Search Results

Sterisheet Sterilization Wraps are single use non-woven sterilization wraps intended to enclose medical devices that are to be sterilized at a healthcare facility. They are used in 3-hour and 6hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.

Sterisheet Sterilization Wraps are single use, non-sterilyzation wraps constructed from cellulose, synthetic fibers (polypropylene), and synthetic binders, with the addition of pigmentation. They are used to enclose medical devices that are to be sterilized by a healthcare provider in 3-hour and 6-hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Devices must be wrapped following manufacturer's instructions. After completion of the sterilization process. Sterisheet Sterilization Wraps maintain sterility of the enclosed medical devices for 6 month.

AN85 EO Indicators, when placed on the outside of the sterilization wraps, may be used to secure the wrapping material on the devices and to indicate ethylene oxide exposure, offering a convenient way to verify processing in the sterilization cycle. The color of the AN85 EO Indicators changes from yellow-green to blue after exposure to ethylene oxide.

The information provided describes the acceptance criteria and a summary of non-clinical testing for the Sterisheet Sterilization Wrap (K200335), which is intended for use in a 6-hour ethylene oxide (EO) gas sterilization cycle.

Here's an analysis of the requested information based on the provided text:

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

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

The document lists "Performance Testing" and "Summary of bench tests" but does not provide details on specific sample sizes for these tests. It indicates that the tests conform to ISO 11607-1, ASTM F2101, DIN 58953-6, ISO 10993, and USP standards. These are bench-level tests (non-clinical) and do not involve human subjects or geographical data provenance in the typical sense. The testing was conducted to prove the performance of the wrap itself.

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 information is not applicable as the study described is a non-clinical performance evaluation of a sterilization wrap, not a diagnostic device relying on expert interpretation for ground truth. The "ground truth" here is the outcome of standardized physical, chemical, and biological tests.

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

This information is not applicable as the tests are objective laboratory tests rather than subjective assessments 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

This information is not applicable as MRMC studies are relevant for diagnostic tools, particularly those involving human interpretation of medical images or data, often with AI assistance. The Sterisheet Sterilization Wrap is a medical device for sterilization, not a diagnostic or AI-powered interpretative tool.

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

This information is not applicable for the same reasons as above. The device is not an algorithm. The "standalone" performance here refers to the wrap's inherent ability to function as a microbial barrier and allow sterilant penetration.

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

The ground truth for the non-clinical tests is established through objective laboratory measurements and validated biological indicators. For example:

• Physical and Chemical Properties: Measured values against established standards (e.g., ISO for substance, permeability).
• Bacterial Filtration Efficiency and Germ Proofness: Efficacy in preventing microbial passage according to ASTM and DIN standards.
• Material Compatibility: Physical, chemical, and microbial barrier properties remaining acceptable after EO exposure.
• Biocompatibility: Absence of toxicity per ISO 10993 and USP (MEM Elution, Sensitization, Irritation).
• Sterilant Penetration: Inactivation of 6-Log biological indicators.
• Maintenance of Package Sterility: Absence of microorganism growth after storage.

8. The sample size for the training set

This information is not applicable. The Sterisheet Sterilization Wrap is not an AI/ML device that requires a "training set." The tests are empirical demonstrations of its physical, chemical, and biological performance.

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

This information is not applicable as there is no training set for this device.

Ask a specific question about this device

Sterisheet Sterilization Wraps are single use non-woven sterilization wraps intended to enclose medical devices that are to be sterilized at a healthcare facility. They are used in the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer.

Sterisheet Sterilization Wraps are single use, non-sterile sterilization wraps constructed from cellulose, synthetic fibers (polypropylene), and synthetic binders, with the addition of pigmentation. They are used to enclose medical devices that are to be sterilized by a healthcare provider in the 12 hour sterilization cycle at 20-29°C in an Anprolene AN75 Ethylene Oxide Gas Sterilizer. Devices must be wrapped following manufacturer's instructions. After completion of the sterilization process, Sterisheet Sterilization Wraps maintain sterility of the enclosed medical devices for at least 3 months.

The provided document is a 510(k) premarket notification for a medical device called "Sterisheet Sterilization Wrap." It is not a document describing a study of an AI/ML powered device, nor does it contain information about acceptance criteria and performance data for such a device.

The product in question is a physical sterilization wrap, and the performance testing mentioned relates to its physical properties, material compatibility, biocompatibility, shelf life, and its ability to allow sterilant penetration and maintain sterility. The "study that proves the device meets acceptance criteria" refers to bench tests of a physical product, not a study of an AI/ML algorithm's performance.

Therefore, I cannot answer your request as it pertains to an AI/ML device study. The document does not contain any of the information you requested regarding:

• A table of acceptance criteria and reported device performance for an AI/ML algorithm.
• Sample sizes for a test set (in the context of an algorithm).
• Data provenance (country, retrospective/prospective) for an algorithmic test set.
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods for an algorithmic test set.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes data).
• Training set sample size or how its ground truth was established.

The document is solely a regulatory submission for a traditional medical device.

Ask a specific question about this device

The Sterisheet Sterilization Wraps are single use non woven sterilization wraps intended to enclose medical devices that are to be sterilized at a healthcare facility. They are used in the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.

The Sterisheet Sterilization Wraps are single use, non-sterilization wraps constructed from cellulose, synthetic fibers (polypropylene), and synthetic binders, with the addition of pigmentation. They are used to enclose medical devices that are to be sterilized by a healthcare provider in the 3 hour sterilization cycle at 50°C in an EOGas 4 Ethylene Oxide Gas Sterilizer. Devices are wrapped following manufacturer's instructions. After completion of the sterilization process, the Sterisheet Sterilization Wraps maintain sterility of the enclosed medical devices for at least 3 month.

The provided text describes the performance testing and acceptance criteria for the Sterisheet® Sterilization Wrap (K152291).

Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes non-clinical performance testing to demonstrate the safety and effectiveness of the Sterisheet® Sterilization Wrap. This is a technical validation rather than a clinical study involving human patients or ground truth established by medical experts for diagnostic purposes. Therefore, some of the requested information (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, training set details) is not applicable or cannot be extracted from this type of document.

The study focuses on demonstrating the physical, chemical, and biological performance of the sterilization wrap itself.

1. Sample size used for the test set and the data provenance: Not explicitly stated in terms of a "test set" as would be used for an AI/diagnostic device. The testing involves physical samples of the sterilization wrap subjected to various conditions and analyses. The provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a sterilization wrap is established through adherence to standards (e.g., ISO 11607-1) and objective measurements of sterility, material integrity, and biological efficacy, not expert consensus on an image or clinical finding.

3. Adjudication method for the test set: Not applicable. Performance is evaluated against objective standards and biological indicators, not through human adjudication of differing opinions.

4. 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 is not an AI/diagnostic device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm.

6. The type of ground truth used:

   • Objective Standards: Compliance with ISO 11607-1 requirements for packaging of terminally sterilized medical devices.
   • Biological Efficacy: Inactivation of 6-Log biological indicators to demonstrate a sterility assurance level of $10^{-6}$ (using the overkill method and half cycle or half dose validation methods under worst-case conditions).
   • Physical and Chemical Properties: Bench testing to verify package integrity, material compatibility, and shelf-life stability.

7. The sample size for the training set: Not applicable. This is not an AI/algorithm and therefore does not have a "training set" in that context.

8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device