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HiChem Calcium Reagent is intended for the quantitative determination of total calcium in serum, plasma and urine. 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 HiChem Calcium Reagent determines calcium by its reaction with arsenazo III to form a blue complex. The resulting increase in absorbance at 650 nm is proportional to the calcium concentration in the sample. The HiChern Calcium Reagent is an adaptation of the arsenazo III calcium method, first reported by Michaylova and Illikova and is intended to be used either as a manual procedure or on clinical analyzers which can automate the required manipulations.

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

Acceptance Criteria and Device Performance

The provided text describes two main scenarios for the HiChem Calcium Reagent: the manual procedure and its use on the Beckman® SYNCHRON CX® Systems (secondary reagent application). The acceptance criteria are largely implied by the reported performance, as the study aims to demonstrate substantial equivalence to an existing predicate device.

Table of Acceptance Criteria and Reported Device Performance

Study Details

The studies described are primarily designed to demonstrate substantial equivalence to the predicate device, the Beckman® Systems Calcium Reagent. This means the new device performs similarly enough to the legally marketed device that it is considered safe and effective for the same intended use.

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

   • Manual Procedure:
     • Linearity: 23 data points (df) for linearity standards spanning 0-18 mg/dL.
     • Precision: 30 replicates (n) for each of 4 control specimens (2 serum, 2 urine).
     • Method Comparison: 92 mixed serum and plasma specimens.
     • Sensitivity: 30 replicates for a diluted serum control.
   • SYNCHRON CX® Systems Application:
     • Linearity: 29 data points (df) for six linearity standards spanning "at least 2.0 mg/dL to 15.0 mg/dL."
     • Precision: 60 replicates (n) for each of 5 control specimens (3 serum, 2 urine).
     • Method Comparison: 153 mixed serum and plasma specimens.
     • Sensitivity: 30 replicates for a diluted serum control.
   • Data Provenance: Not explicitly stated but implied to be laboratory-generated data for performance characteristics and potentially patient samples for method comparisons. No specific country of origin is mentioned, nor is it explicitly stated as retrospective or prospective, though the nature of laboratory validation studies often implies prospective data collection for the specific tests performed.

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

   • This type of study for a laboratory reagent does not typically involve human experts establishing ground truth in the same way as, for example, an imaging AI study. The "ground truth" for these tests comes from:
     • Assigned values of linearity standards: These are precisely manufactured solutions with known calcium concentrations.
     • Assigned values of control sera/urine: These are commercially available reference materials with established target values.
     • Results from the predicate device (Beckman® SYNCHRON® Calcium Reagent): For method comparison studies, the predicate device's results serve as the reference standard against which the new device is compared.
   • Therefore, no information on "number of experts" or their "qualifications" is provided or relevant in this context.

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

   • Not applicable. This is a quantitative reagent study, not an imaging or qualitative diagnostic study requiring expert adjudication of results. The results are numerical measurements.

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 a study of a laboratory reagent's performance in quantitative measurement, not an AI-assisted diagnostic tool involving human readers.

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

   • Yes, the performance data presented (linearity, precision, method comparison, sensitivity, stability) for both the manual procedure and the automated SYNCHRON CX® Systems application represent the standalone performance of the HiChem Calcium Reagent. While a human initiates the tests and interprets the results, the data itself reflects the reagent's analytical capability. There is no "human-in-the-loop" interaction in the sense of an AI interpreting images for a human.

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

   • Reference Method/Comparator: The primary "ground truth" for comparison is the Beckman® SYNCHRON® Calcium Reagent, which is the legally marketed predicate device. The study aims to show that the HiChem reagent produces results substantially equivalent to this established method.
   • Known Reference Values: For linearity and precision studies, the ground truth is based on known, pre-assigned concentrations in linearity standards and commercial control materials. These values are derived through rigorous analytical methods by the manufacturers of these standards/controls.

7. The sample size for the training set:

   • Not applicable. This is a chemical reagent, not a machine learning algorithm that requires a "training set" in the computational sense. The "development" or "formulation" of the reagent would involve extensive R&D and optimization, but it's not parallel to training a neural network on a dataset.

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

   • Not applicable for the reason stated above.

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HiChem ALP/AMP Reagent (product no. 70001) is intended for the quantitative determination of alkaline phosphatase in serum and plasma. The principal diagnostic indications of elevated serum alkaline phosphatase are diseases of the liver, bone, parathyroid and intestine.

The HiChem ALP/AMP Reagent determines alkaline phosphatase by enzymatic hydrolysis of p-nitrophenylphosphate to p-nitrophenoxide at alkaline pH. The HiChem ALP/AMP Reagent is intended to be used either as a manual procedure or on clinical analyzers which can automate the required manipulations. The reagent is supplied as two liquid-stable components which are combined, either before or during use, in the approximate ratio of 1 part ALP/AMP Substrate and 5 parts ALP/AMP Reagent Buffer. The ALP/AMP Substrate can also be used as a start reagent and combined with the Reagent Buffer following sample addition.

Here's a breakdown of the acceptance criteria and study information for the HiChem ALP/AMP Reagent, based on the provided text:

Important Note: The provided document is a 510(k) summary for a diagnostic reagent, not a medical device in the typical sense of AI-powered imaging or diagnostic software. Therefore, many of the requested categories (e.g., number of experts, adjudication methods, MRMC studies, standalone performance for AI, training set details) are not applicable to this type of submission. This document focuses on demonstrating substantial equivalence to existing, legally marketed devices through analytical performance characteristics.

Acceptance Criteria and Reported Device Performance

Device: HiChem ALP/AMP Reagent (product no. 70001)

Intended Use: Quantitative determination of alkaline phosphatase (ALP) in serum and plasma.

Precision Results - Manual Procedure (37°C):

Precision Results - Automated Procedure:

Study Details

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

   • Manual Procedure:
     • Linearity: Standards ranging from 0 to over 1,350 U/L (number of individual standards not specified, but usually involves multiple levels).
     • Precision: 30 replicates for each of 3 control sera.
     • Method Comparison (vs. MAS Reagent): 83 mixed serum and plasma specimens.
     • Anticoagulant Interference: "spiked serum pools" (specific number not given, but plural implies more than one).
     • Stability: Serum controls (ranging from approx. 50 to 750 U/L ALP) tested over 1 month and 3 days.
   • Automated Procedure (Hitachi 704):
     • Linearity: Ten linearity standards spanning the claimed linear range.
     • Precision: 60 replicates for each of 3 commercially available control sera.
     • Method Comparison (vs. BMD Reagent): 178 mixed serum and plasma specimens.
     • Calibration Stability: Serum controls (ranging from approx. 50 to 750 U/L ALP).
     • On-board Stability: Serum controls using the same reagent tested over 15 days.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective analytical performance studies designed to test the reagent's characteristics. The "mixed serum and plasma specimens" for method comparison suggest real-world patient samples.

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

   • N/A. This is an in-vitro diagnostic reagent. Ground truth is established through the measurement of analyte concentrations using the stated methods and comparisons to established, legally marketed predicate devices, not through expert human interpretation.

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

   • N/A. Adjudication methods are relevant for subjective interpretations (e.g., medical imaging reads), not for quantitative chemical measurements.

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:

   • N/A. This applies to AI-assisted diagnostic tools, not chemical reagents.

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

   • N/A. This applies to AI algorithms, not chemical reagents. The performance described is the "standalone" performance of the reagent, either manually or on an automated analyzer.

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

   • Analytical Measurement (Reference Methods/Predicate Devices): The "ground truth" for the linearity studies were known concentrations of alkaline phosphatase in standards. For method comparison studies, the "ground truth" was established by measurements performed using the legally marketed predicate devices (MAS ALP Reagent and BMD Alkaline Phosphatase/AMP Reagent), which are accepted reference points for determining substantial equivalence.

7. The sample size for the training set:

   • N/A. This reagent is not an AI algorithm requiring a training set in the conventional sense. The "training" of the reagent would involve its formulation and optimization during development, which is not detailed here.

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

   • N/A. See point 7.

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