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510(k) Data Aggregation
(145 days)
Clinical Chemistry – The Sentinel Clin Chem Cal is a device intended for medical purposes for use in pancreatic amylase and cholinesterase assays to establish points of reference that are used in the determination of values in the measurement of pancreatic amylase and cholinesterase in human serum and plasma.
The Sentinel Clin Chem Cal is a device intended for medical purposes for use in pancreatic amylase and cholinesterase assays to establish points of reference that are used in the determination of values in the measurement of pancreatic amylase and cholinesterase in human serum and plasma. Sentinel Clin Chem Cal contains the analytes in human serum matrix. The analytes consist of pancreatic amylase and cholinesterase.
The provided text describes the acceptance criteria and the study that proves the device (Sentinel Clin Chem Cal) meets the acceptance criteria for Calibrator Shelf-life Stability and Calibrator After Reconstitution Stability.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and the Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Calibrator Shelf-life Stability | 95% to 105% recovery compared to Time zero | Calibrators showed stability for up to 33 months (See Table 1). For Pancreatic Amylase, % Recovery ranged from 97.2% to 103.6%. For Cholinesterase, % Recovery ranged from 97.9% to 101.8%. The claimed shelf-life is 24 months from the date of manufacture. |
| Calibrator After Reconstitution Stability (2-8°C) | 100% ± 7% recovery (i.e., 93-107%) between days | Pancreatic Amylase (Table 2): After 2 days at 2-8°C, %R (2d vs To) for the three lots tested were 103%, 102%, and 101%, respectively. All within the 93-107% range. Cholinesterase (Table 3): After 2 days at 2-8°C, %R (2d vs To) for the three lots tested were 100%, 100%, and 100%, respectively. All within the 93-107% range. |
| Calibrator After Reconstitution Stability (-20°C) | 100% ± 7% recovery (i.e., 93-107%) between days | Pancreatic Amylase (Table 2): After 14 days at -20°C, %R (30d vs To) for the three lots tested were 104%, 103%, and 102%, respectively. All within the 93-107% range. Cholinesterase (Table 3): After 14 days at -20°C, %R (30d vs To) for the three lots tested were 100%, 100%, and 100%, respectively. All within the 93-107% range. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Calibrator Shelf-life Stability: One lot of Sentinel Clin Chem Cal was used for the test. The stability was monitored prospectively by testing at multiple time points through a minimum of 30 months (and reported up to 33 months). The origin of the data is not explicitly stated but is implicitly from the manufacturer, Sentinel CH. Srl in Milan, Italy.
- Calibrator After Reconstitution Stability: Three lots of calibrator were used for the test (one expired from 13 months, one expired from 8 months, and one still in validity). The study was prospective in nature, assessing stability at specific time points after reconstitution. The origin of the data is implicitly from the manufacturer, Sentinel CH. Srl in Milan, Italy.
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 device is a calibrator for in-vitro diagnostic assays, not an AI or imaging device requiring expert ground truth for interpretation. The ground truth for this device's performance is based on analytical measurements against defined reference standards and the inherent property of a calibrator to maintain its assigned value over time and under specified conditions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an imaging or diagnostic device requiring adjudication of human-interpreted 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
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is an IVD calibrator, not an algorithm. The "standalone" performance is equivalent to the reported analytical performance of the calibrator itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the calibrator's assigned values and stability assessments is based on:
- Traceability to Reference Standards: The Pancreatic Amylase is traceable to IFCC EPS / 37 °C using $\varepsilon$ p-Nitrophenol. Cholinesterase is traceable to DGKC Butyrylthiocholine 37 °C using $\varepsilon$ Hexacyano-ferrate (III).
- Methodology of Value Assignment: Assigned values are determined by taking the mean of measurements from multiple replicates across different instruments (Hitachi 717 and Abbott ARCHITECT® c8000), calibrated against a previous calibrator lot. This establishes the initial "true" or assigned value.
- Recovery Method: For stability studies, the performance is measured as a percentage recovery compared to the "time zero" measurement, which serves as the reference or ground truth for that specific lot.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that typically requires a 'training set'.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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