(240 days)
Human CH50 reagent pack for use on the SPA plus. These reagents are intended for the quantification of total classical complement activity (CH50) in human serum on the Binding Site SPAPLUS analyser. Measurement of complement activity aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components. The test results are to be used in conjunction with clinical findings and other laboratory tests. Human CH50 calibrator set for use on the SPA plus The Human CH50 calibrator set is intended for use on the SPAPLUS in conjunction with the Binding Site Human CH50 reagent pack (product code: NK095.S) for the determination of total complement activity. Human CH50 controls for use on the SPA plus. The Human CH50 controls are intended for use in conjunction with the Binding Site Human CH50 reagent pack for use on the SPAPLUS (product code: NK095.S).
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This looks like a 510(k) clearance letter for an in vitro diagnostic (IVD) device, not a typical AI/ML-driven medical device. Therefore, many of the requested elements (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not directly applicable in the same way they would be for an AI algorithm that processes images or other complex data.
However, I can extract the acceptance criteria and performance information as typically presented in IVD submissions, focusing on analytical performance rather than diagnostic accuracy determined by human experts.
Here's the breakdown based on the provided text, interpreting "acceptance criteria" as the performance specifications and "reported device performance" as the results confirming those specifications:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (a 510(k) clearance letter and Indications for Use) does not contain the detailed acceptance criteria or the study results. This information is typically found in the 510(k) submission itself, often in sections detailing analytical performance studies (e.g., precision, accuracy, linearity, interfering substances). The clearance letter only confirms that the FDA reviewed the information and found the device substantially equivalent.
To illustrate what such a table would look like for an IVD, and as an example if this information were available in the submission, here's a hypothetical structure:
| Performance Characteristic | Acceptance Criteria (Hypothetical) | Reported Device Performance (Hypothetical) |
|---|---|---|
| Precision (Within-Run CV) | ≤ 5% | Sample A: 2.5%, Sample B: 3.1% |
| Precision (Total CV) | ≤ 8% | Sample A: 4.8%, Sample B: 5.9% |
| Accuracy (Bias vs. Reference) | Mean Bias ≤ 10% | Mean Bias: 3.7% |
| Linearity (R-squared) | > 0.98 | 0.995 |
| Interfering Substances | No significant interference (≤ 10% change) for common interferents at specified concentrations. | Met for hemoglobin, bilirubin, triglycerides (details would be in submission). |
| Detection Limit | Undisclosed range, but sufficient for clinical utility. | 5 CH50 U/mL (for example) |
| Range (Analytical Measurement Range) | 10 to 100 CH50 U/mL | 10 to 100 CH50 U/mL (confirmed) |
| Specificity | No cross-reactivity with indicated substances (e.g., C-reactive protein, other complement components) | Confirmed lack of significant cross-reactivity. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the clearance letter or the Indications for Use. For an IVD like this, "test set" would refer to the clinical samples used for analytical verification and validation studies.
- Sample Size: Unknown from this document. IVD studies typically use a range of samples for different studies (e.g., dozens for precision, hundreds for accuracy, specific spiked samples for interference).
- Data Provenance: Unknown from this document. Such studies often use samples collected from various clinical sites, and the country of origin would be part of the detailed study reports within the 510(k) submission. They are typically prospective or retrospective clinical samples, chosen to represent the target patient population.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This specific type of "expert ground truth" as it applies to AI/ML algorithms (e.g., radiologists interpreting images) is not applicable here. For an IVD measuring a biomarker like CH50, the "ground truth" is established through:
- Reference Methods: Comparing the device's results to a recognized, often more laborious or expensive, reference method for CH50 measurement.
- Certified Reference Materials: Using materials with known, assigned CH50 values.
- Clinical Outcomes/Pathology (indirectly): While CH50 levels are used in the diagnosis of immunological disorders, the "ground truth" for the device's measurement itself is analytical accuracy, not a clinical diagnosis established by interpreting the results alone.
4. Adjudication Method for the Test Set
Not Applicable in the context of expert adjudication for an IVD measuring a specific analyte. Adjudication applies to subjective interpretations, not quantitative measurements compared to a reference.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not Applicable. MRMC studies are used for evaluating human reader performance, often with imaging devices, and are not relevant for a quantitative in vitro diagnostic like a CH50 reagent pack.
6. Standalone Performance
Yes, in a way. An IVD device's performance is its standalone performance. The studies performed to support this 510(k) would have demonstrated the analytical performance of the "Human CH50 reagent pack for use on the SPAPLUS" system as a whole, without human interpretation of raw data (other than running the instrument and interpreting the quantitative result displayed).
7. Type of Ground Truth Used
The ground truth for an IVD measuring a specific analyte like CH50 would typically be established by:
- Reference Methods: Comparison against established, often gold-standard, laboratory methods for CH50 (e.g., standard hemolytic assays).
- Calibrators and Controls: Using materials with precisely assigned values, traceable to international standards if available.
- Spiked Samples: Samples engineered with known concentrations of the analyte to test linearity and recovery.
8. Sample Size for the Training Set
Not Applicable. This is an IVD reagent and calibrator/control set, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" for such a system involves the chemical and biological formulation of reagents, optimization of the analytical method, and instrument calibration, not machine learning model training.
9. How the Ground Truth for the Training Set was Established
Not Applicable for an IVD reagent system. The concept of "ground truth for a training set" specifically applies to machine learning algorithms.
§ 866.5240 Complement components immunological test system.
(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).