(261 days)
The U&U sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam and Ethylene Oxide (EtO). The recommended gravity steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EtO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 90 Davs post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.
The U&U Sterilization Pouch and Roll are manufactured from paper and medical plastic film that are heat sealed on three sides. The fourth side has an adhesive tape that is used to seal the pouch or heat-sealed by the heat-seal machine. The paper conforms to recognized material standards and can be sterilized by steam and Eto. The Sterilization Pouch has the same intended use, Essential Component, Raw material, Sterilization method, manufacturing methods and same technological characteristics as the predicate device. Substantial equivalent to the predicate device was established by physical testing of the sterilized finished devices, as well as, performance of these finished devices (seal strength, package burst, and dye migration).
This document is a 510(k) summary for the U&U Sterilization Pouch and Roll, and it focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria for an AI/ML powered device. Therefore, much of the requested information regarding AI/ML studies (such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable or available in this document.
However, the document does contain performance testing results for the sterilization pouch and roll, which can be presented as acceptance criteria and reported device performance.
Here's an attempt to answer your questions based only on the provided document, adapting where necessary to the context of a non-AI/ML medical device submission:
1. A table of acceptance criteria and the reported device performance
The document lists "Performance Tests" and the results for the U&U Sterilization Pouch and Roll. The "acceptance criteria" are implied by the "PASSED" result, meaning the device met the requirements of the standards or internal thresholds for each test. For elements where direct comparison with the predicate device implies the "acceptance criteria", those are noted.
| Element (Acceptance Criteria Implicitly Met) | Reported Device Performance |
|---|---|
| Sterilant Penetration | PASSED |
| Package Integrity | PASSED |
| Maintenance of Package Integrity | PASSED |
| Material Compatibility | PASSED |
| Shelf-Life | PASSED |
| Biocompatibility | PASSED |
| Labeling | PASSED |
| Configurations /Dimensions | PASSED |
| Air permeance | PASSED |
| Maintenance of Sterility | PASSED (90 Days) |
| Endpoint stability of process indicator | PASSED (90 Days) |
| Shelf Life of Process Indicator | PASSED (18 months) |
| Chemical Indicator Efficacy | PASSED (Changed color: EtO- YELLOW to COCOA; Steam- GREEN to PURPLE) |
| Seal strength | PASSED |
| Peel-open characteristic | PASSED |
| Seal width | PASSED |
| Self seal strength | PASSED |
| Visual inspection | PASSED |
| Ethylene oxide residuals | PASSED |
| Specific Comparison with Predicate (Implied Acceptance Criteria) | |
| Air permeance (Max. equivalent pore size diameter) | Not exceed 50um (Reported: Not specified, but implied to meet) |
| Sterilant Penetration (Pore size diameter) | Determined using EN 868-2:1999 Annex C. Reported: 40 to 44 um (Predicate: 38 to 43 um). "The difference can be accepted." |
| Microbial Barrier Properties (LRV) | Using ASTM 1608 method, LRV > 3.5 (Predicate: LRV 3.3). "The data is a little higher than the predicated device, The difference can be accepted." |
| Microbial Barrier Properties (Inspection) | Using ASTM 1929 method, inspection result is PASS (Predicate: PASS) |
| Maintenance of Sterility (Duration) | 90 Days (Predicate: 2 years) |
| Endpoint stability of process indicator (Duration) | 90 Days (Predicate: 2 years) |
| Shelf Life of Process Indicator (Duration) | 18 months (Predicate: 2 years) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: The document does not specify the exact sample sizes used for each performance test. It only states that "Performance testing was conducted" and refers to validation of "Two types of sterilization loads."
- Data provenance: The document is a submission from U&U Medical Technology Co., Ltd, located in China. The testing was conducted to support their 510(k) submission to the US FDA. No specific country of origin for the raw test data is explicitly stated, nor is it specified if the studies were retrospective or prospective, though performance testing for regulatory submission is typically prospective for the device being submitted.
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 question is not applicable to the provided document. The device is a sterilization pouch and roll, not an AI/ML-powered diagnostic or predictive device that relies on expert interpretation to establish ground truth for testing. The "ground truth" for this device's performance is based on established engineering and microbiological test methods (e.g., AAMI/ANSI, ISO, ASTM standards) and physical/chemical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert consensus processes for establishing ground truth in image analysis or similar diagnostic contexts, which is not relevant for this device. The performance tests rely on objective laboratory measurements and standardized methods.
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. MRMC studies are designed for assessing the impact of AI on human reader performance, which is not relevant for a sterilization pouch and roll.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical product (a sterilization pouch and roll), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" (or basis for evaluation) for this device's performance is derived from:
- Compliance with recognized material and performance standards (e.g., AAMI/ANSI ST77, AAMI TIR22, AAMI/ANS//ISO 11140-1).
- Results from standardized physical and chemical tests (e.g., EN 868-2:1999 Annex C, ASTM 1608, ASTM 1929, ISO10993 for biocompatibility).
- Observed changes in chemical indicators (color change).
- Comparison with the performance characteristics of a legally marketed predicate device (SIGMA Sterilization Pouch and Roll - K102158).
8. The sample size for the training set
This question is not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
This question is not applicable as this is not an AI/ML device.
§ 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).