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The Actim PROM test is a visually interpreted, qualitative immunochromatographic rapid test for the detection of amniotic fluid in cervicovaginal secretions during pregnancy. Actim PROM test detects IGFBP-1, which is a major protein in amniotic fluid and a marker of the presence of amniotic fluid in a cervicovaginal sample. The test is intended for professional use to help diagnose the rupture of fetal membranes (ROM) in pregnant women at >34 weeks gestation when patients report signs, symptoms or complaints suggestive of ROM or if such signs are otherwise observed.

The Actim PROM Controls are intended for use as external controls with the Actim PROM test. The controls may also be used to demonstrate negative results and weak and strong positive results.

The Actim PROM is a rapid test for detection of premature rupture of fetal membranes. The test principle is lateral flow immunochromatography. Actim PROM is available in packages of 3, 10 and 20 tests. Each individual test pack contains a sterile polyester swab, specimen extraction solution and a dipstick. The dipstick is packed in a foil pouch with desiccant.

The Actim PROM Controls contain one vial each of negative, low positive and high positive controls, and reconstitution solution.

Acceptance Criteria and Study for Medix Biochemica Actim PROM

The provided text describes the Actim PROM device but does not explicitly state specific acceptance criteria in a quantifiable table format or a detailed study proving performance against such criteria. Instead, it broadly mentions "Performance Testing" and that the device "performed according to its specifications."

However, based on the context of the 510(k) submission, the implicit acceptance criteria are that the device demonstrates substantial equivalence to the predicate device (AmniSure ROM Test) in terms of safety and effectiveness for its intended use. This typically involves demonstrating comparable performance characteristics.

Here's an analysis based on the provided text, highlighting what is and is not available:

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, explicit acceptance criteria values (e.g., specific sensitivity, specificity, accuracy thresholds) are not provided in the document for the Actim PROM. The document primarily focuses on stating that various performance studies were conducted and that the device met its specifications.

Note: The "Device Performance" entries above are direct interpretations of the statement "The results of all studies demonstrated that the Actim PROM and Actim PROM Controls performed according to their specifications." No specific quantitative results (e.g., sensitivity, specificity percentages, LOD, LOQ) are provided in this regulatory summary.

2. Sample Size for the Test Set and Data Provenance

The document states: "A series of nonclinical studies was conducted to assess the performance of the Actim PROM and Actim PROM Controls."

• Sample Size for Test Set: Not specified. The text does not provide any information about the number of samples used in the performance testing.
• Data Provenance: The document does not specify the country of origin of the data. It mentions Medix Biochemica in Finland (applicant) and the contact person in the US, but this does not indicate where the studies were conducted or the origin of patient samples.
• Retrospective or Prospective: Not specified. The nature of the studies (retrospective or prospective) is not mentioned.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified. The document does not mention the use of experts to establish ground truth for the test set. Given the "nonclinical studies" and focus on analytical performance, it's possible that clinical ground truth (e.g., based on physician diagnosis or pathology) was used in a clinical study, but no details are provided here.
• Qualifications of Experts: Not specified. No information is given about the qualifications of any potential experts.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. There is no mention of an adjudication method in the provided text.

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

• MRMC Study: No, it was not done or at least not reported. The document describes "nonclinical studies" for analytical performance. It does not mention a clinical study involving human readers, a comparison of human readers with and without AI assistance, or any effect size.

6. Standalone Performance Study (Algorithm Only)

• Standalone Performance: Yes, implicitly. The "Performance Testing" section describes studies on the device's analytical performance (method comparison, repeatability, reproducibility, analytical sensitivity, analytical specificity, interfering substances). Since the device is a "visually interpreted, qualitative immunochromatographic rapid test," these tests assess the device's ability to produce a result independent of further human interpretation beyond simple visual inspection of the test line. There is no complex algorithm involved beyond the chemical reaction and visual readout.

7. Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated, but likely based on analytical standards and reference methods. Given the description of "nonclinical studies" assessing aspects like analytical sensitivity and specificity, the ground truth would typically be established using known concentrations of the analyte (IGFBP-1) or by using samples confirmed positive/negative by a gold-standard reference method (if applicable for comparison). For clinical aspects, the ground truth for rupture of membranes might be based on clinical diagnosis, but this is not detailed for the "test set" in this summary.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not specified. This device is a rapid diagnostic test, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The development of such a device involves iterative testing and refinement, but not a distinct "training set" for an algorithm.

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable. As explained above, the concept of a "training set" and associated ground truth establishment is not relevant to this type of immunochromatographic rapid test.

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