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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 Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma. Measurement of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Total Bilirubin is an in vitro diagnostic assay for the quantitative determination of total bilirubin in human serum or plasma. The Total Bilirubin assay is a clinical chemistry assay in which the conjugated bilirubin is oxidized to biliverdin. The resulting decrease in absorbance at 444 nm is directly proportional to the concentration of total bilirubin.

The provided 510(k) summary describes the Abbott Laboratories TBil (Total Bilirubin) assay, an in vitro diagnostic device for the quantitative determination of total bilirubin in human serum or plasma.

This submission is a traditional 510(k) for a new device, not an AI/ML powered device. The document explicitly states that the device is an in vitro diagnostic assay and describes its chemical principle (oxidation of conjugated bilirubin to biliverdin). Therefore, many of the questions regarding AI/ML device validation (e.g., sample sizes for test/training sets, number of experts, adjudication methods) are not applicable.

Here's an analysis of the provided information, focusing on the relevant acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

A "comparative performance study" was conducted using the Abbott AEROSET™ System. This study compared the performance of the Abbott TBil assay with the predicate device, the Total Bilirubin on the Johnson & Johnson Vitros™ System. The results, as presented in the table above, demonstrated "acceptable correlation" and other performance characteristics, leading to the conclusion of "substantial equivalence."

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not explicitly state the sample size used for the comparative performance studies (method comparison or precision studies).
• Data Provenance: The document does not specify the country of origin of the data. It implies the studies were conducted by Abbott Laboratories. The studies appear to be prospective in nature, as they involve actively "conducting" comparative performance studies and precision studies for the new device.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This is an in vitro diagnostic assay based on a chemical reaction, not an AI/ML device relying on expert image or data interpretation. Therefore, the concept of "experts establishing ground truth" in the context of clinical interpretation is not applicable. The "ground truth" for method comparison would be the results obtained from the predicate device (Johnson & Johnson Vitros™ System), which is also a quantitative measurement system.

4. Adjudication Method for the Test Set

As this is a quantitative chemical assay and not an AI/ML device with subjective interpretations, adjudication methods are not applicable. The comparison is based on numerical agreement between the new device and the predicate device.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human readers in interpreting complex data (e.g., medical images). The Abbott TBil assay is an automated in vitro diagnostic assay that provides a quantitative measurement.

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

The device is an automated in vitro diagnostic assay. Its performance, as described by linearity, sensitivity, and precision, represents its standalone performance without human interpretation in the loop beyond operating the instrument and collecting the sample. The "method comparison" also evaluates its standalone performance against another standalone device.

7. The Type of Ground Truth Used

The "ground truth" for the method comparison was the quantitative measurements obtained from the legally marketed predicate device (Johnson & Johnson Vitros™ System for Total Bilirubin). For precision, the ground truth refers to the intrinsic variability of the assay itself, demonstrating reproducibility around a given (control) concentration.

8. The Sample Size for the Training Set

This is an in vitro diagnostic assay that performs a chemical reaction, not an AI/ML device that requires a training set. Therefore, the concept of a "training set" in the context of machine learning is not applicable.

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

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

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The TBird Homecare ventilator is intended to provide continuous or intermittent mechanical ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lbs.), who require the following general types of ventilatory support, as prescribed by an attending physician:

• Positive pressure ventilation .
• . Assist/Control, SIMV, CPAP modes of ventilation

The ventilator is suitable for use in institutional and home settings.

The TBird Homecare ventilator employs a revolutionary turbine gas delivery system along with sophisticated microprocessor control to provide support for pediatric to adult patients. Capable of delivering clinically advanced modes of ventilation like Pressure Support with an internal battery or AC power the TBird Homecare has an extensive patient range.

Here's an analysis of the provided text regarding the TBird Homecare Volume Ventilator, focusing on acceptance criteria and supporting studies:

It is important to note that the provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive, detailed clinical study results in the same way a PMA (Premarket Approval) submission would. As such, direct "acceptance criteria" and detailed "study" information as one might expect for a new, novel device might not be explicitly present in this format. The "study" here largely refers to the verification testing against standards.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Study Details

Given that this is a 510(k) for a modification (intended use for home care) and claims substantial equivalence, the "study" described is primarily verification testing against recognized standards and comparison to predicate devices, rather than a clinical trial.

2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of patient data or clinical samples. Instead, it refers to performance testing of the device itself.

• Sample Size: Not applicable in the context of patient data for this type of submission. Performance testing would involve multiple runs and measurements on the device, but specific numbers are not provided.
• Data Provenance: The device "has been verified to meet the requirements of ASTM F1246 (1991)." This implies engineering and bench testing data, rather than clinical data from a specific country. This type of data is internal to the manufacturer's testing and development process. It is "prospective" in the sense that the device was designed and tested to meet these standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of submission. The "ground truth" for verifying a device against a standard like ASTM F1246 is the standard itself and the objective measurements performed by engineers and technicians during verification testing. There were no "experts" establishing ground truth in the sense of clinical consensus on patient cases.

4. Adjudication Method for the Test Set
Not applicable. There was no clinical "test set" 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 ventilator, not an imaging or diagnostic device that would typically involve "human readers" or "AI assistance" in the way implied by an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, a ventilator, which inherently has human interaction (healthcare provider setting parameters, patient use). The "standalone" performance here refers to the device's ability to meet its technical specifications independently, which is covered by the performance testing against standards.

7. The Type of Ground Truth Used
The "ground truth" for the device's performance is derived from:

• Technical Specifications and Design Requirements: The device was designed to achieve certain measurable performance characteristics (e.g., flow rates, pressure control, alarm ranges, battery life).
• Recognized Standards: ASTM F1246 (1991) served as a primary ground truth for homecare ventilator requirements.
• Predicate Device Performance: The functional capabilities and safety profiles of the already marketed TBird VS, Aequitron LP10, and Bear 33 Volume Ventilators served as benchmarks for demonstrating substantial equivalence.

8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm trained on data in the modern sense. The "training" for the device's control system would be the engineering design and software development, refined through iterative testing and calibration.

9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no "training set" in the context of AI/ML. The "ground truth" for the ventilator's functional design and control algorithms would have been established through:

• Physiological Principles: Understanding of respiratory mechanics, gas exchange, and patient ventilation needs.
• Engineering Principles: Control theory, fluid dynamics, electrical engineering, materials science, and software development best practices.
• Clinical Requirements and Standards of Care: How ventilators are used clinically and the parameters necessary for effective and safe patient support. This informs the algorithms and control logic.

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The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Total Bilirubin is an in vitro diagnostic assay for the quantitative determination of Total Bilirubin in human serum or plasma. The Total Bilirubin assay is a clinical chemistry assay in which the analyte in the sample reacts with diazotised sulphanilic acid to produce an acid azobilirubin, the absorbance of which is proportional to the concentration of bilirubin in the sample.

The information provided describes the performance of the Abbott Laboratories TBil (Total Bilirubin) assay. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" with predefined thresholds for each performance characteristic. Instead, it demonstrates substantial equivalence to a predicate device (Roche® Cobas Mira® Plus Automated Chemistry System Total Bilirubin assay) by showing comparable performance. The reported performance metrics are presented below:

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

The document does not explicitly state the sample size used for the comparative performance studies (method comparison and precision studies). It mentions that "comparative performance studies were conducted using the ALCYON™ Analyzer" and "precision studies were conducted using the Total Bilirubin assay... using two levels of control material."

• Sample Size: Not explicitly stated for specific studies.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). However, the study focuses on the analytical performance of the device in a laboratory setting.

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

This type of information is not relevant or provided for this device. The device is an in vitro diagnostic assay for quantitative determination of a chemical analyte (Total Bilirubin). The ground truth for such devices is established by comparing the device's measurements to a reference method or validated predicate device, not by expert interpretation of images or clinical cases.

4. Adjudication Method for the Test Set

Not applicable. As mentioned above, this is an in vitro diagnostic assay, not a subjective diagnostic interpretation. The comparison is objective, based on measured values and statistical correlation.

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 an automated in vitro diagnostic assay for chemical analysis, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.

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

Yes, in essence. The studies described are of the device's standalone analytical performance. The "comparative performance studies" and "precision studies" evaluate the assay itself, operating as an algorithm within the ALCYON™ Analyzer, comparing its output to a predicate device and assessing its inherent variability and limits. There is no human-in-the-loop component in the direct measurement and quantification of bilirubin by the device.

7. The Type of Ground Truth Used

The "ground truth" for this in vitro diagnostic assay is implicitly the measurements obtained from the Roche Cobas Mira Plus Automated Chemistry System Total Bilirubin assay (K910591), which served as the predicate device. The performance of the new device (TBil) was compared against this established method.

8. The Sample Size for the Training Set

Not applicable/provided. This device is a traditional chemical assay, not a machine learning or AI algorithm that requires a "training set" in the computational learning sense. The assay's parameters would have been developed and optimized based on chemical principles and validation studies, not through a data-driven training process as typically understood for AI.

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

Not applicable. As explained in point 8, there is no "training set" in the context of this traditional in vitro diagnostic assay.

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The TBI Stand is used to safely support and reposition a patient for radiation therapy treatment in the vertical (standing) position when a physician desires to treat the patient with whole body irradiation by high energy photons or electrons, usually from a medical electron accelerator. At times, the physician utilizes the optional Scatter Screen to increase the surface dose to the patient during photon treatment.

The TBI Stand is used to safely support and reposition a patient for radiation therapy treatment in the vertical (standing) position when physician desires to treat the patient with whole body irradiation by high energy photons or electrons, usually from a medical electron accelerator. At times, the physicians utilizes the optional Scatter Screen to increase the surface dose to the patient during photon treatment.

The provided document describes a 510(k) premarket notification for a medical device called the "TBI Stand." This type of submission is for demonstrating substantial equivalence to a predicate device, not for establishing novel clinical performance through acceptance criteria and a detailed study.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert involvement, adjudication, MRMC study, standalone performance, ground truth, training set), and effect size cannot be extracted from this document, as these concepts are not applicable to a 510(k) substantial equivalence submission for the TBI Stand.

The document focuses on comparing the TBI Stand's technological characteristics to a legally marketed predicate device (MED-TEC Radio Therapy Treatment Chair K951947) to demonstrate that it is substantially equivalent and thus safe and effective for its intended use.

Here's a breakdown of what can be extracted related to the device and its comparison:

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

Instead of "acceptance criteria," the document provides a "Predicate Comparison Table" which lists technological characteristics of both the predicate device and the TBI Stand. The "reported device performance" in this context is how the TBI Stand meets or exceeds these characteristics compared to the predicate.

Summary of why the other points cannot be answered:

• 2. Sample size used for the test set and the data provenance: Not applicable. This is a comparison of design and features, not a performance study involving a test set of data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established by experts for a test set in this context.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set adjudication occurred.
• 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 physical stand, not an AI or imaging diagnostic device that would involve human readers or AI assistance.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical device, not an algorithm.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a 510(k) of this nature is the established performance and safety of the predicate device, against which the new device's characteristics are compared.
• 8. The sample size for the training set: Not applicable. No training set is involved for this type of device submission.
• 9. How the ground truth for the training set was established: Not applicable, as there is no training set.

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