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The Olympus thyroid stimulating hormone (TSH) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of TSH levels in human serum and plasma using the Olympus AU3000i™ Immunoassay System.

Measurements of TSH produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The Olympus TSH Calibrator is used for calibrating the quantitative Olympus TSH Assay on the Olympus AU3000i Immunoassay System.

The Olympus TSH Control is used for quality control of the Olympus TSH test system on the Olympus AU3000i Immunoassay System.

The Olympus AU3000i Immunoassay System is a chemiluminescent discrete photometric chemistry analyzer for the quantitative determination of analytes in human serum and plasma.

The Olympus TSH assay is a two-step paramagnetic particle enzyme immunoassay. It is based on the sandwich principle and used to quantitate TSH in serum/plasma.

The Olympus TSH assay reagent and sample are added to the assay cuvette in the following sequence:

1. Samples are incubated first with a monoclonal anti-TSH antibody bound to paramagnetic particles.
2. After a washing step, a second monoclonal anti-TSH antibody conjugated with alkaline phosphatase is added. The TSH reacts with the paramagnetic particles and the conjugated antibody to form a sandwich complex. Washing steps remove the unbound material.
3. The chemiluminescent substrate is added to the assay cuvette and reacts with the bound alkaline phosphatase (ALP). Light generated by the reaction is measured by the luminometer. The light emission is proportional to the quantity of TSH in the sample.
4. Results are calculated from a pre-defined calibration curve. The Olympus AU3000i system automatically calculates the TSH concentration of each sample in mIU/L or µIU/mL.

The provided 510(k) summary focuses on demonstrating substantial equivalence of the Olympus TSH Test System to predicate devices rather than establishing novel acceptance criteria and proving the device meets them with a dedicated study. Instead, the performance characteristics of the Olympus TSH Test System are compared directly to those of the predicate Roche Elecsys® TSH Test System.

Therefore, the response below will present the performance characteristics as a comparison to the predicate device, rather than explicit "acceptance criteria" and "reported device performance."

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission demonstrating substantial equivalence, explicit "acceptance criteria" are not stated in the typical sense of a performance goal. Instead, the performance of the Olympus TSH Test System is compared directly to the predicate device, the Roche Elecsys® TSH Test System. The implicit acceptance criterion is that the performance of the new device is comparable to the predicate.

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the performance characteristic studies (e.g., precision, method comparison, interference). The data provenance (e.g., country of origin, retrospective/prospective) is also not specified.

3. Number of Experts and Qualifications for Ground Truth

For in vitro diagnostic (IVD) devices like the Olympus TSH Test System, "ground truth" is typically established through reference methods, certified calibrators, or established analytical techniques, rather than expert human interpretation (like radiologists). The document indicates traceability to "WHO" (World Health Organization) for both the predicate and proposed device, implying the use of international reference standards. No human experts are mentioned for establishing ground truth.

4. Adjudication Method for the Test Set

Not applicable for an IVD device where ground truth is typically assessed through quantitative analytical methods and reference standards, not human adjudication of subjective interpretations.

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

Not applicable. This is an in vitro diagnostic device for quantitative determination of TSH levels, not an imaging or diagnostic aid for human readers.

6. Standalone Performance Study

Yes, the performance characteristics listed in the table above (Precision, Functional Sensitivity, Analytical Sensitivity, Measurable Range, Method Comparison, Interference, Specificity) represent the standalone (algorithm/device only) performance of the Olympus TSH Test System. These are intrinsic analytical performance metrics of the device itself.

7. Type of Ground Truth Used

The ground truth for this type of IVD device is based on reference materials, certified calibrators, and/or comparison to a well-established and accepted reference method. The document states "Traceability: WHO" for both the Olympus TSH Test System (WHO 3rd IS 81/565) and the predicate (WHO 2nd IRP 80/558), indicating that the results are standardized against internationally recognized standards for TSH measurement.

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For IVD devices, method development and optimization studies are conducted, but usually, a distinct "training set" and "test set" in the context of machine learning (where this terminology is common) are not explicitly detailed in 510(k) summaries for traditional immunoassay systems. The performance characteristics described are typically derived from verification and validation studies.

9. How Ground Truth for the Training Set Was Established

Not explicitly detailed as a "training set" in the machine learning sense. However, for the development and calibration of such an assay, ground truth would be established through a combination of:

• Using calibrators with known TSH concentrations (e.g., Olympus TSH Calibrator, referenced to WHO standards).
• Testing against reference samples or patient samples analyzed by established, validated reference methods, often traceable to international standards.
• The "Olympus TSH Calibrator is used for calibrating the quantitative Olympus TSH Assay," and its matrix is "Bovine serum human pituitary TSH," implying that the calibrators themselves embody the "ground truth" for the device's measurement scale.

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The Elecsys TSH CalSet is used for calibrating the quantitative Elecsys TSH assay on the Elecsys immunoassay analyzers.

The Elecsys TSH CalSet consists of equine serum matrix (Cal 1) and a human serum matrix with human TSH (Cal 2) in two concentration ranges. The Elecsys TSH CalSet is supplied in ready for use liquid format.

This 510(k) summary (K060754) for the Elecsys TSH CalSet provides limited information regarding specific performance studies and acceptance criteria typically found for diagnostic devices. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Elecsys TSH CalSet K961491) rather than presenting detailed performance data from a new clinical study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria or report specific device performance metrics in the format of a table with numerical values for sensitivity, specificity, accuracy, etc. This type of information is generally expected for diagnostic devices that analyze patient samples.

The comparison table in the 510(k) summary focuses on device features of the modified Elecsys TSH CalSet versus the predicate, such as intended use, traceability, levels, storage form, matrix, stability, and target concentrations. These are design and manufacturing specifications, not performance metrics against clinical outcomes or a ground truth.

For example, it states "Stability: Unopened... at 2-8°C up to the stated expiration date," and "Opened... after opening in aliquots at 2-8°C for 12 weeks." While these are important characteristics, they are not performance metrics like accuracy or precision.

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

The document does not mention any specific sample size for a test set or provide details on data provenance (e.g., country of origin, retrospective or prospective data). The submission is for a calibrator, which is used to standardize an assay, not to directly diagnose patients from a test set of patient samples. Therefore, a "test set" in the traditional sense of patient samples for diagnostic performance evaluation is not detailed here.

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

This information is not applicable or provided in the context of this 510(k) submission. A calibrator's "ground truth" relates to its traceable concentration values, not to interpretations by medical experts. The document states "Assay standardized against the 2nd IRP WHO reference standard 80/558," which indicates traceability to an international reference standard, not ground truth established by medical experts for diagnostic outcomes.

4. Adjudication Method

This information is not applicable or provided. Adjudication methods are used to resolve discrepancies among experts when establishing ground truth for diagnostic studies using patient data. Since this submission is for a calibrator and does not involve patient diagnoses or expert interpretation, adjudication is not relevant.

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

A MRMC comparative effectiveness study was not conducted and is not mentioned. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., imaging devices) to assess the impact of AI assistance on human reader performance. As the Elecsys TSH CalSet is a chemical calibrator for an automated immunoassay, human readers are not directly involved in its function or interpretation in a way that would necessitate an MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study, as typically understood for diagnostic algorithms, was not conducted and is not mentioned. The Elecsys TSH CalSet itself is a physical calibrator used within an automated immunoassay system. Its performance relates to its ability to correctly set the assay's measurement scale, which is typically evaluated through analytical studies (e.g., precision, accuracy, linearity) of the overall assay system when calibrated. The document implies that the performance of the assay itself (when calibrated with the device) is acceptable, but does not detail studies specifically for the calibrator's standalone performance in isolation.

7. Type of Ground Truth Used

The ground truth used for the Elecsys TSH CalSet is based on international reference standards and defined concentrations. The document explicitly states: "Assay standardized against the 2nd IRP WHO reference standard 80/558." This refers to a recognized international reference for TSH measurements, which provides the basis for establishing the "true" concentration values of the calibrator.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This is because the Elecsys TSH CalSet is a chemical reagent (calibrator), not an AI algorithm or a diagnostic model that requires a training set in the machine learning sense.

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

Since there is no training set for an AI algorithm or diagnostic model, the method for establishing its ground truth is not applicable or provided. The "ground truth" for the calibrator's stated concentrations is established through reference to the 2nd IRP WHO reference standard 80/558, as mentioned above.

In summary:

This 510(k) submission for the Elecsys TSH CalSet focuses on demonstrating substantial equivalence to a predicate calibrator by comparing manufacturing specifications and intended use. It does not contain detailed performance studies or acceptance criteria typical for diagnostic devices that interpret patient data. The "studies" implied are likely internal analytical validations of the calibrator's characteristics (e.g., stability, concentration accuracy) and its impact on the overall TSH assay, rather than clinical trials with patient cohorts.

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