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510(k) Data Aggregation
(26 days)
ST AIA-PACK CEA ENZYME IMMUNOASSAY
ST AIA-PACK CEA is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Carcinoembryonic Antigen (CEA) in human serum to aid in the management of cancer patients in whom changing concentrations of CEA are observed on specific TOSOH AIA System Analyzers.
The ST AIA-PACK CEA is a two-site immunoenzymometric assay which is performed entirely in the AIA-PACK. CEA present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the AJA-PACK. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the CEA concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.
The provided text is a 510(k) summary for the ST AIA-PACK CEA device. This type of document focuses on establishing substantial equivalence to a predicate device for regulatory clearance, rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial report would.
Therefore, much of the requested information (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance details) is not available in the provided text.
Based on the available information, here's what can be extracted:
1. Table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria. Instead, it relies on the concept of "substantial equivalence" to a predicate device.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Equivalence in intended use | The intended use is equivalent to the predicate device. |
| Equivalence in assay principles | The assay principles are equivalent to the predicate device. |
| Equivalence in antibody type | The antibody type is equivalent to the predicate device. |
| Equivalence in analyte detected | The analyte detected is equivalent to the predicate device. |
| Equivalence in performance characteristics | The performance characteristics are equivalent to the predicate device. |
| Modifications do not affect safety and effectiveness | The proposed modifications (packaging, incubation period, conjugate, conjugate diluent) are not substantial changes and do not affect the safety and effectiveness of the device. |
2. Sample sized used for the test set and the data provenance
- Sample size for test set: Not mentioned.
- Data provenance: Not mentioned. The document states "performance characteristics of both assays are equivalent," implying that the original predicate device's performance data is being referenced, but no new test set data is provided for the modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a new study with a test set requiring expert ground truth establishment.
4. Adjudication method for the test set
Not applicable. No new test set data is described.
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 immunoassay for quantitative measurement of CEA, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the immunoassay itself. The document explicitly states: "The performance characteristics of both assays are equivalent." This implies that the standalone performance of the modified device is considered equivalent to the previously cleared predicate device (Tosoh AIA-PACK CEA, P910053). Specific new standalone performance data for the modified device is not provided in this summary.
7. The type of ground truth used
The concept of "ground truth" as typically used in AI/diagnostic imaging studies (e.g., pathology, outcomes data) is not directly applicable here. For an immunoassay, the "ground truth" would be the true concentration of CEA in a sample, established through highly accurate reference methods or certified reference materials during the development and validation of the original predicate device. The current document asserts equivalence in performance characteristics.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
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