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510(k) Data Aggregation
(60 days)
Atellica CH Amylase_2 (AMY_2)
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.
| Performance Characteristic | Acceptance Criteria (Implicit from Predicate & CLSI Guidelines) | Reported Device Performance (Atellica® CH Amylase_2) |
|---|---|---|
| Detection Limit (LoB) | Not explicitly stated; generally as low as feasible and clinically relevant. | 1 U/L (Serum/Plasma/Urine) |
| Detection Limit (LoD) | Not explicitly stated; generally as low as feasible and clinically relevant. | 7 U/L (Serum/Plasma), 9 U/L (Urine) |
| Quantitation Limit (LoQ) | Clinically relevant low end of the measuring interval with Total Error ≤ 30%. | 18 U/L (Serum/Plasma) with TE ≤ 30%; 19 U/L (Urine) with TE ≤ 30% |
| Linearity (Measuring Interval) | Linear across the claimed measuring interval; p-values of non-linear terms > 0.05, OR allowable bias ≤ 10% or ≤ 10 U/L. | Demonstrated linear from 20 to 1500 U/L (Serum, Plasma, Urine). |
| Precision (Repeatability CV) | Not explicitly stated; typically low CV% for analytical methods. | 0.2% - 1.7% (Depends on sample & concentration) |
| Precision (Within-Lab CV) | Not explicitly stated; typically low CV% for analytical methods. | 0.4% - 2.2% (Depends on sample & concentration) |
| Interferences (Bias) | Bias exceeding 10% is considered interference. | No significant interference for Hemoglobin (500 mg/dL), Bilirubin (conjugated 30 mg/dL, unconjugated 30 mg/dL), Lipemia (Intralipid® 650 mg/dL), Acetaminophen (30 mg/dL), Ascorbic Acid (20 mg/dL), Acetylsalicylic Acid (200 mg/dL). |
| Method Comparison (Correlation) | Not explicitly stated; typically good correlation (high 'r' value) and a regression equation close to y=x for substantial equivalence. | Serum: r=0.996, y = 1.09x + 0 U/L (vs. Roche Cobas) |
| Urine: r=0.998, y = 1.11x - 1 U/L (vs. Roche Cobas) | ||
| Matrix Equivalency (Correlation) | Not explicitly stated; typically good correlation and a regression equation close to y=x. | Plasma (Lithium heparin) vs Serum: r=1.000, y = 1.00x + 0 U/L |
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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