(31 days)
For use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of total antibody (IgG and IgM) to hepatitis B core antigen (total anti-HBc) in human serum and plasma (EDTA and citrate). The performance of the Vitros Immunodiagnostic Products Anti-HBc Controls has not been established with any other anti-HBc assays.
Vitros Anti-HBc Controls contain two levels of controls in separate vials. Control 1: Normal human plasma obtained from donors who were tested individually and found to be negative for hepatitis B surface antigen (HBsAg), and for antibodies to human immunodeficiency virus (anti-HIV 1+2) and hepatitis C virus (anti-HCV) using FDA approved methods (enzyme immunoassays). Control 2: Anti-HBc positive plasma diluted in normal human plasmas were obtained from donors who were tested individually and found to be negative HBsAg. and for antibodies to HIV 1+2 and HCV using FDA approved methods (enzyme immunoassays). The anti-HBc positive plasma has also been tested and shown to be positive for anti-HBc antibody. Both controls contain antimicrobial agent. The controls are assigned values from a minimum of 10 assays. The standard deviation is that which would be anticipated for single determinations of each control in a number of different laboratories using different reagent batches.
The provided document is a 510(k) summary for a medical device called "Vitros Immunodiagnostic Products Anti-HBc Controls". This device is a quality control material and not an AI/ML-driven diagnostic device. Therefore, the information requested in your prompt (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI performance validation) is not typically applicable or available in this type of regulatory submission for a control product.
The document focuses on demonstrating substantial equivalence to a predicate device for this control material, rather than proving diagnostic performance against acceptance criteria in the way an AI diagnostic would.
However, I can extract information relevant to acceptance criteria and performance as presented for this control device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the characteristics and intended use of the control device itself, and compares it to a predicate control device. It doesn't present "acceptance criteria" in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC) but rather in terms of the characteristics of the control material and how its expected values are established.
| Characteristic | Acceptance Criteria (as described for new device) | Reported Device Performance (as described for new device) |
|---|---|---|
| Intended Use | For use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for qualitative detection of total antibody (IgG and IgM) to hepatitis B core antigen (total anti-HBc) in human serum and plasma (EDTA and citrate). Performance not established with other anti-HBc assays. | The device meets this intended use, providing controls for the specified system and assay. |
| Matrix of Controls | Human serum with added antimicrobial agents. | Control 1: Normal human plasma. Control 2: Anti-HBc positive plasma diluted in normal human plasmas. Both contain antimicrobial agent. |
| Control Levels | Two levels of controls (Control 1 and Control 2) | Control 1 (Normal human plasma): Negative for HBsAg, anti-HIV 1+2, anti-HCV. Control 2 (Anti-HBc positive plasma): Positive for anti-HBc antibody, negative for HBsAg, anti-HIV 1+2, anti-HCV. |
| Expected Values | Each control has a quoted mean value derived from a minimum of 10 assays and a standard deviation anticipated for single determinations in a number of different laboratories using different reagent lots. Values are lot specific. | Values are assigned from a minimum of 10 assays. The standard deviation is stated to be that which would be anticipated for single determinations of each control in a number of different laboratories using different reagent batches. |
Study Proving Device Meets Acceptance Criteria:
The document states: "The controls are assigned values from a minimum of 10 assays. The standard deviation is that which would be anticipated for single determinations of each control in a number of different laboratories using different reagent batches." This indicates a multi-laboratory study was performed to establish the expected values and variability of the controls.
2. Sample size used for the test set and the data provenance:
- Test set sample size: For establishing control values, it is stated that values are assigned from a minimum of 10 assays. This implies at least 10 measurements were taken for each control level to determine its mean and standard deviation.
- Data provenance: The document does not specify the country of origin of the data. It mentions "human plasma obtained from donors" and "different laboratories." The study appears to be prospective in nature for the establishment of control values, as these controls are created and then characterized.
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. The "ground truth" for a control material is its chemical or biological composition (e.g., "negative for HBsAg," "positive for anti-HBc antibody") and its performance characteristics (mean and standard deviation). These are established through laboratory testing, not by expert consensus or interpretation in the way an AI diagnostic would require.
4. Adjudication method for the test set:
Not applicable for a control material characterization.
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 a quality control material, not an AI diagnostic that would assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical control material, not an algorithm.
7. The type of ground truth used:
The ground truth for the control materials themselves is their inherent biological status and quantitative assays.
- Control 1: "Normal human plasma obtained from donors who were tested individually and found to be negative for hepatitis B surface antigen (HBsAg), and for antibodies to human immunodeficiency virus (anti-HIV 1+2) and hepatitis C virus (anti-HCV) using FDA approved methods (enzyme immunoassays)."
- Control 2: "Anti-HBc positive plasma... tested and shown to be positive for anti-HBc antibody" and "negative for HBsAg, and for antibodies to HIV 1+2 and HCV using FDA approved methods (enzyme immunoassays)."
The "ground truth" for the assigned values (mean and standard deviation) is the statistical analysis of experimental results from repeated measurements.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.