(92 days)
The OsteoMed Mini & Small System Tray is intended to contain Mini and Small implants and surgical instruments for sterilization, storage and handling. The OsteoMed Mini & Small System Tray is suitable for dynamic air removal (pre- vacum) steam sterilization methods. The system tray is not intended to maintain sterlity; it is intended to be used in conjunction with a validated, FDA-cleared sterilization wap in order to maintain sterility of the enclosed devices. The System Tray may also be used in conjunction with a legally marketed rigid container.
The OsteoMed ExtremiFix Mini & Small System Tray is composed of anodized and non-anodized aluminum, stainless steel, silicone, polyethylene terephthalate (Mylar), polyphenylsulfone (Radel), polyamide 11 (nylon), and ZEUS Perfluoroalkoxy (PFA), which are common tray materials, and is used to enclose, protect, and organize OsteoMed ExtremiFix Mini & Small System implants and surgical instruments. This is a product specific sterilization storage system tray (only for use with the OsteoMed ExtremiFix Mini & Small System) that is intended to provide storage for the OsteoMed ExtremiFix screws and accessories during sterilization, storage, and transportation within the hospital environment.
The OsteoMed ExtremiFix Mini & Small System Tray is a single sterilization storage system that is comprised of one outer case (base + lid), two screw modules (any two of the four sizes), and two trays (handle tray + instrument tray). The trays are perforated to allow for steam sterilization. An FDA-cleared wrap or FDAcleared rigid sterilization container must be used for sterilization and to maintain the sterility of the contents. The OsteoMed ExtremiFix Mini & Small SystemTray is designed to be used with standard autoclaves used in hospitals and healthcare facilities. As such, the OsteoMed ExtremiFix Mini & Small System Tray is effective for containing the system devices during sterilization and have been designed to withstand repeated steam sterilization cycles.
The provided text is an FDA 510(k) summary for a medical device: the OsteoMed ExtremiFix Mini & Small System Tray. This document details the device's characteristics, intended use, and the non-clinical testing performed to establish its substantial equivalence to a predicate device.
However, the request asks for information relevant to the study of an AI-powered diagnostic device. The provided text does not describe an AI or diagnostic device. Instead, it pertains to a sterilization tray, which is a physical container used to hold medical instruments for sterilization.
Therefore, many of the requested categories (such as acceptance criteria for AI performance, sample size for test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, training set details, etc.) are not applicable to this type of device and are not present in the provided document.
I will provide the information that is available in the document, acknowledging where the requested information is not applicable due to the nature of the device.
Here's an analysis of the provided text based on your request:
The device in question is the OsteoMed ExtremiFix Mini & Small System Tray, a sterilization tray for medical implants and instruments. It is not an AI-powered diagnostic device. As such, many of the requested criteria, which are typical for studies validating AI diagnostics, are not applicable.
1. A table of acceptance criteria and the reported device performance
The document presents acceptance criteria and results primarily for non-clinical (bench) testing, focusing on the physical performance and safety of the sterilization tray.
| Test Description | Purpose | Acceptance Criteria | Summary of Test Results |
|---|---|---|---|
| Design Validation | To validate the design and performance of the ExtremiFix Mini & Small System. | Surgeons evaluated the functionality of the tray. | Pass; met all requirements |
| Ship Testing | To establish that the ExtremiFix Mini & Small System, and associated packaging, protects and retains the implants and instruments during normal shipping and handling. | Ship packaged plate per ASTM D-4169 and evaluate package contents for damage upon return. | Pass |
| Cleaning Validation (reusable instruments) | To validate the prescribed manual cleaning process for the ExtremiFix Mini & Small System. | Use the T7 cannulated long driver as worst-case device to verify that re-useable instruments can be cleaned per instructions to achieve standard requirements for reusable devices per AAMI TIR 12 and AAMI TIR 30. | Pass |
| Sterilization Validation | To validate the steam sterilization parameters for the ExtremiFix Mini & Small System to ensure that the fully-populated system can be sterilized. | Validate sterilization parameters with 3 consecutive tests. Conducted test for both systems wrapped in polypropylene sterile wrap and system enclosed in rigid container. | Passed for both sterile wrap and rigid container configurations |
| Reliability Verification (Sterilization Cycles Validation) | To assess the reliability, via repeated use and sterilization, of the ExtremiFix Mini & Small System. | Verify functionality and graphics legibility after the system tray is steam sterilized for 100 cycles with the sterilization parameters described in the IFU. | Passed functional and visual criteria after 100 cycles |
| Cytotoxicity | The Minimal Essential Media (MEM) Elution test was designed to determine the cytotoxicity of extractable substances. | The ANSI/AAMI/ISO 10993-5 standard states that the achievement of a greater than 2 is considered cytotoxic effect, or a failing score. | Pass |
| Sensitization | To determine the potential sensitization effects of subject device indirect contact materials. | The test is considered negative for signs of sensitization if the positive response observed is in less than 10% of the test animals. | Pass |
| Irritation | To determine the potential irritation effects of subject device indirect contact materials. | The requirements of the test will be met if the difference between the test article mean score and control mean score is 1.0 or less. | Pass |
| Pyrogen testing | The Bacterial Endotoxins Test, or Limulus Amebocyte Lysate (LAL) test, is an in vitro assay to detect and quantify bacterial endotoxin. | For medical devices, the endotoxin limit is not more than 20.0 EU/device. | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify a quantitative "sample size" in the context of typical AI/diagnostic studies (e.g., number of images or patients). Instead, it refers to:
- "3 consecutive tests" for Sterilization Validation.
- "100 cycles" for Reliability Verification (Sterilization Cycles Validation).
- Testing with "worst-case device" (T7 cannulated long driver) for Cleaning Validation.
- These are engineering and biological validations, not clinical data sets in the AI sense.
- Data Provenance: Not applicable. The tests are benchtop, laboratory-based validations of the physical device, not data collected from patients or clinical settings. It's a manufacturing/performance validation, not a data-driven model validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- For "Design Validation," "Surgeons evaluated the functionality of the tray." The number and specific qualifications of these surgeons are not specified.
- For other tests (e.g., sterilization, biocompatibility, reliability), the "ground truth" is established by adherence to recognized standards (e.g., AAMI TIR, ISO 10993) and measured physical/biological parameters, not human expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no human interpretation or diagnostic "reading" involved that would require an adjudication method. The tests are objective measurements against pre-defined performance criteria.
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 sterilization tray, not an AI-powered diagnostic tool. No MRMC studies were performed or are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance validation is based on engineering performance specifications (e.g., maintaining integrity after shipping, ability to withstand sterilization cycles, effective cleaning), and biocompatibility standards (e.g., absence of cytotoxicity, sensitization, irritation, pyrogenicity). These are determined through standardized testing methods, not clinical outcomes or expert medical consensus.
8. The sample size for the training set
- Not applicable. This is not an AI model, and therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this 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).