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The Serafin is intended for the orthodontic treatment of malocclusion in patients with mixed and permanent dentition.

Serafin® is composed of series of transparent removable orthodontic appliances manufactured using thermoforming technology based on a 3D model of the patient's teeth, customized according to a Dental Practitioner's specific prescription, indicated for treatment of dental malocclusion by applying continuous gentle force to realign teeth.

The time for each stage of aligner usage is set in the personal treatment plan, and this varies for each patient and the Dental Practitioner's choice. Each set of aligners needs to be worn for at least 2 weeks. Patients the total treatment time lasts about 6 to 24 months.

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The Serafin is intended for the orthodontic treatment of malocclusion.

Serafin® is composed of series of transparent removable orthodontic appliances manufactured using thermoforming technology based on a 3D model of the patient's teeth, customized according to a Dental Practitioner's specific prescription, indicated for treatment of dental malocclusion by applying continuous gentle force to realign teeth.

The time for each stage of aligner usage is set in the personal treatment plan, and this varies for each patient and the Dental Practitioner's choice. Each set of aligners needs to be worn for at least 2 weeks. Patients the total treatment time lasts about 6 to 24 months.

The provided text is a 510(k) summary for the Serafin® orthodontic clear aligner system. It focuses on demonstrating substantial equivalence to a predicate device (Invisalign) through non-clinical testing. Crucially, this document does not contain information about clinical studies with human subjects, algorithm performance metrics (such as accuracy, sensitivity, or specificity), or the use of AI/machine learning.

Therefore, I cannot provide details on the following aspects of your request:

• A table of acceptance criteria and reported device performance related to AI/algorithm output (as no such data is present).
• Sample size used for a test set for AI/algorithm performance.
• Number of experts used to establish ground truth for a test set.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI/algorithm performance.
• Sample size for the training set for an AI/algorithm.
• How the ground truth for the training set was established for an AI/algorithm.

The document focuses on the physical, chemical, and biological properties of the device itself (the clear aligner), not on computational performance or diagnostic capabilities associated with AI.

Here's what the document does provide regarding acceptance criteria and testing, albeit for the physical device, not an AI algorithm:

1. Acceptance Criteria and Device Performance (for the physical device):

2. Sample size used for the test set and the data provenance:

• No information on a "test set" for an AI algorithm.
• The non-clinical testing was performed on "test articles" (implied to be samples of the Serafin® aligner material/device). The exact number of samples is not stated.
• Data Provenance: The testing was done by the manufacturer (TNS Co., Ltd., based in South Korea) or their designated testing facilities. It's non-clinical lab testing of material properties.

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

• Not applicable as the testing is for physical/chemical/biological properties of the device material, not for an AI algorithm requiring expert-established ground truth. Standards (e.g., ISO, MFDS, ADA ANSI) define the test procedures and acceptance criteria.

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

• Not applicable. This concept applies to human reader studies or AI validation with human adjudicated ground truth, which is not described.

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:

• No, an MRMC study was not done, as this submission is for a physical medical device (orthodontic aligner), not an AI-powered diagnostic or assistive tool.

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

• Not applicable, as there is no AI algorithm being evaluated in this submission. The "3D software" mentioned is for generating a 3D model of teeth and treatment plan, which is then reviewed by a dental practitioner, not for AI-driven diagnosis or analysis.

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

• For the physical device testing, the "ground truth" or reference was established by international and national standards (ISO 20795-2, ISO 10993 series, MFDS guidelines, ADA ANSI 41-2020) for material properties (e.g., flexural strength, water sorption) and biocompatibility (e.g., cytotoxicity).

8. The sample size for the training set:

• Not applicable, as there is no AI algorithm with a distinct "training set" described in this document.

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

• Not applicable.

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The SeraQuest HSV Type 2 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 2 herpes simplex virus (HSV) in human serum. The test is indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The predictive value of a positive or negative result depends on the prevalence of HSV-2 infection in the pre-test likelihood of HSV-2 infection.

The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatric patients or matrices other than human serum.

The SeraQuest® HSV Type 2 Specific IgG test is a solid-phase enzyme-linked immunoassay (ELISA), which is performed in microwells, at room temperature, and in three thirty-minute incubations. The test detects IgG antibodies which are directed against HSV 2 type-specific antigens in human serum. The Calibrator in the SeraQuest® HSV Type 2 Specific IgG test set has been assigned Index values based on an in-house standard. Test results are reported as Index values.

This document describes the performance of the SeraQuest® HSV Type 2 Specific IgG assay when performed on the ChemWell® Automated Analyzer, comparing it to the previously cleared manual method.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a dedicated section. However, the "Method Comparison Study" presents the core performance metrics (Positive Percent Agreement and Negative Percent Agreement) against the predicate device. For the purpose of this response, we infer that high agreement with the predicate device is the acceptance criterion.

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

• Sample Size for Test Set: 226 samples.
• Data Provenance: Samples were developed from "remnants of patient samples and samples from vendors." Additional samples were prepared by spiking negative samples with positive samples or dilution with diluent reagent to span the range of the assay's measuring interval. The country of origin is not specified, but it can be inferred as being related to the applicant's location (Palm City, Florida, USA). The study appears to be a retrospective evaluation using existing or manufactured samples.

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

The ground truth for the test set was established by comparison against a predicate device (manual method), not by independent expert interpretation. Therefore, experts were not explicitly used to establish the ground truth for this device in the context of this study. The "ground truth" here is the result obtained from the established manual method.

4. Adjudication Method for the Test Set

No adjudication method using multiple readers or experts is described, as the comparison is between two automated/semi-automated assay methods (the new device vs. the predicate). The "truth" for the comparison was the result generated by the manual method.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This study focuses on the equivalence of an automated assay to a manual assay, not on human reader performance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone comparison was done. The study directly compares the performance of the "SeraQuest® HSV Type 2 Specific IgG assay performed by ChemWell® Automated Analyzer" (the new device) against the "SeraQuest® HSV Type 2 Specific IgG assay performed by Manual Method" (the predicate device). This evaluates the algorithm/device performance independently of human interpretation, focusing on concordance between the two methods.

7. Type of Ground Truth Used

The type of ground truth used was comparison to a predicate device (manual assay results). This means the "truth" for evaluating the automated analyzer was the result provided by the already cleared manual method.

8. Sample Size for the Training Set

The document does not explicitly mention a separate training set or its sample size. The study focuses on verifying the performance of the automated analyzer against the predicate manual method using the 226 samples for method comparison and additional samples for precision studies.

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

Since a separate training set is not explicitly described, the method for establishing its ground truth is also not detailed. The validation approach is based on demonstrating equivalence to an existing, cleared method.

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The Sera™ with DPOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. The target population for Sera with DPOAE includes all ages.

The Sera™ with TEOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Transient Evoked Otoacoustic Emissions. The target population for Sera with TEOAE includes all ages.

The Sera™ with ABRIS is intended for use in the audiologic evaluation and documentation of ear and nerve disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The target population for Sera with ABRIS is newborns.

The Sera™ System is to be used by trained personnel only, such as audiologists, ENT surgeons, doctors, hearing healthcare professionals or personnel with a similar level of education. The device should not be used without the necessary knowledge and training to understand its use and how results should be interpreted.

The device is audiometric equipment used for assisting of inner ear and auditory brainstem abnormalities.

Sera™ features a touch-screen display and user-friendly software in a compact hardware design. Sera™ can be purchased with various licenses allowing you to perform different hearing screening tests.

Sera™ uses auditory brainstem response (ABRIS) technology to screen patients for hearing loss. A modified click stimulus, the CE-Chirp", of 35 dB nHL is delivered into the patient's ear while electrodes placed on the patient's head measure EEG activity.

Auditory brainstem response (ABRIS) test produces a short acoustic stimulus and measures via transcutaneous electrodes the auditory evoked potentials from the inner ear, the auditory nerve and the brainstem.

The provided document is a 510(k) summary for the Sera™ audiometric equipment. It indicates that no clinical tests were performed to establish acceptance criteria or demonstrate device performance. The device's safety and effectiveness were affirmed based on its fulfillment of international standards for Otoacoustic Emissions (OAE) and Auditory Brainstem Response (ABR) measurements.

Therefore, the following information cannot be extracted from the document:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Effect size of human readers improvement with AI vs without AI (Multi-reader multi-case comparative effectiveness study was not performed as no clinical testing was done).
• Standalone performance (algorithm only without human-in-the-loop) was not explicitly detailed via clinical study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Summary of Non-Clinical Testing and Device Performance (as described in the document):

The document states:
"Design verification and validation were performed according to current standards for OAE and ABR to assure the device meets its performance specifications. EMC and Safety was performed in compliance with recognized standards IEC 60601-1 series, Medical Equipment – General requirements for basic safety and essential performance. The product meets the requirements from the international standard for OAE measurements IEC 60645 series. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in medical Devices." The software for this device was considered as a 'moderate' level of concern since a malfunction of, or a latent design flaw in, the Software Device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury. The OAE and ABRIS measurements were divided into 3 phases. Phase 1 included when optimization occurred and involved feedback to the operator so that they could adjust such as probe fit, electrode impedance, ambient electrical and acoustic noise etc. Once the pre-test conditions were optimized, phase 2 of data collection proceeded as rapid as possible to allow the maximum quantity of good quality data to be collected in the shortest possible time. Phase 3 proceeded into the data assessment and decision stage and this ran concurrently with Phase 2 once the predetermined minimum amount of data had been collected. Phase 3 then went into the algorithm descriptions for each TEOAE, DPOAE and ABRIS measurements modes and is provided in detail in Annex 16D of this submission. No clinical tests were performed, but based on the fulfillment of the international standards for OAE and ABR we believe the device is safe and effective. The auditory impedance testing characteristics and safety systems were compared and found to be comparable."

Conclusion regarding acceptance criteria and study in the absence of clinical data:

The acceptance criteria for the Sera™ device and its performance are not directly demonstrated through clinical studies with a defined test set, ground truth established by experts, or statistical performance metrics. Instead, the device's acceptability is based on:

1. Compliance with recognized international standards:
   • IEC 60601-1 series (Medical Equipment – General requirements for basic safety and essential performance) for EMC and Safety.
   • IEC 60645 series (international standard for OAE measurements).
2. Software verification and validation: Per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in medical Devices." The software was deemed "moderate" level of concern.
3. Bench testing and design verification/validation: To ensure the device meets its performance specifications according to current standards for OAE and ABR.
4. Comparison to a predicate device (easyScreen, K171506): The document asserts substantial equivalence in technological characteristics and indications for use.

The document implies that by meeting these standards and demonstrating comparability to the predicate device through non-clinical means (bench testing, software validation), the device is considered safe and effective, and thus acceptable. The specific 'acceptance criteria' in terms of clinical performance (e.g., sensitivity, specificity for detecting hearing loss) and a study proving it meets these are not presented because clinical testing was not performed.

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For In Vitro Diagnostic Use Only. The SeraQuest HSV Type 1 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 1 herpes simplex virus (HSV) in human serum. The test is indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 infection. The predictive value of a positive result depends on the prevalence of HSV-1 infection in the population and the pre-test likelihood of HSV-1 infection.

The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatric patients or matrices other than human serum.

The SeraQuest® HSV Type 1 Specific IgG test is a solid-phase enzyme-linked immunoassay (ELISA), which is performed in microwells, at room temperature, and in three thirty minute incubations. The test detects IqG antibodies which are directed against HSV 1 type-specific antigens in human serum. The Calibrator in the SeraQuest® HSV Type 1 Specific IgG test set has been assigned Index values based on an in-house standard. Test results are reported as Index values.

The SeraQuest HSV Type 1 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 1 herpes simplex virus (HSV) in human serum.

Here's an analysis of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state pre-defined acceptance criteria (e.g., "Sensitivity must be >= X%"). Instead, it presents the results of a comparison study against a predicate device and a CDC panel, inferring that the performance achieved is deemed acceptable for substantial equivalence.

2. Sample Size and Data Provenance

   • Test Set (Comparative Study with Predicate Device):
     • Sexually Active Adults: 164 serum samples.
     • Expectant Mothers: 242 serum samples (198 during the first trimester, 19 during the second, 25 during the third).
     • Data Provenance: Prospectively collected, masked, and archived serum samples submitted for HSV serology to clinical laboratories in the Southeastern United States (for sexually active adults) and Northeastern and Southeastern United States (for expectant mothers). This indicates prospective data collection from the United States.
   • Test Set (CDC Panel): 100 serum samples (46 HSV-1 IgG positive, 54 HSV-1 IgG negative).
     • Data Provenance: This is a characterized serum panel provided by the Centers for Disease Control and Prevention (CDC). The specific country of origin for individual samples within the CDC panel is not specified, but the panel itself is a US-based reference.

3. Number of Experts and Qualifications for Ground Truth

   • The document does not mention the use of experts to establish ground truth for the comparative studies.
   • For the comparative study, the predicate device (Focus HerpeSelect® 1 and 2 Immunoblot IgG) served as the reference standard. The ground truth was based on the results of this legally marketed predicate device.
   • For the CDC panel, the CDC HSV 1 Result was used as the ground truth. This panel is composed of "well characterized serum panel" but the methods or experts used by CDC to characterize it are not detailed in this document.

4. Adjudication Method for the Test Set

   • No adjudication method (e.g., 2+1, 3+1) is mentioned for the test set. The results are directly compared to the predicate device's findings or the CDC's characterization of the panel.

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

   • No MRMC comparative effectiveness study was done. The device is an in-vitro diagnostic (IVD) assay, not an imaging device typically evaluated with human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. Standalone Performance

   • Yes, standalone performance was done. The entire submission details the performance of the SeraQuest HSV Type 1 Specific IgG assay as a standalone device, directly comparing its results to a legally marketed predicate device (immunoblot) and a characterized CDC panel. The performance metrics (sensitivity, specificity, precision) are derived from the device's independent operation.

7. Type of Ground Truth Used

   • Comparative Studies: The ground truth was established by another legally marketed device (predicate device): the Focus HerpeSelect® 1 and 2 Immunoblot IgG.
   • CDC Panel: The ground truth was based on the characterization of the CDC serum panel, which is described as "well characterized."

8. Sample Size for the Training Set

   • The document does not explicitly state a "training set" size. For IVD devices, the development and optimization of the assay might involve internal studies and smaller panels, but these are typically not referred to as a separate "training set" in the same way machine learning models are. The performance studies presented are generally considered validation studies on independent test sets.

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

   • As no explicit "training set" is mentioned in the context of this IVD device, the method for establishing its ground truth is not provided. The document focuses on the validation of the device against established external references.

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Intended Use: For In Vitro Diagnostic Use Only. The SeraQuest HSV Type 2 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 2 herpes simplex virus (HSV) in human serum. The test is indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The predictive value of a positive or negative result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection.

The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatric patients or matrices other than human serum.

The SeraQuest® HSV Type 2 Specific IgG test is a solid-phase enzyme-linked immunoassay (ELISA) , which is performed in microwells, at room temperature, and in three thirty minute incubations The test detects IgG antibodies which are directed against HSV 2 type-specific antigens in human serum. The Calibrator in the SeraQuest® HSV Type 2 Specific IgG test set has been assigned Index values based on an in-house standard. Test results are reported as Index values.

Here's a breakdown of the acceptance criteria and study details for the SeraQuest HSV Type 2 Specific IgG device, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

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

   • Precision Testing: 6 serum specimens (2 negative, 4 positive) and the SeraQuest Positive and Negative Controls. Each sample/control was assayed in triplicate, on three separate occasions, at three different laboratories (Quest International and two external independent laboratories). This results in a total of 27 data points per sample/control (3 triplicates * 3 occasions * 3 labs).
   • Specificity Testing:
     • HSV 1 IgG: 9 samples
     • CMV IgG: 11 samples
     • VZV EBNA IgG: 14 samples
     • VZV VCA IgG: 17 samples
     • VZV IgG: 21 samples
     • Measles IgG: 19 samples
     • Rubella IgG: 18 samples
     • Toxoplasma IgG: 6 samples
     • Syphilis IgG: 4 samples
     • Human Papilloma Virus: 7 samples
     • Chlamydia trachomitis: 8 samples
     • Neisseria gonorrhea: 7 samples
     • Provenance: Samples positive for various related pathogens/antibodies but negative for Type 2 HSV by another legally marketed device. Human Papilloma Virus, Chlamydia trachomitis, and Neisseria gonorrhea samples were from individual patients with confirmed sexually transmitted infections.
   • Interference Testing: Samples that were negative, weakly positive, and moderately positive for antibodies to Type 2 HSV were tested with and without the addition of elevated levels of specific interfering substances. (No specific number of samples provided for this test).
   • Comparison with Predicate Device:
     • Sexually Active Adults: 164 serum samples. Provenance: Prospectively collected, masked, archived, and tested at Quest International, Inc. from a clinical laboratory in the Southeastern United States.
     • Expectant Mothers: 242 serum samples. Provenance: Prospectively collected, masked, archived, and tested at Quest International, Inc. from clinical laboratories in the Northeastern and Southeastern United States. 82% from first trimester, 8% second, 10% third.
   • CDC Panel: 100 sera (30 HSV-2 IgG positive and 70 HSV-2 IgG negative samples). Provenance: Centers for Disease Control and Prevention (CDC) serum panel.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated for most studies.

   • For the cross-reactivity study, the samples were determined positive for various related pathogens "by other legally marketed devices" and confirmed negative for Type 2 HSV by a legally marketed device. This implies a standard diagnostic process, but no specific human experts or qualifications are mentioned for this initial determination.
   • For the comparative studies with the predicate device (Immunoblot), the ground truth was established by the predicate device itself. While the predicate device is a "legally marketed" test, it doesn't specify human expert interpretation or qualifications.
   • For the CDC Panel, the ground truth is "CDC consensus results" and the panel samples are described as "well characterized," implying established expert consensus or reference methods. No specific number of experts or their qualifications are detailed.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not explicitly stated. The ground truth seems to be established by reference methods or legally marketed devices rather than direct human adjudication of results in most cases. For the CDC panel, it's "CDC consensus results," which implies an agreed-upon truth, but the adjudication method isn't described.

4. 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:

   • No MRMC comparative effectiveness study involving human readers or AI assistance was conducted or reported for this device. This is an IVD (In Vitro Diagnostic) assay, not an imaging AI device.

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

   • Yes, the performance characteristics (sensitivity, specificity, precision, etc.) of the SeraQuest HSV Type 2 Specific IgG assay were evaluated as a standalone device. Its results are compared to a predicate device (Immunoblot) or a "well characterized serum panel" (CDC panel). There is no "human-in-the-loop" component described for this specific device in the context of its performance evaluation.

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

   • Precision: Internal controls and reference samples.
   • Specificity: Samples characterized by other legally marketed devices (positive for related pathogens, negative for HSV-2) and confirmed sexually transmitted infections.
   • Interference: Artificially spiked samples.
   • Comparison Studies: A "commercial HSV 2 Immunoblot test" (predicate device) was used as the reference standard for both sexually active adults and expectant mothers. This is a type of reference test ground truth.
   • CDC Panel: "CDC consensus results" from a "well characterized serum panel." This implies expert consensus or a gold standard determination for each sample in the panel.

7. The sample size for the training set: Not applicable and not mentioned. This document describes the performance evaluation of a medical device (an ELISA assay), not a machine learning or AI model that requires a "training set."

8. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

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The SeraQuest EBV EA-D IgG test is for the qualitative detection of human IgG antibodies to Epstein-Barr virus early antigen diffuse (EA-D) in human serum by enzyme immunoassay. This assay uses a 28 kd E. coli expressed recombinant Epstein-Barr virus early antigen. When performed in conjunction with other EBV serological tests, this assay can be used as an aid in the laboratory diagnosis of EBV infectious mononucleosis in patients with signs and symptoms of EBV infectious mononucleosis. For In Vitro Diagnostic Use Only.

The SeraQuest EBV EA-D IgG Test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against EBV Early Antigen D (EA-D), in human serum.

The document describes the SeraQuest EBV EA-D IgG Test, a solid-phase enzyme immunoassay (EIA) designed for the qualitative detection of human IgG antibodies to Epstein-Barr virus early antigen diffuse (EA-D) in human serum. This assay aids in the laboratory diagnosis of EBV infectious mononucleosis when used with other EBV serological tests.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds (e.g., "Positive Agreement must be >X%"). Instead, it presents various performance metrics derived from its clinical evaluation, which are then compared to a legally marketed predicate device. The implicit acceptance criterion appears to be "substantial equivalence" to the predicate device in terms of performance characteristics for diagnostic aid in EBV infectious mononucleosis.

The performance is reported in terms of percent agreement and associated confidence intervals, categorized by EBV serological status.

Note: For comparison, the predicate device (Comparator EBV EA-D IgG Test) achieved:

• Acute Infection Positive Agreement: 41.9% (13/31) with CI 24.5-60.9% (prospectively tested)
• Acute Infection Positive Agreement: 64.0% (32/50) with CI 49.2-77.1% (retrospectively tested)
• EBV Seronegative Negative Agreement: 78.3% (47/60) with CI 65.8-87.9% (prospectively tested)
• No Infection Negative Agreement: 73.3% (11/15) with CI 44.9-92.2% (retrospectively tested)
• Past Infection Negative Agreement: 62.7% (195/311) with CI 57.3-68.1% (prospectively tested)

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

• Total Test Set Sample Size: 542 serum samples.
  • Prospectively Collected and Prospectively Tested: 477 samples.
  • Prospectively Collected but Retrospectively Tested: 65 samples (50 acute specimens, 15 EBV seronegative).
• Data Provenance:
  • Country of Origin: 3 U.S. clinical testing sites.
  • Nature of Data: Mixed; primarily prospective (477 samples) with a supplementary retrospective component (65 samples that were prospectively collected but retrospectively tested). The study notes that the 65 specimens were retrospectively tested to "supplement the prospective study data."

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

The document states that specimens were classified into EBV serological states (Acute, EBV seronegative, Past Infection, Indeterminate) "as determined by other EBV serological reagents" and "reference EBV serology assays for EBV VCA IgG, EBV VCA IgM, and EBV EBNA-1 IgG." It does not mention the use of human "experts" or their qualifications to establish the ground truth for the test set. The ground truth was established by the results of established reference serological assays.

4. Adjudication Method for the Test Set

The document does not describe an "adjudication method" in the traditional sense involving human review of discrepancies. Instead, it details how equivocal results from both the SeraQuest test and the comparator test were handled for percent agreement calculations:

• "SeraQuest EBV EA-D IgG test equivocal results were assigned to the opposite test result interpretation than that of the corresponding comparative test results."
• "Likewise, the comparative test equivocal results were assigned to the opposite test result interpretation than that of the corresponding SeraQuest EBV EA-D IgG Test results."
  This is a statistical adjustment for calculation rather than clinical adjudication by experts.

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

This section is not applicable to this device. The SeraQuest EBV EA-D IgG Test is an in vitro diagnostic (IVD) immunoassay, not an AI-assisted diagnostic imaging or interpretation device that would involve human "readers" or "AI assistance." The "comparator" in this study refers to another commercially available EBV EA-D IgG ELISA test, not human readers or an AI system.

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

This section is applicable as the SeraQuest EBV EA-D IgG Test is an immunoassay that operates independently to produce a result. Its performance was evaluated in a standalone manner by comparing its output (positive, negative, equivocal) to the serological classification derived from reference EBV serology assays. The results presented in Tables 6 and 7 directly reflect the standalone performance of the SeraQuest test relative to the established EBV serological classification.

7. The Type of Ground Truth Used

The ground truth for classifying specimens into EBV serological states (Acute, EBV seronegative, Past Infection, Indeterminate) was established using a combination of results from reference EBV serology assays: EBV VCA IgG, EBV VCA IgM, and EBV EBNA-1 IgG. This can be categorized as serological reference assay data. The document explicitly states: "The EBV EA-D IgG result generated by the commercially available comparator EBV EA-D IgG ELISA test was not considered for purposes of characterizing the EBV serological state of the specimen."

8. The Sample Size for the Training Set

The document does not mention a "training set." This device is an immunoassay kit, not a machine learning or AI algorithm that requires a training set in the typical sense. The studies described are for clinical performance validation, not for training a model.

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

Since there is no mention of a "training set" in the context of this immunoassay, this question is not applicable. The "ground truth" for the performance evaluation (test set) was established using reference EBV serology assays, as described in point 7.

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The Seradyn QMS® Topiramate assay is intended for the quantitative determination of topiramate in human serum or plasma on automated clinical chemistry analyzers.

The results obtained are used in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy.

The Seradyn QMS® Topiramate assay is a homogeneous particle-enhanced turbidimetric immunoassay. The assay is based on competition between drug in the sample and drug coated onto a micronariticle for antibody binding sites of the topiramate antibody reagent. The topiramate-coated micropariticle peagent is rapidly agglutinated in the presence of the anti-topiramate antibody reagent and in the abserved of any competing drug in the sample. The rate of absorbance change is measured photometrically. When a smale containing topiramate is added, the agglutination reaction is partially inhibited, slowing down the rate of absorbance change. A concentration-dependent classic agglutination inhibition curve can be obtained with maximum rate of agglutination at the lowest topiramate concentration and the lowest agglutination rate at the highest topiramate concentration.

The assay consists of reagents R1: anti-topiramate polyclonal antibody and R2: topiramate-ooated microparticles. A six-level set of Seradyn QMS® Topiramate Cali three-level set of Seradyn QMS® Topiramate Controls is used for quality control of the assay.

Here's an analysis of the Seradyn QMS® Topiramate assay based on the provided 510(k) summary, structured to address your specific points:

Seradyn QMS® Topiramate Assay Study Analysis

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Accuracy: 12 concentrations for recovery study, each analyzed in triplicate (total of 36 measurements).
• Linearity: 9 concentrations, number of replicates not specified.
• Sensitivity (LOQ): Not specified directly, but implies multiple measurements around the LOQ value to determine CV and recovery.
• Precision: 3 controls, N=80 for each (total 240 measurements for precision components).
• Method Comparison: N = 148 patient samples.
• Interference (Endogenous & HAMA): Not explicitly stated, but for each interferent, samples with two known topiramate levels (approx. 5 and 20 µg/mL) were assayed.
• Interference (Co-Administered Drugs): Not explicitly stated, but for each compound, normal human serum with two known topiramate levels (approx. 5 and 20 µg/mL) was assayed.
• Interference (Anticoagulants): Not explicitly stated, but implied comparison of serum and plasma.

Data Provenance: The document does not specify the country of origin of the data. The studies are described as clinical testing, but it's common for these types of in vitro diagnostic studies to use banked or commercially sourced human serum/plasma samples, often without explicit geographical tags in 510(k) summaries. All studies appear to be prospective in the sense that they were designed experiments to evaluate the new device's performance against predefined criteria or a predicate device.

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

This device is an in vitro diagnostic (IVD) assay for quantitative determination of a drug concentration. The "ground truth" here is the actual concentration of topiramate in the samples. This is typically established through:

• Reference materials: For linearity and accuracy by recovery, known concentrations are prepared by precise dilution of a high calibrator.
• Reference method/predicate device: For method comparison, the predicate Innofluor® Topiramate assay serves as the reference for comparison of patient sample results.

Therefore, no human experts were used to establish the "ground truth" in the way they would be for image analysis or disease diagnosis. The "ground truth" is defined by laboratory standards, precise dilutions, and the established performance of a reference or predicate method.

4. Adjudication Method for the Test Set:

Not applicable, as the ground truth is quantitative (actual concentration) and not based on human interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging where multiple human readers interpret cases, and AI assistance might impact their performance. For a quantitative IVD assay, the performance is measured directly by analytical metrics (accuracy, precision, linearity, etc.) and comparison to a predicate device or reference method, not by human reader performance.

6. Standalone Performance:

Yes, the studies described (Accuracy, Linearity, Sensitivity, Precision, Specificity, Interferences, Stability) evaluate the algorithm's entire workflow (reagent interaction, measurement, and result calculation) standalone, without human-in-the-loop performance influencing the primary measurements. The assay quantifies topiramate concentration directly.

7. Type of Ground Truth Used:

• Known concentrations: For Accuracy by Recovery, Linearity, Sensitivity studies. These are prepared laboratory standards.
• Predicate device results: For Method Comparison, the results from the Seradyn Innofluor® Topiramate assay (K970510) on patient samples serve as the comparison point.
• Laboratory-spiked samples: For interference studies, known amounts of interferent and topiramate are added to serum samples.

8. Sample Size for the Training Set:

The document does not provide a sample size for a "training set." This assay is a homogeneous particle-enhanced turbidimetric immunoassay (PETIA), which is a chemical reaction-based method, not a machine learning or AI algorithm that typically requires a large "training set" of data in the common sense. The "development" or "optimization" of the assay would involve various experiments, but these are not usually referred to as a "training set" in the context of conventional IVD development. The calibration of the device uses a six-level set of Seradyn QMS® Topiramate Calibrators, but this is for operational calibration, not model training.

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

As noted above, the concept of a "training set" with established ground truth as in AI/ML is not directly applicable to this type of chemical immunoassay. The "ground truth" for calibrators and controls used in assay development and validation would be established through highly accurate reference methods, gravimetric/volumetric preparation, and traceability to established standards for the analyte (topiramate).

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For the quantitative detection of IqG antibodies to thyroid peroxidase in human serum by enzyme immunoassay. The SeraQuest Anti-thyroid peroxidase test can be used with other serological tests and clinical findings, to aid in the diagnosis of thyroid diseases such as Autoimmune Thyroiditis and Graves' disease. For in vitro diagnostic use only.

The SeraQuest Anti-Thyroid Peroxidase test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minutes incubations. It has been developed to detect IgG antibodies which are directed against Thyroid Peroxidase, in human serum. The Calibrators in the SeraQuest Anti-Thyroid Peroxidase test kit have been assigned values based on the NIBSC standard. Test results are reported as international units per milliliter (IU/mL).

Here's a breakdown of the acceptance criteria and the study details for the SeraQuest® Anti-Thyroid Peroxidase device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" but rather presents a clinical study comparing the new device (SeraQuest) against a predicate device (Varelisa TPO Antibodies test). The performance metrics of the SeraQuest device against the predicate are what would typically be used to demonstrate equivalence for regulatory acceptance.

Note: The document states, "The SeraQuest Anti-Thyroid Peroxidase test is substantially equivalent in intended use and performance, to the Pharmcia Varelisa TPO Antibodies, Freiburg, Germany." This indicates that the performance of the predicate device serves as the implicit acceptance criteria for the new device.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 141 serum specimens.
• Data Provenance: The study was conducted at Quest International, Inc., implying the data was collected or processed within the United States. The retrospective or prospective nature of the sample collection is not explicitly stated, but the specimens were "tested concurrently" by both devices, suggesting a prospective application to existing samples or a concurrent collection setup.

3. Number and Qualifications of Experts for Ground Truth

• The document does not mention the use of experts to establish a "ground truth" in the traditional sense (e.g., a panel of radiologists for imaging).
• Instead, the "ground truth" for the performance evaluation was established by comparing the SeraQuest device's results against a legally marketed predicate device, the Pharmacia Varelisa TPO Antibodies test. The predicate device itself acts as the reference standard.

4. Adjudication Method for the Test Set

• No explicit adjudication method (like 2+1, 3+1) is described for the test set.
• The comparison was a direct concurrent testing of each specimen by both the SeraQuest device and the Varelisa TPO Antibodies test, with results compared qualitatively (positive, equivocal, negative). For discordant results, one specimen was re-tested using a second legally marketed device (Scimedix Anti-Thyroid Peroxidase Test) to help resolve the discrepancy, but this wasn't a systematic adjudication process for all disagreements.

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

• No MRMC comparative effectiveness study was done. This device is an in-vitro diagnostic (IVD) test, not an imaging AI tool requiring human reader interpretation or assistance.

6. Standalone Performance Study

• Yes, a standalone performance study was done in the sense that the SeraQuest device's results were independently generated for each specimen and then compared to the predicate. The performance metrics (sensitivity, specificity, agreement) directly reflect the algorithm's (or device's) standalone diagnostic capabilities relative to the predicate. There is no human-in-the-loop component for these specific performance metrics.

7. Type of Ground Truth Used

• The ground truth used was the results obtained from a legally marketed predicate device (Pharmacia Varelisa TPO Antibodies test). For one discordant case, a second legally marketed device (Scimedix Anti-Thyroid Peroxidase Test) was used as an additional reference. This is a form of comparative ground truth against an established, similar diagnostic method.

8. Sample Size for the Training Set

• The document does not provide information on a training set or its sample size. This is typical for IVD assay submissions where the focus is on analytical and clinical performance against a reference method rather than AI algorithm training.

9. How Ground Truth for the Training Set Was Established

• Since no training set is mentioned, information on how its ground truth was established is not provided.

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1. For the quantitative detection of IqG antibodies to thyroglobulin in human serum by enzyme immunoassay.
2. The SeraQuest Anti-thyroglobulin test can be used with other serological tests and clinical findings, to aid in the diagnosis of thyroid diseases such as Autoimmune Thyroiditis and Graves' disease.
3. For in vitro diagnostic use only.

The SeraQuest Anti-Thyroglobulin test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IqG antibodies which are directed against thyroglobulin, in human serum.

The Calibrators in the SeraQuest Anti-Thyroglobulin test kit have been assigned values based on the NIBSC standard. Test results are reported as international units per milliliter (IU/mL).

This document describes the validation study for the SeraQuest Anti-Thyroglobulin test.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: 144 serum specimens.
• Data Provenance: The study was conducted at Quest International, Inc., and the specimens were "serum specimens," implying human origin. The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for device clearance, it is generally assumed to be a prospective or at least properly collected retrospective dataset for regulatory purposes.

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

• This study did not use human experts to establish ground truth. Instead, it used a predicate device (Pharmacia Varelisa TG Antibodies test) as the reference standard. The performance of the SeraQuest Anti-Thyroglobulin test was compared directly to this established and legally marketed device.

4. Adjudication Method for the Test Set:

• No adjudication method by human experts was used for the test set. The comparison was directly against the results of the predicate device. When a discordant result occurred between the SeraQuest and Varelisa tests (1 specimen), it was further tested by a second legally marketed device, the Scimedix Anti-Thyroglobulin Test. This serves as a form of secondary verification rather than adjudication by expert consensus.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is an in-vitro diagnostic device comparison, not an imaging or clinical diagnostic aid that typically involves human readers.

6. Standalone (Algorithm Only) Performance Study:

• Yes, a standalone performance study was done. The SeraQuest Anti-Thyroglobulin test (the algorithm/device) was run independently on the 144 serum specimens, and its results were then compared to the results obtained from the predicate device (Pharmacia Varelisa TG Antibodies test), which also operated in a "standalone" fashion.

7. Type of Ground Truth Used:

• The "ground truth" used in this study was the results obtained from a legally marketed predicate device (Pharmacia Varelisa TG Antibodies test). This is a common approach for demonstrating substantial equivalence for in-vitro diagnostic devices. For the one discordant specimen, a second legally marketed device (Scimedix Anti-Thyroglobulin Test) was used for further verification, which gave an equivocal result.

8. Sample Size for the Training Set:

• The document does not explicitly state the sample size used for a "training set." This type of in-vitro diagnostic device likely undergoes development and internal validation and optimization with various samples, but the FDA submission focuses on the validation against a predicate device using a specific test set. The 144 specimens were for the performance study, not explicitly described as a training set.

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

• As a training set is not explicitly described or quantified, the method for establishing its ground truth is not provided. However, for the development and optimization of such an assay, ground truth would typically be established through a combination of well-characterized clinical samples (e.g., from patients with confirmed autoimmune thyroiditis or Graves' disease, and healthy controls), using reference methods or established clinical diagnoses.

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