(43 days)
Pancreatic Amylase (PAM) Reagent is intended for the quantitative determination of pancreas-specific amylase activity in human serum, plasma or urine on SYNCHRON Systems. Measurement of pancreatic amylase is useful in the diagnosis and treatment of pancreatitis.
Beckman Coulter's Pancreatic Amylase (PAM) Reagent is a liquid stable, ready-to-use reagent designed for optimal performance on the SYNCHRON CX and LX Systems. The assay is intended for use in the quantitative determination of pancreas-specific amylase activity in human serum, plasma, or urine. The reagent kit contains two 60-test cartridges.
The provided document describes the safety and effectiveness of the SYNCHRON® Systems Pancreatic Amylase Reagent through a comparison to a predicate device. The information focuses on equivalency to the predicate device and does not involve AI or human reader performance. Therefore, many of the requested categories related to AI performance, expert adjudication, or MRMC studies are not applicable.
Here's the available information relevant to your request, with "Not Applicable" for categories that do not fit this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are demonstrated through method comparison and precision experiments against a legally marketed predicate device. While explicit numerical acceptance criteria for the method comparison are not stated, the conclusion is that the data supports "substantial equivalence."
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (SYNCHRON LX Systems PAM Imprecision) |
|---|---|---|
| Within-Run Imprecision | Not explicitly stated (Substantial Equivalence to Predicate) | |
| Serum Control 1 Mean | 64 U/L | |
| Serum Control 1 S.D. | 0.8 U/L | |
| Serum Control 1 %C.V. | 1.3 % | |
| Serum Control 2 Mean | 410 U/L | |
| Serum Control 2 S.D. | 3.3 U/L | |
| Serum Control 2 %C.V. | 0.8 % | |
| Serum Control 3 (ORDAC) Mean | 772 U/L | |
| Serum Control 3 (ORDAC) S.D. | 8.3 U/L | |
| Serum Control 3 (ORDAC) %C.V. | 1.1 % | |
| Urine Control 1 Mean | 148 U/L | |
| Urine Control 1 S.D. | 1.0 U/L | |
| Urine Control 1 %C.V. | 0.7 % | |
| Total Imprecision | Not explicitly stated (Substantial Equivalence to Predicate) | |
| Serum Control 1 Mean | 64 U/L | |
| Serum Control 1 S.D. | 2.7 U/L | |
| Serum Control 1 %C.V. | 4.3 % | |
| Serum Control 2 Mean | 410 U/L | |
| Serum Control 2 S.D. | 4.5 U/L | |
| Serum Control 2 %C.V. | 1.1 % | |
| Serum Control 3 (ORDAC) Mean | 772 U/L | |
| Serum Control 3 (ORDAC) S.D. | 10.5 U/L | |
| Serum Control 3 (ORDAC) %C.V. | 1.4 % | |
| Urine Control 1 Mean | 148 U/L | |
| Urine Control 1 S.D. | 1.9 U/L | |
| Urine Control 1 %C.V. | 1.3 % |
2. Sample size used for the test set and the data provenance
For the imprecision study, test samples included Serum Control 1, Serum Control 2, Serum Control 3 (ORDAC), and Urine Control 1. For each of these, N = 80 measurements were taken for both within-run and total imprecision. The document does not specify the country of origin of the data or whether it was retrospective or prospective, but this is typically prospective data collection during device development.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is an in vitro diagnostic (IVD) device, and ground truth is established through laboratory measurement principles, not expert interpretation in the medical imaging or diagnostic sense. The "ground truth" for the imprecision study is the known concentration of the controls and the established reference method for comparison (the predicate device).
4. Adjudication method for the test set
Not applicable. This type of submission does not involve adjudication by 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 device is an in vitro diagnostic reagent, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone reagent used on an automated analyzer (SYNCHRON LX Systems). The performance data presented (imprecision) is for the device's analytical performance on this system. There is no "algorithm" in the sense of AI, but rather a chemical assay.
7. The type of ground truth used
For the method comparison study, the ground truth is implicitly the results obtained from the predicate device (Beckman Coulter's SYNCHRON CX Pancreatic Amylase (PAMY) Reagent), as the goal is to demonstrate substantial equivalence. For the imprecision studies, the ground truth for the "mean (U/L)" values of the controls are established values for those control materials.
8. The sample size for the training set
Not applicable. This is an IVD reagent, not an AI system that requires a training set. The development of the reagent formulation is based on chemical principles and optimization, not machine learning training.
9. How the ground truth for the training set was established
Not applicable, as there is no training set in the context of AI.
§ 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.