(14 days)
ST AIA-PACK CA 125 is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 125 in human serum on specific TOSOH AIA System analyzers. ST AIA-PACK CA 125 is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
The ST AIA-PACK CA 125 is a two-site immunoenzymometric assay which is performed entirely in the AIA-PACK. CA 125 present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the AIA-PACK. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbellifery| phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the CA 125 concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.
The provided document is a 510(k) summary for the ST AIA-PACK CA 125 device, which is an in vitro diagnostic assay. It primarily describes the device, its intended use, and its substantial equivalence to a predicate device.
Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation studies.
The 510(k) is for a modification to an already cleared device (K990431), specifically concerning changes in packaging and incubation period. The submission argues that these modifications "are not substantial changes and do not affect the safety and effectiveness of the device." Therefore, it likely relies on the performance data of the original predicate device rather than presenting new, detailed performance studies for clinical acceptance criteria.
Without this information, I cannot complete the table or answer the specific questions thoroughly. However, I can infer some general aspects from the document’s purpose.
Here's an attempt to answer based on the lack of information in the provided text and what a 510(k) generally entails:
1. Table of Acceptance Criteria and Reported Device Performance
(This information is not explicitly provided in the document. A 510(k) summary for a modification often refers to the performance of the predicate device rather than presenting new data. For a full new device clearance, such data would be expected.)
| Acceptance Criteria Category | Specific Criteria (Expected for IVD) | Reported Device Performance (Not present in document) |
|---|---|---|
| Accuracy | Correlation with predicate device, recovery studies | (Likely demonstrated through equivalence to predicate, but not detailed here) |
| Precision (Repeatability/Reproducibility) | Within-run, between-run, between-lot CV% | (Likely demonstrated through equivalence to predicate, but not detailed here) |
| Linearity/Assay Range | Acceptable linearity across reportable range | (Likely demonstrated through equivalence to predicate, but not detailed here) |
| Analytical Sensitivity | Limit of Detection (LoD), Limit of Quantitation (LoQ) | (Likely demonstrated through equivalence to predicate, but not detailed here) |
| Specificity | Interference, cross-reactivity | (Likely demonstrated through equivalence to predicate, but not detailed here) |
| Stability | Reagent, calibrator, sample stability | (Likely demonstrated as unchanged from predicate, but not detailed here) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. Given it's a 510(k) for a modification (packaging and incubation period) and refers to "substantial equivalence" to a predicate, it's highly probable that new clinical test sets were not used. The focus is on demonstrating that the modification does not alter the established performance of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/not specified. For an in vitro diagnostic (IVD) assay like this, "ground truth" typically refers to the analytical performance (e.g., accuracy against a reference method or established clinical cut-offs), not expert consensus on images or clinical diagnoses for a test set.
- Qualifications of Experts: N/A.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/not specified. This method is usually relevant for human-interpreted data (e.g., radiology reads) where discrepancies between reviewers need to be resolved. For an automated IVD assay, the 'judgment' is algorithmic based on predefined analytical parameters.
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. This is an IVD assay measuring a biomarker (CA 125), not an imaging device or AI-assisted diagnostic tool that involves human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: The device is a standalone diagnostic assay (an immunoenzymometric assay). Its performance is evaluated analytically (accuracy, precision, etc.) and its use is "as an aid in monitoring response to therapy." The document implies that the performance characteristics (which would have been established for the predicate device) remain unchanged with the modification. However, specific standalone performance study results for the modified device are not provided in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not specified in this document. For a CA 125 assay, the "ground truth" for analytical performance studies typically involves:
- Reference materials/calibrators: Samples with known concentrations of CA 125 for accuracy and linearity.
- Patient samples: Often used in method comparison studies against a legally marketed predicate device or a gold standard method.
- Clinical correlation: Evaluating the assay's ability to monitor therapeutic response in patients with ovarian cancer, often in conjunction with other clinical methods and patient outcomes.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/not specified. As an immunoenzymometric assay, it is not an AI/machine learning model that requires a "training set" in the conventional sense. The assay works based on established biochemical principles and reagents.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. (See answer to #8). The device's operational parameters (e.g., standard curve construction) are established through a calibration process, not "training" with a labeled dataset.
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.