(498 days)
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack quantitatively measures intact parathyroid hormone (iPTH) in human serum and plasma (K2-EDTA, lithium heparin) using the automated VITROS 3600 Immunodiagnostic System.
Intact PTH is indicated to aid in the diagnosis of hyperparathyroidism, differential diagnosis of hypocalcemia or hypercalcemia and for intraoperative measurement of iPTH levels.
The VITROS Immunodiagnostic Products Intact PTH II assay is performed using the VITROS Intact PTH II Reagent Pack and the VITROS Intact PTH II Calibrators on the VITROS 3600 Immunodiagnostic System.
VITROS Intact PTH II Reagent Pack contains:
1 reagent pack containing:
- 100 coated wells (biotinylated anti-PTH antibody, 2ug/ml). ●
- 7.4 mL assay reagent as buffer with bovine gamma globulin, bovine serum albumin, and antimicrobial agent.
- 7.4 mL conjugate reagent (HRP-mouse monoclonal anti-PTH, 6 ug/mL) in buffer with bovine serum albumin and antimicrobial agent).
The provided text is a 510(k) premarket notification for Ortho-Clinical Diagnostics' VITROS Immunodiagnostic Products Intact PTH II Reagent Pack, a device for quantitatively measuring intact parathyroid hormone (iPTH). While it details various performance characteristics, it does not describe an AI/ML-based device and therefore does not contain information on acceptance criteria for such a device, nor an AI/ML specific study.
The document focuses on the analytical and clinical performance of an in vitro diagnostic (IVD) assay, comparing it to a predicate device (Roche Elecsys PTH assay). The studies described are typical for IVD assays: precision, linearity, detection limits, analytical specificity (interference and cross-reactivity), and method comparison against a commercially available PTH assay and a clinical study for intra-operative use.
Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria and study details from the provided text. The questions below are specifically tailored for AI/ML device evaluations.
However, I can provide the available information relevant to the IVD device's performance studies:
Based on the provided document, here is the information available for the VITROS Immunodiagnostic Products Intact PTH II Reagent Pack, noting that it is an IVD assay, not an AI/ML device:
1. A table of acceptance criteria and the reported device performance
The document does not formally present a table of "acceptance criteria" against which performance is measured in the same way an AI/ML device would demonstrate specified accuracy metrics. Instead, it presents various performance characteristics and states that results "met the acceptance criteria" for certain comparisons without detailing those criteria explicitly in a table.
However, key performance parameters and their reported values are listed below:
| Performance Parameter | Reported Device Performance |
|---|---|
| Measuring (Reportable) Range | 6.8–5000 pg/mL (0.7–530 pmol/L) |
| Limit of Blank (LoB) | 0.8 pg/mL |
| Limit of Detection (LoD) | 1.2 pg/mL |
| Limit of Quantitation (LoQ) | 1.2 pg/mL (at 20% CV) |
| Precision (Repeatability) | CV% between 0.9% and 1.3% across different concentration levels |
| Precision (Within Lab) | CV% between 1.5% and 3.0% across different concentration levels |
| Method Comparison (vs. Predicate) | |
| Slope (VITROS 3600 vs. Comparative Method) | 1.01 |
| Correlation Coefficient (r) | 0.991 |
| Intercept | 0.3 (pg/mL) / 0.0 (pmol/L) |
| Matrix Comparison (Serum vs. Plasma) | Slopes between 0.988 and 1.011; Correlation Coefficients between 0.973 and 0.996 (for K2-EDTA, Li-Hep, Na-Hep plasma vs. serum) |
| Intra-operative Clinical Study Agreement | |
| Primary Endpoint Positive Agreement | 100% (29/29) |
| Primary Endpoint Negative Agreement | 100% (3/3) |
| Primary Endpoint Overall Agreement | 100% (32/32) |
2. Sample size used for the test set and the data provenance
- Precision/Reproducibility: Patient pools tested with 80 observations (measurements) over 20 days for each concentration level. Data provenance not specified (country of origin, retrospective/prospective implied as prospective measurement in lab).
- Method Comparison: 206 patient (serum) samples. Data provenance not specified.
- Intra-operative Clinical Study: 32 subjects (sets of specimens) qualified for primary endpoints. Data provenance not specified (likely prospective for the study measurements, but subjects were undergoing surgery, so possibly a mix of retrospective patient selection and prospective sample collection).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This device is an IVD assay, not an imaging/AI device requiring expert interpretation for ground truth. Ground truth for an IVD is established by standardized reference methods or the performance of a predicate device/comparator assay.
- For the intra-operative clinical study, the "success" criterion for surgery (50% or greater drop in PTH level) is based on the result from the comparator assay (hospital's assay) and the investigational device, rather than expert judgment on the device's output.
4. Adjudication method for the test set
- Not applicable as this is an IVD assay measuring a biomarker concentration, not an AI/ML device relying on human interpretation or adjudication of output.
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 as this is an IVD assay, not an AI/ML imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device is a standalone IVD assay. Its performance (precision, linearity, detection limits, analytical specificity, method comparison) is evaluated directly, without human interpretation of its output in the sense of an AI/ML diagnosis. The intra-operative study compares its quantitative results to another quantitative assay.
7. The type of ground truth used
- Analytical Performance (Precision, Linearity, Detection Limits): Established through laboratory testing using controlled samples (e.g., patient pools, dilutions, blanks) according to CLSI (Clinical and Laboratory Standards Institute) protocols (EP05, EP06, EP17). The "ground truth" here is the expected value of the controlled sample or the known characteristics of the samples used.
- Analytical Specificity (Interference, Cross-Reactivity): Known concentrations of interferents or cross-reactants added to samples with known PTH concentrations. Ground truth is the unbiased PTH value.
- Method Comparison: Comparison against a "commercially available PTH assay" (presumably the predicate device, although it's not explicitly named as such in this section, it's implied by "comparative method") as the reference.
- Intra-operative Clinical Study: The "success" criterion (50% or greater drop in PTH) was determined by comparing the device's results to the results from the hospital's (comparator) assay for the same patient samples. The "ground truth" for surgical success was defined by this 50% drop as measured by the comparator, and the study assessed concordance.
8. The sample size for the training set
- Not applicable. This is an IVD assay, not an AI/ML algorithm that requires a "training set." The system is a reagent pack and instrument system, not a learned model.
9. How the ground truth for the training set was established
- Not applicable (no training set for an IVD assay).
§ 862.1545 Parathyroid hormone test system.
(a)
Identification. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.(b)
Classification. Class II.