(209 days)
The Test is a qualitative immunoassay intended for non professional / Over The Counter Use for qualitative detection of the human chorionic gonadotropin (hCG) in urine. The test is for use as an aid in the diagnosis of early pregnancy.
A single step, visually read, qualitative immuno-chromatographic single use stick test.
Here's an analysis of the provided information, focusing on acceptance criteria and the study detailing device performance:
Acceptance Criteria and Device Performance for Mid Stream Pregnancy Test (K023037)
The document focuses on demonstrating the substantial equivalence of the Mid Stream Pregnancy Test to a predicate device, rather than establishing de novo acceptance criteria. The primary "acceptance criteria" presented are the device's ability to correlate 100% with the predicate device and the high repeatability and precision observed in various studies.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Correlation with Predicate Device: 100% agreement with legally marketed predicate device | 100% correlation between Mid Stream Pregnancy Test and predicate device |
| Repeatability: High consistency of results when tested by different personnel and settings | 100% agreement in POL study and consumer evaluation |
| Precision: Highly consistent results upon repeated testing | >99% precision |
| Ease of Use/Understanding (Consumer): Simple, fast, convenient, easy to understand by consumers | >99% of consumers found the test to be simple, fast, convenient, easy to understand, and accurate |
| Safety and Effectiveness: As safe and effective as a legally marketed OTC device for pregnancy testing | Concluded to be safe, as effective, and performs as well as the legally marketed OTC device |
2. Sample Sizes and Data Provenance
-
Test Set (Correlation Study):
- Sample Size: Not explicitly stated for the "comparison studies" against the predicate device. However, the subsequent "consumer study" used 115 consumers.
- Data Provenance: The document does not specify the country of origin. The studies appear to be prospective evaluations for the purpose of this 510(k) submission.
-
POL Study (Point-of-Care/Laboratory Study):
- Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated. The study involved "different personnel with diverse educational background and work experience," suggesting it was conducted within a controlled (lab or clinical) environment. It's likely prospective.
3. Number of Experts and Qualifications for Ground Truth
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Correlation Study & POL Study:
- The document implies that the predicate device's results served as a form of ground truth for the correlation study. The "different personnel with diverse educational background and work experience" involved in the POL study would have been trained professionals, but their exact number or specific qualifications (e.g., "radiologist with 10 years of experience") are not provided. They are referred to as "professionals" in contrast to "consumers."
-
Consumer Study:
- The results obtained from "professionals" served as the ground truth against which consumer results were compared. The number and specific qualifications of these professionals are not stated.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (like 2+1 or 3+1). For the core comparison/correlation studies, the method appears to be a direct comparison of the new device's results to the predicate device's results. For the consumer study, the "professionals" likely provided the definitive interpretation, against which consumer interpretations were measured.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No Multi Reader Multi Case (MRMC) comparative effectiveness study is mentioned. The comparison is between the new device and a predicate device, and between consumers and professionals, rather than evaluating human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
This device is an immuno-chromatographic stick test, not an algorithm or software. Therefore, the concept of a "standalone" algorithm-only performance study does not apply. The performance described is the standalone performance of the physical test device.
7. Type of Ground Truth Used
- Correlation Study: The results from the predicate device (Acon Midstream Pregnancy Test, K983090) served as the primary ground truth.
- POL Study & Consumer Study: The results obtained by trained professionals using the device (or the predicate device) were used as the ground truth against which other interpretations (e.g., consumer interpretations) were compared. This is a form of expert consensus/professional standard.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of an algorithm or machine learning. For this type of diagnostic test, the "training" typically refers to the development and optimization of the assay itself, which is not detailed in terms of sample sizes here.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of an algorithm, this question is not applicable. The development process would have involved establishing the assay's sensitivity and specificity against known positive and negative samples, but the specifics of how this 'ground truth' was established during development are not 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.