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The Invictus Medical, Inc. GelShield is a gel-filled positioning product that helps alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.

Invictus Medical, Inc. (Invictus) has developed the Invictus Medical, Inc. GELShield to reduce pressure localization on the heads of infants in Neonatal Intensive Care Units (NICU). The Invictus device is a gel-filled positioning product that helps alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated. The product achieves this through two design characteristics: first to reduce overall friction between the outer laver of skin covering the skull and external surface; and second, to evenly redistribute external pressures over boney prominences of the skull.

The device wraps around the back of the head starting just behind the ears. It has a three dimensional curvature from foam panels that creates a curved surface of the primary outer material, Recovery5™ HF Healthcare Fabric, a low-friction material that is also used on surgical mattresses. Coupled with silicone appliques on the inner surface, the design helps the device stay in place on the head allowing the infant to move normally. This is augmented through the use of Velcro™ (as part of the device) which is used to snugly secure the device to the head. The Velcro allows the nursing staff to easily remove and re-secure the device as part of the usual care of the patient. The device also contains panels of hydrogel encased in Versaflex designed to reduce pressure localization. The Invictus Medical GELShield is not sterile when used. The device is single patient use, but can be worn by a given patient for multiple use periods during the patient's stay in NICU.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated for the usability safety study. The text mentions "Consented subjects wore the Invictus GELShield over a representative period of time."
• Data Provenance: Not explicitly stated, though the context of the submission to the FDA for a device to be used in US NICUs suggests the data would likely be from the US. The study appears to be prospective as it involved "Consented subjects wore the Invictus GELShield" and "Safety information was collected at specified time points."

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)

• The text does not specify the number of experts or their qualifications for establishing the dermal assessment ratings. It refers to "overall HCP (Healthcare Provider) assessments."

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

• The text does not describe any specific adjudication method for the dermal assessments. It states that "All rating scale data was collected and analyzed using descriptive statistics to determine overall HCP assessments."

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a "skin pressure protector," not an AI-powered diagnostic or assistive tool for human readers.

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

• No, a standalone algorithm-only performance study was not done. The product is a physical medical device (a gel-filled positioning product), not an algorithm.

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

• For the usability safety study, the "ground truth" for safety and performance (specifically dermal integrity and absence of adverse events) was established by Healthcare Provider (HCP) assessments using a "widely recognized dermal assessment tool" and monitoring for adverse events. This resembles a form of clinical observation/assessment.
• For the pressure mapping profiles, the "ground truth" seems to be derived from in-vitro testing using pressure mapping technology, which quantitatively measures pressure distribution.

8. The sample size for the training set

• This question is not applicable as the device is a physical product and not an AI/ML algorithm that requires a training set.

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

• This question is not applicable as the device is a physical product and not an AI/ML algorithm.

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