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QUANTA Flash® Ro52 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-Ro52 autoantibodies in human serum. The presence of anti-Ro52 autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus, Systemic Sclerosis, Idiopathic Inflammatory Myopathies.

QUANTA Flash Ro52 Controls are intended for use with the QUANTA Flash Ro52 Reagents for quality control in the determination of IgG anti-Ro52 autoantibodies in human serum.

QUANTA Flash Ro52 Calibrators are intended for use with the OUANTA Flash Ro52 Reagents for the determination of Ig G anti-Ro52 autoantibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values.

The QUANTA Flash Ro52 assay is designed to run on the BIO-FLASH® instrument. This platform is a fully automated closed system with continuous load and random access capabilities that automatically processes the samples, runs the assay and reports the results. It includes liquid handling hardware, luminometer and computer with software-user interface. The QUANTA Flash Ro52 assay utilizes a reagent cartridge format, which is compatible with the BIO-FLASH instrument.

Purified recombinant Ro52 antigen is coated onto paramagnetic beads. The bead suspension is lyophilized and stored in the bead tube. Prior to use in the BIO-FLASH system, the sealed reagent tubes are pierced with the reagent cartridge lid and the beads are rehydrated and resuspended using resuspension buffer by pipetting up and down with a transfer pipette. The reagent cartridge is then loaded onto the BIO-FLASH instrument. Samples are also loaded onto the instrument in sample racks. Serum samples are prediluted by the BIO-FLASH with system rinse in a small disposable plastic cuvette. Small amounts of the diluted patient serum, the beads, and assay buffer are all combined into a second cuvette, and mixed. This cuvette is then incubated at 37°C. The beads are magnetized and washed several times. Isoluminol conjugated anti-human IgG antibodies are then added to the cuvette, and again incubated at 37°C. The beads are magnetized and washed repeatedly. The isoluminol conjugate is oxidized when Trigger 1 (Fe(II)coproporphyrin in sodium hydroxide solution) and Trigger 2 (ureahydrogen peroxide in sodium chloride solution) are added to the cuvette, and the flash of light produced from this reaction is measured as Relative Light Units (RLU) by the BIO-FLASH optical system. The RLU are proportional to the amount of isoluminol conjugate that is bound to the human IgG, which is in turn proportional to the amount of anti-Ro52 antibodies bound to the corresponding beads.

For quantitation, the QUANTA Flash Ro52 assay utilizes a predefined lot specific Master Curve that is uploaded onto the instrument through the reagent cartridge barcode. Every new lot number of reagent cartridge must be calibrated before first use, with the QUANTA Flash Ro52 Calibrators. Based on the results obtained with the two Calibrators included in the Calibrator Set (sold separately), an instrument specific Working Curve is created, which is used to calculate chemiluminescent units (CU) from the instrument signal (RLU) obtained for each sample.

The QUANTA Flash Ro52 kit contains the following materials:

One (1) QUANTA Flash Ro52 Reagent Cartridge
One (1) vial of Resuspension buffer
One (1) Transfer pipette

The QUANTA Flash Ro52 reagent cartridge contains the following reagents for 50 determinations:

a. Ro52 antigen coated paramagnetic beads, lyophilized.
b. Assay buffer colored pink, containing Tris-buffered saline, Tween 20, protein stabilizers and preservatives.
c. Tracer IgG - Isoluminol labeled anti-human IgG antibodies in buffer, containing protein stabilizers and preservative.

The QUANTA Flash Ro52 Calibrators kit contains two vials of Calibrator 1 and two vials of Calibrator 2:

QUANTA Flash Ro52 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Ro52 in buffer, protein stabilizer and preservative.
QUANTA Flash Ro52 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Ro52 in buffer, protein stabilizer and preservative.

The QUANTA Flash Ro52 Controls kit contains two vials of Negative Control and two vials of Positive Control:

QUANTA Flash Ro52 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Ro52 in buffer, protein stabilizer and preservative.
QUANTA Flash Ro52 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Ro52 in buffer, protein stabilizer and preservative.

This document describes the QUANTA Flash® Ro52, QUANTA Flash® Ro52 Calibrators, and QUANTA Flash® Ro52 Controls, which are chemiluminescent immunoassays for the semi-quantitative determination of IgG anti-Ro52 autoantibodies in human serum. The presence of these autoantibodies aids in the diagnosis of Systemic Lupus Erythematosus, Sjögren's Syndrome, Systemic Sclerosis, and Idiopathic Inflammatory Myopathies.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents several acceptance criteria and results for various analytical performance characteristics. Below is a compilation of these, focusing on the ones directly stating "Acceptance criteria".

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

• Precision and Reproducibility:
  • Precision: 9 samples, each run in duplicates, twice a day for 21 days (84 replicates per sample).
  • Reproducibility: 3 samples, each run in quadruplicates, two times a day for 10 days (80 data points per sample).
  • Provenance: Not explicitly stated whether retrospective or prospective, or country of origin for these specific samples. Implied to be clinical samples ("samples containing various concentrations of Ro52 antibodies").
• Limit of Blank (LoB) and Limit of Detection (LoD):
  • LoB: 4 blank samples (System Rinse) from two different lots, run in replicates of five on two reagent lots, once per day, for 3 days (60 data points per reagent lot).
  • LoD: 4 low level samples (prepared by diluting anti-Ro52 positive samples with System Rinse), run in replicates of five on two reagent lots, once per day, for 3 days (60 data points per reagent lot).
  • Provenance: Not specified.
• Linearity: 4 serum samples with various Ro52 antibody concentrations, diluted in 10% increments. Assayed in duplicates.
  • Provenance: Not specified.
• Interference: 3 specimens (negative, at cutoff, positive). Interfering substances spiked (bilirubin, hemoglobin, triglycerides, cholesterol, RF IgM). Assessed in triplicates.
  • Provenance: Not specified.
• Cross-reactivity: 199 samples from the total 233 control samples of the clinical validation study. These were from patients with autoimmune diseases (Graves', Hashimoto, Celiac, Crohn's, Ulcerative Colitis, Primary Antiphospholipid Syndrome, Vasculitis, Rheumatoid arthritis, Behçet's disease) or positive infectious disease serology (HCV, HBV, CMV, EBV, HIV, Syphilis).
  • Provenance: Not explicitly stated, but these are referred to as "patient samples" which suggests they are clinical samples.
• Lot to Lot Comparison: 20 unique samples and the Positive and Negative Controls (total 22 specimens), tested in triplicates.
  • Provenance: Not specified.
• Shelf Life and In-use Stability: Involved characterized samples (up to 6 for beads, typically patient specimens for cartridge) and Calibrators/Controls.
  • Provenance: Not specified.
• Cut-off / Reference Range Establishment: 155 subjects: 115 apparently healthy blood donors, 8 viral hepatitis positive samples, 5 HIV positive samples, 5 syphilis positive samples, 22 rheumatoid arthritis patients. All serum samples.
  • Provenance: Not explicitly stated, but implies mixed sources representing different conditions.
• Clinical Performance (Sensitivity/Specificity - Validation Set): 600 characterized samples.
  • Patient Groups: 91 Sjögren's Syndrome (SS), 131 Systemic Lupus Erythematosus (SLE), 80 Systemic Sclerosis (SSc), 65 Idiopathic Inflammatory Myopathies (IIM).
  • Control Groups: 233 control samples (including Graves' Disease, Hashimoto Thyroiditis, Celiac Disease, Crohn's Disease, Ulcerative Colitis, HCV, HBV, CMV, EBV, HIV, Syphilis, Primary Antiphospholipid Syndrome, Secondary Antiphospholipid Syndrome*, Vasculitis, Rheumatoid arthritis, Osteoarthritis, Behçet's disease).
  • Provenance: Not explicitly stated, but these are "characterized samples" suggesting confirmed diagnoses from clinical settings.
• Expected Values: 111 apparently healthy blood donors (90 females, 21 males, ages 17-60, average 32.6 years). This group was different from the one used to establish the cutoff.
  • Provenance: Not explicitly stated, but implies a normal healthy population.
• Method Comparison: 319 samples from the clinical validation study + 27 additional samples having a speckled pattern on HEp-2 by ANA IIF (total 346 samples). 283 samples were within the reportable range.
  • Provenance: Clinical samples.

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

The document does not specify the explicit number or qualifications of "experts" used for establishing ground truth for the test set in the clinical evaluation. The samples are described as "characterized samples," "patients with autoimmune diseases," and "healthy blood donors." This implies that the diagnosis (ground truth) for these samples was established through standard clinical diagnostic procedures, which would involve medical specialists (e.g., rheumatologists) and established laboratory tests, rather than a panel of independent experts reviewing the data solely for this study.

4. Adjudication Method for the Test Set:

Not applicable or not described. The document refers to "characterized samples" for clinical evaluation, indicating pre-existing diagnoses or classifications rather than a prospective adjudication process for this specific device study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed. This device is an automated in vitro diagnostic (IVD) assay (chemiluminescent immunoassay) for direct measurement of autoantibodies in serum, not an imaging analysis tool typically subject to MRMC studies. The comparison is between the automated assay and a predicate ELISA device, or with clinical diagnoses.

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

Yes, the studies described are standalone performance evaluations of the QUANTA Flash® Ro52 assay. The device is a fully automated system that processes samples, runs the assay, and reports results without real-time human intervention in the result determination. The "performance" described throughout the document (precision, linearity, clinical sensitivity/specificity) reflects the algorithm's (assay's) performance independent of direct human interpretive input during routine operation.

7. The Type of Ground Truth Used:

The ground truth for clinical performance evaluation (sensitivity and specificity) appears to be clinical diagnosis and established laboratory markers/conditions. For example:

• Clinical Diagnosis: Patients characterized with Sjögren's Syndrome (SS), Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), Idiopathic Inflammatory Myopathies (IIM) were used as "disease" groups. Control groups were comprised of patients with other autoimmune diseases, infectious diseases, and apparently healthy individuals.
• Predicate Device Comparison: The predicate device (QUANTA Lite® SS-A 52 ELISA) served as a comparator for method comparison studies.
• CDC ANA Reference Sera: Used for value assignment and traceability, but not as the primary ground truth for clinical sensitivity/specificity.

8. The Sample Size for the Training Set:

The document does not explicitly use the term "training set" in the context of machine learning. However, for the development and optimization of the assay, the following samples effectively serve as "development" or "internal validation" data points:

• Master Curve Standards: 6 standards (2.3 CU to 1685.3 CU) were established.
• Calibrators and Controls: Human serum with high titer anti-Ro52 antibodies, diluted to achieve target CU values, and then tested on at least two instruments and two reagent lots in replicates of 10.
• LoB/LoD: 4 blank and 4 low-level samples, run over several days and lots.
• Linearity/Interference/Lot-to-lot: Various characterized samples (e.g., 4 for linearity, 3 for interference, 22 for lot-to-lot).

The specific "training set" for the fundamental algorithm/reagents themselves is not quantified in the typical machine learning sense, but the assay's performance characteristics were developed and internally validated using various sets of characterized samples and standards as outlined above.

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

Again, assuming "training set" refers to the samples used during the development and establishment of the assay's analytical characteristics:

• Master Curve Standards: Generated from in-house standards, traceable internally.
• Calibrators and Controls: Manufactured by diluting human serum containing high-titer anti-Ro52 antibodies with buffer. "Target CU is achieved through trial dilutions on small scale." These are then "bulked, tested, and adjusted." Final value assignment is determined by testing on multiple instruments and reagent lots.
• Other Analytical Studies (Precision, Linearity, Interference, Lot-to-Lot): The ground truth for these samples would be their known concentrations or characteristics (e.g., a sample known to have a certain level of Ro52 antibodies, or a known interfering substance concentration). "Characterized samples" imply that their status was determined by other validated methods prior to their use in these studies.
• Cut-off/Reference Range: Based on the 97th percentile of results from a population of 155 subjects (healthy blood donors and patients with various conditions). This is a statistical determination from measured values, rather than an expert-adjudicated ground truth.

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The QUANTA Lite™ SS-A 52 ELISA is a semiquantitative enzymelinked immunosorbent assay for the detection of IgG anti-SS-A 52 antibodies in patient sera. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.

Not Found

The provided text is a 510(k) premarket notification approval letter for a medical device called "QUANTA Lite™ SS-A 52 ELISA." This document does not contain the detailed acceptance criteria for the device's performance or the full study that proves it meets those criteria in the format requested.

The document states that the FDA has reviewed the submission and determined the device is "substantially equivalent" to legally marketed predicate devices. This means it meets the regulatory requirements for safety and effectiveness based on comparison to existing devices, but the specifics of its performance criteria and the detailed study design (like sample sizes, expert qualifications, etc.) are generally found in the full 510(k) submission which is not provided here.

Therefore, I cannot populate the table and answer the study-related questions based solely on the provided text. The document is an approval letter, not a scientific study report.

However, I can extract the following information that is present:

Device Name: QUANTA Lite™ SS-A 52 ELISA
Indications for Use: The QUANTA Lite™ SS-A 52 ELISA is a semiquantitative enzyme-linked immunosorbent assay for the detection of IgG anti-SS-A 52 antibodies in patient sera. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.
Regulatory Class: Class II
Product Code: OBE
Regulation Number: 21 CFR 866.5100
Regulation Name: Antinuclear antibody immunological test system

Regarding your specific questions, here's what can be inferred or stated about the absence of information:

1. A table of acceptance criteria and the reported device performance: This information is not provided in the approval letter. Acceptance criteria for substantial equivalence are based on performance data (e.g., sensitivity, specificity, reproducibility, correlation with predicate) presented in the 510(k) submission, but these specific metrics and their targets are not listed here.

2. Sample sizes used for the test set and the data provenance: Not mentioned in this document.

   • Data provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned in this document.

4. Adjudication method for the test set: Not mentioned in this document.

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 device is an ELISA kit, which is an in vitro diagnostic (IVD) test, not an AI-powered imaging or diagnostic system that would typically involve human "readers" or an MRMC study comparing human performance with and without AI. So, this question is not applicable to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: As an IVD test, the "standalone" performance of the assay itself is what is evaluated. However, the details of that evaluation are not in this document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For IVD assays, ground truth often involves clinical diagnosis confirmed by other established diagnostic criteria or reference methods. The specific type used for this device is not detailed here.

8. The sample size for the training set: Not mentioned. (Note: For an ELISA, "training set" is not a standard term as it is for machine learning. The equivalent would be samples used during assay development and validation).

9. How the ground truth for the training set was established: Not mentioned.

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