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The Dukal SMS sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:

· In a steam sterilization pre-vacuum cycle at 270°F / 132°C for 4 minutes
o Models 100, 200 and 300 were validated for dry times of 20 minutes: models 400, 500 and 600 were validated for dry times of 30 minutes.
· In 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F / 55°C and 40-80% relative humidity for 60 minutes.
o The wrap was validated for aeration times for EO sterilization of 16 hours at 40.0 ℃.

Dukal SMS sterilization wraps are intended to allow sterilization of the enclosed medical device(s), and also to maintain sterility of the enclosed device(s) for 6 months or until opened. The devices are intended for over-the-counter use and are single use disposable sterilization wraps.

Test results validated that the Dukal SMS sterilization wraps allowed sterilization of the enclosed medical device(s) by ethylene oxide sterilization and by pre-vacuum cycles.

These models of the Dukal SMS sterilization wrap have been validated for use with the ethylene oxide and pre-vacuum cycles listed in below table:

Models 100, 200, 300, 400, 500 and 600
Available in one or two sheets of blue nonwoven Polypropylene fabric. Each sheet of fabric is composed of three thermally- bonded layers consisting of a Meltblown polypropylene layer surrounded by Spunbond polypropylene layers (SMS).

The provided document is a 510(k) Premarket Notification for a medical device, specifically Dukal SMS Sterilization Wrap. It details the device's technical characteristics, indications for use, and a comparison to predicate devices, along with non-clinical test results.

However, this document does not describe a study involving an AI/software device or human-in-the-loop performance. The "device" in this context is a physical sterilization wrap, not an AI or software algorithm. Therefore, many of the requested criteria related to AI/software performance, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this submission.

The acceptance criteria provided in the document are for the physical properties and performance of the sterilization wrap itself (e.g., burst strength, air permeability, sterility maintenance) and its biological compatibility. The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing performed on the physical wrap.

Here's a breakdown based on the provided document, addressing the applicable criteria for a physical medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state sample sizes for each specific test. However, it references numerous ASTM, ISO, AATCC, and USP standards for non-clinical testing. These standards typically define the number of samples required for robust testing. For example, specific test procedures for tensile strength or burst strength would involve testing a statistically relevant number of samples.

• Data Provenance: The document does not specify the country of origin of the data. The tests are "non-clinical," implying laboratory testing of the material. There is no indication of retrospective or prospective data as this refers to patient data collection, which is irrelevant for a physical device like a sterilization wrap.

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

Not applicable. This device is a physical product (sterilization wrap), not an AI/software. Ground truth is established by objective physical and chemical testing methods as per international standards, not by human expert interpretation of images or clinical data.

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

Not applicable. This is not a study requiring adjudication of human interpretations.

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 not an AI/software device, so MRMC studies are irrelevant.

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

Not applicable. This is not an AI/software device.

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

For this physical device, the "ground truth" is defined by the validated and established performance requirements outlined in the referenced national and international standards (e.g., ASTM, ISO, AATCC, USP). These standards define the quantitative and qualitative criteria for material properties, sterilization efficacy, and biocompatibility. For example:

• Sterilant Penetration/Sterility Maintenance: Demonstrated by "BI result: Negative" (Biological Indicator) and "No growth" in sterility tests, which are objective microbiological tests.
• Material Properties: Measured objectively (e.g., in grams per square meter for basis weight, Pascals for bursting strength, Newtons for tearing strength).
• Biocompatibility: Determined by laboratory tests for cytotoxicity, irritation, and sensitization against established biological thresholds.

8. The sample size for the training set

Not applicable. This is not an AI/software device requiring a training set.

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

Not applicable. This is not an AI/software device requiring a training set or ground truth for training.

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