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The Quantech Total β-hCG Assay is intended to be used, as aid in the early detection of pregnancy.
The Quantech Total β-hCG Assay is intended to be used for the quantitative determination of human chorionic gonadotropin in EDTA-stabilized plasma, for the early detection of pregnancy.

Device Description

The Quantech Total ß-hCG assay is based on the principle of two site, or sandwich immunoassay in combination with surface plasmon resonance (SPR) surface mass measurement. Each test module contains a solid phase anti-ß-hCG monoclonal antibody immobilized onto a gold surface. An anti-hCG polyclonal antibody, used to enhance the specific detection by SPR is introduced sequentially.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the Quantech Total β-hCG Assay based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit, numerical acceptance criteria for each performance metric. However, we can infer the implied acceptance criteria based on the comparison to the predicate and general expectations for in vitro diagnostic devices.

Performance Metric	Acceptance Criteria (Inferred)	Reported Device Performance
Dilution Linearity/Parallelism	Percent of expected should be close to 100% (indicating linearity and accuracy across dilutions).	The average percent of expected was 101%.
Recovery	Percent recovery of added analyte should be close to 100% (indicating accurate measurement of known concentrations).	After correcting for endogenous β-hCG content, the average recovery was 104%.
Analytical Sensitivity	Detectable minimum quantity of β-hCG should be sufficiently low for early pregnancy detection and comparable to predicate.	The calculated analytical sensitivity is 8.8 mIU/mL.
Precision (INTRAASSAY)	Coefficient of Variation (% C.V.) should be within acceptable limits for a quantitative assay, generally lower for higher concentrations.	For 38.7 mIU/mL: 15.8% C.V.
For 132 mIU/mL: 12.8% C.V.
For 617 mIU/mL: 4.5% C.V.
Precision (INTERASSAY)	Coefficient of Variation (% C.V.) should be within acceptable limits, demonstrating reproducibility over time.	For 41.3 mIU/mL: 13.0% C.V.
For 156 mIU/mL: 11.4% C.V.
For 746 mIU/mL: 7.0% C.V.
Total Imprecision	Overall variability (% C.V.) across multiple runs and days should be acceptable.	For 41.3 mIU/mL: 18.5% C.V.
For 156 mIU/mL: 14.8% C.V.
For 746 mIU/mL: 9.4% C.V.
Interfering Substances	No significant interference from common physiological substances. Percent recovery should be acceptable.	Percent recovery of β-hCG was determined to be acceptable in all three solutions (hemoglobin, bilirubin, triglycerides) based on overlapping expected ranges. No interference noted.
Hook Effect	No erroneous low results for greatly elevated samples.	No high dose hook effect was observed up to at least 100,000 mIU/mL.
Normal Range	Performance similar to predicate at/below 25 mIU/mL cut-off. No false positives in healthy non-pregnant individuals. Agreement with published expected values.	Performs similarly to predicate. Mean of normals below detection limit of both assays. No false positive results. 100% agreement with predicate device in healthy, non-pregnant individuals.
Patient Sample Correlation	High correlation coefficient with a commercially available method (predicate or similar standard). Results linearly related over a broad range.	Correlation coefficient of 0.98 (slope = 0.86, y-intercept = 7.2 mIU/mL) when compared to a commercially available fluorogenic ELISA.
Substantial Equivalence	Demonstrated essential equivalence to the predicate device (Abbott AxSYM® Total β-hCG assay) in technological characteristics and performance.	"The Quantech Total ß-hCG Assay provides results which are internally accurate, unaffected by ordinary variation of sample matrix and equivalent to the results obtained using the approved device in a valid laboratory setting."
"Both clinically-based studies... demonstrated essential equivalence between the two devices..."

2. Sample Sizes Used for the Test Set and Data Provenance

Dilution Linearity/Parallelism: Plasma samples "separately spiked with hCG and serially diluted" - specific number of samples not given.
Recovery: Not specified, but involved "test results as the percentage of added analyte."
Analytical Sensitivity: "Multiple replicates of zero samples (male plasma)" - specific number not given.
Precision (INTRAASSAY): Three pools, 10 different biosensors.
Precision (INTERASSAY): Three pools, tested in triplicate on different days - specific number of days not given.
Interfering Substances: A plasma pool of hCG spiked with 3 different substances (hemoglobin, bilirubin, triglycerides).
Hook Effect: "Samples well beyond the standard curve range" - specific number not given.
Normal Range: "Apparently healthy, non-pregnant individuals" - specific number not given.
Patient Sample Correlation: "Human samples with values distributed throughout the quantitative range of the Quantech Total β-hCG Assay" - specific number not given.

Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the context of a 510(k) submission, the data would typically be generated by the manufacturer for the purpose of the submission, likely in a controlled laboratory setting. Clinical samples are typically prospective, but the document does not confirm this.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This type of in vitro diagnostic device (an immunoassay) does not typically rely on human expert interpretation for establishing ground truth in the same way an imaging AI device would. The "ground truth" for the test set is established through:

Known concentrations: For linearity, recovery, analytical sensitivity, precision, and hook effect, the ground truth is the precisely known concentration of hCG in spiked samples or reference materials.
Clinical status (pregnancy/non-pregnancy): For the normal range study, the ground truth is the clinically determined non-pregnant status of individuals.
Predicate device results: For validation and comparison, the results from the legally marketed predicate device (AxSYM® Total β-hCG assay) or another commercially available method (fluorogenic ELISA) serve as the comparative ground truth.

Therefore, the concept of "experts" to establish ground truth in the traditional sense of medical image interpretation is not directly applicable here. The accuracy of measurements relies on established biochemical and analytical methods.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth for this type of assay is objective measurement or clinical status, not subjective interpretation requiring adjudication of expert opinions.

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 is an in vitro diagnostic device (an immunoassay), not an AI-powered diagnostic system that assists human readers/interpreters. There is no human-in-the-loop component for reading assay results in the context of diagnostic interpretation that would warrant an MRMC study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, implicitly. The performance data presented (linearity, recovery, sensitivity, precision, interference, hook effect, normal range, patient correlation) reflects the standalone performance of the Quantech Total β-hCG Assay itself, without human intervention in the result generation or initial interpretation. The device's output is a quantitative value of β-hCG concentration.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for this device is a combination of:

Reference standard concentrations: For analytical performance metrics like linearity, recovery, sensitivity, precision, interference, and hook effect, the ground truth is established by precisely prepared samples with known concentrations of hCG.
Clinical status: For the normal range study, the ground truth is the confirmed non-pregnant status of the individuals.
Predicate device performance/established clinical methods: For comparison and validation (patient sample correlation, normal range comparison), the results obtained from a legally marketed device (AxSYM® Total β-hCG assay) or another "commercially available method (fluorogenic ELISA)" serve as the established reference or comparative ground truth.

8. The Sample Size for the Training Set

Not applicable. This document describes a traditional immunoassay, not a machine learning or AI-based device that requires a "training set." The device is built on established biochemical principles and analytical methods, not learned from data in a training phase.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" for this type of device.

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