(168 days)
The MUMPS IgG ELISA TEST is to be used in the testing of human serum specimens from asymptomatic and symptomatic children and adults for whom quantitation of the presence or the qualitative presence or absence of detectable IgG antibody to mumps virus is warranted in the determination of immunological experience pertaining to infection with mumps virus and as an aid in the diagnosis of mumps infection.
The Mumps IgG ELISA Test is an in vitro diagnostic medical device intended for the qualitative and semi-quantitative detection of IgG antibody to the mumps virus in human serum by the enzyme-linked immunosorbent assay (ELISA) method. The Mumps IgG ELISA Test is comprised of the following items: Mumps Antigen-Coated ELISA Plate; IgG Specimen Diluent; Conjugate; Substrate Buffer; p-NPP Tablets; Stopping Reagent; Calibrator 1 and 2; Positive Control and Negative Control; Reference Serum; 20X Wash Solution; ELISA Plate Sealer; Resealable Storage Bag; ELISA Worksheet; Activity Units Graph Paper. When the Mumps IgG ELISA Test is employed, diluted patient serum is incubated with purified mumps virus antigen bound to the ELISA plate wells. If antibodies to the mumps virus are present, they bind to the antigen and do not rinse off. Subsequently when enzyme-labeled antihuman IgG is added to the reaction site it binds to the immobilized IgG antibodies. After washing and the addition of a chromogenic substrate and stopping reagent, specimens containing antibodies to the mumps virus produce a color endpoint reaction which can be read with a standard ELISA plate reader.
I am sorry, but the provided text does not contain typical acceptance criteria and reported device performance in a structured format suitable for direct extraction into the requested table. The document describes a 510(k) submission for an in vitro diagnostic medical device (Mumps IgG ELISA Test) and focuses on demonstrating substantial equivalence to a predicate device.
Instead of explicit acceptance criteria, the document presents results from comparative studies against a predicate device, focusing on agreement, relative sensitivity, and relative specificity. These are measures of how well the new device performs compared to an existing, approved device, rather than against predefined absolute clinical performance benchmarks.
Therefore, I cannot generate the table as requested with "Acceptance Criteria" and "Reported Device Performance" in the traditional sense of a clinical trial's primary and secondary endpoints.
However, I can extract the performance data presented in the document by comparing the Mumps IgG ELISA Test to the Mumps Stat Test Kit (predicate device).
Here is the information extracted from the document based on your request, formatted to the best of my ability given the content:
Device Performance Information: Mumps IgG ELISA Test
The document describes several studies comparing the Mumps IgG ELISA Test to its predicate device, the Mumps Stat Test Kit. The performance is reported in terms of agreement, relative sensitivity, and relative specificity when compared to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, explicitly defined "acceptance criteria" for the Mumps IgG ELISA Test were not provided in the document. The studies aimed to demonstrate "substantial equivalence" to the predicate device. The reported performance metrics are presented below:
| Performance Metric (vs. Mumps Stat Test Kit) | Blood Bank Study (N=144) | Hospital Study (Northeastern region) (N=123) | Hospital Study (Southwestern region) (N=123) |
|---|---|---|---|
| Overall Agreement | 97.9% (139/142) | 96.6% (114/117) | 93.2% (109/117) |
| Relative Sensitivity (95% CI) | 97.5% (119/122) (93.0% - 99.5%) | 98.0% (96/98) (92.8% - 99.8%) | 94.3% (99/110) (88.0% - 97.9%) |
| Relative Specificity (95% CI) | 100% (20/20) (83.2% - 100%) | 94.7% (18/19) (74.0% - 99.9%) | 83.3% (10/13) (51.6% - 97.9%) |
| Excluded Equivocal Samples | 2 samples | 6 samples | 6 samples |
Note: The reported performance is relative to the predicate device, not an absolute measure against a true gold standard. The 95% Confidence Intervals (CI) were determined by the Exact Method.
2. Sample Size and Data Provenance for Test Set
- Sample Sizes:
- Study 1 (Blood Bank): 144 donors. After excluding 2 equivocal samples, 142 samples were used for calculations (e.g., 122 positive and 20 negative for relative sensitivity/specificity).
- Study 2 (Hospital, Northeastern region): 123 patient specimens. After excluding 6 equivocal samples, 117 samples were used for calculations (e.g., 98 positive and 19 negative for relative sensitivity/specificity).
- Study 3 (Hospital, Southwestern region): 123 patient specimens. After excluding 6 equivocal samples, 117 samples were used for calculations (e.g., 110 positive and 13 negative for relative sensitivity/specificity).
- Data Provenance:
- Study 1: Blood samples from a regional blood bank. Location not specified, but the submitter (Gull Laboratories, Inc.) is based in Salt Lake City, Utah, USA.
- Study 2: Clinical specimens from a hospital in the Northeastern region of the United States.
- Study 3: Clinical specimens from a hospital in the Southwestern region of the United States.
- Retrospective/Prospective: Not explicitly stated, but the description "Blood samples from 144 donors were evaluated" and "Clinical specimens from 123 patients were tested" suggests these were retrospective analyses of collected samples.
3. Number of Experts and Qualifications for Ground Truth
- Ground Truth Establishment: The ground truth for the test sets was established by comparing the results of the Mumps IgG ELISA Test directly against a predicate device, the "Mumps Stat Test Kit". This is a comparative study, not one where an independent "expert ground truth" was established.
- Number/Qualifications of Experts: The document does not mention the involvement of independent experts to establish a "ground truth" for the test set. The predicate device itself served as the reference standard for comparison.
4. Adjudication Method for the Test Set
- Adjudication Method: "Discordant samples were retested using the same two tests." This implies a re-testing mechanism for cases where the Mumps IgG ELISA Test and the Mumps Stat Test Kit initially disagreed. However, the reported results ("Without incorporating the results of retesting the discordant samples") do not include these retest results in the primary statistical calculations for agreement, sensitivity, and specificity. This means the initial read was used for the primary statistics. The document does not specify further adjudication if the retests remained discordant or what criteria were used to resolve discrepancies if the retest results were to be used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC Study: This is an in vitro diagnostic test (ELISA). MRMC studies, which involve multiple human readers interpreting cases with and without AI assistance, are not applicable to this type of device. The device itself performs the detection of antibodies.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: Yes, the described studies represent the standalone performance of the "Mumps IgG ELISA Test" device. It is an "algorithm only (device only)" performance in the sense that the device delivers a result (qualitative or semi-quantitative detection of IgG antibody) without real-time human intervention in the result generation process itself, beyond standard laboratory procedures for running an ELISA. The comparison is between two such standalone diagnostic tests.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth was established by comparison to a predicate device (Mumps Stat Test Kit). The predicate device itself serves as the reference for determining relative performance. This is a common approach for demonstrating "substantial equivalence" for in vitro diagnostic devices under 510(k) pathway, rather than comparison to a definitive clinical or pathological gold standard.
8. Sample Size for the Training Set
- Training Set Sample Size: The document does not mention a "training set" in the context of developing the Mumps IgG ELISA Test. ELISA tests are typically developed and optimized through laboratory experiments and verification studies using characterized samples, but these are generally not referred to as "training sets" in the same way as machine learning algorithms. The provided text focuses on the performance evaluation of the finalized device.
9. How Ground Truth for Training Set was Established
- Not Applicable: As there is no mention of a "training set" in the machine learning sense, the method for establishing its ground truth is not described. The device's components (antigen, controls, etc.) would have been validated through standard analytical performance studies during development, but this is distinct from establishing ground truth for a dataset used to "train" an algorithm.
§ 866.3380 Mumps virus serological reagents.
(a)
Identification. Mumps virus serological reagents consist of antigens and antisera used in serological tests to identify antibodies to mumps virus in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used in serological tests to identify mumps viruses from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of mumps and provides epidemiological information on mumps. Mumps is an acute contagious disease, particularly in children, characterized by an enlargement of one or both of the parotid glands (glands situated near the ear), although other organs may also be involved.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.