(60 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.
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 container, 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, screwdrivers, and irrigation needles.
The PureSet™ Trays were validated for a maximum load of 1635 grams (Trefoil™ PureSet™ Tray), 1122 grams (NobelActive® / NobelParallel™ CC PureSet™ Tray), 1063 grams (NobelReplace® CC PureSet™ Tray), 454 grams (Nobel Biocare N1™ PureSet™ Tray), 486 grams (Prosthetic PureSet™ Tray), 1143 grams (NobelActive® Guided PureSet™ Tray), 1146 grams (NobelParallel™ CC Guided PureSet™ Tray), 1176 grams (NobelReplace® CC Guided PureSet™ Tray), and 1035 grams (NobelSpeedy® Groovy® / Brånemark System® Mk III TiUnite / Replace Select™ TC PureSet™ Tray) and 1202 grams (NobelZygoma PureSet™ Tray).
Method: Steam Sterilization (Moist Heat Sterilization) for Wrapped Instruments
Cycle: Dynamic-Air-Removal (fractionated vacuum), Gravity-Displacement
Temperature: 132°C (270°F), 132°C (270°F)
Exposure time for a single-use pouched device: 4 minutes (full-cycle), 15 minutes (full-cycle)
Minimum drying times: 20 minutes, 30 minutes
PureSet Trays are reusable surgical trays to be used in combination with Nobel Biocare surgical instruments and components. PureSet Trays are used to organize and store the instruments and components during both surgical and reprocessing procedures.
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, or container.
All components of the PureSet Tray are perforated with an evenly-distributed hole pattern and are designed to be used for sterilization via steam sterilization. Because the PureSet Trays are perforated, an FDA-cleared sterilization wrap, pouch, or container must be used during sterilization and storage to maintain the sterility of the contents.
PureSet Trays are designed to be used with standard autoclaves used in hospitals and healthcare facilities.
This is a 510(k) Pre-Market Notification for a medical device called the "NobelZygoma PureSet™ Tray," a type of sterilization wrap. The document is primarily concerned with demonstrating "substantial equivalence" to previously cleared predicate devices, rather than presenting a groundbreaking study with novel acceptance criteria and deep dives into AI performance statistics.
However, I can extract the relevant information regarding acceptance criteria and the types of studies performed, as described in the provided text, recognizing that these are not clinical studies in the typical sense for AI devices.
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like the NobelZygoma PureSet™ Tray (a sterilization tray), acceptance criteria are typically related to its functionality in terms of cleaning, sterilization, biocompatibility, and durability, ensuring it performs as intended and is safe for patient contact.
| Acceptance Criteria Category | Specific Criteria/Standard (as implied or stated) | Reported Device Performance |
|---|---|---|
| Cleaning & Sterilization | Validation according to AAMI TIR12, AAMI TIR 30, ISO 15883-1, ISO 15883-5, ISO 10993-5, AAMI ST79, AAMI ST77, ISO 17665-1, ISO14161, ISO14937, AAMI ST8, ISO 11737-2, AAMI TIR17, and FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. | |
| (Ensuring effective removal of contaminants and sterilization of instruments within the tray, including worst-case scenarios). | Cleaning and sterilization validation testing on representative worst-case devices was performed according to the listed standards. | |
| Result: PASS | ||
| Biocompatibility | Evaluation and testing in accordance with ISO 10993-1, ISO 10993-5, and ISO 10993-12. | Biocompatibility testing on representative worst-case devices demonstrated that the Subject device is biocompatible. |
| Result: PASS | ||
| Repeated Reprocessing | Withstand repeated reprocessing cycles as described in ANSI/AAMI ST77 and ISO 17664. | Testing on representative worst-case devices demonstrated that the Subject device can withstand repeated reprocessing cycles. |
| Result: PASS | ||
| Instrument Retention | Retention ability of instrument features during reprocessing; no dislodgment of instruments; no protrusion of sharp edges/components from the tray after reprocessing. | The retention ability of the instrument retention features in the Subject NobelZygoma PureSet™ Tray during reprocessing was assessed. Testing demonstrated that instruments are not dislodged after reprocessing. There was no sign of protrusion of sharp edges or components from the tray. |
| Result: PASS | ||
| Durability (Handle & Closing Mechanism) | Withstand at least 4 times the maximum weight of a full loaded tray. (Acceptance criteria fulfilling ANSI/AAMI ST77 requirements). | Testing on representative worst-case device demonstrated that the tray handle and the closing mechanism can withstand at least 4 times the maximum weight of a full loaded tray. |
| Result: PASS | ||
| Maximum Load Support | Specific maximum load capacities were validated for various PureSet™ Trays (e.g., 1202 grams for NobelZygoma PureSet™ Tray). | The PureSet™ Trays were validated for a maximum load of 1202 grams (NobelZygoma PureSet™ Tray). This specific value is presented as a validated performance characteristic rather than a distinct "test result" in the summary table, but it's an inherent part of the device's acceptable performance. |
| Result: Met (implied) |
2. Sample Size Used for the Test Set and Data Provenance
This document describes validations for a physical medical device, not an AI/ML model for diagnostic or prognostic purposes involving patient data. Therefore, the concept of a "test set" and "data provenance" in the context of country of origin or retrospective/prospective data as it applies to software or AI is not directly applicable here.
- Sample Size for Testing: The document refers to "representative worst-case devices" for all non-clinical tests. It doesn't specify a numerical sample size (e.g., N=3, N=50) for these physical device tests. The selection of "worst-case" implies that a specific configuration or condition that would pose the greatest challenge to cleaning, sterilization, or durability was chosen for testing.
- Data Provenance: Not applicable in the context of clinical/patient data for AI. The tests are laboratory-based, non-clinical evaluations of the device itself.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not explicitly provided in the document. For physical device validations like these, "ground truth" is established through adherence to recognized international and national consensus standards (e.g., ISO, AAMI) and testing protocols, rather than expert consensus on diagnostic images or pathology. The testing laboratories performing these validations would employ qualified personnel, but their specific roles or number are not detailed.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective, laboratory-based validations against predefined physical/mechanical and microbiological criteria defined by recognized standards. There isn't a need for expert adjudication in the way it's used for interpreting ambiguous clinical data or establishing ground truth for AI model outputs.
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 specifically designed for evaluating the impact of AI on human reader performance for diagnostic tasks, usually involving medical images or clinical data. The NobelZygoma PureSet™ Tray is a physical sterilization tray, not an AI/ML diagnostic or therapeutic device.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone study in the context of an "algorithm only" or AI performance was not done. This device is not an algorithm. The non-clinical tests described were "standalone" in the sense that they evaluated the device's intrinsic characteristics (cleaning, sterilization, durability) without human intervention in the performance of the device itself, but not in the AI-specific meaning.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by adherence to and successful completion of recognized international and national consensus standards for sterilization, cleaning, biocompatibility, and durability. These standards incorporate scientific principles and validated methodologies to empirically determine if a device meets safety and effectiveness requirements.
- Examples of such standards cited: AAMI TIR12, AAMI TIR 30, ISO 15883-1, ISO 15883-5, ISO 10993-1, ISO 10993-5, ISO 10993-12, AAMI ST79, AAMI ST77, ISO 17665-1, ISO14161, ISO14937, AAMI ST8, ISO 11737-2, AAMI TIR17, FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, ISO 17664-1, ANSI/AAMI ST77.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI/ML model that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical 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).