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Prism Enterprises, Inc.'s Mityvac® Merlin™ is intended to be utilized to assist a clinician in the delivery of an infant during childbirth. This device is indicated for use during vaginal delivery and Cesarean sections.

The Mityvac® Merlin™ System is a modification of the cleared Mityvac® MityOne™ System with M-Style® or MitySoft® Bell Cups (K011532). The primary difference between the Mityvac® Merlin™ System and the MityOne™ System is that the Merlin™ System utilizes a CO2 canister to create the energy for vacuum, while the MityOne™ uses a builtin hand driven pump as the energy source.

Let's break down the information about the Mityvac® Merlin™ Vacuum Assist Delivery System based on the provided document.

Acceptance Criteria and Device Performance

The provided document (K020447) is a 510(k) summary for a medical device. In this context, "acceptance criteria" and "device performance" are typically evaluated by establishing substantial equivalence to a predicate device, rather than explicit numerical performance metrics like sensitivity/specificity for a diagnostic AI model.

The core acceptance criterion for a 510(k) device is demonstrating that the new device is substantially equivalent in intended use, technological characteristics, and safety and effectiveness to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable (N/A). This 510(k) submission for the Mityvac® Merlin™ is for a physical medical device (obstetrical vacuum assist delivery system), not an AI/ML-based device that would typically rely on a "test set" of data for performance evaluation in the way an AI model does.
• The evaluation is based on a comparison of the device's design, intended use, and technological characteristics to an existing predicate device (Mityvac® MityOne™). No specific patient "data" or "test set" in the computational sense is mentioned or implied.

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

• N/A. As explained above, this is not an AI/ML device, so there is no "ground truth" established by experts for a test set in this context. The FDA's review process itself involves expert evaluation by their staff, but this is an regulatory assessment, not a ground-truth labeling process.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• N/A. No test set or associated adjudication is relevant to this type of device submission.

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:

• N/A. This is a physical medical device, not an AI-assisted diagnostic or treatment device. Therefore, an MRMC study is not applicable.

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

• N/A. This is a physical medical device; there is no "algorithm" or "standalone" performance in the context of AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• N/A. For this device, the "ground truth" for demonstrating safety and effectiveness relies on the legally marketed status and established safety/effectiveness profile of the predicate device (Mityvac® MityOne™). The manufacturer demonstrates that the new device is fundamentally similar and does not introduce new risks.

8. The sample size for the training set:

• N/A. No training set is relevant for this type of device.

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

• N/A. No training set is relevant for this type of device.

In summary, the provided document outlines a 510(k) submission for a physical medical device, not an AI/ML device. Therefore, many of the requested details concerning test sets, ground truth, experts, and AI-specific studies are not applicable to this type of regulatory submission. The device's "performance" and "acceptance" are determined through its substantial equivalence to a legally marketed predicate device based on its intended use and technological characteristics, as reviewed by the FDA.

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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:

1. 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.

2. 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.

3. 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.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 device is a physical obstetrical vacuum cup, not an AI or imaging device with "readers."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.

7. 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.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.

9. 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.

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