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510(k) Data Aggregation
(271 days)
The Access Total (BhCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems. The assay is intended for use as an aid in the early detection of pregnancy.
The Access Total BhCG (5th IS) calibrators are intended to calibrate the Access Total BhCG (5" IS) assay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems.
The Access Total βhCG (5" IS) assay (standardized to WHO 5" International Standard), Access Total BhCG (5th IS) calibrators, and the Access Immunoassay analyzers comprise the Access Immunoassay System for the quantitative determination of total βhCG in human serum and plasma.
The provided text describes the performance of the Beckman Coulter Access Total βhCG (5th IS) Assay and Calibrators. The primary "acceptance criteria" for this device, as presented in the 510(k) summary, are derived from various analytical performance studies, which aim to demonstrate substantial equivalence to a predicate device.
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" as a separate compiled list. Instead, performance characteristics are presented as results from various studies. I will infer the acceptance criteria from the reported results and the context of device validation for regulatory submission (e.g., meeting established thresholds for imprecision, linearity, etc.).
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Method Comparison (vs. Predicate): | |
| Slope of Passing-Bablok regression: Approximately 1.00 (CI around 1.00) | Slope = 1.04 (95% CI: 1.02 to 1.06) |
| Intercept of Passing-Bablok regression: Approximately 0 mIU/mL | Intercept = 2.87 mIU/mL |
| Pearson correlation (r): Close to 1.00 | r = 0.99 |
| Imprecision (CV% or SD): | |
| Total imprecision for concentrations > 3.9 mIU/mL: < 10% CV | Total imprecision: 2.6 to 6.6 %CV |
| Total imprecision for concentrations < 3.9 mIU/mL: < 0.39 SD | Total imprecision: < 0.39 SD (at concentrations < 3.9 mIU/mL) |
| High-dose Hook Effect: | |
| No high-dose hook effect observed within expected range | No high-dose hook to 1,000,000 mIU/mL |
| Linearity: | |
| Linear across the assay range | Linear across the range of the assay (0.6 to 1350 mIU/mL) |
| Dilution Recovery: | |
| Average recovery: 100 ± 15% | Average recovery: 100 ± 15% (for 200-fold dilution of samples 1150-270,000 mIU/mL) |
| Limit of Blank (LoB): | |
| LoB: ≤ 0.5 mIU/mL | LoB: ≤ 0.5 mIU/mL |
| Limit of Detection (LoD): | |
| LoD: ≤ 0.5 mIU/mL (95% probability) | LoD: ≤ 0.5 mIU/mL |
| Limit of Quantitation (LoQ): | |
| LoQ: ≤ 0.6 mIU/mL | LoQ: ≤ 0.6 mIU/mL |
| Analytical Specificity: | |
| No significant interference from common interferents | No significant interference from total protein, bilirubin, hemoglobin, or triglycerides. No significant cross-reactivity with similar substances. |
| Isoform Recognition: | |
| Recognizes specified hCG isoforms | Recognizes intact hCG, ß subunit, nicked intact hCG, and nicked ßhCG isoforms. No detectable response from free ɑ-subunit and ß-core fragment. |
| Expected Values (Non-pregnant females): | |
| 100% of samples ≤ 11.6 mIU/mL | All measured samples (100%) were ≤ 11.6 mIU/mL |
| Matrix Comparison (Serum vs. Serum (gel), Serum vs. Plasma): | |
| Slope (Serum vs. Serum (gel)): Approx. 1.00 (CI around 1.00) | Slope = 0.99 (CI: 0.98 to 1.01) |
| Intercept (Serum vs. Serum (gel)): Approx. 0 mIU/mL | Intercept = -0.05 mIU/mL (CI: -0.15 to 0.10 mIU/mL) |
| Slope (Serum vs. Plasma): Approx. 1.00 (CI around 1.00) | Slope = 1.05 (CI: 1.02 to 1.07) |
| Intercept (Serum vs. Plasma): Approx. 0 mIU/mL | Intercept = -0.08 mIU/mL (CI: -0.28 to 0.05 mIU/mL) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size:
- Method Comparison: 224 serum samples
- Imprecision: Not explicitly stated, but samples were run multiple times.
- High-dose Hook Effect: One serum sample tested at 1,000,000 mIU/mL.
- Linearity: Not explicitly stated how many samples, but tested across range.
- Dilution Recovery: Samples containing hCG from ~1150 mIU/mL to 270,000 mIU/mL (number of distinct samples not specified).
- Limit of Blank (LoB): n=156 (samples with no analyte).
- Analytical Specificity: Patient serum sample with ~2.9 mIU/mL hCG.
- Expected Values: 100% of samples (number not specified) from apparently healthy non-pregnant females.
- Matrix Comparison: 42 matched sets of serum (gel and no gel) and plasma (lithium-heparin) samples.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This is common for this type of 510(k) summary, as it generally focuses on analytical performance, not clinical trial data which typically provides more demographic/provenance detail.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is an analytical device for quantitative measurement of a biomarker. The "ground truth" for such devices is typically established by:
- Measurement against a highly standardized reference material (e.g., WHO International Standard).
- Quantitative comparison to an established, legally marketed predicate device.
- The inherent properties of the measured analyte (concentration, linearity, etc.).
There are no human experts involved in establishing ground truth for the analytical performance studies described in this 510(k) summary, as it's not and image-based or diagnostic interpretation device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
None. Adjudication methods are typically employed in studies where human interpretation (e.g., of medical images) is involved and a consensus or tie-breaking mechanism is needed to establish ground truth or resolve discrepancies between readers. This device is an automated immunoassay system, not subject to human interpretative variability in the same way.
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
No. An MRMC study is not applicable to this type of immunoassay device. MRMC studies are used for evaluating diagnostic devices that involve human interpretation (like radiology or pathology) and are designed to determine how a new technology (e.g., AI) impacts human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are standalone algorithm-only performance evaluations for the immunoassay. The device (Access Total βhCG assay and Access Immunoassay Systems) performs the quantitative measurement automatically without human interpretative input in the analytical process itself. The "algorithm" here refers to the assay's chemical and detection methodology and the instrument's processing of signals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the analytical performance studies is established by:
- Comparison to a predicate device: The Siemens ADVIA Centaur Total hCG Assay (e.g., in the Method Comparison study). The predicate device itself represents a current standard for hCG measurement.
- Reference materials/standards: The assay is standardized to WHO 5th International Reference Preparation, Chorionic Gonadotropin, NIBSC Coded 07/364. This is the ultimate ground truth for concentration measurements.
- Known concentrations: For studies like linearity, dilution recovery, LoB, LoD, LoQ, samples with known or precisely formulated concentrations are used to verify the assay's ability to accurately measure these.
- Biological state: For "Expected Values" studies, the ground truth is the physiological state of the subjects (e.g., apparently healthy non-pregnant females).
8. The sample size for the training set
The provided document describes analytical validation studies, not the development or training of a machine learning model. Therefore, there is no specific "training set" mentioned in the context of typical machine learning. The term "training set" is not applicable to the validation of this chemical immunoassay.
9. How the ground truth for the training set was established
As there is no "training set" in the context of a machine learning algorithm, this question is not applicable. The assay's chemical and enzymatic reactions (its "design") are based on established biochemical principles and are not "trained" on data in the same way an AI model is.
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