(48 days)
The CARDS® Q.S.® hCG Serum/Urine (also sold under the brand name Concise® Performance Plus™ hCG-Combo) is a one-step immunoassay intended for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early detection of pregnancy. The test is intended for use by health care professionals.
The device, CARDS Q.S. hCG Serum/Urine (also sold under the brand name Concise Performance Plus hCG-Combo), is similar to other FDA-cleared devices used for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine. The test is used in the early detection of pregnancy and is intended to measure hCG, a placental hormone, in serum, plasma or urine (21 CFR 862.1155). The FDA has proposed that hCG test systems be classified as Class II.
Here's a breakdown of the acceptance criteria and the study details for the CARDS® Q.S.® hCG Serum/Urine and Concise® Performance Plus™ hCG-Combo device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative "acceptance criteria" with specific numerical thresholds prior to testing. Instead, it describes general performance characteristics that were demonstrated. The reported device performance is based on fulfilling these general characteristics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to other FDA-cleared devices | The test was shown to be similar to other commercially distributed in vitro tests in terms of features and intended use. Demonstrated substantial equivalence to existing products already marketed. |
| Excellent precision (intra- and inter-assay) | The test was shown to have excellent intra- and inter-assay precision. |
| Reproducible manufacturability (Lot-to-lot consistency) | Lot-to-lot consistency analyses showed the test to be reproducibly manufacturable. |
| No interference from common substances | Common drugs, chemicals, and biologicals were shown not to interfere with the test's performance. |
| High accuracy compared to a predicate device | Using samples obtained from women presenting for pregnancy testing, a direct comparison of the test to another FDA-cleared device for qualitative hCG detection was conducted. An accuracy exceeding 99% was observed. |
| Suitability for use by healthcare professionals (including POLs) | Physician's Office Laboratory (POL) studies were conducted to show that doctor's office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly. Testing was performed at three geographically distinct sites in the United States. The results obtained at each site agreed greater than 100% with the expected results (this suggests perfect agreement with the "expected results" for the POL studies, rather than a direct comparison to a predicate like the accuracy study). The studies "demonstrated the suitability of the product for use by health care professionals." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for the "direct comparison" accuracy study. It mentions "samples obtained from women presenting for pregnancy testing."
- Data Provenance:
- Country of Origin: Not explicitly stated for all samples, but the Physician's Office Laboratory (POL) studies were conducted at "three geographically distinct sites in the United States."
- Retrospective or Prospective: Not explicitly stated, but the description "samples obtained from women presenting for pregnancy testing" often implies a prospective collection, or at least a collection of residual diagnostic samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide details on the number or qualifications of experts used to establish the ground truth.
- For the accuracy study, the comparison was made against "another FDA-cleared device for qualitative hCG detection," implying that the ground truth was essentially the result from this predicate device. It doesn't describe an expert panel reviewing cases for ground truth.
- For the POL studies, the results were compared to "expected results," which likely refers to a gold standard produced by specialized lab personnel or the predicate device, rather than expert interpretation of each case.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The primary comparison methodology was a direct comparison to another FDA-cleared device, and for POL studies, against "expected results."
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
This is not applicable to the provided document. The device is a qualitative diagnostic immunoassay (hCG test), not an AI-assisted diagnostic tool that involves human readers interpreting images or complex data. Therefore, an MRMC study and AI assistance effect size are not relevant here.
6. If a Standalone (Algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an immunoassay that produces a visual result (a plus or minus sign). While it can be interpreted as an "algorithm" in a very broad sense, it's a chemical test, not a computational algorithm that performs standalone analysis. The "human-in-the-loop" aspect for this device is simply the user performing the test and reading the visual result. The Physician's Office Laboratory (POL) studies assess this human interpretation in a real-world setting.
7. The Type of Ground Truth Used
- For the accuracy study: The ground truth was established by the results of "another FDA-cleared device for qualitative hCG detection." This effectively means a predicate device's result was used as the reference standard.
- For the POL studies: The results were compared to "expected results," which again implies a reference standard, likely from a central lab or the predicate device, rather than a pathology report or direct outcomes data in the usual sense.
8. The Sample Size for the Training Set
The document does not explicitly describe a "training set" in the context of a machine learning model. This is an immunoassay device, not an AI or machine learning product. Therefore, the concept of a training set as commonly understood in AI development does not apply here. The document describes studies to demonstrate performance and equivalence, which are akin to validation studies.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI/ML product, this question is not applicable. The device's underlying "ground truth" for its operation is based on the chemical principle of detecting hCG, and its performance is validated against established methods (predicate devices).
§ 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.