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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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