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An enzyme linked immunosorbent assay (ELISA) for the qualitative detection of anti-mitochondria antibodies (AMA) in human serum to aid in the diagnosis of primary biliary cirrhosis (PBC) in conjunction with other laboratory tests and clinical findings.

An enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of anti-mitochondria IgG antibodies in human serum to aid in the diary cirrhosis (PBC) in conjunction with other laboratory tests and clinical findings.

This test is performed as a solid phase immunoassy. Microwells are coated with recombinant Mitochondrial antigen. Controls, calibrators and patient sera are incubated in the antibodies present in the serum to bind to the Mitochondria antigen. Bound antibodies are detected by adding an enzyme labeled anti-human IgG or IgA/JgG/JgM conjugate. Specific enzyme substrate (TMB) is then added and the presence of antibodies is detected by a color change that is read by a spectrophotometer at 450 nm. Results are expressed in ELISA units per milliliter (EU/ml) and reported as positive or negative.

This test is performed as a solid phase immunoassy. Microwells are coated with recombinant mitochondrial antigen. Controls, calibrators and patient sera are incubated in the antigen coated wells to allow specific antibodies present in the serum to bind to the Mitochondria antigen. Bound antibodies are detected by adding an enzyme labeled anti-human IgG or IgA/gG/lgM conjugate. Specific enzyme substrate (TMB) is then added and the presence of antibodies is detected by a color change that is read by a spectrophotometer at 450 nm. Results are expressed in ELISA units per milliliter (EU/ml) and reported as positive or negative.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

Note: The document describes two devices:

1. ImmuLisa Enhanced™ Anti-Mitochondria IgG Antibody (AMA) ELISA (referred to as "AMA IgG ELISA")
2. ImmuLisa Enhanced™ Anti-Mitochondria IgA/IgG/IgM Antibody (AMA) ELISA (referred to as "AMA IgA/IgG/IgM ELISA")

Since the structure of the provided text details similar studies for both, I will present the information for both devices where available, clearly distinguishing between them. The acceptance criteria themselves are implied from the "Clinical Study" results where clinical sensitivity and specificity are reported.

1. Table of Acceptance Criteria and Reported Device Performance

For ImmuLisa™ Enhanced Anti-Mitochondria IgG Antibody (AMA) ELISA:

For ImmuLisa™ Enhanced Anti-Mitochondria IgA/IgG/IgM Antibody (AMA) ELISA:

Note on Acceptance Criteria: The document does not explicitly state pre-defined acceptance criteria values (e.g., "Sensitivity must be >= 80%"). Instead, it presents the results of the clinical study, implying that these achieved performance metrics are acceptable for regulatory clearance.

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

The document describes "Clinical Study" results, which serve as the test set performance.

For both AMA IgG ELISA and AMA IgA/IgG/IgM ELISA:

• Sample Size for Test Set:
  • 193 primary biliary cirrhosis (PBC) subjects.
  • 898 autoimmune and infectious disease controls.
  • Total: 1091 samples.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study states "Sets of clinical samples were tested," suggesting they are human clinical samples. It does not specify if these were retrospective or prospective, but based on the overall context of a 510(k) summary, they are typically retrospective or collected for the purpose of the study.

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

• The document states that the samples were "well-characterized primary biliary cirrhosis subjects and disease controls." This implies that the diagnosis of PBC and the control conditions were established by medical professionals.
• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. However, the nature of diagnosing primary biliary cirrhosis and various autoimmune/infectious diseases requires specialized medical expertise, likely from clinicians, hepatologists, or infectious disease specialists.

4. Adjudication Method

• Adjudication Method: Not explicitly stated. The phrase "well-characterized" suggests a established diagnosis rather than a specific adjudication process for the study.

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

• No, an MRMC comparative effectiveness study was not done. The studies presented are "standalone" performance evaluations of the device against established clinical diagnoses.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, standalone performance studies were done. The clinical sensitivity and specificity results are for the device (ELISA kit) itself, used as a diagnostic aid. Human interpretation is involved in reading the spectrophotometer results and applying the cutoff values, but it's not a human-in-the-loop AI system in the typical sense where AI provides an initial read for human verification/modification. The device provides a quantitative or qualitative result (EU/ml, positive/negative) that aids clinical findings.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was based on clinical diagnosis of primary biliary cirrhosis (PBC) and various autoimmune/infectious diseases for the control group. This is implied by the term "well-characterized primary biliary cirrhosis subjects and disease controls." "Indeterminate samples for these studies were considered positive."

8. Sample Size for the Training Set

• The document does not explicitly mention a separate training set or its sample size. The studies described appear to be validation studies of the finished device. For an ELISA kit, development and optimization (analogous to training) are typically part of the manufacturing and design control process, not usually reported as a separate "training set" in the same way as machine learning algorithms. The "Method Comparison" and "Cross Reactivity" sections utilize larger sample sizes, but these are for testing characteristics rather than training.

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

• Since a separate "training set" is not explicitly detailed in the provided text in the context of machine learning, the method for establishing its ground truth is also not described. Device development typically involves internal validation using reference materials and clinically characterized samples, which would serve a similar purpose to a training set for optimizing assay parameters.

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