Search Results

The VicTorch Meditek Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Strip device (also rne vioron moditor Haman Sherion's designed as a rapid in vitro diagnostic (IVD) qualitative lateral flow color-conjugated immuno-chromatographic (CCI) assay for the early detection of pregnancy, now done ourick direct visual test for the placental hormone, hCG, at the required cut-off level of 20 mlU hCGml of human urine. VicTorch hCG Test Strip devices are intended to meet all requirements for rioUing rapid, easily read, qualitative results for the purpose of early pregnancy detection via CCI assay of ylolang rapid, outlif rodal quality of the may be present in human plasma or urine, according to the requirements set forth in Title 21, section 862.1155 of the Code of Federal Regulation or CFR, and in subsequent federal Guidance Documents. VicTorch hCG Test Strip devices are not intended for quantitative results, nor for over the counter (OTC) sales. VicTorch hCG Test Strip devices are designed for professional use nor of of of over to over (viran analytical data. For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.

The VicTorch hCG Test Strip device is a lateral flow qualitative color-conjugated immunochromatographic (CCI) in vitro diagnostic (IVD) assay for human Chorionic Gonadotropin (hCG) at the cutoff level of 20 mlU/ml of human urine, for detection of early pregnancy as commonly used by professionals. Measurements obtained by the qualitative VicTorch hCG Test Strips are used to aid in the diagnosis of pregnancy.

Here's a breakdown of the acceptance criteria and the study that demonstrates the VicTorch hCG Test Strip device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Accuracy Study (Clinical Performance Test Set):

  • Sample Size: 172 female patients.
    • 91 hCG positive patients
    • 81 hCG negative patients
  • Data Provenance: Retrospective (implied, as patients were recruited and tested, then compared to results from a predicate device). The study was conducted at an "external OBGYN clinical center." The country of origin is not explicitly stated but can be inferred to be the USA given the FDA submission.

• Other Studies (Sensitivity, Specificity, Interference, Specimen Collection & Storage, Stability):

  • Specific sample sizes for these analytical studies (e.g., number of urine samples spiked for sensitivity, number of samples with interfering substances) are not detailed in the provided text. The text only describes the types of studies conducted and their positive outcomes.
  • Data Provenance: These appear to be laboratory-based analytical studies, likely conducted "in-house" or by contract labs.

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

• The ground truth for the clinical accuracy study was established by the predicate device, ABI's SureStrip™ hCG Test. The text does not mention human experts establishing ground truth for individual cases in the test set. Instead, it relies on the established accuracy and FDA approval of the predicate device.

4. Adjudication Method for the Test Set

• None specified for human review. The adjudication was by direct comparison of the VicTorch hCG Test Strip results to the results of the ABI's SureStrip™ hCG Test. Any discrepancies would presumably have been investigated, but the text states "complete agreement (accuracy = 100%)" which suggests no adjudication of conflicting results was necessary.

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

• No, an MRMC comparative effectiveness study was not done. The device is a qualitative, visual test strip intended for professional use, but the study described is a comparison of the device's output against a predicate device, not a study of human reader performance with and without AI assistance. The "AI" in this context is the test strip itself, providing a direct visual result.

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

• Yes, in essence, the entire evaluation is a standalone performance assessment. The VicTorch hCG Test Strip device is designed to provide a direct visual result (color change) without requiring further algorithms or human interpretation beyond reading the positive/negative indicator. The studies (sensitivity, specificity, interference, accuracy) all assess the device's inherent performance.

7. Type of Ground Truth Used

• For the accuracy study (clinical performance), the ground truth was based on the results from a legally marketed and FDA-approved predicate device (ABI's SureStrip™ hCG Test).
• For the analytical studies (sensitivity, specificity, interference), the ground truth would have been established by known concentrations of hCG, known concentrations of interfering substances, and known concentrations of cross-reactive substances, which is a form of reference standard or spike-in validation.

8. Sample Size for the Training Set

• Not applicable / Not specified. This device is a qualitative immunochromatographic test strip, not a software algorithm that requires a "training set" in the machine learning sense. Its performance is based on its chemical/biological design and manufacturing, not learned from data. Therefore, there is no "training set."

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

• Not applicable. As stated above, this device does not utilize a training set in the context of machine learning. Its "ground truth" is inherent to its design and the chemical reactions it facilitates.

Ask a specific question about this device

The VicTorch Meditek Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Card device (also The VicTorch hCG Test Card) is designed as a rapid in vitro diagnostic (IVD) qualitative lateral flow color-conjugated immuno-chromatographic (CCI) assay for the early detection of pregnancy, now bolor only gated "immal test for the placental hormone, hCG, at the required cut-off level of 20 mlU hCG/ml of human urine. VicTorch hCG Test Card devices are intended to meet all requirements for yielding rapid, easily read, qualitative results for the purpose of early pregnancy detection via CCI assay of hCG, a placental hormone that may be present in human plasma or urine, according to the requirements set forth in Title 21, section 862.1155 of the Code of Federal Regulation or CFR, and in subsequent federal Guidance Documents. VicTorch hCG Test Card devices are not intended for quantitative results, nor for over the counter (OTC) sales. VicTorch hCG Test Card devices are designed for professional use only, and provide only preliminary analytical data. For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.

The VicTorch hCG Test Card device is a lateral flow qualitative color-conjugated immunochromatographic (CCI) in vitro diagnostic (IVD) assay for human Chorionic Gonadotropin (hCG) on the cutoff level of 20 mlUml of human urine, for detection of early pregnancy as commonly used by professionals. Measurements obtained by the qualitative VicTorch hCG Test Cards are used to aid in the diagnosis of pregnancy.

The VicTorch Meditek Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Card Device is a qualitative lateral flow color-conjugated immunochromatographic (CCI) in vitro diagnostic (IVD) assay designed for the early detection of pregnancy by identifying hCG at a cutoff level of 20 mIU/mL in human urine. It is intended for professional use only and provides preliminary analytical data, with a more specific alternative clinical method required for confirmed diagnosis.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Accuracy Study: 172 female patients.
  • 91 hCG positive
  • 81 hCG negative
• Data Provenance: The accuracy study was conducted at an "external OBGYN clinical center." The country of origin is not explicitly stated, but given FDA submission, it's likely the US or a region with comparable clinical standards. The study appears to be prospective in nature, as it involves testing patients and comparing results.

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

• The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with 10 years of experience) used to establish the ground truth for the test set.
• However, the accuracy study used ABI's SureStep hCG Test as the predicate device to establish the ground truth for human urine samples. Since it was an "external OBGYN clinical center," it implies that medical professionals (clinicians/laboratory personnel) were involved in collecting and evaluating samples, and determining the "true" pregnancy status based on the predicate device's results.

4. Adjudication Method for the Test Set:

• The document implies a direct comparison method for the accuracy study. The VicTorch device's results were compared directly against those of the ABI's SureStep hCG Test for each of the 172 patient samples. A "complete agreement" (100%) indicates no discrepancy, thus an explicit adjudication method like 2+1 or 3+1 was not necessary as there were no disagreements between the test device and the established ground truth (predicate device).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• No, an MRMC comparative effectiveness study was not done.
• This device is a rapid in vitro diagnostic test, not an AI-powered diagnostic tool for human readers. It provides a direct, qualitative result (positive/negative) that is read visually. Therefore, the concept of human readers improving with AI assistance does not apply in this context.

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

• Yes, a standalone performance study was inherently done.
• The VicTorch hCG Test Card is a device where the "algorithm" (the lateral flow immunochromatographic assay itself) provides the result directly, without requiring human interpretation beyond reading a positive or negative line. The sensitivity, specificity, interference, and stability studies, as well as the accuracy study comparing it to a predicate device, all demonstrate its standalone performance.

7. The Type of Ground Truth Used:

• The primary ground truth for the accuracy study was established by comparison to a legally marketed predicate device: ABI's SureStep hCG Test. This is a common practice for demonstrating substantial equivalence for new IVD devices.
• For the other studies (sensitivity, specificity, interference), the ground truth was based on controlled sample preparations (e.g., specific concentrations of hCG, LH, TSH, FSH, or interfering substances).

8. The Sample Size for the Training Set:

• The document describes performance evaluation studies for the final device to support its 510(k) submission, not the development or training of an algorithm in the machine learning sense. Therefore, there isn't a "training set" as understood in AI/ML contexts. The data presented are from validation/verification studies.

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

• As there is no "training set" in the context of an AI/ML algorithm for this device, this question is not applicable. The development of such a lateral flow assay involves extensive R&D and optimization (analogous to training), but the "ground truth" during that phase would be based on known concentrations of analytes and clinical samples with confirmed pregnancy status, iteratively used to refine the reagent formulations and device design.

Ask a specific question about this device