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IDS ACTH II assay is an automated in vitro diagnostic device intended for the quantitative, determination of ACTH in human K2 and K3 EDTA plasma on the IDS system. Results are to be used in conjunction with other clinical and laboratory data as an aid in the assessment of pituitary and adrenal gland function and the differential diagnosis of hyper- and hypo-cortisolism.

The IDS ACTH II assay consists of a reagent cartridge. The reagent cartridge contains multiple reagents:

• MP: Magnetic particles coated with mouse monoclonal anti-ACTH antibody and buffer containing phosphate with blocking proteins and ProClin 300 as preservative.
• R1: Mouse monoclonal anti-ACTH antibody labelled with an acridinium ester derivative, in buffer containing phosphate with BSA and ProClin 300 as preservative.
• R2: Buffer containing phosphate with blocking proteins and ProClin 300 as preservative.

The provided text describes the performance characteristics of the IDS ACTH II assay, which is an automated in vitro diagnostic device for the quantitative determination of ACTH in human K2 and K3 EDTA plasma. The study aims to demonstrate that the device meets the acceptance criteria for various analytical performance parameters.

Here's a breakdown of the requested information:

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

The document does not explicitly state "acceptance criteria" as a separate column for each test. Instead, it describes the methodology used to determine each performance characteristic and then presents the results. Based on the context and the nature of these studies, the reported values often serve as the demonstrated "performance" which, by the conclusion of the 510(k) summary, are deemed sufficient to support substantial equivalence. For analytical characteristics like Linearity, Interference, and Cross-Reactivity, the document does specify thresholds for acceptable performance.

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

• Analytical Limits (LoB, LoD, LoQ):
  • LoB and LoD: 60 replicates of 4 blank samples and 6 low concentration samples per reagent lot.
  • LoQ: 90 replicates of 6 low concentration samples per reagent lot.
• Precision (Repeatability): 5 plasma samples, 80 replicates each (duplicate, twice a day for 20 days).
• Precision (Reproducibility – between sites/systems): 5 plasma samples, 75 replicates each (5 replicates, once a day for 5 days on 3 systems).
• Precision (Reproducibility – between lots): 5 plasma samples, 75 replicates each (5 replicates, once a day for 5 days on 1 system using 3 reagent lots).
• Linearity: The sample size isn't explicitly stated as a single number but involved testing across the analytical measuring interval of 4 to 1000 pg/mL.
• Analytical Specificity (Interference): 2 samples containing 15 and 200 pg/mL ACTH for most interfering agents; 2 samples containing 30 and 500 pg/mL ACTH for Total Cholesterol.
• Analytical Specificity (Cross-Reactivity): 2 samples containing 20 and 400 pg/mL ACTH spiked with various cross-reactants.
• Method Comparison: 170 patient samples for comparison against the predicate device.
• Matrix Comparison: 55 matched samples for K2 vs K3 EDTA comparison.
• Expected Values (Reference Interval): 140 apparently healthy adults.

Data Provenance: The document does not specify the country of origin of the data or whether the samples were retrospective or prospective, except that the submitter is based in the United Kingdom.

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 is an in vitro diagnostic device (an assay), not an imaging or diagnostic AI system that requires expert interpretation for ground truth. The "ground truth" for the performance characteristic studies (like LoQ, precision, linearity, interference, cross-reactivity, and method comparison) is established by the analytical measurement itself, often compared against a reference method or known spiked concentrations. For method comparison, another commercially available, quantitative automated assay serves as the comparative reference. For the reference interval study, the "ground truth" is derived from the measured ACTH concentrations in a defined population of apparently healthy adults using the IDS ACTH II assay itself, following CLSI guidelines for establishing reference intervals.

Therefore, the concept of "experts establishing ground truth" in the way it applies to imaging studies (e.g., radiologists) is not relevant here.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or diagnostic studies where there's human interpretation involved and potential for disagreement. This document describes analytical performance studies of an IVD assay, where the results are quantitative measurements. The methods followed standard CLSI guidelines (e.g., EP17-A, EP05-A3, EP06, EP07-A3, EP-9A2, C28-A3) for laboratory testing, which do not generally involve an adjudication process in the same way clinical judgment studies would.

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

No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that involves human readers.

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

This is an automated in vitro diagnostic assay, meaning it operates in a standalone manner (algorithm only, without human-in-the-loop performance for result generation or interpretation, beyond standard laboratory procedures). The performance data presented are for the device's inherent analytical capabilities.

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

• Analytical Limits, Precision, Linearity, Interference, Cross-Reactivity: Ground truth is established through controlled laboratory experiments using known concentrations (e.g., spiked samples, blank samples, reference materials) and rigorous statistical analysis as per CLSI guidelines.
• Method Comparison: The "ground truth" for method comparison is the measurement obtained from a predicate, commercially available quantitative automated assay using patient samples, against which the candidate device's measurements are compared.
• Reference Intervals: The "ground truth" for expected values is the statistical distribution of ACTH concentrations measured by the IDS ACTH II assay itself in a predefined population of apparently healthy adults (n=140).

8. The sample size for the training set

The concept of a "training set" is typically associated with machine learning or AI models. This document describes the validation of an IVD assay. The assay itself does not involve a machine learning model that requires a distinct training set. The various sample sizes mentioned in point 2 are for different performance characteristic evaluation tests.

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

As there is no "training set" in the context of an AI/ML model for this IVD assay, this question is not applicable. The assay's analytical characteristics are established through chemical and immunochemical principles and validated through the performance studies described.

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ST AIA-PACK ACTH is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of adrenocorticotropic hormone (ACTH) in human EDTA plasma. Measurements of ACTH are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.

ST AIA-PACK ACTH Calibrator Set is designed for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK ACTH assay on Tosoh AIA System Analyzers

ST AIA-PACK ACTH Control Set is designed for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AIA-PACK ACTH assay on Tosoh AIA System Analyzers

The ST AIA-PACK ACTH is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK ACTH test cups. ACTH present in the test sample is bound with anti-ACTH goat polyclonal antibody immobilized on magnetic beads and enzyme-labeled anti-ACTH goat polyclonal antibody. The magnetic beads are washed to remove unbound enzyme-labeled anti-ACTH goat polyclonal antibody and are then incubated with a fluorogenic substrate, 4methylumbelliferyl phosphate (4MUP). The enzyme alkaline phosphatase causes oxidation of 4MUP to 4MU. 4MU is excited at 365 nm and comes to ground state at 448 nm releasing florescent energy. The amount of florescent energy is measured by the detector.

The amount of enzyme-labeled anti-ACTH goat polyclonal antibody that binds to the beads is directly proportional to the ACTH concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.

The ST AIA-PACK ACTH assay is designed to quantitatively measure adrenocorticotropic hormone (ACTH) in human EDTA plasma for in vitro diagnostic use. The following information details the acceptance criteria and the studies conducted to demonstrate the device's performance, as outlined in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Precision Study: Three levels of unaltered EDTA plasma specimens were used. For each level, measurements were taken across 3 reagent lots, 3 analyzers, 2 replicates per run, 2 times a day for 20 non-consecutive days, totaling 80 determinants per reagent set/analyzer combination for precision evaluation. The exact number of individual "samples" (patient specimens) is not explicitly stated beyond "three levels of unaltered EDTA plasma specimens."
• Linearity Study: The number of samples/specimens is not explicitly stated. The study aimed to demonstrate linearity over the range of 2.0 to 2,000 pg/mL using the EP6-A CLSI protocol.
• Correlation Study: A total of 160 EDTA plasma specimens were used (154 unaltered and 6 altered specimens). The data provenance is not explicitly stated (e.g., country of origin). The study used a combination of fresh and frozen specimens.
• LoD/LoQ Study: Not specified, but based on CLSI Protocol EP17-A.
• Interference Study: Not specified, but various interfering substances were added to samples.
• Specificity Study: Not specified, but "Control" (presumed matrix without ACTH fragments) and samples spiked with different ACTH fragments were used.

The data provenance (country of origin) is not provided in the summary. The studies appear to be retrospective in the sense that existing plasma samples were used, or samples were created with specific characteristics for testing (e.g., altered specimens for correlation, spiked samples for interference/specificity).

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

This device is an in vitro diagnostic assay that measures a quantitative biomarker (ACTH concentration). The concept of "ground truth" for the test set is established through reference methods and clinical guidelines, rather than expert human interpretation of results like in imaging studies.

• For the Correlation Study, the predicate device (Roche Elecsys ACTH Immunoassay on the MODULAR ANALYTICS E170 analyzer) served as the comparative "reference" against which the new device's measurements were assessed for agreement. The "ground truth" for the quantitative values of ACTH in the 160 specimens would have been the values reported by the predicate device (or potentially a definitive reference method, though not stated).
• For other studies like Precision, Linearity, LoD/LoQ: The "ground truth" is defined by the expected performance characteristics based on established analytical standards (CLSI protocols) and the intrinsic properties of the assay and the analyte itself.

Therefore, the concept of "number of experts used to establish ground truth" with specific qualifications is not directly applicable in the same way it would be for, for example, a diagnostic imaging study where radiologists interpret images.

4. Adjudication Method for the Test Set:

Not applicable in the usual sense for this type of quantitative biochemical assay. The "ground truth" is established through the measurement by a comparative method (predicate device) and adherence to CLSI statistical protocols for analytical performance characteristics. There is no mention of a human adjudication process for resolving discrepancies in quantitative measurements.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images, and the AI's impact on their performance is being evaluated. The ST AIA-PACK ACTH is a laboratory assay for quantitative measurement, and its performance is assessed through analytical validation studies (precision, linearity, correlation, etc.) as described.

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

Yes, the studies presented (Precision, Linearity, Correlation, LoD/LoQ, Interference, Specificity) represent the standalone performance of the ST AIA-PACK ACTH assay system. The device produces a quantitative measurement of ACTH in a sample, and these studies assess the accuracy, reproducibility, and reliability of those measurements as produced by the instrument and reagent system, without human interpretation of the primary output (the ACTH concentration value). While a human ultimately interprets the clinical significance of the numerical ACTH result, the performance metrics described here are purely analytical/algorithm-only.

7. The Type of Ground Truth Used:

The "ground truth" in these studies is primarily based on:

• Comparator Method (Predicate Device): For the correlation and method comparison study, the Elecsys ACTH Immunoassay on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 served as the reference method. The agreement between the new device's readings and the predicate device's readings was assessed.
• Known Concentrations/Spiked Samples: For linearity, LoD/LoQ, interference, and specificity studies, samples were likely prepared with known concentrations of ACTH (or interfering substances/fragments) or serially diluted to establish the expected "true" value for evaluation.
• Adherence to CLSI Protocols: These protocols provide a framework for establishing acceptable analytical performance, and meeting these statistical and methodological guidelines serves as a form of "ground truth" for demonstrating device competency.

8. The Sample Size for the Training Set:

This information is not provided in the 510(k) summary. Given that this is a biochemical immunoassay (fluorescence-based sandwich immunoassay), it's unlikely that a "training set" in the context of machine learning algorithms (which often have large training datasets) was used in the same way. Immunoassays are developed through chemical and biological engineering, and their operating parameters are typically optimized through experimental design and iterative changes to reagents and protocols, rather than a data-driven "training" phase.

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

As discussed in point 8, the concept of a "training set" and associated "ground truth" for a biochemical immunoassay is not applicable in the typical sense of AI/machine learning. The "development" and "optimization" of such an assay involve:

• Selection and Development of Reagents: Antibodies, enzymes, fluorogenic substrates, and beads are chosen and optimized for specificity and sensitivity.
• Calibration Standards: Known concentrations of ACTH (gravimetrically prepared standards like ACTH (Human, 1-39) Bachem AG: code. H-1160) are used to establish the standard curve, which is the basis for calculating unknown sample concentrations. These standards effectively define the "ground truth" for the quantitative measurement.
• Quality Control Materials: Known-value control samples are used to monitor the assay's performance over time.

These elements constitute how the assay's ability to measure ACTH accurately is "established" during its development, rather than through a machine learning training process.

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Elecsys ACTH Assay: Immunoassay for the in vitro quantitative determination of adrenocorticotropic hormone (ACTH) in human EDTA plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E 170 (Elecsys module) immunoassay analyzers. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushings syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.

Elecsys ACTH CalSet is used for calibrating the quantitative Elecsys ACTH assay on the Elecsys immunoassay analyzers.

Elecsys ACTH CalCheck: For use in the verification of the calibration established by the Elecsys ACTH reagent on Elecsys 1010/2010 and MODULAR E170 immunoassay analyzers.

Elecsys PreciControl ACTH is used for quality control of the Elecsys ACTH immunoassay on the Elecsys immunoassay analyzers.

(1) The Elecsys ACTH Assay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.
(2) The Elecsys ACTH CalSet is a lyophilized product consisting of equine serum with added ACTH in two concentration range. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
(3) The Elecsys ACTH CalCheck is a lyophilized product consisting of buffered equine serum with added ACTH. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
(4) The Elecsys PreciControl ACTH is a lyophilized product consisting of equine serum with added ACTH in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
Note: The reagent, calibrator, calibration verification material and the quality control are all packaged separately.

This document describes the Elecsys ACTH Immunoassay, CalSet, CalCheck, and PreciControl ACTH. The study focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria with acceptance criteria and a study to prove it.

However, based on the provided text, we can extract the reported performance of the device and compare it to the predicate device, which implicitly serves as a benchmark for "acceptance." The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds for the Elecsys ACTH system, but rather presents its performance characteristics and compares them to legally marketed predicate devices to establish substantial equivalence.

Here's an attempt to structure the information in the requested format, acknowledging the limitations of the provided text which is a 510(k) summary focused on substantial equivalence rather than a detailed performance study report:

1. Table of Acceptance Criteria and Reported Device Performance

Since no explicit "acceptance criteria" are given for the Elecsys ACTH Immunoassay, the table below presents its reported performance characteristics and compares them to the predicate Immulite ACTH assay, as demonstrating comparable performance to a legally marketed device is the basis for 510(k) clearance. The implied "acceptance criteria" for a 510(k) submission is that the new device performs acceptably and substantially equivalently to the predicate.

Study Proving Device Meets Acceptance Criteria (as per 510(k) Summary):

The document provided is a 510(k) Summary, which aims to demonstrate "substantial equivalence" of the new device (Elecsys ACTH Test System) to legally marketed predicate devices. The "study" referenced within this context is a series of performance evaluations and comparisons described in the "Substantial equivalence" sections. The Elecsys ACTH Immunoassay's performance characteristics (measuring range, precision, sensitivity, method comparison, specificity, and interferences) were measured and compared to the predicate Immulite ACTH assay (K960066) or other relevant predicate devices for the CalSet, CalCheck, and PreciControl components.

The data presented shows that the Elecsys ACTH Immunoassay generally meets or exceeds the performance of the predicate device, particularly in terms of measuring range, precision, and analytical sensitivity. The method comparison also indicates a strong correlation with a commercially available ACTH test.

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

• Sample Size for Method Comparison (Test Set): n=180 samples were used for the method comparison study (Elecsys ACTH (y) vs. a commercially available ACTH test (x)).
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given it's a 510(k) submission for a global company (Roche Diagnostics), it is likely to include data from various testing sites, potentially international, and both prospective and retrospective samples may have been used. However, this information is not detailed.

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

• Number of Experts & Qualifications: This is not applicable in the context of an immunoassay performance study. The "ground truth" for the test set (patient samples) would be the actual ACTH concentration as determined by a reference method or a legally marketed comparative device, not by expert interpretation. The commercially available ACTH test (x) used for method comparison serves as the reference for comparative accuracy.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. For quantitative immunoassays, the "ground truth" is typically established by quantitative measurement on a reference or predicate device, not by expert adjudication of subjective results.

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

• This is not applicable. The device described is a fully automated immunoassay system for quantitative determination of ACTH levels. It does not involve human readers interpreting images or data where AI assistance would improve their performance. It's an in-vitro diagnostic (IVD) device, not an AI software diagnostic aid for human interpretation.

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

• The Elecsys ACTH Immunoassay is a standalone automated assay. Its performance characteristics (precision, analytical sensitivity, measuring range, specificity) are evaluated as the algorithm/system only, without human intervention in the result generation. Human involvement is limited to sample loading, system maintenance, and result review.

7. The Type of Ground Truth Used

• The "ground truth" for evaluating the Elecsys ACTH Immunoassay's performance (specifically for method comparison) was established by comparison to a commercially available ACTH test. This implies using an already established and validated quantitative method. For other performance aspects like precision and analytical sensitivity, the ground truth is inherent in the known concentrations of spiked samples or statistically derived from repeated measurements.

8. The Sample Size for the Training Set

• The document does not specify a separate "training set" for the assay. For immunoassays, the "training" typically refers to the development and optimization process, where various formulations and parameters are tested. The "calibration" of the device uses reference materials (CalSet) with known concentrations to establish a standard curve. The document mentions a master curve provided with the reagent bar code, which is essentially pre-determined calibration data based on extensive prior testing during development and manufacturing.

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

• As a traditional immunoassay, there isn't a "training set" in the sense of machine learning algorithms.
  • Calibration: The "ground truth" for calibrators (Elecsys ACTH CalSet) is established by spiking known concentrations of ACTH into the matrix and gravimetric standardization with synthetic ACTH produced at Roche.
  • Control Materials: Similarly, for control materials (Elecsys PreciControl ACTH), known concentrations of ACTH are spiked into the matrix.
  • The "master curve" used by the instrument is derived from extensive testing of reference materials with confirmed ACTH concentrations during the assay development process.

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The Scantibodies Laboratory, Inc. Adrenocorticotropic Hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands, such as Cushing's syndrome, and the ectopic ACTH syndrome.

ACTH Immunoradiometric (IRMA) Assay

The provided document is a 510(k) clearance letter from the FDA for a device called "ACTH Immunoradiometic (IRMA) Assay" manufactured by Scantibodies Laboratory, Inc. This letter primarily confirms the substantial equivalence of the device to legally marketed predicate devices.

However, the document does not contain the specific acceptance criteria, study details, or performance data that would typically be found in a study report or a more detailed submission. It states that the FDA "reviewed your Section 510(k) premarket notification" and deemed the device substantially equivalent. The information provided is primarily administrative and regulatory.

Therefore, based solely on the provided text, I cannot generate the requested information about acceptance criteria, detailed study design, sample sizes, ground truth establishment, or multi-reader multi-case studies because that specific data is not present in this regulatory clearance letter.

To provide the requested information, a different document, such as a summary of safety and effectiveness, the 510(k) submission itself, or a published study report, would be needed.

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The Scantibodies Laboratory, Inc. Adrenocorticotropic Hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands, such as Cushing's syndrome, adrenocortical insufficiency and the ectopic ACTH syndrome.

ACTH Immunoradiometric (IRMA) Assav

This appears to be a 510(k) premarket notification approval letter for a medical device (ACTH Immunoradiometric (IRMA) Assay) and not a study report. Therefore, the provided text does not contain the detailed information required to describe acceptance criteria and a study proving device performance in the manner requested.

Specifically, the document is an FDA letter stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not contain:

• A table of acceptance criteria and reported device performance.
• Details on sample size, data provenance, or ground truth establishment for a test set.
• Information on expert adjudication or qualifications.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information on standalone algorithm performance.
• Details on the sample size or ground truth for a training set.

The document only states the "Indications For Use" of the ACTH IRMA Assay.

Therefore, I cannot provide the requested information based on the input text.

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