmol/L), high (3.4 mmol/L) levels.
  Total precision (CV limits): 1.6% for low (1.8 mmol/L), middle (2.4 mmol/L), high (3.4 mmol/L) levels. | Within-Run (%CV):
• Control N: 0.6%
• Control P: 0.5%
• Sample 1: 0.8%
• Sample 2: 0.6%
• Sample 3: 0.5%
  Total (%CV):
• Control N: 1.5%
• Control P: 1.4%
• Sample 1: 1.7%
• Sample 2: 1.6%
• Sample 3: 1.8%
  (Note: "Although the %CV of Total Precision is superior to the Acceptance criteria for some samples, the p-value with 5% acceptable remains acceptable for all the samples tested.") |
  | Precision (Urine) | Within run (CV limits): 3.0% for low (1.0mM), middle (2.5mM), high (4.0mM) levels.
  Total precision (CV limits): 4.0% for low (1.0mM), middle (2.5mM), high (4.0mM) levels. | Within-Run (%CV):
• Control L1: 0.7%
• Control L2: 0.5%
• Sample 1: 1.6%
• Sample 2: 0.8%
• Sample 3: 0.7%
• Sample 4: 0.6%
• Sample 5: 0.6%
  Total (%CV):
• Control L1: 3.8%
• Control L2: 3.9%
• Sample 1: 2.6%
• Sample 2: 2.1%
• Sample 3: 2.0%
• Sample 4: 1.7%
• Sample 5: 1.6%
  (Note: "The results are within the specifications.") |
  | Interferences | Acceptable bias is +/-10% of the value without interfering substances. | Highest values for which no interferences > 10% were observed provided for Hemoglobin, Triglycerides, Total Bilirubin, Direct Bilirubin, Acetylsalicylic Acid, Ascorbic Acid, Ibuprofen, Acetaminophen (for serum/plasma) and additionally Glucose for urine. |
  | Matrix Comparison | Not explicitly stated, but high correlation values (e.g., 0.997) suggest equivalence to predicate. | Calcium (mmol/L): Intercept 0.1159, Slope 0.9423, Correlation 0.997. (Plasma vs. Predicate) |
  | Method Comparison (Serum/Plasma) | Not explicitly stated, but high correlation values (e.g., 0.976) suggest equivalence to predicate. | Calcium (mmol/L): Intercept 0.06, Slope 1, Correlation (r2) 0.976. (Native serum vs. Predicate) |
  | Method Comparison (Urine) | Not explicitly stated, but high correlation values (e.g., 0.995) suggest equivalence to predicate. | Calcium (mmol/L): Intercept +0.1381, Slope 0.9436, Correlation (r2) 0.995. (Native urine vs. Predicate) |
  | Closed Reagent Stability | Stable up to the expiry date on the label if stored at 2-8°C. Shelf life claim: 24 months. | Claim supported by CLSI EP25-A. |
  | Open Reagent Stability | Supported by CLSI EP25-A. | Reagent stability claim: 6 weeks (on board). |
  | Reference Range | Verification studies support established ranges from literature. | Serum/Plasma (Adults): 2.15 - 2.55 mmol/L (8.6 - 10.2 mg/dL)
  Urine (24h): Women 10% were observed provided for Hemoglobin, Triglycerides, Total Bilirubin, Direct Bilirubin, Acetylsalicylic Acid, Ascorbic Acid, Ibuprofen, Acetaminophen, Glucose, Total Proteins (for serum/plasma) and additionally Glucose for urine (not listed, but implied from calcium's urine list). Note: Glucose for Creatinine urine interference is not listed in the table, but was for Calcium urine. Acetaminophen listed for Creatinine serum/plasma but not urine, similar to Calcium. |
  | Matrix Comparison | Not explicitly stated, but high correlation values (e.g., 0.999) suggest equivalence to predicate. | Creatinine (µmol): Intercept -7.102, Slope 1.087, Correlation 0.999. (Plasma vs. Predicate) |
  | Method Comparison (Serum/Plasma) | Not explicitly stated, but high correlation values (e.g., 0.995) suggest equivalence to predicate. | Creatinine (µmol/L): Intercept 9.158, Slope 0.9633, Correlation (r2) 0.995. (Native serum vs. Predicate) |
  | Method Comparison (Urine) | Not explicitly stated, but high correlation values (e.g., 0.997) suggest equivalence to predicate. | Creatinine (mmol/L): Intercept -41.4, Slope 0.9483, Correlation (r2) 0.997. (Native urine vs. Predicate) |
  | Closed Reagent Stability | Stable up to the expiry date on the label if stored at 2-8°C. Store protected from light. Shelf life claim: 24 months. | Claim supported by CLSI EP25-A. |
  | Open Reagent Stability | Supported by CLSI EP25-A. | Reagent stability claim: 7 days (on board). |
  | Calibration Stability | At least 3 days (Predicate). | 24 hours (Candidate). (Note: Candidate's calibration stability is shorter than predicate.) |
  | Reference Range | Verification studies support established ranges from literature. | Serum/Plasma: Mens: 62-106 µmol/L (7-12 mg/dL), Womens: 44-80 µmol/L (5-9 mg/dL)
  Urine (24h): Men: 14-26 mg/kg/day (124-230 µmol/kg/day), Women: 11-20 mg/kg/day (97-177 µmol/kg/day) |

2. Sample sizes for the test set and data provenance:

• Yumizen C1200 Calcium AS:

  • Matrix Comparison (Plasma): 108 individual plasma samples. Data provenance: Not specified (but likely from within France, given the manufacturer's location).
  • Method Comparison (Serum/Plasma): 166 native serum samples. Data provenance: Not specified.
  • Method Comparison (Urine): 105 native urine samples. Data provenance: Not specified.
  • Precision (Serum/Plasma & Urine): "N" is 240 for each sample type/control tested. This is for multiple runs/days/instruments. Samples are controls (Yumizen C1200 N/P Multi Control, Urine Level 1/2 Control) and individual "Samples" (1-5).
  • Reference Range Verification (Serum/Plasma): 40 "normal samples" from blood bank.
  • Reference Range Verification (Urine): Not explicitly stated, but inferred to be derived from literature and verified through internal testing.
  • Limit of Quantitation/Linearity/Interferences: Sample sizes for these studies are not explicitly stated, but are implied to be sufficient for CLSI guidelines EP17-A2 and EP06-A.

• Yumizen C1200 Creatinine Jaffé:

  • Matrix Comparison (Plasma): 69 individual plasma samples. Data provenance: "individual donors from blood bank." Not explicitly stated country of origin.
  • Method Comparison (Serum/Plasma): 131 native samples. Data provenance: Not specified.
  • Method Comparison (Urine): 148 native samples. Data provenance: Not specified.
  • Precision (Serum/Plasma & Urine): "N" is 240 for each sample type/control tested. Samples are controls (Yumizen C1200 N/P Multi Control, Urine Level 1/2 Control) and individual "Samples" (1-5).
  • Reference Range Verification (Serum/Plasma): 35 "normal samples" from blood bank (Men), 25 "normal samples" from blood bank (Women).
  • Reference Range Verification (Urine): Not explicitly stated, but inferred to be derived from literature and verified through internal testing.
  • Limit of Quantitation/Linearity/Interferences: Sample sizes for these studies are not explicitly stated, but are implied to be sufficient for CLSI guidelines EP17-A2 and EP06-A.

Data Provenance (General): The general provenance of the "individual donors from blood bank" for Matrix Comparisons (plasma) is not specified geographically. The studies are described as analytical performance evaluations, suggesting they are prospective studies conducted in a controlled laboratory setting.

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

This document describes the performance of in-vitro diagnostic (IVD) reagents, which measure specific analytes in biological samples. The concept of "ground truth" here is tied to the accurate and precise measurement of these analytes by established laboratory methods, often against a reference method or predetermined values for controls/calibrators.

• Ground Truth Establishment: For IVD devices, "ground truth" is typically established by:
  • Certified Reference Materials/Control Materials: These have assigned values determined by highly accurate reference methods or extensive inter-laboratory studies.
  • Reference Methods: Highly accurate and precise analytical methods used to determine true values (e.g., isotope dilution mass spectrometry for some analytes).
  • Predicate Devices: Comparison against an already cleared and widely accepted device.
  • Expert Consensus/Pathology/Outcomes Data: These are generally relevant for diagnostic imaging or clinical decision support AI, not typically for quantitative chemical assays like Calcium and Creatinine.

The document does not mention the use of "experts" in the traditional sense (e.g., radiologists, pathologists) to establish ground truth for this type of IVD testing. The focus is on analytical performance metrics (linearity, precision, interference, method comparison to a predicate).

4. Adjudication method for the test set:

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where subjective interpretation (e.g., reading medical images) is involved and multiple experts are used to reach a consensus for ground truth. This document describes the analytical performance of quantitative chemical assays, where measurements are objective.

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. MRMC studies are used for evaluating diagnostic imaging or AI systems that assist human readers in interpretation. This document pertains to the analytical performance of reagents for quantitative chemical measurements, which do not involve human "readers" in the context of interpretation.

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

Yes, in a sense. The studies described (e.g., measuring range, precision, interference, method comparison) evaluate the performance of the reagent and instrument system in generating a quantitative value for Calcium and Creatinine. This is akin to a "standalone" performance evaluation of the reagent system itself, without human interpretation of the final result, beyond standard laboratory quality control and result review. The device output is a numerical value, not an interpretation requiring human assistance.

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

The ground truth for these studies is established through:

• Reference Methods/Assigned Values: For precision studies, control materials with known target values are used. For linearity, serially diluted samples or spiked samples with known concentrations are employed.
• Comparison to a Predicate Device: For method comparison, patient samples are tested on both the candidate device and a legally marketed predicate device, with the predicate serving as the reference for equivalence.
• Literature Reference Intervals: For reference range verification, the device's measurements on "normal samples" are compared against established reference intervals from scientific literature.

8. The sample size for the training set:

Not applicable. This is an IVD reagent and instrument system, not an AI/Machine Learning model that undergoes a distinct "training" phase with a large dataset in the way a medical image analysis algorithm would. The development of reagents involves chemical formulation and optimization, and instrument calibration relies on calibrator materials, not necessarily "training datasets" in the AI sense.

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

Not applicable for the same reasons as point 8. The "ground truth" for calibrators (used for instrument calibration, which is analogous to "training" in the sense of setting up the system for accurate measurement) is typically established by the calibrator manufacturer using highly accurate reference methods and/or extensive certification processes. The document mentions "Yumizen C1200 Multical" as the calibrator for the candidate device.

Ask a specific question about this device

The Randox Calcium (Ca) device is intended for the quantitative in vitro determination in serum, plasma and urine. This product is suitable for use on the RX series analyzer, RX daytona plus. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases and chronic renal failure.

The Randox Calcium (Ca) kit consists of a ready to use reagent solution.

The Randox Calcium (Ca) device is an in vitro diagnostic intended for the quantitative determination of calcium concentration in serum, plasma, and urine on the RX series analyzer RX daytona plus. The device demonstrates substantial equivalence to the predicate device, the ADVIA Chemistry Calcium_2 (CA_2) Method (K083386), based on performance characteristics including precision, linearity, analytical specificity, and method comparison.

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

ELITech Clinical Systems CALCIUM ARSENAZO is intended for the quantitative in vitro diagnostic determination of total calcium in human serum, plasma and urine using ELITech Clinical Systems Selectra Pro Series Analyzers.

It is not intended for use in Point of Care settings.

Calcium measurements are used in the diagnosis and treatment of parathyroid diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

ELITech Clinical Systems CALCIUM ARSENAZO is available as a kit only. It consists of a mono-reagent R whose composition is: 100 mmol/L MES buffer (pH 6.50), 200 µmol/L Arsenazo III.

This document describes the performance of the ELITech Clinical Systems CALCIUM ARSENAZO IVD device. The information provided outlines the analytical performance characteristics and comparison studies rather than clinical or AI-assisted studies typically associated with detailed acceptance criteria of AI/ML-based medical devices.

Therefore, many of the requested categories (e.g., number of experts, adjudication methods, MRMC studies, effect size of AI improvement, standalone AI performance) are not applicable to this type of device submission, which is for an in vitro diagnostic reagent. The "ground truth" here refers to established analytical methods and reference materials, not expert consensus on medical images or clinical outcomes data.

Here's a breakdown of the available information based on your request, focusing on the analytical performance studies conducted for this IVD reagent:

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

The document doesn't present explicit "acceptance criteria" in a singular table for all performance characteristics against which the device passed or failed, but rather describes the methodology and results for each analytical performance study. The "acceptance criteria" are generally implied by standard clinical laboratory practices and regulatory expectations for IVD devices (e.g., CLSI guidelines, demonstrating substantial equivalence).

Device Performance Summaries (from the document):

2. Sample Size and Data Provenance:

• Precision Studies: 80 measurements for each of 3 levels for both serum and urine (total of 160 measurements per sample type across 20 operating days on 2 instruments).
• Linearity Studies: 11 levels of mixed samples for both serum and urine.
• Interference Studies: For each interferent, 2 sample pools (low and high calcium concentration) were tested, with aliquots spiked at various concentrations (7-9 different concentrations). Each point was measured in triplicate per run.
• Method Comparison (Serum): 106 serum patient samples.
• Method Comparison (Urine): 52 urine patient samples.
• Matrix Effect: 63 paired serum and plasma patient specimens.

Data Provenance: The document generally refers to "patient samples" but does not specify the country of origin. The studies are described as analytical performance evaluations, typically performed retrospectively on collected samples in a controlled laboratory setting. The submitting company is based in France.

3. Number of Experts and Qualifications:

Not applicable for this type of IVD analytical performance study. The ground truth for this device is based on quantitative chemical measurements, established analytical methods (e.g., predicate device, reference methods), and certified reference materials (NIST SRM 956c). Expertise is in analytical chemistry and clinical laboratory science for study design and interpretation, not expert medical opinion on, for example, image interpretation.

4. Adjudication Method:

None applicable. This is an analytical device for quantitative determination, not a diagnostic aid requiring adjudication of clinical findings or interpretations.

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

Not applicable. This is an IVD reagent, not an AI/ML-based diagnostic system for human-in-the-loop assistance.

6. Standalone (Algorithm Only) Performance:

This device is a chemical reagent. Its performance is inherent to its chemical reaction and measurement on a specific analyzer (ELITech Clinical Systems Selectra Pro Series Analyzers). Therefore, the concept of "standalone performance" as it applies to an AI algorithm is not applicable. The reported performance metrics (precision, linearity, LoD, LoQ, interference) are its standalone analytical performance.

7. Type of Ground Truth Used:

The ground truth for the analytical performance studies is established by:

• Reference materials: Such as NIST SRM 956c for traceability of calibration.
• Established analytical methods: Comparison against a legally marketed predicate device (ABX Pentra Calcium AS CP) and adherence to CLSI (Clinical and Laboratory Standards Institute) protocols (e.g., EP05-A2 for precision, EP06-A for linearity, EP17-A for detection limits, EP07-A2 for interference, EP09-A2 for method comparison).
• Gravimetric or Volumetric Preparations: For linearity and interference studies, samples are prepared by mixing known concentrations or spiking with known amounts of analytes/interferents.

8. Sample Size for Training Set:

Not applicable. This device is a chemical reagent, not an AI/ML model that requires a "training set." The performance characteristics are determined through standard analytical validation studies.

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

Not applicable for the same reason as above.

Ask a specific question about this device

ABX Pentra Calcium AS CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of calcium in human serum, plasma and urine based on a colourimetric method, using the ABX Pentra 400 Clinical Chemistry analyzer. Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba Medical methods on Horiba Medical clinical chemistry analyzers.

The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers.

The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers.

The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision of Horiba Medical methods on Horiba Medical clinical chemistry analyzers.

All the reagent, controls and calibrator included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.

The ABX Pentra Calcium AS CP is an in vitro diagnostic assay for the quantitative in vitro determination of calcium in human serum, plasma and urine based on colourimetric method. It is composed of a monoreagent cassette (79 mL). The reagent is chemical solution with additives.

The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer.

This calibrator is provided in ten vials of 3 ml.

The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexes, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.

The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annex, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.

Here's a summary of the acceptance criteria and study details for the ABX PENTRA CALCIUM AS CP device and its associated controls and calibrators, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Detection Limit & Limit of Quantitation: Not specified for individual samples, but determined according to CLSI (NCCLS), EP17-A protocol.
• Repeatability (within-run precision):
  • 3 specimens (low, medium, high concentration)
  • 2 controls
  • Each tested 20 times.
  • Data provenance: Not explicitly stated, but likely from laboratory testing conducted by Horiba ABX SAS, France. Retrospective/Prospective is not specified.
• Reproducibility (total precision):
  • 3 specimens (low, medium, high levels)
  • 2 controls
  • Each tested in duplicate for 20 days (2 series per day).
  • Data provenance: Not explicitly stated, but likely from laboratory testing conducted by Horiba ABX SAS, France. Retrospective/Prospective is not specified.
• Method Comparison:
  • Serum/Plasma: n = 145 patient samples
  • Urine: n = 143 patient samples
  • Data Provenance: Not explicitly stated beyond "patient samples," but implied to be from a clinical setting, likely in France given the company's location. Retrospective/Prospective is not fully specified, but patient samples are used to compare against a "commercial reagent taken as reference," suggesting a retrospective collection of samples for comparison.
• Matrix Comparison:
  • n = 32 paired serum and lithium plasma samples (3 samples were altered)
  • Data Provenance: Not explicitly stated beyond "samples," but implied to be from a clinical setting, likely in France. Retrospective/Prospective is not specified.

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

This type of information is generally not applicable to in vitro diagnostic (IVD) assays for quantitative chemical measurements. The "ground truth" for these studies is typically established by measurements from a well-characterized reference method or a predicate device, rather than expert consensus on images or clinical assessments. The studies performed here compare the device to a "commercial reagent taken as reference" (predicate device K061575) and uses established laboratory protocols (CLSI, Valtec).

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" is derived from quantitative measurements by reference methods, not subjective assessments requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret images, sometimes with AI assistance. This document describes a clinical chemistry analyzer and reagents, which do not involve human interpretation of images in the same way.

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

Yes, the studies described are standalone performance evaluations of the assay system (reagent and instrument). The performance metrics (detection limits, precision, linearity, method comparison, stability) reflect the algorithm's and the physical assay's performance without direct human interpretation influencing the measurement results. The human input is in setting up the system, running controls, and interpreting the numerical output, but the analytical measurement itself is automated.

7. Type of Ground Truth Used

• Reference Method/Predicate Device Comparison: For the method comparison study, the "ground truth" was established by measurements from a "commercial reagent taken as reference" (Olympus Calcium Arsenazo reagent, K061575).
• CLSI/NCCLS Protocols: Other performance parameters (detection limit, quantitation limit, precision, linearity) were evaluated against established CLSI/NCCLS and Valtec protocols, which define acceptable measurement performance characteristics. These protocols inherently define the "truth" in terms of statistical and analytical performance.

8. Sample Size for the Training Set

Not applicable. This device is a quantitative in vitro diagnostic reagent and assay system, not an AI/machine learning model that requires a training set in the conventional sense. The development of the reagents and assay parameters is based on chemical and analytical principles, and the performance is validated through the studies listed.

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

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

Ask a specific question about this device

Vital Diagnostics Eon Calcium Reagent is a device intended to measure the total calcium level in serum and plasma using the Eon 100 Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Not Found

The provided document is a 510(k) premarket notification letter from the FDA regarding "Eon Calcium Reagent." This document is a regulatory approval letter for an in vitro diagnostic (IVD) reagent intended to measure calcium levels in serum and plasma. The information requested (acceptance criteria, study details, sample sizes, ground truth establishment, etc.) is typically found in the scientific documentation submitted as part of the 510(k) application, not in the approval letter itself. Regulatory letters primarily acknowledge substantial equivalence and outline ongoing regulatory responsibilities.

Therefore,Based on the provided FDA 510(k) approval letter (K120626) for the "Eon Calcium Reagent," none of the requested information regarding specific acceptance criteria, device performance tables, study details (sample sizes, provenance, expert qualifications, adjudication methods), multi-reader multi-case studies, standalone performance, or ground truth establishment for either test or training sets is present.

The document is purely an FDA approval letter stating that the device is substantially equivalent to legally marketed predicate devices for the indicated use of measuring total calcium levels in serum and plasma. It does not contain the technical or clinical study data that would detail how the device's performance was evaluated against specific acceptance criteria.

To answer your questions, one would need access to the actual 510(k) submission document, which contains the analytical and clinical performance studies.

Ask a specific question about this device

For in vitro diagnostic use in the quantitative determination of calcium in human serum, plasma, and urine on the ADVIA Chemistry systems. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal failure, and tetany.

Summary and Explanation: the Calcium 2 (CA 2) method is based on the work of Michaylova and Illkova, (Anal Chem Acta 1971; 53: 194), who found that Arsenazo III could form a stable complex with calcium with high selectivity at low pH.

Principles of the Procedure: Calcium ions form a colored complex with Arsenazo III, which is measured at 658/694 nm. The amount of calcium present in the sample is directly proportional to the intensity of the colored complex formed.

Reaction Equation: Ca2+ + Arsenazo III ---> Ca-Arsenazo III Complex (purple)

The provided document is a 510(k) summary for the ADVIA® Chemistry Calcium 2 Method, which is an in vitro diagnostic device for quantitative determination of calcium. It aims to demonstrate substantial equivalence to a predicate device. The document describes the device, its intended use, and a comparison with the predicate. However, it does not contain specific acceptance criteria, detailed study results (like sample sizes for test/training sets, data provenance, expert details, or MRMC studies), or a comprehensive description of how ground truth was established, beyond stating "comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance."

Therefore, much of the requested information cannot be extracted from this document.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document states that "Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance," but it does not present the acceptance criteria for that testing or the specific performance metrics achieved against those criteria.

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

This information is not provided in the document.

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. Establishing ground truth for a clinical chemistry assay typically involves reference methods or certified reference materials, not human experts in the same way as imaging analysis. However, the document does not specify how ground truth was established for the comparative performance study.

4. Adjudication method for the test set

This information is not provided in the document.

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

This is not applicable to this type of chemical assay device. MRMC studies are typically used for imaging or diagnostic devices where human interpretation is involved. This device is an automated quantitative chemical analysis system.

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

This device is essentially a standalone algorithm/system. Its performance is measured independently of human interpretation in the analytical sense. The document implicitly supports this by describing it as a "quantitative determination of calcium" on automated chemistry systems. However, a formal "standalone study" in the context of an algorithm's performance vs. a human reader for a specific diagnostic task (like in imaging AI) is not relevant here. The comparison is between the new device and a predicate device, both automated diagnostic tests.

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

This information is not explicitly stated. For quantitative chemical assays, ground truth is typically established using:

• Reference methods (e.g., atomic absorption spectroscopy for calcium)
• Certified reference materials with known analyte concentrations
• Comparative analysis against a legally marketed predicate device (as done here, for substantial equivalence)

The document refers to "comparative testing" against the predicate device (ADVIA Chemistry 1650 Calcium method), implying that the predicate's results might serve as a form of reference or comparison for the new device's accuracy and precision.

8. The sample size for the training set

This information is not provided in the document. Algorithms for chemical assays like this are typically developed and validated using calibration materials and quality control samples, rather than a "training set" in the machine learning sense.

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

This information is not provided in the document. As mentioned for #8, the concept of a "training set" with established ground truth is less directly applicable for this type of device. Calibration and quality control procedures involve materials with known concentrations, but these are part of the operational system rather than a "training set" for a learning algorithm.

Ask a specific question about this device

The S-Test Calcium Reagent is intended for the quantitative determination of calcium concentration in serum or heparin plasma using the S40 Clinical Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany (intermittent muscular contractions or spasms). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Calcium (CA) reagent cartridge, used with the S40 Clinical Analyzer, is intended for quantitative in vitro diagnostic determination of CA in serum or heparin plasma based on a photometric test measuring the formation of a reddish-purple complex under strong alkaline conditions.

The provided 510(k) summary describes the acceptance criteria and the study that proves the device meets those criteria for the S-Test CA Reagent cartridge, used for quantitative determination of calcium in serum or heparin plasma.

Here's a breakdown of the requested information:

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

The summary does not explicitly state "acceptance criteria" as pass/fail thresholds. Instead, it presents performance data for precision, accuracy, and sensitivity, which are implicitly the criteria for demonstrating substantial equivalence.

• Within-run CV: 1.1 to 1.2% (3 CA levels)
• Total CV: 1.6 to 2.2% |
  | | | POL Sites (5 days):
• Within-run CV: 0.4 to 3.9%
• Total CV: 0.7 to 4.3% |
  | Accuracy | High correlation with comparison method; low error | Correlation Study (181 samples):
• Correlation Coefficient: 0.978
• Standard Error Estimate: 0.4
• Confidence Interval Slope: 0.950 to 1.003
• Confidence Interval Intercept: -0.30 to 0.17 |
  | | | Patient Correlation (4 POL sites):
• Correlation Coefficients: 0.929 to 0.965
• Standard Error Estimates: 0.49 to 0.68
• Confidence Interval Slopes: 0.833 to 1.048
• Confidence Interval Intercepts: -0.62 to 1.54 |
  | Sensitivity | Low detection limit | Detection Limit: 2.3 mg/dL |

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

• Test Set Sample Size: For accuracy/correlation studies, 181 samples were used in the main correlation study, ranging from 2.4 to 14.5 mg/dL CA values.
• Data Provenance: The document does not explicitly state the country of origin. It mentions studies conducted "at three separate Physician Office Laboratory (POL) sites and in-house" as well as "four separate POL sites," suggesting these were conducted within the US, where the applicant (Alfa Wassermann Diagnostic Technology, LLC) is located. The studies appear to be prospective as they involve assaying samples on the S40 Clinical Analyzer and a comparison method for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is a clinical chemistry device for quantitative measurement. The "ground truth" is established by a comparison method, which is another established clinical analyzer or laboratory method for measuring calcium. Experts are not typically used to establish ground truth in this context; rather, the accuracy of the new device is validated against the results of a recognized, validated reference method. The document does not specify details about the "comparison method" used, such as its specific identity or the qualifications of those operating it beyond being a "comparison method."

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

N/A. Adjudication methods are typically employed in studies where human interpretation of results is involved (e.g., radiology image interpretation). For quantitative chemistry assays, the comparison is made directly between the numerical output of the new device and the comparison method.

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

N/A. This is a quantitative in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers interpreting results. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not applicable.

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

This device is a standalone diagnostic test system (reagent cartridge + analyzer). The performance data presented (precision, accuracy, sensitivity) directly reflects the performance of the "algorithm" and instrument without human interpretive subjectivity in the measurement itself. Human action involves operating the instrument and interpreting the numerical output, but the measurement itself is automated.

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

The ground truth for the accuracy studies was established by a comparison method (another clinical analyzer or laboratory assay) that is presumably already clinically validated and accepted.

8. The sample size for the training set

N/A. This 510(k) summary describes a traditional in vitro diagnostic device, not a machine learning model that requires a "training set." The device's performance is based on its chemical and photometric principles and calibration, not on data-driven training.

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

N/A. (See point 8).

Ask a specific question about this device

The Calcium test system is intended for in vitro diagnostic use in the quantitative determination of the calcium concentration in human serum or plasma on T60 instruments. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.

For in vitro diagnostic use for quantitative testing on T60 instrument. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.

For in vitro diagnostic use for quantitative testing on T60 instrument. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.

Not Found

The provided text describes the Thermo Fisher Scientific Calcium Test System (Calcium, sCal, Nortrol, Abtrol) and its substantial equivalence to a predicate device, the Bayer ADVIA Calcium assay. The information largely focuses on comparing performance metrics between the new device and the predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text, structured according to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a set of pre-defined thresholds the new device had to meet. Instead, it presents a comparison table (Table 1) of various performance attributes between the new device (Calcium) and the predicate device (Bayer ADVIA Calcium assay). The implicit "acceptance" is that the new device's performance is substantially equivalent to or better than the predicate's.

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

• Method Comparison (Serum):

  • Sample Size: N = 112
  • Data Provenance: Not explicitly stated, but it's a comparison to the Bayer ADVIA 2400. Given the submission is from Thermo Fisher Scientific Oy in Finland, and the clinical chemistry context, it's highly likely to be prospective clinical samples, but the country of origin is not specified. It is an in vitro diagnostic device, so the samples used for this study would be human serum/plasma.

• Precision Studies:

  • Sample Size: Not explicitly stated as "N" for the precision studies, but rather by "levels" (e.g., Level 4.0 mg/dL). Typically, precision studies involve running a sample multiple times within a run and across multiple runs. The 'SD' and 'CV(%)' values are calculated from these repeated measurements. The exact number of replicates is not provided.
  • Data Provenance: Not explicitly stated. Likely laboratory-prepared control samples or spiked patient samples.

• Limitations (Interference):

  • Sample Size: Not explicitly stated. Interference studies typically involve spiking samples with known interferents at various concentrations.
  • Data Provenance: Not explicitly stated.

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

For this type of in vitro diagnostic device (a chemical assay), the "ground truth" is established through analytical reference methods or highly accurate laboratory instruments, not by human experts in the way image analysis or clinical diagnosis might be.

• Method Comparison: The new device was compared to the predicate device (Bayer ADVIA 2400). The predicate device itself would have been validated against a reference method. The text also mentions the Bayer ADVIA Calcium assay's traceability to a NIST atomic absorption reference method.
• Traceability: The new device's value has been assigned by using NIST SRM 909b as a primary reference. This implies that NIST standards and reference methods are the "ground truth" for calibrating and validating the assay.

Therefore, there were no human "experts" establishing ground truth in the sense of clinical reviewers for this device. The ground truth relies on established analytical standards and reference measurement procedures.

4. Adjudication Method for the Test Set

Not applicable. As this is an in vitro diagnostic assay, adjudication methods such as 2+1 or 3+1 (often used in clinical image interpretation) are not relevant. The "adjudication" is inherent in the analytical process, where results are compared against reference methods or statistically analyzed for agreement.

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

Not applicable. This is not an AI-assisted diagnostic tool or an imaging device requiring human interpretation. It is a chemical reagent and calibrator system for measuring calcium concentration. Therefore, MRMC studies and "human readers improving with AI" are not relevant to this submission.

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

Yes, in a sense, the entire performance evaluation presented is "standalone" for the device itself. The studies on precision, measuring range, and interference demonstrate the performance of the Calcium test system (reagents, calibrators, and the T60 instrument) independently. The method comparison study also assesses the direct output of the new device relative to the predicate without human intervention in result generation.

7. The Type of Ground Truth Used

The ground truth used for establishing the performance and enabling substantial equivalence determination includes:

• NIST Standards: NIST SRM 909b for primary reference, and the predicate's traceability to a NIST atomic absorption reference method. (This is a form of highly certified reference measurement procedure/material).
• Predicate Device Output: The Bayer ADVIA 2400 Chemistry System's Calcium assay served as the comparative "ground truth" for the method comparison study. The predicate itself would have been validated against a reference standard.
• Laboratory Control Materials/Spiked Samples: Likely used for precision and interference studies.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device that requires a "training set" in the computational sense. It is a chemical reagent-based assay. Its performance is characterized through traditional analytical validation, not by training an algorithm on a dataset.

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

Not applicable, as there is no "training set" for this chemical assay device.

Ask a specific question about this device

For in vitro diagnostic use only. VITROS Ca DT Slides quantitatively measure calcium (Ca) concentration in serum and plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disorders, chronic renal disease and tetany (intermittent muscular contractions or spasms).

For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMY, AST, TBIL, NBIL, BUN/CREA, Ca, CHOL, CK, CI, CO2 CREA, CRSC, Fe, GGT, GLU, HDLC, K*, LAC, LDH, LIPA, Mg, Na*, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

The VITROS Chemistry Products Ca DT Slide assay is performed using the VITROS Chemistry Products Ca DT Slide and the VITROS Chemistry Products DT Calibrator Kit on the VITROS DT60/ DT60 II Chemistry Systems. The VITROS Ca DT Slide is a multilayered, analytical element coated on a polyester support. All reactions necessary for a single quantitative measurement of calcium take place within the multi-layered analytical element of a VITROS Chemistry Products Ca DT slide. A drop of patient sample is deposited on the VITROS Ca DT Slide and is evenly distributed by the spreading layer to the underlying lavers. The bound calcium is dissociated from binding proteins, allowing the calcium to penetrate through the spreading layer into the underlying reagent layer. In the reagent layer, the calcium forms a complex with Arsenazo III dye, causing a shift in the absorption maximum. After incubation, the reflection density of the colored complex is measured spectrophotometrically. The amount of colored complex formed is proportional to the calcium concentration in the sample fluid. The test result is reported in milligrams per deciliter (mg/dL) or millimoles per liter (mmol/ L). VITROS Chemistry Products DT Calibrator Kit contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from bovine serum albumin and processed bovine serum to which enzymes, electrolytes, stabilizers, preservatives and other organic analytes have been added. The companion diluents are prepared from processed water to which inorganic salts have been added. The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the VITROS Chemistry Products Ca DT Slides.

Disclaimer: The provided document is a 510(k) summary for a diagnostic test system, not a typical document detailing AI/ML model performance. Therefore, many standard AI/ML study components (like expert ground truth, MRMC studies, training set details) are not applicable or explicitly mentioned in this type of submission. The analysis below extracts what is available and notes what is not.

Acceptance Criteria and Reported Device Performance

The document describes a modification to an existing device, the VITROS Chemistry Products Ca DT Slides, and asserts its substantial equivalence to the predicate device. The primary characteristics compared are:

Acceptance Criteria (Implicit from Substantial Equivalence): The fundamental acceptance criterion for this 510(k) submission is substantial equivalence to the predicate device. This means the modified device must perform comparably to the previously cleared device, not introducing new questions of safety oreffectiveness. The "reported device performance" is essentially the claim of substantial equivalence, backed by data showing comparable analytical performance to the predicate.

Study Details (Based on an IVD 510(k) Submission)

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

• Sample Size: "patient and quality control samples with measured calcium values spanning the assay range." (Page 3) No specific number of samples is given.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in the sense that it evaluates the modified device's performance against historical or concurrent data from the predicate device. It is a performance verification rather than a prospective clinical trial.

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

• This information is not applicable for this type of in vitro diagnostic device submission concerning analytical performance. The "ground truth" for a calcium assay is typically established through reference methods or the predicate device's measured values, not by human expert interpretation.

4. Adjudication method for the test set:

• Not applicable. This pertains to expert consensus on interpretation, which is not relevant for a quantitative chemical assay.

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

• No. This is an in vitro diagnostic device for quantitative measurement, not an AI/ML-based diagnostic imaging or assessment tool. Therefore, MRMC studies and human reader improvement with AI are not relevant.

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

• Yes, implicitly. The device is an automated, quantitative chemical assay. Its performance is measured independently of human interpretation of the result (though humans operate the instrument and interpret the final numerical value relative to clinical ranges). The "algorithm" here is the chemical reaction and spectrophotometric measurement, which operates in a standalone fashion.

7. The type of ground truth used:

• The ground truth for this type of IVD device is the actual calcium concentration in the samples. This would be established by:
  • Reference methods or highly characterized control materials.
  • Agreement with the predicate device's measurements for comparison/equivalence.
  • The "measured calcium values spanning the assay range" implies these are known or established concentrations against which the device's accuracy and precision are evaluated.

8. The sample size for the training set:

• Not applicable in the context of AI/ML training sets. This device system, while involving some manufacturing process adjustments, is based on established chemical principles, not a machine learning model that undergoes a "training" phase with a dataset. The "training" in this context refers to the calibration of the instrument, for which the VITROS Chemistry Products DT Calibrator Kit is used. The calibrator kit contains "four levels of lyophilized standards." (Page 2)

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

• For the calibrator kit (which serves a similar function to a training set in establishing the measurement curve), the ground truth (assigned values for each of the four levels) would be established by certified reference materials and/or traceability to international standards for calcium measurement. The document states they are "lyophilized standards" prepared from "bovine serum albumin and processed bovine serum," with "enzymes, electrolytes, stabilizers, preservatives and other organic analytes" added (Page 2).

Ask a specific question about this device