(44 days)
IL Test™ Amylase is an in vitro diagnostic test for use with Instrumentation Laboratory's line of clinical chemistry systems in the quantitative determination of amylase in human serum, plasma or urine by CNP-Maltotrioside methodology. Amylase is used in the diagnosis and treatment of pancreatitis.
IL Test™ Amylase is an in vitro diagnostic test for use with Instrumentation Laboratory's line of clinical chemistry systems in the quantitative determination of amylase in human serum, plasma or urine by CNP-Maltotrioside methodology.
Here's a breakdown of the acceptance criteria and the study details for the IL Test™ Amylase, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria/Metric | Reported Device Performance |
|---|---|---|
| Method Comparison (Serum) | Correlation (r) to predicate IL Test™ Amylase | 1.000 (47 samples) |
| Method Comparison (Urine) | Correlation (r) to predicate IL Test™ Amylase | 0.999 (71 samples) |
| Precision (Serum - Low) | Within-run CV | 1.6 % at a mean of 49 U/L |
| Precision (Serum - High) | Within-run CV | 1.0 % at a mean of 157 U/L |
| Precision (Urine - Low) | Within-run CV | 1.5 % at a mean of 278 U/L |
| Precision (Urine - High) | Within-run CV | 1.6 % at a mean of 302 U/L |
| Substantial Equivalence | Same intended use, substantially equivalent performance and safety/effectiveness to predicate device | Met |
Study Details
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Sample sizes used for the test set and the data provenance:
- Serum samples: 47 samples
- Urine samples: 71 samples
- Data provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, the context of a 510(k) submission for a diagnostic device suggests these would typically be clinical or analytically relevant samples.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This study evaluates an in vitro diagnostic test against a predicate device, not against a clinical expert's interpretation. The "ground truth" for the test set is established by the results from the predicate IL Test™ Amylase device. Therefore, human experts were not used to establish the ground truth in the traditional sense of image or clinical interpretation.
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Adjudication method for the test set:
- Not applicable. The study compares the new device's quantitative results directly to those of a predicate device. There is no human interpretation or adjudication involved beyond the analytical measurement.
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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 MRMC study was done. This is an in vitro diagnostic device for quantitative determination of amylase, not an imaging or interpretive AI device that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance data presented is for the standalone device (IL Test™ Amylase) in comparison to a predicate device. This is a measurement device, so its performance is inherently "standalone" in generating quantitative results.
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The type of ground truth used:
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The sample size for the training set:
- The document does not mention a training set. This is typical for in vitro diagnostic tests based on established chemical methodologies, where "training" in the machine learning sense is not applicable. The device's methodology is CNP-Maltotrioside, which is a chemical reaction, not a machine learning algorithm requiring a training set.
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How the ground truth for the training set was established:
- Not applicable, as no training set was used or mentioned.
§ 862.1070 Amylase test system.
(a)
Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).(b)
Classification. Class II.