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For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include Testosterone and NTx.

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine. Coated microwells are used as the solid phase separation system.

The system is comprised of three main elements:

• 1. The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Reagent Pack, VITROS Immunodiagnostic Products Calibrators, which are combined by the VITROS Immunodiagnostic System to perform a VITROS assay).
• 2. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
• 3. Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K984310).

The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.

The provided text describes a 510(k) pre-market notification for VITROS Immunodiagnostic Products Testosterone Range Verifiers and NTx Range Verifiers. The submission aims to demonstrate substantial equivalence to a predicate device. However, the document does not contain specific acceptance criteria, a detailed study proving performance against acceptance criteria, or most of the requested information about test sets, expert adjudication, or training sets for a device utilizing AI.

The device in question is a "Range Verifier," which is used to verify the calibration range of an immunodiagnostic system. This is a quality control product, not an AI-powered diagnostic device. Therefore, the questions related to AI-specific performance, human reader improvement, and extensive data set details are not applicable or not present in the provided text.

Based on the provided text, here's what can be extracted and inferred:

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

The document does not explicitly state numerical acceptance criteria for performance (e.g., sensitivity, specificity, accuracy) because it is a range verifier, not a diagnostic test. Its performance is demonstrated by its "substantial equivalence" to a predicate device based on its characteristics and intended use.

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

Not applicable/Not provided for this type of device. The document mentions "data presented in the pre-market notification" but does not detail a specific test set, its size, or provenance for performance evaluation in the context of sensitivity/specificity that would be relevant for a diagnostic or AI device. The equivalence is primarily based on device characteristics and intended use comparison.

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

Not applicable/Not provided. The device is a range verifier, not a diagnostic interpretation tool, so "ground truth" in the clinical diagnostic sense with expert review is not relevant here.

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

Not applicable/Not provided.

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 device is a quality control product for an immunoassay system, not an AI-assisted diagnostic tool involving human readers.

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

Not applicable. The device is not an algorithm.

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

Not explicitly stated in terms of a clinical ground truth. The "ground truth" for a range verifier would be its ability to correctly verify the expected range of the VITROS Immunodiagnostic System. This would be established by the manufacturer through internal quality control and analytical validation, ensuring the spiked analytes are at known concentrations and that the verifier performs consistently within established tolerance limits for its intended purpose. The document primarily focuses on demonstrating equivalence to another verifier product.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/machine learning model.

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

Not applicable.

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For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include Free T4, Estradiol, CK-MB and Ferritin.

Not Found

This document is a 510(k) clearance letter for the VITROS Immunodiagnostic Products Range Verifiers. Based on the provided text, the device is an in vitro diagnostic (IVD) product. The available information primarily focuses on regulatory clearance and intended use, rather than a detailed study description with specific acceptance criteria and performance data as might be found in a clinical trial report for an AI device.

Therefore, many of the requested items (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not typically included in this type of regulatory document for this kind of device.

However, I can extract the relevant information that is present:

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

Based on the nature of the device (Range Verifiers for an immunodiagnostic system), the primary "acceptance criteria" for regulatory clearance would be substantial equivalence to a predicate device. The performance is assessed in terms of its ability to verify the calibration range for specific immunoassays.

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. As this is a range verifier, the "test set" would likely refer to internal validation data, which is not detailed here.
• Data Provenance: Not specified.

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/not specified for this type of IVD device regulatory clearance. Ground truth for a range verifier would be established through a comparison to a known standard or reference method, not typically by human experts interpreting results.

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

• Not applicable/not specified.

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 not an AI diagnostic device that assists human readers.

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

• Not applicable. This is an IVD device, not an algorithm, and its function is to verify calibration ranges.

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

• For a range verifier, the "ground truth" would be the expected concentration/range values of the analytes being measured, established through highly accurate reference methods or certified reference materials. The device is designed to confirm that the VITROS Immunodiagnostic System is performing within these established ranges.

8. The sample size for the training set

• Not applicable/not specified. This is not an AI/machine learning device that requires a training set in the conventional sense.

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

• Not applicable.

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For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include TSH, Total T4. Total T3, T3 Uptake, LH, Progesterone, FSH, Total βhCG, Free T3 and Prolactin.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA to Johnson & Johnson Clinical Diagnostics, Inc. regarding a device called "VITROS Immunodiagnostic Products Range Verifiers."

This document does not contain information about acceptance criteria or a study proving device performance in the way typically required for AI/ML medical devices. The device described, "VITROS Immunodiagnostic Products Range Verifiers," is a Class I device (product code JJY) and appears to be a laboratory control or calibrator product rather than an AI/ML diagnostic tool.

Therefore, the requested information elements related to AI/ML device performance (like sample size for test/training sets, ground truth experts, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable and not present in this document.

The primary content of the document is the FDA's determination of substantial equivalence for the device.

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