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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.

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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.

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