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The OsteoPlan™ System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the OsteoPlan™ System and the result is an output data file that may then be provided as digital models or used as input to the additive manufacturing portion of the system that produces physical outputs including anatomic models and splints for use in maxillofacial surgery. The OsteoPlan System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

OsteoMed uses computer aided modeling to assist the physician with planning complex maxillofacial surgeries. Specifically, the OsteoPlan™ System provides patient-specific anatomical models, splints, and patient-specific surgical plans and digital files of the surgical plan to assist physicians with maxillofacial surgeries. Outputs of the OsteoPlan™ System are designed with physician input and reviewed by the physician prior to finalization and distribution. All outputs are manufactured by OsteoMed using additive manufacturing (SLS and SLA), only with direct physician involvement to reduce the criticality of the outputs.

The system uses electronic medical images of the patient anatomy (CT and CBCT) with input from the physician to create the plan and splints for executing surgery. Off-the-shelf (OTS) software is used for surgical planning.

The outputs of the system include Orthognathic Occlusal Splints, Case Reports, and Anatomic models. The splints are offered in commonly used forms, in both intermediate and final positioning, and some are available with ligature holes.

Case reports are digital and physical documents created to lay out the surgical plan, dictated by the surgeon, and show outputs of the OsteoPlan™ system that will be used to translate the plan during surgery.

Anatomic models are tools provided to physicians for complex anatomy visualization or to preplan surgery with an accurate physical representation of patient anatomy. Anatomic models may include maxilla, mandible, or skull models.

This Premarket Notification (510(k)) summary for the OsteoPlan System does not include specific details on acceptance criteria and device performance in the format requested. The document focuses on establishing substantial equivalence to predicate devices through a comparison of technological characteristics and a summary of non-clinical testing.

Here's what can be extracted and what information is not present based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the given text in a quantifiable table format for the OsteoPlan System's primary functions (e.g., accuracy of segmentation, precision of surgical planning). The document generally states that "All testing passed" or "all acceptance criteria being met" for various validations, but doesn't detail what those criteria were nor the specific performance metrics achieved.

2. Sample Size Used for the Test Set and Data Provenance

This information is not explicitly provided for the software's core functionality (image segmentation, surgical planning).

• For the "Cadaver Study," a "simulated use" study was conducted, indicating a test set was used, but its size and specific provenance (e.g., number of cadavers, country of origin) are not mentioned. The study is prospective in nature as it verified the functionality of the design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. The document states that "Outputs of the OsteoPlan™ System are designed with physician input and reviewed by the physician prior to finalization and distribution," implying expert involvement in the design and review process, but it doesn't specify how many experts or their qualifications for establishing ground truth in a formal validation test set.

4. Adjudication Method for the Test Set

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not mentioned. There is no indication of a comparative effectiveness study comparing human readers with and without AI assistance.

6. Standalone Performance

The document mentions "Software Validation and documentation for software of moderate level of concern was provided per the FDA Guidance Document 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' and 'Off-The-Shelf Software Use in Medical Devices.' All software verification/validation passed." This indicates that standalone testing of the software was performed, but the specific standalone performance metrics (e.g., accuracy, precision) are not detailed. It states "The OsteoPlan™ System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner... The input data file is processed by the OsteoPlan™ System and the result is an output data file," implying standalone operation.

7. Type of Ground Truth Used

For the software's core functions (segmentation, planning), the specific type of ground truth (e.g., expert consensus on anatomies, pathology reports) used for validation is not explicitly stated. Given the pre-operative planning nature, it would likely involve expert consensus or established anatomical landmarks.

8. Sample Size for the Training Set

This information is not provided. The document doesn't mention a training set, which is typical for AI/ML models. However, the OsteoPlan System is described as using "Off-the-shelf (OTS) software used for surgical planning," suggesting it might be an adaptation or integration of existing tools rather than a completely novel AI model requiring extensive de novo training data for its core algorithms.

9. How the Ground Truth for the Training Set Was Established

This information is not provided, as no training set is mentioned.

Summary of available information regarding acceptance criteria and performance:

The document broadly states that various non-clinical tests were conducted and "all acceptance criteria being met" or "All testing passed." These tests cover:

• Equipment/Process Qualification (IQ/OQ/PQ)
• Software Validation (for moderate level of concern)
• Cleaning Validations
• Steam Sterilization Validation
• Biocompatibility testing (cytotoxicity, sensitization, irritation, acute toxicity, pyrogenicity, subchronic toxicity, implantation) for worst-case splint and anatomical model
• Packaging Validation
• Shelf Life (functional testing)
• Cadaver Study (simulated use to verify design functionality)

Crucially, the document does not provide the specific quantifiable acceptance criteria or the numerical results of performance tests for the software's primary functions of image segmentation or surgical planning accuracy. Instead, it relies on a general statement of "all testing passed" and "performance equivalence was shown through the verification comparison to the predicate device" to establish substantial equivalence.

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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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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.

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The OsteoMed ExtremiFix Mid & Large Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, and fracture fixation of foot, ankle, and long bones (upper and lower extremity). The screws are intended for single use only. The system drills and guide wires are single use instruments.

The OsteoMed ExtremiFix Mid & Large Screw System is a rigid fixation system consisting of screws in both cannulated and solid versions, all of which are available in various overall and distal thread lengths to accommodate specific patient anatomies. The headed and headless compression screws are made of biocompatible Ti 6-Al 4-V Titanium Alloy. Longer sizes of the single-use only implants are provided individually sterile packed, while the majority of screws and all instruments are provided in modules to allow for customization specific to the surgical indication. The system includes washers for use with 4.5mm, 5.5mm, 6.5mm and 7.0mm headed screws. The washers are made of biocompatible Titanium Alloy. The OsteoMed ExtremiFix Mid & Large Screw System is sterilized in a sterilization tray which is available from OsteoMed.

The provided text describes the OsteoMed ExtremiFix Mid & Large Screw System, a bone fixation device. It details the performance data presented to the FDA for substantial equivalence, which primarily relies on bench testing and biocompatibility evaluation. It explicitly states that no clinical studies or animal studies were performed to demonstrate safety and efficacy. Therefore, the concept of "acceptance criteria" and "device performance" in the context of clinical outcomes, expert adjudication, or human reader improvement with AI assistance, as outlined in the request, is not applicable to this submission.

The acceptance criteria and performance are related to the mechanical properties and biocompatibility of the screws, compared to predicate devices.

Here's the information parsed from the document, tailored to the available data:

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated for each bench test. However, the testing was conducted on samples of the OsteoMed ExtremiFix Mid & Large Screw System.
• Data Provenance: The document implies in-house laboratory testing ("Verification testing was conducted") as part of the submission to the FDA. No geographical origin or retrospective/prospective nature of the performance testing is specified beyond it being non-clinical bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. The ground truth for this device's performance was established through standardized engineering bench tests and material characterization, not human expert interpretation or adjudication.

4. Adjudication method for the test set

• Not Applicable. As the performance evaluation was based on objective physical and material tests, there was no adjudication method involving human experts.

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

• No. This is a medical implant (bone fixation screw system), not an AI-powered diagnostic device. Therefore, MRMC studies and AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a medical implant, not an algorithm or software. The device itself (the screws) is the "standalone" component in the context of its physical function.

7. The type of ground truth used

• Bench Test Results and Material Standards: The ground truth was based on the objective measurements from bench testing (e.g., force, strength, torque, pullout) and compliance with established material standards (e.g., ASTM F-136 for Titanium alloy) and biocompatibility guidance (ISO 10993-1).

8. The sample size for the training set

• Not Applicable. This device does not involve a training set as it is not an AI/machine learning product. Performance was assessed through direct testing and comparison to predicate devices, not through a learning algorithm.

9. How the ground truth for the training set was established

• Not Applicable. (See #8).

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