(2 days)
CLINITEK® hCG Test Strips are for the qualitative measurement of Human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. CLINITEK hCG Test Strips are for professional use in clinical laboratories, physician offices and other point-of-care healthcare locations.
CLINITEK® hCG Test Strips are unitized reagent strips used with the CLINITEK® 50 and CLINITEK® 100 Urine Chemistry Analyzers. Each bottle contains 25 test strips.
Here's an analysis of the provided text regarding the CLINITEK® hCG Test Strips, structured according to your request. Please note that the provided text is a "510(k) Safety and Effectiveness Summary" and thus focuses on demonstrating equivalence to predicate devices rather than a detailed scientific publication. As such, some specific details you requested (like exact sample sizes for training/test sets or detailed ground truth establishment for all cases) may not be fully explicit in this summary.
Acceptance Criteria and Device Performance for CLINITEK® hCG Test Strips
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state numerical "acceptance criteria" in the form of specific sensitivity and specificity thresholds. Instead, it states that the performance was "assessed according to the FDA Reviewer's Guidance Review Criteria for Assessment of Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVD's)" and "Chorionadotropin Testing: Nomenclature, Reference Preparations, Assay Performance, and Clinical Application" (NCCLS guideline). The conclusion is that the device is "equivalent in performance to predicate devices."
Therefore, the "acceptance criteria" can be inferred as meeting the performance standards (sensitivity, specificity, accuracy) demonstrated by the predicate devices and established by the FDA and NCCLS guidelines for hCG IVDs. Since specific numerical performance metrics are not given for the CLINITEK® hCG Test Strips in this summary, the table will reflect this by stating the reported equivalence rather than specific values.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Performance equivalent to predicate devices (QuickVue® One-Step HCG Combo and Test Pack +Plus hCG Combo) as per FDA & NCCLS guidelines for hCG IVDs. | "Equivalent in performance to predicate devices currently in interstate commerce." |
| Suitable for professional use in clinical laboratories, physician offices, and other point-of-care healthcare locations. | "Suitable for use in point-of-care locations." |
2. Sample Sizes and Data Provenance for Test Set
- Sample Size for Test Set: The document mentions "Studies were performed in-house and in external field evaluations utilizing clinical urine specimens." However, it does not specify the exact sample size for these evaluations.
- Data Provenance: The data was collected from "clinical urine specimens." The location of these collections is not explicitly stated beyond "in-house and in external field evaluations," implying a mix of internal (Bayer Corporation) and external (presumably clinical sites) sources. It can be inferred that these were prospective collections for the purpose of the study, as they describe performance assessment through evaluations.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). For immunoassay devices like this, ground truth is typically established using a reference method (e.g., a highly sensitive laboratory-based quantitative hCG assay) rather than expert consensus on visual interpretation.
4. Adjudication Method for Test Set
The document does not describe an adjudication method involving multiple readers for interpreting the test results. Given that the device is an instrumental reader (CLINITEK® 50 and CLINITEK® 100 Urine Chemistry Analyzers) that outputs "positive" or "negative," human adjudication of the device's output would not typically be required. Adjudication would more likely apply to discordant results between the device and the reference method, but this detail is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
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Was a MRMC study done? No, a MRMC comparative effectiveness study was not mentioned or implied. This type of study is more relevant for diagnostic aids where human interpretation is a critical part of the workflow and the AI is designed to assist that interpretation. The CLINITEK® hCG Test Strips are read instrumentally, not by human visual interpretation.
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Effect size of human readers improve with AI vs. without AI assistance: Not applicable, as there's no human-in-the-loop AI assistance described for this device's operation. The "AI" here is the instrument's algorithm converting reflectance to a positive/negative result.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone study (algorithm only) was done. The "Assessment of Performance" describes evaluations of the CLINITEK® hCG Test Strips being read instrumentally by the CLINITEK® 50 and CLINITEK® 100 Urine Chemistry Analyzers. The instruments "analyze the color and intensity of the light reflected from the test strip" and convert "measured reflectance and displays the results as either 'positive' or 'negative'". This describes the algorithm's direct output without human intervention for interpretation.
7. Type of Ground Truth Used
The text implies that the ground truth was established using reference methods for hCG detection. The adherence to FDA and NCCLS guidelines for hCG IVDs strongly suggests that these studies would compare the device's results against a highly reliable, perhaps quantitative, laboratory method for hCG detection, which would serve as the "gold standard" or ground truth. It is unlikely to be solely expert consensus (as it's an objective measurement) or outcomes data (as it's an in vitro diagnostic).
8. Sample Size for the Training Set
The document does not specify the sample size used for training the instrument's algorithm. For a device approved in 1997, the "training" of such algorithms (which convert reflectance to positive/negative) would likely involve calibration and standardization processes using a range of known positive and negative samples, rather than a large "deep learning" style training set as understood today.
9. How the Ground Truth for the Training Set Was Established
Similar to the test set, the ground truth for any "training" or calibration would have been established using reference methods for hCG detection (e.g., known concentrations of hCG in urine, likely confirmed by a highly accurate quantitative laboratory assay). This would ensure that the instrument's algorithm was correctly calibrated to differentiate between positive and negative hCG levels according to clinical thresholds.
§ 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.