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510(k) Data Aggregation
(65 days)
One Step urine hCG (cassette format) Pregnancy Test is for the in vitro diagnostic use --- for the detection of hCG (human Chorionic Gonadotropin) presence in female urine specimens and in turn for the early detection of pregnancy. This test kit is used (only once) to obtain a visual and qualitative results for the Over-the-Counter Use.
Urine RCG (Cassette Format) One Step Test Kit
While the provided documents confirm FDA clearance for the Urine HCG (Cassette Format) One Step Test Kit and describe its intended use, they do not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria in the format requested.
Specifically, the documents are a 510(k) clearance letter and an Indications for Use statement. These documents confirm substantial equivalence to a predicate device and outline the intended use, but they do not present the technical performance data, study design, or specific acceptance criteria in the way a scientific study report would.
Therefore, I cannot fulfill the request for information on acceptance criteria and study details based solely on the provided text.
However, based on what is typically expected for an in vitro diagnostic device like a pregnancy test and what might be inferred from such a regulatory submission, here's a general idea of what that information would look like if it were present:
Hypothetical Acceptance Criteria and Study Information (Based on typical IVDD requirements, NOT the provided document)
Since the provided document is an FDA clearance letter and an "Indications For Use" statement, it does not contain the detailed technical performance study information you are asking for. However, for a device like a pregnancy test, the following information would typically be part of the submission that led to this clearance:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Hypothetical) | Reported Device Performance (Hypothetical) |
|---|---|---|
| Sensitivity (Detection of hCG at 25 mIU/mL) | ≥ 99% | 99.5% |
| Specificity (Absence of hCG in negative samples) | ≥ 99% | 100% |
| Accuracy (Overall agreement with reference method) | ≥ 99% | 99.8% |
| Cross-Reactivity (Interference from related hormones) | ≤ 1% positive bias (LH, FSH, TSH) | No significant cross-reactivity observed |
| Hook Effect (High-dose insensitivity) | No hook effect up to 500,000 mIU/mL hCG | No hook effect up to 500,000 mIU/mL hCG |
| Expected Values (Correct identification of pregnant/non-pregnant samples) | Clinically acceptable range | Consistent with expected clinical outcomes |
| Precision (Reproducibility between runs/lots) | CV ≤ 10% | CV < 5% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Typically, hundreds to thousands of urine samples would be used for a comprehensive clinical study. For a general pregnancy test, this might involve:
- Positive samples: 100-200 confirmed pregnant urine samples (various stages of pregnancy).
- Negative samples: 200-500 confirmed non-pregnant urine samples.
- Spiked samples: A range of hCG concentrations (e.g., 0, 10, 25, 50, 100, 500,000 mIU/mL) to assess sensitivity, linearity, and hook effect.
- Data Provenance: Likely a combination of:
- Prospective collection: From clinical sites within Canada (where the manufacturer is located) and potentially the US.
- Retrospective collection: Archived samples with known hCG status, potentially from various countries if adequately characterized.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Ground Truth Determination: For clinical samples, the ground truth for hCG status is typically established by:
- Confirmation with a highly sensitive and quantitative reference laboratory method: Such as a validated immunoassay (e.g., chemiluminescent immunoassay) performed at a College of American Pathologists (CAP) accredited laboratory.
- Clinical confirmation: Including follow-up with patient medical records for pregnancy confirmation (e.g., ultrasound, continued elevated hCG levels over time).
- "Experts": While individual "experts" don't typically "read" the ground truth for every sample, the ground truth is overseen by:
- Board-certified Clinical Pathologists or Clinical Biochemists: Supervising the reference laboratory testing. (e.g., Clinical Biochemist with 10+ years of experience, similar to Dr. David Lee's qualifications).
- Clinical Obstetricians/Gynecologists: Providing clinical correlation for patient outcomes.
4. Adjudication Method for the Test Set
- Not applicable in the typical sense for a quantitative ground truth. Adjudication (e.g., 2+1) is more common when human readers are involved in interpreting images or subjective results.
- For a quantitative ground truth (like a reference immunoassay), the result itself is the "adjudicated" truth, usually with established cut-off values. Discrepancies between the investigational device and the reference method would be resolved by re-testing (e.g., re-running both tests on an aliquot, using a third confirmatory method).
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
- Highly Unlikely for this device. This is a standalone diagnostic kit with a visual, qualitative result (a line appearing or not appearing). There are no "human readers" interpreting complex images or data that AI would assist with in this context. MRMC studies are typical for imaging AI, not for a simple in vitro diagnostic test like a pregnancy strip.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, this is a standalone device. The performance claimed (sensitivity, specificity, accuracy) is inherently the "standalone" performance of the test kit itself, without a human interpretation component that could be "assisted" or compared to. The user simply observes the line/no line.
7. The Type of Ground Truth Used
- Reference Laboratory Assay + Clinical Outcomes: The primary ground truth would be established by a highly sensitive and quantitative laboratory hCG assay, combined with clinical correlation like ultrasound confirmation or longitudinal hCG observation to confirm pregnancy status.
8. The Sample Size for the Training Set
- Not applicable in the traditional "AI training set" sense. This device is a biochemical assay (lateral flow immunoassay), not an AI algorithm that undergoes machine learning training. The "training" for such a device involves iterative development and optimization of the reagents and strip components. The "test set" described above serves as the validation for the final product.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8. The "ground truth" during development involves ensuring the assay correctly detects hCG at specific concentrations and does not cross-react with other substances, which is done through laboratory experiments using purified hCG and known interferents, not through a "training set" of patient data in the AI sense.
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