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510(k) Data Aggregation
(141 days)
The Sentinel Ceruloplasmin assay is used for the quantitation of ceruloplasmin (copper-transporting serum protein) levels in human serum or plasma. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorder.
Sentinel Ceruloplasmin is an in vitro diagnostic assay for the quantitative determination of ceruloplasmin in serum or plasma. The Sentinel Ceruloplasmin assay is a two-reagent format based on the immunological reaction between anti-ceruloplasmin antibonds specific for ceruloplasmin. The turbidity of the immunocomplex is proportional to the concentration of the analyte in the sample.
Here's an analysis of the provided text regarding the Sentinel Ceruloplasmin assay, broken down according to your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Sentinel Ceruloplasmin) |
|---|---|---|
| Method Correlation (Slope) | Close to 1.0 (indicating good agreement) | 1.0256 |
| Method Correlation (Y-intercept) | Close to 0 (indicating no systematic bias) | -1.0205 mg/dL |
| Total %CV (Precision) - Level 1 | Comparable to predicate (not explicitly stated, but generally <10% for clinical assays) | 3.69% |
| Total %CV (Precision) - Level 2 | Comparable to predicate | 5.33% |
| Total %CV (Precision) - Level 3 | Comparable to predicate | 4.53% |
| Linearity (Upper Limit) | At least comparable to predicate assay | Up to 110 mg/dL |
| Limit of Quantitation (Sensitivity) | At least comparable to predicate assay | 2 mg/dL |
Study Proving Device Meets Acceptance Criteria:
The study conducted to prove the device meets the acceptance criteria is a comparative performance study against a legally marketed predicate device, the Roche Ceruloplasmin assay on the Roche/Hitachi 911 Analyzer. This study focused on demonstrating substantial equivalence in performance characteristics.
Detailed Information about the Study:
- Test Description: "Sentinel Ceruloplasmin is an in vitro diagnostic assay for the quantitative determination of ceruloplasmin in serum or plasma."
- Substantial Equivalence Claim: "The Sentinel Ceruloplasmin assay is substantially equivalent to the Roche Ceruloplasmin assay (which was exempted from the Premarket Notification) on the Roche/Hitachi 911 Analyzer (Previously named Boehringer Mannheim Hitachi 911 Analyzer, K921661). These assays yield similar Performance Characteristics."
- Study Execution: "Comparative performance studies were conducted using the AEROSET® System."
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: The document does not explicitly state the sample size used for the comparative performance study or the precision studies.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given the nature of in vitro diagnostic device studies, it's typically prospective data collected in a controlled laboratory setting, but this is not confirmed in the text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of device and study. The "ground truth" for this in vitro diagnostic assay is established by the direct measurement of ceruloplasmin concentration using the predicate device, not by expert interpretation.
4. Adjudication Method for the Test Set
This information is not applicable to this type of in vitro diagnostic device study. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology studies where multiple readers interpret images to establish a consensus ground truth). Here, the comparison is between two quantitative assays.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers and is relevant for AI-powered diagnostic tools, not for a standalone in vitro diagnostic assay like Sentinel Ceruloplasmin.
- Effect Size of AI Improvement: This is not applicable as there is no AI component or human-in-the-loop scenario described for this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The "comparative performance studies" and "precision studies" evaluate the Sentinel Ceruloplasmin assay as a standalone device, comparing its quantitative results directly to the predicate device's quantitative results. There is no human interpretation or human-in-the-loop component mentioned.
7. The Type of Ground Truth Used
The "ground truth" for evaluating the Sentinel Ceruloplasmin assay was the results obtained from the legally marketed predicate device, the Roche Ceruloplasmin assay on the Roche/Hitachi 911 Analyzer. This is considered a "reference method" or "comparator" for establishing substantial equivalence.
8. The Sample Size for the Training Set
The document does not mention a training set. This is because the Sentinel Ceruloplasmin assay is a traditional in vitro diagnostic device (immunological reaction leading to turbidity measurement), not a machine learning or AI-based algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no training set for this traditional in vitro diagnostic device.
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