(282 days)
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.
| Acceptance Criteria (Study) | Performance (Results Summary) |
|---|---|
| Microbial Barrier Properties: Maintenance of Package Integrity Test (Microbial Aerosol Challenge) | PASSED |
| Microbial Barrier Properties: Event Related Shelf Life Test - 365 days | PASSED |
| Sterrad® 200 Sterilant Penetration | PASSED |
| Material Compatibility with Indicated Sterilization Method (Basis weight, Air permeability, Material burst strength, Tensile strength and elongation, Tear strength, Hydrostatic Pressure, Lint Generation) | Compatible |
| Biocompatibility Testing: Cytotoxicity ISO 10993-5: 2009 | Non-cytotoxic, under the conditions of the test |
| Biocompatibility Testing: Sensitization, ISO 10993-10: 2010 | Non-sensitizing, under the conditions of the test |
| Biocompatibility Testing: Irritation, ISO 10993-10:2010 | Non-irritating, under the conditions of the test |
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.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).