(107 days)
the professional use of solid phase chromatographic immunoassay in vitro diagnostic test kit for the qualitative determination of human chorionic gonadotropin in urine.
solid phase chromatographic immunoassay in vitro diagnostic test kit for the qualitative determination of human chorionic gonadotropin in urine.
The provided document (K96323) is a "Summary of Safety and Effectiveness" for the Excel OneStep Urine hCG Pregnancy Module Test, dated June 24, 1995. This document is a pre-market notification (510(k)) submission to the FDA. Such documents describe the device and compare it to a legally marketed predicate device, but they typically do not contain detailed study results, acceptance criteria, or comprehensive performance data in the format typically requested for AI/ML device evaluations.
Based on the content of K96323, here's what can be extracted and what information is not available:
Information Available:
- Device: Excel OneStep Urine hCG Pregnancy Module Test (for qualitative determination of human chorionic gonadotropin in urine).
- Predicate Device: Syntron QuikPac I enzyme immunoassay.
- Cutoff: 25 mIU/mL (for both the new device and the predicate).
- Mechanism: Sandwich solid phase dye-conjugate non-enzyme chromatographic immunoassay.
Information NOT Available in the Provided Document:
The document does not contain the detailed study results required to fill out a table of acceptance criteria vs. reported device performance, nor does it provide information on sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance. This type of detailed study data is generally found in a separate study report, often referenced in or summarized in more detail within a comprehensive 510(k) submission, but not typically in the "Summary of Safety and Effectiveness" itself.
Therefore, for almost all points requested, the answer is "Not available in the provided document."
Detailed Response based on available information (and noting what is missing):
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in this summary. For a qualitative pregnancy test, typical acceptance criteria would involve sensitivity (detection limits, often comparing to known hCG concentrations) and specificity (accuracy in negative samples, no cross-reactivity), and sometimes reproducibility. The document only states the cutoff is 25 mIU/mL, implying this is the performance target for hCG detection.
- Reported Device Performance: Not detailed in this summary. No performance metrics like sensitivity, specificity, accuracy, positive predictive value, or negative predictive value are provided. The summary describes the mechanism by which a positive (pink-rose color band at 25 mIU/mL or greater) or negative result is indicated, and how the control zone functions.
Acceptance Criteria Reported Device Performance Not specified Not specified -
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not available in the provided document.
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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)
- Not applicable/available. For a qualitative chemical assay like a pregnancy test, the "ground truth" is typically established by known concentrations of the analyte (hCG in this case) in control samples, and/or by a reference method with established accuracy, rather than expert interpretation of results. No information on this is provided.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/available. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which isn't the primary method for validating a chemical immunoassay.
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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 a point-of-care, qualitative immunoassay, not an AI/ML device requiring human-in-the-loop studies.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This device is the standalone test. The performance of the immunoassay itself is what would be evaluated. However, the results of such an evaluation are not detailed in this summary document.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated, but for this type of device, ground truth would typically be established by:
- Known concentrations of hCG in spiked urine samples.
- Comparison to a highly accurate reference method (e.g., quantitative laboratory hCG assay or the predicate device itself as a comparator).
- Clinical correlation (e.g., follow-up for pregnancy confirmation).
- The document mentions the cutoff of 25 mIU/mL, implying that detection at or above this concentration is the "true positive" benchmark.
- Not explicitly stated, but for this type of device, ground truth would typically be established by:
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The sample size for the training set
- Not available in the provided document. For a non-AI device, the concept of a "training set" in the machine learning sense doesn't directly apply. However, method development and optimization would have involved numerous samples, but their numbers are not specified here.
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How the ground truth for the training set was established
- Not available/applicable for a non-AI device in the context of "training set" as understood in ML. For method development, ground truth would have been established as described in point 7.
§ 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.