(315 days)
The Atad Pre-Induction Cervical Dilator is indicated for mechanical dilation of the cervical canal prior to labor induction a term when the cervix is unfavorable for induction.
The Atad Dilator is an 18Fr, 400mm, natural latex, three-lumen, double latex balloon catheter with a corresponding valve for each balloon and a disabled third lumen that is not intended to be used.
Acceptance Criteria and Device Performance Study for the Atad Pre-Induction Cervical Dilator
Based on the provided 510(k) summary (K040625), the Atad Pre-Induction Cervical Dilator is a medical device for cervical dilation. The provided documentation does not explicitly state "acceptance criteria" in the typical sense of numerical thresholds for performance metrics. Instead, the summary focuses on demonstrating substantial equivalence to a predicate device (Quality Medical Solutions, LLC Laminaria Cervical Dilator, K021012), primarily through a comparison of technological characteristics and clinical performance.
The "acceptance criteria" can be inferred from the comparative table and the stated conclusion of "substantial equivalence" to the predicate device. The study aims to show that the Atad Dilator is as safe and effective as the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit acceptance criteria are not provided, the table below infers "acceptance criteria" as the comparable performance to the predicate device and lists the reported performance of the Atad Dilator.
| Feature / Acceptance Criteria (Inferred from Predicate) | Reported Atad Dilator Performance |
|---|---|
| Lithotomy position & vaginal speculum for insertion | Yes |
| Insertion through cervical external os | Yes |
| Prevention of cervical tears and fistula | Yes |
| Gradual dilation of the cervix | Yes |
| No higher incidence of preterm labor or late abortions | True |
| Time required to achieve dilation: 6-24 hrs (Laminaria) | 6-12 hrs |
| Effectiveness of the method: Comparable to Laminaria | Comparable |
| Safety: Comparable to Laminaria | Comparable |
| Mean insertion to delivery time (Hours): 6-23 (Laminaria) | 19-25 |
| Cesarean delivery range (%): 20%-40% (Laminaria) | 13%-28% |
| Increased risk to the outcome of pregnancy: None | None |
| Vaginal packing required to avoid expulsion/displacement: Required (Laminaria) | Not required |
| Difficulties in removal: Possible (Laminaria) | Not recorded |
| Need of lithotomy and vaginal speculum for removal: Needed (Laminaria) | No need |
Note: The reported performance of the Atad Dilator meets or in some cases exceeds (e.g., shorter required dilation time, lower Cesarean delivery range, no packing needed) the characteristics of the predicate device, supporting substantial equivalence.
2. Sample Size and Data Provenance for the Test Set
The document states: "The safety and effectiveness of the Atad Dilator for cervical dilation prior to labor induction in women at term has been demonstrated in several clinical trials."
- Sample Size Used for the Test Set: The specific sample sizes for the "several clinical trials" are not provided in this 510(k) summary.
- Data Provenance: The country of origin of the data is not explicitly stated. Given the submitter's address (Haifa, Israel), it is plausible that some or all of the clinical trials were conducted in Israel, but this is not confirmed in the document. The data is prospective, as it comes from clinical trials demonstrating safety and effectiveness.
3. Number of Experts and Qualifications for Ground Truth Establishment
The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical trials mentioned. Clinical trials typically involve medical professionals (doctors, nurses) for patient management and data collection, but the role of specific "experts" for ground truth adjudication (as might be seen in imaging studies) is not detailed.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the data collected in the clinical trials. Clinical trial data collection involves standard medical procedures and possibly independent monitoring, but a formal adjudication process for "ground truth" in the context of diagnostic device assessment is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The Atad Pre-Induction Cervical Dilator is a medical device (a catheter for mechanical dilation), not an imaging or diagnostic AI device. Therefore, a multi-reader multi-case study comparing human readers with and without AI assistance is not applicable to this type of product.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) study was not done. This device is a physical medical instrument (a catheter) that functions through mechanical dilation, not an algorithm. Therefore, an "algorithm only" performance study is not applicable. Its performance is evaluated through its physical interaction with the human body in a clinical setting.
7. Type of Ground Truth Used
The ground truth for the clinical trials would have been established through direct clinical observation and measurement of outcomes. This includes:
- Clinical Measurements: Cervical dilation (e.g., in centimeters or Bishop score changes).
- Patient Outcomes: Time to delivery, mode of delivery (vaginal vs. Cesarean), incidence of preterm labor, late abortions, complications (cervical tears, infection), and ease of device insertion/removal.
- Clinical Assessment: Physicians' assessments of safety and effectiveness.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The "training" for such devices typically refers to engineering design, material selection, and manufacturing process optimization, which are not based on data sets in the same way an AI model is.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, this device does not have a "training set" in the context of AI/ML. The "ground truth" in its development would refer to engineering specifications, material properties, and preclinical testing results (e.g., burst pressure, flow rate testing as mentioned in the summary) compared against established standards for medical devices.
§ 884.4260 Hygroscopic Laminaria cervical dilator.
(a)
Identification. A hygroscopicLaminaria cervical dilator is a device designed to dilate (stretch open) the cervical os by cervical insertion of a conical and expansible material made from the root of a seaweed (Laminaria digitata orLaminaria japonica). The device is used to induce abortion.(b)
Classification. Class II (performance standards).