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The QuickVue One-Step hCG-Combo is a one-step immunoassay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in serum or urine for the early detection of pregnancy. The test is intended for use by health care professionals.

The test is a rapid immunoassay for the qualitative detection of hCG in serum or urine. Serum or urine is added to the Sample Well on the Test Cassette. Shortly after addition of the sample, a blue procedural Control Line will appear in the Result Window. If hCG is present in the sample, a pink-to-red Test Line will also appear. If hCG is not present, only the blue procedural Control Line will appear.

Here's a breakdown of the acceptance criteria and study information for the QuickVue® One-Step hCG-Combo device, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated. The document mentions "samples obtained from women presenting for pregnancy testing."
   • Data Provenance: Not explicitly stated, but given the manufacturer is a U.S. company (Quidel Corporation, San Diego, CA), it is likely the data originated from the U.S. The studies were likely prospective as they involved "women presenting for pregnancy testing" and "Physicians' Office studies" to assess performance in real-world settings.

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

   • Not specified. The study compared the device to a "commercially available qualitative hCG test." It's reasonable to infer that the ground truth was established by the results of this comparative method, which would themselves be interpreted by trained laboratory personnel or healthcare professionals. The document does not provide details on the qualifications of such individuals for establishing ground truth but references that the device is "intended for use by health care professionals."

3. Adjudication method for the test set:

   • Not described. The comparison was direct, suggesting the results of the QuickVue device were compared against the established results of the predicate device.

4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:

   • Yes, indirectly. The "Physicians' Office studies" can be considered a form of MRMC study. These studies demonstrated that "physician office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly."
   • Effect size of human readers with AI vs. without AI assistance: Not applicable. This device is a rapid immunoassay kit, not an AI-powered diagnostic tool. The "human readers" (physician office personnel) are performing the test and interpreting the visual result, not being assisted by AI. The study simply confirms they can do this accurately.

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

   • Yes. The primary performance characteristic of "accuracy exceeding 99%" was observed in a "direct comparison of the test to a commercially available qualitative hCG test." This refers to the standalone analytical performance of the device itself.

6. The type of ground truth used:

   • Comparative Reference Standard: The ground truth was established by comparing the device's results to a "commercially available qualitative hCG test." This is a form of reference standard comparison, where the predicate device's results are considered the "truth." While not explicitly stated, it's highly probable that these commercial tests are themselves correlated with patient outcomes (pregnancy status confirmed by other clinical means, e.g., ultrasound, continued monitoring).

7. The sample size for the training set:

   • Not applicable. This device is a rapid immunoassay, not a machine learning or AI algorithm requiring a specific "training set." The development of the device would involve R&D and optimization, but not in the sense of a machine learning training set.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" in the context of an immunoassay. The development process would involve internal validation and quality control measures to ensure the assay performs as intended.

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The QuickVue® One-Step hCG-Combo is a one-step immunoassay intended for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early detection of pregnancy. The QuickVue One-Step hCG-Combo is intended for use by health care professionals.

The test is a rapid immunoassay for the qualitative detection of hCG in serum or urine. This test is to be used for the early detection of pregnancy. Serum or urine is added to the Sample Well on the Test Cassette. Shortly after addition of the sample, a blue procedural Control Line will appear in the Result Window. If hCG is present in the sample, a pink-to-purple Test Line will also appear. If hCG is not present, only the blue procedural Control Line. will appear.

Here's a breakdown of the acceptance criteria and study information for the QuickVue One-Step hCG-Combo device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative "acceptance criteria" for accuracy, precision, or other measures as a predetermined threshold that must be met. Instead, it describes performance characteristics and comparisons to establish substantial equivalence.

Based on the information provided, here's a table summarizing the performance aspects:

2. Sample Size and Data Provenance

• Test Set Sample Size: Undisclosed. The document states "samples obtained from women presenting for pregnancy testing" were used for the direct comparison study.
• Data Provenance:
  • Direct Comparison Study: Samples were "obtained from women presenting for pregnancy testing." The specific country of origin is not stated, but given FDA submission, it's highly probable the study was conducted in the U.S.
  • Physician's Office Laboratory Studies: Conducted at "three geographically distinct sites in the United States."
  • Retrospective or Prospective: Not explicitly stated, but the phrasing "samples obtained from women presenting for pregnancy testing" suggests these were likely prospective or collected contemporaneously with the study. The Physician's Office Lab studies appear to be prospective.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method (Test Set)

• Not explicitly described. The comparison was made "to the Hybritech ICON II HCG ImmunoConcentration Assay," which served as the reference standard. This implies independent determination by the predicate device as the ground truth, rather than human expert adjudication of agreement between the two tests.

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

• No, an MRMC comparative effectiveness study was not done. The studies focused on the performance of the device itself, either in comparison to a predicate device or by laboratory personnel, rather than measuring the improvement of human readers (clinicians) with or without AI assistance. This device is an in-vitro diagnostic, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance assessment was conducted. The "accuracy exceeding 99%" reported for the comparison against the Hybritech ICON II HCG ImmunoConcentration Assay represents the standalone performance of the QuickVue One-Step hCG-Combo device. The Physician's Office Laboratory studies also demonstrated the device's standalone performance when used by varied personnel.

7. Type of Ground Truth Used

• For Accuracy Study: The ground truth was established by a predicate device, specifically the "Hybritech® ICON® II HCG ImmunoConcentration™ Assay for qualitative hCG detection." This assay itself would have its own established ground truth (likely clinical diagnosis or another gold standard for hCG detection).
• For Usability (Physician's Office Lab) Study: The ground truth was "expected results," which would be based on known positive and negative hCG samples or clinical diagnoses.

8. Sample Size for the Training Set

• Not applicable / Not disclosed. This device is a rapid immunoassay, a chemical and biological test system, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The "development" and "optimization" phase of such a device would involve extensive testing and validation, but not typically a "training set" as understood in AI/ML contexts.

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

• Not applicable. As mentioned above, there isn't a "training set" in the AI/ML sense for this type of immunoassay. The development and validation would involve biochemical principles and rigorous quality control rather than machine learning training.

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