(40 days)
The qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early determination of pregnancy for use in the physician's office and clinical laboratories.
Rapid membrane based immunoassay for the qualitative detection of hCG using mouse monoclonal anti-hCG and sheep anti-alpha hCG polyclonal antibodies.
The provided text describes a 510(k) summary for the Genzyme Diagnostics Contrast® Rapid™ hCG test, a qualitative assay for human chorionic gonadotropin (hCG) in urine or serum.
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Detection of hCG in serum (presumably for early pregnancy determination) | Ability to detect 10 mIU/mL hCG in serum at 7 minutes. |
The document implies that detecting 10 mIU/mL hCG in serum within 7 minutes is a key performance metric for early pregnancy determination. The study confirms the device meets this level of sensitivity.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as a single number. The study used "Coded serum specimens, spiked with hCG at different levels." These specimens were tested in triplicate on three different days. This implies a set of specimens, each tested 9 times in total (3 triplicates * 3 days). The exact number of unique "spiked specimens" at "different levels" is not provided.
- Data Provenance:
- Country of Origin: Not explicitly stated, but given the manufacturer (Genzyme Diagnostics) is in San Carlos, CA, it's highly probable the study was conducted in the USA.
- Retrospective or Prospective: Prospective, as "Coded serum specimens, spiked with hCG at different levels, were provided to all sites." This indicates a controlled, pre-planned study with specific samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- The document does not mention the use of experts to establish ground truth in the traditional sense of clinical interpretation.
- The "ground truth" for this diagnostic test is based on the known, spiked concentrations of hCG in the serum specimens. The device's performance is measured against these pre-defined concentrations, not against expert interpretation of biological samples.
- The study was conducted in "three physician's offices/clinics (POL)," implying testing was performed by laboratory personnel or healthcare professionals in those settings, but their role was to perform the test, not to establish the ground truth of the hCG levels.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- None in the context of expert adjudication. The ground truth was based on the known spiked hCG concentrations.
- The study design involved testing in "triplicate on each of three different days," which provides internal replication and can be used for reproducibility assessment, but not for adjudicating expert disagreement.
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 comparative effectiveness study was not done.
- This device is a standalone diagnostic assay, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance study was done. The described activity is a "multicenter sensitivity and reproducibility study" of the device itself (the "Genzyme Diagnostics Rapid hCG™ Urine/Serum Test"). The performance metric ("can detect 10 mIU/mL hCG in serum at 7 minutes") is a measure of the device's inherent capability. While performed by humans, the device's output (positive/negative line on the test) is the primary outcome, reflecting the "algorithm only" in the context of a rapid immunoassay.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth used was spiked concentrations of human chorionic gonadotropin (hCG) in serum specimens. This is a form of analytical gold standard where the true concentration of the analyte is known and controlled.
8. The sample size for the training set
- Not applicable / not mentioned. This document describes the performance evaluation of a rapid diagnostic test, not a machine learning algorithm that requires a training set. The device is based on immunoassay principles, not AI.
9. How the ground truth for the training set was established
- Not applicable. As a non-AI diagnostic device, there is no "training set" in the context of machine learning. The device's components (antibodies, reagents) are developed and optimized through R&D processes, but this isn't the same as training an algorithm.
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.