(560 days)
Surearly™ Pregnancy Test Strip is an in vitro diagnostic medical device for the rapid detection of human chorionic gonadotropin (hCG) in urine. The test is for the qualitative detection of hCG to aid in the early determination of pregnancy. It is intended for over-the-counter (OTC) use only.
Surearly™ Digital Pregnancy Test is an in vitro diagnostic medical device for the rapid detection of human chorionic gonadotropin (hCG) in urine. The test is for the qualitative detection of hCG to aid in the early determination of pregnancy. It is intended for over-the-counter (OTC) use only.
Both Surearly™ Pregnancy Test Strip and Surearly™ Digital Pregnancy Test are in vitro diagnostic medical devices, which use the qualitative assay for the detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early determination of pregnancy. The assays are based on a lateral-flow immunochromatographic assay.
Surearly™ Pregnancy Test Strip is a strip coated with reagents. One end of the strip is a sample pad for urine dipping, and the control and test regions are located in the middle of the strip. Users immerse the sample pad of the strip into the collected urine and see the test results from the colored lines appeared on the strip. The test results are interpreted by users according to the instructions for use.
Surearly™ Digital Pregnancy Test is a digital test reader with a LCD display, combining with an absorbent tip covered by a plastic cap. The absorbent tip that protrudes from the end of the test reader absorbs and delivers urine to reagents on a RAPID type test strip which is located inside a plastic housing of the device. The test reader is automatically switched on, by removing the power film located at the grip. The absorbent tip is placed in urine stream directly or alternatively immersed into the collected urine. The test reader detects the colored lines and shows the digital test result on the display.
The provided document describes the Surearly™ Pregnancy Test Strip and Surearly™ Digital Pregnancy Test. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a table format with numerical targets that the device needed to meet directly. Instead, it describes performance studies and their outcomes, implying that successful completion of these studies with satisfactory results constitutes meeting the implicit acceptance criteria for substantial equivalence to a predicate device.
However, based on the performance characteristics mentioned, we can infer some implied criteria and the reported performance:
| Implied Acceptance Criteria | Reported Device Performance (Surearly™ Pregnancy Test Strip & Digital Test) |
|---|---|
| Sensitivity (Limit of Detection) | 25 mIU/mL |
| Specificity (Interference with other hormones) | No interferences with LH, FSH, and TSH |
| Agreement with Comparative Method (Pregnancy Status) | 100% agreement for positive samples (156 samples) |
| Lay-user Readability and Operability | Instructions easy to understand, device easy to operate, results easy to read (demonstrated by lay-user study) |
| False positive rate (in non-pregnant women, including menopausal) | 0% false positives observed (no false positive result found in 510 non-pregnant women samples) |
| Accuracy (Overall for lay-users) | No specific overall accuracy percentage provided for lay-users, but implied high accuracy given 100% agreement with comparative method by lab professionals and successful lay-user study. |
| Electrical Safety (Digital Test only) | Meets all requirements of IEC61010-1:2001, IEC 61010-2-101:2002, IEC 61326-1:2005, and IEC 61326-2-6:2005. |
| Mechanical Safety (Digital Test only) | Confirmed |
| Software Validation (Digital Test only) | Performed to ensure performance of electronic read-out result |
| Environmental Stability | Storage at 2 - 30°C |
2. Sample Size and Data Provenance for Test Set
The document describes several studies that can be considered as part of the "test set" evaluation:
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Comparison Study (with comparative method by lab professionals):
- Sample Size: Total 456 urine samples.
- 306 samples from women clinically confirmed pregnant.
- 150 samples from randomly chosen non-pregnant women.
- Among the positive samples, 156 were collected from women suspected of being pregnant or in their first trimester.
- Data Provenance: Not explicitly stated, but generally, for such applications, samples are collected from clinical settings relevant to the device's intended use. The document doesn't specify country of origin.
- Retrospective/Prospective: Not explicitly stated. The phrasing "obtained from... women collected from" suggests these were collected for the purpose of the study, so it could be prospective, or existing banked samples fitting the criteria.
- Sample Size: Total 456 urine samples.
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Lay-user (OTC) Study:
- Sample Size: Total 198 lay users.
- 100 non-pregnant women.
- 98 pregnant women (recruited from those who might be pregnant or had been confirmed pregnant).
- Data Provenance: Not explicitly stated, but implies recruitment of individuals for the study.
- Retrospective/Prospective: Seems prospective, as users "participated" and "tested their own urine by themselves."
- Sample Size: Total 198 lay users.
-
Menopausal Study:
- Sample Size: Total 510 samples from non-pregnant women.
- 170 samples in pre-menopausal age (18-40 years old).
- 170 samples in peri-menopausal age (41-55 years old).
- 170 samples in post-menopausal age (over 55 years old).
- Data Provenance: Not explicitly stated.
- Retrospective/Prospective: Not explicitly stated.
- Sample Size: Total 510 samples from non-pregnant women.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
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Comparison Study: Ground truth was established by "lab professionals" using a "comparative method" and "clinically confirmed" pregnancy status. The number and specific qualifications of these lab professionals (e.g., number of years of experience, specific certifications) are not detailed in the provided text.
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Lay-user Study: The lay users tested their own urine. "The lay users' same urine samples were also tested by professionals." This implies that expert testing provided a ground truth to compare against the lay users' results. The number and qualifications of these "professionals" are not detailed.
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Menopausal Study: The ground truth for their non-pregnant status is implied by categorization into age groups and the intent to assess false positives. "Clinically confirmed" positive samples for the comparison study suggest expert input for ground truth.
4. Adjudication Method for the Test Set
The document does not specify a formal adjudication method (e.g., 2+1, 3+1). For the comparison study, it states results demonstrated "100% agreement with comparative method," which means an adjudicator wasn't needed to resolve discrepancies. For the lay-user study, it mentions that professionals also tested the samples, likely serving as the reference for accuracy, but does not describe the method for resolving discrepancies if any arose between lay user interpretation and professional interpretation.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A formal MRMC comparative effectiveness study, comparing human readers with and without AI assistance to quantify an "effect size" of improvement, was not performed, nor is it applicable to this type of device. These are diagnostic tests where the output (visual lines or digital display) is interpreted by a single user (lay-user). The "Digital" device does involve an automated "reader" (the device itself), but there's no comparison of human reader performance with and without this digital assistance in the traditional MRMC sense.
6. Standalone Performance Study (Algorithm Only)
The Surearly™ Digital Pregnancy Test contains an automated reading component. The document states, "Software validation was performed specifically to ensure the performance of Surearly™ Digital Pregnancy Test electronic read-out result." This confirms that a standalone validation of the algorithm's performance was done to ensure its accuracy in interpreting the test strip results, although the specifics of this validation (e.g., specific metrics, sample size for algorithm testing) are not detailed beyond the mention of the activity.
7. Type of Ground Truth Used
The ground truth primarily used is:
- Clinical Confirmation/Comparative Method: For the comparison study, pregnancy status was "clinically confirmed" or determined by "comparative method," which implies a gold standard laboratory assay or clinical assessment for hCG levels.
- Known (Non-pregnant) Status: For the menopausal study and the non-pregnant arms of other studies, the non-pregnant status was the ground truth.
8. Sample Size for the Training Set
The document does not provide information regarding a "training set" or its sample size. This is typical for in vitro diagnostic devices like pregnancy tests, which often rely on established biochemical principles and extensive internal R&D/optimization rather than machine learning models that require distinct training sets. The "software validation" for the digital test would be a verification/validation activity rather than a training process.
9. How Ground Truth for Training Set Was Established
As no training set is described, information on how its ground truth was established is not applicable/provided.
§ 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.