(50 days)
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:
| Study Category | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Sensitivity | Consistent detection of 20 mIU hCG/mL or greater in human urine. | Consistently detects 20 mIU hCG/mL or greater hCG in human urine. Studies included 20% above and below 20 mIU hCG/mL and other levels from 0 to 100 mIU hCG/mL, confirming claimed detection capabilities. |
| Specificity | No cross-reactivity with structurally related hormones (LH, TSH, FSH) at specified concentrations. | No cross-reactivity with 500 mIU/mL of LH, 1000 µIU/mL of TSH, and 1000 mIU/mL of FSH. |
| Interference | No false positive or false negative results due to common OTC, prescription, abuse drugs, chemical analytes, and urine pH variations. | Common OTC, prescription, abuse drugs, chemical analytes, and normal urine pH variations did not interfere with performance, yielding no false positive or false negative results. |
| Specimen Collection and Storage | Maintained performance with refrigerated urine specimens. | Validated performance for hCG negative and hCG positive urine specimens refrigerated for up to three days. |
| Accuracy (vs. Predicate Device) | 100% agreement with the predicate device (ABI's SureStep hCG Test). | Achieved 100% agreement (172/172) with ABI's SureStep hCG Test, with a 95% Confidence Interval of 99.1-99.8%. |
| Stability | Stable performance for at least one year. | Performance was stable for at least one year as shown in accelerated and real-time evaluations. |
| Substantial Equivalence | Demonstrate substantial equivalence to currently marketed predicate devices. | Support data from various studies (including 100% relative accuracy with predicate) indicate substantial equivalence. |
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.
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.