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The Cardinal Health™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:

· Gravity steam at 250°F/121°C for 30 minutes.

· Pre-vacuum steam at 270°F/132°C for 4 minutes.

• 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.

• · Advanced Sterilization Products (ASP) STERRAD® 100S system.
  · Advanced Sterilization Products (ASP) STERRAD® NX system, Standard and Advanced Cycles.

· Advanced Sterilization Products (ASP) STERRAD® 100NX System, Standard, Flex, Express and Duo Cycles.

· Advanced Sterilization Products (ASP) STERRAD® 200 System.

• Lumen, Non Lumen, and Flexible Cycles in the STERIS V-PRO® 1 Plus, STERIS V-PRO® maX and STERIS V-PRO® 60 Low Temperature Sterilization Systems.

· TSO3 STERIZONE® VP4 System Cycle 1 (Refer to Table 5 for load)

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

Cardinal Health™ Sterilization Wraps are made from 100% polypropylene spunbondmeltblown-spunbond (SMS) nonwoven fabric. The sterilization wrap is provided in six different material basis weights (models) of four product offerings in various dimensions. Cardinal Health™ Sterilization Wrap, Single Layer is comprised of a single sheet or one layer of SMS fabric. Cardinal Health™ Sterilization Wrap, Dual Layer and Cardinal Health™ Sterilization Wrap, TwoColor are comprised of two single layer sheets of SMS fabric ultrasonically bonded along two opposing sides. The wrap design allows for use of the sequential or simultaneous double-wrapping technique per recommendations from ANSVAAMI ST79:2017 and allows for a sterilized pack to be opened aseptically. All models utilize the same material technology. These products are a single-use device and for over-the-counter use only.

The Cardinal Health™ Sterilization Wrap is intended to enclose medical devices for sterilization and maintain their sterility until use. The device has been tested against various sterilization methods and loads.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document describes various validation studies performed for different sterilization methods and wrap models. The studies involved a range of loads, including medical instruments with different geometries, lumens, flexible endoscopes, towels, drapes, and metal mass. The specific sample sizes for each test set (e.g., number of wrapped packages, number of sterilization cycles) are not explicitly stated as numerical values in the provided text.

The data provenance is not explicitly stated in terms of country of origin, nor whether it was retrospective or prospective. Given that it is a 510(k) submission for a medical device and describes "Performance testing," it is implied to be prospective testing conducted in a controlled environment to validate the device's claims.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not specify the number or qualifications of experts used to establish the "ground truth" for the test set. The nature of the device (sterilization wrap) and the tests performed (microbial growth, physical properties, biocompatibility) suggest that the "ground truth" would be established through laboratory analyses and adherence to standardized testing protocols (e.g., ANSI/AAMI, ISO, ASTM), rather than expert consensus on subjective observations.

4. Adjudication Method for the Test Set:

An adjudication method is not mentioned, as it is not typically applicable to the type of objective, quantitative testing (e.g., microbial growth, physical property measurements) described for this device.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is irrelevant for a sterilization wrap, which is a physical device, 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:

A standalone performance study was not done. This term is applicable to AI algorithms, not physical medical devices like sterilization wraps. The performance evaluation focuses on the physical and microbiological properties of the wrap itself.

7. The Type of Ground Truth Used:

The ground truth used for these studies is based on:

• Microbial Growth/Sterility: Absence of microbial growth, determined by standard microbiological culture techniques after sterilization and shelf-life challenges.
• Physical Properties: Quantitative measurements of material characteristics (e.g., weight, air permeability, tensile strength, tear strength, burst strength, hydrostatic pressure) compared against defined specifications before and after sterilization.
• Biocompatibility: Absence of detectable residuals, clear and pH-neutral extracts, and negligible irritant response as determined by standardized ISO tests.

8. The Sample Size for the Training Set:

A training set is not applicable to this device. This concept relates to machine learning models, whereas the Cardinal Health™ Sterilization Wrap is a physical product evaluated through traditional laboratory and material science testing.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this device.

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The Cardinal Health™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by using:
• Advanced Sterilization Products (ASP) STERRAD® 200 System
The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed devices until it is used.

The Cardinal Health™ Sterilization Wraps are made from 100% polypropylene spunbondmeltblown-spunbond (SMS) trilaminate nonwoven fabric. The sterilization wraps are provided in six different material basis weights (models) of four product offerings in various dimensions. Cardinal Health™ Sterilization Wrap, Single Layer is comprised of a single sheet or one layer of SMS fabric. Cardinal Health™ Sterilization Wrap, Dual Layer and Cardinal Health™ Sterilization Wrap, Two Color comprised of two single layer sheets of SMS fabric ultrasonically bonded along two opposing sides. The wrap design allows for use of the sequential or simultaneous double-wrapping technique per recommendations from ANSVAAMI ST79:2010 and also allows for a sterilized pack to be opened aseptically. All models utilize the same material technology. These products are a single-use device and for over-the-counter use only.

They are intended to be used to enclose another medical device that is to be sterilized by a health care provider using the Advanced Sterilization Products (ASP) STERRAD® 200 System.

This document is an FDA 510(k) premarket notification for a medical device: Cardinal Health™ Sterilization Wrap. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets acceptance criteria through an AI/ML-driven study.

Therefore, the information required for a study proving a device meets acceptance criteria, especially for an AI/ML device (e.g., sample size for test/training set, expert involvement, MRMC study, ground truth establishment), is not present in this document. This submission is for a physical product (a sterilization wrap) and relies on non-clinical testing for performance and safety.

Let's break down why the requested information isn't available and what information is provided:

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

The document provides a "Summary of Non-Clinical Testing" in Table 4 (on page 13). This table essentially acts as the acceptance criteria and the reported performance for the physical device.

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

This information is not provided in the document because it's not relevant to a physical product's performance testing in the context of this 510(k) submission. The testing would involve laboratory evaluation of material properties and sterilization efficacy, not data sets for an AI/ML algorithm.

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

This information is not applicable as there is no "ground truth" establishment in the sense of expert annotation for an AI/ML algorithm. The ground truth for this device's performance is determined by established laboratory testing standards (e.g., ISO, ASTM, AATCC standards).

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

This is not applicable as there is no human interpretation or adjudication involved in the performance testing for this device in the context of an AI/ML evaluation.

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 is not applicable as the device is not an AI/ML product and does not involve human readers interpreting data.

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

This is not applicable as the device is not an AI/ML product.

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

The "ground truth" for this device's performance is based on established scientific and engineering principles and standardized test methods (e.g., ASTM, ISO, AATCC standards) for material properties (e.g., burst strength, air permeability), microbial barrier efficacy, and biocompatibility. It's not a clinical "ground truth" derived from patient outcomes or expert consensus on medical images.

8. The sample size for the training set

This is not applicable as there is no AI/ML training set for this device.

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

This is not applicable as there is no AI/ML training set for this device.

In summary:

This FDA 510(k) document is for a traditional medical device (sterilization wrap) and demonstrates substantial equivalence through a series of non-clinical laboratory tests rather than AI/ML performance studies. The questions posed in the prompt are highly specific to AI/ML device evaluation, which is why the answers are predominantly "Not applicable" in this context.

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Cardinal Health™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by using:

·Gravity steam at 250°F/121°C for 30 minutes

·Pre-vacuum steam at 270°F/132°C for 4 minutes

· 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

· Advanced Sterilization Products (ASP) STERRAD® 100S System

· Advanced Sterilization Products (ASP) STERRAD® NX System, Standard and Advanced Cycles

· Advanced Sterilization Products (ASP) STERRAD® 100NX, Standard, Flex, Express, and DUO cycles

• Lumen, Non Lumen, and Flexible Cycles in the STERIS V-PRO® 1 Plus and STERIS V-PRO® 1 Plus and STERIS V-PRO® maX Low Temperature Sterilization Systems

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

Cardinal Health™ Sterilization Wraps are made from 100% polypropylene spunbondmeltblown-spunbond (SMS) trilaminate nonwoven fabric. The sterilization wrap is provided in six different material basis weights (models) of four product offerings in various dimensions. The wrap design allows for use of the sequential or simultaneous double-wrapping technique per recommendations from ANSI/AAMI ST79:2010 and also allows for a sterilized pack to be opened aseptically. All models utilize the same material technology. This product is a single-use device and for over-the-counter use only.

This document describes the validation of Cardinal Health™ Sterilization Wrap, specifically to demonstrate its substantial equivalence to a predicate device and support its use with gravity steam sterilization.

Here's the breakdown of acceptance criteria and the study that proves the device meets them:

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

Study Proving Device Meets Acceptance Criteria:

The study is referred to as "extensive performance testing" and "sterility validation studies" completed on Cardinal Health™ Sterilization Wrap. This included:

• Sterilization Performance Tests: Demonstrated that the wrap allows for sterilization of enclosed contents and maintains sterility.
• Physical Properties Testing: Supported that the integrity of the wrap properties is not compromised after sterilization by the indicated processes and storage.
• Biocompatibility Testing: Conducted in compliance with ISO 10993 methods.

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

The document lists specific "loads" used for each sterilization method and for each wrap model (CH100-CH600) during "Sterility Validation Studies" (pages 5-6 and 13-14). These loads represent the test sets for demonstrating sterilization efficacy, microbial barrier, and maintenance of sterility.

• Gravity Steam Sterility Validation Studies:
  • CH100: 1 tray liner, 1 lb metal mass.
  • CH200: 1 tray liner, 3 lbs metal mass.
  • CH300: 1 tray liner, 6 lbs metal mass.
  • CH400: 1 tray liner, 10 lbs metal mass.
  • CH500: 1 tray liner, 12 lbs metal mass.
  • CH600: 1 tray liner, 20 lbs metal mass.
• Pre-vacuum Steam Sterility Validation Studies:
  • CH100: 16 huck towels.
  • CH200: 2 huck towels, 3 fluid-resistant drapes.
  • CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs metal mass.
  • CH400: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 8 lbs metal mass.
  • CH500: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 12 lbs metal mass.
  • CH600: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 20 lbs metal mass.
• EO Sterility Validation Studies:
  • CH100: 16 huck towels.
  • CH200: 2 huck towels, 2 fluid-resistant drapes, 2.5 lbs metal mass.
  • CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs metal mass.
  • CH400: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 7.5 lbs metal mass.
  • CH500: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 11.5 lbs metal mass.
  • CH600: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 19.5 lbs metal mass.
• Advanced Sterilization Products (ASP) STERRAD® 100S Sterility Validation Studies:
  • CH100: Metal instruments.
  • CH200-CH600: 15 in. x 10 in. x 1.2 in. tray containing metal instruments.
• Advanced Sterilization Products (ASP) STERRAD® NX® and STERRAD® 100NX® Sterility Validation Studies:
  • CH100-CH600: 23 in. x 11 in. x 4 in. tray containing metal instruments.
• STERIS V-PRO® Sterility Validation Studies:
  • CH100: Metal instruments.
  • CH200-CH600: 17 in. x 10 in. x 3.5 in. tray containing metal instruments.

The data provenance is not specified beyond the fact that Cardinal Health is a US-based company, suggesting the studies likely occurred in the USA. The nature of these validation studies (evaluating specific loads under controlled sterilization conditions) implicitly indicates they were prospective studies for the purpose of demonstrating device performance and substantial equivalence.

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)

This document pertains to the physical and biological performance of a sterilization wrap. The "ground truth" for such devices is established through laboratory testing following recognized standards for sterilization efficacy (e.g., sterility testing, microbial barrier testing) and physical/biocompatibility characteristics. It does not involve human expert interpretation of images or clinical data in the same way an AI diagnostic device would. Therefore, the concept of "number of experts used to establish ground truth" with specific qualifications like radiologists is not applicable here. The ground truth is determined by the results of validated scientific and engineering tests.

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

Not applicable. As explained above, the "test set" involves physical samples subjected to defined sterilization processes and subsequent lab analyses, not human interpretation of data requiring adjudication.

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 device is a sterilization wrap, not an AI diagnostic tool that assists human readers.

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

Not applicable. This device is a physical product (a sterilization wrap), not an algorithm or software.

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

The ground truth for this device is based on objective laboratory measurements and tests designed to assess:

• Sterilization Efficacy: Absence of microbial growth after sterilization.
• Microbial Barrier Properties: Resistance to microbial penetration.
• Maintenance of Sterility: Absence of microbial contamination after storage period.
• Physical Properties: Integrity and strength of the wrap material after sterilization.
• Material Compatibility: No adverse interaction with sterilization agents or enclosed devices.
• Biocompatibility: Absence of cytotoxicity, irritation, and sensitization as per ISO standards.

This ground truth is established through adherence to recognized industrial and medical device standards (e.g., AAMI ST79, ISO 10993) and scientific testing methodologies.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/software product that requires a "training set" in the context of machine learning. The term "training set" is usually associated with AI model development.

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

Not applicable, for the same reason as point 8.

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