(390 days)
Smith & Nephew ACUFEX™ GRAFTMASTER™ III SYSTEM TRAYS are intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The instrument trays are suitable for use in a prevacuum steam method. They are intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices.
The Smith & Nephew ACUFEX™ GRAFTMASTER™ III SYSTEM TRAY is a reusable stainless steel sterilization tray and lid fitted with a silicone pin mat and instrument holders designed to contain and protect reusable surgical instruments during transport, sterilization, and storage. Perforations in the tray and lid allow for optimal exposure of the tray's contents to sterilant during the sterilization process.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text only refers to "pre-defined acceptance criteria" for sterilization and functional strength testing and states that performance "meets the requirements of its pre-defined acceptance criteria." It does not explicitly list the quantitative acceptance criteria or the specific numerical performance results for these criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization | Met pre-defined criteria |
| Functional Strength | Met pre-defined criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It only states that "Non clinical validation testing was conducted for sterilization and functional strength."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study involves non-clinical validation testing of a sterilization tray, not a diagnostic device requiring expert interpretation of results.
4. Adjudication Method for the Test Set
This information is not applicable for the type of non-clinical validation study described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a sterilization tray, and the testing performed was non-clinical validation of its physical properties and sterilization effectiveness.
6. Standalone Performance Study
Yes, a standalone study was done. The "Non clinical validation testing was conducted for sterilization and functional strength" for the device itself to demonstrate its safety and effectiveness. This indicates an algorithm-only (device-only in this context) assessment of its performance.
7. Type of Ground Truth Used
The ground truth for the sterilization testing would likely be based on established sterilization standards (e.g., biological indicator kill rates, physical indicators) and for functional strength, it would be based on engineering standards and measurements of mechanical integrity. The document mentions "Performance testing was conducted in accordance with AAMI ST77:2006 Containment Devices for reusable medical device sterilization," indicating that the ground truth for sterilization was aligned with this standard.
8. Sample Size for the Training Set
This information is not applicable as the validation described is for a physical medical device (a sterilization tray) and not for an AI algorithm that would typically require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device validation.
§ 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).