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Pro-Guard Double Duty, like the other wrap products available, is intended to wrap other medical devices for exposure to saturated steam or ethylene oxide sterilization processes and to maintain sterilization for a reasonable time under reasonable conditions.

Device Description

Pro-Guard Double Duty joins two of these materials, polyester/cellulose and polypropylene, through the ultrasonically bonding of a sheet of one to a sheet of the other. This provides the traditional two sheets of wrap but allows the user to wrap the tray or pack with both sheets at the same time as in the Kimberly-Clark One Step product rather than sequentially. No additional materials are added as a bonding agent or for any other reason. Sheets of two different materials were used rather than two sheets of the same material in an effort to provide the best characteristics of each for the end user. The cellulose/polyester (Pro-Guard) is used as the outside sheet for its non-irritating handling properties and good biobarrier characteristics and 100% polypropylene is used on the inside as a strengthening member with its resistance to tear. Both materials are non toxic when used as directed for the purpose intended. The resulting product is puncture resistant, offers the same biobarrier qualities as other premium wrap products while allowing the user to save time by wrapping an item intended for sterilization once rather than twice.

AI/ML Overview

This 510(k) submission describes a sterile wrap, not a device that would typically involve a "test set" and "ground truth" in the way an AI/ML medical device would. Therefore, many of the requested categories are not applicable. I will extract the relevant information about acceptance criteria and testing, and explicitly state when a category is not applicable.

Here's the information based on the provided text:

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

Acceptance Criteria (Implied)	Reported Device Performance
Non-irritating for operators (Primary Skin Irritation)	Scores for primary skin irritation in rabbit testing were 0.00, indicating it should not cause irritation to an operator.
Allows sterilant penetration (Steam and Ethylene Oxide)	All survival and all kill points for biological indicators contained in Double Duty Pro-Guard were lower or very close to those for other wraps existing on the market. Low levels of residuals indicate free movement of EO for ethylene oxide sterilization.
Maintains sterility (Biobarrier Shelf-life)	The only positives concerning Double Duty Pro-Guard were made with double-wrapped packs, which were more difficult to test due to extra layers, and were very probably caused by contamination. This implies effective biobarrier properties under normal use.
Safe levels of Ethylene Oxide residuals (if EO sterilized)	The low level of residuals indicate that Double Duty Pro-Guard allows free movement of EO, suggesting residuals are within acceptable limits (though specific limits are not stated, "low level" implies meeting safety criteria).
Puncture resistant	Stated that the "resulting product is puncture resistant." (No specific quantitative test result provided, but this is a claimed performance characteristic based on the material combination.)
Biobarrier qualities comparable to premium wrap products	Stated that it "offers the same biobarrier qualities as other premium wrap products." (No specific quantitative test result provided, but this is a claimed performance characteristic based on the material combination and shelf-life testing.)
Non-toxic when used as directed	Stated that "Both materials [polyester/cellulose and polypropylene] are non toxic when used as directed for the purpose intended." (No specific quantitative test result provided, but this is a claimed characteristic of the materials.)

2. Sample sizes used for the test set and the data provenance

Primary Skin Irritation Testing: "rabbit testing" - specific number of rabbits not stated.
Sterilant Penetration: Not specified how many biological indicators or test runs were performed.
Six Month Biobarrier Shelf-life Testing: Not specified how many packs or test iterations.
Ethylene Oxide Residuals and Outgassing: Not specified how many tests were performed.
Data Provenance: The text does not provide country of origin or whether the tests were retrospective or prospective, but these are clearly pre-market, prospective tests conducted by the manufacturer for regulatory submission.

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

Not applicable. This is not a diagnostic device requiring expert interpretation for ground truth. Performance is assessed through objective laboratory and biological tests.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on image interpretation, which is not relevant here.

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 is a sterile wrap, not an AI-assisted diagnostic device.

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

Not applicable. This is a sterile wrap, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established through direct physical, biological, and chemical testing:

Biological/Chemical Testing: For skin irritation, sterilant penetration, biobarrier efficacy, and EO residuals.
Material Properties: For inherent characteristics like puncture resistance and non-toxicity of the materials.

8. The sample size for the training set

Not applicable. This is a sterile wrap, not a machine learning model that requires a training set.

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

Not applicable. This is a sterile wrap, not a machine learning model.

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