(127 days)
The Mini Sterilizable Tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA cleared sterilizer for one of the following cycles:
Pre-vacuum Steam – At 132°C for 4 minutes with a 20 minutes dry time. Gravity Steam - At 132°C for 15 minutes with a 30 minutes dry time.
- The tray is intended for sterilization of non-porous loads.
- Do not stack trays during sterilization.
- The tested Tray represents the worst case validated load of 354.10 grams.
- Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Mini Sterilizable Tray.
The Mini Sterilizable Tray is a reusable perforated instrument cassette system to hold dental instruments in place during transport, steam sterilization, and storage. The tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses.
The Mini Sterilizable Tray is a container composed of three main components: a lid, a cassette base and a variable inner tray, all made of polyphenylsulfone (Radel R5000). The inner tray has silicone rubber that is co-molded in the plastic of the inner tray as well as silicone grommets. In addition, accessory stainless-steel components such as a pan and a bracket may be included in the tray.
The Mini Sterilizable Tray is available in one size with outer dimensions of 5.5 inch x 4.0 inch x 2.25 inch and offered in 5 inner tray configurations with varied instrument loads.
The provided document describes the FDA 510(k) clearance for a medical device called the "Mini Sterilizable Tray." This is a Class II device (Sterilization Wrap, Product Code: KCT). The document details the device's indications for use, its description, and a comparison to a predicate device, along with summary information on the non-clinical performance data used to demonstrate substantial equivalence.
However, the provided text does not contain information about an AI/ML powered device or a study involving human readers or expert consensus for ground truth establishment. Instead, it focuses on the physical and biological safety and effectiveness of a medical device used for organizing, steam sterilizing, and transporting dental instruments. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and biocompatibility testing required for medical devices, rather than the performance of an AI algorithm on a dataset.
Therefore, many of the requested fields related to AI/ML study design (such as sample size for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types related to AI/ML) are not applicable to this document.
Below, I will extract the relevant information regarding the device's acceptance criteria and the studies performed, interpreting "acceptance criteria" as the performance standards the device must meet to be considered safe and effective for its intended use, and "study" as the non-clinical testing performed.
Acceptance Criteria and Study for the Mini Sterilizable Tray
This submission is for a physical medical device (sterilization tray), not an AI/ML-powered device. Therefore, the "acceptance criteria" relate to the physical and biological performance of the device, and the "study" refers to non-clinical laboratory testing. The concept of "ground truth" here is based on established scientific and regulatory standards for sterilization, biocompatibility, and physical integrity.
1. A table of acceptance criteria and the reported device performance
For a physical medical device like this, the acceptance criteria are typically defined by recognized standards (e.g., ISO, AAMI, ASTM) and internal specifications. The "reported device performance" is a statement that the device successfully met these standards.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 and ISO 10993-5 (absence of cytotoxicity). | "The Mini Sterilizable Trays were successfully tested for biocompatibility testing in accordance with ISO 10993-1 and ISO 10993-5. The results of a cytotoxicity tests demonstrated that extracts of the device did not elicit a cytotoxic response in the test system." (Page 9) |
| Device Performance & Wear | Maintain functionality after simulated use cycles. | "Non-clinical performance and wear testing of the Mini Sterilizable Tray through simulated use testing. The Sterilizable Mini Tray and its co-packaged components were subjected to 120 simulated uses cycles. Simulated use testing demonstrated that the co-packaged components worked as designed after the simulated use." (Page 9) |
| Cleaning Validation | Effective cleaning; residuals within acceptable limits (TOC, protein). | "Cleaning efficiency was successfully conducted in accordance with AAMI TIR30 and AAMI TIR12. The study used a clinically-relevant, simulated soil, extended drying time between soiling and processing, and minimal processing parameters for the cleaning process. Extracts of proposed devices were analyzed for total organic carbon (TOC) and protein as residual soil markers." (Page 9) |
| Sterilization | Achieve a Sterility Assurance Level (SAL) of 10⁻⁶. | "Sterilization validation was successfully conducted in accordance with ISO 17665-1. The overkill approach as per ISO 17665-1 was used to demonstrate an SAL of 10⁻⁶." (Page 9) |
| (Note: The document states "10°" which appears to be a typographical error, and given the context of SAL for sterilization, it should be 10⁻⁶ for medical devices to achieve terminal sterility). | ||
| The specific sterilization cycles validated are: |
- Pre-vacuum Steam: 132°C for 4 minutes with a 20 minutes dry time.
- Gravity Steam: 132°C for 15 minutes with a 30 minutes dry time. (Page 5) |
| Transportation Simulation| Maintain physical integrity and component retention during transit. | "Transportation simulation testing validates the packaging and distribution of the Mini Sterilizable Tray and co-packaged instruments. The tests performed included Handling, Stacking, Loose-Load Vibration, Vehicle Vibration, Concentrated Impact, and an additional Handling test per ASTM D4169-16 DC-13, Assurance Level I, Schedules: A, C, F, E, J, A. The transportation testing demonstrates that the Mini Sterilizable Trays and co-packed components were not damaged and remained in their designated location." (Page 9) |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify exact numerical sample sizes for each test (e.g., how many trays were tested for biocompatibility or cleaning). It mentions "120 simulated uses cycles" for performance and wear testing (Page 9). Regulatory standards for these types of tests typically specify minimum sample sizes, but these are not enumerated in the summary.
- Data Provenance: Not explicitly stated regarding country of origin for the testing data. The testing is non-clinical (laboratory-based), not human clinical. All tests appear to be prospective as they are conducted specifically to demonstrate the performance of the new device for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This pertains to a physical medical device. "Ground truth" for biocompatibility, sterilization, and physical performance is established through adherence to international and national standards (e.g., ISO, AAMI, ASTM) and scientific principles, not through expert consensus on labeled image data.
4. Adjudication method for the test set
- Not applicable. This pertains to a physical medical device. Decisions about test success are based on whether the device meets pre-defined quantitative or qualitative acceptance criteria per the relevant standards, not on adjudication of subjective interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a physical sterilization tray, not an AI/ML diagnostic or assistive tool. No human readers or AI assistance are involved in its primary function or testing for this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" for this device's performance is based on established scientific principles and consensus standards for medical device safety and effectiveness.
- For biocompatibility: Absence of cytotoxic response (measured in lab assays against scientific benchmarks).
- For sterilization: Achieving a defined Sterility Assurance Level (SAL), typically 10⁻⁶, based on validated microbiological methods.
- For cleaning: Residuals (TOC, protein) below recognized safe limits.
- For performance/wear: Functional integrity after simulated use cycles.
- For transportation: Physical integrity after simulated shipping stresses.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device relying on a training set of data.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device relying on a training set of data.
§ 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).