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The VIDAS® TBI (GFAP, UCH-L1) test is composed of two automated assays - VIDAS® TBI (GFAP) and VIDAS® TBI (UCH-L1) - to be used on the VIDAS® 3 instrument for the quantitative measurement of Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase (UCH-L1) in human serum using the ELFA (Enzyme Linked Fluorescent Assay) technique. The results of both assays are requred to obtain an overall qualitative test interpretation.

The overall qualitative VIDAS® TBI (GFAP, UCH-L1) test result is used, in conjunction with clinical information, to aid in the evaluation of patients (18 years of age or older), presenting within 12 hours of suspected mild traumatic brain injury (Glasgow Coma Scale score 13-15), to assist in determining the need for a Computed Tomography (CT) scan of the head. A negative interpretation of VIDAS® TBI (GFAP, UCH-L1) test is associated with the absence of acute intracranial lesions visualized on a head CT scan.

The VIDAS® TBI (GFAP, UCH-L1) test is composed of two automated assays – VIDAS® TBI (GFAP) and VIDAS® TBI (UCH-L1) – to be used on the VIDAS® 3 instrument. Similar to other VIDAS assays, VIDAS TBI (GFAP) and VIDAS TBI (UCH-L1) test kits (specific to each biomarker) contain the solid phase receptacles (SPRs®), the reagent strips, Product Calibrator S1 and Product Control C1. These test kits will also contain the master lot entry (MLE) data i.e., a barcode printed on the outer label of the packaging, as well as the reference number of the package insert to download from the bioMérieux website.

Whether it be for the GFAP or UCH-L1 quantification, the test combines a three-step enzyme immunoassay sandwich method with a final fluorescent detection step, also known as enzyme-linked fluorescent assay (ELFA).

The Solid Phase Receptacle (SPR) serves as the solid phase as well as the pipetting device. The inner surface of the SPR is coated with antibodies aqainst the substance of interest i.e., anti-GFAP or anti-UCH-L1 antibodies. The reagent strip consists of 10 wells covered with a labeled foil seal. Well 1 is designated for the sample. Eight of the wells contain sample diluent, wash buffer, conjugate, and tracer. The last well contains the fluorescent substrate. All of the assay steps are performed automatically by the instrument.

The intensity of the fluorescence is proportional to the concentration of the analyte the sample. At the end of the assay, the biomarker concentration is automatically calculated by the instrument in relation to the calibration curve and stored in the Master Lot Entry (MLE) data.

VIDAS TBI (GFAP) and VIDAS TBI (UCH-L1) results are reported separately: the VIDAS 3 reports the calculated concentration and the qualitative interpretation for each. The final result i.e., the patient's status in relation to suspected mild traumatic brain injury, must be interpreted by the user according to the decision tree presented in the package insert.

This document describes the validation of the VIDAS® TBI (GFAP, UCH-L1) test, an automated assay for diagnosing mild traumatic brain injury. The submission compares the device to a predicate device, the BANYAN BTI™, and summarizes non-clinical and clinical testing results. The following points address the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" for each performance metric in a table format. However, it presents the results of various assays and often implies that the results "demonstrate" or "confirm" the required performance, indicating these are the achieved results compared to an internal standard or regulatory expectation. Below is a table summarizing various performance metrics and their reported results. Specific acceptance criteria values are not provided in this public summary.

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

• Test set sample size: For the diagnostic accuracy study, the sample size is not explicitly stated but refers to the "ALERT cohort." For the reference interval study, 513 apparently healthy US adult subjects were used.
• Data provenance: The diagnostic accuracy study was performed using the "ALERT cohort." The reference interval study was conducted at three sites (one internal European site and two external US sites). It is not specified whether these studies were retrospective or prospective, though "ALERT cohort" could suggest a pre-existing dataset.

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

This information is not provided in the document. The diagnostic accuracy study compares the device's results to the presence/absence of acute intracranial lesions visualized on a head CT scan, but the number or qualifications of experts interpreting these CT scans to establish ground truth are not mentioned.

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

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an in vitro diagnostic test for quantitative measurement of biomarkers, not an AI-assisted imaging device that impacts human reader performance.

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

Yes, the diagnostic accuracy study presents the standalone performance of the VIDAS® TBI (GFAP, UCH-L1) assay. The results (sensitivity, specificity, etc.) are based on the device's output compared to the ground truth (CT scan findings). The device is used "in conjunction with clinical information," but the reported diagnostic accuracy figures are for the test itself.

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

The ground truth for the diagnostic accuracy study was "absence of acute intracranial lesions visualized on a head CT scan." This indicates that CT scan results were used as the reference standard for traumatic brain injury assessment.

8. The sample size for the training set

This document describes a diagnostic device and its validation. It does not explicitly mention a "training set" in the context of machine learning or AI models with distinct training and test phases. The "test set" for diagnostic accuracy is referred to as the "ALERT cohort." The reference interval was established using 513 apparently healthy subjects.

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

As there is no explicitly defined "training set" for an AI model in this submission, the method for establishing ground truth for a training set is not applicable or described. The clinical performance data presented (Diagnostic Accuracy and Reference interval) seems to represent the evaluation of the final device.

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The i-STAT TBI test is a panel of in vitro diagnostic immunoassays for the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in whole blood and a semi-quantitative interpretation of test results derived from these measurements, using the i-STAT Alinity instrument. The interpretation of test results is used, in conjunction with other clinical information, to aid in the evaluation of patients, 18 years of age or older, presenting with suspected mild traumatic brain injury (Glasgow Coma Scale score 13-15), which may include one of the following four clinical criteria: 1) any period of loss of consciousness, 2) any loss of memory for events immediately before and after the accident, 3) any alteration in mental state at the time of accident, and/or 4) focal neurological deficits, within 24 hours of injury, to assist in determining the need for a CT (computed tomography) scan of the head. A 'Not Elevated' test interpretation is associated with the absence of acute traumatic intracranial lesions visualized on a head CT scan.

The test is to be used with venous whole blood collected with EDTA anticoagulant in point of care or clinical laboratory settings by a healthcare professional.

The i-STAT TBI cartridge is a multiplex immunoassay that contains assays for both ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP). The assays test for the presence of these biomarkers in a whole blood sample and vield a semi-quantitative test interpretation based on measurements of both UCH-L1 and GFAP in approximately 15 minutes. The i-STAT TBI cartridge is designed to be run only on the i-STAT Alinity instrument.

The i-STAT Alinity instrument is a handheld, in vitro diagnostic device. The instrument is the main user interface of the i-STAT Alinity System and functions as the electro-mechanical interface to the test cartridge. The instrument executes the test cycle, acquires and processes the electrical sensor signals converting the signals into quantitative results. These functions are controlled by a microprocessor.

The i-STAT Alinity System is comprised of the i-STAT Alinity instrument, the i-STAT test cartridges and accessories (i-STAT Alinity Base Station, Electronic Simulator and Printer).

Assaved quality control materials are also available for use with the i-STAT TBI cartridge and include i-STAT TBI Control Level 1, i-STAT TBI Control Level 2, and the i-STAT TBI Calibration Verification Levels 1-3.

The i-STAT TBI Controls are available to monitor the performance of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) assays on the i-STAT Alinity instrument.

The i-STAT TBI Calibration Verification Materials are available to verify the calibration of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) assays throughout the reportable range on the i-STAT Alinity instrument.

The provided text describes the analytical and clinical performance of the i-STAT TBI cartridge with the i-STAT Alinity System, which measures GFAP and UCH-L1 to aid in the evaluation of patients with suspected mild traumatic brain injury (TBI). The information is presented to support a 510(k) premarket notification for substantial equivalence to a predicate device.

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

1. A Table of Acceptance Criteria (Implied) and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with predefined thresholds. Instead, it describes performance characteristics that are presumably deemed acceptable for demonstrating substantial equivalence. The core clinical performance criterion for this device, a TBI assessment test, is its ability to correctly identify patients not needing a head CT scan, which translates to high sensitivity and negative predictive value (NPV) for the absence of acute intracranial lesions.

Here's a summary of the reported core performance:

Key Implied Acceptance Criteria based on Regulatory Context:

• High Clinical Sensitivity: The device must reliably identify patients with acute intracranial lesions, minimizing false negatives to ensure patient safety and avoid missing critical injuries. A 96.5% sensitivity is presented as acceptable.
• High Negative Predictive Value (NPV): Crucially, the device's main utility is to aid in determining the need for a CT scan. A high NPV means that a "Not Elevated" result reliably indicates the absence of acute traumatic intracranial lesions. The 96.5% NPV (and higher adjusted NPV) supports this.
• Acceptable False Negative Rate: The reported 3.5% false negative rate, with the additional detail that "None of these ten (10) subjects with false negative results required surgical intervention related to their head injury as no neurosurgical lesions were identified by CT scan in these subjects," addresses a critical safety aspect.
• Analytical Performance: The document provides extensive data on analytical precision (semi-quantitative and qualitative, 20-day and multi-site), linearity, hook effect, traceability, reference interval, detection limit, analytical specificity (interference, cross-reactivity, cross-talk), and hematocrit sensitivity. These are all standard analytical performance characteristics that would need to meet predefined criteria (often internal to the manufacturer or based on regulatory guidance) to ensure the assay's reliability and robustness. While specific numerical acceptance criteria for each are not stated (e.g., "CV must be

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The TBI test is a panel of in vitro diagnostic chemiluminescent microparticle immunoassays (CMIA) used for the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in human plasma and serum and provides a semi-quantitative interpretation of test results derived from these measurements using the ARCHITECT i1000SR System.

The interpretation of test results is used, in conjunction with other clinical information, to aid in the evaluation of patients, 18 years of age or older, presenting with suspected mild traumatic brain injury (Glasgow Coma Scale score 13-15) within 12 hours of injury, to assist in determining the need for a CT (computed tomography) scan of the head. A negative test result is associated with the absence of acute intracranial lesions visualized on a head CT scan.

The TBI test is intended for use in clinical laboratory settings by healthcare professionals.

The TBI test is a panel of in vitro diagnostic quantitative measurements of GFAP and UCH-L1 and provides a semi-quantitative interpretation of GFAP and UCH-L1 in human plasma and serum.

GFAP: This assay is an automated, two-step immunoassay for the quantitative measurement of GFAP in human plasma and serum using chemiluminescent microparticle immunoassay (CMIA) technology.

UCH-L1: This assay is an automated, two-step immunoassay for the quantitative measurement of UCH-L1 in human plasma and serum using CMIA technology.

Interpretation of Results: The assay cutoffs were established to be 35.0 pg/mL (35.0 ng/L) for GFAP and 400.0 pg/mL (400.0 ng/L) for UCH-L1. The GFAP and UCH-L1 results are reported separately and the software provides a TBI interpretation relative to the respective cutoff values.

The provided text describes the TBI (Traumatic Brain Injury) test, an in vitro diagnostic device, and its performance evaluation for the ARCHITECT i1000SR system. The submission is a 510(k) for substantial equivalence to a predicate device (TBI on the Alinity i system).

Here's an analysis of the acceptance criteria and study as per your request, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" in the format of specific thresholds for the performance metrics. Instead, it states that the device "met the pre-defined product requirements for all characteristics evaluated in the verification studies." The performance metrics reported are for precision (20-Day and Reproducibility), Limits of Blank (LoB), Detection (LoD), Quantitation (LoQ), and Linearity, along with a comparison summary using Passing-Bablok regression against the predicate device.

Table of Reported Device Performance (Implied Acceptance through Meeting Requirements):

Study Details:

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

   • Test Set (Method Comparison): N=123 for both GFAP and UCH-L1 assays in the comparison study against the predicate device.
   • Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It refers to "verification studies" and "studies were performed based on guidance from CLSI EP09c, 3rd ed." These are typically laboratory-based analytical performance studies. The clinical utility of the test (used to aid in evaluation of patients with suspected mild TBI to determine need for CT scan) suggests that patient samples were likely used for the comparison study, but details about their collection (retrospective/prospective, patient demographics, clinical context) are not provided in this summary.

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 and not provided in the document. The TBI test is an in vitro diagnostic (IVD) quantitative measurement of biomarkers (GFAP and UCH-L1). The "ground truth" for its performance is established by comparison to a legally marketed predicate device (K223602, TBI for Alinity i) and internal analytical performance studies using known concentrations or reference methods. The "interpretation of test results" for the TBI test (positive/negative) is based on established cutoff values for GFAP and UCH-L1, which are compared to CT scan results (absence of acute intracranial lesions). There is no mention of human experts directly establishing "ground truth" for the device's output itself in this context.

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

   • Not applicable. This is an IVD device measuring biomarkers. Adjudication methods like 2+1 or 3+1 are typically used in image-based diagnostic studies where human readers interpret images, and consensus is sometimes needed to establish ground truth or resolve discrepancies.

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 an in vitro diagnostic (IVD) test, not an AI-assisted imaging device that impacts human reader performance. Therefore, an MRMC study and effect size on human readers are not applicable.

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

   • Yes, in a sense. The TBI test is a standalone device (a panel of immunoassays interpreted by defined cutoffs). Its performance is evaluated analytically (precision, linearity, LoD/LoQ) and by direct comparison of its measurements to those of a predicate device, which is also a standalone IVD. The interpretation of the test results (positive/negative) is an automated process based on the measured biomarker levels and predefined cutoffs. While the "interpretation of test results is used, in conjunction with other clinical information, to aid in the evaluation of patients... to assist in determining the need for a CT (computed tomography) scan," the device itself provides the result as an algorithm-driven interpretation (based on raw measurement data).

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

   • For the quantitative measurements (GFAP, UCH-L1), the "ground truth" in the comparative study is the performance of the legally marketed predicate device (TBI on Alinity i system, K223602). Analytical performance metrics (LoB, LoD, LoQ, linearity, precision) are established using reference materials or samples with known or characterized concentrations.
   • For the clinical context of determining the "need for a CT scan of the head," the ground truth stated for a negative test result is its association with "the absence of acute intracranial lesions visualized on a head CT scan." This implies that CT scan findings serve as the clinical ground truth for evaluating the negative predictive value of the test, though this specific performance characteristic is not detailed in the provided summary. For the positive result, the test aids in determining the need for a CT scan, but the summary doesn't explicitly state the ground truth for a positive result (e.g., presence of lesions, clinical outcome).

7. The sample size for the training set:

   • No information about a "training set" is provided. This is an IVD device based on established immunoassay technology and predefined cutoffs, not a machine learning or AI algorithm that typically requires a distinct training phase with labeled data. The cutoffs (35.0 pg/mL for GFAP and 400.0 pg/mL for UCH-L1) are stated as "established," but the method and data used for their establishment are not described in this summary.

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

   • Not applicable as no "training set" is mentioned in the context of this 510(k) summary.

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The TBI test is a panel of in vitro diagnostic chemiluminescent microparticle immunoassays (CMIA) used for the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in human plasma and serum and provides a semi-quantitative interpretation of test results derived from these measurements using the Alinity i system.

The interpretation of test results is used, in conjunction with other clinical information, to aid in the evaluation of patients, 18 years of age or older, presenting with suspected mild traumatic brain injury (Glasgow Coma Scale score 13-15) within 12 hours of injury, to assist in determining the need for a CT (computed tomography) scan of the head. A negative test result is associated with the absence of acute intracranial lesions visualized on a head CT scan.

The TBI test is intended for use in clinical laboratory settings by healthcare professionals.

The TBI test is a panel of in vitro diagnostic quantitative measurements of GFAP and UCH-L1 and provides a semi-quantitative interpretation of GFAP and UCH-L1 in human plasma and serum.

The GFAP assay (subject device) is an automated immunoassay for the quantitative measurement of GFAP in plasma and serum using chemiluminescent microparticle immunoassay (CMIA) technology on the Alinity i system.

The UCH-L1 assay (subject device) is an automated immunoassay for the quantitative measurement of UCH-L1 in plasma and serum using chemiluminescent microparticle immunoassay (CMIA) technology on the Alinity i system.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Abbott Laboratories TBI test:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the TBI test are implicitly defined by the clinical performance observed in the pivotal study, particularly regarding its ability to aid in determining the need for a head CT scan in patients with suspected mild TBI. The key performance metrics are Sensitivity and Negative Predictive Value (NPV) as these are critical for a rule-out test for a serious condition like intracranial lesions.

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The i-STAT TBI Plasma test is a panel of in vitro diagnostic immunoassays for the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in plasma and a semiquantitative interpretation of test results derived from these measurements, using the i-STAT Alinity Instrument. The interpretation of test results is used, in conjunction with other clinical information, to aid in the evaluation of patients, 18 years of age or older, presenting with suspected mild traumatic brain injury (Glasgow Coma Scale score 13-15) within 12 hours of injury, to assist in determining the need for a CT (computed tomography) scan of the head. A 'Not Elevated' test interpretation is associated with the absence of acute traumatic intracranial lesions visualized on a head CT scan.

The test is to be used with plasma prepared from EDTA anticoagulated specimens in clinical laboratory settings by a healthcare professional. The i-STAT TBI Plasma test is not intended to be used in point of care settings.

The i-STAT TBI Plasma cartridge is a multiplex immunoassay that contains assays for both ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP). The assays test for the presence of these biomarkers in a plasma sample and yield a semi-quantitative test interpretation based on measurements of both UCH-L1 and GFAP in approximately 15 minutes. The i-STAT TBI Plasma cartridge is designed to be run only on the i-STAT Alinity instrument.

The i-STAT Alinity instrument is a handheld, in vitro diagnostic device designed to run only i-STAT test cartridges. The instrument is the main user interface of the i-STAT System and functions as the electro-mechanical interface to the test cartridge. The instrument executes the test cycle, acquires and processes the electrical sensor signals converting the signals into quantitative results. These functions are controlled by a microprocessor.

The i-STAT Alinity System is comprised of the i-STAT Alinity instrument, the i-STAT test cartridges and accessories (i-STAT Alinity Base Station, Electronic Simulator and Printer).

Here's a breakdown of the acceptance criteria and study information for the i-STAT TBI Plasma cartridge with the i-STAT Alinity System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in a table format. However, it presents clinical performance parameters for sensitivity, specificity, and negative predictive value (NPV). The implied "acceptance criteria" are derived from comparison to the predicate device and the clinical utility for reducing unnecessary CT scans.

Note: The document explicitly states that the device was deemed "substantially equivalent" to the predicate, and a "benefit-risk assessment was performed," suggesting that the performance metrics achieved were considered acceptable for its intended use and comparative to the existing predicate.

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

• Pivotal Study:
  • Sample Size: 1901 subjects (120 with positive CT, 1781 with negative CT).
  • Data Provenance: Prospectively collected and archived (frozen) plasma specimens. Subjects enrolled at 22 clinical sites in three countries: United States, Germany, and Hungary.
• Supplemental Fresh Specimen Study:
  • Sample Size: 88 subjects (29 with positive CT, 59 with negative CT).
  • Data Provenance: Freshly collected plasma specimens. Subjects enrolled across 4 clinical sites of the TRACK-TBI study in the United States.

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

• Number of Experts: At least two neuroradiologists, with a third neuroradiologist for adjudication if necessary.
• Qualifications of Experts: Neuroradiologists (specific years of experience or subspecialty certification not detailed, but implied by the term "neuroradiologist").

4. Adjudication Method for the Test Set

The adjudication method used was consensus interpretation between two neuroradiologists, with adjudication by a third neuroradiologist if necessary. This is commonly referred to as a "2+1" or "multiple reader, with adjudication" method.

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

No, an MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not described in this document. The clinical studies focused on the standalone diagnostic performance of the device itself (i-STAT TBI Plasma test interpretation) against a CT scan ground truth, not on evaluating human reader performance with or without the device. The device's output is an "interpretation of test results...to aid in the evaluation of patients...to assist in determining the need for a CT scan," suggesting it's designed to be used by a healthcare professional as an aid, but the study design doesn't directly measure the improvement of human readers through its use.

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

Yes, the clinical studies presented here (Pivotal and Supplemental) are effectively standalone performance studies for the i-STAT TBI Plasma test. The results (sensitivity, specificity, NPV) are reported for the device's interpretation ("Elevated" or "Not Elevated") directly against the CT scan ground truth, without measuring the impact of a human healthcare professional's subsequent decision-making. The device provides "a semiquantitative interpretation of test results derived from these measurements," which is then used "in conjunction with other clinical information, to aid in the evaluation of patients...to assist in determining the need for a CT scan." So, while it's an aid to a human, the performance metrics reported are for the device's output itself.

7. The Type of Ground Truth Used

The primary ground truth used for the clinical studies was the presence or absence of acute traumatic intracranial lesions visualized on a head CT (Computed Tomography) scan. This ground truth was established by consensus interpretation of neuroradiologists.

8. The Sample Size for the Training Set

• Assay Cutoff Determination: A training set of 420 subjects (274 males and 146 females) with suspected mild TBI was used to determine the assay cutoffs for GFAP and UCH-L1.

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

For the 420 subjects in the training set used to establish assay cutoffs:

• Subjects had suspected mild traumatic brain injury (Glasgow Coma Scale score of 13-15).
• Blood was drawn within 12 hours of injury.
• A head CT scan determination was performed.
• The ground truth would have been established by the head CT scan results (presence or absence of acute traumatic intracranial lesions), similar to the clinical study's ground truth, though the specific process of expert review for these 420 cases is not detailed beyond "head CT scan determination." It's reasonable to infer a similar process of expert radiologist interpretation.

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The Banyan BTI is an in vitro diagnostic chemiluminescent enzyme-linked immunosorbent assay (ELISA). The assay provides a semi-quantitative measurement of the concentrations of ubiquitin C-terminal hydrolase-L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) in human serum, and is used with the Synergy 2 Multi-mode Reader.

The assay results obtained from serum collected within 12 hours of suspected head injury are used, along with other available clinical information, to aid in the evaluation of patients 18 years of age and older with suspected traumatic brain injury (Glasgow Coma Scale score 13-15). A negative assay result is associated with the absence of acute intracranial lesions visualized on a head CT (computed tomography) scan.

The Banyan BTI is for prescription use only.

The Banyan BTI consists of two kits, one for the UCH-L1 assay components and one for GFAP assay components. Each kit is packaged individually in a box and consists of the following: 96-well microtiter strip plate, each well coated with mouse monoclonal UCH-L1 antibody or mouse monoclonal GFAP capture antibody (1 plate); UCH-L1 or GFAP calibrators (1 vial); UCH-L1 or GFAP calibrator diluent (1 vial, 4 mL); UCH-L1 or GFAP control 1 (1 vial); UCH-L1 or GFAP control 2 (1 vial); mouse monoclonal UCH-L1 or mouse monoclonal GFAP detection antibody (1 vial, 0.23 mL); UCH-L1 or GFAP detection antibody diluent (2 vials, 6.5 mL per vial for UCH-L1 or 1 vial, 14 mL for GFAP); ready-to-use assay diluent (2 vials, 5 mL per vial for UCH-L1 or 1 vial, 10 mL for GFAP), chemiluminescent substrate solution A (2 vials, 4.5 mL per vial) and solution B (2 vials, 4.5 mL per vial); a wash tablet and four adhesive plate seals. Components within the same kit are intended to be used together. In each kit, sufficient quantities of each component are provided to test samples from up to 30 patients. Each kit is stored at 2°C to 8°C until ready for use.

Here's an analysis of the Banyan Brain Trauma Indicator (BTI) based on the provided document, addressing each of your points:

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

The document doesn't explicitly state "acceptance criteria" in a single table with performance targets. Instead, it describes various performance evaluations and their results, implying that the observed performance met the manufacturer's pre-determined acceptance criteria (as stated under "Analytical performance: All results met the manufacturer's pre-determined acceptance criteria.").

However, we can infer some key acceptance criteria for clinical performance based on the discussion of clinical validity and Special Controls. The FDA's classification specifies that the device must demonstrate clinical sensitivity and specificity, and positive and negative predictive value.

Here's a table summarizing the clinical performance and related analytical performance highlights:

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