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InVision Precision Cardiac Amyloid is an automated machine learning-based decision support system, indicated as a screening tool for adult patients aged 65 years and over undergoing cardiovascular assessment using echocardiography.

When utilized by an interpreting physician, this device provides information alerting the physician for referral to confirmatory investigations.

InVision Precision Cardiac Amyloid is indicated in adult populations over 65 years of age. Patient management decisions should not be made solely on the results of the InVision Precision Cardiac Amyloid.

The InVision Precision Cardiac Amyloid (InVision PCA) is a Software as a Medical Device (SaMD) machine-learning screening algorithm to identify high suspicion of cardiac amyloidosis from routinely obtained echocardiogram videos. The device assists clinicians in the diagnosis of cardiac amyloidosis.

The InVision PCA algorithm uses a machine learning process to identify the presence of cardiac amyloidosis. The device inputs images and videos from echocardiogram studies, and it outputs a report suggestive or not suggestive of cardiac amyloidosis.

The device has no physical form and is installed as a third-party application to an institution's PACS system.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) clearance letter:

InVision Precision Cardiac Amyloid: Acceptance Criteria and Performance Study

InVision Precision Cardiac Amyloid (InVision PCA) is a Software as a Medical Device (SaMD) machine-learning screening algorithm developed to identify a high suspicion of cardiac amyloidosis from routinely obtained echocardiogram videos. It acts as a decision support system, alerting interpreting physicians for referral to confirmatory investigations for adult patients aged 65 years and over undergoing cardiovascular assessment using echocardiography.

The device's performance was validated through a comprehensive study, demonstrating its substantial equivalence to the predicate device.

1. Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the InVision PCA device were established based on its ability to reliably screen for cardiac amyloidosis. The reported performance metrics from the validation study are as follows:

Note: While specific numerical acceptance thresholds are not explicitly stated as "passing" values (e.g., "must achieve >X% sensitivity"), these reported values are presented as the results that successfully met the predefined endpoints of the validation study, implying they satisfied the implicit acceptance criteria deemed necessary for clearance.

2. Sample Size and Data Provenance for Test Set

• Sample Size: 1221 unique echocardiogram studies.
• Data Provenance: The data were selected from three geographically different U.S. sites. The study was conducted on "previously acquired" images, indicating it was a retrospective study.

3. Number of Experts and Qualifications for Ground Truth

The provided document does not explicitly state the number of experts used to establish the ground truth nor their specific qualifications. It mentions "confirmatory reference data," which could imply a consensus of expert opinion but does not detail the process.

4. Adjudication Method for Test Set

The document does not explicitly state the adjudication method used (e.g., 2+1, 3+1). It refers to the ground truth being established by "confirmatory reference data, such as diagnostic imaging or pathology," suggesting a definitive diagnostic pathway rather than a multi-reader visual interpretation adjudication.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was explicitly described in the provided text, meaning there is no information on how much human readers improve with AI vs. without AI assistance. The study focused on the standalone performance of the AI model.

6. Standalone (Algorithm Only) Performance

Yes, a standalone (algorithm only) performance study was conducted. The reported sensitivity of 0.607 and specificity of 0.990 are directly attributable to the InVision PCA algorithm's performance in analyzing echocardiogram studies against confirmed ground truth.

7. Type of Ground Truth Used

The ground truth for the test set was established using confirmatory reference data, such as diagnostic imaging or pathology. This indicates a high-fidelity ground truth derived from definitive diagnostic procedures rather than solely expert consensus on images.

8. Sample Size for Training Set

The document does not specify the sample size used for the training set. It only details the sample size for the validation/test set.

9. How Ground Truth for Training Set Was Established

The document does not explicitly state how the ground truth for the training set was established. It is assumed that similar rigorous methods involving confirmatory diagnostic imaging or pathology would have been used for the training data, consistent with the approach for the test set, but this is not directly mentioned.

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The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio is an in vitro test using human plasma (K2EDTA) that combines the results of Lumipulse G pTau 217 Plasma and Lumipulse G β-Amyloid 1-42-N Plasma assays into a ratio of pTau 217 to β-Amyloid 1-42 concentrations using the LUMIPULSE G1200 System.

The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio is intended to aid healthcare providers to identify patients with amyloid pathology associated with Alzheimer's disease.

The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio is indicated for adult patients, aged 50 years and older, presenting at a specialized care setting with signs and symptoms of cognitive decline.

A test result ≤ 0.00370 is a negative result which is consistent with patients who are unlikely to have amyloid pathology. These patients should be investigated for other causes of cognitive decline.

A test result ≥ 0.00738 is a positive result which is consistent with patients who are likely to have amyloid pathology. This result does not establish a diagnosis of Alzheimer's disease or other cognitive disorders.

A test result between 0.00371 and 0.00737 is an indeterminate result which is consistent with patients who are uncertain to have amyloid pathology. These patients should be considered for further testing.

The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio results must be interpreted in conjunction with other patient clinical information.

This test is not intended as a screening or stand-alone diagnostic test.

The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio is a test that combines the test results of the Lumipulse G pTau 217 Plasma assay and Lumipulse G β-Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio from 0.00000 – 1.00000. The numerical ratio will be compared to the established cutoffs.

Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio = Lumipulse G pTau 217 Plasma (results in pg/mL) / Lumipulse G β-Amyloid 1-42-N Plasma (results in pg/mL) = a numerical value targeted up to 1.00000.

The Lumipulse G pTau 217 Plasma and Lumipulse G β-Amyloid 1-42-N Plasma are assay systems including a set of immunoassay reagents for the quantitative measurement of pTau 217 and β-amyloid1-42, respectively, in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology. The LUMIPULSE G1200 is an instrument platform that can perform automated chemiluminescence immunoassays of specimens using LUMIPULSE G reagents. The LUMIPULSE G1200 reports the results of the two individual assays separately, and the ratio calculation must be done manually by the operator.

This document describes the acceptance criteria and the study proving the device meets those criteria, based on the provided FDA 510(k) Clearance Letter for the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test.

Acceptance Criteria and Device Performance Study for Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio

The Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic test intended to aid healthcare providers in identifying patients with amyloid pathology associated with Alzheimer's disease. The FDA 510(k) clearance letter details various performance characteristics and clinical study results that demonstrate the device meets its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is primarily evaluated against its ability to classify patients into "Positive," "Indeterminate," and "Negative" categories based on their Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio, correlated with amyloid pathology confirmed by PET imaging or CSF testing.

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EchoGo Amyloidosis 1.0 is an automated machine learning-based decision support system, indicated as a screening tool for adult patients aged 65 years and over with heart failure undergoing cardiovascular assessment using echocardiography.

When utilised by an interpreting physician, this device provides information alerting the physician for referral to confirmatory investigations.

EchoGo Amyloidosis 1.0 is indicated in adult patients aged 65 years and over with heart failure. Patient management decisions should not be made solely on the results of the EchoGo Amyloidosis 1.0 analysis.

EchoGo Amyloidosis 1.0 takes a 2D echocardiogram of an apical four chamber (A4C) as its input and reports as an output a binary classification decision suggestive of the presence of Cardiac Amyloidosis (CA).

The binary classification decision is derived from an AI algorithm developed using a convolutional neural network that was pre-trained on a large dataset of cases and controls.

The A4C echocardiogram should be acquired without contrast and contain at least one full cardiac cycle. Independent training, tune and test datasets were used for training and performance assessment of the device.

EchoGo Amyloidosis 1.0 is fully automated without a graphical user interface.

The ultimate diagnostic decision remains the responsibility of the interpreting clinician using patient presentation, medical history, and the results of available diagnostic tests, one of which may be EchoGo Amyloidosis 1.0.

EchoGo Amyloidosis 1.0 is a prescription only device.

The provided text describes the acceptance criteria and a study proving that the EchoGo Amyloidosis 1.0 device meets these criteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as clear, quantitative thresholds in a "table" format within the provided text. Instead, the document describes the study that was conducted to demonstrate performance against generally accepted metrics for such devices (e.g., sensitivity, specificity, PPP, NPV, repeatability, reproducibility).

However, based on the results presented in the "10.2 Essential Performance" and "10.4 Precision" sections, we can infer the achieved performance metrics. The text states: "All measurements produced by EchoGo Amyloidosis 1.0 were deemed to be substantially equivalent to the predicate device and met pre-specified levels of performance." It does not, however, explicitly list those "pre-specified levels."

Here's a table summarizing the reported device performance:

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

• Test Set Sample Size: 1,164 patients
  • 749 controls
  • 415 cases
• Data Provenance: Retrospective case:control study, collected from multiple sites spanning nine states in the USA. The data also included some "Non-USA" origin (as seen in the subgroup analysis table, but the overall testing data seems to be primarily US-based based on the description).

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

The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologists with X years of experience) used to establish the ground truth for the test set. It mentions that clinical validation was conducted to "assess agreement with reference ground truth" but does not detail how this ground truth was derived or by whom.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) used for the test set's ground truth establishment.

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

No, the document does not describe an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. The study described is a standalone performance validation of the algorithm against a defined ground truth.

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

Yes, a standalone performance study was done. The results presented (sensitivity, specificity, PPV, NPV) are for the algorithm's performance without a human-in-the-loop. The device is described as "fully automated without a graphical user interface" and is a "decision support system" that "provides information alerting the physician for referral." The performance metrics provided are directly from the algorithm's output compared to ground truth.

7. The Type of Ground Truth Used

The document states: "The clinical validation study was used to demonstrate consistency of the device output as well as to assess agreement with reference ground truth." However, it does not specify the nature of this "reference ground truth" (e.g., expert consensus, pathology, outcomes data).

8. The Sample Size for the Training Set

The training data characteristics table shows the following sample sizes:

• Controls: 1,262 (sum of age categories: 118+197+337+388+222)
• Cases: 1,302 (sum of age categories: 122+206+356+389+229)
• Total Training Set Sample Size: 2,564 patients

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

The document states: "The binary classification decision is derived from an AI algorithm developed using a convolutional neural network that was pre-trained on a large dataset of cases and controls." It mentions that "Algorithm training data was collected from collaborating centres." However, it does not explicitly describe how the ground truth labels (cases/controls) for the training set were established. It is implied that these were clinically confirmed diagnoses of cardiac amyloidosis (cases) and non-amyloidosis (controls), but the method (e.g., biopsy, clinical diagnosis based on multiple tests, expert review) is not detailed.

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Amydi-med Disposable Non-invasive EEG Sensor is applied directly to an adults/pediatrics patient's skin to record physiological signals (e.g., the electroencephalogram, EEG) in the healthcare facility / hospital.

Amydi-med Disposable Non-invasive EEG Sensor is a low impedance, single patient use, disposable, non-sterile provided sensor that is designed for application to the sites including forehead, temporal, above eyebrow, and mastoid process. It is designed to provide ease of use and accurate electrode placement.

The main components of this sensor are the flexible PCB with electrodes, polyethylene base pad with medical grade pressure sensitive adhesive on its double sides, nylon plastic tine disks, polyurethane foam disks, aqueous gel ( , and cable connector. Each sensor has three (3) to six (6) electrodes on the flexible PCB for different application sites.

The provided text describes the 510(k) summary for the Amydi-med Disposable Non-invasive EEG Sensor (K240668), focusing on its substantial equivalence to a predicate device (K220448). The document highlights performance data for safety and electrical characteristics.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the test sets in the biocompatibility, electrical, adhesive, or shelf-life testing. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective.

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 section is not applicable as the device is a medical sensor (hardware) undergoing performance and safety testing, not an AI/software device requiring expert consensus for ground truth establishment.

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

This section is not applicable for the type of device and testing described. Adjudication methods are typically relevant for studies involving human interpretation or assessments where discrepancies need resolution.

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 done. This type of study is relevant for AI-powered diagnostic or interpretive tools, not for a disposable non-invasive EEG sensor.

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

A standalone performance evaluation (algorithm only) was not done. This refers to AI algorithm performance without human intervention, which is not applicable to a physical medical device like an EEG sensor.

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

The concept of "ground truth" as typically applied to AI/diagnostic studies is not directly applicable here. For hardware testing:

• Biocompatibility: Ground truth is established by the specified standards (e.g., cell viability for cytotoxicity, skin reaction for irritation) and determined by laboratory tests.
• Electrical Performance: Ground truth is defined by the parameters and limits specified in the ANSI/AAMI EC12 standard.
• Adhesive Performance: Ground truth is defined by the parameters and limits specified in the IEC 60601-2-2 standard.
• Shelf Life: Ground truth is determined by the device's ability to meet its performance specifications over time following accelerated aging and real-time stability testing.

8. The sample size for the training set

The document does not mention a training set. This is a physical medical device, not an AI/machine learning model that typically undergoes training.

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

This question is not applicable as there is no mention of a training set for this device.

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Elecsys ß-Amyloid (1-42) CSF II and Elecsys Total-Tau CSF are in vitro electrochemiluminescence immunoassays for the measurement of the ß-Amyloid (1-42) (Abeta42) and Total-Tau (tTau) concentrations in cerebrospinal fluid (CSF) from adult patients aged 55 years and older being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment to generate a tTau/Abeta42 ratio value.

A negative result, defined as tTau/Abeta42 ratio value below cut-off or an Abeta42 value above the measuring range, is consistent with a negative amyloid position emission tomography (PET) scan result. A negative result reduces the likelihood that a patient's cognitive impairment is due to AD. A postive result, defined as tTau/Abeta42 ratio value above cut-off, is consistent with a positive amyloid PET scan result does not establish a diagnosis of AD or other cognitive disorder. The tTau/Abeta42 ratio result is used as an adjunct to other clinical diagnostic evaluations.

Limitations of Use

The performance of the tTau/Abeta42 ratio has not been established for:

· Predicting development of dementia or other neurologic conditions
· Monitoring responses to therapies

The Elecsys ß-Amyloid (1-42) II immunoassay makes use of a two-step, double antigen sandwich principle using a biotinylated monoclonal β-Amyloid (1-42)-specific and monoclonal ß-Amyloid (1-42) antibodies labeled with a ruthenium complex. The Elecsys ß-Amyloid (1-42) II immunoassay is intended for the in vitro quantitative determination of ß-Amyloid (1-42) in human CSF.

Similarly, the Elecsys Total-Tau immunoassay makes use of a two-step, double antigen sandwich principle using two biotinylated monoclonal Tau-specific antibodies (5.28.464 and 4.35.411) and a monoclonal Tau-specific (PC1P6) antibody labeled with a ruthenium complex. The Elecsys Total-Tau immunoassay is intended for the in vitro quantitative determination of Total-Tau in human CSF.

The assays are indicated for use with adult subjects being evaluated for Alzheimer's disease and other causes of cognitive impairment.

The results of the measurement of a CSF sample for each analyte in pg/mL is used in a ratio (tTau/Abeta42). The assays manually calculated ratio result is compared to a cutoff to determine if the test result indicates an amyloid PET positive or negative result. The result does not establish a diagnosis of AD or other cognitive disorders. Additionally, the result does not predict development of dementia or other neurologic disorders, nor does the result monitor responses to therapies. Both assays are intended for use on the cobas e 601 immunoassay analyzer.

Results for each assay are determined by an analyte specific calibration curve generated by 2point calibration and a master curve provided via the reagent barcode or e-barcode.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:

Device: Elecsys B-Amyloid (1-42) CSF II and Elecsys Total-Tau CSF (used to generate a tTau/Abeta42 ratio value).

Intended Use: In vitro electrochemiluminescence immunoassays for the measurement of Abeta42 and tTau concentrations in CSF from adult patients aged 55 years and older being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment. The ratio result is used as an adjunct to other clinical diagnostic evaluations, consistent with amyloid PET scan results.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes two separate phases of evaluation for the tTau/Abeta42 ratio: a BioFINDER cutoff setting cohort (using first-generation assays) and a clinical validation in an ADNI cohort (using a specific version of the assays, either first or second generation, with adjustments). The acceptance criteria are implicitly derived from the reported performance in the ADNI validation study which is stated to have "met the acceptance criteria."

Acceptance Criteria and Reported Device Performance (Clinical Validation in ADNI cohort):

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

• Test Set (Clinical Validation in ADNI cohort):

  • Sample Size: 646 participants.
  • Data Provenance: Retrospectively collected CSF samples from the Alzheimer's Disease Neuroimaging Initiative (ADNI-GO and ADNI2) studies.
  • Country of Origin: The ADNI study is primarily based in the United States and Canada.
  • Subject Characteristics: Patients with significant memory concerns (SMC, N = 94), early MCI (N = 272), late MCI (N = 152), and Alzheimer's Disease (AD, N = 128). Average age 72 years (range 55-91), 46% female / 54% male, 50% ApoE4 carriers / 50% non-carriers.

• BioFINDER Cohort (for initial cutoff setting):

  • Sample Size: 277 participants with mild cognitive symptoms.
  • Data Provenance: Retrospective samples from the Swedish BioFINDER1 study.
  • Country of Origin: Sweden.
  • Subject Characteristics: 120 subjective cognitive decline (SCD), 153 mild cognitive impairment (MCI), 4 not assigned.

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

• Number of Experts: 3 trained readers.
• Qualifications of Experts: They were "trained readers." No specific professional qualifications (e.g., "radiologist with 10 years of experience") are provided beyond being "trained." They were blinded to clinical information, diagnosis, and CSF biomarker measurements.

4. Adjudication Method for the Test Set

• Adjudication Method (for Amyloid PET scans): Majority voting was used to classify each image as amyloid positive or negative.

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

• No, a "multi-reader multi-case (MRMC) comparative effectiveness study" involving human readers improving with AI vs. without AI assistance was not done or described. This study focuses on the diagnostic performance of the device (a blood test generating a ratio) against an established ground truth (amyloid PET scan results). The "trained readers" mentioned were establishing the ground truth (PET read), not evaluating the device's impact on their own performance.

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

• Yes, this study primarily represents a standalone performance evaluation of the device. The device (Elecsys B-Amyloid (1-42) CSF II and Elecsys Total-Tau CSF assay system) produces a tTau/Abeta42 ratio. This ratio is then compared directly to the amyloid PET scan status. There is no human-in-the-loop component for the device's interpretation; it provides a direct output (ratio) that is then compared to a cut-off to determine a positive or negative amyloid status.

7. The Type of Ground Truth Used

• The primary ground truth used for the clinical validation of the tTau/Abeta42 ratio was amyloid Positron Emission Tomography (PET) scan results, classified as amyloid positive or negative via visual read and majority voting by 3 trained readers.
• For the initial cutoff setting (BioFINDER cohort), the ground truth was also amyloid PET scan results ([18F]-Flutemetamol PET) by visual read.

8. The Sample Size for the Training Set

The document does not explicitly describe a separate "training set" for an AI algorithm in the traditional sense. It describes:

• Initial Cutoff Setting Cohort (BioFINDER): This cohort of 277 participants was used to define the initial ratio cutoff (0.26) based on agreement with amyloid PET status. While not a "training set" for an ML model, it served a similar purpose in establishing initial parameters for the assay's interpretation.
• Bridging Studies: Two bridging studies were conducted (N=20/17 and N=25/24) to adjust the cutoff based on pre-analytical differences and assay updates. These are not typical "training sets" for an algorithm, but rather calibration/normalization studies for the assay system.

Therefore, there isn't a "training set" for an AI model in this context, as the device is an in-vitro diagnostic immunoassay system, not an AI algorithm learning from data. The cut-off and the adjustments resemble empirical derivation from study data ("training" the cut-off, not an AI).

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

As noted above, there isn't a "training set" for an AI algorithm. However, for the data used to establish the cutoff for the assay:

• BioFINDER Cohort: The ground truth was established by amyloid PET scan results via visual read. The specifics of how many readers or their adjudication for this initial phase are not detailed, but it's implied to be based on clinical interpretation of PET scans.
• Conversion Factors/Bridging Studies: The ground truth for these studies involved paired CSF samples handled under different pre-analytical protocols or measured with different assay generations. The "ground truth" here is the comparative measurement of samples under controlled conditions to determine conversion factors.

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Elecsys ß-Amyloid (1-42) CSF II and Elecsys Phospho-Tau (181P) CSF are in vitro electrochemiluminescence immunoassays for the measurement of the ß-Amyloid (1-42) (Abeta42) and Phospho-Tau (181P) (pTau181) protein concentrations in cerebrospinal fluid (CSF) from adult patients aged 55 years and older being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment to generate a pTau181/Abeta42 ratio value. A negative result, defined as pTaul 81/Abeta42 ratio value below cut-off or an Abeta42 value above the measuring range. is consistent with a negative amyloid position tomography (PET) scan result. A negative result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive result, defined as pTaul 81/Abeta42 ratio value above cut-off, is consistent with a positive amyloid PET scan result does not establish a diagnosis of AD or other cognitive disorder. The pTaul 81/Abeta42 ratio result is used as an adjunct to other clinical diagnostic evaluations.

The Elecsys ß-Amyloid (1-42) II immunoassay makes use of a two-step, double antigen sandwich principle using a biotinylated monoclonal β-Amyloid (1-42)-specific and monoclonal ß-Amyloid (1-42) antibodies labeled with a ruthenium complex. The Elecsys ß-Amyloid (1-42) II immunoassay is intended for the in vitro quantitative determination of ß-Amyloid (1-42) (Abeta42) in human CSF.

Similarly, the Elecsys Phospho-Tau (181P) immunoassay makes use of a two-step, double antigen sandwich principle using a biotinylated monoclonal Phospho-Tau (181P)-specific and monoclonal Phospho-Tau (181P) antibodies labeled with a ruthenium complex. The Elecsys Phospho-Tau (181P) immunoassay is intended for the in vitro quantitative determination of Phospho-Tau (181P) (pTau181) in human CSF.

The assays are indicated for use with adult subjects being evaluated for Alzheimer's disease and other causes of cognitive impairment.

The results of the measurement of a CSF sample for each analyte in pg/mL is used in a ratio (pTau181/Abeta42). The assays manually calculated ratio result is compared to a cutoff to determine if the test result indicates an amyloid PET positive or negative result. The result does not establish a diagnosis of AD or other cognitive disorders. Additionally, the result does not predict development of dementia or other neurologic disorders, nor does the result monitor responses to therapies. Both assays are intended for use on the cobas e 601immunoassay analyzer.

Results for each assay are determined by an analyte specific calibration curve generated by 2point calibration and a master curve provided via the reagent barcode or e-barcode.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria, structured according to your request:

Device: Elecsys β-Amyloid (1-42) CSF II and Elecsys Phospho-Tau (181P) CSF (used to generate a pTau181/Abeta42 ratio)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The validation met the acceptance criteria" indicating that the reported PPA, NPA, and OPA were considered acceptable by the FDA, even though specific numerical targets for these metrics are not explicitly listed as "acceptance criteria" in the same way as, for example, precision limits. The initial cutoff setting cohort did have agreement rate percentages (PPA 90.9%, NPA 89.2%, OPA 89.9%) which can be inferred as a benchmark for acceptability.

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

• Test Set (Clinical Validation in ADNI cohort): 646 participants
• Data Provenance: Retrospectively collected CSF samples from the Alzheimer's Disease Neuroimaging Initiative (ADNI) studies (ADNI-GO and ADNI2). The document also mentions a "BioFINDER cutoff setting cohort" from the Swedish BioFINDER1 study (277 participants, retrospective) used to initially define the cutoff, and subsequent "pre-analytical bridging studies" (N=19 for pTau181 and N=17 for Abeta42 for the first bridging study; N=25 for Abeta42 and N=22 for pTau181 for the second bridging study) primarily for adjusting the cutoff due to pre-analytical differences and assay updates, not as the primary clinical validation test set.

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

• Number of Experts: 3 trained readers
• Qualifications of Experts: They were "trained readers" who read and interpreted amyloid PET scans. No further specific qualifications (e.g., medical specialty, years of experience) are provided in the document.
• Blinding: The independent readers were blinded to any clinical information, including the patient's clinical status, diagnosis, and CSF biomarker measurements.

4. Adjudication Method for the Test Set

• Adjudication Method: Majority voting. If at least 2 out of 3 readers classified an image as amyloid positive, it was classified as positive, and vice versa for negative. This resulted in 347 (53.7%) positive and 299 (46.3%) negative amyloid PET reads.

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 involving human readers with and without AI assistance was not conducted or reported in this document. This device is an in vitro diagnostic (IVD) immunoassay that measures biomarker concentrations in CSF, not an AI-powered image analysis tool for human readers.

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

Yes, the clinical validation study evaluates the performance of the immunoassay (the "algorithm only") in classifying amyloid status based on the pTau181/Abeta42 ratio, compared to the ground truth established by expert-read amyloid PET scans. This is a standalone performance assessment of the device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used was expert consensus on amyloid PET scan results.

8. The Sample Size for the Training Set

The document does not explicitly describe a separate "training set" for the clinical validation of the specific pTau181/Abeta42 ratio cutoff. Instead:

• The BioFINDER cutoff setting cohort (277 participants) appears to have functioned as the dataset for determining the initial cutoff value (0.022). While not a "training set" in the machine learning sense, it was used to establish an operational parameter for the device.
• Subsequent bridging studies (N=19/17 and N=25/22 samples respectively) were used to adjust this cutoff to 0.028 and then to 0.023, accounting for pre-analytical differences and assay updates.

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

For the BioFINDER cutoff setting cohort (which served a similar purpose to a training set for cutoff determination):

• Ground Truth: Amyloid PET scan results obtained with the tracer [18F]-Flutemetamol.
• Establishment: The document does not detail how the amyloid PET status was determined for the BioFINDER cohort, but it implies a visual read, similar to the ADNI cohort, as the cutoff was "calculated based on the agreement with amyloid PET status by visual read."

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The Amylase2 assay is used for the quantitation of amylase in human serum, plasma, or urine on the ARCHITECT c System. The Amylase2 assay is to be used primarily as an aid in the diagnosis and treatment of pancreation of the pancreas).

The Amylase2 assay is an automated clinical chemistry assay. The Amylase2 assay is a two-part reaction. Ethylidene-4-NP-G7 (EPS) is hydrolyzed by a-amylase to form 4,6ethylidene-α-(1,4)-D-glucopyranosyl-Gx and 4-nitrophenyl-α-(1,4)-glucopyranosyl-G(7-x). The 4-nitrophenyl-a-(1,4)-glucopyranosyl-G(7-x) is then hydrolyzed into glucose monomers and the assay chromophore (4-nitrophenol) by a-glucosidase. The resulting change in absorbance at 404 nm is proportional to the a-amylase concentration in the sample. Methodology: Enzymatic/Colorimetric. The device is a reagent kit.

Here's a breakdown of the acceptance criteria and the study details for the Amylase2 device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list "acceptance criteria" in a singular table, but rather presents the results of various performance studies. I've extracted the performance metrics and their corresponding observed results to form this table, interpreting the reported successful values as meeting implicit acceptance criteria for substantial equivalence.

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

The document provides details on various studies, each with its own sample size and design:

• Precision (Serum/Plasma & Urine - Within-Laboratory):
  • Sample Size: For each of the controls (2 levels) and panels (3 for serum/plasma, 5 for urine), N=80 data points were collected. This involved testing samples in duplicate, twice per day for 20 days.
  • Provenance: Human serum/plasma and human urine panels were used. No specific country of origin is mentioned, but the context implies an in-vitro diagnostic study conducted under CLSI guidelines, likely in a controlled laboratory setting. It is a prospective study as samples were tested according to a pre-defined protocol.
• System Reproducibility (Serum/Plasma & Urine):
  • Sample Size: For each of the controls (5 for serum/plasma, 4 for urine), N=90 data points were collected. This involved testing samples in a minimum of 3 replicates at 2 separate times per day on 5 different days across 3 instruments and 3 technicians.
  • Provenance: The study used controls, implying commercially prepared materials or pooled biological samples. It is a prospective study.
• Accuracy:
  • Sample Size: Not explicitly stated but implies a set of calibrator materials and potentially patient samples based on "material standardized to the Certified Reference Material IRMM/IFCC-456."
  • Provenance: Relies on certified reference materials and likely patient samples.
• Lower Limits of Measurement (LoB, LoD, LoQ):
  • Sample Size: n ≥ 60 replicates of zero-analyte and low-analyte level samples for each determination (LoB, LoD, LoQ).
  • Provenance: Control materials or spiked biological samples designed to have specific low analyte levels. Prospective.
• Linearity:
  • Sample Size: Not explicitly stated, but typically involves a series of diluted/spiked samples to cover the analytical range.
  • Provenance: Spiked or diluted biological samples. Prospective.
• Potentially Interfering Substances (Serum/Plasma & Urine):
  • Sample Size: Not explicitly stated, but each substance was tested at 2 levels of the analyte (approximately 50 U/L and 200 U/L for serum/plasma; 450 U/L and 1400 U/L for urine). This implies numerous replicates for each interferent and analyte level.
  • Provenance: Biological samples (serum/plasma/urine) spiked with various endogenous and exogenous substances. Prospective.
• Method Comparison:
  • Sample Size: 124 serum samples and 103 urine samples.
  • Provenance: Human serum and urine samples. The description doesn't explicitly state if prospective or retrospective, but typically such studies involve prospectively collected samples from a diverse patient population. No country of origin specified.
• Tube Type:
  • Sample Size: Samples collected from a minimum of 40 donors.
  • Provenance: Human blood samples collected into different tube types. Prospective.
• Dilution Verification:
  • Sample Size: 5 human serum samples and 5 urine samples, each tested in replicates of 5 after automated and manual dilution.
  • Provenance: Human serum and urine samples spiked with α-amylase from porcine pancreas. Prospective.

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

This information is not provided in the document. For an in-vitro diagnostic device, "ground truth" often refers to the true concentration of the analyte, which is usually established by highly precise reference methods, certified reference materials, or by comparison with a well-established predicate device, rather than expert consensus on images or clinical diagnoses. The document indicates standardization against IRMM/IFCC-456, which is a reference material for amylase, and comparison to a predicate device (AMY, K981653). These serve as the "ground truth" or reference for the device's performance.

4. Adjudication Method for the Test Set

This section is not applicable as this is an in-vitro diagnostic (IVD) device for quantitative measurement of amylase. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or subjective evaluations, where multiple experts independently assess data and discrepancies are resolved. For an IVD, the "ground truth" is measured quantitatively against a reference standard or predicate.

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

This information is not provided and is not applicable to this device. An Amylase2 assay is an automated clinical chemistry assay, not an AI-powered diagnostic imaging device that requires human "readers" or involves AI assistance in interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this product.

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

The Amylase2 assay is an automated clinical chemistry assay, meaning its performance is inherently "standalone" in the sense that it provides a quantitative result without direct human intervention in the measurement process itself, beyond sample loading and general instrument operation. The studies described (precision, accuracy, linearity, interference, method comparison) are all evaluating the algorithm/reagent system's performance independently.

7. The Type of Ground Truth Used

The ground truth for the Amylase2 device's performance studies relies on:

• Reference Materials: For accuracy, the device was compared against "material standardized to the Certified Reference Material IRMM/IFCC-456."
• Predicate Device: For method comparison, the Amylase2 assay was compared to the predicate device, Amylase assay (List Number 7D58), which serves as the established reference standard in this context.
• Spiked Samples: For linearity, lower limits of measurement, interference, and dilution verification, samples were often "spiked" with known concentrations of α-amylase or interfering substances to create samples with a known "true" value.
• Commercial Controls: For precision and reproducibility studies, commercially available controls with known target ranges were used.

8. The Sample Size for the Training Set

The document describes studies for validation and verification purposes (test sets). For an IVD like Amylase2, the "training set" would refer to the data used by the manufacturer during the assay development phase to optimize reagents, calibrate the instrument response, and refine the measurement algorithms. This specific information about the development/training data size is not provided in the 510(k) summary, as the summary focuses on the performance of the final device.

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

Similar to point 8, the specific details on how ground truth was established for any internal "training set" used during development are not provided. Typically, for such IVDs, this would involve a rigorous process of using purified analytes, gravimetric/volumetric standards, certified reference materials, and comparison to established reference methods to assign "true" values to a large panel of samples during the assay's development and optimization.

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The Lumipulse G B-Amyloid Ratio (1-42/1-40) is an in vitro cerebral spinal fluid (CSF) test that combines the results of Lumipulse G B-Amyloid 1-42 and Lumipulse & B-Amyloid 1-40 assays into a ratio of ß-amyloid 1-42 to ß-amyloid 1-40 concentrations using the LUMIPULSE G 1200 System. The Lumipulse G B-Amyloid Ratio (1-42/1-40) is intended to be used in adult patients, aged 55 years and older, presenting with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline.

A test result ≥ 0.073 is a negative result which is consistent with a negative amyloid positron emission tomography (PET) scan result. A negative result reduces the likelihood that a patient's cognitive impairment is due to AD.

A test result ≤ 0.058 is a positive result which is consistent with a positive amyloid PET scan result. A positive result does not establish a diagnosis of AD or other cognitive disorder.

A test result between 0.059 and 0.072 is considered as a likely positive result as it is more likely consistent with a positive amyloid PET scan result. A likely positive result does not establish a diagnosis of AD or other cognitive disorders and has increased uncertainty in regard to amyloid PET positivity.

The Lumipulse G B-Amyloid Ratio (1-42/1-40) results must be interpreted in conjunction with other patient clinical information .

This test is not intended as a screening or stand-alone diagnostic test.

The Lumipulse G B-Amyloid Ratio (1-42/1-40) is an in vitro cerebral spinal fluid (CSF) test that calculates the ratio of two analytes, Lumipulse G ß-Amyloid 1-42 and Lumipulse & ß-Amyloid 1-40 assays to generate a numeric value between 0.001 to 1.000.

The test system consists of two component assays, Lumipulse & ß-Amyloid 1-42 and the Lumipulse G B-Amyloid 1-40 assay, running on LUMIPULSE G1200 system, and Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator Tool to calculate the Lumipulse G B-Amyloid Ratio (1-42/1-40). Lumipulse G B-Amyloid 1-42 and the Lumipulse G B-Amyloid 1-40 assays are packed individually. Results of individual assays have not been assessed to support the intended use except for determination of the Lumipulse G ß-Amyloid Ratio (1-42/1-40).

Acceptance Criteria and Device Performance for Lumipulse G ß-Amyloid Ratio (1-42/1-40)

This document describes the acceptance criteria and the study demonstrating the performance of the Lumipulse G ß-Amyloid Ratio (1-42/1-40) device.

1. Acceptance Criteria and Reported Device Performance

The core of the device's utility lies in its ability to predict amyloid PET scan results. The acceptance criteria and reported performance relate to the predictive values of the test for classifying patients as PET positive, likely positive, or negative.

Note on "Predictive Value for Negative Result (Ratio ≥ 0.073) for PET positivity": The table in the provided text for "Clinical Performance" presents the "Predictive Value %" as (Positive (n) / N), where N is the total for that Lumipulse G B-Amyloid Ratio category. Therefore, for the "Negative" category, "16.1% (15/93)" means that out of 93 patients with a negative Lumipulse G B-Amyloid Ratio, 15 (16.1%) were actually PET positive. This implicitly means that 93 - 15 = 78 (83.9%) were indeed PET negative when the Lumipulse test was negative.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: 292 patients.
• Data Provenance: The data for the clinical performance study (test set) was obtained from the Alzheimer's Disease Neuroimaging Initiative (ADNI) sample bank.
  • Country of Origin: Not explicitly stated, but ADNI is a large-scale North American-based research study.
  • Retrospective or Prospective: The study utilized "banked CSF samples," indicating a retrospective approach to sample collection for the purpose of this device's validation. However, the PET evaluation was conducted, and the time interval between CSF sampling and PET evaluation was analyzed, suggesting that while samples were banked, their correlation to PET was part of the study design.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: A minimum of three trained independent readers.
• Qualifications of Experts: The experts were "trained independent readers" who were blinded to all other clinical data. Their specific professional qualifications (e.g., radiologist, neurologist) or years of experience are not explicitly stated in the provided text.

4. Adjudication Method for the Test Set

• Adjudication Method: 2+1 adjudication method. The amyloid PET status for each patient was determined by a minimum of three trained independent readers. If the first two readers disagreed, an adjudicator's reading was used.

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

• Was an MRMC comparative effectiveness study done? No, the provided text does not describe an MRMC comparative effectiveness study comparing human readers with AI assistance versus human readers without AI assistance (i.e., the effect size of how much human readers improve with AI vs without AI assistance). The device is an in-vitro diagnostic (IVD) assay that produces a numerical ratio result, not an AI assisting human image interpretation.

6. Standalone Performance Study

• Was a standalone (algorithm only without human-in-the loop performance) done? Yes, the clinical performance study evaluates the performance of the Lumipulse G B-Amyloid Ratio (1-42/1-40) device in isolation against the ground truth (visual amyloid PET read). The device generates a numerical ratio which is then categorized (positive, likely positive, negative) and compared directly to the PET results, without direct human intervention in interpreting the device's output or integrating it into a diagnostic workflow with human readers.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was visual amyloid PET scan results. This was determined by "Florbetapir (18F) PET evaluation," with images analyzed by visual read and scored as either amyloid PET positive or amyloid PET negative by trained independent readers with adjudication.

8. Sample Size for the Training Set

• Sample Size for Training Set: 235 patients were used to determine the assay cutoff. This group was from the Amsterdam Dementia Cohort (ADC). It is important to note that this was explicitly stated as "distinct from the subjects ... evaluated in the pivotal clinical validation study (test set)."

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

• How Ground Truth for Training Set was Established: For the 235 patients from the Amsterdam Dementia Cohort (ADC) used to determine the assay cutoff, the ground truth was visual amyloid PET scan status.
  • PET Tracers Used: Florbetaben (18F), Florbetapir (18F), and Flutemetamol (18F).
  • Interpretation: Images were analyzed by visual read and scored as either amyloid PET positive or amyloid PET negative.
  • Protocol: CSF collection, processing, and handling were conducted according to a "standardized ADC protocol." A "pre-analytical bridging study was conducted using fresh prospectively collected individual CSF samples" to account for variations between ADC and ADNI protocols.

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The Atellica® CH Amylase_2 (AMY_2) assay is for in vitro diagnostic use in the quantitative determination of amylase activity in human serum, plasma (lithium heparin), and urine using the Atellica® CH Analyzer. Such measurements are used primarily in the diagnosis and monitoring of acute pancreatitis (inflammation of the pancreas).

The Atellica® CH Amylase_2 (AMY_2) assay is based on the procedure of Jensen and Wydeveld. The Atellica CH AMY 2 assay uses ethylidene blocked p-nitrophenylmaltoheptaoside as substrate. The indicator enzyme a-glucosidase, used to release pnitrophenol (PNP), is also employed in the assay. The terminal glucose of the substrate is chemically blocked, preventing cleavage by the indicator enzymes. The released pnitrophenol is measured at 410/694 nm.

The Siemens Healthcare Diagnostics Inc. Atellica® CH Amylase_2 (AMY_2) assay is an in vitro diagnostic device for the quantitative determination of amylase activity in human serum, plasma (lithium heparin), and urine. These measurements are used primarily in the diagnosis and monitoring of acute pancreatitis.

Here's an analysis of its acceptance criteria and the supporting study data:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with pass/fail thresholds for each performance characteristic. Instead, it presents performance results which are implicitly considered acceptable for substantial equivalence to the predicate device. Based on the provided data, the table below summarizes the reported device performance for key analytical characteristics.

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

Detection Limit (LoB/LoD):

• Sample Size: LoB: 4 samples with no analyte tested (N=20 repetitions) for 3 days, using 3 reagent lots. LoD: 4 low analyte samples tested (N=20 repetitions) for 3 days, using 3 reagent lots. This totals to 240 replicates for LoB and 240 replicates for LoD.
• Data Provenance: Not explicitly stated, but implies laboratory-prepared control samples or de-identified human samples with near-zero or low analyte levels. Likely internal data from Siemens Healthcare Diagnostics Inc. R&D organization.

Limit of Quantitation (LoQ):

• Sample Size: 4 low samples processed for 3 reagent lots for 3 days, on one instrument. This totals 120 measurements per lot.
• Data Provenance: Not explicitly stated, but likely internal data from Siemens Healthcare Diagnostics Inc. R&D organization, using prepared low-concentration samples.

Linearity:

• Sample Size: 9 samples spanning the assay measuring interval for serum specimens and 9 samples for urine specimens. Each sample was measured in 5 replicates.
• Data Provenance: Samples were prepared by mixing high and low concentration samples, and by spiking native serum or urine pools with amylase. Low pools were created by diluting with CH diluent. Origin of native serum/urine pools not specified, but likely internal or commercially sourced.

Precision:

• Sample Size: n=2 replicates, two times per day for at least 20 days, for a total of 80 replicates per sample. This was done for controls, serum, plasma, and urine pools.
• Data Provenance: Laboratory controls, serum, plasma, and urine pools were used. Likely internal data from Siemens Healthcare Diagnostics Inc. R&D organization.

Interferences:

• Sample Size: Not explicitly given for the number of distinct samples, but tests were conducted using "fresh sample pools" (low and high measurand levels in serum and urine) spiked with interferents.
• Data Provenance: Fresh sample pools implies human serum and urine, likely obtained or prepared internally.

Method Comparison:

• Sample Size: Serum: N=118 samples. Urine: N=114 samples.
• Data Provenance: Remnant de-identified samples were tested. The study included native and spiked samples. The studies were conducted internally by Siemens Healthcare Diagnostics Inc. R&D personnel and externally by a contracted laboratory. The country of origin for these remnant samples is not specified, but typically would be from US clinical labs if the filing is for the US market.

Matrix Equivalency:

• Sample Size: N=66 matched serum and lithium heparin plasma sets.
• Data Provenance: Matched serum and lithium heparin plasma sets. Some samples were spiked with amylase. Likely internal data, origin of native samples unspecified.

Expected Values (Reference Intervals):

• Sample Size: Not explicitly stated for the verification study, but reference intervals were "verified". CLSI EP28-A3 suggests a minimum of 20 samples for verification.
• Data Provenance: Verified on the Atellica® CH Analyzer. Reference "Data on file at Siemens Healthcare Diagnostics".

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

This device is an in vitro diagnostic assay that measures amylase activity, not an imaging or a subjective diagnostic device requiring expert interpretation of results for ground truth. Therefore, no external experts were used to establish a "ground truth" for the test set in the way one might for diagnostic imaging or pathology. The ground truth (or 'true value') for quantitative assays is established through meticulous analytical methods, calibration using traceable reference materials (IRMM/IFCC-456 for this device), and comparison to a legally marketed predicate device.

The personnel conducting the method comparison study were "laboratory technicians with training similar to personnel who would conduct the tests in a hospital laboratory setting."

4. Adjudication method for the test set

Not applicable. As a quantitative assay, the results are numerical and objectively measured, not subject to individual interpretation and thus do not require an adjudication method among experts.

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 is an in vitro diagnostic assay performed by an automated analyzer, not an AI-assisted diagnostic device that would involve human readers (e.g., radiologists, pathologists) interpreting images or clinical data.

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

Yes, the performance data presented (Detection Limit, LoQ, Linearity, Precision, Interferences, Method Comparison, Matrix Equivalency) are all standalone performance data of the Atellica® CH Amylase_2 analyzer and its reagents, without human-in-the-loop performance influencing the assay results directly. The device automatically performs the quantitative determination of amylase activity.

7. The type of ground truth used

The "ground truth" for this quantitative assay is established via:

• Calibration Traceability: Traceable to IRMM/IFCC-456 Pancreatic Alpha-Amylase Reference Material and commutable to the IFCC Alpha-Amylase Primary Reference Procedure.
• Comparison to Predicate: Performance is demonstrated as substantially equivalent to a legally marketed predicate device (Roche Cobas Amylase Reagent), implying that the predicate's established accuracy serves as a benchmark.
• Analytical Standards and Controls: Use of internal and external quality control materials with known target values.
• Spiked Samples: For linearity, method comparison, and matrix equivalency, samples were spiked with known concentrations of amylase to cover the measuring range.

8. The sample size for the training set

Not applicable. This is a traditional in vitro diagnostic assay based on enzymatic colorimetric reactions, not an AI/ML-based algorithm that would require a "training set" in the context of machine learning. The "training" for such a device involves chemical formulation, instrument design, and analytical validation.

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 for this device.

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alpha-AMYLASE DIRECT: Reagent for the measurement of alpha-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronic pancreatitis. This reagent institus of in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

alpha-AMYLASE EPS: Reagent for the measurement of alpha-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronic pancreatitis. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

alpha-AMYLASE PANCREATIC: Reagent for the measurement of pancreatic c-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronin pancreatitis. This reagentis for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

BILIRUBIN DIRECT: Reagent for the measurement of direct bilirubin concentration in human serum or plasma. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hematological and metabolic disorders, including hepatitis and gall bladder block. This reagent is for use in the BioSystems Blockers. Only for in vitro use in the clinical laboratory.

BILIRUBIN TOTAL: Reagent for the measurement of total bilirubin concentration in human serum or plasma. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, herrytological and metabolic disorders, including hepatitis and gall bladder block. This reagent is for nuse in the BioSystems Blockers. Only for in vitro use in the clinical laboratory.

Not Found

This 510(k) summary provides information about the substantial equivalence of several Biosystems S.A. reagents (alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL) to legally marketed predicate devices. It states that the devices are intended for in vitro diagnostic use in the clinical laboratory for measuring specific analyte concentrations in human serum, plasma, or urine, which are useful as aids in the diagnosis and treatment of certain medical conditions. However, the document does not contain any data, studies, or information regarding acceptance criteria or device performance statistics. It is a regulatory clearance letter, not a performance study report.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

To answer your request, I would need a different document, such as a summary of safety and effectiveness (SSE) or a clinical study report that details the validation and performance characteristics of these reagent systems.

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