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The S TEST Reagent Cartridge Calcium (CA) is intended for the quantitative determination of calcium in serum, lithium heparinized plasma, and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge Calcium is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

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 Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for use in clinical laboratories or physician office laboratories. The instrument consists of a desktop analyzer unit, an operations screen that prompts the user for operation input and displays data, a printer, and a unit cover. The analyzer unit includes a single probe, an incubation rotor, carousels for sample cups and reagent cartridges, and a multi-wavelength photometer. The single-use reagent cartridges may be placed in any configuration on the carousel, allowing the user to develop any test panel where the reagent cartridges are available.

The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters, calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) × 28.mm (D) × 20.2 mm (H).

System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or plasma and results are available in approximately 15 minutes per test. This submission is for Reagent Cartridge Calcium.

Chemistry reactions: Calcium in the sample combines with o-cresolphthalein complexone to form a purple-red complex. The concentration of calcium can be determined by measuring the absorbance of the resulting purple-red color. (With this method, the influence of magnesium is excluded by the addition of 8-hydroxyquinoline.)

Here's a breakdown of the acceptance criteria and study information for the Hitachi S TEST Reagent Cartridge Calcium, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for each performance characteristic. Instead, it presents the results of various studies (precision, linearity, method comparison, interference, matrix comparison) and implies that these results meet regulatory and performance expectations for substantial equivalence. For the purpose of this analysis, I will infer the implied acceptance by comparing the device performance to the predicate device where applicable, or noting the performance demonstrated without a direct comparative statement if no specific target is given.

Study Details

This device is an in vitro diagnostic (IVD) chemistry analyzer for calcium, not an AI/ML device. Therefore, several of the requested sections regarding AI-specific studies (experts, adjudication, MRMC, training set) are not applicable.

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

   • Analytical Sensitivity (LOD): Not explicitly stated, but the study followed CLSI EP17-A.
   • Linearity: Not explicitly stated, but the study followed CLSI EP-6A.
   • 20-day In-house Precision: Three levels of samples, each tested in two runs, twice a day, for 20 days. (Total of 120 measurements per level).
   • Interference Testing: Two serum pools.
   • In-house Method Comparison: 97 clinical specimens (spanning 1.2 to 14.8 mg/dL).
   • Matrices Comparisons: 44 matched serum/plasma samples (spanning 0.9 to 14.7 mg/dL).
   • External Site Precision (Clinical Data): Three blinded serum samples (low, middle, high calcium concentrations) tested at each of three external POL sites. Each sample was assayed 6 times per day for 5 days, resulting in 30 results per level per site.
   • External Method Comparison (Clinical Data): Approximately 55 serum specimens (ranging from 1.3 to 14.6 mg/dL) at each of three external POL sites.
   • Data Provenance: Not explicitly stated for specific samples, but the studies were conducted by "Hitachi Chemical Diagnostics, Inc." (in-house) and at "three external POL-type sites." The specimens are clinical specimens (serum and plasma). The country of origin is not specified but implicitly the US given the FDA submission. All data appears to be prospective collection for the validation of this device.

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

   • Not applicable. This is an IVD device for quantitative chemical analysis; ground truth is established by the analytical reference methods or comparative methods used.

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

   • Not applicable. This is an IVD device for quantitative chemical analysis.

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:

   • Not applicable. This is an IVD device for quantitative chemical analysis, not an AI-assisted diagnostic imaging device involving human readers.

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

   • Yes, implicitly. All studies (precision, linearity, method comparisons, interference, matrix comparisons) evaluate the performance of the device itself (Hitachi E40 Clinical Analyzer with S TEST Reagent Cartridge Calcium) in an automated or semi-automated standalone fashion, generating quantitative results. Human intervention is limited to sample loading, programming, and result interpretation, not in the analytical process itself.

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

   • For Method Comparison studies, "ground truth" is established by a "standard laboratory system" or "comparative method" (predicate or other established analyzer), generating quantitative calcium values.
   • For Analytical Sensitivity, Linearity, Precision, Interference, and Matrix Comparison studies, "ground truth" refers to the expected or known concentrations of calcium in control samples, calibrators, or spiked samples, verified through established analytical methods.

7. The sample size for the training set:

   • Not applicable. This is an IVD device for quantitative chemical analysis, not an AI/ML device requiring a training set in the typical sense. The "training" of the device is its calibration and quality control procedures, which are part of standard IVD practices.

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

   • Not applicable. (See above.)

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