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The TheraTest EL-anti-CCP/2™ test is intended for use in clinical laboratories as an in vitro diagnostic test for the detection and measurement of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum by enzyme-linked immunosorbent assay (ELISA). It is intended to aid in the diagnosis of Rheumatoid arthritis (RA) in conjunction with other clinical findings and laboratory tests.

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Based on the provided text, the following information can be extracted regarding the acceptance criteria and the study that proves the device meets them:

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

The provided text is a 510(k) clearance letter from the FDA. It does not contain a table of specific acceptance criteria or detailed reported device performance. The letter states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This implies that the device met the performance standards demonstrated by the predicate device(s) in the 510(k) submission, but those specific criteria and performance values are not present in this document.

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

This information is not available in the provided text. The FDA letter is a conclusion of the review, not the detailed submission itself.

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 available in the provided text. The device is a "Rheumatoid factor immunological test system," implying its output is a direct measurement, and ground truth would likely be established through clinical diagnosis of Rheumatoid Arthritis, but the specifics are not detailed here.

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

This information is not available in the provided text.

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

The device described is an "ELISA" (enzyme-linked immunosorbent assay) for detecting autoantibodies. This is a laboratory test, not an AI-based imaging or diagnostic tool that would typically involve "human readers" or MRMC studies in the context of improving human performance. Therefore, an MRMC study with human readers and AI assistance is not applicable to this type of device.

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

This refers to the device's performance as a standalone test. The "TheraTest EL-anti-CCP/2TM" is an in vitro diagnostic test, meaning its performance is inherently standalone in the sense that it provides a result (detection and measurement of autoantibodies) without direct human intervention in the assay itself. The indication for use states it is "intended to aid in the diagnosis of Rheumatoid arthritis (RA) in conjunction with other clinical findings and laboratory tests," acknowledging that a physician still interprets the result within a broader clinical picture. The specific performance metrics (e.g., sensitivity, specificity, accuracy) of this standalone test are not provided in the letter, but would have been part of the 510(k) submission.

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

The ground truth for this type of device would likely be the clinical diagnosis of Rheumatoid Arthritis (RA), established by rheumatologists based on a combination of patient symptoms, physical examination, imaging, and other laboratory tests (e.g., ACR/EULAR classification criteria for RA). The device itself measures specific autoantibodies, and its performance would be assessed against this clinical diagnosis. However, the exact methodology for establishing this ground truth is not detailed in the provided text.

8. The sample size for the training set

Given that this is an ELISA diagnostic kit, there isn't typically a "training set" in the machine learning sense. The device's performance is established through validation studies on clinical samples. The sample size used for these validation studies is not available in the provided text.

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

As noted in point 8, the concept of a "training set" in the machine learning context does not directly apply to this type of in vitro diagnostic device. For the clinical validation samples (which would be analogous to a test set in ML), the ground truth would be established by clinical diagnosis of Rheumatoid Arthritis, likely by rheumatologists using established diagnostic criteria. The specifics are not available in the provided text.

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The TheraTest EL-Anti-TPO™ is an enzyme immunoassay for the qualitative detection or quantitative determination of IgG class antibodies against thyroid peroxidase (TPO) in human serum. The TheraTest EL-Anti-TPO™ assay is intended for use as an aid in the diagnosis of autoimmune thyroid disorders in conjunction with other clinical and laboratory findings.

The TheraTest EL-Anti-Thyroglobulin™ is an enzyme immunoassay for the qualitative detection or quantitative determination of IgG class antibodies against thyroglobulin in human serum. The TheraTest EL-Anti-ThyroglobulinTM assay is intended for use as an aid in the diagnosis of autoimmune thyroid disorders in conjunction with other clinical and laboratory findings.

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This looks like a 510k clearance letter for a medical device. There is no information in the document to extract an answer for the user's request. There is no mention of acceptance criteria or study details within the given text.

Therefore, I cannot answer the question.

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The TheraTest EL-tTG™ IgA/IgG and TheraTest EL-GLIATM IgA/IgG Kits are enzyme-linked immunosorbent assay (ELISA) test systems for the semi-quantitative measurement of IgA and IgG anti-tissue transglutaminase (tTG) and anti-gliadin antibodies in human serum. Detection and semi-quantitation of these antibodies is intended to aid the diagnosis of patients with gluten sensitive enteropathies: celiac disease and dermatitis herpetiformis, in conjunction with other clinical findings and laboratory tests.

enzyme-linked immunosorbent assay (ELISA) test systems for the semi-quantitative measurement of IgA and IgG anti-tissue transglutaminase (tTG) and anti-gliadin antibodies in human serum.

The provided text is a 510(k) premarket notification letter from the FDA regarding two ELISA test systems (TheraTest EL-tTG™ IgA/IgG and TheraTest EL-Glia™ IgA/IgG) for aiding in the diagnosis of celiac disease and dermatitis herpetiformis.

However, the provided document does not contain any information about acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance.

The letter is a notification of substantial equivalence to predicate devices, allowing the manufacturer to market the device, subject to general controls. It does not include specific study results or performance data that would detail acceptance criteria and a study proving the device meets them.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them based on the provided text. This information would typically be found in the 510(k) submission itself, or in accompanying performance data summaries, which are not part of this letter.

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TheraTest EL- ANCATM: anti-MPO- and EL- ANCA™: anti-PR3 are intended for use in clinical laboratories as in vitro diagnostic tests for the detection and measurement of autoantibodies in human serum directed against human neutrophil myeloperoxidase and proteinase 3, respectively. Measurement of anti-MPO aids in the diagnosis of microscopic polyangiitis. Measurement of anti-PR3 aids in the diagnosis of Wegener's granulomatosis.

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I am sorry, but the provided document describes a 510(k) premarket notification for "TheraTest EL-ANCA™" devices, which are in vitro diagnostic tests. The document is a letter from the FDA determining substantial equivalence to predicate devices. It outlines the intended use of the devices for detecting and measuring autoantibodies.

However, the document does not contain information on:

• Acceptance criteria and reported device performance in a table format.
• Sample sizes for test sets, data provenance, number of experts, their qualifications, or adjudication methods for establishing ground truth.
• Information about multi-reader, multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for the training set or how ground truth for the training set was established.

This document primarily focuses on the regulatory clearance of the device based on substantial equivalence, rather than detailed performance study design and results that would typically include the requested information.

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The TheraTest EL-aCL™screen and TheraTest EL-aCL™ IgM, InG, IgA are intended for use in clinical laboratories as an in vitro diagnostic test for the detection and measurement of autoantibodies in human serum directed against the phospholipid cardiolipin.

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I am sorry, but the provided text describes a 510(k) premarket notification for an in vitro diagnostic test (TheraTest EL-aCL™ screen and TheraTest EL-aCL™ IgM, IgG, IgA). This document is a regulatory approval letter from the FDA.

This type of device is a laboratory assay, not an AI/ML powered device, and therefore the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they apply to AI-powered medical devices (like those involving image analysis, decision support systems, etc.) are not directly relevant in the way you've framed the request with terms like "test set," "ground truth," "MRMC study," and "training set."

The document does not contain the information needed to fill out your request, as it does not describe an AI/ML algorithm or its development and validation.

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The EL-ANA Profiles™ is an in vitro diagnostic test for the detection and measurement of autoantibodies directed against the following autoantigens: single-stranded DNA (ssDNA), double-stranded DNA (dsDNA), Smith, RNP/Sm, SSA (Ro) "R, SSB (La) "R (30217), Gould Carding Ribosomal Protein P, Centromere™, and Chromatin (Nucleosomes). This test system is intended as an aid in diagnosis of systemic lupus erythematosus, Sjogren's syndrome, progressive systemic sclerosis (scleroderma), drug-induced lupus and polymyositis.

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This is a 510(k) premarket notification for an in vitro diagnostic device, not an AI/ML medical device. Therefore, much of the requested information, such as sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types related to image analysis or AI model evaluation, are not applicable.

However, I can extract information relevant to the device's performance based on the provided document, even if it doesn't align perfectly with the AI/ML specific questions.

Here's the closest possible interpretation of your request based on the provided 510(k) summary for the TheraTest EL-ANA Profiles:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (a FDA 510(k) clearance letter) does not contain a detailed table of specific acceptance criteria. FDA 510(k) clearances for in vitro diagnostics usually reference substantial equivalence to a predicate device, which implies that the new device performs at least as well as the predicate device. The performance data would typically be found in the 510(k) summary or the full submission, but is not present in this clearance letter.

Therefore, this table cannot be accurately completed from the given text. The clearance states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This implies that the device met the implicit acceptance criteria by demonstrating substantial equivalence.

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

This information is not provided in the clearance letter. For an in vitro diagnostic device, the "test set" would refer to clinical samples used for validation, but the details of this are not in the provided text.

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

This information is not explicitly stated in the clearance letter. For in vitro diagnostics like this, "ground truth" would typically be established through clinical diagnosis of the patients from whom the samples were collected, potentially by qualified clinicians (e.g., rheumatologists, immunologists).

4. Adjudication Method for the Test Set

This information is not provided in the clearance letter.

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

MRMC studies are typically for image-based diagnostic devices where human readers interpret images. This device is an in vitro diagnostic test for autoantibodies, not an imaging device. Therefore, an MRMC study would not be applicable or performed for this type of device.

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

This device is an in vitro diagnostic test, not an algorithm. Its performance is inherent to the chemical and biological reactions involved in detecting the autoantibodies. Therefore, the concept of "standalone algorithm performance" is not applicable. The device is the "standalone" diagnostic tool, providing results without an intervening human interpretation step in the same way an AI model's output would need.

7. The Type of Ground Truth Used

The "ground truth" for an in vitro diagnostic test like the TheraTest EL-ANA Profiles would typically be the clinical diagnosis of the patients (e.g., diagnosis of SLE, Sjogren's syndrome, etc.) based on a combination of clinical symptoms, other laboratory tests, and expert medical opinion. The specific method for establishing this ground truth for the study supporting this 510(k) is not described in the provided document.

8. The Sample Size for the Training Set

This device is an in vitro diagnostic kit, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device's performance is based on its analytical and clinical validation, not on a machine learning training process.

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

As there is no training set for an AI/ML algorithm, this question is not applicable.

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To aid in the diagnosis of systemic lupus erythematosus and related conditions.

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I am sorry, but the provided text does not contain the detailed information necessary to answer the request about acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for a diagnostic device, which confirms substantial equivalence but does not describe the specific performance studies, sample sizes, ground truth establishment, or expert qualifications that would typically be detailed in a submission summary or a scientific publication.

Therefore, I cannot extract the following information:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance. (Note: This is an in-vitro diagnostic, not an AI-based imaging device, so this question is likely not applicable)
6. If a standalone (algorithm only) performance study was done. (Note: This is an in-vitro diagnostic, not an AI-based algorithm, so this question is likely not applicable)
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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The EL-ANA Profiles™ is intended to measure autoantibodies directed against the following autoantigens: single-stranded DNA (ssDNA), doublestranded DNA (dsDNA), Sm, RNP/Sm, SSA (Ro), SSB (La), Scl-70, Histones, Jo-1, Ribosomal Protein P , and Centromere. This system is intended as an aid in diagnosis of systemic lupus erythematosus and related rheumatic diseases.

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This is an FDA premarket notification (510(k)) letter for the EL-ANA Profiles™ device. The letter states that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls.

Unfortunately, this document does not contain the detailed acceptance criteria or the study that proves the device meets those criteria. The letter is an official approval document, but it does not include the technical data and results of the clinical studies or performance validation studies. Such information is typically found in the 510(k) summary or the full 510(k) submission, which are separate documents.

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

To address your request fully, I would need to review the actual 510(k) summary or the entire 510(k) submission for K024151.

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The EL-ANA Profiles™ is intended to measure autoantibodies directed against the following autoantigens: single-stranded DNA (ssDNA), doublestranded DNA (dsDNA), Sm, RNP/Sm, SSA (Ro), SSB (La), Scl-70, Histones, Jo-1, Ribosomal Protein P, and Centromere. This system is intended as an aid in diagnosis of systemic lupus erythematosus and related rheumatic diseases.

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Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the EL-ANA Profiles™ device. Unfortunately, the provided text is a 510(k) clearance letter and an "Indications For Use" statement. It does not contain the detailed information about the acceptance criteria or the study that proves the device meets those criteria.

A 510(k) clearance letter confirms that the FDA has determined the device is substantially equivalent to a predicate device, meaning it's as safe and effective. It does not typically include the full clinical study details that would outline acceptance criteria and performance data. Those details would normally be found in the 510(k) submission itself, which is a much more extensive document.

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text. I can only infer what the "acceptance criteria" were from the FDA's clearance, which is substantial equivalence to a predicate device for the stated indications for use.

Here's what I can provide based on the given information:

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

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

• Information Not Provided in the Text.

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)

• Information Not Provided in the Text.

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

• Information Not Provided in the Text.

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

• This device is an "immunological test system" for autoantibodies, not an imaging device typically analyzed by human readers in the same way. Therefore, an MRMC study as described (human readers with/without AI assistance) is not applicable to this type of device.
• Information regarding a comparative effectiveness study is not provided in the text. The 510(k) process focuses on substantial equivalence, not necessarily a comparative effectiveness study against a human standard or AI.

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

• This device is an in vitro diagnostic (IVD) test. IVDs are inherently "standalone" in their analytical function; the test provides results based on the sample. The "human-in-the-loop" for this type of device is the medical professional interpreting the quantitative or qualitative results in the context of a patient's clinical presentation.
• The document does not detail the specific performance study, but IVD tests are evaluated for their analytical performance (e.g., accuracy, precision) in a standalone manner.

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

• For an immunological test system, the ground truth for establishing performance would typically involve:
  • Clinical diagnosis: Confirmation of diseases like systemic lupus erythematosus (SLE) or related rheumatic diseases based on established diagnostic criteria (e.g., ACR criteria) and patient follow-up, which can involve expert consensus or established clinical practice.
  • Reference methods/assays: Comparison against well-characterized and established assays for the same autoantibodies, often considered "gold standards" or established methods in the field.
• The specific type of ground truth used in the EL-ANA Profiles™ study is not provided in this text.

8. The sample size for the training set

• Information Not Provided in the Text. This document is about FDA clearance, not the development process. Furthermore, for a laboratory test like this, the concept of a "training set" in the machine learning sense is not generally applicable unless a computational algorithm is specifically being "trained" to interpret complex patterns, which is not indicated here for a standard immunoassay. Instead, assay parameters are optimized during development.

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

• Information Not Provided in the Text. (See the reasoning for point 8).

In summary: The provided FDA 510(k) clearance letter confirms substantial equivalence but does not offer the granular detail of the performance study sought by your questions. This detailed information would be found in the original 510(k) submission, which is a much more extensive document.

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