(156 days)
The Nobel Biocare PureSet Tray is used in healthcare facilities to store and organize Nobel Biocare surgical instruments and components during cleaning/sterilization and during implant/prosthetic treatment. The Nobel Biocare PureSet Trays are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization pouch or sterilization wrap. Sterilization validations for the worst-case PureSet Tray included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, screw taps, screw driver and irrigation needles. The PureSet Trays were validated for a maximum load of 1635 grams (Trefoil PureSet Tray), 1082 grams (NobelActive/NobelParallel CC PureSet Tray) and 945 grams (NobelReplace CC PureSet Tray).
The PureSet Tray is a reusable surgical tray to be used in combination with Nobel Biocare surgical instruments and components. The PureSet Tray is used to store and organize the instruments and components during both the surgical and reprocessing procedures. The PureSet Trays are not intended to maintain sterility on their own. They are intended to be used in conjunction with an FDA cleared sterilization wrap/pouch.
Each PureSet Tray consist of multiple components designed to be integrated into a single unit, which protects the interior components during transportation, and storage. All the components of the PureSet Tray are perforated with an evenly distributed hold pattern and are designed to be used for sterilization via steam sterilization. Since the PureSet Trays are perforated, an FDA cleared wrap or pouch must be used for sterilization purposes and to maintain the sterility of the contents. The PureSet Trays are designed to be used with standard autoclaves used in hospitals and healthcare facilities.
This document is a 510(k) premarket notification for the Nobel Biocare PureSet Tray, a Class II medical device. It's not a study proving the device meets acceptance criteria for an AI/ML product or diagnostic tool. Instead, it demonstrates the substantial equivalence of the PureSet Tray to legally marketed predicate devices, primarily regarding its function as a sterilization tray for surgical instruments.
Therefore, the requested information (acceptance criteria for an AI/ML product, study design for AI/ML performance, ground truth establishment for a diagnostic AI, etc.) cannot be extracted from this document because it pertains to a different type of medical device entirely. The document focuses on performance data related to material compatibility, sterilization effectiveness (for the tray itself, not its contents' sterility), durability, and reprocessing, which are relevant to a physical medical device like a surgical tray.
Here's why the specific questions cannot be answered based on this document:
- Table of acceptance criteria and reported device performance (for an AI/ML product): This document references acceptance criteria for physical and sterilization performance (e.g., handle durability, cleaning/sterilization effectiveness for the tray), not for AI/ML model performance metrics like sensitivity, specificity, AUC, etc.
- Sample size for the test set and data provenance: No "test set" in the context of AI/ML is mentioned. The testing involves physical prototypes of the tray.
- Number of experts used to establish ground truth and qualifications: "Ground truth" in the AI/ML sense (e.g., diagnosed diseases) is not applicable here. Ground truth concerns the physical properties and performance of the tray.
- Adjudication method for the test set: Not applicable to a physical device's performance testing.
- MRMC comparative effectiveness study: Not applicable to a physical device. There are no "human readers" or "AI assistance" in this context.
- Standalone (algorithm only) performance: Not applicable. This is a physical device, not an algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" used for this device would be established by physical testing standards and validated sterilization methods, not medical expert consensus on diagnostic images or pathology.
- Sample size for the training set: Not applicable. There is no AI/ML model being trained.
- How ground truth for the training set was established: Not applicable. There is no AI/ML model being trained.
In summary: The provided document is a 510(k) premarket notification for a physical medical device (sterilization tray), not an AI/ML-based device. Therefore, the specific questions related to AI/ML product acceptance criteria and study design cannot be answered from this content.
§ 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).