(116 days)
Smith & Nephew Multi-Purpose Sterilization trays are intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The subject instrument trays are suitable for use in prevacuum steam sterilization method. The subject instrument trays are not intended to maintain sterility; they are intended to be used in conjunction with a FDA cleared sterilization wrap in order to maintain sterility of the enclosed devices.
The Smith & Nephew Multi-Purpose Sterilization tray is a stainless steel tray provided with a Silicone mat. The tray is designed to contain surgical instruments and to allow optimal exposure of the tray's contents to sterilant during the sterilization process.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Smith & Nephew Multi-Purpose Sterilization Tray:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from AAMI ST77:2006) | Reported Device Performance |
|---|---|
| Sterilization performance | Demonstrated that performance meets redefined acceptance criteria and intended uses. |
| Functional strength | Demonstrated that performance meets redefined acceptance criteria and intended uses. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the test set (non-clinical validation testing). It only states that "Non-clinical validation testing was conducted for sterilization and functional strength."
The data provenance is not explicitly mentioned (e.g., country of origin). However, given the FDA 510(k) submission, it's implied that the testing was conducted to U.S. regulatory standards. The testing is non-clinical validation, which is a form of prospective testing.
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 document. The testing described is non-clinical performance and sterilization validation, which typically relies on established scientific methods and instrumental measurements rather than human expert interpretation of results for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable to the type of non-clinical validation described. Adjudication methods are typically used when human interpretation or assessment is involved in determining ground truth (e.g., in clinical trials or image analysis studies with multiple readers).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation of data (e.g., AI-powered diagnostic tools assisting radiologists). The Smith & Nephew Multi-Purpose Sterilization Tray is a physical device for containing instruments during sterilization, and its performance is assessed through non-clinical validation of sterilization efficacy and physical durability.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This question is relevant for AI algorithms. The device described is a physical sterilization tray, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the non-clinical validation was based on established scientific methods and instrumental measurements for assessing:
- Effective sterilization of contents (implying the ability of sterilant to penetrate).
- Functional strength and integrity of the tray after sterilization cycles.
The document references AAMI ST77:2006 Containment Devices for reusable medical device sterilization, which provides the standards and methodologies for this type of ground truth establishment.
8. The Sample Size for the Training Set
This information is not applicable as the device is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is not an AI algorithm requiring a training set.
§ 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).