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510(k) Data Aggregation
(203 days)
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:
| Performance Metric | Acceptance Criteria (Internal/Guideline) | Reported Device Performance |
|---|---|---|
| Precision (Within-Run CV%) | Not explicitly stated as acceptance criteria, but within typically acceptable ranges for immunoassays. | Reagent Set #1: Level A: 3.1%, Level B: 2.1%, Level C: 1.5%Reagent Set #2: Level A: 2.8%, Level B: 2.1%, Level C: 2.1%Reagent Set #3: Level A: 2.2%, Level B: 2.3%, Level C: 2.2% |
| Precision (Total CV%) | Not explicitly stated as acceptance criteria, but within typically acceptable ranges for immunoassays. | Reagent Set #1: Level A: 3.3%, Level B: 2.5%, Level C: 2.2%Reagent Set #2: Level A: 4.2%, Level B: 3.8%, Level C: 3.4%Reagent Set #3: Level A: 2.5%, Level B: 2.8%, Level C: 2.2% |
| Linearity | Repeatability CV% <= 10% | Repeatability CV% met the criterion of <= 10%. Linear from 2.0 to 2,000 pg/mL. |
| Correlation (Slope) | Not explicitly stated as acceptance criteria, but compared to predicate. | Deming: 1.10 (95% CI: 1.075 to 1.116)Regular: 1.09 (95% CI: 1.067 to 1.107) |
| Correlation (Intercept) | Not explicitly stated as acceptance criteria, but compared to predicate. | Deming: -0.84 (95% CI: -8.921 to 7.234)Regular: 0.76 (95% CI: -7.305 to 8.817) |
| Correlation Coefficient (R) | Not explicitly stated as acceptance criteria, but compared to predicate. | 0.993 |
| Bias | Not explicitly stated as acceptance criteria, but reported for comparison. | All samples: 17.8 pg/mLAt medical decision point (7.4-64.3 pg/mL): 4.87 pg/mLAt 7.73 pg/mL: -0.87 pg/mLAt 64.97 pg/mL: -17.93 pg/mL |
| Limit of Quantitation (LoQ) | Not explicitly stated as an acceptance criterion for the study, but the assay low claim is 2.0 pg/mL. | Calculated LoQ: 1.2 pg/mL (Conservative claim of 2.0 pg/mL in event of lot-to-lot variability) |
| Limit of Detection (LoD) | Not explicitly stated as an acceptance criterion for the study. | 0.7 pg/mL |
| Limit of Blank (LoB) | Not explicitly stated as an acceptance criterion for the study. | 0.5 pg/mL |
| Interference | Recovery within 100 ± 10% | No interference from: Hemoglobin (up to 440 mg/dL), Conjugated bilirubin (up to 19 mg/dL), Free bilirubin (up to 17 mg/dL), Lipemia (up to 1,600 mg/dL triglycerides), Ascorbic acid (up to 20 mg/dL), EDTA.2K (up to 7 mg/mL), Human albumin (up to 5.0 g/dL), Rheumatoid factor (up to 500 IU/mL), Heparin (up to 50 U/mL), Acetominaphen (up to 20 mg/L), Acetylsalicylic acid (up to 300 mg/L), Ampicillin (up to 200 mg/L), Ibuprofen (up to 50 mg/L), Theophylline (up to 10 mg/L). |
| Specificity | Recovery within 90 - 110% | ACTH 1-10: 100-102% recovery at various concentrations.ACTH 11-24: 98-99% recovery at various concentrations.Beta-MSH: 95-100% recovery at various concentrations.Beta-Endorphin: 97-100% recovery at various concentrations. |
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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