Search Results

The Elecsys TSH CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys TSH reagent on the indicated Elecsys cobas e immunoassay analyzers.

The Elecsys TSH CalCheck 5 is a lyophilized product consisting of TSH in equine serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

The provided 510(k) summary for the device, "Elecsys TSH CalCheck 5," is for an in-vitro diagnostic control material. As such, it does not involve clinical studies with human patients, image analysis, or expert-based ground truth establishment in the same way a diagnostic imaging device would. Instead, its "performance" is assessed based on its chemical and physical characteristics and how accurately it can verify instrument calibration and assay ranges.

Therefore, many of the requested categories in the prompt are not applicable to this type of device submission.

Here is an analysis based on the information provided in the K093836 document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative, pass/fail table as would be expected for a diagnostic device. Instead, it states that the device was evaluated for "value assignment and stability." The implication is that the performance characteristics (e.g., how well the assigned values match expectations, and the stability over time) were deemed acceptable for substantial equivalence to the predicate device.

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

• Test set: Not applicable in the traditional sense of patient data. The "test set" would be samples of the manufactured control material itself, used for evaluation. The document does not specify the number of batches or individual vials tested.
• Data Provenance: The exact location or nature of the testing is not specified, but it would have been conducted by Roche Diagnostics as part of their product development and validation process. This would be considered prospective manufacturing and testing data.

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

• Not Applicable. For an in-vitro diagnostic control, the "ground truth" is established through highly controlled analytical methods and established reference materials/methods, not through expert human interpretation. The concentrations of TSH in the control material are assigned through a rigorous internal process, not "established by experts."

4. Adjudication Method for the Test Set

• Not Applicable. No human adjudication is involved for this type of chemical control material. The "adjudication" is metrological, relating to the accuracy and precision of the analytical measurements used to assign values and assess stability.

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

• No. An MRMC study is relevant for diagnostic devices that involve human interpretation of medical images or data. This device is a quality control material for an automated immunoassay analyzer.

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

• Not Applicable / Inherent. This device itself is not an algorithm or a diagnostic tool; it's a calibrator/control. Its performance is entirely "standalone" in the sense that it is a physical product with defined chemical characteristics. Its interaction is with the immunoassay analyzer, not a human interpreter directly.

7. The Type of Ground Truth Used

• Assigned Values based on Analytical Methods and Reference Materials: The "ground truth" for the Elecsys TSH CalCheck 5 is the assigned TSH concentration values for each of its five levels. These values are determined by the manufacturer (Roche Diagnostics) using highly precise and accurate analytical methods, typically traceable to international reference standards and/or internal established reference methods. This ensures that the control material has known concentrations to verify the performance of the Elecsys TSH reagent and analyzer.

8. The Sample Size for the Training Set

• Not Applicable. This device is a chemical control product, not a machine learning algorithm that requires a "training set" of data.

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

• Not Applicable. See point 8.

Ask a specific question about this device

The Boehringer Mannheim Elecsys CalCheck AFP is used to verify the calibration assignment for the Boehringer Mannheim Elecsys AFP assay.

The Elecsys® CalCheck™ AFP is a three level single analyte set of lyophilized, human based materials. After reconstitution, they are assayed in triplicate and the results compared to the target values.

This document does not contain the detailed information necessary to answer your request. It's a 510(k) summary for a calibration verification material (Elecsys® CalCheck™ AFP), which is a laboratory control, not a diagnostic device that would typically undergo the kind of performance studies you're asking about (e.g., studies with human readers, ground truth consensus, etc.).

The document focuses on:

• Device Name and Intended Use: The Elecsys® CalCheck™ AFP is used to verify the calibration of the Elecsys AFP assay.
• Predicate Device Comparison: It establishes substantial equivalence to a previously marketed calibration material (Elecsys® CalCheck™ TSH).
• Description: It's a three-level set of lyophilized, human-based materials to be assayed in triplicate.

The "Performance Characteristics" section is introduced but the actual details are cut off. However, even if they were present, for a calibration verification material, typical "performance" would involve things like:

• Value Assignment: How accurately the assigned values for the control material are determined.
• Stability: How long the lyophilized material and reconstituted material remain stable within specifications.
• Homogeneity: Ensuring consistent concentration throughout the material.
• Lot-to-lot consistency: Ensuring different manufacturing lots perform similarly.

It would not involve:

• A test set with ground truth established by experts.
• MRMC studies to evaluate human reader improvement.
• Standalone algorithm performance in a diagnostic context.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device

The Elecsys® CalCheck™ CEA is used to verify the calibration assignment for the Elecsys® CEA assay.

The Elecsys® CalCheck™ CEA is a three level single analyte set of lyophilized, human based materials. After reconstitution, they are assayed in triplicate and the results compared to the target values.

This is a pre-AI/ML device, and the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of AI/ML performance. The device is a calibration verification material for an immunoassay. Therefore, I cannot fulfill your request based on the provided input.

Ask a specific question about this device

The Boehringer Mannheim Elecsys CalCheck PSA is used to verify the calibration assignment for the Boehringer Mannheim Elecsys PSA assay.

The Elecsys® CalCheck™ PSA is a three level single analyte set of lyophilized, human based materials. After reconstitution, they are assayed in triplicate and the results compared to the target values.

The provided text describes a medical device called "Elecsys® CalCheck™ PSA," a calibration verification material. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way described in the request (e.g., performance metrics, sample sizes, ground truth establishment, expert adjudication, or MRMC studies).

The text focuses on establishing substantial equivalence to a predicate device (Elecsys® CalCheck™ TSH) based on configuration, intended use, and general performance characteristics like value assignment and stability, but it does not detail the quantitative performance of the Elecsys® CalCheck™ PSA against predefined acceptance criteria.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them from the provided text for the following reasons:

1. No Acceptance Criteria Table or Reported Performance: The document does not explicitly state any quantitative acceptance criteria for the Elecsys® CalCheck™ PSA's performance. It mentions "specific data on the performance of the test have been incorporated into the draft labeling," but this data is not included in the provided text.
2. No Study Details for Test Set: There is no mention of a specific study to prove performance against acceptance criteria, including sample sizes, data provenance (country of origin, retrospective/prospective), or how a test set was constructed.
3. No Expert Details or Adjudication: The concept of "experts" to establish ground truth or "adjudication methods" is not applicable to this type of device (calibration verification material) as described in the provided text. Its function is to verify calibration, meaning its "ground truth" would be its assigned value, not an expert interpretation of, for example, an image.
4. No MRMC or Standalone Study: The device is a calibration material, not an AI or diagnostic imaging device that would typically undergo Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance studies.
5. Type of Ground Truth: The "ground truth" for a calibration material is its assigned value, determined through a specific manufacturing and assay process, not expert consensus, pathology, or outcomes data.
6. No Training Set Details: Since this is a calibration verification material and not an AI algorithm, there is no concept of a "training set" or "how ground truth for the training set was established" in the context of the provided information.

In summary, the provided document is a 510(k) summary for a calibration verification material, which focuses on demonstrating substantial equivalence to a predicate device for its intended use rather than presenting a performance study against specific acceptance criteria in the manner requested.

Ask a specific question about this device