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The K-ASSAY Haptoglobin Assay is intended to be used for the quantitative determination of Haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in human serum by immunoturbidimetric assay. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) relating to the formation of hemoglobin complexes and certain kidney diseases. FOR IN VITRO DIAGNOSTIC USE.

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Here's an analysis based on the provided FDA 510(k) clearance letter and Indications for Use statement for the K-ASSAY Haptoglobin device.

It's important to note that this document is an FDA clearance letter, which means it confirms substantial equivalence to a predicate device. It typically does not contain the full details of the study that established the device's performance against specific acceptance criteria in the way a clinical trial report or a comprehensive validation study might. Many of the requested details (like sample size, ground truth establishment, expert qualifications, etc., for AI performance) are not applicable or not present here because this is for an In Vitro Diagnostic (IVD) assay, not an AI/ML-based diagnostic device.

However, I will extract what is relevant and indicate where information is not available from the provided text.

Device: K-ASSAY Haptoglobin

Device Type: In Vitro Diagnostic (IVD) assay (immunoturbidimetric assay)

Intended Use: Quantitative determination of Haptoglobin in human serum to aid in the diagnosis of hemolytic diseases and certain kidney diseases.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria or detailed performance metrics from a validation study. For IVD devices like this one, acceptance criteria would typically involve analytical performance characteristics (e.g., precision, accuracy, linearity, reportable range, interference) and potentially clinical performance (e.g., correlation with clinical status or another accepted method).

The FDA's review for a 510(k) involves determining substantial equivalence to a legally marketed predicate device. This implies that the sponsor demonstrated the new device performs "as safely and effectively as" a predicate, but the specific numerical benchmarks of that comparison are not in this letter.

2. Sample size used for the test set and the data provenance

• Not explicitly stated in the provided document.
• For IVD assays, test sets would include patient samples (serum in this case) covering the expected analytical range and potentially clinical conditions.
• Data Provenance: Not specified. Typically, clinical samples might be from various clinical sites.
• Retrospective or Prospective: Not specified. Could be either or a combination.

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

• Not applicable in the context of this being an IVD assay clearance.
• Ground truth for an IVD assay usually refers to the true concentration of the analyte, often established by a gold standard reference method or laboratory. It doesn't typically involve multiple human experts interpreting data for a diagnostic decision.

4. Adjudication method for the test set

• Not applicable. As above, this is for an IVD assay, not a device requiring human interpretation adjudication.

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 IVD assay, not an AI-assisted diagnostic device. Therefore, no human reader improvement with AI assistance would be studied or reported here.

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

• Not applicable. This is an IVD assay that quantifies a biomarker. Its "performance" is its analytical accuracy and precision in measuring haptoglobin, not an algorithmic interpretation of an image or other complex data.

7. The type of ground truth used

• Implied ground truth: For an IVD assay, the ground truth would be the true concentration of Haptoglobin in a sample. This is typically established by:
  • Reference materials/calibrators: Samples with precisely known concentrations.
  • Comparison methods: Results from a well-established, often predicate or gold-standard, analytical method.
  • Clinical correlation: Demonstrating that the measured Haptoglobin levels correlate with the presence or absence of the intended clinical conditions (hemolytic diseases, kidney diseases).
• Not explicitly detailed in the document.

8. The sample size for the training set

• Not applicable in the AI/ML sense. For an IVD assay, there isn't a "training set" in the context of machine learning. There would be samples used during assay development and optimization (which might be analogous to "training data" in a very broad sense) and then independent validation samples. The size of these development samples is not specified.

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

• Not applicable in the AI/ML sense. As above, the concept of "ground truth for a training set" as it pertains to AI/ML models does not directly apply to the development of this type of immunoturbidimetric IVD assay. The accuracy of the assay is established through analytical validation against known concentrations and comparison with established methods.

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Immunoturbidometric assay for the quantitative in-vitro determination of Haptoglobin.

Immunological latex agglutination test for the in vitro quantitative determination of haptoglobin in human scrum and plasma.

Mcasurement of haptoglobin may aid in the diagnosis of hemolytic discases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobinhaptoglohin complexes and ccrtain kidncy discascs.

The Haptoglobin determination is based upon turbidimetric immunoinhibition (TINIA) using a serum or plasma blood sample. The sample containing Haptoglobin is transferred into a TRIS buffer solution (R₁ reagent). In the second step, an aliquot of solution of polyclonal anti-human Haptoglobin antibodies (R₂ reagent) is added to mixture of the first step. The antibody will bind to the Haptoglobin in the sample to form “aggregates” such that the amount of aggregate formed is proportionate to the amount of Haptoglobin present in the sample.

The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of Haptoglobin in the sample is directly proportional to the amount of turbidity formed.

The provided document describes the Tina-quant® Haptoglobin Assay, an immunoturbidimetric assay for the quantitative in-vitro determination of Haptoglobin. The document focuses on demonstrating substantial equivalence to a predicate device, the Behring BN® Haptoglobin assay, rather than presenting a standalone study with defined acceptance criteria and subsequent proof.

Therefore, much of the requested information cannot be directly extracted as it pertains to a typical new device validation study with specific acceptance criteria. However, I can provide the available information in the requested format, clearly indicating where data is not available or not applicable based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" for the Tina-quant® Haptoglobin Assay in the way a new, independent validation study would. Instead, it presents performance characteristics and compares them to a predicate device to demonstrate substantial equivalence. The "acceptance criteria" are implied to be the comparable performance to the predicate device.

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

• Sample Size for Test Set:
  • Precision (Intra-Assay): N=21 for both Pool (low) and Pool (high). The document mentions "N=21" for the Tina-quant® Intra-Assay; for the Behring BN®, it states "N=30", implying 30 replicates.
  • Precision (Inter-Assay): N=21 for Sample 1, N/A for Sample 2 for Tina-quant®. The Behring BN® reports "N=10" for Sample 1 and 2. It's unclear if Sample 1 and Sample 2 for Tina-quant® represent independent samples or duplicates run over 21 days for example.
  • Method Comparison: N=98 for the comparison between Tina-quant® Haptoglobin and Behring BN® Haptoglobin.
• Data Provenance: Not explicitly stated. Given the manufacturer's location in the USA and the FDA submission, it's highly likely the studies were conducted in the USA, but no specific country of origin is mentioned. The studies appear to be prospective for the purpose of this submission (i.e., data was collected specifically to demonstrate device performance).

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

Not applicable. This is an in-vitro diagnostic assay that measures a specific analyte (Haptoglobin) quantitatively. The "ground truth" for such devices is typically established through reference methods or highly accurate comparative methods, not expert consensus. The comparison is made against existing commercial devices (Behring BN® Haptoglobin and Partigen® Haptoglobin).

4. Adjudication Method for the Test Set

Not applicable. As this is an in-vitro diagnostic assay measuring an analyte, there is no expert adjudication process in the traditional sense. The "adjudication" is essentially the statistical analysis comparing the new device's results to the predicate device's results.

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

No. This is an automated in-vitro diagnostic assay, not an imaging device or a diagnostic tool requiring human interpretation of cases. Therefore, an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this is a standalone device. The performance characteristics (precision, linearity, method comparison, interfering substances, specificity) are reported for the Tina-quant® Haptoglobin Assay itself, without human-in-the-loop performance influencing the quantitative result. The device automates the measurement process.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance evaluation is established by:

• Comparison to a legally marketed predicate device: Behring BN® Haptoglobin assay.
• Comparison to another established method: Partigen® Haptoglobin (for linear regression).
• Internal validation metrics: Precision, linearity, interfering substances, and specificity are evaluated against internal standards or clinically accepted ranges/thresholds for these parameters.

8. The Sample Size for the Training Set

Not applicable. This document describes an in-vitro diagnostic assay, which is a chemical/biological reaction-based system, not a machine learning algorithm that requires a "training set" in the context of AI.

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

Not applicable, as there is no "training set" for this type of device.

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The N-Assay TIA Haptoglobin Test Kit is intended to be used for the quantitation of haptoglobin in human serum by immunoturbidimetric assay. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.

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I'm sorry, but this document does not contain the information needed to create the requested response. The provided text is a letter from the FDA regarding a 510(k) premarket notification for a device called "N-Assay TIA Multi V-NL." It confirms the device's substantial equivalence to a legally marketed predicate device and outlines regulatory information.

However, it does not include any details about:

• Acceptance criteria for the device's performance
• A study that proves the device meets acceptance criteria
• Sample sizes for test or training sets
• Data provenance
• Number or qualifications of experts
• Adjudication methods
• Multi-reader multi-case studies or effect sizes
• Standalone algorithm performance
• Type of ground truth used or how it was established

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

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The IMMAGE Immunochemistry System Haptoglobin (HPT) reagent, in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of human haptoglobin concentrations in human serum samples by rate nephelometry. This assay is designed for use with Beckman's IMMAGE Immunochemistry System.

The IMMAGE Immunochemistry System Haptoglobin (HPT) reagent, in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of human haptoglobin concentrations in human serum samples.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the IMMAGE™ Immunochemistry System Haptoglobin (HPT) Reagent.

Please note: The provided document is a 510(k) summary, which often focuses on demonstrating substantial equivalence to a predicate device rather than presenting de novo acceptance criteria for a novel device. As such, some information (like standalone performance targets without a comparative predicate, or extensive details on ground truth setting for complex clinical scenarios) might be less explicit or not present, as the primary goal is to show the new device performs similarly to an already-approved device.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Implicit Criteria:
For 510(k) submissions, the acceptance criteria are largely implicit in demonstrating "substantial equivalence" to a predicate device. This means the new device needs to perform as well as, or virtually identically to, the predicate device in relevant performance characteristics. The strong correlation (r = 0.996) and slope/intercept close to 1 and 0 respectively for method comparison are key indicators of this equivalence. Similarly, the stability and imprecision data are presented without explicit numerical targets but are intended to show acceptable performance for an in vitro diagnostic.

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

• Test Set Sample Size:
  • Method Comparison: Not explicitly stated, but the summary refers to "method comparison" studies. The number of samples (e.g., patient samples) used to generate the slope, intercept, and 'r' value is not provided.
  • Imprecision:
    • For each of the three control levels, 80 results were used to calculate the mean, SD, and %CV.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This type of detail is often omitted in a 510(k) summary for in vitro diagnostic devices unless there are specific clinical or demographic implications. The samples are human serum, but their origin is not described.

3. Number of Experts and Qualifications for Ground Truth

• Ground Truth Establishment: For an in vitro diagnostic (IVD) reagent like this, "ground truth" typically refers to the reference method (the predicate device in this case) or highly characterized control materials. It does not generally involve human expert interpretation in the same way as imaging or clinical decision support AI.
• Experts: Not applicable in the context of human expert review for establishing ground truth for a quantitative immunoassay.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This document describes performance characteristics of a quantitative immunoassay, not a subjective diagnostic interpretation requiring adjudication among human readers.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. These studies are typically relevant for AI-powered diagnostic imaging or interpretation tools where human readers are involved in the diagnostic process. This device is a reagent for a quantitative immunoassay system.
• Effect Size with AI Assistance: Not applicable, as no human readers or AI assistance in interpretation are described for this IVD.

6. Standalone Performance Study

• Standalone Performance: Yes, standalone performance was assessed for the IMMAGE HPT Reagent. The "Method Comparison Study Results" compare the IMMAGE HPT Reagent's measurements against the predicate device, effectively showing its performance in isolation (though compared to a reference). The "Estimated Within-Run Imprecision" also represents a standalone performance characteristic of the device.
  • Method Comparison: The IMMAGE HPT results were directly correlated with the predicate.
  • Imprecision: The device's internal variability was measured independently.

7. Type of Ground Truth Used

• Ground Truth Type:
  • For Method Comparison: The "ground truth" was established by the predicate device (Beckman's HPT Haptoglobin Reagent on the Array® Systems). The IMMAGE HPT Reagent's values were compared to those obtained from the predicate.
  • For Imprecision: The "ground truth" for the mean values was derived from control materials with established concentrations (Level 1, Level 2, Level 3).

8. Sample Size for the Training Set

• Training Set Sample Size: Not specified. For IVD reagents, the concept of a "training set" in the context of machine learning (where the term is most common) is generally not applicable. Reagent development involves extensive analytical validation (specificity, linearity, interference, matrix effects, etc.) rather than training an algorithm on a 'sample set'. The development process involves optimizing the chemical formulation and assay parameters based on performance against established analytical standards and reference methods.

9. How Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable in the machine learning sense. The "ground truth" during the development and optimization of such a reagent would be based on:
  • Chemical principles and established analytical methods for quantitative determination of haptoglobin.
  • Reference materials and calibrators with certified or highly accurate haptoglobin concentrations.
  • Performance characteristics required for clinical utility.

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