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The AlphaID™ At Home Genetic Health Risk Service uses qualitative genotyping to detect clinically relevant genetic variants associated with alpha-1 antitrypsin deficiency (AATD) in genomic DNA isolated from human saliva collected from individuals ≥ 18 years with ORAcollect Dx OCD-100.014 for the purpose of reporting and interpreting Genetic Health Risks (GHR).

This Service is indicated for reporting 14 genetic variants in the SERPINA1 gene: PIS; PIM procida; PIM malton; PIS iiyama; PIQ0 granite falls; PIQ0 west; PIQ0 bellingham; PIF; PIQ0 mattawa; PIQ0 clayton, and PI*M heerlen. The report describes if a person is at an increased risk of developing either liver disease linked to AATD. The report does not describe a person's overall risk of developing lung and/or liver disease. AATD is more common in persons of European descent.

The AlphaID™ At Home Genetic Health Risk Service (AlphaID At Home) uses qualitative genotyping to detect clinically relevant genetic variants associated with alphal-antitrypsin deficiency (AATD) and provides a report describing if a person is at risk of developing either lung and/or liver disease linked to AATD. This Service is direct-to-consumer and intended for an Over-the Counter (OTC) use.

The AlphaID™ At Home Genetic Health Risk Service is composed by AlphaID™ At Home Saliva Collection kit for human saliva sample collection (ORAcollect®·Dx OCD-100.014), A1AT Genotyping Test for the genetic analysis and detection of genetic variants associated with alpha-1 antitrypsin deficiency (AATD), and AlphaID™ At Home Genetic Health Risk Service website and result portal software to provide the contents and the procedure to order and use the over the counter (OTC) Service.

A consumer's saliva is self-collected using custom version ORAcollect Dx (model OCD-100.014) device manufactured by DNA Genotek, Inc (See K212745) which consists of collection tube containing a stabilizing buffer solution. Once the sample is collected, it is shipped to Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory for processing.

Human DNA from the saliva sample is isolated and processed with the A1AT Genotyping Test device (K211115) that provides results on 14 genetic variants in the SERPINA / gene: PIS; PIZ; PIM procida; PIM malton; PIS iiyama; PIO0 granite falls: PIO0 west: PIO0 bellingham: PIF; PIP lowell; PIO0 mattawa; PIQ0 clayton, and PI*M heerlen.

Briefly, genomic DNA extracted from human saliva is amplified and biotinylated by multiplex PCR and PCR products are denatured and hybridized to oligonucleotide probes coupled to color-coded beads. Hybridized DNA is labeled with a fluorescent conjugate and the resulting signal is detected with a Luminex® 200™ system. Raw fluorescence data is processed with the A1AT Genotyping Test ANALYSIS SOFTWARE to provide allelic variant genotypes, which are subsequently converted into associated alleles, based on current scientific evidence. Additionally, the software application also provides the type of Genetic Health Risk Report associated with the identified alleles, which is subsequently used as the basis for the generation of personalized reports by the AlphaID™ At Home Genetic Health Risk Service website and result portal.

Depending on the specific variant combination detected, the AlphaID™ At Home Genetic Health Risk Service provides the individuals' genetic health risk for developing lung and liver disease linked to AATD. Personalized reports, in an easy-to-understand format are generated for each consumer that provide results of the testing performed.

Here's a breakdown of the acceptance criteria and study information for the AlphaID™ At Home Genetic Health Risk Service, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Increased risk: >80% development.
• Slightly at Increased risk: 20-80% development.
• Not likely at increased risk:

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The Progenika A1AT genotyping kit is a qualitative, polymerase chain reaction (PCR) and hybridization-based in vitro diagnostic test to be used with the Luminent (with xPONENT software) for the simultaneous detection and identification of 14 allelic variants and their associated alleles found in the Alpha-1 antitrypsin (AIAT) codifying gene SERPINA1. The test is intended for use with genomic DNA extracted from human whole blood samples collected as dry blood spots (DBS) or in K2-EDTA or from human saliva samples collected as buccal swabs using ORAcollect Dx OCD-100. The A1AT allelic variant genotypes and associated allele results, when used in conjunction with clinical findings and other laboratory tests, are intended as an aid in the diagnosis of individuals with A1AT deficiency (A1ATD). The kit is indicated for prescription use only.

Alpha 1 antitrypsin (A1AT) Genotyping Test utilizes Luminex xMAP technology. Genomic DNA is extracted from DBS, from human EDTA anticoagulated whole blood or from human saliva samples collected as buccal swabs using ORAcollect-Dx OCD-100. Extracted DNA is amplified and biotinylated by multiplex PCR and PCR products are denatured and hybridized to oligonucleotide probes coupled to color-coded beads. Hybridized DNA is labeled with a fluorescent conjugate and the resulting signal is detected with a Luminex® 200 system. Raw data obtained is processed with the A1AT Genotyping Test ANALYSIS SOFTWARE in order to obtain the final report. The A1AT Genotyping Test ANALYSIS SOFTWARE algorithm converts the allelic variant genotypes into associated alleles, based on the current literature.

The A1AT Genotyping Test Kit is composed of 4 reagent components (A1AT PCR Master Mix, A1AT Beads Master Mix, SAPE, SAPE Dilution Buffer) required to perform all the abovementioned processing steps. The A1AT Genotyping Test ANALYSIS SOFTWARE, instructions for use and other necessary files are uploaded on a Grifols website. Two kit configurations are available: for 48 or 192 tests (different amounts of the same reagent components are provided in each case).

The provided document describes the A1AT Genotyping Test. This 510(k) submission (K211115) is for a modified version of a previously cleared device (K192858), primarily involving a software update. Therefore, much of the performance data refers back to the original submissions (K192858 and K171868).

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size:
  • LoD: 20 replicates of nine DNA dilutions for a "Sample Panel" (total of 180 tests per lot, across two lots used).
  • Precision (Lot-to-Lot): Five DNA samples ("Sample Panel") tested in triplicate, with three different reagent lots, by two operators, on six non-consecutive days, alternating between two Luminex instruments (5 samples * 3 replicates * 3 lots * 2 operators * 6 days = 540 tests, plus additional factors for instruments).
  • Accuracy: For the predicate device, 147 samples were used. The document refers to K171868 and K192858 for specific method comparison data for the modified device, so the exact number for the modified device's accuracy testing isn't explicitly stated but would be similar to or larger than the predicate's 147.
• Data Provenance: Not explicitly stated as "country of origin for data" or "retrospective/prospective." However, the applicant is Progenika Biopharma S.A. based in Spain, suggesting the studies likely occurred in Spain or affiliated regions. The nature of the studies (analytical performance) implies laboratory-based testing, which can be seen as a form of controlled prospective data collection for the device's technical performance.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• The document does not mention the use of experts to establish ground truth for the test set for the analytical performance studies described (LoD, Precision). These studies focus on the device's ability to consistently and accurately detect specific genetic variants based on known DNA samples.
• For Accuracy (Method Comparison), the ground truth was established by Bi-directional Sanger sequencing. This is considered a gold standard in genetic sequencing, not typically requiring "experts" to interpret the sequence output, but rather highly skilled laboratory personnel and bioinformaticians.

4. Adjudication Method (Test Set)

• Not applicable as the ground truth for analytical performance studies is typically objective (e.g., known DNA concentrations, Sanger sequencing results). The results are compared directly to these objective standards.

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

• No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) genetic test, which generates objective results (detection of allelic variants). The performance evaluation focuses on the analytical accuracy and precision of the device itself, rather than human interpretation of complex images or clinical scenarios that would necessitate an MRMC study.

6. Standalone Performance Study (Algorithm Only)

• Yes, a standalone performance study was done. The entire "Performance Data" section (H) describes the analytical studies to determine the device's capabilities (LoD, precision, stability, accuracy). These are evaluations of the algorithm and the assay itself, demonstrating its standalone performance from DNA input to reported genotype. The device includes "A1AT Genotyping Test ANALYSIS SOFTWARE" which processes raw data to obtain the final report, indicating its role as a standalone algorithm in the diagnostic process once the PCR and hybridization steps are completed.

7. Type of Ground Truth Used

• For LoD and Precision: Known DNA samples with established genotypes/concentrations were used.
• For Accuracy (Method Comparison): Bi-directional Sanger sequencing was used as the comparator (a gold standard laboratory method) to establish the ground truth for the samples tested.

8. Sample Size for the Training Set

• The document does not explicitly state the sample size used for the training set. This is a 510(k) submission for a device with a software update (v1.0.8.16 from v1.0.6.1). The software's algorithm for converting allelic variant genotypes into associated alleles is based on current literature. It's possible that the "training" for such an algorithm is not based on a 'training set' in the machine learning sense, but rather on established scientific knowledge and rules coded into the software. If any machine learning components were present, their training data is not disclosed here.

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

• Given that the document refers to the algorithm converting genotypes into alleles "based on the current literature," the ground truth for the "training" (or more accurately, the ruleset development) of the algorithm would be derived from published scientific literature and established genetic associations between allelic variants and their corresponding alleles for the SERPINA1 gene. There is no indication of a specific "training set" of patient samples with prospectively established ground truth for algorithm development in this context.

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The Progenika A1AT genotyping kit is a quantitative, polymerase chain reaction (PCR) and hybridization-based in vitro diagnostic test to be used with the Luminex 200 instrument (with xPONENT software) for the simultaneous detection and identification of 14 allelic variants and their associated alleles found in the Alpha-1 antitrypsin (A1AT) codifying gene SERPINA1. The test intended for use with genomic DNA extracted from human whole blood samples collected as dry blood spot (DBS) or in K2-EDTA or from human saliva samples collected as buccal swabs using ORAcollect Dx model OCD-100. The A1AT allelic variant genotypes and associated allele results, when used in conjunction with clinical findings and other laboratory tests, are intended as an aid in the diagnosis of individuals with A1AT deficiency (A1ATD). The kit is indicated for prescription use only.

Alpha 1 antitrypsin (A1AT) Genotyping Test utilizes Luminex xMAP technology. Genomic DNA is extracted from DBS or from human EDTA anticoagulated whole blood or from human saliva samples collected as buccal swabs using ORAcollect-Dx model OCD-100. Extracted DNA is amplified and biotinylated by multiplex PCR and PCR products are denatured and hybridized to oligonucleotide probes coupled to color-coded beads. Hybridized DNA is labeled with a fluorescent conjugate and the resulting signal is detected with a Luminex® 200 system. Raw data obtained is processed with the A1AT Genotyping Test ANALYSIS SOFTWARE in order to obtain the final report. The A1AT Genotyping Test ANALYSIS SOFTWARE algorithm converts the allelic variant genotypes into associated alleles, based on the current literature.

The A1AT Genotyping Test Kit is composed of 4 reagent components (A1AT PCR Master Mix, A1AT Beads Master Mix, SAPE, SAPE Dilution Buffer) required to perform all the above mentioned processing steps, and a CD containing the A1AT Genotyping Test ANALYSIS SOFTWARE and other necessary files. Two kit configurations are available: for 48 or for 192 tests (different amounts of the same reagent components are provided in each case).

Here’s a summary of the acceptance criteria and study details for the A1AT Genotyping Test, as extracted from the provided FDA 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" in a separate section with specific numerical thresholds for each performance metric. Instead, the study aims to demonstrate "100% concordance" with bi-directional Sanger sequencing for accuracy. The "Performance specifications" section outlines the areas tested, and the "Comparison Data" section reports the accuracy.

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

• Sample Size for Accuracy Test Set: 147 DNA samples.
  • 140 archived left-over clinical genomic DNA samples obtained from human saliva (buccal swabs using ORAcollect Dx model OCD-100).
  • 3 genomic DNA samples extracted from cell lines.
  • 4 synthetic DNA samples.
• Data Provenance: The 140 clinical samples were "archived left-over clinical genomic DNA samples," suggesting a retrospective collection of samples from clinical practice. The country of origin for the clinical samples is not specified in the provided text.

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

Not applicable. The ground truth was established by bi-directional Sanger sequencing, which is a laboratory method, not human expert interpretation.

4. Adjudication Method for the Test Set

Not applicable, as the ground truth was based on a laboratory method (bi-directional Sanger sequencing) rather than expert review requiring adjudication.

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

Not applicable. This device is a genotyping test, not an image-based AI-assisted diagnostic tool for human readers. It provides direct genetic results.

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

A standalone performance study was done for the device, where its results were compared directly against bi-directional Sanger sequencing (the ground truth). The A1AT Genotyping Test ANALYSIS SOFTWARE algorithm processes raw data to obtain the final report, effectively representing the "algorithm only" performance against the comparator.

7. The Type of Ground Truth Used

The ground truth used for the accuracy study was bi-directional Sanger sequencing.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the device itself in the context of an AI/ML algorithm. This device is a PCR and hybridization-based assay with associated analysis software. The performance data presented refers to the evaluation of this assay. If the "ANALYSIS SOFTWARE" incorporates machine learning, the training set details are not provided. However, given the nature of the device (genotyping test), it is unlikely to involve a dynamic machine learning model in the typical sense that would require a separate, distinct training set in the context of this submission. The software's algorithm converts allelic variants into associated alleles based on existing literature.

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

Not applicable, as a distinct training set (in the context of AI/ML) and its ground truth establishment are not discussed in the provided text. The "analysis software algorithm" is described as converting genotypes into alleles "based on the current literature," implying established scientific knowledge rather than a learned model from a specific training dataset.

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The QNext is a fully-automated, random-access instrument, intended for in vitro diagnostic use in clinical laboratories to perform hemostasis testing by detecting the changes in optical density.

DG-PT is a thromboplastin reagent for the quantitative determination of Prothrombin Time on human plasma samples collected in 3.2% sodium citrate.

The product is used for the evaluation of the extrinsic and common coagulation pathways in seconds and for the monitoring Oral Anticoagulant Therapy with warfarin in International Normalized Ratio (INR).

For use with ONext.

For clinical professional laboratory and prescription use only.

For in vitro diagnostic use.

The performance of this device has not been established in neonate and pediatric patient populations.

QNext is designed to automatically perform all stages of the procedures associated to hemostasis tests allowing the operator to:

• Absorb the workload involved in running hemostasis laboratory tests profiles, optimizing the execution of these profiles in the shortest time possible, and ensuring the maximum possible precision and accuracy in the results.
• Increase the reliability of the analytical process, eliminating any possible errors in the identification ● and treatment of samples and products and in the revision and transcription of the results.
• Reduce the risk of Operator contamination by minimizing interaction between the Operator and ● samples and products during the analytical process.

To perform the operations for which it has been designed, QNext automatically follows the steps listed below:

• Sample management: loading, positive identification, dilution (if required) and dispensation into cuvettes.
• Reagent management: loading, positive identification, cooling, stirring, aspiration and dispensation into cuvettes.
• Cuvette management: loading, transport, incubation during the reactions and management of used cuvettes.
• Management of test requests. ●
• Execution of test procedures.
• Result management: optical measurement of the reactions, algorithm calculation of analytical parameters from reaction curves, validation of results, traceability, bi-directional transmission of requests and results to the LIS.
• Management of disposable components. ●

The data analyzed can be stored, displayed and printed. Additionally, the analyzer allows conducting integrated functions, such as the analysis of urgent samples or the Quality Control module.

DG-PT consists of a glass vial containing lyophilized thromboplastin (tissue factor and phospholipids) from rabbit brain tissue, buffer, calcium ions and preservative. The closure system includes a stopper and a screw сар.

DG-PT reagent is used to perform PT tests for:

• the evaluation of the extrinsic and common coagulation pathways.
• The monitoring Oral Anticoagulant Therapy with warfarin.

The assay is based on the activation of the extrinsic coagulation pathway by the addition of the reagent to the plasma sample. The thromboplastin interacts with FVII and calcium ions activating a series of specific enzymes that comprise the extrinsic and common pathways of the coagulation cascade ultimately leading to the formation of a fibrin clot. The QNext reader measures the light change produced during the reaction.

The provided text describes the performance testing of the ONext instrument and DG-PT reagent for Prothrombin Time (PT) determination, but it does not contain information related to an AI/ML powered device. Therefore, many of the requested criteria regarding AI/ML device performance (e.g., multi-reader multi-case studies, human-in-the-loop performance, training set details, expert ground truth adjudication) are not applicable to this document.

However, I can extract and present the acceptance criteria and performance data for the described in-vitro diagnostic device:

Device: ONext (fully-automated hemostasis instrument) and DG-PT (thromboplastin reagent for PT determination).

Study Proving Device Meets Acceptance Criteria:
The submission details several performance studies conducted according to CLSI guidelines to demonstrate the substantial equivalence of the ONext and DG-PT to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined quantitative acceptance criteria thresholds for each study (e.g., "Precision CV must be less than X%"). Instead, it presents the results of various performance studies (Precision, Reference Interval, Sensitivity, Specificity, Method Comparison) which are implicitly understood to meet the necessary performance characteristics for substantial equivalence. The "performance" column therefore reflects the observed results from these studies.

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

• Precision Studies:
  • Repeatability and Within-laboratory: 7 patient-derived samples. Data provenance not explicitly stated (e.g., country of origin), assumed to be clinical samples. Retrospective/prospective not specified, but typically for precision studies, these would be collected prospectively or obtained from a biobank.
  • Reproducibility: 7 patient-derived samples. Data provenance not explicitly stated (e.g., country of origin), assumed to be clinical samples. Retrospective/prospective not specified.
• Reference Interval Study: 243 reference samples. Data provenance not explicitly stated.
• Sensitivity Study: Not specified, but involved a set of samples spanning from 100% to

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The Progenika A1AT genotyping kit is a qualitative, polymerase chain reaction (PCR) and hybridization-based in vitro diagnostic test to be used with the Luminex 200TM instrument (with xPONENT® software) for the simultaneous detection and identification of 14 allelic variants and their associated alleles found in the Alpha-1 antitypsin (A1AT) codifying gene SERPINA1. The test is intended for use with genomic DNA extracted from human whole blood samples collected as dry blood spots (DBS) or in K2-EDTA. The A1AT allelic variant genotypes and associated allele results, when used in conjunction with clinical findings and other laboratory tests, are intended as an aid in the diagnosis of individuals with A1AT deficiency (A1ATD).

The kit is indicated for prescription use only.

Alpha 1 antitrypsin (A1AT) Genotyping Test utilizes Luminex xMAP technology. Genomic DNA is extracted from DBS or from human K2-EDTA anticoaqulated whole blood. Extracted DNA is amplified and biotinylated by multiplex PCR and PCR products are denatured and hybridized to oligonucleotide probes coupled to color-coded beads. Hybridized DNA is labeled with a fluorescent conjugate and the resulting signal is detected with a Luminex® 200 system. Raw data obtained is processed with the A1AT Genotyping Test ANALYSIS SOFTWARE in order to obtain the final report. The A1AT Genotyping Test ANALYSIS SOFTWARE algorithm converts the allelic variant genotypes into associated alleles, based on the current literature.

The A1AT Genotyping Test Kit is composed of 4 reagent components (A1AT PCR Master Mix, A1AT Beads Master Mix, SAPE, SAPE Dilution Buffer) required to perform all the above mentioned processing steps, and a CD containing the A1AT Genotyping Test ANALYSIS SOFTWARE and other necessary files. Two kit configurations are available: for 48 or for 192 tests (different amounts of the same reagent components are provided in each case).

Here's a breakdown of the acceptance criteria and study information for the A1AT Genotyping Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA summary does not explicitly list "acceptance criteria" but rather presents the results of various performance studies. The reported performance implies the acceptance criteria were met for each category.

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

The "test set" for the primary method comparison study consisted of 116 DNA samples.

• Data Provenance:
  • Clinical Samples: 66 samples, type not specified (retrospective/prospective, country of origin not specified).
  • Genomic DNAs from Cell Lines: 46 samples, type not specified.
  • Synthetic DNA Samples: 4 samples, type not specified.

For the External Reproducibility study, 17 samples were used (5 collected in DBS, 11 archived genomic DNA samples, and 1 synthetic sample). These were tested at external sites in the USA (LifeShare Blood Center and Progenika Inc.) and Italy (University of Pavia). This suggests a mix of prospective and retrospective data, depending on the nature of the archived samples.

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

The ground truth for the test set in the Method Comparison study was established by bi-directional Sanger sequencing. This is a laboratory-based method of genetic sequencing and does not involve human experts in the interpretation of the results to establish ground truth in the same way clinical image or pathology interpretation would. Therefore, the concept of "number of experts" or their "qualifications" is not directly applicable in this context.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by bi-directional Sanger sequencing, which is an objective laboratory method, not subject to adjudication by multiple human readers.

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 comparative effectiveness study was not done. This device is a diagnostic test for genetic variants, not an AI-assisted interpretation tool for human readers. Its performance is evaluated fundamentally as a standalone test against an established gold standard (Sanger sequencing).

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

Yes, a standalone performance study was done. The entire performance data presented (analytical and method comparison) reflects the performance of the A1AT Genotyping Test system (including the assay and its associated software) as a standalone diagnostic tool. The A1AT Genotyping Test ANALYSIS SOFTWARE algorithm converts the allelic variant genotypes into associated alleles.

7. The Type of Ground Truth Used

The primary ground truth used for the method comparison study was bi-directional Sanger sequencing, a molecular biology technique considered a gold standard for genetic sequence verification.

8. The Sample Size for the Training Set

The document does not specify a training set size. As a diagnostic test that relies on PCR and hybridization, it is unlikely to have a "training set" in the machine learning sense. The device's underlying chemistry and software algorithm are likely developed and validated using a different process than data-driven AI models.

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

Not applicable, as a "training set" in the context of machine learning for an AI algorithm is not explicitly mentioned or implied for this device. The development of the assay and its software would involve standard molecular biology and software engineering validation processes.

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Gri-Fill Peristaltic Set fluid transfer set is an ancillary device used in conjunction with the Gri-Fill Pharmacy Compounder and ancillary Gri-Fill sets in hospital pharmacy to provide a fluid pathway through which one solution source is delivered into a final IV container. This device is not intended to be directly connected to the patient.

Gri-fill Peristaltic Set is a disposable fluid transfer set for connection to a source container and to Gri-fill sets for use with the Gri-Fill Pharmacy Compounder. lt consists of a silicone tube linking a male luer-lock connector and a spike (with a 1.2 um hydrophobic air filter) for connecting to the source container, and a female luer-lock connection, for connecting to the Gri-fill set. The silicone tube allows the set to be used with a peristaltic pump. The Gri-fill Peristaltic Set is intended to be used by trained health-care personnel. The product is presented sterile (SAL = 1 x 10-6) in peel-pack pouches each containing 1 unit. Sterility is achieved using a validated ethylene oxide sterilization process. Gri-fill Peristaltic Set is not intended to be used for direct patient contact.

The provided document describes the 510(k) premarket notification for the Gri-fill Peristaltic Set, a fluid transfer set used in hospital pharmacies. It claims substantial equivalence to a predicate device, the KIRO Set (K152441).

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against which a device's performance is measured in a quantitative manner as typically seen in clinical performance studies of AI/diagnostic devices. Instead, the "acceptance criteria" are implied by the various performance tests conducted to demonstrate substantial equivalence to the predicate device and adherence to relevant standards. The "reported device performance" is described qualitatively as "All tests yielded correct results."

However, the closest equivalent to quantitative acceptance criteria and performance data are those related to Dose Range and Accuracy, which are compared between the subject device and the predicate.

Note: For most other performance tests (e.g., leakage, tensile strength, functionality, residuals, endotoxins), the document states "All tests yielded correct results," implying they met their respective standard-defined acceptance criteria, but these criteria are not numerically specified in the provided text.

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

The document does not provide specific sample sizes (e.g., number of devices tested) for the performance tests conducted. It only mentions that "Performance testing was conducted in accordance with 'FDA Guidance for Industry and FDA Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]' dated July 11, 2008."

The data provenance is implied to be from laboratory bench testing performed by the manufacturer, Laboratorios Grifols, S.A. (SPAIN). All studies were prospective bench tests rather than retrospective or prospective human data clinical studies.

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

This information is not applicable as the device is a physical medical device (fluid transfer set) and not an AI or diagnostic tool requiring ground truth established by human experts for interpretation of images or patient data. The "ground truth" for its performance is derived from physical and chemical measurements against established standards.

4. Adjudication Method for the Test Set

This information is not applicable as there are no human interpretations or classifications of data that would require an adjudication method. Performance is assessed through objective physical and chemical testing.

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 information is not applicable. The device is a physical medical device (fluid transfer set), not an AI or diagnostic tool, and therefore, no MRMC study or AI assistance evaluation was performed.

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

This information is not applicable. The device is a physical medical device. It does not involve algorithms or AI.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective measurements against established engineering and safety standards, such as:

• ISO 11607-1 for individual packaging validation.
• ISO 11135:2014 for ethylene oxide sterilization process validation.
• ISO 10993-7:2008 for residuals of ethylene oxide sterilization.
• ANSI/AAMI ST72:2002 and FDA Guidance for Industry for bacterial endotoxin testing.
• ISO 8536-4 for chemical, physical, and functional performance (leakage, tensile strength).
• ISO 22413 for chemical, physical, and functional performance.
• ISO 594-1 and ISO 594-2 for physical testing of luer-locks.
• ISO 10993-1 for biocompatibility (hemocompatibility, cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity).

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device. It does not involve AI or machine learning models that require a "training set."

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

This information is not applicable for the same reason as above.

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The a-Gliatest® IgA is intended for the semi-quantitative determination of IgA antibodies directed against gliadin in human serum. The assay is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.

The a-Gliatest® IgG is intended for the semi-quantitative determination of IgG antibodies directed against gliadin in human serum. The assay is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.

The a-GliaPep® IgA is intended for the semi-quantitative determination of IgA antibodies directed against deamidated gliadin peptide in human serum. The assay is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.

The a-GliaPep® IgG is intended for the semi-quantitative determination of IgG antibodies directed against deamidated gliadin peptide in human serum. The assay is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.

Each test kit for a-Gliatest® IgA, a-Gliatest® IgG, a-GliaPep® IgA, and a-GliaPep® IgG consists of one (1) microtiter plate (12 strips of 8 microwells coated with purified a-gliadin antigen or deamidated gliadin peptide antigen), assay controls (positive and negative), a ready-to-use set of five (5) calibrators, Horseradish Peroxidase (HRP) goat anti-human IgA or IgG conjugate, serum diluent, Tetramethylbenzidine (TMB) enzyme substrate, stop solution, and washing solution required for the assay.

The provided document describes the Grifols USA, Inc. a-Gliatest® IgA, a-Gliatest® IgG, a-GliaPep® IgA, and a-GliaPep® IgG devices, which are intended for the semi-quantitative determination of IgA/IgG antibodies directed against gliadin or deamidated gliadin peptide in human serum as an aid in the diagnosis of celiac disease.

Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied through comparison with a predicate device (Aeskulisa® Glia A/G (K052439)) and through performance metrics like precision, linearity, and detection limits. The method comparison and clinical studies aim to demonstrate substantial equivalence and adequate diagnostic performance.

Below is a summary of the reported performance for each device, with implied acceptance criteria based on the context of 'substantial equivalence' to the predicate and satisfactory clinical utility. The document does not explicitly state pre-defined acceptance criteria for the clinical or method comparison studies in terms of specific percentages, but rather presents the results. For analytical performance, the studies demonstrate what is considered acceptable.

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

• α-Gliatest® IgA:
  • Method Comparison Test Set: 178 clinical samples. Provenance: Includes clinically-diagnosed celiac positive (clinical history and/or biopsy) and negative samples (healthy blood donors, IBD, IBS, food intolerances, autoimmune disorders, infectious diseases, Type 1 diabetes patients). Retrospective.
  • Clinical Study Test Set: 262 clinical samples (114 celiac positive, 148 negative from disease controls). Provenance: Celiac patient samples diagnosed with clinical findings and/or confirmed with biopsy. Negative samples from disease control patients (autoimmune disorders, infectious diseases, IBD, IBS, Type 1 diabetes). Also, 196 healthy blood donor samples. Retrospective.
• α-Gliatest® IgG:
  • Method Comparison Test Set: 198 clinical samples (51 celiac positive, including 10 IgA-deficient celiac patients; negative samples from healthy blood donors, IBD, IBS, food intolerances, autoimmune disorders, infectious diseases, Type 1 diabetes patients). Retrospective.
  • Clinical Study Test Set: 285 clinical samples (127 celiac positive, 10 IgA-deficient celiac patients; 148 negative from disease controls). Provenance: Celiac patient samples diagnosed with clinical findings and confirmed with biopsy. Negative samples from disease control patients (autoimmune disorders, infectious diseases, IBD, IBS, Type 1 diabetes). Also, 196 healthy blood donor samples. Retrospective.
• α-GliaPep® IgA:
  • Method Comparison Test Set: 179 clinical samples. Provenance: Clinically-diagnosed celiac positive (clinical history and/or biopsy) and negative samples (healthy blood donors, IBD, IBS, food intolerances, autoimmune disorders, infectious diseases, Type 1 diabetes patients). Retrospective. The samples were within the linearity range of the assay.
  • Clinical Study Test Set: 241 clinical samples (93 celiac positive, 148 negative from disease controls). Provenance: Celiac patient samples diagnosed with clinical findings and confirmed with biopsy. Negative samples from disease control patients (autoimmune disorders, infectious diseases, IBD, IBS, Type 1 diabetes). Also, 145 healthy blood donor samples. Retrospective.
• α-GliaPep® IgG:
  • Method Comparison Test Set: 201 clinical samples (57 celiac positive, including 10 IgA-deficient celiac patients; 146 negative samples recruited similarly to other assays). Provenance: Clinically-diagnosed celiac positive (clinical history and/or biopsy) and negative samples (healthy blood donors, IBD, IBS, food intolerances, autoimmune disorders, infectious diseases, Type 1 diabetes patients). Retrospective. The samples were within the linearity range of the assay.
  • Clinical Study Test Set: 253 clinical samples (95 celiac positive, including 10 IgA-deficient celiac patients; 148 negative from disease controls). Provenance: Celiac patient samples diagnosed with clinical findings (31.6%) and confirmed with biopsy (68.4%). Negative samples from disease control patients (autoimmune disorders, infectious diseases, IBD, IBS, Type 1 diabetes). Also, 145 healthy blood donor samples. Retrospective.

For all studies, data provenance is global/not specified, and the data is retrospective.

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

The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with X years of experience) used to establish the ground truth for the test sets. It mentions that celiac positive samples were "clinically-diagnosed celiac positive (clinical history and/or biopsy)" and "diagnosed with clinical findings and confirmed with biopsy." This implies that the ground truth was established by medical professionals, likely gastroenterologists or pathologists, based on established diagnostic criteria for celiac disease, including clinical presentation and histological findings from biopsy. However, the specific number and formal qualifications of these experts are not provided.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in ground truth determination or in the interpretation of clinical findings and biopsies for the test set. The ground truth seems to be implicitly accepted based on the "clinical findings and/or biopsy" diagnosis.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. These devices are in vitro diagnostic (IVD) assays, not imaging interpretation algorithms where human readers would typically be involved in interpreting results. The studies compare the performance of the device itself to a predicate device or to clinical ground truth, not to human reader performance with or without AI assistance.

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

Yes, the studies conducted are standalone performance evaluations of the assay devices. The "method comparison studies" and "clinical studies" evaluate the performance of each assay (α-Gliatest® IgA, α-Gliatest® IgG, α-GliaPep® IgA, α-GliaPep® IgG) in isolation, comparing its output to a predicate device's output or to the clinical ground truth. There is no human-in-the-loop component described for the operation or interpretation of these assays beyond standard laboratory procedures.

7. The Type of Ground Truth Used

The ground truth for celiac positive samples was established based on:

• Clinical findings: Clinical history and presentation consistent with celiac disease.
• Biopsy: Histological confirmation from intestinal biopsy, which is a gold standard for celiac disease diagnosis.

For negative samples, the ground truth was based on:

• Healthy blood donors.
• Patients with other relevant conditions (IBD, IBS, autoimmune disorders, infectious diseases, Type 1 diabetes) who would not be expected to have celiac disease.

This can be categorized as a combination of expert consensus (clinical findings) and pathology (biopsy).

8. The Sample Size for the Training Set

The document primarily describes validation studies (test sets) and does not explicitly mention a separate "training set" for the development of these IVD assays. IVD products are typically developed through iterative processes of antigen/antibody selection and optimization, with assay parameters being refined, but these development phases are not usually referred to as "training sets" in the same way machine learning models are. The calibrators and controls are formulated from pooled sera, and new lots are calibrated against original calibrators, which involves testing (effectively a form of internal "training" or standardization) against:

• Original calibrators
• Normal human sera
• Clinical samples
• Internal standards

However, a specific "training set" size for algorithm development (as would be typical for AI/ML devices) is not applicable or stated for this type of immunoassay.

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

As noted above, a distinct "training set" for an algorithm in the AI/ML sense is not applicable to these IVD assays. Instead, the assay's operational parameters (like calibrator values) are established using:

• Pooled sera with known anti-gliadin antibody levels from celiac patients.
• Normal human sera.
• Clinical samples.
• Internal standards.

The ground truth for these calibrators and controls would stem from the clinical diagnoses (clinical findings and/or biopsy) of the patient populations from which the sera were obtained. The document states, "Calibrators are dilutions of pooled sera with anti-gliadin antibody from patients with celiac disease." This implies that the ground truth for these pooled sera was established through the diagnosis of celiac disease in the donor patients.

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The Immunofixation Electrophoresis (IFE) Test using Interlab G 26 v2.0 instrument is for the qualitative in vitro diagnostic separation and identification of immunoglobulins (IgG, IgA and IgM), and kappa and lambda chains in human serum and concentrated urine using agarose gel supported on Mylar®. The test is useful as an aid in identifying suspected monoclonal proteins. The test result is to be used in conjunction with clinical and other laboratory findings.

The Interlab IFE kits 2, 4, and 6 samples per gel, are intended to be used with the automated Interlab G26 v1.0 and v2.0 electrophoresis analyzers in conjunction with the Easy Mask antisera application device.

The Immunofixation Electrophoresis (IFE) Test kit is packaged as a 20 (2 samples/ gel), 40 (4 samples/ gel) or 60 (6 samples/ gel) test kits. The kit contains ready-to-use components: 10 gel plates, 2 buffered sponges, acid violet stain (500 mL), washing solution for applicators (80 mL), washing solution 1 for IFE (80 mL), washing solution 2 for IFE (80 mL), IFE diluent (6 or 12 mL), disposable sample trays 26 (10 pcs) or 39 (10 pcs), blotters A (10 pcs), blotters L (10 pcs), blotters G (10 pcs), and 1 CD Package Insert.

The following components are required for the test but are not supplied in the test kit: destain solution pack (6x100 mL), fixative solution (1.5 mL) and specific antisera Anti-Human-IgG (1 mL), Anti-Human-IgA (1 mL)), Anti-Human-IgM (1 mL), Anti-Human-Kappa (1 mL) and Anti-Human-Lambda (1 mL).

The Automated Interlab G 26 ver. 2 Electrophoresis Analyzer provides automated pipetting of samples from barcode sample tubes in a rack and dilutes the samples into a sample tray for dispensing onto an agarose gel. The protein fraction separation uses the principle of electrophoresis; separation involving electrically charged molecules that orient and migrate at different rates when subjected to an electric field. The migration is performed at a constant temperature, obtained through the use of a Peltier device, on assay specific buffered agarose gel plates. The agarose gel medium provides a support and molecular sieve allowing the different fractions to migrate to points based on individual net charges.

After electrophoresis, the gel is heated to "fix" the focalized proteins, followed by assay specific staining, destaining, washing and drying. All methods utilizing a quantitative assessment are immediately processed using the on-board densitometer. The signal obtained for each specimen result is sent to the personal computer and presented using the Elfolab interpretive software. The Interiab G26 instrument is preprogrammed with all necessary firmware to conduct and manage all phases of the analytical procedures used in Interlab manufactured assays. The instrument works in coniunction with a personal computer using Windows® based software featuring pull down menus and intuitive icons for easy instrument control, selection of analytical methods, and data evaluation.

Instrument design includes: automated application of the samples on the agarose gel; electrophoretic migration; "heat fixing" proteins to the gel; gel staining/ destaining/ drying, densitometric reading of the gel; and data transmission and processing.

The Interlab Easy Mask Antisera Applicator Device is a standalone electronic instrument identical to the peltier contained within the Interlab G26 and is designed to work in conjunction with the Interlab G26. This device allows for accurate and simplified processing of various electrophoretic agarose gel assays that require reagent or antisera overlays. This device allows for easier user processing of the manual steps necessary in antisera type assays (IFE, BJ, Penta) by allowing the user to work unencumbered from mechanical arms and instrument covers.

The Easy Mask provides functions identically to the processing steps used in other agarose gel systems that require the user to perform the manual antisera steps directly on the instrument. Through the use of a Peltier and vacuum pump, the temperature across the surface of the gel remains at a precise and controlled temperature, thus improving assay quality and decreasing time. Instrument is designed to receive the Gel Holder from the Interiab G26 Instrument. The Gel Holder is inserted into a template which places the gel in direct contact with the peliter plate assuring uniform and controlled temperature over the entire surface of the gel. Perfect adhesion of the geltier plate is accomplished using a vacuum pump. Assay specific application masks are placed in the frame, which provide precise application of the antisera or reagents during the incubation phase. After the incubation phase is complete, the frame locks over the gel providing a calibrated heated press to blot away un-bound antisera and reagents. When processing is completed on the Easy Mask, the operator places the Gel Holder back in the parking location on the Interlab G26 for the final steps of the analysis.

Here's a breakdown of the acceptance criteria and the study details for the Immunofixation Electrophoresis Test using Interlab G26 Instrument, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

For this particular device, the "acceptance criteria" are implicitly defined by the demonstration of 100% agreement and reproducibility with a previously cleared predicate device. The performance is reported as concordance. There are no explicit numerical thresholds for sensitivity or specificity stated as acceptance criteria, as this is a qualitative test comparing to a predicate.

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

• Reproducibility (Within-Run): 2 series of 8 samples (1 normal, 7 pathological with monoclonal bands). For each sample, 6 replicates were run. Total replicates = (2 series * 8 samples/series * 6 replicates/sample) = 96.
• Reproducibility (Between-Run): 4 cycles of 3 agarose gel plates used to analyze 18 samples (3 normal, 15 pathological with monoclonal bands). Total runs/gels = (4 cycles * 3 gels/cycle) = 12 gels.
• Inter-Lot Reproducibility: 9 different samples (1 normal, 8 pathological with monoclonal bands) analyzed using 3 different batches of antisera on 9 agarose gel plates.
• Interference (Serum): Not explicitly stated, but implies a sufficient number of spiked and un-spiked samples.
• Interference (Urine): 8 urine samples (7 pathological, 1 normal).
• Method Comparison (Serum): 102 serum samples (10 normal, 92 suspected pathological).
• Method Comparison (Urine): 64 urine samples (56 pathological, 8 negative).

Data Provenance: The document does not explicitly state the country of origin for the patient samples. The studies seem to be retrospective, using existing samples.

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

The ground truth for the test set interpretations (e.g., comparison studies, reproducibility) was established by visual inspection. The document does not specify the number of experts, nor their qualifications (e.g., "radiologist with 10 years of experience"). This type of qualitative visual interpretation is typically done by trained laboratory professionals or experts in immunofixation electrophoresis.

4. Adjudication Method for the Test Set

The document does not detail a formal adjudication method (e.g., 2+1, 3+1). The evaluation was based on visual inspection for agreement and reproducibility. It can be inferred that either a single expert visually inspected and confirmed the results, or multiple experts reviewed, and any discrepancies were resolved, but the process is not explicitly described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focused on the performance of the device itself compared to a predicate device, not on the improvement of human reader performance with or without AI assistance. The device is for qualitative diagnostic separation and identification, interpreted visually.

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

Yes, the studies described are essentially standalone performance evaluations of the Interlab G26 v2.0 instrument. The visual inspection "evaluation" is about the clarity and accuracy of the bands produced by the instrument, which is then interpreted by a human. The "standalone" here refers to the instrument's ability to process samples and produce the electrophoretic patterns correctly, rather than an AI or algorithm making a final diagnosis without human input. The output is a visual pattern that a human then interprets.

7. The Type of Ground Truth Used

The ground truth used for the test set appears to be:

• Visual Inspection/Expert Consensus: For reproducibility, precision, and interference, the "ground truth" for what constitutes a correct pattern (monoclonal bands, normal pattern, etc.) is based on established interpretation criteria for immunofixation electrophoresis and is visually confirmed.
• Predicate Device Agreement: For the method comparison studies, the results obtained from the predicate G26 v1 device (which was previously cleared by the FDA) served as the "reference method" or de-facto ground truth for qualitative agreement.

There is no mention of pathology, long-term outcomes data, or other definitive "gold standard" methods used to establish ground truth.

8. The Sample Size for the Training Set

The document does not specify a training set in the context of machine learning or AI. This device submission is for an automated electrophoresis instrument, not an AI/ML algorithm that requires a training set. The "preprogrammed" firmware and software (Elfolab system) manage the analytical procedures and data evaluation, but it's not described as an adaptive learning system that undergoes a "training" phase with data.

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

As no training set (in the AI/ML sense) is described, there's no information on how its ground truth was established.

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The Immunofixation Electrophoresis (IFE) Test using the Interlab G26 instrument is for the qualitative in vitro diagnostic separation and identification of immunoglobulins (IgG, IgA and IgM), and kappa and lambda light chains in human serum and concentrated urine using agarose gel supported on Mylar®. The test is useful as an aid in identifying suspected monoclonal proteins. The test result is to be used in conjunction with clinical and other laboratory findings.

The Interlab IFE kits (2, 4, 6 samples per gel), are intended to be used with the automated Interlab G26 electrophoresis analyzer in conjunction with the Easy Mask antisera application device.

Not Found

The provided text is a 510(k) clearance letter from the FDA for an Immunofixation Electrophoresis Test using the Interlab G26 Instrument. It does not contain information about formal acceptance criteria, device performance reports, or details of a study used to prove the device meets acceptance criteria.

The letter primarily:

• Identifies the device and its regulatory classification.
• States that the device has been determined substantially equivalent to legally marketed predicate devices.
• Outlines general regulatory requirements for the manufacturer.
• Provides the "Indications for Use" for the device, which describes its intended purpose but not performance metrics.

Therefore,Based on the provided document, the following information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: The document is an FDA 510(k) clearance letter and does not contain detailed acceptance criteria or performance data. It indicates that the device was found "substantially equivalent" to predicate devices, implying that its performance is comparable, but no specific metrics are given.
2. Sample size used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
4. Adjudication method for the test set: Not available in this document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not available in this document.
6. If a standalone performance study was done: Not available in this document.
7. The type of ground truth used: Not available in this document.
8. The sample size for the training set: Not available in this document.
9. How the ground truth for the training set was established: Not available in this document.

The document only provides:

• Device Name: Immunofixation Electrophoresis Test using Interlab G26 Instrument
• Indications For Use: "The Immunofixation Electrophoresis (IFE) Test using the Interlab G26 instrument is for the qualitative in vitro diagnostic separation and identification of immunoglobulins (IgG, IgA and IgM), and kappa and lambda light chains in human serum and concentrated urine using agarose gel supported on Mylar®. The test is useful as an aid in identifying suspected monoclonal proteins. The test result is to be used in conjunction with clinical and other laboratory findings. The Interlab IFE kits (2, 4, 6 samples per gel), are intended to be used with the automated Interlab G26 electrophoresis analyzer in conjunction with the Easy Mask antisera application device."

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The Eu-tTG® IgA is an in vitro diagnostic enzyme immunoassay for the semi-quantitative detection of IgA specific antibodies directed against tissue transglutaminase (tTG) in human serum. It is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.

The Eu-tTG® IgG is an in vitro diagnostic enzyme immunoassay for the semi-quantitative detection of IgG specific antibodies directed against tissue transglutaminase (tTG) in human serum. It is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.

Each test kit for Eu-tTG® IgA & Eu-tTG® IgG consists of one (1) microtiter plate (12 strips with 8 microwells coated with the human recombinant tTG antigen), assay controls (positive and negative), a ready-to-use set of five (5) calibrators, Horseradish Peroxidase (HRP) goat anti-human IgA or IgG conjugate, serum diluent, Tetramethylbenzidine (TMB) enzyme substrate, stop solution, and washing solution required for the assay.

The provided text describes two diagnostic devices, Eu-tTG® IgA and Eu-tTG® IgG, both intended as aids in the diagnosis of celiac disease. The study described focuses on their analytical and clinical performance.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve a sensitivity of at least X%"). Instead, it presents the results of method comparison and clinical studies, implying that the achieved performance was deemed sufficient for substantial equivalence to predicate devices. The comparator devices' performance would implicitly serve as a benchmark for acceptability.

However, based on the provided data, we can infer performance metrics. For this response, I will list the observed performance from the clinical studies as the "Reported Device Performance." Since no explicit "acceptance criteria" are given for these values, they serve as the performance characteristics that were reviewed for market clearance.

Eu-tTG® IgA

Eu-tTG® IgG

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

• Eu-tTG® IgA Clinical Study Test Set: 363 clinical samples (121 positive celiac patients, 242 negative samples).
• Eu-tTG® IgG Clinical Study Test Set: 407 clinical samples (165 positive celiac patients, 242 negative samples).
• Data Provenance: The document does not explicitly state the country of origin. It indicates that samples were from "clinically diagnosed celiac positive" and "negative samples... from healthy blood donors, IBD patients, patients affected by food intolerances and patients with autoimmune or infectious diseases." This suggests the samples are retrospective, sourced from clinical settings or blood banks, and are clinical samples, not necessarily from a controlled prospective study for this submission.

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

The document states that "The positive celiac patient samples were diagnosed with clinical findings and/or confirmed with biopsy." It does not specify the number of experts or their qualifications involved in establishing this ground truth (e.g., gastroenterologists, pathologists, etc.).

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing the ground truth. It relies on existing clinical diagnoses and biopsy confirmations.

In the method comparison studies, the "comparator test" results served as the reference for agreement calculations, but this is not an adjudication of ground truth for the clinical diagnosis itself.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the performance of a diagnostic immunoassay, not on human readers' interpretation of images or other data, with or without AI assistance.

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

Yes, the studies presented are for the standalone performance of the Eu-tTG® IgA and Eu-tTG® IgG immunoassay kits. These are in vitro diagnostic devices that directly analyze human serum samples; they do not involve a human-in-the-loop for interpreting the assay's output to render a diagnosis. The results (AU/mL values) are generated solely by the device.

7. The Type of Ground Truth Used

The ground truth for the clinical studies was established by:

• Clinical findings: This implies a physician's assessment of symptoms, medical history, and other diagnostic indicators.
• Biopsy confirmation: This refers to histological examination of intestinal tissue, which is the gold standard for diagnosing celiac disease.
• For negative samples, the ground truth was based on being "healthy subjects and patients with autoimmune disorders, infectious disease and IBD" without celiac disease.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" in the context of machine learning or AI development. These are immunoassay kits, which are typically developed and optimized through laboratory procedures, rather than being "trained" on data in the AI sense.

However, the "Assay Cut-off" section refers to testing "153 samples" (103 healthy subjects and 50 non-celiac controls) to establish the normal range and cut-off values. While not a "training set" in the AI sense, these samples were used to define parameters of the assay.

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

As explained above, there isn't a "training set" in the typical AI sense. However, for the 153 samples used to establish cut-off values:

• Healthy subjects: Presumed to be healthy without celiac disease.
• Non-celiac controls (IBD patients): Diagnosed with IBD but implicitly confirmed not to have celiac disease.

The exact methods for establishing the "ground truth" (e.g., confirmation of health status, specific IBD diagnosis without co-occurring celiac disease) for these 153 samples are not detailed in the provided text.

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