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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:

| Metric | Combined (All Gestational Ages) | ≥ 37 Weeks EGA | 34-37 Weeks EGA |

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The Amnisure® ROM (rupture of fetal membrane) Test is a rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of ammiotic fluid in vaginal secretion of pregnant women. Amnisure® detects PAMG-1 protein marker of the amnictic fluid in vaginal secretions. The test is for use by health care professionals to aid in the detection of ROM when patients report signs, symptoms or complaints suggestive of ROM.

The Amnisure® ROM (rupture of fetal membrane) Test is a rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of ammiotic fluid in vaginal secretion of pregnant women. Amnisure® detects PAMG-1 protein marker of the amnictic fluid in vaginal secretions.

The request asks to extract information about the acceptance criteria and study details for the Amnisure® ROM (rupture of fetal membrane) test. However, the provided document is a 510(k) clearance letter from the FDA, which confirms the substantial equivalence of the device but does not contain the detailed study results, acceptance criteria, or performance data that would typically be found in a clinical study report or a more comprehensive submission summary.

The letter explicitly states that it is a substantial equivalence determination and does not imply that the FDA has made a determination that the device complies with other requirements of the Act or other federal statutes and regulations. The details of the performance study are not included in this document.

Therefore,Based on the provided document, the following information cannot be extracted:

• A table of acceptance criteria and the reported device performance: This information is not present in the FDA clearance letter. Such details would typically be in the 510(k) submission itself or a summary thereof, not the clearance letter.
• Sample sized used for the test set and the data provenance: Not available in this document.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
• Adjudication method for the test set: Not available in this document.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not available in this document. This device is an in-vitro diagnostic test, not an AI-assisted diagnostic tool for image interpretation or similar.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is an immunochromatographic test, not an algorithm.
• The type of ground truth used: Not available in this document.
• The sample size for the training set: Not applicable as this is not an AI/algorithm-based device in the sense of requiring a "training set" for machine learning.
• How the ground truth for the training set was established: Not applicable for the same reason as above.

The document only describes the device, its indication for use, and its classification and clearance by the FDA based on substantial equivalence to a predicate device. It does not contain the specific performance study details requested.

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