(192 days)
The OsteoMed MMF Sterilization Tray is intended to contain MMF implants and surgical instruments for sterilization, storage and handling. The OsteoMed MMF Sterilization Tray is suitable for dynamic air removal (pre-vacuum) steam sterilization methods. The tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The sterilization tray may also be used in conjunction with a legally marketed rigid container.
Sterilization validation was performed on MMF implants and as surgical instrumentation. Do not exceed a maximum load of 2.3 lbs. in the sterilization tray.
Validated sterilization parameters for OsteoMed MMF Sterilization Tray: Method: Steam Cycle Pre-Vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Minimum Dry Time: 30 minutes
The OsteoMed MMF Sterilization Tray is composed from a material commonly used (anodized and non-anodized Aluminum) to enclose, protect, and organize OsteoMed's dental non-sterile devices, which meet national or international standards. The OsteoMed MMF Sterilization Tray is intended to provide storage for appropriate dental (MMF) devices and accessories during sterilization, storage, and transportation within the hospital environment.
The tray is composed of a base, a lid, and locking latch that secure the device and accessories. The tray is perforated to allow for steam sterilization. An FDAcleared wrap or FDA-cleared rigid sterilization container must be used for sterilization and to maintain the sterility of the contents. The OsteoMed MMF Sterilization Tray is designed to be used with standard autoclaves used in hospitals and healthcare facilities. As such, the OsteoMed MMF Sterilization Tray is effective for containing devices during sterilization and have been designed to withstand repeated steam sterilization cycles.
The request asks for details about the acceptance criteria and study that proves a device meets the acceptance criteria. However, the provided document is a 510(k) summary for a sterilization tray, which is a medical device for sterilizing other instruments, not a diagnostic AI device. Therefore, the information typically requested (e.g., sample sizes for training/test sets, ground truth methodology, expert qualifications, MRMC studies) is not applicable to this type of device.
This document describes the performance testing (bench testing) performed for the OsteoMed MMF Sterilization Tray to demonstrate its substantial equivalence to a predicate device.
Here's a summary of the available information relevant to acceptance criteria and performance, as best as can be extrapolated from the provided text for a non-AI device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Description | Acceptance Criteria (Inferred from "Summary of Test Results") | Reported Device Performance |
|---|---|---|
| Design Validation | Met all requirements for functionality | Pass; met all requirements |
| Ship Testing | No damage to package contents after shipping | Pass |
| Cleaning Validation | Reusable instruments can be cleaned per instructions to achieve standard requirements per AAMI TIR 30 | Pass |
| Sterilization Validation | Validated sterilization parameters with 3 consecutive tests | Passed for both sterile wrap and rigid container configurations |
| Sterilization Cycles Validation | Met pre-determined acceptance criteria for functional and visual aspects after 100 cycles | Passed functional and visual criteria after 100 cycles |
2. Sample size used for the test set and the data provenance: Not applicable to a sterilization tray. The "test set" here refers to the physical devices undergoing bench testing. The origin of the "data" is the manufacturing site / testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable in the traditional sense. For Design Validation, "Surgeons evaluated the functionality of the tray." The number and qualifications of these surgeons are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to this type of device.
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, as this is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
7. The type of ground truth used:
* Design Validation: "Surgeons evaluated the functionality of the tray." The "ground truth" was likely subjective expert opinion on usability and functionality.
* Ship Testing: Visual inspection for damage.
* Cleaning Validation: Adherence to AAMI TIR 30 standards.
* Sterilization Validation: Successful sterilization parameters (demonstrated by, for example, biological indicators, chemical indicators, or other validated methods, though not explicitly detailed here).
* Sterilization Cycles Validation: Functional and visual criteria.
8. The sample size for the training set: Not applicable, as this is not an AI device that undergoes training.
9. How the ground truth for the training set was established: Not applicable.
Summary of the study that proves the device meets the acceptance criteria:
The study proving the OsteoMed MMF Sterilization Tray meets its acceptance criteria is a series of bench tests (non-clinical tests) on production-equivalent devices. These tests evaluated various aspects of the tray's performance and durability:
- Design Validation: Surgeons provided feedback on the tray's functionality.
- Ship Testing: Evaluated the integrity of the packaged tray after simulated shipping conditions (ASTM D-4169).
- Cleaning Validation: Used a "worst-case device" (ratchet handle) to ensure reusable instruments could be cleaned according to instructions and AAMI TIR 30 standards.
- Sterilization Validation: Conducted three consecutive tests to validate the specified sterilization parameters (Steam Cycle Pre-Vacuum, 270°F (132°C), 4 minutes exposure, 30 minutes dry time) for both sterile wrap and rigid container configurations. This likely involved verifying the ability of the tray to allow sterilant penetration and achieve sterility of the contents.
- Sterilization Cycles Validation: The device underwent 100 steam sterilization cycles to assess its long-term functionality and visual integrity.
All these bench tests "passed," indicating the device met its pre-determined acceptance criteria for each test. The conclusion drawn is that based on these non-clinical tests, the device is substantially equivalent to the predicate device and is safe and effective for its intended use.
§ 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).