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Synthgene Home Test HCG Test Midstream is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy.

Synthqene Home Test HCG Test Cassette is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy.

Synthqene Home Test HCG Test Strip is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy.

Synthgene Home Test HCG Test is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. The test devices are in three different formats: Strip, Cassette and Midstream. Each test kit contains the individually packaged test pen/strip/cassette, medical waste bag, urine cup and instructions for Use. The cassette format also contains a dropper. The device is in a readyto-use format and does not require assembly before use.

The provided text describes the performance characteristics and acceptance criteria for the "Synthgene Home Test HCG Test" (Strip, Cassette, and Midstream formats) for qualitative detection of human chorionic gonadotropin in urine. This is a medical device for home use, so the study focuses on analytical performance and comparison with a predicate device, as well as a lay-user study for ease of use. This is not an AI/ML powered device, so "human readers improve with AI vs without AI assistance" or "algorithm only without human-in-the-loop performance" are not applicable.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" in the same format as an AI/ML performance study with specific sensitivity/specificity targets. Instead, it describes various analytical performance tests and method comparison studies to demonstrate that the device performs as intended and is substantially equivalent to a predicate device.

However, based on the studies conducted, we can infer the performance:

Inferred Acceptance Criteria & Reported Performance:

• 0, 12.5, 18.75 mIU/mL: 0% positive results (100% negative).
• 22.5 mIU/mL: High positivity (e.g., Dip: 87.3%, Midstream: 84.9%, Cassette: 86.2%, Strip: 85.11%). This demonstrates the detection threshold is around 25 mIU/mL.
• 25, 50, 100, 200 mIU/mL: 100% positive results. The sensitivity is demonstrated to be 25 mIU/mL. |
  | Precision/Reproducibility | Consistent results across different lots, operators, sites, and times of day. | No significant differences in performance were observed between lots, operators, sites, or times of day. The sensitivity data (Table 9.1.a) shows consistent results for each concentration across 3 different lots. |
  | Cross-Reactivity/Specificity | No interference from tested concentrations of LH, FSH, TSH, and hCG β-core fragment. | No interference observed at 500 mIU/mL LH, 1000 mIU/mL FSH, 1000 mIU/L TSH, and 2,000,000 pmol/L hCG β-core fragment, for both negative and positive urine samples. |
  | Interfering Substances | No interference from a list of common exogenous and endogenous substances at specified concentrations. | No interferences observed from the comprehensive list of 30 tested substances (e.g., Acetaminophen, Aspirin, Vitamin C, Ethanol, Bilirubin, Glucose) at their specified concentrations for both negative and positive urine samples. |
  | Effects of Urine pH | No interference in hCG detection across a physiological pH range. | Changes in pH range of 4-9 do not interfere with results for either positive (25 mIU/mL) or negative (0 mIU/mL) hCG urine samples. |
  | Effects of Specific Gravity | No interference in hCG detection across a range of urine specific gravities. | Urine samples with a specific gravity between 1.000-1.035 do not interfere with results for either positive (25 mIU/mL) or negative (0 mIU/mL) hCG urine samples. |
  | Hook Effect | No false negative results at very high hCG concentrations. | No hook effect observed at hCG concentrations ranging from 2325 to 1,860,000 mIU/mL; all tested concentrations gave a positive result. |
  | Method Comparison with Predicate Device | Substantial agreement (e.g., high positive and negative agreement) with the legally marketed predicate device. | All formats (Midstream-Dip, Midstream-Midstream, Cassette, Strip) showed 100% positive agreement and 100% negative agreement with the predicate device (HIGHTOP Pregnancy Rapid Test).
• Midstream (Dip): 38 Positive, 23 Negative (61 total) - 100% agreement.
• Midstream (Midstream): 40 Positive, 20 Negative (60 total) - 100% agreement.
• Cassette: 60 Positive, 49 Negative (109 total) - 100% agreement.
• Strip: 54 Positive, 49 Negative (103 total) - 100% agreement. |
  | Lay-User Comprehension & Performance | Users can adequately understand and use the instructions for use, perform the test, and interpret results correctly. | 333 subjects participated across three sites. The results from the lay-user study for each device format mirrored the 100% agreement found in the method comparison study.
  Questionnaire results indicated consumers found the test easy to use, and had no trouble understanding labeling or interpreting results. |

2. Sample sizes used for the test set and the data provenance

• Analytical Performance (Sensitivity/Reproducibility):

  • Sample Size: For each HCG concentration level (0, 12.5, 18.75, 22.5, 25, 50, 100, 200 mIU/mL), and for each of the three device formats (Dip, Midstream, Cassette, Strip), a total of 450 replicates were tested. This translates to (3 lots * 3 operators * 10 runs/day * 5 days = 450 replicates per concentration per format).
  • Data Provenance: The document does not explicitly state the country of origin for the samples used in the analytical performance studies. It mentions "Negative urine collected from females" and "Negative urine samples were spiked with varying hCG concentrations." This suggests controlled laboratory-prepared samples. It's an analytical study, not a clinical trial with patient samples. The manufacturer is based in China.
  • Retrospective/Prospective: These analytical studies appear to be prospective, controlled laboratory experiments designed specifically for device validation.

• Method Comparison Study & Lay-User Study (combined in the document):

  • Sample Size: Urine samples were collected from 333 women aged 18-49.
    • Synthgene Home Test HCG Test Midstream: 121 samples (61 dip, 60 midstream)
    • Synthgene Home Test HCG Test Cassette: 109 samples
    • Synthgene Home Test HCG Test Strip: 103 samples
    • Note: The sum of samples for each format (121+109+103 = 333) matches the total number of women, suggesting that each woman typically provided a sample tested by one specific format, or multiple samples which were divided among the different test formats. The samples were randomly collected.
  • Data Provenance: "Urine samples were collected from 333 women aged 18 - 49 who presented for pregnancy testing at 3 sites." The document does not specify the country of origin for these clinical samples or the sites. Given the manufacturer's location, China is a possibility, but not explicitly stated.
  • Retrospective/Prospective: The samples were "collected at various times throughout the day and blinded," which suggests a prospective clinical performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• For the analytical performance studies, the ground truth was established by the known concentrations of spiked hCG in urine. This falls under controlled laboratory conditions, not requiring expert readers for ground truth.
• For the method comparison study, the predicate device (HIGHTOP Pregnancy Rapid Test) serves as the comparator, essentially establishing a "ground truth" relative to a legally marketed device. The document states "tested by professionals using the candidate devices and the predicate device." It does not specify the number or qualifications of these "professionals."
• For the lay-user study, the "ground truth" (actual pregnancy status, i.e., presence or absence of hCG) was likely based on the results from the predicate device that the professionals used, or potentially a reference lab method. The study's primary purpose was to assess the lay user's ability to use and interpret the device, rather than to establish a new ground truth.

4. Adjudication method for the test set

• Analytical Performance: Not applicable, as the ground truth is defined by the known spiked concentration.
• Method Comparison and Lay-User Studies: The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The comparison is direct, stating that samples were "blinded before being tested by professionals using the candidate devices and the predicate device." The results show 100% agreement, suggesting no need for further adjudication or dispute resolution between readers/methods.

5. 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

• This question is not applicable as the device (HCG Test Strip/Cassette/Midstream) is a rapid diagnostic test and not an AI/ML-powered medical device. It does not involve human readers interpreting images with or without AI assistance. The "reader" in this context is the lay user or a professional reading a visual line on a test strip.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This question is not applicable as the device is not an AI/ML algorithm. Its performance is inherent to its biochemical reaction and visual readout, which is then interpreted by a human user.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Analytical Performance: Ground truth was established by known, spiked concentrations of hCG in urine, controlled in a laboratory setting.
• Method Comparison and Lay-User Studies: The ground truth for presence/absence of hCG was established by comparison to a legally marketed predicate device (HIGHTOP Pregnancy Rapid Test), used by professionals, and inferred from the women "who presented for pregnancy testing."

8. The sample size for the training set

• This document describes performance studies for market clearance (510(k)), not the development or training of an AI/ML model. Therefore, there is no "training set" in the context of machine learning. The studies described are validation and verification studies of a finished product.

9. How the ground truth for the training set was established

• This question is not applicable as there is no training set for an AI/ML model in this context.

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