(100 days)
Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in CHAMBER mode, is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERLINK™ sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 1 month post sterilization.
The maximum load weight that can be placed in the Tyvek® roll is 3.97 pounds (1.8kg).
The roll is printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK™ sterilizer.
The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in the follow 1 type:
• Sterilization roll, Flat
Tyvek® Roll with CI for STERLINK™ Sterilizer is intended to contain medical devices to be terminally sterilized in the STERLINK™ sterilization system. The medical devices are inserted into the roll, sealed, and then sterilized in the STERLINK™ sterilization system. After completion of the sterilization process, the roll maintains sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices for up to 1 month post sterilization.
The roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK™ sterilizer.
The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in one type as a Flat Sterilization roll. The sterilization roll is made from a Tyvek® sheet and a clear plastic film that are heat sealed together on opposite two sides. After being cut into a suitable length, the product to be sterilized is placed inside and the two open ends are heat sealed. The process indicator printed on the Tyvek® will exhibit a color change after the roll is exposed to hydrogen peroxide (H2O2).
The provided text describes the regulatory clearance of a medical device, the Tyvek® Roll with CI for STERLINK™ Sterilizer, by the FDA. It outlines the device's intended use, its technical characteristics compared to a predicate device, and the non-clinical testing performed to establish its substantial equivalence.
However, the request asks for specific details related to the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/Machine Learning (ML) device, including information like sample size for test/training sets, data provenance, expert ground truth establishment, MRMC studies, and human reader improvement with AI.
The provided document does not describe an AI/ML device. It describes a physical medical device (sterilization wrap) and its chemical indicator. Therefore, the information requested about AI/ML specific study design elements (e.g., sample size for training/test sets, expert adjudication methods, MRMC studies, standalone algorithm performance, effect size of human reader improvement with AI, ground truth establishment for AI models) is not present in the provided text.
The document focuses on non-clinical performance and safety testing of the physical sterilization wrap and its chemical indicator based on established ISO and ASTM standards.
Below is a summary of the acceptance criteria and performance as presented in the document for the physical medical device, acknowledging that it does not pertain to an AI/ML system.
Acceptance Criteria and Device Performance (for a physical medical device, not AI/ML)
The document details performance and safety tests for the "Tyvek® Roll with CI for STERLINK™ Sterilizer" against various standards. The acceptance criteria are implicit in the "Pass" result for each test against the specified standard.
1. Table of Acceptance Criteria (Implicit) and Reported Device Performance
| Performance Testing | Standard | Reported Device Performance |
|---|---|---|
| Sterilant Penetration | ISO 14937 | Pass |
| CI of sterilization roll validation | ANSI/AAMI/ISO 11140-1 | Pass |
| Shelf-life - Internal pressurization test | ASTM F1980-16, ASTM F1140/F1140M-13 | Pass |
| Shelf-life - Visual inspection test | ASTM F1980-16, ASTM F1886/F1886M-16 | Pass |
| Shelf-life - Dye penetration test | ASTM F1980-16, ASTM F1929-15 | Pass |
| Shelf-life - Tensile strength of Tyvek® | ASTM F1980-16, ASTM D5035-11 | Pass |
| Shelf-life - Tensile strength of plastic film | ASTM F1980-16, ASTM D882 | Pass |
| Shelf-life - Seal strength | ASTM F1980-16, ASTM F88 | Pass |
| Tear resistance | ASTM F1980-16, ASTM D1922-20 | Pass |
| Microbial Barrier Test | ASTM F1980-16, DIN 58953-6 | Pass |
| CI of sterilization roll validation | ANSI/AAMI/ISO 11140-1 | Pass |
| Toxicological Properties (Biocompatibility Tests) | ISO 10993-5 | Pass - Test article is non-cytotoxic after the sterilization. |
| Residual sterilant on Tyvek® validation | Internal test standard | Pass |
| Material compatibility test | Various ASTM standards and Internal test standard | Pass |
2. Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (number of units tested) for each of the performance and safety tests listed. It only indicates that testing was "evaluated using the STERLINK™ FPS-15s Plus system, operating in Chamber mode."
- Data Provenance: The testing was conducted by Plasmapp Co., Ltd. (Applicant/Submitter based in South Korea) or their designated testing facilities. The specific geographical origin of the data (e.g., country) beyond the company's location is not further specified. The studies described are non-clinical (laboratory-based) performance and safety tests, not clinical studies on human subjects, so the "retrospective or prospective" designation as it applies to patient data is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the device is a physical sterilization wrap and chemical indicator, not an AI/ML device requiring expert interpretation for ground truth establishment. The "ground truth" for this device's performance is determined by adherence to established, quantitative engineering and biological standards (e.g., presence of sterilant, barrier integrity, physical strength).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable as the device is a physical product and the testing involves adherence to quantitative standards, not subjective expert review or 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:
- This question is not applicable as the device is a physical product (sterilization wrap) and its chemical indicator, not an AI-assisted diagnostic or interpretative tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This question is not applicable as the device is a physical product, not an algorithm.
7. The type of ground truth used:
- The ground truth for the performance of the sterilization wrap and its chemical indicator is based on established standard specifications and laboratory testing protocols for material properties, sterilization efficacy, barrier integrity, and chemical indicator function (e.g., color change upon exposure to hydrogen peroxide). This is not expert consensus, pathology, or outcomes data in the context of diagnostic AI.
8. The sample size for the training set:
- This question is not applicable as there is no mention of a training set for an AI/ML model. The device underwent non-clinical performance and safety testing.
9. How the ground truth for the training set was established:
- This question is not applicable for the same reason as above.
§ 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).