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The Trinity Biotech Captia™ Mycoplasma IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for semi-quantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience. The Mycoplasma IgG ELISA kit may be used to evaluate paired sera for seroconversions and the presence of a significant increase in specific IgG as and aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population.

The Mycoplasma IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for semi-quantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience. The Mycoplasma IgG ELISA kit may be used to evaluate paired sera for the presence of seroconversions and a significant increase in specific IgG as an aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population. For In Vitro Diagnostic Use Only.

The Mycoplasma IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Mycoplasma pneumoniae. Purified Mycoplasma pneumoniae antigen is attached to a solid phase microtiter well. Diluted test sera are added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation, the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present, the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing and indirect measurement of specific antibody in the patient specimen.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document primarily presents performance characteristics and compares them to a predicate device or implied standards (e.g., "With appropriate technique the user should obtain precision of < 15% CV"). Explicit, pre-defined numerical acceptance criteria are not always stated, but the reported values demonstrate the device's performance in relation to the predicate or common laboratory standards. For precision, the text itself suggests "< 15% CV" as an expected outcome with appropriate technique.

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

• Agreement with Predicate Device (IFA):
  • Study 1: 187 frozen retrospective sera.
    • Provenance: Normal individuals of various ages, gender, from Lyme disease endemic and non-endemic areas. (Country of origin not specified, but commercial companies were located in Maryland and New York, affiliated with the manufacturer).
  • Study 2: 176 frozen retrospective sera.
    • Provenance: Randomly selected sera from normal individuals of various ages, gender, and geographical location. (Country of origin not specified, but commercial companies were located in Maryland and New York, affiliated with the manufacturer).
• Precision:
  • 7 sera, each assayed 10 times on 3 different assays at 2 different sites. This means 7 * 10 * 3 * 2 = 420 individual tests for sera, plus controls.
  • Provenance: Not explicitly stated for the sera samples themselves, but the testing was done at R&D laboratories at commercial companies affiliated with the manufacturer (Maryland and New York).
• Linearity (Simulated Paired Sera):
  • 20 positive sera, serially two-fold diluted. The number of dilutions is not specified, but at least 4-5 dilutions per serum would be typical (Neat, 1:2, 1:4, 1:8, 1:16 as shown in the graph).
  • 56 paired sera (for % agreement positive detection of four-fold increase).
  • Provenance: Not specified for individual sera or paired sera.
• Complement Fixation Paired Serum Study:
  • 11 serum pairs, with 7 ultimately used for analysis.
  • Provenance: From patients suspected of having acute Mycoplasma pneumoniae infection, tested by CF. (Country of origin not specified).
• Reproducibility Study:
  • 50 different sera.
  • Provenance: Assayed at three different sites: two R&D labs at commercial companies (Maryland and New York) and one large clinical laboratory (Pennsylvania).

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

• No "experts" per se were used to establish ground truth in the traditional sense for the primary agreement studies.
• The ground truth for the agreement studies (Studies 1 and 2) was the Mycoplasma IFA (1:32) kit, which is the predicate device. This is a comparative study against an existing, legally marketed device, not a comparison to a clinical diagnosis established by experts.
• For the Complement Fixation Paired Serum Study, the ground truth for "significant rise in antibody" was established by the CF method.
• The "expected results" for the Reproducibility Study were derived from "previous Trinity Biotech ELISA testing of the samples."

4. Adjudication Method for the Test Set

• For the primary agreement studies (Studies 1 and 2), the comparison was directly between the new Trinity Biotech Mycoplasma IgG ELISA and the commercial IFA kit. There was no mention of an adjudication process between different readers or methods beyond the direct comparison.
• In cases where the Trinity Biotech ELISA and the IFA kit disagreed, all 20 sera in Study 1 and 20 sera in Study 2 that were positive by IFA but negative by the Trinity Biotech ELISA were further tested by "an alternate ELISA" to confirm their positive status. This serves as a form of secondary evaluation or tie-breaking for discordant results.
• For the reproducibility study, "expected results were derived from previous Trinity Biotech ELISA testing." This suggests a pre-defined reference, not an adjudication of new readings.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
• This device is an in vitro diagnostic (ELISA test kit), not an imaging or interpretation device that would typically involve multiple human readers interpreting results with and without AI assistance. The performance studies focus on the analytical and clinical agreement of the assay itself with a predicate device and its internal consistency (precision, linearity, reproducibility).

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

• Yes, the studies presented are all standalone performance evaluations of the Mycoplasma IgG ELISA kit.
• The ELISA kit is a laboratory test where the "algorithm" is the biochemical reaction and photometric measurement, yielding a quantitative or semi-quantitative result. There is no human-in-the-loop variable being tested in terms of interpreting algorithmic output. The performance metrics (agreement, precision, linearity, reproducibility) represent the intrinsic performance of the device on its own.

7. The Type of Ground Truth Used

• Primary Ground Truth for Agreement Studies: The predicate device (commercial IFA kit) was used as the comparator for determining "% Agreement Positive" and "% Agreement Negative." This is a comparator or reference method ground truth.
• Secondary Ground Truth for Discordant Results: An "alternate ELISA" was used to confirm positive status for samples where the predicate IFA was positive but the study device was negative.
• Paired Sera Studies: The "significant rise in antibody" was determined by either the calculated % rise in ISR value within the Trinity Biotech ELISA or by the Complement Fixation (CF) method as a reference.
• Reproducibility Study: "Expected results" were derived from "previous Trinity Biotech ELISA testing".

8. The Sample Size for the Training Set

• No explicit training set is mentioned in the description.
• ELISA kits, particularly for a 510(k) submission, are typically validated through analytical and clinical performance studies, not by training a machine learning algorithm. The "development" or "optimization" would involve chemical and biological engineering, not data training in the AI sense.
• The provided studies evaluate the final product's performance, not the iterative development process that might involve a 'training set' for an AI model.

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

• As no explicit training set for an AI/algorithm was described, the concept of establishing ground truth for a training set does not apply directly to this device's validation as presented in the summary.
• The 'ground truth' pertinent to the evaluation was established by either a predicate device (IFA), an alternate ELISA, or a CF method as described in section 7.

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The Mycoptasma IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for semi-quantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience The Mycoplasma IgG ELISA kit may be used to evaluate paired sera for seroconversions and the presence of a significant increase in specific IgG as an aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population.

The Mycoplasma IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for semiquantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience. The Mycoplasma IgG ELISA kit may be used to evaluate paired sera for the presence of seroconversions and a significant increase in specific IgG as an aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population. For In Vitro Diagnostic Use Only.

The Mycoplasma IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Mycoplasma pneumoniae. Purified Mycoplasma pneumoniae antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

K971393 Mycoplasma IgG ELISA Test Kit: Acceptance Criteria and Study Details

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Mycoplasma IgG ELISA Test Kit are primarily defined by its "relative" performance against a predicate commercial IFA kit, rather than absolute diagnostic accuracy against a confirmed disease state.

Note on "Relative" Performance: The report explicitly states, "Please be advised that 'relative' refers to the comparison of this assay's results to that of a similar assay. There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison assay's accuracy to predict disease." This is crucial context for interpreting the results.

2. Sample Size and Data Provenance

• Test Set (Comparative Studies):

  • Study 1: 187 frozen retrospective sera.
  • Study 2: 176 frozen retrospective sera.
  • Data Provenance: From two R&D laboratories at commercial companies in Maryland and New York, affiliated with the manufacturer. Sera in Study 1 were from "normal individuals of various ages, gender, from Lyme diseases endemic and non-endemic areas." Sera in Study 2 were "randomly selected sera from normal individuals of various ages, gender, and geographical location." Crucially, none of the performance characteristics were established with specimens from patients having documented mycoplasma infections.

• Test Set (Linearity): 20 positive sera (serially diluted).

• Test Set (Paired Sera Evaluation): 56 pairs of sera (acute sera with ISR < 2.18).

• Test Set (Complement Fixation Paired Serum Study): 11 serum pairs from patients suspected of having acute Mycoplasma pneumoniae infection (7 usable pairs).

• Test Set (Reproducibility Study): 50 different sera with various levels of activity.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable in the context of expert review for image-based diagnostics. The "ground truth" for the comparative studies was the result of a commercial IFA kit (predicate device).
• Qualifications of Experts: Not specified, as the comparison was against another diagnostic test, not expert clinical judgment of individual cases solely.

4. Adjudication Method for the Test Set

• No adjudication method described for establishing the primary ground truth (IFA results). The IFA results were taken as the reference.
• In the comparative studies (Tables 2 and 3), "equivocals were not included in the above calculations" for sensitivity and specificity, indicating a simple exclusion rather than an adjudication process for those specific cases.
• For the 20 sera found positive by IFA but negative by the Wampole ELISA in both studies, it is noted that "* All 20 sera were found to be positive by an alternate ELISA." This suggests a secondary verification, but not a formal adjudication process involving multiple independent readers to establish a definitive consensus ground truth.

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

• No, an MRMC comparative effectiveness study was not done. This report describes the performance of a diagnostic kit against a predicate device and its internal consistency, not the improvement of human readers with AI assistance.

6. Standalone Performance Study (Algorithm Only)

• Yes, a standalone performance study was done. The entire submission details the performance of the "Mycoplasma IgG ELISA Test Kit" (an assay, not an algorithm in the modern AI sense) as a standalone diagnostic device. The reported sensitivity, specificity, agreement, linearity, paired sera detection, precision, and reproducibility demonstrate its performance without human-in-the-loop assistance for interpretation beyond reading the assay results.

7. Type of Ground Truth Used

• Comparative Reference Standard: The primary "ground truth" for the relative sensitivity and specificity studies was the results from a commercial IFA kit (predicate device).
• Internal Consistency: For linearity, precision, and reproducibility, the ground truth was derived from the expected behavior of serially diluted samples, repeated measurements, and inter-site comparisons.
• Clinical Correlation (Limited): For the paired sera analysis, the "ground truth" was a four-fold increase in antibody level or comparison against Complement Fixation (CF) results for a subset. However, the report explicitly states that there was no attempt to correlate the assay's results with disease presence or absence.

8. Sample Size for the Training Set

• Not Applicable. This is an ELISA test kit, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML model development. The development of the kit involved internal optimization and validation, but this is distinct from training a statistical or AI model.

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

• Not Applicable. As noted above, there is no training set for this type of device. The development process would have involved establishing the optimal antigen coating, reagent concentrations, incubation times, and cutoff values through internal technical validation, rather than an ML-style "ground truth" establishment for training.

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M. pneumoniae is the simplest self-replicating microorganism known. It is primarily a respiratory tract pathogen, and is one of the most common causes of pneumonia and upper-respiratory tract infections. Symptomatic infections attributable to this organism most commonly occur in children and young adults; however, the elderly may also be at risk.

Clinical signs of the onset of illness are gradual and characterized by headache, malaise, and fever, cough is prominent, and sore throat is frequent. For patients presenting such clinical symptoms, this test system may aid in the determination of the patient's serological status, and therefore, may aid in the diagnosis of disease associated with M. pneumoniae. The test system provides a means for the qualitative detection of IgG-class antibody to M. pneumoniae in human serum. The test system is for in vitro diagnostic use.

Not Found

This document is a 510(k) clearance letter for an in vitro diagnostic device, the Mycoplasma IgG ELISA Test System. It does not contain the detailed study information required to fill out the table of acceptance criteria and device performance as it's a regulatory approval document, not a clinical study report. Therefore, most of the requested information is not available in the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be answered from the provided text. This document is a clearance letter, not a performance study report. It states that the device is "substantially equivalent" to a predicate device, implying its performance is acceptable, but does not specify the acceptance criteria or reported performance metrics (e.g., sensitivity, specificity, accuracy).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be answered from the provided text. The document does not discuss the specifics of any test sets or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be answered from the provided text. This information would typically be found in a study report, not a clearance letter.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be answered from the provided text. Study design details like adjudication methods are not included in this regulatory letter.

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

• Cannot be answered from the provided text. This device is an ELISA test system, an in vitro diagnostic for antibody detection, not an AI-assisted imaging device. Therefore, an MRMC study or AI-related metrics are irrelevant and not present.

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

• Cannot be answered from the provided text. This question is formulated for AI/algorithm-based devices. An ELISA test system inherently has a "standalone" performance, as it's a laboratory test, but the question's premise doesn't directly apply. The document does not describe the specific laboratory validation.

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

• Cannot be answered from the provided text. While the test aims to "aid in the diagnosis of disease associated with M. pneumoniae" by detecting IgG-class antibody, the specific ground truth used for validating the test (e.g., culture, PCR, a reference serological method) is not mentioned.

8. The sample size for the training set

• Cannot be answered from the provided text. The concept of a "training set" as understood for machine learning models is not directly applicable to an ELISA test system in the same way. The document does not provide details on sample sizes used for internal assay development or calibration.

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

• Cannot be answered from the provided text. Similar to point 8, this question is not directly applicable to the type of device and the information provided.

Summary of available information from the document:

• Device Name: Mycoplasma IgG ELISA Test System
• 510(k) Number: K970150
• Regulatory Class: I
• Product Code: LJZ
• Intended Use: Qualitative detection of IgG-class antibody to M. pneumoniae in human serum to aid in the diagnosis of disease associated with M. pneumoniae. For in vitro diagnostic use.
• Type of device: ELISA (Enzyme-Linked Immunosorbent Assay) for serological testing.
• Approval Type: Substantial Equivalence to a predicate device.

To obtain the requested information, one would need to review the actual 510(k) submission document or any peer-reviewed publications detailing the device's validation studies, which are not included in this regulatory clearance letter.

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