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EliA SmDP-S is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and EDTA-plasma as an aid in the diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP-S uses the EliA IgG method.

The EliA SmD -S is a semi-quantitative solid-phase fluoroimmunoassay, for the determination of autoantibodies against Sm. The EliA SmDP-S test System is fully integrated and automated system which comprises of assay-specific reagents, EliA method-specific reagents, and general reagents.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EliA SmDP-S device are not explicitly stated as distinct criteria with numerical targets in the provided document. Instead, the document presents performance characteristics that implicitly serve as acceptance criteria by demonstrating that the device is substantially equivalent to a predicate device. Below is a summary of the reported device performance for key analytical and clinical characteristics.

2. Sample Sizes and Data Provenance

• Test Set (Method Comparison):
  • Sample Size: A total of 628 patient samples were initially tested in the method comparison study with the predicate device. For statistical analyses, 460 samples were used after excluding 168 values outside the measuring range.
  • Data Provenance: Not explicitly stated, but typically such studies involve samples collected from various clinical sites. It is implied to be clinical patient samples, likely retrospective given they were previously collected for comparison.
• Test Set (Clinical Sensitivity and Specificity):
  • Sample Size: 328 clinically defined samples: 104 with Systemic Lupus Erythematosus (SLE) and 224 disease controls (Mixed connective tissue disease, Sjögren's syndrome, Scleroderma, Polymyositis/Dermatomyositis, Rheumatoid arthritis, Graves' disease, Hashimoto's disease, Bacterial infections, Viral infections).
  • Data Provenance: Not explicitly stated, but implied to be from clinical settings for diagnosed patients and controls. Likely retrospective.
• Reference Range/Expected Values:
  • Sample Size: 632 apparently healthy subjects.
  • Data Provenance: Sera obtained from a blood bank, equally distributed by age and gender, from Caucasian, African American, Hispanic and Asian populations.

3. Number of Experts and their Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: The ground truth for clinical sensitivity and specificity was based on "clinically defined samples with a diagnosis". This implies that the diagnosis was established by medical professionals (e.g., rheumatologists, infectious disease specialists) based on a comprehensive clinical assessment, which would include other laboratory and clinical findings. The document does not provide details on the number or specific qualifications (e.g., years of experience) of these clinicians or specialists.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (like 2+1 or 3+1 consensus) for establishing the ground truth of the test set samples. The samples were "clinically defined with a diagnosis" or "apparent healthy subjects," implying that their disease status or health status was established through standard clinical practice/diagnostic criteria rather than a specific expert adjudication process for the purpose of this study.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The device is an in vitro diagnostic (IVD) immunoassay, which typically does not involve human readers interpreting results in the same way imaging devices do. The performance evaluation focuses on the analytical and clinical accuracy of the assay itself compared to a predicate device and clinical diagnoses, not on human reader improvement with AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was done. The entire document describes the performance of the EliA SmDP-S device as an in vitro diagnostic assay, which functions independently (algorithm only) to measure IgG antibodies. There is no human-in-the-loop component described for its operation or result generation. The device produces a semi-quantitative measurement (EliA U/mL) that is then interpreted based on defined cut-offs.

7. Type of Ground Truth Used

• For Method Comparison: The ground truth was the result obtained from the predicate device (EliA SmDP assay) for common patient samples.
• For Clinical Sensitivity and Specificity: The ground truth was based on "clinically defined diagnoses" of patients with Systemic Lupus Erythematosus (SLE) and various disease controls. This implies a diagnosis established through standard clinical criteria, which would include medical history, physical examination, other laboratory tests, and imaging findings (i.e., clinical diagnosis/outcomes data).
• For Reference Range: The ground truth was a group of "apparently healthy subjects."

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of device development or algorithm training. For IVD devices like this, the development process usually involves internal validation and optimization batches, but not typically a formally labeled "training set" in the sense of machine learning. The studies described are primarily for validation and verification of the final device performance.

9. How Ground Truth for Training Set was Established

As no explicit "training set" is mentioned, the method for establishing its ground truth is also not detailed. However, for the development and optimization of such assays, ground truth for sample panels would typically be established using confirmed clinical diagnoses, reference methods, or well-characterized reference materials, similar to how the validation samples' ground truth was established using clinical diagnoses and predicate device comparisons.

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EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and EDTA-plasma to aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instrument Phadia 2500/5000.

The method-specific reagents are identical with K132631 (EliA SmDº on Phadia 250), but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of:

• Test Wells: -EliA SmDP Wells are coated with a synthetic SmD3 peptide – 4 carriers (12 wells each), ready to use;
• EliA Sample Diluent: PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 6 bottles, 48 mL each, ready to use; or 6 bottles, 400 mL each, ready to use;
• -EliA IgG Conjugate 50 or 200: ß-Galactosidase labeled anti-IgG (mouse monoclonal antibodies) in PBS containing BSA and 0.06% (w/v) sodium azide – 6 wedge shaped bottles, 5 mL each, ready to use; or 6 wedge shaped bottles, 19 mL each, ready to use
• EliA IgG Calibrator Strips: Human IgG (0, 4, 10, 20, 100, 600 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 5 strips, 6 singleuse vials per strip, 0.3 mL each, ready to use;
• -EliA IgG Curve Control Strips: Human IgG (20 µg/L) in PBS containing BSA, detergent and 0.095% (w/v) sodium azide - 5 strips, 6 single-use vials per strip, 0.3 mL each, ready to use;
• EliA IgG Calibrator Well: Coated with mouse monoclonal antibodies 4 carriers (12 wells each), ready to use.

The Phadia EliA Immunodiagnostic System is an automated system for immunodiagnostic testing. The EliA reagents are available as modular packages, each purchased separately. All packages are required to carry out EliA SmDP tests.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device under review is the EliA SmDP Immunoassay on the Phadia 2500/5000 instrument. The study primarily evaluated the performance of this new instrument platform compared to a previously cleared device (EliA SmDP on Phadia 250, K132631). The acceptance criteria for the new device's performance are largely demonstrated through its equivalence to the predicate device.

• 24.8% at 2.2 EliA U/mL
• 8.8% at 10.0 EliA U/mL
• 6.5% at 146.6 EliA U/mL
• 8.8% at 408.1 EliA U/mL
  (within acceptable limits for immunoassays of this type) |
  | Linearity/Reportable Range | Implied to be linear across the measuring range, with slopes close to 1 and R2 values close to 1. | Linearity (Slope, 95% CI):
• 1.04 (0.95-1.12)
• 0.98 (0.94-1.02)
• 1.01 (0.97-1.05)
• 1.01 (0.99-1.02)
  R2 values: All 0.99 or 1.00
  Linear Range: 1.6 EliA U/mL (LoQ) to 480 EliA U/mL (upper limit)
  Reportable Range: 0.8 EliA U/mL (LoD) to 480 EliA U/mL (upper limit) |
  | Detection Limit (LoD) | Not explicitly stated as a specific numerical value. The study aimed to determine it. | LoD: 0.8 EliA U/mL (with

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EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instrument Phadia 100.

EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instrument Phadia 250.

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This document is a 510(k) summary, not a detailed study report. Therefore, it primarily focuses on the "Indications for Use" and the substantial equivalence determination rather than a comprehensive description of acceptance criteria and a deep dive into the study details. However, based on the provided text, here's what can be extracted and inferred:

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

The provided text does not contain a table of specific acceptance criteria (e.g., sensitivity, specificity thresholds) or detailed reported device performance metrics in a structured table format. The EliA™ SmDP Immunoassay is an "Antinuclear Antibody Immunological Test System" (21 CFR §866.5100), and its performance would typically be evaluated based on its ability to detect IgG antibodies directed to Sm with acceptable sensitivity and specificity for aid in the clinical diagnosis of systemic lupus erythematosus (SLE).

Without a dedicated section on performance data, it's impossible to create the requested table from the provided text.

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

The document does not explicitly state the sample size used for the test set or its data provenance (e.g., country of origin, retrospective/prospective). This information would typically be found in the detailed study report submitted as part of the 510(k) application.

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

The document does not specify the number or qualifications of experts used to establish the ground truth for any test set. For immunological assays like this, the "ground truth" often involves clinical diagnosis of SLE based on established ACR or SLICC criteria, which might involve expert physicians, but this isn't detailed here.

4. Adjudication method for the test set

The document does not mention any adjudication method used for a test set.

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, the EliA™ SmDP Immunoassay, is an in vitro diagnostic (IVD) assay designed to semi-quantitatively measure antibodies. It is not an AI-based device that would typically involve "human readers" or "AI assistance" in the way a medical imaging AI device would. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable to this type of device, and no such study is mentioned.

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

This is an IVD immunoassay, essentially a laboratory test system. Its "performance" is inherently standalone in the sense that the assay results are generated by the instrument (Phadia 100 or Phadia 250) based on the sample, without real-time human interpretation affecting the raw measurement. The human-in-the-loop comes in when a clinician interprets the results in conjunction with other clinical findings. The document doesn't provide a specific study abstract, but the nature of an immunoassay implies standalone analytical performance.

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

Given the "Indications for Use" state "as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings," the ground truth for evaluating the device's performance would most likely be established based on clinical diagnosis of SLE, potentially using established classification criteria (e.g., American College of Rheumatology (ACR) criteria or Systemic Lupus International Collaborating Clinics (SLICC) criteria), which implicitly involves a form of expert consensus and possibly other laboratory and pathology findings. The document itself doesn't explicitly state the methodology for establishing this ground truth for the studies conducted.

8. The sample size for the training set

The document does not provide details about a training set or its sample size. For an immunoassay, the concept of a "training set" in the context of machine learning (where this question typically applies) is not directly relevant. Instead, the assay's parameters would be established during development and analytical validation, which involves calibration and analytical studies, not a "training set" as understood in AI/ML.

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

As in point 8, the concept of a "training set" and its ground truth establishment, as typically applied to AI/ML, isn't directly applicable for this type of immunoassay. The clinical "ground truth" for evaluating its diagnostic utility would be established through clinical studies, as described in point 7.

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The QUANTA Flash Sm is a chemiluminescent immunoassay for the semi-quantitative determination of lgG anti-Sm antibodies in human serum. The presence of antibodies, in conjunction with clinical findings and other laboratory tests, can aid in the diagnosis of Systemic Lupus Erythematosus (SLE).

The QUANTA Flash RNP is a chemiluminescent immunoassay for the semi-quantitative determination of lgG anti-ribonucleoprotein (RNP) antibodies in human serum. The presence of anti-RNP antibodies, in conjunction with clinical findings and other laboratory tests, can aid in the diagnosis of Systemic Lupus Erythematosus (SLE) and Mixed Connective Tissue Disease (MCTD).

QUANTA Flash Sm Calibrators are intended for use with the QUANTA Flash Sm chemiluminescent immunoassay for the determination of IgG anti-Sm antibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values.

QUANTA Flash RNP Calibrators are intended for use with the QUANTA Flash RNP chemiluminescent immunoassay for the determination of IgG anti-RNP antibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values.

QUANTA Flash Sm Controls are intended for use with the QUANTA Flash Sm chemiluminescent immunoassay for quality control in the determination of IgG anti-Sm antibodies in human serum.

QUANTA Flash RNP Controls are intended for use with the QUANTA Flash RNP chemiluminescent immunoassay for quality control in the determination of IgG anti-RNP antibodies in human serum.

The QUANTA Flash Sm and RNP assays are 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 Sm and RNP assays utilize a reagent cartridge format, which is compatible with the BIO-FLASH instrument.

Native Sm or RNP antigen that is purified from calf thymus 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. A patient serum sample is 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(III)coproporphyrin in sodium hydroxide solution) and Trigger 2 (urea-hydrogen 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 lgG, which is in turn proportional to the amount of anti-RNP antibodies bound to the Sm or RNP on the beads.

For quantitation, the QUANTA Flash Sm and RNP assays utilize 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 Sm and RNP 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 Sm kit contains the following materials:
One (1) QUANTA Flash Sm Reagent Cartridge
One (1) vial of Resuspension buffer
One (1) Transfer pipette

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

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

The QUANTA Flash RNP kit contains the following materials:
One (1) QUANTA Flash RNP Reagent Cartridge

• One (1) vial of Resuspension buffer
• One (1) Transfer pipette

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

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

The QUANTA Flash Sm Calibrators kit and the QUANTA Flash™ RNP Calibrators kit each contain 2 vials of Calibrators:

QUANTA Flash Sm Calibrators:

• QUANTA Flash Sm Calibrator 1: Two (2) barcode labeled tubes containing 0.3 ml prediluted, ready to use reagent. Calibrators contain human antibodies to Sm in buffer, protein stabilizers, and preservatives.
• QUANTA Flash Sm Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Sm in buffer, protein stabilizers, and preservatives.

QUANTA Flash RNP Calibrators:

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

The QUANTA Flash Sm Controls kit and the QUANTA Flash™ RNP Controls kit each contain 2 vials of Negative Control and two vials of Positive Control:

QUANTA Flash Sm Controls:

• QUANTA Flash™ Sm Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Sm in buffer, protein stabilizers, and preservatives.
• QUANTA Flash™ Sm Positive Control: Two (2) barcode labeled tubes containing 0.5 ml, ready to use reagent. Controls contain human antibodies to Sm in buffer, protein stabilizers, and preservatives.

QUANTA Flash RNP Controls:

• QUANTA Flash™ RNP Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to RNP in buffer, protein stabilizers, and preservatives.
• QUANTA Flash™ RNP Positive Control: Two (2) barcode labeled tubes containing 0.5 ml, ready to use reagent. Controls contain human antibodies to RNP in buffer, protein stabilizers, and preservatives.

Acceptance Criteria and Device Performance for QUANTA Flash® Sm and RNP Assays

This information is extracted from the provided 510(k) summary for the QUANTA Flash® Sm and QUANTA Flash® RNP assays.

1. Table of Acceptance Criteria and Reported Device Performance

Note on "Acceptance Criteria" for Clinical Sensitivity/Specificity: For diagnostic device submissions like this, the criteria are often for demonstrating reasonable performance that supports the intended use and shows substantial equivalence to a predicate, rather than predefined absolute thresholds that must be met. The device sponsor presents the performance data to the FDA for review against the predicate and the defined intended use.

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

For Clinical Sensitivity and Specificity:

• QUANTA Flash Sm:

  • Test Set Size: 379 samples
    • 63 SLE patients (Neuss Center for Rheumatology, Neuss, Germany)
    • 83 SLE patients (Dr. Carlos von Mühlen, Germany)
    • 74 systemic sclerosis patients
    • 70 rheumatoid arthritis patients
    • 5 Sjögren's syndrome patients
    • 53 patients with other systemic rheumatic diseases
    • 2 patients with autoimmune liver disease
    • 19 patients with viral hepatitis
    • 10 patients with other infectious diseases (5 HIV, 5 syphilis)
  • Data Provenance: Mixed (Germany, likely other origins for disease controls). Retrospective, as these were existing samples used for validation.

• QUANTA Flash RNP:

  • Test Set Size: 424 samples
    • 62 SLE patients (Neuss Center for Rheumatology, Neuss, Germany)
    • 32 MCTD patients (Neuss Center for Rheumatology, Neuss, Germany)
    • 84 SLE patients (Dr. Carlos von Mühlen, Germany)
    • 48 patients with other systemic rheumatic diseases
    • 2 patients with autoimmune liver disease
    • 6 patients with Sjögren's syndrome
    • 76 patients with systemic sclerosis
    • 70 patients with rheumatoid arthritis
    • 14 patients with polymyositis/dermatomyositis
    • 20 patients with viral hepatitis
    • 10 patients with other infectious diseases (5 HIV, 5 syphilis)
  • Data Provenance: Mixed (Germany, likely other origins for disease controls). Retrospective.

For Reference Range Establishment:

• QUANTA Flash Sm:

  • Test Set Size: 232 subjects (129 apparently healthy blood donors, 41 non-autoimmune thyroid disease, 42 autoimmune thyroid disease, 20 infectious diseases)
  • Data Provenance: Not explicitly stated, but appears to be general reference populations. Retrospective.

• QUANTA Flash RNP:

  • Test Set Size: 255 subjects (127 apparently healthy blood donors, 41 non-autoimmune thyroid disease, 42 autoimmune thyroid disease, 20 infectious diseases, 25 rheumatoid arthritis)
  • Data Provenance: Not explicitly stated, but appears to be general reference populations. Retrospective.

For Method Comparison:

• QUANTA Flash Sm:

  • Test Set Size: 119 samples (from clinical validation studies, proficiency surveys (CAP and NEQAS), and apparently healthy blood donors)
  • Data Provenance: Mixed (includes proficiency testing samples, likely retrospective).

• QUANTA Flash RNP:

  • Test Set Size: 167 samples (from clinical validation studies and apparently healthy blood donors)
  • Data Provenance: Mixed (likely retrospective).

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

The document does not explicitly state the number or qualifications of "experts" used to establish the ground truth for the clinical test sets of patients with SLE, MCTD, and other conditions. For these types of diagnostic immunoassays, the "ground truth" for patient classification (e.g., "SLE patient," "MCTD patient") is typically based on a clinical diagnosis by treating physicians, often rheumatologists, according to established diagnostic criteria (e.g., ACR criteria for SLE). The specific details of how these clinical diagnoses were confirmed for each sample are not provided, nor is the number or specific qualifications of the clinicians who made the diagnoses. These are generally assumed to be standard clinical practice in the institutions mentioned (e.g., Neuss Center for Rheumatology).

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is described for the clinical diagnoses that constitute the ground truth. The samples were collected from diagnosed patient populations.

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

No MRMC comparative effectiveness study was done. This device is an in-vitro diagnostic (IVD) assay, not an imaging or algorithmic-interpretation device that would involve human readers interpreting results with or without AI assistance. The output is a semi-quantitative antibody level.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, this is implicitly a standalone study. The device is an automated chemiluminescent immunoassay system (BIO-FLASH instrument with QUANTA Flash assays). The results (Chemiluminescent Units, CU) are generated by the algorithm/system and reported directly. While a human laboratory technician operates the instrument and interprets the final CU values against a cutoff, the performance metrics (sensitivity, specificity, precision, etc.) presented are characteristic of the assay system's inherent ability to detect and quantify the antibodies from the sample, without human-in-the-loop "improvement" on the detection itself.

7. Type of Ground Truth Used

The ground truth for the clinical studies (sensitivity and specificity) was clinical diagnosis (e.g., Systemic Lupus Erythematosus, Mixed Connective Tissue Disease) provided by the centers from which the patient samples were sourced. For analytical studies (precision, linearity, LoD, etc.), the ground truth was based on established analytical methods and reference materials.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an AI/machine learning algorithm. For these types of immunoassay devices, the equivalent concept might be the samples used for assay development, initial optimization, and master curve establishment.

• Master Curve: A predefined lot-specific Master Curve is uploaded onto the instrument. This curve is central to the assay's function. The data used to establish this master curve is not explicitly detailed in terms of sample size or how the ground truth was established, but it would typically involve a large set of characterized samples with known concentrations to define the relationship between RLU and CU.
• Calibrator and Control Value Assignment: "at least two instruments, on at least two lots of reagent cartridge, in replicates of 10 to determine final value assignment." This is akin to a small-scale internal dataset used to finalize product specifications. There are currently no recognized international standards for the measurement of anti-RNP antibodies, so values are traceable to in-house standards.

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

As noted above, there is no explicit "training set" in the AI/ML sense. The functionality of the device relies on:

• Reagent Development & Formulation: The components (antigens, antibodies, buffers, etc.) are developed and purified based on chemical and biological principles to ensure specific binding.
• Master Curve Generation: While not explicitly detailed, the Master Curve that links RLU to CU for each lot of reagents is established using a set of reference samples with known concentrations of anti-Sm or anti-RNP antibodies. The "ground truth" for these reference samples would be determined through rigorous characterization using established analytical methods, potentially including comparative analysis with existing gold standard methods or highly characterized internal reference materials. The document states "Calibrator and Control values are directly traceable to in-house Standards that are used to create the Master Curve." This implies that internal, well-characterized standards form the basis of the "ground truth" for the quantitative aspect of the assay.

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The EL-ANA Profiles™ is an in vitro diagnostic test for the detection and measurement of autoantibodies directed against the following autoantigens: single-stranded DNA (ssDNA), double-stranded DNA (dsDNA), Smith, RNP/Sm, SSA (Ro) "R, SSB (La) "R (30217), Gould Carding Ribosomal Protein P, Centromere™, and Chromatin (Nucleosomes). This test system is intended as an aid in diagnosis of systemic lupus erythematosus, Sjogren's syndrome, progressive systemic sclerosis (scleroderma), drug-induced lupus and polymyositis.

Not Found

This is a 510(k) premarket notification for an in vitro diagnostic device, not an AI/ML medical device. Therefore, much of the requested information, such as sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types related to image analysis or AI model evaluation, are not applicable.

However, I can extract information relevant to the device's performance based on the provided document, even if it doesn't align perfectly with the AI/ML specific questions.

Here's the closest possible interpretation of your request based on the provided 510(k) summary for the TheraTest EL-ANA Profiles:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (a FDA 510(k) clearance letter) does not contain a detailed table of specific acceptance criteria. FDA 510(k) clearances for in vitro diagnostics usually reference substantial equivalence to a predicate device, which implies that the new device performs at least as well as the predicate device. The performance data would typically be found in the 510(k) summary or the full submission, but is not present in this clearance letter.

Therefore, this table cannot be accurately completed from the given text. The clearance states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This implies that the device met the implicit acceptance criteria by demonstrating substantial equivalence.

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

This information is not provided in the clearance letter. For an in vitro diagnostic device, the "test set" would refer to clinical samples used for validation, but the details of this are not in the provided text.

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

This information is not explicitly stated in the clearance letter. For in vitro diagnostics like this, "ground truth" would typically be established through clinical diagnosis of the patients from whom the samples were collected, potentially by qualified clinicians (e.g., rheumatologists, immunologists).

4. Adjudication Method for the Test Set

This information is not provided in the clearance letter.

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

MRMC studies are typically for image-based diagnostic devices where human readers interpret images. This device is an in vitro diagnostic test for autoantibodies, not an imaging device. Therefore, an MRMC study would not be applicable or performed for this type of device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is an in vitro diagnostic test, not an algorithm. Its performance is inherent to the chemical and biological reactions involved in detecting the autoantibodies. Therefore, the concept of "standalone algorithm performance" is not applicable. The device is the "standalone" diagnostic tool, providing results without an intervening human interpretation step in the same way an AI model's output would need.

7. The Type of Ground Truth Used

The "ground truth" for an in vitro diagnostic test like the TheraTest EL-ANA Profiles would typically be the clinical diagnosis of the patients (e.g., diagnosis of SLE, Sjogren's syndrome, etc.) based on a combination of clinical symptoms, other laboratory tests, and expert medical opinion. The specific method for establishing this ground truth for the study supporting this 510(k) is not described in the provided document.

8. The Sample Size for the Training Set

This device is an in vitro diagnostic kit, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device's performance is based on its analytical and clinical validation, not on a machine learning training process.

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

As there is no training set for an AI/ML algorithm, this question is not applicable.

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The Varelisa Sm Antibodies EIA kit is designed for the semiquantitative and qualitative determination of SmD antibodies in serum or plasma to aid in the diagnosis of systemic lupus erythematosus (SLE).

The new device is an enzyme-linked immunosorbent assay (ELISA) using microtiter plates as the solid phase. The plate wells are coated with a synthetic SmD peptide as antigen, which allow anti-SmD antibodies to react with the immobilized antigen (sample). The conjugate is rabbit anti-human IgG horseradish peroxidase (HRP), which uses 3, 3'5, 5' tetramethylbenzidine dihydrochloride (TMB) as substrate. The kit contains a set of six calibrators, positive and negative controls. The kit also contains sample diluent, wash buffer concentrate and stop solution.

The provided document is a 510(k) summary for Varelisa® Sm Antibodies, an in vitro diagnostic device, not an AI or medical imaging device. Therefore, many of the requested criteria such as sample size for test and training sets, number of experts, adjudication methods, multi-reader multi-case studies, and standalone performance are not applicable or typically reported in this type of submission.

However, I can extract information related to acceptance criteria and the study performed to demonstrate substantial equivalence to a predicate device.

Acceptance Criteria and Reported Device Performance

For in vitro diagnostic devices like the Varelisa® Sm Antibodies, acceptance criteria often revolve around demonstrating comparable performance (e.g., sensitivity, specificity, agreement) to a legally marketed predicate device. The document states that the new device is a successor to the predicate and that "all available data support that the new device is substantially equivalent to the predicate device and that the new device performs according to state-of-the-art expectations." While specific numerical performance values (e.g., sensitivity/specificity percentages) are not provided in this summary, the outcome of the study (comparability) serves as the "reported device performance."

• results obtained within a comparison study analyzing positive, equivocal and negative sera.
• results obtained for clinically defined sera and for international reference sera.
• results obtained for samples from apparently healthy subjects (normal population)."

"In summary, all available data support that the new device is substantially equivalent to the predicate device and that the new device performs according to state-of-the-art expectations." |

Study Details:

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

   • Sample Size: Not explicitly stated in the provided text. The submission refers to a "data set" that included "positive, equivocal and negative sera," "clinically defined sera and for international reference sera," and "samples from apparently healthy subjects (normal population)." However, specific numbers for each group or total are not given.
   • Data Provenance: Not explicitly stated, but the manufacturer is "Sweden Diagnostics (Germany) GmbH," suggesting European origin, though international reference sera would be globally sourced. The study appears to be retrospective as it uses collected sera.

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

   • This information is not applicable to this type of in vitro diagnostic device. The "ground truth" for diagnostic kits is typically established by the clinical status of the patient (e.g., diagnosed with SLE or healthy) and/or by established reference methods or reference materials (like international reference sera), not by individual expert consensus on image interpretation.

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

   • Not applicable for this type of in vitro diagnostic device. Adjudication methods are relevant for subjective interpretations, often in imaging, to resolve discrepancies among experts. Clinical diagnoses and reference standards provide objective "ground truth."

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:

   • Not applicable. This is an in vitro diagnostic assay (laboratory test), not an AI-based system or a device that involves human readers or interpretation of cases in the context of AI assistance.

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

   • Not applicable. This is an in vitro diagnostic kit. The device itself performs the assay (detecting antibodies). The "performance" is the assay's ability to correctly identify the presence or absence of antibodies, which then aids a clinician in making a diagnosis. There isn't a "standalone algorithm" in the typical sense of AI. The device is the standalone diagnostic tool (in the context of laboratory analysis).

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

   • The ground truth would be based on:
     • Clinical Diagnosis: For "clinically defined sera," the patient's existing clinical diagnosis of SLE or healthy status would serve as the ground truth.
     • Reference Standards: For "international reference sera," these are standardized biological materials with known characteristics, serving as a form of "ground truth."
     • Predicate Device Results (for comparison study): While not true ground truth, the predicate device's results would be used as a reference point for demonstrating comparability.

7. The sample size for the training set:

   • Not applicable in the context of typical machine learning or AI device development for which this question is usually posed. This device is an immunoassay kit; it is wet-lab developed and validated, not "trained" on a data set in the computational sense.

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

   • Not applicable, as there is no "training set" in the computational sense for this type of device. The assay's parameters (e.g., reagent concentrations, incubation times) are optimized through laboratory development, potentially using a different set of samples (often called "development" or "optimization" samples), but these are not "training sets" in the AI context.

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Liquichek Anti-Sm Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of Smith (Sm) autoantibodies.

This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.

This document is a 510(k) premarket notification for a quality control device, the Liquichek™ Anti-Sm Control, Positive. It's important to understand that 510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than proving direct clinical performance or effectiveness against a disease state in the way a pharmaceutical trial might.

Therefore, many of the typical acceptance criteria and study designs associated with direct diagnostic or therapeutic devices, such as multi-reader multi-case studies, effect sizes of AI assistance, or standalone algorithm performance, are not applicable here. This document focuses on the stability and characteristics of the control material itself.

Here's the breakdown of the information requested, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are related to its stability and its ability to function as an unassayed quality control material, demonstrating substantial equivalence to a previously cleared predicate device.

Study Details

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

   • The document does not explicitly state a "test set" in the context of diagnostic accuracy. The studies performed were stability studies.
   • Data Provenance: Not specified, but the studies were conducted internally by Bio-Rad Laboratories. The data is retained "on file at Bio-Rad Laboratories." This implies internal, retrospective testing of the control material itself rather than patient-derived data from any specific country.

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

   • Not applicable. This device is a quality control material, not a diagnostic test that generates ground truth about patient conditions. The "ground truth" here is the established stability of the control material based on internal lab testing.

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

   • Not applicable. As above, this is not a diagnostic device requiring expert adjudication of results.

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. This is a quality control material, not an AI-powered diagnostic device. An MRMC study is completely irrelevant.

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

   • No. This is a biological quality control reagent, not an algorithm or software device.

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

   • The "ground truth" for the stability studies would be the measured concentration/reactivity of the Anti-Sm analyte within the control over time, under specified storage conditions, compared to initial measurements. These measurements are performed using laboratory assays, not expert consensus or pathology on patient samples.

7. The sample size for the training set:

   • Not applicable. This device does not use a "training set" in the context of an algorithm or machine learning. Its manufacturing and testing follow established quality control procedures.

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

   • Not applicable. As above, there is no "training set" for this type of device.

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The Fred Hutchinson Cancer Research Center Anti-SR test is an enzyme immunoassay (EIA) for the detection and semiquantitative measure of human antibodies against a type of ribonucleoproteins (RNPs) called SR Proteins. The test is intended as an aid in the diagnosis of Systemic Lupus Erythematosis (SLE) .

The Fred Hutchinson Cancer Research Center Anti-SR test is an enzyme immunoassay (EIA) for the detection and semiquantitative measure of human antibodies against a type of ribonucleoproteins (RNPs) called SR Proteins.

The provided text is a 510(k) clearance letter from the FDA for a device called "FHCRC Anti-SR Test." This letter grants clearance based on substantial equivalence to a predicate device, but it does not contain the detailed study information, acceptance criteria, or performance data that would be found in a 510(k) submission document itself.

Therefore,Based on the provided document, I cannot extract the acceptance criteria or a study proving the device meets those criteria. The document is solely an FDA clearance letter, which references a 510(k) premarket notification but does not contain the specifics of that submission.

Here's why the requested information cannot be found in the provided text:

• No Acceptance Criteria or Performance Data: The letter states the device is "substantially equivalent" to a predicate device but does not detail the specific performance metrics (like sensitivity, specificity, accuracy) or the thresholds for those metrics that would constitute "acceptance criteria."
• No Description of a Study: While a study would have been part of the 510(k) submission that led to this letter, the letter itself does not describe the study design, sample sizes, ground truth establishment, or expert qualifications.

The letter explicitly mentions:

• Trade/Device Name: Fred Hutchinson Cancer Research Center (FHCRC) Anti-SR Test
• Regulation Name: Antinuclear Antibody Immunological Test System
• Indications For Use: An enzyme immunoassay (EIA) for the detection and semiquantitative measure of human antibodies against SR Proteins, intended as an aid in the diagnosis of Systemic Lupus Erythematosis (SLE).

To answer your request, one would need access to the original 510(k) submission for device K013263.

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