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CareGUARD* Sterilization Wrap is a single-use, non-woven sterilization wrap intended to be sterilized by a health care provider using pre-vacuum steam at 273ºF / 134ºC for 4 minutes. The CareGUARD* Sterilization Wrap was validated for a dry time of 30 minutes. The CareGUARD* Sterilization wrap is recommended to be used with trays weighing up to 13.7 lbs.

The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.

Test results validated that CareGUARD* Sterilization wraps allowed sterilization of the enclosed devices by pre-vacuum cycles.

CareGUARD* Sterilization Wrap is made from 100% polypropylene spunbond-meltblownspunbond (SMS) non-woven fabric. The sterilization wrap is provided in three different material basis weights of three product offerings in various dimensions. CareGUARD* Single Layer Sterilization wrap is comprised of a single sheet or one layer of SMS fabric. CareGUARD* Dual Layers Sterilization Wrap and CareGUARD* Contrast Sterilization Wrap, are comprised of two single layer sheets of SMS fabric ultrasonically bonded along two opposing edges. The wrap design allows for use of the sequential or simultaneous double-wrapping technique per recommendations from ANSI/AAMI ST79:2017 and allows for a sterilized pack to be opened aseptically. All basis weights utilize the same material technology. This product is a single-use and a non-sterile medical device.

CareGUARD* Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using pre-vacuum steam at 273°F/134°C for 4 minutes.

The "CareGUARD* Sterilization Wrap" device, which is a single-use, non-woven sterilization wrap, has undergone non-clinical testing to demonstrate its performance and substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and data provenance:

The document doesn't explicitly state the exact sample sizes for each test in the test set. However, it indicates:

• For the Pre-vacuum steam Sterility Maintenance Study, the load used was: "50 GSM: 21 in. x 10 in. x 4 ¾ in. (54 cm x 25 cm x 12 cm) tray containing 13.7 lbs (6.2 kg) of metal mass. The metal mass included surgical instruments used for orthopedic joint replacement." This describes the type of load rather than a numerical sample size.
• The studies are non-clinical (laboratory-based performance tests), not clinical trials involving human subjects or patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective does not apply in the same way it would for clinical studies. The standards referenced (e.g., ISO, EN, ASTM, AS/NZS, ANSI/AAMI) suggest international standardization of testing methodologies.

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

This information is not applicable. For non-clinical performance and material characteristic tests like those conducted for a sterilization wrap, "ground truth" is established by adherence to recognized international and national standards and validated testing protocols, not by expert consensus on observational data.

4. Adjudication method for the test set:

This information is not applicable. Non-clinical performance tests follow predefined analytical methods and acceptance criteria from standards, rather than requiring adjudication of subjective observations by experts. The results are quantitative measurements or qualitative pass/fail outcomes against objective criteria.

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:

This information is not applicable. The device is a physical sterilization wrap, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study and effects of AI assistance are irrelevant.

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

This information is not applicable. This is a physical medical device, not an algorithm, so the concept of standalone algorithm performance does not apply.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is established by:

• Compliance with recognized international and national standards: Such as ISO 11607-1, EN 868-2, ISO 10993 series, ASTM F2101-14, AS/NZS 4187:2014, ANSI/AAMI/ST8:2013, ANSI/AAMI ST79:2017, and EN 285:2015+A1:2021.
• Scientifically validated test methods and predefined acceptance criteria: These standards outline specific methodologies and thresholds for determining performance characteristics like physical properties, chemical properties, biocompatibility, bacterial filtration efficiency, sterilization validation, sterilant penetration, dry time, and maintenance of sterility.

8. The sample size for the training set:

This information is not applicable. The CareGUARD* Sterilization Wrap is a physical product, not an AI model requiring a training set.

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

This information is not applicable for the same reason as above; there is no AI training set for this device.

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