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The MDI SS-B Test reagents (P/N; SBKi-G) are intended for the semi-quantitative determination of IgG antibodies to SS-B in human serum. The principal diagnostic value of this test is detection of autoantibodies, which are used as an aid in patients with rheumatoid diseases.
The MDI SS-B Test is a semi- quantitative Enzyme Immunoassay (EIA) Kit for the detection of auto- antibodies against human SS-B in human serum The test is intended as an aid in the diagnosis of rheumatic diseases. FOR IN VITRO DIAGNOSTIC USE ONLY.

The Micro Detect, Inc. SS-B reagent ( MDI SS-B Test) is intended to be used as a manual procedure. The reagents are supplied as a micro plate coated with specific antigens and Controls. Wash Buffer. Sample Diluent, Conjugate, Substrate, and Stop Solution.

The provided document describes the MDI SS-B Test, an in vitro diagnostic device, and its performance. Here's an analysis based on your requested categories:

1. Table of Acceptance Criteria and the Reported Device Performance

Note: The document implies these performance metrics were deemed "substantially equivalent" to predicate assays, which serves as the implicit acceptance criteria.

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions "The patient results obtained using the MDI SS-B Test is substantially equivalent to those obtained by using predicate assays," which describes the type of comparison made.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. Autoantibodies are typically identified through laboratory methods, not expert consensus in the same way an image interpretation might be.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. This type of in vitro diagnostic device relies on laboratory assay results, not subjective interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation (e.g., medical imaging), not for an in vitro diagnostic test for autoantibodies.

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

Yes, this is an in vitro diagnostic device, meaning its performance metrics (sensitivity, specificity, precision) are inherently standalone; they represent the performance of the assay itself without human intervention in the result generation or initial interpretation. The "manual procedure" mentioned refers to the laboratory technician performing the steps of the assay, not interpreting an image or complex data requiring AI.

7. The Type of Ground Truth Used

The ground truth for an in vitro diagnostic device like the MDI SS-B Test would typically be established by:

• Clinical Diagnosis: A definitive clinical diagnosis of a rheumatic disease based on a comprehensive assessment (symptoms, other lab tests, physician evaluation).
• Reference Method/Predicate Device: Comparison to a well-established and validated reference method or a predicate device that is already cleared for similar use. The document explicitly states "substantially equivalent to those obtained by using predicate assays," indicating comparison to predicate device results as part of the ground truth establishment.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is expected as the MDI SS-B Test is an immunoassay kit, not a machine learning or AI-based device that typically requires a training set for algorithm development.

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

Since there is no mention of a training set, the establishment of ground truth for a training set is not applicable in this context.

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The MDI Sm Test is a semi- quantitative Enzyme Immunoassay (EIA) Kit for the detection of auto- antibodies against human Sm in human serum. The test is intended as an aid in the diagnosis of theumatic diseases. FOR IN VITRO DIAGNOSTIC USE ONLY.

The Micro Detect, Inc. Sm reagent ( MDI Sm Test) is intended to be used as a manual procedure. The reagents are supplied as a micro plate coated with specific antigens and Controls, Wash Buffer, Sample Diluent, Conjugate, Substrate, and Stop Solution.

Here's an analysis of the provided text to extract the requested information about the device's acceptance criteria and the study proving it:

Device: MDI Sm Test

1. Table of acceptance criteria and reported device performance

Note: The document states that the stability of one year at 2-8°C was predicted from stress condition studies, and real-time stability had only been monitored for two weeks at 2-8°C. This suggests that the one-year stability criterion was based on accelerated testing, with ongoing real-time monitoring.

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

The document does not explicitly state the sample size used for the test set.

Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions the use of "human serum."

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

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set.

4. Adjudication method for the test set

The document does not specify any adjudication method for the test set.

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

No. The MDI Sm Test is described as a "manual procedure" using a micro plate ELISA format. It is an in vitro diagnostic (IVD) device designed for semi-quantitative determination of IgG antibodies, not an AI-powered diagnostic system involving human readers interpreting images or data for improvement with AI assistance. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not applicable and was not performed.

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

Yes, in the context of an IVD device, the performance metrics (sensitivity, specificity, precision, stability) are indicative of the standalone performance of the device itself (the reagents and protocol). There is no "human-in-the-loop" component in the device's performance evaluation as described, beyond the standard laboratory technician performing the manual procedure as instructed. The performance values reported are for the device's ability to detect antibodies independently.

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

The document implies that the ground truth was established by comparison to results obtained from predicate assays. It states: "The patient results obtained using the MDI Sm Test is substantially equivalent to those obtained by using predicate assays: Relative Sensitivity: 100% Relative Specificity: 100 %". This suggests that the "true" positive or negative status for Sm antibodies was determined by these established predicate assays.

8. The sample size for the training set

The document does not mention a "training set" as would be used for machine learning. This is an IVD device, and its development would typically involve optimization and validation studies, rather than machine learning training.

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

As there is no mention of a "training set" in the context of machine learning, this question is not applicable. For conventional IVD development, ground truth for developmental and validation samples would likely be established using reference methods, defined clinical criteria, or established predicate devices.

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The MDI RF Test is a semi quantitative Enzyme Immunoassay (EIA) Kit for the detection of IgM antibodies against human IgG (RF) in human serum. The test is intended as an aid in the diagnosis of rheumatoid arthritis. FOR IN VITRO DIAGNOSTIC USE ONLY.

The Micro Detect, Inc. RF reagent ( MDI RF Test) is intended to be used as a manual procedure. The reagents are supplied as a micro plate coated with specific antigens and Controls, Wash Buffer, Sample Diluent, Conjugate, Substrate, and Stop Solution.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for sensitivity, specificity, or precision. These are inferred from the context of a 510(k) submission, where performance metrics are presented to demonstrate substantial equivalence to predicate devices. The values presented are the reported performance of the device, which is implicitly deemed acceptable by the FDA's clearance.

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

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions "patient results obtained using the MDI RF Test."

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

The document does not provide any information on the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set.

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

No. The document describes a diagnostic device (an immunoassay kit) for detecting antibodies, not an imaging or interpretive AI system that would typically involve human readers. Therefore, an MRMC comparative effectiveness study is not applicable here, and no information on human reader improvement with/without AI assistance is provided.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, implicitly. The MDI RF Test is described as a "manual procedure" and an "in vitro diagnostic device." The reported sensitivity, specificity, and precision figures represent the standalone performance of the assay itself, without a "human-in-the-loop" in the sense of interpreting results from an AI system. The "human" in this context would be laboratory personnel performing the manual steps and reading the results, which is inherent to an IVD.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. However, given that the test is "intended as an aid in the diagnosis of rheumatoid arthritis" and detects "IgM antibodies against human IgG (RF)," the ground truth for establishing sensitivity and specificity would likely be based on:

• Clinical Diagnosis of Rheumatoid Arthritis: Established by a physician using a combination of clinical symptoms, physical examination, and other diagnostic tests (e.g., ACR criteria for RA).
• Reference Methods: Comparison against established, perhaps more labor-intensive or expensive, methods for detecting RF or diagnosing RA.

8. The Sample Size for the Training Set

The provided text does not specify the sample size for a training set. This is consistent with a traditional IVD device development rather than a machine learning/AI model, where "training set" is a more common term. The development of reagents and assay parameters would involve extensive experimentation, but not typically a "training set" in the computational sense.

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

Since there is no mention of a "training set" in the context of an AI/ML model, there is no information on how ground truth for such a set was established. For a traditional IVD, the development and optimization of the assay would involve using known positive and negative controls, and samples from patients with confirmed diagnoses (or lack thereof), but these are part of the overall assay validation rather than a distinct "training set."

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The MDI Sm/RNP Test reagents (P/N: RNKi-G) are intended for the semi quantitative determination of IgG antibodies to Sm/RNP in human serum. The principal diagnostic value of this test is detection of autoantibodies, which are used as an aid in patients with rheumatoid diseases.

The MDI Sm/RNP Test is a semi- quantitative Enzyme Immunoassay (EIA) Kit for the detection of auto- antibodies against human Sm/RNP in human serum. The test is intended as an aid in the diagnosis of theumatic diseases. FOR IN VITRO DIAGNOSTIC USE ONLY.

The Micro Detect, Inc. Sm/RNP reagent ( MDI Sm/RNP Test) is intended to be used as a manual procedure. The reagents are supplied as a micro plate coated with specific antigens and Controls, Wash Buffer, Sample Diluent, Conjugate, Substrate, and Stop Solution.

Here's an analysis of the provided text regarding the MDI Sm/RNP Test, outlining the acceptance criteria and study details:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states the device is "substantially equivalent to those obtained by using predicate assays," which implies the acceptance criteria for sensitivity and specificity were met by matching or exceeding the performance of the predicate device. The exact numerical criteria are not explicitly listed, but the reported values are presented as meeting these implicit criteria.

Study Details:

The provided document is a summary of 510(k) safety and effectiveness information, not a detailed study report. Therefore, many of the specific details requested about the study methodology are not present in the provided text.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set:

• Adjudication Method: Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• This device is an in-vitro diagnostic (IVD) lab test (Enzyme Immunoassay Kit), not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study with human readers and AI assistance is not applicable and not mentioned.

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

• This device is a standalone test; it performs the semi-quantitative determination of IgG antibodies. Its performance (sensitivity, specificity, precision) is what's reported. Human intervention is limited to performing the manual procedure, not interpreting results in conjunction with an AI.

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

• The document implies ground truth was established by comparison to "predicate assays" and through clinical performance for "detection of autoantibodies, which are used as an aid in patients with rheumatoid diseases." This suggests the ground truth was likely established through a combination of:
  • Clinically established diagnoses: Patients with confirmed rheumatoid diseases vs. healthy controls or other conditions.
  • Comparison to a gold standard or well-established reference method for Sm/RNP antibody detection (the "predicate assays").
  • Outcome data is not explicitly stated but is inherent in the "aid in patients with rheumatoid diseases" statement.

8. The sample size for the training set:

• Sample Size: Not specified. Information about training sets is typically relevant for machine learning algorithms, which is not the primary focus of this type of IVD kit (though internal assay development would involve optimizing reagents).

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

• Ground Truth Establishment: Not specified. Similar to point 8, this detail is less explicit for a chemical/biological assay kit than for an AI algorithm. Ground truth for optimizing such a kit would generally involve known positive and negative samples, often characterized by reference labs or with clinically confirmed diagnoses.

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The MDI SS-A Test is a semi- quantitative Enzyme Immunoassay (EIA) Kit for the detection of auto- antibodies against human SS-A in human serum. The test is intended as an aid in the diagnosis of rheumatic diseases. FOR IN VITRO DIAGNOSTIC USE ONLY.

The Micro Detect, Inc. SS-A reagent ( MDI SS-A Test) is intended to be used as a manual procedure. The reagents are supplied as a micro plate coated with specific antigens and Controls, Wash Buffer, Sample Diluent, Conjugate, Substrate, and Stop Solution.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MDI SS-A Test, addressing your specific questions:

Acceptance Criteria and Device Performance Study for MDI SS-A Test

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state pre-defined acceptance thresholds for sensitivity, specificity, and precision. Instead, it reports the achieved performance values, implying these met the internal or regulatory expectations for substantial equivalence.

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature).

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

The provided document does not specify the number of experts used to establish the ground truth for the test set or their qualifications.

4. Adjudication Method for the Test Set

The provided document does not specify any adjudication method used for the test set.

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

An MRMC comparative effectiveness study was not performed or reported in this document. The device is a diagnostic reagent, and the study focuses on its analytical performance (sensitivity, specificity, precision) rather than human reader improvement with AI assistance.

6. Standalone (Algorithm Only) Performance

The device is a manual procedure using a microplate ELISA format (a reagent kit). It is not an algorithm or AI-powered device. Therefore, a standalone (algorithm only) performance study is not applicable and was not performed. The reported performance metrics (sensitivity, specificity, precision) inherently reflect the standalone performance of the reagent kit when used as intended.

7. Type of Ground Truth Used

The document states that "The patient results obtained using the MDI SS-A Test is substantially equivalent to those obtained by using predicate assays." This implies that the ground truth for determining sensitivity and specificity was established by comparing the MDI SS-A Test results with results from legally marketed predicate devices. The exact nature of how those predicate devices established their ground truth (e.g., expert consensus, pathology, clinical diagnosis, or outcomes data) is not detailed for this particular study, but it relies on the established accuracy of the predicate tests.

8. Sample Size for the Training Set

The provided document does not specify a training set sample size. Given that this is a diagnostic reagent and not an AI/machine learning model, the concept of a "training set" in the context of model development is not directly applicable. The "training" in such a context would typically involve optimizing the assay's reagents and conditions, which is part of the product development process, not usually reported as a "training set" in regulatory submissions.

9. How Ground Truth for the Training Set Was Established

As noted above, the concept of a "training set" for an AI/ML model is not applicable here. The assay development process would involve optimizing parameters against known positive and negative samples, often characterized by predicate method results or clinically diagnosed patient samples. However, the document does not provide details on how the ground truth for these developmental samples (if considered a "training set") was established.

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