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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.

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The Osteomed ExtremiFix Mini & Small Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. Screws are intended for single use only.

The OsteoMed Mini & Small Cannulated Screw System is comprised of screws and washers used for bone fixation of the hand and foot following trauma or osteotomy. The System features cannulated screws in the following dimensions:

2.0mm screw diameter - 6 mm to 42 mm screw length; 2.4mm screw diameter - 6 mm to 50 mm screw length; 3.0mm screw diameter - 10 mm to 40 mm screw length; 4.0mm screw diameter - 12 mm to 52 mm screw length;

The system instruments include depth gauges, screwdrivers, countersinks, guide wires, and other instruments to facilitate the placement of screws.

The implants (screws and washers) of the OsteoMed ExtremiFix Mini & Small Cannulated Screw System are made from titanium alloy (ASTM F136). Modifications to the screws include changing the screw drive connection from a trilobe to a hexalobe and adding a headed screw option for each of the screw size offerings (2.0, 2.4, 3.0, and 4.0 mm diameters). The screws and washers are intended for single use only.

The subject device's system instruments include k-wires, drills, countersinks, drivers, tissue protectors, and screw extractor. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymer. The k-wires, screw extractor, and drills are intended for single use only.

The provided text is a 510(k) summary for the OsteoMed ExtremiFix Mini & Small Cannulated Screw System. This document describes a medical device, specifically bone fixation fasteners, and its equivalence to a predicate device already on the market.

However, the questions posed (acceptance criteria, study details like sample size, experts, adjudication, MRMC, standalone performance, ground truth establishment for training and test sets) are typically relevant for Artificial Intelligence/Machine Learning (AI/ML) powered medical devices which involve complex algorithms, image analysis, or clinical decision support systems.

The OsteoMed ExtremiFix Mini & Small Cannulated Screw System is a physical medical device (screws and instruments). Its "performance data" refers to bench testing for mechanical strength and material properties to ensure it functions as intended and is equivalent to existing devices. Therefore, the detailed questions about AI/ML study methodologies, such as those concerning "ground truth," "expert consensus," "training set," "test set," "human-in-the-loop," "MRMC," and "effect size of human readers improving with AI" do not apply to this type of device.

The document explicitly states: "Clinical testing is not required to support substantial equivalence." This reinforces that the evaluation is based on mechanical and material properties compared to a predicate, not on a clinical AI/ML performance study.

Therefore, I cannot extract the requested information (acceptance criteria as per AI/ML studies, details of AI/ML study design, MRMC, training/test set specifics, etc.) from this document because it describes a traditional hardware medical device, not an AI/ML device.

The relevant "performance data" provided are:

• Type of Study: Bench testing.
• Purpose of Study: To ensure the design features met the required mechanical strength criteria for their intended use and to show performance equivalence to the predicate device (OsteoMed Headless Cannulated Screw System, K063298).
• Conclusion: The device "demonstrates the subject devices are as safe, as effective, and performs as well as the predicate device."

This document does not contain the information required to answer your specific questions related to AI/ML device validation.

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