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Shinetell Plus™ Digital Early Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

Shinetell Plus™ Digital Early Pregnancy Test is used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and is designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The device is in a ready-to-use format.

Shinetell Plus™ Digital Early Pregnancy Test uses lateral flow immunoassay and light reflection for the detection of the HCG in urine specimens. The test would detect the light intensity by using the LED as the light source. After that, the result can be displayed on the display screen.

Here's a breakdown of the acceptance criteria and study information for the Shinetell Plus™ Digital Early Pregnancy Test, based on the provided 510(k) clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter does not explicitly state "acceptance criteria" as a separate, quantitative table. However, we can infer the acceptance criteria from the performance studies presented, particularly the sensitivity and agreement rates. The primary criterion is demonstrating a sensitivity of 10 mIU/mL and high agreement with professional results and the predicate device.

2. Sample Sizes and Data Provenance

• Analytical Performance (Precision/Reproducibility/Sensitivity):

  • Test Set Sample Size: For each hCG concentration (0, 3, 5, 7.5, 8, 10, 25, 50 mIU/mL), 10 replicates were tested per day for 5 days for each of 3 device lots, by 3 different operators. This sums to (8 concentrations * 10 replicates/day * 5 days * 3 lots) = 1200 tests for Midstream and another 1200 tests for Dip Testing.
  • Data Provenance: Not explicitly stated, but typically these are laboratory-controlled, prospective studies with spiked samples. The hCG standard is traceable to the 5th WHO.

• Specificity (Non-pregnant females):

  • Test Set Sample Size: 300 urine samples (100 from pre-menopausal, 100 from peri-menopausal, 100 from post-menopausal women).
  • Data Provenance: Not explicitly stated, but implies prospectively collected urine samples from healthy non-pregnant females.

• Method Comparison Study (vs. Predicate):

  • Test Set Sample Size: Urine samples from 200 women suspected to be pregnant in the early stage (<5 weeks).
  • Data Provenance: Collected from women presenting to test for pregnancy, implying a prospective, clinical setting, likely in an unspecified country (as no country of origin is mentioned).

• Lay Person Study:

  • Test Set Sample Size: 200 women for self-testing. For spiked samples, 200 lay persons tested the samples.
  • Data Provenance: Individuals with varying educational and occupational backgrounds from three sites. This is a prospective, user study.

• Early Pregnancy Test Study:

  • Test Set Sample Size: 650 urine samples from 65 pregnant women (65 characterized cycle segments of conceptive cycles).
  • Data Provenance: Collected from pregnant women. This is a prospective, clinical study.

3. Number of Experts and Qualifications for Ground Truth for Test Set

• Analytical Performance: The ground truth for hCG concentrations was established by spiking negative urine with a known hCG standard (Traceable to the 5th WHO). No human experts were involved in establishing this ground truth, as it's an analytical measurement.
• Specificity (Non-pregnant females): The ground truth was based on the healthy, non-pregnant status of the female participants. No specific experts or their qualifications for this judgment are mentioned, but it's assumed to be based on medical history or clinical assessment.
• Method Comparison Study: The ground truth was the result obtained from the predicate device (Wondfo One Step HCG Urine Pregnancy Test Midstream/Strip/Cassette, K150022). No human experts were involved in establishing a separate ground truth.
• Lay Person Study (vs. Professional Results): The "Professional Result" served as the ground truth. The qualifications of these "professionals" are not specified.
• Early Pregnancy Test Study: The "Expected Menstrual Period (EMP)" and "pregnant women" served as the ground truth, implying clinical determination of pregnancy and cycle dating. No specific experts or their qualifications for this determination are mentioned.

4. Adjudication Method for the Test Set

• No explicit adjudication method (like 2+1, 3+1) is mentioned for any of the studies.
• For analytical performance, the ground truth was established by precise spiking of known concentrations.
• For method comparison and lay person studies, direct comparison was made to the predicate device or "professional results" without specifying expert adjudication process if discrepancies arose.
• For the early pregnancy test study, the ground truth seems to be clinical data (EMP, confirmed pregnancy) rather than expert review of the test results themselves.

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

• No MRMC comparative effectiveness study was done to assess how much human readers improve with AI vs. without AI assistance.
• This device is an Over-The-Counter (OTC) pregnancy test, where the "reader" is typically the lay user interpreting a digital display. The studies focused on the device's standalone performance, comparison to a predicate, and lay user comprehension/accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, a standalone study was done. The entire analytical performance section (sensitivity, hook effect, cross-reactivity, interfering substances) and the early pregnancy test study evaluated the device's technical performance to detect hCG and display a result ("Pregnant" or "Not Pregnant") without human interpretation beyond reading the digital display.
• The "Professional Results" in the Lay Person study also reflect the device's standalone performance when used by trained individuals.

7. Type of Ground Truth Used

• Analytical Performance: Known concentrations of hCG spiked into negative urine (traceable to WHO International Standard). This is an analytical gold standard.
• Specificity: Healthy, non-pregnant status of study participants. This is an outcome/status-based ground truth related to the absence of the target analyte.
• Method Comparison: Results from a legally marketed predicate device.
• Lay Person Study: "Professional Results" using the Shinetell Plus™ device. This indicates a reference test ground truth, where the "professionals" are presumably highly accurate users.
• Early Pregnancy Test Study: Clinically determined pregnancy and cycle dating relative to the Expected Menstrual Period (EMP). This is outcomes data/clinical status ground truth.

8. Sample Size for the Training Set

• The document does not explicitly state a training set size or methodology for the Shinetell Plus™ Digital Early Pregnancy Test. This is common for this type of immunoassay device, which relies on established chemical and optical detection principles rather than machine learning algorithms that typically require large training datasets. The device's "learning" is inherent in its design and manufacturing.
• The testing described is primarily for validation (verification and validation), not for training a predictive model.

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

• As a training set is not explicitly mentioned or implied for an AI/machine learning model, this question is not directly applicable based on the provided document. The device operates on an immunoassay principle with "light reflection" and "photodiode" detection, suggesting a pre-programmed algorithm based on known HCG detection thresholds, rather than a learned model.

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