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The Optilite Cl Inactivator Kit is intended for the quantitative in vitro measurement of human C1 Inactivator in human serum using the Binding Site Optilite analyser. Measurement of CI inactivator levels in serum is an aid in the diagnosis of hereditary angioedema (HAE) in conjunction with other laboratory and clinical findings.

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I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the Optilite C1 Inactivator and an Indications for Use statement. It confirms the device's substantial equivalence to a predicate device but does not detail the specific performance acceptance criteria or the study design and results (sample sizes, ground truth establishment, expert qualifications, etc.) that would demonstrate the device meets those criteria.

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This Human C1 Inactivator kit for use on SPAPLUS is intended for the in vitro measurement of human C1 inactivator in human serum using the SPAPLUS Analyzer. Measurement of C1 inactivator levels in serum is an aid in the diagnosis of hereditary angioedema (HAE) in conjunction with other laboratory and clinical findings.

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The provided document is an FDA 510(k) clearance letter for an in vitro diagnostic device, the "Human C1 Inactivator Kit for use on SPAPLUS." It does not contain any information about the acceptance criteria or study details for proving the device meets those criteria, as typically found in a clinical study report or a 510(k) summary (which is a separate document).

The letter primarily confirms that the FDA reviewed the premarket notification and determined the device is substantially equivalent to a legally marketed predicate device. It defines the device name, regulation number, regulation name, regulatory class, and product codes. It also outlines responsibilities of the manufacturer regarding general controls, labeling, and reporting.

Therefore, I cannot provide the requested information based on the given text. The text does not include:

• A table of acceptance criteria or reported device performance.
• Sample sizes for test or training sets, nor data provenance.
• Details about experts for ground truth establishment or adjudication methods.
• Information on MRMC studies or standalone algorithm performance.
• The type or establishment method of ground truth.

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Dimension Vista® C1IN Flex® reagent cartridge: The C1IN method is an in vitro diagnostic test for the quantitative measurement of C1 inhibitor in human serum and plasma on the Dimension Vista® System. Measurements of C1 Inhibitor aid in the diagnosis of hereditary angioneurotic edema (increase blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).

Dimension Vista® C1IN CAL: The C1IN CAL is an in vitro diagnostic product for the calibration of the C1 Inhibitor (C1IN) method on the Dimension Vista® System.

Dimension Vista® C1IN CON: C1 Inhibitor Control is an assayed, mid level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of C1 Inhibitor (C1IN).

Dimension Vista® C1IN Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista® C1IN CAL: C1 Calibrator is a lyophilized, human plasma based product containing C1 Inhibitor (C1IN).

Dimension Vista® C1IN CON: C1 Control is a lyophilized, mid-level, human plasma based products containing C1 Inhibitor (C1IN).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, 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

• Sample Size: 196 (serum and plasma samples)
• Data Provenance: The text does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "human serum and plasma samples."

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

The document does not describe the use of experts to establish a "ground truth" for the test set in the conventional sense of clinical interpretation. This is a comparison study between two assays, not a diagnostic study where human readers are making interpretations.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this study compares the performance of two analytical assays, not diagnostic interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This study is an analytical method comparison between a new device (Dimension Vista® C1IN assay) and a legally marketed predicate device (Dade Behring N Antisera to Human C1 Inhibitor assay) on two different laboratory platforms. It does not involve human readers evaluating cases or the effect of AI assistance.

6. Standalone Performance Study

Yes, a standalone study was done in the sense that the performance of the Dimension Vista® C1IN assay was evaluated on its own by comparing its results to results from a predicate device. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices. It's not "algorithm only" in the context of AI, but "device only" performance in the context of analytical measurement.

7. Type of Ground Truth Used

The "ground truth" in this context is the results obtained from the legally marketed predicate device, the Dade Behring N Antisera to Human C1 Inhibitor assay on the BN ProSpec® System. The study aims to show that the new device produces results that are comparable or equivalent to the established method.

8. Sample Size for the Training Set

Not applicable. This is an in vitro diagnostic assay, not an AI/ML device that requires a training set in the machine learning sense. The "training" for such a device typically involves method development and optimization, but not with a distinct "training set" of patient data as understood in AI.

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

Not applicable. See point 8.

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The K-ASSAY C1-INA Assay is intended for the quantitative determination of human Complement-1 Inactivators in human plasma by immunoturbidimetric assay for hereditary angioedema. FOR IN VITRO DIAGNOSTIC USE.

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I am sorry, but the provided text only contains an FDA 510(k) clearance letter and an "Indications for Use Statement" for the K-ASSAY Complement-1 Inactivator (C1-INA) device. This document does not include information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in your prompt regarding a study that proves the device meets acceptance criteria.

The information primarily confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed subject to general controls. It does not contain the technical details of the validation studies conducted for the device.

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In vitro diagnostic reagent for the quantitative determination of C1-inactivator, C1-esterase inhibitor) in human plasma and serum with the Behring Nephelometers. Measurement of C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).

In vitro diagnostic reagent for the quantitative determination of C1-inactivator, C1-esterase inhibitor) in human plasma and serum with the Behring Nephelometers. Measurement of C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of anqioedema associated with lymphoma (lymph node cancer).

In an immunochemical reaction, C1 Inhibitor in the human plasma sample form immune complexes with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.

This appears to be a 510(k) summary for an in vitro diagnostic (IVD) device, not a medical device in the typical sense of AI-powered diagnostics. Therefore, many of the requested categories like "multi reader multi case (MRMC) comparative effectiveness study," "effect size of how much human readers improve with AI vs without AI assistance," and "number of experts used to establish the ground truth" are not applicable to this type of submission.

Here's the information extracted and formatted to the best of my ability given the nature of the document:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implies the acceptance criteria through the presentation of performance data and the claim of substantial equivalence. Specific thresholds for 'acceptable' correlation coefficients or %CVs are not explicitly stated, but the reported values would have been deemed acceptable by the FDA for clearance.

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

• Sample Size for Correlation Study: 50 serum samples.
• Data Provenance: Not explicitly stated. Given the manufacturer is in Germany and the distributor in the US, the samples could be from either region or a mix. The document does not specify if the data is retrospective or prospective.

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

Not applicable. This is an IVD device for quantitative measurement, not an AI diagnostic that requires expert interpretation to establish ground truth for image or clinical data. The "ground truth" for this device is based on the performance of a legally marketed, predicate device and established laboratory precision methods.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication method (like 2+1, 3+1) is relevant for this type of IVD device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done, as this is an IVD for quantitative measurement and does not involve human readers interpreting results in the way AI diagnostics do.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is an IVD medical device. Its "standalone performance" is represented by its analytical performance characteristics (correlation, precision) when measuring samples. It is inherently a standalone device in that it provides a quantitative result without direct human interpretation of a complex output, unlike an AI algorithm that might flag or diagnose.

7. The Type of Ground Truth Used

The "ground truth" for proving equivalence was the results obtained from the legally marketed predicate device (BIND A RID™ C1 assay) when tested on the same samples. For precision, the ground truth is statistical measurements based on repeated testing of control samples.

8. The Sample Size for the Training Set

Not applicable. This is an IVD device that uses specific antibodies for an immunochemical reaction and nephelometry, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" of the system involves calibration using standards of known concentration.

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

Not applicable as there is no "training set" in the AI sense. For calibration where "standards of known concentration" are used, the ground truth for these standards would be established through highly controlled laboratory procedures, often traceable to reference materials or primary calibrators.

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