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For in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in serum, heparinized plasma, and EDTA plasma using the ADVIA Centaur XP systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

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The provided text describes an update to a previously approved device, the ADVIA Centaur® TSH3-Ultra assay, to include updated pediatric reference intervals. Crucially, the 510(k) submission (K150403) explicitly states that no additional analytical performance data was collected for this update. Instead, it cross-references all performance data to the original 510(k) submission (K083844) for the device.

Therefore, the acceptance criteria and the study that "proves the device meets the acceptance criteria" in this context primarily pertain to the establishment of the pediatric reference intervals, and not to the broader analytical performance of the device (such as precision, linearity, sensitivity, etc.), which was evaluated in the original submission.

Here's the breakdown based on the information provided for the pediatric reference interval update:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for the device performance itself (e.g., accuracy, precision) is not explicitly detailed in this document for the current submission (K150403), as that data was accepted in the original 510(k). The focus of this submission is on the establishment of new reference intervals. For the purpose of these new intervals, the acceptance criteria would be that the established intervals are representative of the studied pediatric population and align with recognized medical practice for TSH interpretation in these age groups.

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

• Sample Size: A total of 442 patients were analyzed.
  • 94 infants
  • 198 children
  • 150 adolescents
• Data Provenance: Not explicitly stated (e.g., country of origin, specific sites). The document is a 510(k) submission to the FDA for a device manufactured by Siemens Healthcare Diagnostics, Inc. (Tarrytown, NY), but this does not specify the origin of the clinical samples.
• Retrospective or Prospective: Not explicitly stated. The phrasing "Data from a total of 442 patients... were analyzed to establish..." suggests this could be retrospective analysis of existing samples or prospectively collected samples for this study. The document focuses on the analysis of these patients' data.

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

• Number of Experts: Not mentioned in this document. The establishment of reference intervals typically involves statistical analysis of a healthy population, with clinical review of the resulting intervals by medical professionals. However, specific details on expert involvement for this particular data are absent.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

• Not applicable/Not mentioned. The study involved establishing reference intervals, which is a statistical process based on a healthy population, rather than assessing diagnostic accuracy against "ground truth" labels that would require adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic assay (a laboratory test), not an imaging or diagnostic device that typically involves human readers interpreting results. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this type of device.

6. Standalone Performance Study (Algorithm Only)

• Yes, in a sense, a standalone study was presented for the establishment of the reference intervals. The output (the reference interval values) is directly derived from the measurements from the device (ADVIA Centaur TSH3-Ultra) on the patient samples. The device itself performs the quantitative determination of TSH. The performance characteristics of the assay (precision, linearity, etc.) were established in the original 510(k) (K083844) as a standalone algorithm/device. This current submission focuses on applying that standalone performance to interpret results within newly defined pediatric reference ranges.

7. Type of Ground Truth Used (for pediatric reference intervals)

• The "ground truth" for establishing reference intervals is typically based on measurements from a statistically representative population of healthy individuals (euthyroid individuals in this case). The objective is to define the range of normal values within specific demographics (age groups) for a given analyte. The document specifies that these are for "ADVIA Centaur thyroid assay reference intervals for the studied pediatric population," implying these individuals were considered clinically "normal" or "euthyroid" for TSH levels.

8. Sample Size for the Training Set

• The 442 patients (94 infants, 198 children, 150 adolescents) mentioned for establishing the pediatric reference intervals essentially serve as the "training set" (or more accurately, the reference population set) for these intervals. There's no separate mention of a distinct training set vs. test set for the reference interval establishment itself, as the goal is to define the range from this population.
• For the analytical performance of the assay (linearity, precision, etc.), the training sets would have been part of the original K083844 submission and are not detailed here.

9. How the Ground Truth for the Training Set (Reference Population) Was Established

• The ground truth for the pediatric reference population (i.e., defining "healthy" or "euthyroid") is implied to be through clinical assessment and exclusion criteria, although not explicitly detailed. Reference interval studies typically involve recruiting subjects who are free from conditions that might affect the analyte being measured. The standard followed, CLSI EP28-A3c ("Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory"), describes methods for selecting and characterizing a reference population to establish clinical reference intervals.

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For in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in serum using the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The ADVIA Centaur TSH assay is a two-site sandwich immunoassay using direct chemiluminometric technology. It utilizes a ReadyPack Primary Reagent Pack containing both Solid Phase (Polyclonal sheep anti-TSH antibody covalently coupled to paramagnetic particles) and Lite Reagent (Monoclonal mouse anti-TSH antibody labeled with acridinium ester) in separate wells. The assay is performed on the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems.

This document is a 510(k) premarket notification for the ADVIA Centaur TSH assay, specifically focusing on its use with the new ADVIA Centaur XPT system. The notification seeks to demonstrate substantial equivalence to the previously cleared ADVIA Centaur TSH assay used with the ADVIA Centaur XP system.

It's important to note that this document does not describe a study proving a device meets acceptance criteria in the traditional sense of a clinical trial for a new diagnostic device. Instead, it focuses on demonstrating that modifications to an existing assay (ADVIA Centaur TSH assay) and a new instrument platform (ADVIA Centaur XPT) do not negatively impact the performance, safety, or effectiveness of the assay, and thus maintain substantial equivalence to the predicate device.

The "acceptance criteria" here are essentially the performance characteristics established for the predicate ADVIA Centaur TSH assay on the ADVIA Centaur XP system. The "study" refers to verification testing done to ensure the modified system (ADVIA Centaur TSH assay on ADVIA Centaur XPT) performs equivalently.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria and reported performance in a single section. Instead, it describes changes and states that verification testing met pre-determined acceptance criteria. The key change discussed that directly relates to performance is the Lower Limit of Detection (LoD).

Note: The document states that "All verification testing met pre-determined acceptance criteria." and that the "performance of the ADVIA Centaur TSH assay on the ADVIA Centaur XPT system is substantially equivalent to the ADVIA Centaur TSH assay running on the currently-marketed predicate ADVIA Centaur XP system." This implies that other performance characteristics (e.g., precision, linearity, interference) were evaluated and found to be acceptable, even though specific numerical acceptance criteria and results are not detailed in this summary.

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

The document does not specify the sample size used for the verification testing.
It also does not specify the data provenance (e.g., country of origin, retrospective or prospective). The testing would typically be performed internally by the manufacturer during the development and verification phases of the new instrument and its compatibility with the assay.

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

Since this is a submission for an in vitro diagnostic (IVD) device assessing a biomarker (TSH), the "ground truth" for individual sample values is generally established by the device itself or a reference method. It's not a scenario where human experts (like radiologists) establish a ground truth from images. Therefore, this information is not applicable in the context of this document.

4. Adjudication Method for the Test Set

As this is an IVD device measuring a biomarker, the concept of an adjudication method (like 2+1, 3+1 for expert review) for a test set is not applicable. The instrument directly provides quantitative results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical image analysis where human readers interpret cases, and AI assistance might impact their performance. For an automated in vitro diagnostic assay, this type of study is not applicable.

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

The device itself, the ADVIA Centaur TSH assay on the ADVIA Centaur XPT system, operates in a standalone manner. It is an automated in vitro diagnostic test that provides quantitative TSH values. There is no "human-in-the-loop" component in the direct generation of results from the instrument. The results are then used by healthcare professionals for diagnosis.

7. The Type of Ground Truth Used

For a quantitative in vitro diagnostic device like a TSH assay, the "ground truth" for accuracy often refers to:

• Reference methods or highly characterized reference materials for accuracy and calibration.
• Agreement with the predicate device for substantial equivalence demonstrations.

The document implicitly uses agreement with the predicate device (ADVIA Centaur XP system) as the primary "ground truth" for demonstrating substantial equivalence of the modified device (ADVIA Centaur XPT system) performance. The performance of the predicate device itself would have been established against reference methods or clinical outcomes during its initial clearance.

8. The Sample Size for the Training Set

The document does not specify a sample size for a training set. This is because the ADVIA Centaur TSH assay is a reagent-based immunoassay run on an automated instrument, not an AI/ML-based algorithm that typically requires a large training dataset for model development. The "training" for such a system involves calibrating the instrument and assay using specific calibrator materials.

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

As explained in point 8, there isn't a "training set" in the sense of AI/ML. The "calibration" of the assay utilizes specific calibrator materials. The document states:

• Calibration: "2-point calibration using Calibrator B"
• Calibrators: "Calibrators checked with barcode; Calibrator lot numbers stored and displayed"

The ground truth for these calibrators would have been established by the manufacturer through rigorous testing, potentially against reference methods and with traceability to international standards, to ensure their assigned TSH values are accurate.

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