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The Clearblue® Early Detection Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e. as early as five (5) days before the day of the expected period.

The test is intended for home use.

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The provided document is a 510(k) clearance letter from the FDA for the Clearblue® Early Detection Pregnancy Test. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about the acceptance criteria or the study data that proves the device meets those criteria. This type of information is typically found in the 510(k) submission itself, not in the public-facing clearance letter.

Therefore, I cannot provide the requested information based on the provided text. The document confirms the device's clearance and its intended use, but it does not detail the technical performance studies.

To answer your questions, I would need access to the actual 510(k) submission document or a summary thereof, which would typically include performance data, study designs, sample sizes, and ground truth establishment methods.

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The Clearblue® Early Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e. as early as five (5) days before the day of the expected period.

The test is intended for home use.

The Clearblue® Early Pregnancy Test is an over-the-counter (OTC), visual pregnancy test and is indicated for use up to 6 days before the missed period (5 days before expected period). The device employs an immunochromatographic sandwich assay to detect hCG on a lateral flow test strip.

The test incorporates a proprietary, FSH modulated, hCG scavenger system positioned upstream of the hCG test line to maintain high specificity to pregnancy. The scavenger system captures hCG when there are high levels of FSH in the sample. This ensures that hCG is removed from samples with elevated levels of FSH, reducing the chance of false positive results which while rare, may occur in some women.

The result is displayed to the user in the test window as two lines for a 'Pregnant' result and one line for a `Not Pregnant' result.

The provided document describes the performance and testing of the "Clearblue® Early Pregnancy Test," a qualitative immunoassay for detecting human chorionic gonadotropin (hCG) in urine. This document pertains to its 510(k) premarket notification (K213379) to the FDA.

Here's a breakdown of the acceptance criteria and study proving device performance, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a table format with pass/fail remarks. However, the performance characteristics sections imply certain criteria are met for the device to be considered substantially equivalent. Based on the studies, here is a summary of the implicit criteria and reported performance:

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One Step Pregnancy Test is an over-the-counter lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. The visual test is intended for home use as an aid in early detection of pregnancy. The test is indicated for use from 4 days before the day of the expected period (5 days before the day of the missed period).

The One Step Pregnancy Test is an over-the-counter, visual pregnancy test with sensitivity of 25mIU/mL hCG (human chorionic gonadotropin) and is indicated for use up to 4 days before the expected period (5 days before the missed period). The device eeeploys an immunochromatographic sandwich assay to detect hCG on a lateral flow test strip housed in a cassette. Following sample application using the supplied pipette, the user is required to visually interpret the results displayed as lines in a result window.

This document describes the validation of the "One Step Pregnancy Test," an over-the-counter lateral flow immunoassay for qualitative detection of human chorionic gonadotropin (hCG) in urine.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

• Peri-menopausal (n=150) and Post-menopausal (n=150) women: 100% specificity.
• Pre-menopausal (18-40 years) non-pregnant women (n=133) from the comparison study: 100% specificity. |
  | Early Pregnancy Detection | The ability of the device to detect pregnancy accurately at various stages relative to the missed period, as claimed in the indications for use (from 4 days before the day of the expected period). | At 4 days before the expected period (-4 days relative to missed period), the device detected 91.7% of pregnancies (121/132). Performance increased closer to the missed period, reaching 100% on the day of the missed period (Day 0). This supports the claim for use from 4 days before the expected period. |

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

• Analytical Performance (Precision/Reproducibility/Sensitivity):

  • Sample Size: 1440 devices tested (180 devices per hCG standard concentration x 8 concentrations). Each concentration had 45 devices from each of 4 batches.
  • Data Provenance: Not explicitly stated, but implied to be generated in a controlled laboratory setting (likely in the UK, given the applicant's address). This was a prospective study where samples were spiked with known concentrations of hCG.

• High Dose Hook Effect Study:

  • Sample Size: 75 devices (5 replicates per concentration x 3 batches x 5 concentrations).
  • Data Provenance: Laboratory setting, spiked samples.

• Interfering Substances Study:

  • Sample Size: 2 (urine standards) x Number of interfering substances (approx. 20-30 substances) x 5 devices x 3 batches. So, potentially 300-450 devices per interfering substance.
  • Data Provenance: Laboratory setting, spiked samples.

• Cross Reactants Study:

  • Sample Size: 3 cross reactants x 2 (urine standards) x 5 devices x 3 batches = 90 devices. The hCG ß-core fragment study involved 165 devices (11 conditions x 5 devices x 3 batches).
  • Data Provenance: Laboratory setting, spiked samples.

• Urine pH and Specific Gravity Studies:

  • Sample Size: 6 pH conditions x 2 (urine standards) x 15 devices = 180 devices for pH. 5 SG conditions x 2 (urine standards) x 15 devices = 150 devices for SG.
  • Data Provenance: Laboratory setting, adjusted urine samples.

• Comparison Study with Predicate Device:

  • Sample Size: 300 urine samples (150 pregnant, 150 not pregnant). Each sample was tested on the subject device and the predicate device.
  • Data Provenance: Not explicitly stated, but refers to "urine samples from pregnant women and not pregnant women," implying real patient samples. Retrospective (samples collected and then tested).

• Early Pregnancy Detection Clinical Samples:

  • Sample Size: 1197 One Step Pregnancy Test devices used. The table shows varying numbers of samples per day relative to missed period, totaling 1197.
  • Data Provenance: Early pregnancy urine samples collected from days 0 to -9 relative to the day of the missed period. Implied to be real patient samples. Retrospective.

• Lay User Study (Own Urine Sample):

  • Sample Size: 120 volunteers (21 pregnant, 99 not pregnant). Each volunteer tested their own urine sample.
  • Data Provenance: Prospective, real-world (home-use simulation). Participants were "pregnant and not pregnant women volunteers with diverse educational and professional backgrounds." The "clinical status" was the ground truth.

• Lay User Study on Biobank Samples:

  • Sample Size: 79 volunteers (70 pregnant, 9 not pregnant). Each volunteer tested a single biobank sample.
  • Data Provenance: Prospective, using "biobank samples" with "confirmed clinical pregnancy status."

• Specificity Study (False-Positive Rate - Peri/Post-menopausal):

  • Sample Size: 300 urine samples (150 from peri-menopausal women, 150 from post-menopausal women).
  • Data Provenance: Real patient samples from specific demographic groups. Retrospective.

3. Number of Experts and Qualifications for Ground Truth

• For the Analytical Performance studies (sensitivity, specificity, precision, hook effect, pH, SG), the ground truth was established by the precise spiking of hCG to known concentrations or the verified absence of hCG in negative urine, as well as the addition of known interfering/cross-reacting substances. No human "experts" were needed for interpretation of these analytical measurements; the results were quantitative (concentration) or verified qualitative properties.
• For the Comparison Study, Early Pregnancy Detection Clinical Samples, and False-Positive Rate Study (Peri/Post-menopausal), the ground truth was "clinical status" or "clinical pregnancy status." It is implied that this clinical status was established by medical professionals or standard clinical diagnostic methods. The document does not specify the number or qualifications of these experts, as the device is being compared to a clinical status rather than an expert's interpretation of an image.
• For the Lay User Studies, the ground truth was the "clinical pregnancy status" of the volunteers' own urine samples or the "confirmed clinical pregnancy status" of the biobank samples. Again, the number and specific qualifications of the medical professionals establishing this clinical status are not detailed.

4. Adjudication Method for the Test Set

• Adjudication, in the sense of multiple experts reviewing and reaching consensus on an image or case, is not applicable here. This is a diagnostic immunoassay that provides a binary (Pregnant/Not Pregnant) visual result.
• For the analytical studies, the "ground truth" was established based on the controlled preparation of the samples (e.g., precise spiking of hCG).
• For the clinical studies, results were compared against an established clinical status of the urine samples or volunteers.
• In the lay user studies, volunteer interpretations were compared against their clinical status and/or technician interpretations. The document states "100% agreement" implies a direct comparison without a complex adjudication process.

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

• No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI assistance. This device is a standalone over-the-counter visual test, not an AI-assisted diagnostic tool interpreted by medical professionals.
• The "Lay User Study" can be considered a form of human performance evaluation, showing that lay users can correctly interpret the test without assistance, but it is not an MRMC study and does not involve AI assistance.

6. Standalone Performance

• Yes, standalone performance was done. The entire analytical performance section (Precision/Reproducibility/Sensitivity, High dose hook effect, Analytical specificity, Effects of urine pH/SG) evaluates the device's performance independently of human interpretation bias. In these studies, trained technicians performed the tests, ensuring correct execution of the device's mechanism.
• The comparison to the predicate device and the early pregnancy detection studies also represent the device's standalone performance in a clinical context.

7. Type of Ground Truth Used

• Expert Consensus: Not applicable in the typical sense for medical image interpretation.
• Pathology: Not applicable.
• Outcomes Data: The "clinical pregnancy status" (e.g., pregnant or not pregnant) serves as the ultimate ground truth for the clinical and lay user studies. This is an outcome, based on medical assessment.
• Spiked Samples/Known Concentrations: For analytical studies, the ground truth was the precisely known concentrations of hCG or other substances added to the urine samples.

8. Sample Size for the Training Set

• Not applicable. This document describes a traditional in-vitro diagnostic (IVD) device, not an AI/Machine Learning model. Therefore, there is no "training set" in the computational sense. The device's performance is determined by its inherent chemical and physical properties, which are developed through R&D and manufacturing processes.

9. How Ground Truth for the Training Set Was Established

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

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The Clearblue® Early Digital Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This digital test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e. as early as five (5) days before the day of the expected period.

The test is intended for home use.

The Clearblue® Early Digital Pregnancy Test is an over-the-counter (OTC), digital pregnancy test with sensitivity to 10mIU/ml hCG (hormone human chorionic gonadotrophin) and is indicated for use up to 6 days before the missed period (5 days before expected period). The device employs an immunochromatographic sandwich assay to detect hCG on a lateral flow test strip. The result is displayed to the user, in words, on an LCD.

The Clearblue® Early Digital Pregnancy Test is an over-the-counter chromatographic immunoassay designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It is intended as an aid in the early detection of pregnancy, up to six days before a missed period.

Here's the breakdown of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a bulleted or numbered list with predefined thresholds. Instead, the performance characteristics are presented as evidence of the device's capability and equivalence to a predicate device. Based on the provided data, the implied acceptance criteria would revolve around:

• Analytical Sensitivity: Ability to detect hCG at a specified concentration (e.g., 10 mIU/ml).
• Analytical Cut-off: The hCG concentration at which approximately half of the devices yield positive results.
• Specificity: No significant interference from common substances or cross-reactivity with related hormones.
• Lay User Performance: High agreement with clinical pregnancy status and technician results when used by laypersons.
• Early Detection Claim: Demonstrated detection rates at various days relative to the missed period.

2. Sample Sizes and Data Provenance

• Test Set for Analytical Performance (Precision/Reproducibility):
  • Sample Size: For each of the nine hCG standards, 324 total samples were tested (162 with dip method, 162 with simulated in-stream method). This was further broken down by technicians and days (e.g., 108 samples per technician/day for each standard).
  • Data Provenance: Not explicitly stated, but implies laboratory-prepared spiked urine samples. No country of origin is specified, but the applicant addresses are in Switzerland and the UK. This is prospective for the test devices.
• Test Set for Method Comparison with Predicate Device:
  • Sample Size: 102 urine samples from pregnant women and 102 urine samples from non-pregnant women.
  • Data Provenance: Not explicitly stated, but refers to "urine samples from pregnant women" and "not pregnant women," suggesting retrospective clinical samples or samples collected for the study. No country of origin for samples is specified.
• Test Set for Early Pregnancy Detection (Clinical Samples):
  • Sample Size: 831 early pregnancy urine samples from days -10 to -1 relative to the day of the missed period.
  • Data Provenance: Clinical samples. No country of origin is specified.
• Test Set for Lay User Study (Clinical Samples):
  • Sample Size: 394 volunteers (205 not pregnant, 189 pregnant).
  • Data Provenance: Volunteers. No country of origin is specified.
• Test Set for Specificity Study (False-positive rate):
  • Sample Size: 450 urine samples (150 from pre-menopausal, 150 from peri-menopausal, 150 from post-menopausal women).
  • Data Provenance: Clinical samples. No country of origin is specified.
• Test Set for Lay User Spiked Standard Study:
  • Sample Size: 200 samples per hCG standard (3, 7.5, 8.5, 10 mIU/ml), totaling 800 samples.
  • Data Provenance: Laboratory-prepared spiked urine samples, tested by lay users. No country of origin is specified.

3. Number of Experts and Qualifications for Ground Truth

• For Analytical Performance (Precision/Reproducibility): 3 technicians performed the testing. Their specific qualifications are not detailed beyond "trained technicians."
• For Method Comparison with Predicate Device: "Trained technicians" performed the testing.
• For Early Pregnancy Detection (Clinical Samples): There is no mention of experts establishing ground truth for these samples, but it's implied that the "Days Relative to Missed Period" serves as the clinical ground truth for assessing early detection.
• For Lay User Study: Technician results via dip method and the "clinical pregnancy status" of the volunteers served as ground truth. The qualifications of these technicians are not explicitly stated, but their role suggests expertise in properly performing and interpreting the test.
• For Specificity Study: Technicians performed the testing. The "clinical status" of the non-pregnant women was the ground truth.
• For Lay User Spiked Standard Study: Lab-prepared hCG standards define the ground truth.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned for any of the studies. All results appear to be direct observations or comparisons to established clinical status or laboratory standards.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was done. The device is a standalone in-vitro diagnostic (IVD) device, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study

Yes, a standalone performance study (algorithm only, without human-in-the-loop performance) was performed. The "Analytical Performance" section, particularly the Precision/Reproducibility study, evaluates the device's ability to detect hCG at various concentrations independently. The results obtained by technicians also represent the device's standalone performance, albeit with trained human operation. The "Lay User Studies" also assess the device's performance when used by the intended end-user, essentially as a standalone OTC product.

7. Type of Ground Truth Used

• Analytical Performance (Precision/Reproducibility, Spiked Standard Studies): Laboratory-prepared hCG spiked urine standards (known concentrations of hCG).
• Method Comparison with Predicate Device: Clinical status (pregnant/not pregnant) of urine samples and comparison with a legally marketed predicate device.
• Early Pregnancy Detection (Clinical Samples): Days relative to the missed period (biological/clinical stages of pregnancy).
• Lay User Study: Clinical pregnancy status of the volunteers and technician-performed test results.
• Specificity Study: Clinical status (non-pregnant) of women from different age cohorts.

8. Sample Size for the Training Set

The document describes performance studies for analytical and clinical validation. It does not provide information about a "training set" in the context of machine learning or AI development. This device is a chromatographic immunoassay, not an AI/ML-based device that typically requires a distinctive training set.

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

As noted above, the device is not an AI/ML-based device, so the concept of a "training set" and associated ground truth establishment is not applicable in this context. The various studies used laboratory standards or clinical status as their ground truth for evaluation.

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