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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.

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.

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Laminaria is intended for use whenever it is desirable to dilate the cervical canal, such as Uterine curettage, Labor induction, IUD placement and removal, and Radium placement

This single use device is a hygroscopic laminaria cervical dilator designed to dilate (stretch open) the cervical os by cervical insertion of a cylindrical and expansible material into the cervical canal, made from the root of a seaweed (laminaria digitata). Laminaria expands when it absorbs moisture.

The ability to increase in size slowly (usually 6 to 24 hours) is of advantage in physiologically dilating a closed body orifice such as the cervical canal. When used improperly, it may cause the patient major discomfort or uterine complications

Laminaria is available in 2, 3, 4, 5, 6, 7, 8 and 9 mm diameter sizes with a length varving between 50 and 65 mm. Each laminaria is drilled and attached to a 75-95 mm string to facilitate removal from the cervical canal (the last digit of the product code reflects its size)

Laminaria is intended for use whenever it is desirable to dilate the cervical canal, such as uterine or suction curettage, labor induction, IUD placement and removal, and Radium placement

This 510(k) submission describes the Laminaria cervical dilator and claims substantial equivalence to a predicate device, the Staol Laminaria Tents from Norscan Trading Group. The submission focuses on demonstrating that the new device has identical characteristics to the predicate, rather than presenting a study to prove its performance against acceptance criteria in the typical sense of a novel device.

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of predefined acceptance criteria and a performance study against them, the submission uses a comparative approach against a predicate device. The "performance" is considered "identical" to the predicate.

2. Sample size used for the test set and the data provenance

The document does not describe a specific "test set" or clinical study with patient data. The argument for the device's safety and effectiveness relies on its technological characteristics being identical or similar to the predicate device, which is already legally marketed. Therefore, there's no data provenance in the context of a new clinical study. This is typical for a 510(k) submission where substantial equivalence is claimed based on similarities to a predicate rather than novel performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no new clinical "test set" was generated, there was no need for experts to establish ground truth for such a set.

4. Adjudication method for the test set

Not applicable. No new clinical "test set" was generated.

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

Not applicable. This is a medical device (cervical dilator), not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to this submission.

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

Not applicable. This device is a physical medical instrument, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context is the safety and effectiveness profile established for the predicate device. The underlying assumption is that because the Laminaria device is technologically equivalent to the predicate, it shares the same safety and effectiveness profile.

8. The sample size for the training set

Not applicable. There is no machine learning or AI component that would require a "training set."

9. How the ground truth for the training set was established

Not applicable. There is no machine learning or AI component.

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Ask a specific question about this device

Ask a specific question about this device