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Innovita HCG Pregnancy Rapid Combo Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy. The test is for health care professionals use including professionals at point of care (POC).

The Innovita HCG Pregnancy Rapid Combo Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine or serum for the early detection of pregnancy. During pregnancy, HCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test device is used as a single cassette device.

The provided text describes the performance characteristics of the Innovita HCG Pregnancy Rapid Combo Test, a rapid chromatographic immunoassay for qualitative detection of human chorionic gonadotropin (HCG) in urine or serum to aid in early detection of pregnancy.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The "Acceptance Criteria" for this device are implicitly tied to its performance characteristics, aiming to demonstrate substantial equivalence to a legally marketed predicate device (K203272, Alltest Pregnancy Rapid Combo Test Cassette). The document doesn't explicitly list "acceptance criteria" as pass/fail thresholds in a formal table, but rather presents the results of various analytical studies that collectively support the device's accuracy, precision, and reliability.

However, based on the performance data presented, here's a table summarizing the implicit criteria and the reported performance:

2. Sample Sizes and Data Provenance

• Test Set Sample Size:

  • Precision/Reproducibility/Cut-Off Value Study: For each HCG concentration, 6 replicates per day for 5 days, using 3 different lots, across 3 testing sites. This totals 90 individual tests per concentration (6 replicates * 5 days * 3 lots = 90). The number of unique samples (negative serum/urine spiked with HCG) is not explicitly stated beyond "Negative serum or urine specimens from females were spiked with varying HCG concentrations."
  • High Dose Effect Study: Spiked samples tested by 3 different lots and 3 different operators. The exact number of replicate tests is not specified, but multiple concentrations were tested.
  • Effects of hCG ß-core fragment, LH, FSH, TSH interference studies: Samples tested by 3 different lots and 3 different operators. Number of replicates not specified.
  • Interference from Common Exogenous Compounds: Each spiked sample tested using 3 different lots; number of replicates per lot not specified.
  • Effect of Urine Specific Gravity and Urine pH: Tested using 3 different lots by 3 different operators; number of replicates not specified.
  • Method Comparison Study: 108 urine samples and 102 serum samples from 210 women.

• Data Provenance:

  • No specific country of origin is mentioned for the clinical samples. The submitter is INNOVITA (Tangshan) Biological Technology Co., Ltd. in China, and the contact person is in the USA.
  • The method comparison study states: "108 urine and 102 serum samples were collected from 210 women... from three testing sites." The study is described as "A method comparison study was performed," suggesting a prospective collection of samples for the purpose of the study, rather than retrospective. The samples were from "women expecting to be pregnant, early stage at less than 5 weeks."

3. Number of Experts and Qualifications for Ground Truth

• The document states that for the Precision/Reproducibility study, tests were performed by six different operators for each sample concentration across three sites, and the interference studies were performed by three different operators.
• The "Method Comparison Study" states: "Samples were tested by different health professionals with the proposed and the predicate devices at each site."
• Qualifications of these "operators" or "health professionals" are not specified beyond their role in performing the tests. No mention is made of "experts" specifically establishing a ground truth through consensus in the studies described.
• The ground truth for the analytical studies (precision, cut-off, interference) was established by the known concentrations of spiked HCG (traceable to the 5th WHO international Standard).
• For the comparative study, the "ground truth" was essentially the result of the predicate device (K203272). The study aims to show agreement with the predicate, not necessarily against an independent clinical "true" state confirmed by external means like pathology or clinical outcomes.

4. Adjudication Method for the Test Set

• For the analytical studies (precision, cut-off, interference), the "ground truth" was the known spiked concentration of HCG. The "adjudication" was the comparison of the device's result ("-" or "+") against this known concentration. There's no mention of an expert adjudication process in this context, as results are quantitative comparisons to predefined levels.
• For the Method Comparison Study, the document states "The study result shows 100% agreement for all samples to the predicate device." This implies a direct comparison of the new device's result to the predicate device's result for each sample. There's no indication of an adjudication method (e.g., 2+1 or 3+1 expert review) for resolving discrepancies, as presumably, there were no discrepancies ("100% agreement").

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study, as typically understood for evaluating AI-assisted workflows in diagnostic imaging, was not performed. This device is a rapid diagnostic test kit, not an AI or imaging device that assists human readers.
• The comparison study was between the new device and a predicate device, both read by "different health professionals." The effectiveness is measured by agreement between the devices, not by human reader performance improvement with/without AI assistance.

6. Standalone (Algorithm Only) Performance

• This question is not applicable to this device. The Innovita HCG Pregnancy Rapid Combo Test is a lateral flow immunoassay cassette, not a software algorithm or an AI system that would have a "standalone" algorithmic performance. Its performance is intrinsically linked to the physical test kit's chemical reactions and visual interpretation.

7. Type of Ground Truth Used

• For the analytical performance studies (precision, cut-off, high dose, specificity, interference, pH/SG): The ground truth was analytical truth based on known, precisely controlled concentrations of HCG (traceable to WHO international standard) and interferents spiked into negative or known positive samples.
• For the method comparison study: The ground truth was effectively the results obtained from the legally marketed predicate device (K203272). This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices. No pathology or long-term clinical outcome data was used as ground truth for this submission.

8. Sample Size for the Training Set

• Not applicable / Not explicitly stated. This is a rapid diagnostic test kit, not a machine learning model that typically requires a large "training set" of data. The "training" of such a device is in its chemical and biological design and manufacturing process, not in data-driven algorithmic learning.

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

• Not applicable. As above, there's no "training set" in the context of an AI/ML device. The "ground truth" for developing and manufacturing such a chemical assay would involve rigorous quality control, calibration, and R&D studies based on established biological and chemical principles, likely using purified HCG standards and clinical samples. However, the document does not detail these developmental processes.

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