Search Results

ACESO 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.

Important note regarding positive results:

Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

This device is intended for home-use only.

ACESO 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.

The provided document is a 510(k) summary for the ACESO Early Pregnancy Test, a qualitative human chorionic gonadotropin (hCG) test system. It details the device's performance characteristics and studies conducted to demonstrate its substantial equivalence to a legally marketed predicate device.

Here's an analysis of the provided information, framed around acceptance criteria and the study that proves the device meets them:

Device: ACESO Early Pregnancy Test

Intended Use: 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). Intended for home use only.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a separate table, but rather presents performance data that implicitly serves as the proof for meeting certain thresholds. Based on the studies performed, the following can be inferred as intended performance and the results obtained:

2. Sample Sizes Used for the Test Set and Data Provenance

• Analytical Performance (Precision/Sensitivity):

  • Sample Size: For each hCG concentration (0, 3, 5, 8, 10, 15, 25, 50 mIU/mL), 10 replicates were tested per day for 10 days for each of 3 device lots. This totals 10 * 10 * 3 = 300 tests per concentration, for a grand total of 8 concentrations * 300 tests/concentration = 2400 tests for each testing method (dip and midstream).
  • Data Provenance: Negative female urine was spiked with hCG standard (Traceable to the 5th WHO). This is prospective, laboratory-controlled spiking for analytical validation. The document does not specify the country of origin of the source urine, but it's likely from a lab collection.

• Specificity (Non-pregnant females):

  • Sample Size: 300 urine samples.
  • Data Provenance: Collected from healthy, non-pregnant females (100 each from pre-menopausal, peri-menopausal, and post-menopausal groups). This is prospective, clinical sample collection. No country of origin is specified.

• Hook Effect Test:

  • Sample Size: Not specified in terms of number of individual tests, but varying hCG concentrations were spiked into negative urine samples.
  • Data Provenance: Laboratory-controlled spiking.

• Method Comparison Study:

  • Sample Size: 100 urine samples.
  • Data Provenance: Collected from women presenting to test for pregnancy, with approximately half suspected of early pregnancy (<5 weeks). This is prospective, clinical sample collection. Not country of origin is specified, but it took place at "three POC sites."

• Lay Person Study:

  • Sample Size: 100 women/lay persons.
  • Data Provenance:
    • Clinical Samples: Urine samples from 100 women whose individual pregnancy status was self-tested. This is prospective, involving self-collection and self-testing.
    • Spiked Samples: Urine samples prepared with hCG at specific concentrations (3, 5, 8, 10 mIU/mL) spiked into negative pooled urine. This is prospective, laboratory-controlled spiking for assessing interpretation accuracy.
  • Data Provenance/Origin: Individuals with varying educational and occupational backgrounds from "three sites." No country of origin is specified.

• Early Pregnancy Test Study:

  • Sample Size: 650 urine samples from 65 pregnant women (65 characterized cycle segments).
  • Data Provenance: Collected from pregnant women. Samples were masked and randomized, indicating a controlled, prospective clinical study. No country of origin is specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Analytical Performance: Ground truth was established by precise laboratory spiking of hCG standard (Traceable to the 5th WHO) at known concentrations. This does not involve human experts establishing ground truth in the traditional sense, but rather relies on the accuracy of the hCG standard and laboratory controls. Three different operators performed the tests, contributing to reproducibility data, but not establishing ground truth.
• Method Comparison Study: "Professional testing" or "professional results" are mentioned, suggesting lab or medical professionals determined the ground truth using the predicate device. The document does not specify the number or qualifications of these "professionals."
• Lay Person Study: "Professional testing" is mentioned as the comparator for lay person results. Again, the number and qualifications of these professionals are not specified.
• Early Pregnancy Test Study: The study mentions "65 characterized cycle segments of conceptive cycles were collected from 65 pregnant women." This implies clinical characterization of pregnancy status (e.g., through blood tests, clinical examination, LMP), which serves as the ground truth. The number and qualifications of the clinicians establishing this "characterized" status are not specified, but it presumes standard medical practice.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in any of the studies.

• For analytical studies, ground truth is based on spiked concentrations.
• For clinical studies (method comparison, lay person, early pregnancy), ground truth seems to be derived from a "professional result" or "characterized cycle segments," implying a single objective determination or standard clinical practice rather than a multi-reader adjudication process.

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

No, an MRMC comparative effectiveness study was not done in the context of this 510(k) summary. This type of study typically assesses the improvement in human reader performance (e.g., radiologists interpreting images) with AI assistance versus unaided reading. The ACESO Early Pregnancy Test is a qualitative in-vitro diagnostic test, not an imaging AI device that assists human readers.

The closest analogue is the "Lay Person Study," which assesses user performance with the device instructions, comparing their interpretation to professional results. This is a usability and interpretation study, not an MRMC study.

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

The ACESO Early Pregnancy Test is a rapid chromatographic immunoassay (a physical test strip), not a software algorithm. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply directly. The "analytical performance" section (precision, sensitivity, specificity) effectively demonstrates the device's inherent performance characteristics independent of human interpretation variability, which is then assessed in the "lay person study."

7. The Type of Ground Truth Used:

• Analytical Performance: Laboratory-spiked concentrations of hCG (traceable to WHO International Standard). This is akin to a reference standard.
• Specificity (Cross-reactivity, pH, Density, Interfering Substances): Laboratory-spiked concentrations of interfering substances or physical manipulation of urine properties, combined with "negative urine samples" for specificity. This uses reference standards and known clinical states (non-pregnant females).
• Method Comparison Study: Results from a legally marketed predicate device ("Wondfo One Step HCG Urine Pregnancy Test").
• Lay Person Study: "Professional results" (likely laboratory testing or trained personnel reading the device) for clinical samples, and laboratory-spiked concentrations for test samples.
• Early Pregnancy Test Study: "Characterized cycle segments of conceptive cycles" collected from "65 pregnant women." This implies clinical diagnosis/outcomes data (confirmed pregnancy status relative to menstrual cycle).

8. The Sample Size for the Training Set

The document describes performance studies for the ACESO Early Pregnancy Test, which is a physical immunoassay device, not a machine learning or AI model. Therefore, the concept of a "training set" for an algorithm is not applicable here. The manufacturing process and quality control would be the "training" equivalent in terms of ensuring consistent device performance.

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

As noted above, there is no "training set" in the context of an AI/ML algorithm for this physical device. The ground truth for validating the device's performance (which is analogous to testing a trained model) is described in point 7.

Ask a specific question about this device