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I am sorry, but the provided text is a standard FDA clearance letter and does not contain information about the acceptance criteria, study details, or performance of the "Transferrin" device mentioned. The letter confirms that the device is substantially equivalent to a predicate device and can be marketed, but it does not include the technical or clinical study data.

To answer your request, I would need a document that describes the actual performance study and its results.

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The Binding Site Human Transferrin Kit is intended for the quantitative determination of human transferrin using the Binding Site SPAPLus turbidimetric analyzer in human serum. The measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection and iron deficiency anemia. This test should be used in conjunction with other laboratory and clinical findings

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The provided document is a 510(k) clearance letter from the FDA for a diagnostic kit, specifically "Human Transferrin kit for use on the SPAPlus™". This type of document primarily confirms that a new device is substantially equivalent to a legally marketed predicate device, and it typically does not include detailed study reports with specific acceptance criteria, performance data, or details about training and test sets in the way that would be provided for an AI/ML medical device submission.

The information requested in the prompt (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is characteristic of the rigorous clinical validation studies required for AI/ML devices, not typically for a traditional in vitro diagnostic kit like the one described here.

Therefore, I cannot extract the requested information from the provided text because the document does not contain details about:

• A table of acceptance criteria and reported device performance in the context of an AI/ML device. The "performance" mentioned for this kit would usually refer to analytical performance characteristics (e.g., accuracy, precision, linearity) which are not detailed here.
• Sample sizes for test sets or data provenance.
• Number of experts or their qualifications.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone performance (as it's not an AI/ML algorithm).
• Type of ground truth used (beyond implying the "gold standard" for transferrin measurement).
• Sample size for training sets.
• How ground truth for training was established.

The document is a regulatory approval letter, specifically stating the device's substantial equivalence and its intended use for the quantitative determination of human transferrin to aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia using the Binding Site SPAPlus™ turbidimetric analyzer.

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The transferrin test system is intended for the quantitative in-vitro diagnostic determination of transferrin in serum or plasma using T60 Clinical chemistry Analyzers. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, acute infection and iron deficiency anemia.

SpeciCal protein calibrator is used as a stock calibrator for both quantification of specific proteins in serum and plasma by immunoturbidimetry and for antigen excess detection using methods defined by Thermo Electron Oy

SpeciTrol is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Ov

Specitrol High is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Oy

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The provided text does not contain detailed information about the acceptance criteria or a study that proves the device meets those criteria. The document is primarily a 510(k) clearance letter from the FDA for a device named "Transferrin, Specical Calibrator, Specitrol Control and Specitrol High Control."

The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. However, it does not include:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes used for test sets, data provenance (country, retrospective/prospective).
• Details about the number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• Results from a multi-reader multi-case (MRMC) comparative effectiveness study, nor the effect size of AI assistance.
• Results from a standalone algorithm-only performance study.
• The type of ground truth used (e.g., pathology, outcomes data).
• The sample size for the training set or how its ground truth was established.

The document states the intended use of the devices, which is for the quantitative in-vitro diagnostic determination of transferrin in serum or plasma using T60 Clinical Chemistry Analyzers, aiding in the diagnosis of malnutrition, acute inflammation, acute infection, and iron deficiency anemia. It also specifies the use of SpeciCal as a stock calibrator and SpeciTrol/SpeciTrol High as assayed control serums to monitor precision.

Therefore, I cannot fulfill the request for information on acceptance criteria, study details, or AI-related metrics based on the provided text.

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Good Biotech Corp. Transferrin test system is intended to be used for the quantitative determination of transferrin in human serum by turbidimetric immunoassay (TIA). Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Good Biotech Corp. Transferrin Calibrator Set is intended to be used with Transferrin TIA for the quantitative determination of transferrin in serum samples.

Good Biotech Corp. Transferrin Controls are intended to be used as the assayed quality control material for transferrin analysis.

For In Vitro Diagnostic Use.

Good Biotech Corp. Transferrin TIA is a ready to use reagent for the quantitative determination of transferrin in human serum by turbidimetric immunoassay (TIA). When transferrin of the serum sample encounters with duck anti-transferrin antibody, the aqqlutination based on the antigen-antibody reaction increases the turbidity of the sample. The value of the absorbance change at 505 nm is proportional to the transferrin concentration of the sample and is recorded by a general chemistry autoanalyzer. Then, the actual transferrin concentration of the serum sample is determined by interpolation of the calibration curve obtained by standard samples with known transferrin concentrations.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in terms of specific numeric thresholds for slope, intercept, and correlation coefficient. Instead, it relies on a "high correlation coefficient" as an indicator of substantial equivalence. The predicate device's performance characteristics (slope, intercept, correlation coefficient) likely serve as an implicit benchmark for "high correlation."

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

• Sample Size: 82 serum samples
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "serum samples."

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 this kind of diagnostic device (immunoassay). The "truth" for the test set is established by the measurements obtained from the predicate device, which is an already legally marketed and validated assay. No human experts are used to interpret the results or establish "ground truth" in the way they would for imaging or clinical diagnosis.

4. Adjudication Method for the Test Set

Not applicable. The comparison is between two quantitative assays, not subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices that involve human interpretation, such as imaging AI, where the impact of AI assistance on human reader performance is evaluated. This submission is for a quantitative immunoassay.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, a standalone study was performed. The device's performance was compared directly against the predicate device without human intervention or interpretation as part of the primary measurement. The "algorithm" here refers to the immunoassay's ability to quantitatively determine transferrin levels.

7. Type of Ground Truth Used

The "ground truth" in this context is the quantitative determination of transferrin levels by the predicate device (Roche Tina-quant Transferrin ver.2). This is a common approach for establishing substantial equivalence for new diagnostic assays, where a well-established and legally marketed device serves as the reference standard.

8. Sample Size for the Training Set

The document does not specify a training set. This is a pre-market submission for an immunoassay, not a machine learning algorithm that typically requires a distinct training and test set in the same way. The development and optimization of the immunoassay reagents and methodology would have been an iterative process by the manufacturer, but the term "training set" as commonly applied to AI/ML is not relevant here. The studies described are for validation/testing.

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

As no training set (in the AI/ML sense) is explicitly mentioned, this question is not directly applicable. The "ground truth" for the comparative performance study was established by the predicate device's measurements.

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FOR IN VITRO DIAGNOSTIC USE.
The Transferrin SPQ™ III ANTIBODY REAGENT SET is designed for the quantitative determination of transferrin in human serum by immunoprecipitin analysis.

Transferrin (TRF) Immunological Test Kit

The provided document is a 510(k) summary for the Transferrin SPQ™ III Antibody Reagent Set, which is a modification of an existing device. It discusses the substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and detailed performance metrics. Therefore, many of the requested details about acceptance criteria, specific performance numbers, sample sizes, ground truth establishment, and expert involvement are not explicitly stated in the provided text.

Based on the information available:

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

The document does not provide a specific table of acceptance criteria with numerical targets. Instead, it states that the modified device was compared to a predicate device (Transferrin SPQ™ II Antibody Reagent Set) and found to be "substantially equivalent."

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 for Test Set: Not specified in the provided document.
• Data Provenance: Not specified in the provided document. It is not mentioned whether the data was retrospective or prospective, nor the country of origin.

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. The document describes an in vitro diagnostic device for quantitative determination of transferrin, not an imaging or diagnostic device that typically involves expert interpretation for ground truth establishment in a study of this nature. The "ground truth" for such a device would typically be established by a reference method or validated assays, not expert consensus on images.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. This is an in vitro diagnostic device, and its performance is evaluated against chemical/biological measurements, not human consensus on visual findings.

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. An MRMC study is relevant for AI systems assisting human readers, typically in medical imaging. This document describes an in vitro diagnostic reagent set for chemical analysis, not an AI-assisted diagnostic tool for human readers.

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

This is an in vitro diagnostic reagent set. Performance refers to the assay's ability to accurately measure transferrin levels. The "algorithm only" concept does not directly apply in the way it would for AI/software devices. The "standalone" performance would be the analytical performance of the assay itself (e.g., precision, accuracy, linearity, limit of detection), which is what "Nonclinical Testing" and "Clinical Testing" generally refer to for such devices. The document states that both nonclinical and clinical testing demonstrated substantial equivalence to the predicate device.

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

The document does not explicitly state the type of ground truth used. For an in vitro diagnostic quantitative assay like this, "ground truth" would typically be established by:

• Reference method/assay: Comparing results to a recognized, highly accurate, and precise reference method for transferrin measurement.
• Calibrators and controls: Using materials with known transferrin concentrations.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set in that context. It is an in vitro diagnostic reagent set. The development involved modification of an existing reagent set, not training an algorithm.

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

Not applicable, as there is no "training set" in the context of an AI/machine learning algorithm for this type of device.

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