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The modified Fact PLUS Pregnancy Test (Cup and Dropper) is an over-the counter in vitro diagnostic immunoassav intended for the qualitative detection of human chorionic gonadotropin (hCG), in urine. A labeling modification to the currently marketed Fact PLUS® Pregnancy Test enables the test results to be read in three minutes or less without altering the accuracy, sensitivity or specificity of the test.

The Fact PLUS Pregnancy Test is indicated for consumer use to detect pregnancy as early as first day of a missed period, any time of the day. Negative test results are confirmed after three minutes, some positives results can be read as soon as one minute.

The modified Fact PLUS Pregnancy Test is a disk-shaped ("Test Disk") device constructed of two pieces of molded plastic. The test chemistries are coated on a test strip housed within the test disk. The test strip contains three reactive sites: a conjugate site, an antibody site and a control site. Three openings on the upper surface of the test disk correspond to these sites: "Urine Well," "Result Window," "Control Window" (CW) respectively.

When urine is added via the Urine Well it wets the conjugate (anti-α hCG antibody) mobilizing it. If hCG molecules are present in the urine specimen, an hCG/conjugate complex is formed. This complex and any remaining unbound coniuqate migrate along the strip attaching to the anti-8 hCG antibody contained on the vertical bar (positive) and also to the polyclonal antibodies on the intersecting horizontal bar (negative) causing a pink reaction. The appearance of pink color on the horizontal and vertical bars forms the "plus" sign or positive "pregnant" result.

When no hCG molecules are present in the urine specimen, the conjugate remains unbound and attaches only to the horizontal or "minus" bar causing it to turn pink. The appearance of only one pink horizontal bar constitutes the negative or ("not pregnant") result.

The urine flow continues on to the Control Window where it activates a special dye causing a red color to appear. The red color in the CW tells the user the that enough urine was added. It is can also play an important role in helping the Consumer Service representatives on our toll free number to evaluate consumer reported problems. It takes approximately five minutes for the urine to reach the Control Window. The appearance of a "plus" or a "minus" in the Result Window however, appears sooner usually within three minutes or less. Some positive results can appear as soon as one minute. The appearance of a plus or minus in the Result Window and red color in the Control Window are the built-in controls which indicate the test chemistries worked properly and that a sufficient volume of urine was added.

Here's an analysis of the provided text regarding the Fact PLUS® Pregnancy Test, broken down into the requested sections:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds (e.g., "sensitivity must be >95%"). Instead, the study aims to demonstrate "substantial equivalence" to existing, marketed devices in terms of accuracy, sensitivity, and specificity. The reported performance is 100% agreement.

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

• Laboratory Validation Testing (Accuracy, Sensitivity, Specificity):

  • Sample Size: Not explicitly stated as a distinct number of specimens for the main laboratory validation. It mentions "hCG-positive and hCG-negative female clinical urine specimens" and testing across "three different lots of Fact PLUS Pregnancy Test and one lot of Fact PLUS One Step." This implies multiple specimens per lot, but a total count is not given.
  • Data Provenance: Retrospective (clinical urine specimens). The country of origin is not specified, but it can be inferred to be the US given the 510(k) submission.

• Consumer Testing:

  • Sample Size: 150 evaluable female volunteers (152 enrolled, 2 dropped due to protocol violations).
  • Data Provenance: Prospective (recruited for the study). The location was "Central New Jersey."

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

• Laboratory Validation Testing:

  • Number of Experts: Not specified. The ground truth for hCG-positive and hCG-negative urine specimens would likely be established prior to the study using a reference method, but the text doesn't detail this.
  • Qualifications: Not specified.

• Consumer Testing:

  • Number of Experts: Not applicable in the same sense as laboratory ground truth. The "ground truth" for this part of the study was whether the provided urine sample was indeed hCG-positive or hCG-negative, which was controlled by the study design (i.e., participants were given "randomized hCG positive or hCG negative urine sample"). The subjects themselves were the "interpreters" whose accuracy was being measured against this known truth.

4. Adjudication Method for the Test Set

• Laboratory Validation Testing: Not explicitly stated. The "100% agreement" implies a direct comparison, likely by trained laboratory personnel. There's no mention of an adjudication process like 2+1.
• Consumer Testing: No formal adjudication process among consumers is described. Each consumer performed the test and recorded their own result, which was then compared to the known status of the urine sample they received.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the device's performance standalone and its interpretability by consumers, not on comparing human readers' performance with and without AI assistance. The device is the diagnostic tool in this context, not an AI assisting human readers.

6. Standalone Performance Study

Yes, a standalone performance study was done.

• Laboratory Validation Testing: This section ("Performance Data") describes the device's accuracy, sensitivity, and specificity in detecting hCG in urine specimens, comparing the modified reading time to the original. This is a standalone assessment of the device's performance.
• Consumer Testing: While involving human interaction, the "consumer accuracy rating" of 100% demonstrates the standalone performance of the device with the modified instructions when used by the intended lay user.

7. Type of Ground Truth Used

• Laboratory Validation Testing: The ground truth was established by classifying clinical urine specimens as "hCG-positive" or "hCG-negative." This would typically be determined by a reference laboratory method (e.g., a highly sensitive immunoassay) considered the gold standard for hCG detection. The text doesn't specify the exact method but implies established clinical classification.
• Consumer Testing: The ground truth was based on the known status of the urine samples provided to the volunteers (either hCG-positive or hCG-negative, as controlled by the study design).

8. Sample Size for the Training Set

Not applicable. This device is a diagnostic immunoassay, not an AI/ML device that requires a training set in the conventional sense. The "training" of the device is inherent in its chemical design and manufacturing process.

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

Not applicable, as there is no training set for this type of device.

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The FactPLUS® One Step Pregnancy Test is an over-the-counter in vitro diagnostic immunoassay intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This device is the same device as ADVANCE® Pregnancy Test, with a labeling modification that provides for reading the test in three minutes without affecting the accuracy, sensitivity or specificity of the test.

FactPLUS Cne Step Pregnancy Test is indicated for consumer use to detect pregnancy as early as first day of a missed period, using a direct urine stream sampling mode. Test results can be read after three minutes. Some positives appear as soon as one minute, neaative results are confirmed in three minutes.

The FactPLUS One Step Pregnancy Test is an elongated "Test Stick" constructed of two pieces of molded plastic which house the internal chemistry strip. The chemistry strip contains a conjugate site, an antibody reaction site and a test control site. There are three openings on the upper surface of the Test Stick:

• "Urine Well" .
• "Result Window" .
• "Control Window" .

Urine is absorbed through the Urine Well and travels along the test membrane to the Result Window (reaction site) and finally to the Control Window. The conjugate (anti-α hCG antibody) present on the membrane is mobilized by the urine flow. If hCG molecules are present in the urine, an hCG/conjugate/complex is formed. The mobilized hCG/conjugate/ complex continues to migrate along the strip to the reaction site where it binds with the anti-ß hCG antibody present on the vertical bar and the polyclonal antibody present on the horizontal bar causing both bars to turn pink. The appearance of pink color on both intersecting bars create the plus sign or "pregnant" result. This reaction generally appears within three minutes. Some positives appear as soon as one minute; however, negative results are confirmed in three minutes.

In the absence of hCG molecules, the conjugate remains unbound and attaches only to the antibody present on the horizontal bar, causing it to turn pink. The appearance of only one reaction bar constitutes the minus or ("not pregnant") result. The urine continues to migrate until it reaches the Control Window where it reacts with a special dye causing a red color to appear. The red color in the CW is an indication that enough urine was added to the device. It takes approximately five minutes after the addition of urine for the Control Window to turn red. A labeling modification and optimization of the test antibodies, enable the results to be read sooner than previous versions of the test and eliminates the restriction of waiting for red color in the Control Window before reading the results.

Here's a breakdown of the acceptance criteria and study information for the FactPLUS® One Step Pregnancy Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Accuracy, Specificity, Sensitivity Laboratory Test: The text states, "Accuracy was performed using hCG-positive and hCG-negative female clinical urine specimens across three different lots of marketed ADVANCE." It does not specify the exact number of specimens/samples used for these laboratory tests.
• Consumer Clinical Study:
  • Sample Size: 150 female volunteers.
  • Data Provenance: Prospective. The volunteers were "recruited from a Central New Jersey location."

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

• Laboratory Tests (Accuracy, Specificity, Sensitivity): The text mentions "Results were confirmed by running another currently marketed pregnancy test simultaneously." However, it does not specify the number or qualifications of experts involved in establishing the ground truth for the lab tests. It implies a comparison against a reliable reference method (another marketed test).
• Consumer Clinical Study: The ground truth for the consumer study was the "correct interpretation" of the test results by the consumers themselves, as assessed by the study design, presumably against a known positive/negative status of the volunteer based on the hCG levels in their urine. There's no mention of experts establishing a separate ground truth for this segment beyond the inherent "correctness" of the test's binary outcome.

4. Adjudication Method for the Test Set

• Laboratory Tests: No explicit adjudication method (like 2+1 or 3+1) is mentioned. The comparison was against "another currently marketed pregnancy test."
• Consumer Clinical Study: Not applicable in the traditional sense, as the evaluation was of the consumers' ability to interpret the test, not of the device's reading requiring expert consensus.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a manual, over-the-counter diagnostic test, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Again, this is not applicable. The FactPLUS® One Step Pregnancy Test is a non-AI, in-vitro diagnostic immunoassay. Its "standalone" performance is essentially its laboratory performance for accuracy, sensitivity, and specificity, which was indeed evaluated. The consumer study evaluated human-in-the-loop performance (user interpretation).

7. The Type of Ground Truth Used

• Laboratory Tests (Accuracy, Specificity, Sensitivity):
  • For accuracy, it was a comparison against readings at a longer, established time (5 minutes with ADVANCE®) and confirmed by "another currently marketed pregnancy test." This suggests a reference method/established test comparison acting as the ground truth.
  • The "hCG-positive and hCG-negative female clinical urine specimens" implies that the true hCG status of these specimens was known. This would be a form of laboratory-confirmed ground truth (e.g., quantitative hCG levels).
• Consumer Clinical Study: The ground truth was the known positive or negative status of the volunteers (based on their hCG levels), against which the consumers' interpretations were compared.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning. This device does not use machine learning, so there is no training set for an algorithm. The "training" or optimization referred to is likely in the chemical formulation and labeling, not an AI model.

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

As there is no training set for a machine learning algorithm, this question is not applicable. The "optimization of the test antibodies" refers to product development, not AI training.

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