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Atteris No Sting Skin Protectant is intended for application to intact or damaged skin as a liquid, film-forming product, which creates a long-lasting waterproof barrier, protecting the skin from bodily wastes, fluids, add friction. It is intended as a primary barrier against irritation from body fluids.

Device Description

Atteris No Sting Skin Protectant is a polymeric solution which forms a uniform film when applied to the skin. The product is biocompatible, non-stinging, and fast drying. Atteris No Sting Skin Protectant shields intact or damaged skin from irritation caused by bodily fluids, wound drainage, adhesives, and friction. The film is colorless, transparent, and possesses good oxygen and moisture vapor permeability. Atteris No Sting Skin Protectant will be supplied in a High Density Polyethylene (HDPE) bottle with pump spray cap.

AI/ML Overview

The provided document describes the Atteris No Sting Skin Protectant and its performance characteristics, primarily to demonstrate substantial equivalence to a predicate device. It does not contain information about a study proving the device meets acceptance criteria in the context of typical AI/software device evaluation (e.g., diagnostic accuracy on a test set). Instead, it details performance testing to substantiate specific product claims related to its physical and biological properties.

Therefore, many of the requested sections related to AI device evaluation (such as sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are not applicable to the information contained in this document.

However, I can extract the acceptance criteria (claims) and the reported device performance from the provided text for the aspects that were evaluated.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic (Claim)	Acceptance Criteria (Implied)	Reported Device Performance
No Sting	Non-stinging	"NSP is non-stinging."
Barrier Film	Functions as a barrier film	"NSP is a barrier film."
Sterile	Meets sterility requirements	"NSP passed the requirements for sterility with no observed turbidity in the 10 test samples."
Breathable	Breathable	"NSP is breathable."
Biocompatible	Non-cytotoxic, non-sensitizing, non-irritating	"NSSB is non-cytotoxic, non-sensitizing, and non-irritating."
Dries in ~60 seconds	Dries in approximately 60 seconds	"NSP dries in approximately 60 seconds."
Good in Skin Folds (non-self-adherent)	Non-self-adherent	"NSP is consider non-self-adherent."
Single Patient Use (Use life-28 days after opening)	Retains performance characteristics for 28 days after opening	"product retains its performance characteristics, and it does. The Use Life is 28 days after opening..."

Summary of inapplicable AI/Software Device Evaluation Criteria:

The following items are not applicable as this document describes a physical medical device (skin protectant) and its chemical/biological properties, not an AI/software device for diagnostic or predictive purposes.

Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
If a multi reader multi case (MRMC) comparative effectiveness study was done
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

Details of the Studies Conducted (as per the document):

No Sting:
- Study: Human testing using the Skin Trauma After Razor Shaving (STARS) bioassay.
- Purpose: To determine if the protectant caused subjective stinging when applied to skin challenged by dry shaving.
Barrier Film:
- Study: Human testing conducted at cyberDERM Clinical Studies.
- Method: Carbon retention test method.
Sterile:
- Study: USP 71, Sterility Tests.
- Sample Size: 10 test samples.
- Conditions: After 2 months of accelerated aging.
Breathable:
- Study: Oxygen and moisture vapor transmission rate testing.
Biocompatible:
- Study: Testing consistent with ISO 10993.
- Specific Tests:
  - Cytotoxicity: L929 Agar Diffusion Test (Direct Contact); ISO Final GLP Report: 15-04007-G1. Test article: Atteris Skin Protectant on mouse fibroblast L929 cells.
  - Direct Primary Skin Irritation: ISO Final GLP Report: 15-04007-G2. Test article: Atteris Skin Protectant on abraded skin sites of New Zealand White rabbits (single topical minimum 4-hour application).
  - Direct Buehler Sensitization: ISO Final GLP Project: 15-04007-G3. Test article: Atteris Skin Protectant on albino guinea pigs (topical application).
Dries in ~60 seconds:
- Study: Human testing conducted at cyberDERM Clinical Studies.
- Purpose: To determine dry time.
Good in Skin Folds (non-self-adherent):
- Study: Human testing conducted at cyberDERM Clinical Studies.
- Comparison: To the commercial control, 3M Cavilon No Sting Barrier Film.
Single Patient Use (Use life-28 days after opening):
- Study: Use life testing.
- Method: Product opened, sprayed, left open for 28 days, then re-tested to confirm performance characteristics.

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