(175 days)
ONE TRAY® Sealed Sterilization Containers are intended to be used to hold temperature tolerant medical devices, surgical supplies, single instruments or an instruments or an instrument set for immediate use following flash sterilization. This includes sterilization of lumens 3 mm in diameter or larger with lengths of up to 400 mm.
After sterilization, ONE TRAY provides for the safe transport and assured delivery for immediate use of the enclosed devices in a sealed container with tamper evident security and load record documentation according to AAMI and AORN guidelines.
ONE TRAY® is a sealed rigid container with a rectangular patterned group of perforations forming vented areas in the lid and base. Dispossable hydrophobic SMS filters cover each vented area and are held firmly in place by a perforated stainless steel filters cover. This assembly permits the penetration of steam during the sterilization process and serves as a bacterial and fluid barrier at the conclusion of the sterilization cycle.
The provided 510(k) summary for the "ONE TRAY® Sealed Sterilization Container" (K052567) details its intended use and performance testing relative to predicate devices. However, it does not contain specific numerical acceptance criteria or a detailed study report that would typically include the requested information for AI/ML device evaluations.
This submission is for a physical medical device (a sterilization container), not an AI/ML diagnostic or predictive device. Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "training set sample size," or "expert qualifications for ground truth," are not applicable.
The performance testing described is focused on the functional equivalence of the sterilization container to predicate devices, assessing its ability to achieve sterilization and maintain sterility.
Here's a breakdown of the information available based on your request, with a clear indication of what is not present due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device | "Based on the results of laboratory tests; the ONE TRAY® is substantially equivalent to the predicate container." |
| Sterilization Efficacy (Steam Penetration) | Performance testing included "steam penetration." (No specific numerical criteria or results provided, implied efficacy for described cycles). |
| Sterilization Efficacy (Half Cycle Validation) | Performance testing included "half cycle validation." (No specific numerical criteria or results provided, implied efficacy for described cycles). |
| Package Integrity | Performance testing included "package integrity." (No specific numerical criteria or results provided, implied integrity). |
| Shelf Life | Performance testing included "shelf life." (No specific numerical criteria or results provided, implied appropriate shelf life). |
| Material Compatibility | Performance testing included "material compatibility." (No specific numerical criteria or results provided, implied compatibility). |
| Biocompatibility | Performance testing included "biocompatibility studies." (No specific numerical criteria or results provided, implied biocompatibility). |
| Ability to hold medical devices during steam sterilization | "The ONE TRAY® Sealed Sterilization Containers are intended to be used to hold medical devices during steam sterilization." |
| Rapid sterilization in flash cycles | "intended to be used for rapid sterilization of instruments or instrument sets in flash cycles." |
| Support 25 lb gross weight load | "been validated in all of the various size configurations listed in the following table to process a twenty five pound (25 lb) gross weight load (single container plus contents)" |
| Compatibility with steam pre-vacuum cycle | "in a steam pre-vacuum cycle at 132°C for 4 minutes exposure time" |
| Compatibility with steam gravity cycle | "in a steam gravity cycle at 132°C for 34 minutes exposure time" |
| Safe transport and assured delivery of enclosed devices in sealed container | "After sterilization, ONE TRAY® provides for the safe transport and assured delivery of the enclosed devices in a sealed container with tamper evident protection according to AAMI and AORN guidelines." |
| Sterilization of lumens 3 mm or larger, up to 400 mm length | "This includes sterilization of lumens 3 mm in diameter or larger with lengths of up to 400 mm." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "laboratory tests" but does not detail the number of containers tested, cycles performed, or specific test articles used.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing would have been conducted by the manufacturer, Sterile Containment Technology, LLC, likely in a controlled laboratory environment. It is a prospective evaluation as the device was being developed and tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. This information is not relevant for a physical sterilization container. "Ground truth" in this context would refer to objective measurements of sterility, steam penetration, integrity, etc., performed in a laboratory, not subjective interpretations by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations, typically in diagnostic imaging or clinical trials involving human readers. This is not applicable to performance testing of a physical sterilization container.
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
- N/A. This device is not an AI-assisted diagnostic tool, so an MRMC study and
measurement of human reader improvement with AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device would be established through objective laboratory measurements based on recognized standards for sterilization (e.g., AAMI, AORN guidelines mentioned) and device performance (e.g., sterility indicators, microbial challenge tests, physical integrity assessments). It would not be expert consensus, pathology, or outcomes data in the typical sense applied to diagnostic tools.
8. The sample size for the training set
- N/A. This device does not involve a training set as it's not an AI/ML algorithm.
9. How the ground truth for the training set was established
- N/A. Not applicable, as there is no training set for this physical 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).