Search Results

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.

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.

Ask a specific question about this device

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:

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.

Ask a specific question about this device