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510(k) Data Aggregation
(60 days)
MITYVAC MERLIN, MODEL 10027
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
| Acceptance Criteria (for 510(k) Substantial Equivalence) | Reported Device Performance (Summary Basis for Finding) |
|---|---|
| Intended Use: Device has the same intended use as the predicate device. | The Merlin™ System and the MityOne™ System have the same intended use (to facilitate the delivery of the fetus during childbirth) and the same indications (for use during vaginal delivery and caesarean sections). |
| Indications for Use: Device has the same indications for use as the predicate device. | The Merlin™ System and the MityOne™ System have the same intended use and same indications. |
| Technological Characteristics: Device has similar technological characteristics to the predicate device, or if there are differences, those differences do not raise new questions of safety or effectiveness. | The primary difference is that the Merlin™ uses a CO2 canister for vacuum, while the MityOne™ uses a built-in hand pump. This difference "does not raise new questions of safety or effectiveness." The principles of operation are "very similar," with the only difference being the activation of the CO2 canister. |
| Safety and Effectiveness: Data demonstrates the device is as safe and effective as the predicate device, or that any differences in technological characteristics do not raise new questions of safety or effectiveness. (This is generally inferred from the above points for 510(k)s, rather than requiring extensive clinical trials for a modified device). | The document states, "Merlin™ has the same intended use and indications and very similar principles of operation and technological characteristics as the predicate device. Therefore, Merlin™ is substantially equivalent." This implicitly means it is considered as safe and effective as the predicate. |
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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