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For the qualitative and semi-quantitative determination of IgGi antibodies to Mumps virus m human serum of adults over cighteen vears of age by indirect enzyme immunoassay as an aid in the diaunosis at Mumps infection. The evaluation of paired sera, to determine a significant increase in Mumps IgG antihody itel can also aid in the diagnosis of acute infection by seroconversion through testing acute and convalescent sera. The test can be performed either manually or in conjunction with the MAGO® Plus Automated EIA processor. Performance characteristics have not been established on children

The & Mumps IgG ELISA Kit is an Enzyme-Linked ImmunoSorbent Assay (E.I.S.A) (6) the detection of IgG antibodies to Mumps antigen in human serum.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Mumps IgG ELISA Kit:

Acceptance Criteria and Device Performance for Is-Mumps IgG Test Kit

• Positive Sera (A, B, C, D): CV% generally in the range of 4-9% (Interassay CV% 6.36%-8.70%).
• Negative Sera (E, F): CV% generally in the range of 21-40% (Interassay CV% 32.18%-39.03%).
  Intra-Assay/Interassay CV% (Site #2):
• Positive Sera (A, B, C, D): CV% generally in the range of 4-10% (Interassay CV% 8.92%-9.63%).
• Negative Sera (E, F): CV% generally in the range of 4-18% (Interassay CV% 13.02%-18.06%).
  Intra-Assay/Interassay CV% (Site #3):
• Positive Sera (A, B, C, D): CV% generally in the range of 2-10% (Interassay CV% 4.06%-8.04%).
• Negative Sera (E, F): CV% generally in the range of 8-35% (Interassay CV% 17.49%-35.19%). |
  | Correlation (Manual vs. MAGO Plus) | Strong correlation between manual assay results and results obtained using the MAGO® Plus Automated EIA Processor. (Implicitly, a high Pearson Correlation Coefficient is expected). | Pearson Correlation Coefficient: 0.954 (indicating good correlation, as stated). |
  | Reproducibility (MAGO Plus) | Acceptable intra-assay and interassay coefficients of variation (CV%) for both positive and negative sera when performed on the MAGO® Plus. (No explicit numerical targets are given for CV%). | Intra-Assay/Interassay CV% (MAGO Plus - Site #2):
• Positive Sera (A, B, C, D): CV% generally in the range of 6-13% (Interassay CV% 8.84%-11.50%).
• Negative Sera (E, F): CV% generally in the range of 0-28% (Interassay CV% 21.19%-23.79%). |

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Accuracy (Comparison Study): 173 fresh sera samples.
     • Provenance: "a clinical commercial laboratory, located in the Mid-Atlantic area" (United States, retrospective).
   • Reproducibility (Manual & MAGO Plus): 6 sera (4 positive, 2 negative) for each site, assayed 10 times in 3 runs. This means for each Reproducibility section (Manual, MAGO Plus), a total of (6 sera * 10 replicates * 3 runs) + (interassay variability) were evaluated at each site. This refers to the number of measurements/replicates rather than unique patient samples like in the accuracy study.
     • Provenance: Not explicitly stated for the source of these 6 sera, but the testing was done at "the manufacturer, a research and development laboratory, and a clinical laboratory."

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

   • The ground truth for the comparison study was established by a "commercially available kit for Mumps IgG antibodies" (the predicate device), not by human experts. The study clarifies: "There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison's accuracy to predict disease."

3. Adjudication method for the test set:

   • Not applicable as the ground truth was established by another ELISA test, not by human interpretation requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC study was not done. This device is an in-vitro diagnostic (IVD) assay, not a medical imaging or interpretation device that would typically involve multiple human readers.

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

   • Yes, the performance characteristics (accuracy against a predicate, reproducibility) are reported for the device as a standalone test system, both in manual operation and when automated with the MAGO® Plus. Human "readers" are not part of the performance evaluation beyond performing the lab procedures.

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

   • Comparative Device Results: The primary "ground truth" for the accuracy study was the results from a predicate, commercially available Mumps IgG ELISA kit.
   • IFA Reference: The footnotes in Table 1 mentioned "313 sera were positive by IFA" and "373 sera were positive by II/A", suggesting that some samples may have also been referenced against Immunofluorescence Assay (IFA), but the main comparison was with the predicate ELISA. The report explicitly states it was not correlated with disease presence/absence.

7. The sample size for the training set:

   • The document does not explicitly mention a separate "training set" for the device itself. For IVDs, the development process typically involves internal validation and optimization, but the performance data presented here are usually from a "test set" demonstrating the final product's characteristics.

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

   • Not applicable, as a distinct training set with established ground truth is not detailed in the provided information. If there were a training phase, it would likely involve similar methods as the test set (e.g., comparison to a reference method, known positive/negative samples).

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• 1. For in vitro diagnostic use only.
• 2. For the qualitative and semi-quantitative detection of IgG antibodies to mumps virus in human serum by enzyme immunoassay.
• 3. Individual specimens may be used for the determination of immune status.
• 4. Paired (acute / convalescent) sera, may be used to demonstrate seroconversion or significant rises in antibody level, as an aid in the diagnosis of primary infection.
• 5. For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

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The provided text for device K980059 is a 510(k) clearance letter from the FDA for the "SeraQuest Mumps IgG" device. This document primarily focuses on regulatory approval and does not contain the detailed study information needed to answer your questions regarding acceptance criteria, performance data, sample sizes, ground truth establishment, or expert qualifications.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has been determined to be as safe and effective as a previously cleared device. However, it does not include the actual study data, acceptance criteria, or performance metrics from the studies submitted by Quest International, Inc. to demonstrate this substantial equivalence.

Therefore, I cannot provide the requested information based on the given text. To answer your questions, I would need access to the full 510(k) summary or the original study reports submitted to the FDA by the manufacturer.

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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:

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.

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