(169 days)
To facilitate delivery of a fetus during vaginal deliver
Prism's Mityvac and Gesco's Vac-U-Nate consist primarily of the following components: (1) a suction cup and shaft; and (2) handle and valve assemblies. Each device's cup and shaft have a positioning reference printed on them and the shaft has three molded ridges on it. Both devices have the same components. These components are composed of the same materials and processed in the same manner.
This is a 510(k) premarket notification for a medical device called Mityvac, an obstetrical vacuum cup. The submission aims to demonstrate substantial equivalence to a predicate device, Gesco International, Inc.'s Vac-U-Nate. Therefore, the information requested in your prompt regarding acceptance criteria and a study proving device performance is not typically found in this type of submission.
Here's why and what information is available:
This document describes a 510(k) submission, which focuses on demonstrating "substantial equivalence" to a predicate device, not on proving device performance against specific acceptance criteria through a clinical study in the way you've outlined.
In a 510(k), the manufacturer argues that their new device is as safe and effective as a legally marketed predicate device. This is achieved by comparing the intended use, technological characteristics, and principles of operation. Clinical studies to establish new safety and effectiveness (and thus, acceptance criteria and performance data) are usually required for Premarket Approval (PMA) applications, which are for higher-risk devices or those without a substantially equivalent predicate.
Therefore, for this specific document:
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A table of acceptance criteria and the reported device performance: Not applicable. The document does not define specific performance acceptance criteria for the Mityvac, nor does it report performance data from a study designed to meet such criteria. It states that the Mityvac has the "same intended use and very similar indications, principles of operation, and technological characteristics" as the predicate device.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There is no test set or associated data mentioned for a novel performance study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as there is no specific test set requiring expert ground truth establishment mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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 device is a physical obstetrical vacuum cup, not an AI or imaging device with "readers."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in the context of device performance studies is not relevant to this 510(k) submission.
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The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established: Not applicable.
What the document does provide in lieu of a performance study is a "Summary Basis for the Finding of Substantial Equivalence":
- Comparison to Predicate Device:
- Intended Use: Identical to the predicate device (Gesco's Vac-U-Nate) for facilitating fetal delivery during vaginal childbirth.
- Indications for Use: Mityvac's only indication (vaginal delivery) is the same as one of the predicate device's indications.
- Principles of Operation: Identical (connection to vacuum, cup insertion, attachment to fetal scalp, negative pressure application, traction, release/removal).
- Technical Characteristics: Consist of the same primary components (suction cup, shaft, handle, valve assemblies), which are composed of the same materials and processed in the same manner.
This approach demonstrates that because the Mityvac is so similar to a device already deemed safe and effective, it can also be considered safe and effective without requiring a new, extensive clinical trial.
§ 884.4340 Fetal vacuum extractor.
(a)
Identification. A fetal vacuum extractor is a device used to facilitate delivery. The device enables traction to be applied to the fetal head (in the birth canal) by means of a suction cup attached to the scalp and is powered by an external vacuum source. This generic type of device may include the cup, hosing, vacuum source, and vacuum control.(b)
Classification. Class II (performance standards).