Search Results

The Actim PROM test is a visually interpreted, qualitative immunoassay rapid test for the detection of amniotic fluid in cervicovaginal secretions during pregnancy. The Actim PROM test detects IGFBP-1, a major protein in amniotic fluid and a marker of the presence of amniotic fluid in a vaginal sample. The test is intended for prescription use in point of care and clinical laboratory settings to help diagnose the rupture of fetal membranes (ROM) in pregnant women ≥29 weeks gestation who present with signs, symptoms or complaints suggestive of ROM.

The Actim PROM test is a rapid test to aid in diagnosis of premature rupture of fetal membranes in pregnant women who present with signs, symptoms or complaints suggestive of RQM. The test is based on lateral flow immunoassay. It utilizes two monoclonal antibodies to human IGFBP-1. One of the two antibodies is bound to blue latex particles (detecting antibody). The other antibody is immobilized as a test line on the membrane (catching antibody). The test strip (dipstick) is composed of the sample/conjugate pad, the membrane with test and control lines, and the absorbent pad assembled between plastic films. The upper film contains a test window. When the sample area of the dipstick is placed in an extracted sample, the dipstick absorbs liquid, which starts to flow up the dipstick. If the sample contains IGFBP-1 it binds to the antibody labeled with latex particles. The particles are carried by the liquid flow, and if IGFBP-1 is bound to them, they bind to the catching antibody. A blue line (test line) will appear in the result area if the concentration of IGFBP-1 in the sample exceeds the detection limit of the test. A second blue line, the control line, confirms correct operator performance of the test.

The provided text describes a 510(k) submission for the Actim PROM test, which is a rapid diagnostic test to aid in the diagnosis of premature rupture of fetal membranes (PROM).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity and specificity thresholds. However, the clinical study's results are presented, and the FDA's clearance implies that these results were deemed acceptable for the expanded intended use. For the purpose of this analysis, we can infer that the reported performance in Table 1 represents the "met" criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 222 pregnant women for the overall study (≥ 29 weeks gestational age).
  • For samples collected without a speculum: 222 (used in the overall analysis).
  • For samples collected with a speculum: 220 (2 invalid results excluded).
• Data Provenance:
  • Country of Origin: Multi-center study conducted at six US clinical sites.
  • Retrospective or Prospective: Prospective clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The text does not specify the number of experts who established the ground truth. It states that the ground truth was determined by "clinical diagnosis as determined by the conventional clinical criteria identified above." These criteria include:

• Amniotic fluid seen leaking from the cervical os upon diagnostic speculum examination.
• Two of the three following clinical signs being positive: visual pooling of fluid in the posterior fornix, positive nitrazine test, or microscopic evidence of ferning.

The qualifications of the individuals making this clinical diagnosis (e.g., attending physicians, gynecologists, obstetricians) are not explicitly mentioned, but it is implied to be experienced medical professionals involved in patient care.

4. Adjudication Method for the Test Set

The adjudication method for establishing the ground truth was based on a combination of clinical observations and tests:

• Primary criterion: Amniotic fluid seen leaking from the cervical os upon diagnostic speculum examination.
• Secondary criteria (if the primary was not met): Fulfillment of at least two out of three conventional clinical signs (visual pooling, positive nitrazine test, or microscopic ferning).

This effectively acts as a consensus/hierarchical adjudication for clinical diagnosis, where direct observation is definitive, and a combination of other signs confirm in its absence.

5. 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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted, nor is the device an AI. The Actim PROM test is a visually interpreted, qualitative immunoassay rapid test. The study compared the device's performance against conventional clinical diagnosis, not against human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The Actim PROM test is a standalone test in the sense that its result (the appearance of a blue line) is interpreted visually by a human operator. However, it's not an "algorithm only" device; it's a diagnostic kit. The study evaluates the performance of this standalone kit. The stated intended use is "visually interpreted." The "standalone" performance shown in the tables is the performance of the device without further human interpretation beyond reading the test line.

7. The Type of Ground Truth Used

The ground truth used in the clinical study was expert clinical diagnosis based on a set of conventional clinical criteria for PROM. These criteria included:

• Amniotic fluid seen leaking from the cervical os upon diagnostic speculum examination.
• Two of the three following clinical signs being positive: visual pooling of fluid in the posterior fornix, positive nitrazine test, or microscopic evidence of ferning.

8. The Sample Size for the Training Set

The text does not explicitly mention a separate "training set" for the Actim PROM device itself, as it is a lateral flow immunoassay device rather than a machine learning algorithm that requires a training phase. The clinical study described is a performance validation study on a test set.

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

As there's no mention of a traditional "training set" in the context of an algorithm, this question is not directly applicable. If an older version of the device was "trained" or developed, the information is not provided in this specific submission summary. The current submission focuses on expanding the intended use for an existing device.

Ask a specific question about this device

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.

Ask a specific question about this device