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The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is for the qualitative determination of antibodies to Islet Antigen-2 (IA-2) in human serum. The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit may be useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is not to be used alone and is to be used in conjunction with other clinical and laboratory findings.

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This document is an FDA clearance letter for an in vitro diagnostic (IVD) device, specifically an ELISA kit. It does not contain information about an AI/ML-driven medical device study or its performance characteristics. Thus, most of the requested information regarding acceptance criteria, study design, ground truth establishment, and expert involvement for an AI medical device cannot be extracted from this document.

The document discusses the clearance of the KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit (K220085) for the qualitative determination of antibodies to Islet Antigen-2 (IA-2) in human serum, to be used as an aid in the diagnosis of Type 1 diabetes mellitus.

Therefore, I cannot provide the requested information based on the provided text. The questions are specifically tailored for an AI/ML device study, not for an ELISA kit's regulatory clearance.

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The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is for the quantitative determination of antibodies to Islet Antigen-2 (IA-2) in human serum. The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit may be useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is not to be used alone and is to be used in conjunction with other clinical and laboratory findings.

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The provided text is an FDA 510(k) clearance letter for the KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit. This letter confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

However, the letter does not contain any information about the acceptance criteria, study design, or performance data for the KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit. It merely states the device's indications for use and general regulatory information.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method.
5. Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Information on standalone (algorithm only) performance studies.
7. The type of ground truth used.
8. The sample size for the training set.
9. How ground truth for the training set was established.

This type of detailed study information is typically found in the 510(k) submission itself (which is not provided here) or in accompanying technical documentation or scientific publications, not in the clearance letter. The letter is the outcome of the review process, not the detailed report of the review findings.

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The KRONUS IA-2 Autoantibody RIA Assay Kit is for the semi-quantitative determination of antibodies to tyrosine phosphatase (1A-2) in human serum. The KRONUS IA-2 Autoantibody RIA Assay is useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device. This type of document confirms that a device is substantially equivalent to a previously marketed device, without requiring a full premarket approval application. It does not typically include the detailed technical study information that would allow me to populate the table and answer the specific questions about acceptance criteria and device performance as if it were an AI diagnostic device study.

Therefore, many of the questions cannot be answered based on the provided text alone. The text focuses on the regulatory clearance process rather than a detailed technical performance study.

However, I can extract what limited information is available and explain why other information is not present.

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

This information is not present in the provided document. The document is an FDA clearance letter, not a detailed study report. It mentions that the device is "substantially equivalent" to predicate devices, implying its performance is comparable, but does not provide specific acceptance criteria or reported performance metrics like sensitivity, specificity, or accuracy.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the provided document.

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)

This information is not present in the provided document.

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

This information is not present in the provided document.

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

There is no indication that an MRMC study was performed, and this device (KRONUS IA-2 Autoantibody RIA Assay Kit) is an in vitro diagnostic assay kit, not an AI-assisted diagnostic tool. Therefore, questions about human reader improvement with AI assistance are not applicable.

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

This question is not applicable as the device is an in vitro diagnostic assay kit, not an algorithm. The "standalone" performance would typically refer to the assay's performance itself, which is what would be evaluated. However, specific results from such an evaluation are not present in this document.

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

This information is not present in the provided document. For an assay kit, ground truth would typically be established through clinical diagnosis, often incorporating multiple factors beyond just the assay result.

8. The sample size for the training set

This information is not present in the provided document. For an in vitro diagnostic assay, there might not be a "training set" in the machine learning sense, but rather a set used for assay development and validation.

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

This information is not present in the provided document.

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