(86 days)
The Nobel Biocare PureSet Trays are used in healthcare facilities to store and organize Nobel Biocare surgical/prosthetic 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; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. Sterilization wap. Sterlization validations for the worstcase PureSet Tray included surgical/prosthetic instruments such as torque wrenches, implant drivers, 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 (NobelParallel CC PureSet Tray), 945 grams (NobelReplace CC PureSet Tray), 454 grams (Nobel Biocare N1™ PureSet) and 486 grams (Prosthetic PureSet).
The PureSet Trays are reusable trays to be used in combination with Nobel Biocare surgical/prosthetic instruments and components. The PureSet Trays are used to store and organize the instruments and components during both the surgical, restorative 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 consists 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. The PureSet Tray consists of three parts: 1) a base with holders to accommodate the different surgical/prosthetic instruments, 2) a removable PureSet Plate (spare part) to indicate the surgical workflow (in case of the surgical tray) and the position of the instruments and components within the tray, and 3) a lid to securely contain the instruments and components during reprocessing and transportation
The Nobel Biocare PureSet Trays underwent several non-clinical performance tests to demonstrate substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Safety and Performance Aspects | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Acceptance criteria are defined per ISO 10993-1 and ISO 10993-5. | Pass |
| Cleaning/Disinfection/Sterilization | For Cleaning Validation: Acceptance criteria defined as per AAMI TIR 30. | |
| For Steam Sterilization Validation: Acceptance criteria defined in ISO 17665-1; AAMI ST79; AAMI TIR 12. Achievement of a SAL 10-6. | Pass | |
| Repeated Reprocessing (Legibility) | Each laser marking is human readable in an office environment after 500 reprocessing cycles, despite expected fading compared to non-processed Trays. | Pass |
| Repeated Reprocessing (Plate) | The information on the plate is still readable after 250 cycles of cleaning and sterilization. | Pass |
| Tool Movement During Tray Transport | The instruments stay in the designated location within the tray. The assembled instruments do not disassemble during transport. | Pass |
| Shipping Simulation | Visual Inspection of the shipping box Acceptance criteria based on ASTM4169-16. Inspection of label legibility Labels are present and legible. Abrasion and smudge are acceptable as long as information is human legible. | Pass |
| Risk Analysis | N/A (Risk analysis performed in accordance with ISO 14971, which implies that identified risks are mitigated to an acceptable level, but specific quantitative acceptance criteria are not provided in this table for the risk analysis itself beyond its completion.) | N/A (Risk analysis performed) |
2. Sample Size and Data Provenance:
- Test Set Sample Size: The document does not explicitly state a specific "sample size" in terms of number of devices for each test. However, it mentions quantities in the context of repeated reprocessing:
- Legibility: 500 cleaning and sterilization cycles.
- Plate Reprocessing: 250 cycles of cleaning and sterilization.
- Worst-case product was used for shipping simulation.
- Data Provenance: The tests were conducted by Nobel Biocare AB, presumably in a laboratory setting, to evaluate the device's performance against established standards. The document does not specify the country of origin of the data beyond Nobel Biocare's location. The testing appears to be prospective as it was performed specifically for this submission.
3. Number of Experts and Qualifications for Ground Truth:
- This device is a sterilization tray, and the testing focuses on its physical and functional performance (biocompatibility, cleaning efficacy, sterilization efficacy, durability, transport integrity, packaging). These tests typically rely on standardized methods and laboratory measurements rather than human expert opinion to establish ground truth. Therefore, the concept of "experts used to establish ground truth" as it would apply to diagnostic AI is not directly relevant here. The ground truth is established by the objective measures defined by the standards (e.g., SAL 10-6 for sterilization).
4. Adjudication Method:
- Not applicable. As described in point 3, the evaluation of a sterilization tray's performance against physical and biological standards does not involve expert adjudication in the way diagnostic image review might.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This device is a medical accessory (sterilization tray), not an AI-powered diagnostic tool. Therefore, an MRMC study to compare human reader performance with and without AI assistance is irrelevant.
6. Standalone Performance Study:
- Yes, a standalone performance study was conducted. The non-clinical performance tests mentioned in the table (biocompatibility, cleaning/sterilization, repeated reprocessing, tool movement during transport, shipping simulation) represent the standalone performance evaluation of the Nobel Biocare PureSet Tray itself, without human intervention in the primary function being tested (beyond, for example, loading/unloading for cleaning/sterilization tests).
7. Type of Ground Truth Used:
- The ground truth used for these tests is based on objective, standardized measurements and criteria defined by consensus standards (e.g., ISO 10993-1, ISO 10993-5, AAMI TIR 30, ISO 17665-1, AAMI ST79, AAMI TIR 12, ASTM D4169-16, ISO 14971). For example, achieving a Sterility Assurance Level (SAL) of 10-6 in sterilization validation is an objective ground truth.
8. Sample Size for the Training Set:
- Not applicable. This device is a physical medical accessory, not an AI/machine learning algorithm. Therefore, there is no "training set."
9. How Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set for this type of medical 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).