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The IGG1 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 1 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista® System. Measurements of immunoglobulin G subclass 1 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.

The IGG2 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 2 in human serum. heparinized plasma and EDTA plasma on the Dimension Vista" System. Measurements of immunoglobulin G subclass 2 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.

The IGG3 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 3 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System. Measurements of immunoglobulin G subclass 3 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings.

The IGG4 method is an in vitro diagnostic test for the quantitative measurement of immunodobulin G subclass 4 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista" System. Measurements of immunoglobulin G subclass 4 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findinas.

Dimension Vista® IGG 1-2 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 respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista® IGG 3-4 Flex® reagent cartridge: Antibodies as well as polystyrene particles coated with antibodies specific to human IGG3 or IGG4 are aggregated when mixed with samples containing IGG3 or IGG4. These aggregates 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension Vista® IGG Subclass assays:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as 'acceptance criteria' in the document. Instead, the study aims to demonstrate substantial equivalence to legally marketed predicate devices through method comparison. The performance is reported as the results of the regression analysis comparing the new device to the predicate device.

Note on IGG2 data: The provided text has a gap in reporting the specific method comparison results (Slope, Intercept, Correlation Coefficient) for Dimension Vista® IGG2. While it states it was compared, the table only shows IGG1's results against the N Antiserum.

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

• Dimension Vista® IGG1: The test set used a sample size (n) of 129 (human serum/plasma samples, as described in the device's intended use).
• Dimension Vista® IGG3: The test set used a sample size (n) of 142 (human serum/plasma samples).
• Dimension Vista® IGG4: The test set used a sample size (n) of 150 (human serum/plasma samples).
• Data Provenance: The document does not specify the country of origin of the data. It does not explicitly state if the data was retrospective or prospective, although method comparison studies usually involve prospectively collected samples or a mixed approach of existing and newly collected samples for spanning the measuring range.

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

This type of information is generally not applicable to in vitro diagnostic (IVD) devices like the one described. The "ground truth" in this context is the measurement obtained from the legally marketed predicate device (Siemens N Antisera to Human IgG Subclasses 1 and 2, and Siemens N Latex IgG3 and 4 assays run on the BN ProSpec® System). These are established diagnostic assays, and their results are treated as the reference for comparison, not requiring expert consensus for individual sample values.

4. Adjudication Method for the Test Set

Not applicable. For IVD devices comparing to a predicate, the predicate device's result is the reference point, not an adjudicated "ground truth" derived from human experts.

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. This is an in vitro diagnostic assay, not an imaging device or AI-assisted diagnostic tool that involves human readers/interpreters in the decision-making process. The device performs quantitative measurements directly.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance study was done. The method comparison described (new device vs. predicate device) assesses the performance of the Dimension Vista® IGG Subclass assays as standalone devices. The results are quantitative measurements, not dependent on human interpretation of the assay's output for diagnosis, though clinicians interpret the quantitative results in conjunction with other findings.

7. The Type of Ground Truth Used

The "ground truth" for the method comparison studies was the results obtained from the legally marketed predicate devices:

• Siemens N Antisera to Human IgG Subclasses 1 and 2 (for IGG1 and IGG2)
• Siemens N Latex IgG3 and 4 (for IGG3 and IGG4)

These predicate devices were run on the BN ProSpec® System.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" or its sample size. For an IVD device submission, the focus is typically on verification and validation studies (like method comparison) using clinical samples, rather than a separate "training set" in the context of machine learning algorithms. The development and internal optimization of the assay might involve various samples, but these are generally considered part of the development phase leading up to the formal validation studies.

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

As no training set is explicitly mentioned or detailed in the document in the context of algorithm development, this question is not applicable. The performance characteristics are evaluated against established predicate methods.

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This kit is intended for the quantification of IgG subclasses in serum on the Hitachi 911 (7070). Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Human IgG Subclass Liguid Reagent Kit for use on the Hitachi 911/7070 Turbidimetric Analyzer

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Human IgG Subclass Liquid Reagent Kit":

Based on the provided document, which is an FDA 510(k) clearance letter, it's important to understand that this letter grants clearance based on a demonstration of substantial equivalence to a predicate device. It does not present the detailed study findings or acceptance criteria directly within the letter itself.

The letter refers to the "510(k) premarket notification" as the document that contains the actual study details and data. To answer your questions fully, one would typically need access to the full 510(k) submission, which is not provided here.

However, I can extract what is implied and what is explicitly not present in this particular document:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in this document. For an in vitro diagnostic device like this, acceptance criteria would typically involve analytical performance characteristics such as:

  • Accuracy/Correlation: Comparison with a reference method or predicate device, often assessed by linear regression (slope, intercept, r-value) and/or bias plots (e.g., Bland-Altman).
  • Precision/Reproducibility: Within-run, between-run, and total precision studies (CV%).
  • Analytical Measurement Range (AMR): The range over which the device can accurately quantify the analyte.
  • Limit of Detection (LoD) / Limit of Quantitation (LoQ): The lowest concentration that can be reliably detected/quantified.
  • Interference: Studies demonstrating lack of significant interference from common endogenous and exogenous substances.
  • Specificity: Absence of cross-reactivity with related substances.
  • Method Comparison: Direct comparison with the predicate device or a gold standard method using clinical samples.
  • Clinical Performance: (Less common for new 510(k) analytes with well-established uses, but could involve comparing results with clinical diagnosis or outcomes).

• Reported Device Performance: Not explicitly stated in this document. The letter only confirms that the FDA reviewed the submission and found the device substantially equivalent. The actual performance data would be in the 510(k) submission itself.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in this document.
• Data Provenance: Not specified in this document.

3. 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/not specified. For an in vitro diagnostic device that quantifies an analyte (IgG subclasses), the "ground truth" is typically established by:
  • Quantitative results from a well-characterized reference method or a legally marketed predicate device.
  • Certified reference materials or commutable reference materials.
  • Pathology (e.g., for calibrator assignment if a new analyte).
• Expert consensus is not typically involved in establishing ground truth for quantitative laboratory tests in the same way it is for image interpretation or diagnosis.

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

• Not applicable/not specified. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in scenarios involving human interpretation (e.g., image reading, clinical diagnosis), not for quantitative laboratory test results.

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

• No, an MRMC comparative effectiveness study was not done. This type of study applies to devices (often AI-based) that assist human readers (e.g., radiologists, pathologists) in interpreting complex data, especially images. This device is an in vitro diagnostic reagent kit for automated turbidimetric analysis, which does not involve human interpretation in the same way.

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

• Yes, in essence, this device represents a "standalone" performance. The "algorithm" here is the chemical reaction and optical measurement performed by the Hitachi 911/7070 Turbidimetric Analyzer using the provided reagents. The performance claimed for this device (quantification of IgG subclasses) is its direct analytical output, without requiring human interpretation or assistance for the measurement itself. The results are then used by clinicians for diagnosis.

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

• For an in vitro diagnostic device like this, the ground truth for performance studies (e.g., accuracy, method comparison) would typically be:
  • Reference method results: Results obtained from a well-established, validated, and often more laborious or expensive laboratory method.
  • Predicate device results: Comparison to the quantitative results generated by the legally marketed predicate device.
  • Certified Reference Materials (CRMs) / Reference Materials (RMs): Samples with accurately assigned values.

8. The sample size for the training set

• Not applicable/not specified. This is a reagent kit for a turbidimetric analyzer. It is not an AI/machine learning device that requires a "training set" in the computational sense. The "training" of such a system involves calibrating the instrument with known standards and ensuring the reagents perform correctly; this is part of standard laboratory practice and manufacturing quality control, not a separate "training set" study for regulatory clearance in the AI context.

9. How the ground truth for the training set was established

• Not applicable/not specified. As explained above, the concept of a "training set" with established ground truth, as used in AI/ML, does not apply to this type of device.

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The contents of the Peliclass™ Human IgG Subclass Nephelometric IMMAGE® Kit will allow quantitative determination of all four IgG Subclasses in at least 50 serum samples with the Beckman IMMAGE® Immunochemistry System. The determination of IgG subclasses is to be used in conjunction with other clinical findings to aid in the assessment of the humoral immune status.

Sheep antibodies to human IgG subclasses with the four subclasses of human IgG immunoglobulins, forming immuno-precipitates. This reaction consequently causes changes in the intensity of scattered light at a rate that increases gradually at first, then rapidly and finally proceeds through a peak rate of change (peak rate value) for the component being analyzed.

The provided text is a 510(k) summary for a medical device (Peliclass™ Human IgG Subclass Nephelometric IMMAGE® Kit) and correspondence from the FDA confirming substantial equivalence. This document type does not typically contain detailed study data, acceptance criteria, or performance metrics in the format requested.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel effectiveness study results with specific acceptance criteria and performance data. It describes the device, its intended use, and identifies a predicate device. It does not include information typically found in a clinical study report or a validation study.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text. This information would typically be found in accompanying technical documentation or detailed study reports, which are not part of this 510(k) summary document.

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Ask a specific question about this device