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INDICATIONS FOR USE:

• 1. Non-reassuring fetal status.
• Failure of the fetus to deliver spontaneously following an appropriately 2. managed second stage.
• Maternal need to avoid voluntary expulsive effort. 3.
• 4. Inadequate maternal expulsive effort.
• Selective shortening of the second stage when the fetal head is at the outlet 5. as defined by ACOG technical bulletin # 196 Aug. 1994.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding the Swift Low Profile Cup (Pro Cup) fetal vacuum extractor. It does not contain any information about acceptance criteria, device performance, or details of a study.

Therefore, I cannot provide the requested information in the table or answer the subsequent questions based on the provided text. The letter only states that the device is substantially equivalent to legally marketed predicate devices.

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The Indications For Use for this vacuum device in childbirth are the following:
Uterine inertia
Maternal Exhaustion - ineffective voluntary effort
Vertex Presentation
Engagement of the Head
Optional:
A. Maternal distress
B. Fetal distress

The new product is an improved vacuum extractor cup. The improvement is found in the location of the vacuum tubing attachment point, vacuum release valve and an adaptor for electric vacuum pumps.

The provided text describes a 510(k) premarket notification for a medical device, the "Swift Delivery Product #003 - Vacuum Extractor Cup." This submission is focused on demonstrating substantial equivalence to a predicate device (K970170). Therefore, the information provided primarily concerns the modifications made to the device and the rationale for their safety and effectiveness, rather than a rigorous study with formal acceptance criteria and statistical performance measures typically associated with new technology.

Based on the provided text, a formal study with defined acceptance criteria and performance metrics, as one would find for a novel AI or diagnostic device, was NOT conducted. The submission relies on a comparison to a predicate device and a survey of physicians to justify the improvements.

Here's a breakdown based on your requested information, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the typical sense of a new device performance study. The "acceptance criteria" here implicitly refer to demonstrating substantial equivalence to the predicate device K970170.

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

• Sample Size: Not explicitly stated as a formal "test set" for performance evaluation.
  • A "survey was distributed to a select group of physicians in nine states." The exact number of physicians who responded or were part of this "select group" is not provided.
• Data Provenance: Retrospective (based on physician opinions about potential improvements to existing products). Country of origin is the United States (nine states mentioned).

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

Not applicable. There was no "ground truth" to establish in the context of a performance study for this type of device submission. The "experts" were the "select group of physicians" surveyed, and their qualifications are generally described as "physicians," implying medical doctors who use vacuum extractors in practice. No specific years of experience or sub-specialty (e.g., OB/GYN) are detailed.

4. Adjudication Method for the Test Set

Not applicable. No formal test set or adjudication method was used. The "conclusions" were drawn from the collective opinions gathered in the survey.

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 not an AI/software device. No MRMC study was conducted.

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

Not applicable. This is not an AI/software device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of a formal performance study. The "ground truth" for the claims made (e.g., increased safety, reduced delivery time, improved cup) is based on the subjective opinions and perceived needs of the surveyed physicians. There is no objective, independently verified ground truth such as pathology, clinical outcomes, or expert consensus on specific cases.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for this device. It is a modification of an existing physical medical device, not a machine learning algorithm.

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

Not applicable. As there is no training set, there is no ground truth for it.

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Vacuum Extractor Cup used in child birth

The new Tulip Cup is a design change to the current Mityvace (004M) vacuum extractor cup. The change is found in the location of the vacuum tubing attachment point.

I am sorry, but the provided text does not contain the information required to answer your request. The document describes a medical device called "The Tulip Cup" and its comparison to an existing device, Mityvac. It mentions a survey of physicians indicating an improvement was needed in vacuum products, but it does not provide details about acceptance criteria, device performance metrics, sample sizes for testing or training, ground truth establishment, or any studies demonstrating the device meets specific acceptance criteria in a structured scientific manner.

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