(126 days)
The TSO3 Ozone Sterilization Wrap is a single-use, non-sterile device. It is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device, and also to maintain sterility of the enclosed device until used. This wrap is intended for use with TSO3 Ozone Sterilization process.
The TSO3 Ozone Sterilization Wrap is a single-use, non-sterile device. It is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device, and also to maintain sterility of the enclosed device until used. This wrap is intended for use in the TSO3 Ozone Sterilization process.
The TSO3 Ozone Sterilization Wrap is a 2 layer laminate consisting of an ePTFE membrane and a 100% Polyethylene/Polyester (PE/PET) bi-component nonwoven backer.
The TSO3 Ozone Sterilization Wrap is a single-use, non-sterile device intended to enclose a medical device for sterilization and maintain its sterility until use, specifically with the TSO3 Ozone Sterilization process.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Effectiveness (Sterilization Performance) | Not explicitly stated, but implied to meet industry standards for sterilization wraps. | "Sterilization performance studies... were conducted and all acceptance criteria were met." |
| Effectiveness (Shelf-life Sterility) | Not explicitly stated, but implied to meet industry standards for maintaining sterility over time. | "...and shelf-life sterility tests were conducted and all acceptance criteria were met." |
| Biocompatibility (Skin Irritation) | No induction of skin irritation. | "A skin irritation test was performed by an independent laboratory to demonstrate that the final product does not induce any biocompatibility hazard." "All acceptance criteria established in the applicable portions of the standards were met." |
| Biocompatibility (Cytotoxicity) | No induction of cytotoxicity. | "These materials [ePTFF/PE/PET] were evaluated for skin irritation, cytotoxicity testing, and sensitization... All acceptance criteria established in the applicable portions of the standards were met." |
| Biocompatibility (Sensitization) | No induction of sensitization. | "These materials [ePTFF/PE/PET] were evaluated for skin irritation, cytotoxicity testing, and sensitization... All acceptance criteria established in the applicable portions of the standards were met." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set for the sterilization performance and shelf-life sterility studies. It only mentions that "sterilization performance studies and shelf-life sterility tests were conducted."
For biocompatibility testing, it states that "A skin irritation test was performed by an independent laboratory to demonstrate that the final product does not induce any biocompatibility hazard." The specific sample size for this test is not provided in the summary.
The provenance of the data (country of origin, retrospective/prospective) is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not done as this device is a sterilization wrap, not an AI-assisted diagnostic tool where human readers would be involved in interpreting results. Therefore, there is no effect size of human readers improving with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the device is a physical sterilization wrap, not an algorithm.
7. Type of Ground Truth Used
- For Effectiveness (Sterilization Performance and Shelf-life Sterility): The ground truth would likely be established by microbiological testing, confirming the absence of viable microorganisms after sterilization and during the shelf-life. The document states "all acceptance criteria were met," implying these tests confirmed the desired outcome.
- For Biocompatibility (Skin Irritation, Cytotoxicity, Sensitization): The ground truth was established by laboratory testing according to ISO 10993 standard, part 1. This involves observing biological responses (e.g., cell viability, skin reactions) to the device materials.
8. Sample Size for the Training Set
This information is not applicable as the device is a physical product, not an AI model that requires 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.
§ 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).