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Baby Pod is intended to convey a baby to or from a medical facility, between facilities or between departments within a single medical facility.

Baby Pod is designed to convey a baby to or from a medical facility, between facilities or between departments within a single medical facility. Baby Pod consists of a lightweight carbon fiber outer shell, which is lined with a shock absorbent foam inner layer, and has transparent shields for viewing the baby. Baby Pod contains a patient positioning vacuum mattress, stretcher fixing straps to secure the device for transport, and safety straps to secure the baby inside the device during transport.

The provided text describes a 510(k) submission for a medical device called "Baby Pod." This document is a premarket notification for a Class I device and focuses on establishing substantial equivalence to a predicate device, rather than detailed performance studies with strict acceptance criteria often seen in Class II/III devices or AI/software as a medical device (SaMD) clearances.

Therefore, many of the requested elements (like acceptance criteria for performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance with metrics like sensitivity/specificity, or detailed ground truth methodologies) are not applicable or not provided in this type of submission.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable/Not Provided: This submission focuses on substantial equivalence based on design characteristics and material biocompatibility, not performance metrics derived from a test set of data or patient outcomes. There is no mention of a "test set" in the context of clinical or performance data.

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

• Not applicable/Not Provided: No clinical "ground truth" or expert review of a test set is mentioned. The ground truth for biocompatibility would be established by laboratory testing against ISO standards.

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

• Not applicable/Not Provided: No test set requiring adjudication by experts is described.

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 pediatric carrier-stretcher accessory, not an AI or imaging device. Therefore, no MRMC study or AI assistance is relevant.

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

• Not applicable: This is a physical medical device, not an algorithm or software.

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

• Biocompatibility Standards: For the specified acceptance criteria, the "ground truth" for material safety relied on ISO-10993 recognized test methods for biocompatibility.
• Predicate Device Comparison: The determination of "substantial equivalence" served as the primary "ground truth" or benchmark for this type of submission, comparing the new device's features, intended use, and indications to a legally marketed predicate device.

8. The sample size for the training set:

• Not applicable/Not Provided: There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Not applicable/Not Provided: No training set is involved.

Summary of the Study Proving Device Meets Acceptance Criteria:

The "study" described in this 510(k) submission is primarily a comparison to a predicate device and biocompatibility testing.

• Predicate Device Comparison: The "Baby Pod" was compared to the WEEVAC 6 Infant Evacuation Stretcher (K902521). The study aimed to demonstrate that the Baby Pod has the "same intended use and similar indications for use." The minor technological differences (materials of construction and configuration) were characterized and deemed "more contemporary" but "biocompatible," ensuring they did not raise new questions of safety or effectiveness. This comparison facilitated the substantial equivalence determination by the FDA.
• Biocompatibility Testing: "Material components in contact with the baby have been evaluated in accordance with ISO-10993 recognized test methods and found to be biocompatible." This testing directly addressed the safety aspect of the materials used in the device.

In essence, for a Class I device seeking 510(k) clearance, the "study" is often an engineering and design comparison combined with relevant safety testing (like biocompatibility), rather than a clinical trial or performance evaluation using patient data.

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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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Ask a specific question about this device

Ask a specific question about this device