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The EUROIMMUN Anti-BP230-CF ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of immunoglobulin class IgG antibodies against BP230 in human serum and plasma (K3-EDTA, Li+heparin, Na+-citrate). It is used as an aid in the diagnosis of bullous pemphigoid, in conjunction with other laboratory and clinical findings.

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This FDA 510(k) clearance letter pertains to an In Vitro Diagnostic (IVD) device, specifically an ELISA test for autoantibodies. The provided text does not contain the kind of information typically associated with the development and validation of an AI/ML-based medical device, which would usually include details about:

• Algorithms and machine learning models
• Training and test datasets (sizes, provenance, ground truth establishment)
• Expert review processes (number of experts, qualifications, adjudication)
• MRMC studies or standalone AI performance metrics

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions related to sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details based on the provided text.

The document describes the regulatory clearance for the EUROIMMUN Anti-BP230-CF ELISA (IgG) test kit, which is a laboratory assay.

Here's what can be extracted from the document:

• Device Name: EUROIMMUN Anti-BP230-CF ELISA (IgG)
• Regulation Number: 21 CFR 866.5660
• Regulation Name: Multiple autoantibodies immunological test system
• Regulatory Class: Class II
• Product Code: OEG
• Indications for Use: The test kit is intended for the qualitative or semi-quantitative determination of immunoglobulin class IgG antibodies against BP230 in human serum and plasma. It is used as an aid in the diagnosis of bullous pemphigoid, in conjunction with other laboratory and clinical findings.

To answer the detailed questions about acceptance criteria and study data for an AI/ML device, a different type of regulatory submission document (e.g., a summary of safety and effectiveness data or a clinical study report) would be required.

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The EUROIMMUN Anti-BP180-4X ELISA (IgG) test kit is intended for the qualitative or semiquantitative determination of IgG class autoantibodies against BP180 in human serum and plasma. It is used as an aid in the diagnosis of bullous pemphigoid (PB), in conjunction with other laboratory and clinical findings.

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This is a 510(k) premarket notification decision letter, not a study report. It does not contain the detailed information about acceptance criteria or specific study results to prove device performance. The letter only states that the device is "substantially equivalent" to a legally marketed predicate device.

Therefore, I cannot provide the requested information based on the text provided. The document primarily focuses on regulatory approval and classification, not on the individual studies proving performance.

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The MESACUP BP180 or BP230 TEST is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti BP180 or BP230 antibodies in human serum. The MESACUP TESTS are intended for in vitro diagnostic use as an aid in the diagnosis of bullous pemphigoid in conjunction with other laboratory and clinical findings. Patients with Bullous Pemphigoid are known to have either BP180 or BP230 or both types of antibodies in serum. It is recommended that each patient be tested for BP180 and BP230 antibodies.

BP means Bullous pemphigoid. Bullous pemphigoid (BP) is a chronic blistering of the skin. It ranges from mildly itchy welts to severe blisters and infection, and may affect a small area of the body or be widespread. The vast majority of those affected are elderly, but it has been seen at all ages. It is an autoimmune disorder, meaning it is caused when the body's immune system malfunctions. The immune system is meant to defend the body against bacteria, viruses, and disease, but instead produces against healthy tissue, cells and organs. Some patients with BP have other autoimmune diseases such diabetes and rheumatoid arthritis. Various other factors have been reported to play a role in triggering BP. These include drugs (furosemide, penicillin's), mechanical trauma, and physical traumas (burns from radiation, sun or heat). The BP180 Elisa kit is designed to detect the BP180 protein. The related BP230 Elisa kit is designed to detect the autoantigen BP230, also known as bullous pemphigoid antigen.

This appears to be a 510(k) summary for an ELISA kit, which is a laboratory diagnostic device, not an AI/ML powered device. As such, many of the requested categories (like MRMC studies, number of experts for ground truth, sample size for training set, etc.) are not applicable in the context of this traditional in-vitro diagnostic device submission.

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

Acceptance Criteria and Device Performance for MESACUP BP180 ELISA Kit and MESACUP BP230 ELISA Kit

The provided 510(k) summary (K071961) focuses on establishing "substantial equivalence" to predicate devices, rather than defining specific quantitative performance acceptance criteria in the way a novel AI/ML device might. The core "acceptance criteria" here is that the device is "comparably safe and effective" and has "similar indications" to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "The results of clinical and nonclinical testing indicates that the new device is as safe and effective as the predicate devices and methods." However, specific sample sizes for clinical or nonclinical test sets are not provided in this 510(k) summary. The summary does not mention country of origin or whether the data was retrospective or prospective.

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

This information is not provided in the 510(k) summary. For an ELISA kit, ground truth typically comes from a reference method or clinical diagnosis, but details about expert involvement are not included here.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary.

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

No, an MRMC comparative effectiveness study was not applicable and not done for this type of in-vitro diagnostic device (ELISA kit). MRMC studies are typically performed for imaging or other diagnostic devices where human readers interpret results. This is a laboratory test where the result is quantitative or semi-quantitative, not interpreted by human readers in the same way.

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

This is an ELISA kit, not an algorithm. Therefore, the concept of a "standalone" algorithm performance study is not applicable. The device itself is the "standalone" diagnostic tool.

7. The Type of Ground Truth Used

The 510(k) summary does not explicitly state the type of ground truth used. However, for a diagnostic test like this, the ground truth for clinical studies would typically be established based on:

• Clinical Diagnosis: Established by a physician based on the patient's symptoms, physical examination, and other laboratory/histopathological findings consistent with bullous pemphigoid.
• Reference Methods: Comparison to established "gold standard" or highly accepted diagnostic methods for detecting BP180 or BP230 antibodies (e.g., Western blot, immunofluorescence, or other validated assays).

8. The Sample Size for the Training Set

The concept of a "training set" in the context of machine learning or AI is not applicable here. This is a traditional ELISA diagnostic kit, not an algorithm that learns from data.

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

As there is no "training set" in the AI/ML sense, this question is not applicable.

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