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The Optilite CH50 reagents are intended for the quantitative in vitro determination of total classical complement activity (CH50) in human serum using the Binding Site Optilite turbidimetric analyser. Measurement of complement activity aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components. This test should be used in conjunction with other laboratory and clinical findings. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.

The Optilite CH50 calibrator is intended for use on the Optilite analyser in conjunction with the Binding Site Optilite CH50 Reagent (product code NK095.OPT) for the determination of total complement activity. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.

The Optilite CH50 controls are intended for use on the Optilite analyser in conjunction with the Binding Site Optilite CH50 Reagent (product code NK095.OPT) for the determination of total complement activity. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.

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I am sorry, but the provided text does not contain the detailed information necessary to complete the requested table and study description. The document is an FDA 510(k) clearance letter for the Optilite CH50 Reagent, Controls, and Calibrator, and it primarily focuses on the device's indications for use and regulatory compliance.

It does not include:

• A table of specific acceptance criteria and reported device performance.
• Details about sample sizes for test sets, data provenance, or training sets.
• Information on the number or qualifications of experts for establishing ground truth, or adjudication methods.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
• The type of ground truth used.

Therefore, I cannot fulfill your request based on the provided input.

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Human CH50 reagent pack for use on the SPA plus. These reagents are intended for the quantification of total classical complement activity (CH50) in human serum on the Binding Site SPAPLUS analyser. Measurement of complement activity aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components. The test results are to be used in conjunction with clinical findings and other laboratory tests. Human CH50 calibrator set for use on the SPA plus The Human CH50 calibrator set is intended for use on the SPAPLUS in conjunction with the Binding Site Human CH50 reagent pack (product code: NK095.S) for the determination of total complement activity. Human CH50 controls for use on the SPA plus. The Human CH50 controls are intended for use in conjunction with the Binding Site Human CH50 reagent pack for use on the SPAPLUS (product code: NK095.S).

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This looks like a 510(k) clearance letter for an in vitro diagnostic (IVD) device, not a typical AI/ML-driven medical device. Therefore, many of the requested elements (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not directly applicable in the same way they would be for an AI algorithm that processes images or other complex data.

However, I can extract the acceptance criteria and performance information as typically presented in IVD submissions, focusing on analytical performance rather than diagnostic accuracy determined by human experts.

Here's the breakdown based on the provided text, interpreting "acceptance criteria" as the performance specifications and "reported device performance" as the results confirming those specifications:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (a 510(k) clearance letter and Indications for Use) does not contain the detailed acceptance criteria or the study results. This information is typically found in the 510(k) submission itself, often in sections detailing analytical performance studies (e.g., precision, accuracy, linearity, interfering substances). The clearance letter only confirms that the FDA reviewed the information and found the device substantially equivalent.

To illustrate what such a table would look like for an IVD, and as an example if this information were available in the submission, here's a hypothetical structure:

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

This information is not provided in the clearance letter or the Indications for Use. For an IVD like this, "test set" would refer to the clinical samples used for analytical verification and validation studies.

• Sample Size: Unknown from this document. IVD studies typically use a range of samples for different studies (e.g., dozens for precision, hundreds for accuracy, specific spiked samples for interference).
• Data Provenance: Unknown from this document. Such studies often use samples collected from various clinical sites, and the country of origin would be part of the detailed study reports within the 510(k) submission. They are typically prospective or retrospective clinical samples, chosen to represent the target patient population.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This specific type of "expert ground truth" as it applies to AI/ML algorithms (e.g., radiologists interpreting images) is not applicable here. For an IVD measuring a biomarker like CH50, the "ground truth" is established through:

• Reference Methods: Comparing the device's results to a recognized, often more laborious or expensive, reference method for CH50 measurement.
• Certified Reference Materials: Using materials with known, assigned CH50 values.
• Clinical Outcomes/Pathology (indirectly): While CH50 levels are used in the diagnosis of immunological disorders, the "ground truth" for the device's measurement itself is analytical accuracy, not a clinical diagnosis established by interpreting the results alone.

4. Adjudication Method for the Test Set

Not Applicable in the context of expert adjudication for an IVD measuring a specific analyte. Adjudication applies to subjective interpretations, not quantitative measurements compared to a reference.

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

Not Applicable. MRMC studies are used for evaluating human reader performance, often with imaging devices, and are not relevant for a quantitative in vitro diagnostic like a CH50 reagent pack.

6. Standalone Performance

Yes, in a way. An IVD device's performance is its standalone performance. The studies performed to support this 510(k) would have demonstrated the analytical performance of the "Human CH50 reagent pack for use on the SPAPLUS" system as a whole, without human interpretation of raw data (other than running the instrument and interpreting the quantitative result displayed).

7. Type of Ground Truth Used

The ground truth for an IVD measuring a specific analyte like CH50 would typically be established by:

• Reference Methods: Comparison against established, often gold-standard, laboratory methods for CH50 (e.g., standard hemolytic assays).
• Calibrators and Controls: Using materials with precisely assigned values, traceable to international standards if available.
• Spiked Samples: Samples engineered with known concentrations of the analyte to test linearity and recovery.

8. Sample Size for the Training Set

Not Applicable. This is an IVD reagent and calibrator/control set, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" for such a system involves the chemical and biological formulation of reagents, optimization of the analytical method, and instrument calibration, not machine learning model training.

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

Not Applicable for an IVD reagent system. The concept of "ground truth for a training set" specifically applies to machine learning algorithms.

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For measuring human haemolytic complement activity by the Classical pathway in human serum, as an aid in the diagnosis of disease associated with complement activation, and with complement component deficiencies.

Total Haemolytic Complement RID Kit

This FDA document, K992488, is a 510(k) clearance letter for a device called "Total Haemolytic Complement RID Kit." It states that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this type of document is a clearance, not a study report or a detailed performance evaluation. Therefore, it does not contain the information requested about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment.

Here's why the requested information cannot be extracted from the provided text:

• 510(k) clearances focus on substantial equivalence. They confirm that a new device is as safe and effective as a legally marketed predicate device, often by demonstrating similar technological characteristics and indications for use. They do not typically provide the detailed clinical study data or performance metrics that would be found in a full study report or premarket approval (PMA) application.
• The document is a letter, not a scientific paper. It's a regulatory communication from the FDA to the manufacturer, not a publication describing a study's methodology and results.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample size, or ground truth based solely on the provided text.

To obtain the requested information, one would need to access the original 510(k) submission document (if publicly available) or any associated clinical study reports that the manufacturer submitted to the FDA to support their claim of substantial equivalence. These documents would contain the detailed performance data, acceptance criteria, and study methodologies.

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The QUIDEL CH50 Eq EIA intended to measure the total classical complement pathway activity in human serum, thereby allowing detection of a deficiency of one or more of the complement components C1 through C9. The QUIDEL CH50 Eq EIA is intended for laboratory and professional use.

The QUIDEL CH50 Eq EIA provides a direct measure of the total classical complement activity in serum by quantifying the amount of TCC generated under standard conditions. The test uses a monoclonal antibody to a unique neoantigen to capture the TCC analyte. Since both the QUIDEL CH50 Eq EIA and the CH50 test rely on the generation of TCC and correlate, the QUIDEL CH50 Eq EIA's results are expressed in CH50 unit equivalents per milliliter.

Here's a breakdown of the acceptance criteria and study information for the QUIDEL CH50 Eq EIA, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: 226 patient samples.
   • Data Provenance: Tested at a "major clinical reference laboratory in the United States." The samples were likely retrospective, though not explicitly stated as such.

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

   • The document does not specify the number of experts or their qualifications for establishing ground truth.
   • The ground truth was established by "the combined results from three hemolytic and one EIA-based assay," rather than expert consensus on individual cases.

3. Adjudication method for the test set:

   • Not applicable directly. Ground truth was established by comparing the QUIDEL CH50 Eq EIA results against a combination of reference assays, not by human adjudication of individual cases.

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

   • No. This study is for an in-vitro diagnostic (IVD) device (an EIA assay) that directly measures an analyte. It does not involve human readers or AI in the interpretation of images or other subjective data, so an MRMC study is not relevant here.

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

   • Yes, effectively. The "overall accuracy" of the QUIDEL CH50 Eq EIA "when compared to the combined results from three hemolytic and one EIA-based assay" demonstrates its standalone analytical performance. The device is intended for laboratory and professional use, implying a human operator performs the test and interprets the result, but the accuracy measurement itself is of the device's output.

6. The type of ground truth used:

   • Comparative Reference Assays: The ground truth was established by the "combined results from three hemolytic and one EIA-based assay." These are established laboratory methods for measuring total classical complement activity.

7. The sample size for the training set:

   • The document does not indicate a separate "training set" or its size. For an IVD assay like this, development typically involves optimizing reagents and protocols during analytical validation, rather than distinct training and test sets in the machine learning sense. The 226 patient samples can be considered the core clinical validation dataset.

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

   • As no explicit training set is identified, this question is not directly applicable. If developmental work used samples, the ground truth would have likely been established through similar reference methods to those used for the test set, or through known healthy/diseased donor samples.

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