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The Clinical Innovations ROM Plus fetal membrane rupture test is a rapid, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal secretions of pregnant women with signs and symptoms of ROM. The test detects AFP (alpha-fetoprotein) and PP12 (placental protein 12 or insulin growth factor binding protein) from amniotic fluid in vaginal secretion. The test is for prescription use by health care professionals to aid in the detection of rupture of membranes (ROM) in pregnant women in conjunction with other signs and symptoms.

The ROM Plus Quality Control Kit monitors the performance of the ROM Plus Fetal Membranes Rupture Test for the purposes of external quality control. The lyophilized human positive protein control is an assayed control material for qualitative testing.

The ROMPlus is a rapid test for detection of premature rupture of fetal membranes. The test principle is lateral flow immunochromatography. ROM Plus is available in packages of 5 tests. Each individual test pack contains a sterile polyester swab. specimen extraction buffer solution in a plastic vial and a cassette with integral timer containing the lateral flow strip packed in a foil pouch with desiccant.

The ROM Plus Controls contain one vial each of negative, and positive controls, with integral reconstitution solution.

Here's a breakdown of the acceptance criteria and the study details for the ROM Plus device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state pre-defined acceptance criteria in the form of target sensitivity, specificity, PPV, or NPV percentages. Instead, it presents the achieved performance in clinical studies for review. The reported performance is summarized below:

Note: NPV for 34-37 EGA and <34 EGA is not explicitly provided but can be calculated from the raw numbers if needed.

2. Sample Size and Data Provenance for the Test Set

• Sample Size (Test Set):
  • Combined (all gestational ages): 264
  • ≥ 37 weeks EGA: 182
  • 34-37 weeks EGA: 37
  • < 34 weeks EGA: 45
• Data Provenance: The study was a "multi-center prospective observational study." The country of origin is not explicitly stated, but the applicant (Clinical Innovations, LLC) is based in Murray, Utah, USA, suggesting the study likely took place in the USA. The data is prospective, as it's an "observational study" where "Clinicians performing ROM Plus testing were masked from the standard Clinical Assessment results."

3. Number of Experts and Their Qualifications for Ground Truth

The document does not explicitly state the "number of experts" or their specific "qualifications" involved in establishing the ground truth. It refers to "Clinicians performing ROM Plus testing were masked from the standard Clinical Assessment results." This implies that the standard clinical assessment was performed by healthcare professionals, though their specific expertise level (e.g., obstetrician with X years of experience) is not detailed.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1). The ground truth for the test set was based on "the clinical standard of either leaking from cervical os, or pooling/ferning/nitrazine." It also states, "Corrections for ROM based on subsequent patient chart review was not used in this study for the detection of ruptured membranes," indicating that the initial clinical assessment was the definitive truth, without further adjudication by additional experts or by consulting patient chart outcomes later to resolve discrepancies.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not done. The ROM Plus device is a rapid diagnostic test intended for standalone use, providing a visual positive or negative result, rather than an AI interpretation tool for human readers.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The device's performance (sensitivity, specificity, PPV, NPV) was evaluated against the "clinical standard of either leaking from cervical os, or pooling/ferning/nitrazine" without human interpretation being factored into the device's result itself. The results presented in the table are for the ROM Plus device in isolation.

7. Type of Ground Truth Used

The ground truth used was based on clinical assessment, specifically "the clinical standard of either leaking from cervical os, or pooling/ferning/nitrazine." This is a combination of direct observation and established clinical tests.

8. Sample Size for the Training Set

The document does not specifically mention a "training set" or its sample size. This is common for rapid diagnostic devices, where the development process often involves internal R&D validation and optimization rather than a distinct "training set" for a machine learning model. The clinical study described in Section 7 served as the primary performance evaluation.

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

Since a specific "training set" is not detailed, the method for establishing its ground truth is also not described. For the clinical performance evaluation, as mentioned in point 7, the ground truth was established by "the clinical standard of either leaking from cervical os, or pooling/ferning/nitrazine." This method would have been used for any data utilized in the development and validation of the device.

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