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The Mini-OSTEO Pedicle Fixation System is intended for posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and/or sacral spine: degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scollosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

The Mini-OSTEO Pedicle Fixation System consists of the following non-sterile, single-use components: monoaxial screws, polyaxial screws, rods, pedicle bars, laminar and transverse hooks, connectors, and a pedicle locking component for connectors. The connectors are provided in a variety of sizes and shapes to accommodate variations in anatomy and spacing/positioning of existing screw and rod hardware.

The provided text details a 510(k) premarket notification for the "Mini-OSTEO Pedicle Fixation System." This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing de novo safety and effectiveness through extensive clinical trials for software or AI-driven devices. Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML-driven medical device.

Specifically:

• No Acceptance Criteria Table: The document doesn't define quantitative or qualitative acceptance criteria for an AI/ML system's performance.
• No AI/ML Device Performance Study: The device described is a physical implant (pedicle fixation system), not a software or AI/ML-based diagnostic or therapeutic device. The "Non-Clinical Test Summary" and "Clinical Test Summary" sections confirm this:
  • Non-Clinical Tests: These are mechanical and material strength tests (e.g., ASTM F1717, F543, F1798), typical for orthopedic implants, to ensure mechanical safety and performance are equivalent to predicates.
  • Clinical Studies: The document explicitly states, "No clinical studies were performed." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical testing and comparison to existing predicate devices.

Therefore, I cannot provide the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, ground truth types, training set details) because the provided text pertains to a physical medical device submission (pedicle fixation system) and not an AI/ML-driven device that would involve such performance evaluations.

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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 ExtremiLOCK Ankle Plating System is intended for fixation of fractures, and non-unions of the tibia and fibula as well as arthrodesis of the ankle including Tibiotalocalcaneal joint. The ExtremiLOCK Ankle Plating System implants are intended for single use only.

The 1/3 tubular plates, hook plates, screws, and washers are also intended for use in trauma, general surgery, and reconstructive procedures of bones appropriate for the size of the device.

The OSTEOMED ExtremiLOCK Ankle Plating System can be used for adult and adolescent (greater than 12-21 years of age) patients.

The OsteoMed ExtremiLOCK Lateral Ankle Fusion Plates are a line extension to be included in the OsteoMed ExtremiLOCK Ankle Plating System (previously cleared for market in premarket notification K133691). The OsteoMed ExtremiLOCK Ankle Plating System provides a comprehensive solution for ankle fractures and ankle fusion management. The OsteoMed ExtremiLOCK Ankle Plating System plates, screws, washers and instrumentation are contained in a single instrument tray. The system instrumentation is used to facilitate placement, screw insertion and/or removal of implants.

The OsteoMed ExtremiLock Lateral Ankle Fusion Plates are designed for use in Tibiotalar (TT) and Tibiotalocalcaneal (TTC) arthrodesis procedures through a lateral transfibular approach. The plates feature universal holes that accept angulated locking and standard non-locking 3.5mm and 4.0mm screws and 4.0mm fully threaded cannulated double lead screws. The TT and TTC plates have been designed to optimize compression, strength, and construct stability by providing up to 5 points of fixation in the tibia, talus and calcaneus. The innovative plate design, rounded edges and highly polished surface allows for reduced dissection of soft tissue structures and minimizes soft tissue irritation. Both plates offer multiple compression hole options including oblong holes, transfixation holes, and an anatomic transfixation 5.5mm lag screw compression hole. The 5.5mm transfixation lag screw hole is designed to cross the arthrodesis site within the plate maximizing uniform axial compression across the joint and capturing the medial tibial side.

The OsteoMed ExtremiLOCK Lateral Ankle Fusion Plates are made from commercially pure titanium grade 4 (ASTM F67). The plates are intended for single use only.

The provided text describes a 510(k) premarket notification for the "OsteoMed ExtremiLOCK Lateral Ankle Fusion Plates." This submission is for a medical device that is a metallic bone fixation appliance, not an AI/ML powered device. As such, the acceptance criteria and study information typically associated with AI/ML device evaluations (e.g., test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable or detailed in this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through bench testing rather than clinical or AI performance studies.

Here's a breakdown of the available information based on the questions, with an emphasis that this is not an AI/ML device submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided. The evaluation was primarily bench testing of physical devices, not data-driven analysis from a test set of patient cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. "Ground truth" in the context of AI/ML algorithms, derived from expert review of medical data, is not relevant to this device's evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are used for resolving disagreements among experts when establishing ground truth for AI/ML performance evaluation.

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

This information is not applicable and not provided. An MRMC study is relevant for evaluating the impact of AI assistance on human performance, which is not the subject of this 510(k) submission.

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

This information is not applicable and not provided. "Standalone performance" refers to the performance of an AI algorithm without human involvement, which is not relevant for this physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable and not provided. The "ground truth" for this device would relate to its structural integrity and material properties, confirmed by engineering standards and bench testing, not clinical diagnoses or outcomes data in the sense of AI/ML evaluation.

8. The sample size for the training set

This information is not applicable and not provided. Training sets are used for developing AI/ML algorithms.

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

This information is not applicable and not provided. Training sets and their associated ground truth are specific to AI/ML development.

In summary: The provided document details a 510(k) submission for a metallic bone fixation device, not an AI/ML product. Therefore, the evaluation criteria and study methods are based on mechanical bench testing and material biocompatibility, focusing on demonstrating substantial equivalence to predicate devices, rather than the performance metrics and study designs used for AI/ML medical devices.

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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 PINNACLE Driver is intended for drilling into bone, in conjunction with cranial surgical procedures.

The PINNACLE Driver is a handheld, cordless, software driven, battery operated driver for high speed insertion of screws and drilling of pilot holes. The device operates in both the forward and reverse directions. A sterile, single use battery powers the device and is intended for use solely with the PINNACLE Driver. Accessories for the PINNACLE Driver include hex shank drill bits and driver stems. The optional driver stems are reusable while the drill bits are single use. The PINNACLE Driver may be sterilized in a sterilization tray and/or rigid sterilization container, both of which are available from OsteoMed.

The PINNACLE Driver is intended for use in a healthcare facility/hospital for use by a clinician. The PINNACLE is a prescription device.

The PINNACLE Driver and lithium battery is made of medical grade stainless steel, aluminum, silicone, PEEK, gold plated brass, and medical plastic. The driver stems and drill bits are made of medical grade stainless steel. The sterilization trays and rigid sterilization containers are made of aluminum.

The PINNACLE Driver is a battery operated driver/drill that operates in both the forward and reverse directions. The PINNACLE Driver contains torque limiting software to prevent over-torquing and stripping of screws in drive mode.

The provided text is a 510(k) Premarket Notification from the FDA regarding the OsteoMed Pinnacle Driver. This document describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to predicate devices. However, this document does not describe a study involving an AI/Machine Learning device or a medical imaging system that would typically have acceptance criteria focused on diagnostic performance (e.g., sensitivity, specificity, AUC).

Instead, the acceptance criteria and performance data presented here are related to the safety and functionality of a mechanical medical device (a surgical drill/driver). Therefore, I cannot extract the information required for questions 2, 3, 4, 5, 6, 7, 8, and 9 as they are specific to AI/ML driven diagnostic/imaging devices.

I can, however, provide the table of acceptance criteria and reported device performance from the provided text, focused on the mechanical and electrical aspects of the device.

1. Table of Acceptance Criteria and the Reported Device Performance

Information not available from the provided text for an AI/ML diagnostic device:

2. Sample sizes used for the test set and the data provenance: Not applicable to this type of device (mechanical/electrical, not AI/ML diagnostic).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for this device involves functional tests, not expert interpretation of medical images/data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 document does not describe an AI-assisted diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth here refers to engineering specifications and functional performance.
8. The sample size for the training set: Not applicable. This document is not describing a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

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The PINNACLE Driver is intended for driving screws and for drilling into bone, in conjunction with dental, orthognathic, and mandibular surgical procedures.

The PINNACLE Driver is a handheld, cordless, software driven, battery operated driver for high speed insertion of screws and drilling of pilot holes. The device operates in both the forward and reverse directions. A sterile, single use battery powers the device and is intended for use solely with the PINNACLE Driver. Accessories for the PINNACLE Driver include hex shank drills and driver stems. The optional driver stems are reusable while the drills are single use. The PINNACLE Driver may be sterilized individually wrapped in two layers of 1-ply polypropylene wrap or unwrapped in a sterilization organizational tray inside a rigid sterilization container, which is available from OsteoMed.

The PINNACLE Driver is intended for use in a healthcare facility/hospital for use by a clinician. The PINNACLE is a prescription device.

The PINNACLE Driver and lithium battery is made of medical grade stainless steel, aluminum, silicone, PEEK, gold plated brass, and medical plastic. The driver stems and drills are made of medical grade stainless steel. The sterilization organizational trays and rigid sterilization containers are made of aluminum.

The PINNACLE Driver is a battery operated driver/drill that operates in the both in the forward and reverse directions. The PINNACLE Driver contains torque limiting software to prevent over-torquing and stripping of screws in drive mode.

The provided document is a 510(k) premarket notification for a medical device called the "PINNACLE Driver." It describes the device, its intended use, comparison to predicate devices, and performance data to support substantial equivalence.

Based on the information provided, this document does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-driven medical device for diagnostic or prognostic purposes, nor does it refer to a multi-reader multi-case (MRMC) comparative effectiveness study.

The "PINNACLE Driver" is a surgical tool (battery-operated driver/drill for bone, primarily for dental, orthognathic, and mandibular procedures). The "software" mentioned in the document is for torque limiting ("senses torque to prevent over-torquing and stripping of screws") and "bit recognition," not for diagnostic interpretation or image analysis.

Therefore, many of the requested elements (e.g., ground truth, sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance of an algorithm) are not applicable to this type of device and its regulatory submission.

However, I can extract the closest applicable information regarding "acceptance criteria" and "performance study" for this mechanical/software-controlled surgical device:

Acceptance Criteria and Device Performance (for a Mechanical/Software-Controlled Surgical Device)

Since this is a mechanical surgical device with integrated software for operational control (torque limiting), the "acceptance criteria" and "performance" are primarily addressed through engineering and safety standards, and bench testing, rather than diagnostic accuracy metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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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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The OsteoMed ExtremiLOCK Wrist Plating System is indicated for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures.

OsteoMed ExtremiLOCK Wrist Plating System implants are intended for single use only.

The OsteoMed ExtremiLOCK Wrist Plating System is a rigid fixation and fusion system consisting of plates and screws in various configurations along with the appropriate instrumentation to facilitate modification and implantation. Plates are anatomically pre-contoured in various shapes and sizes. Screws are provided with variable angle locking and non-locking heads and are either fully threaded or partially threaded in various lengths. These screws are either solid core or cannulated and can be used with or without plates. The system also contains K-wire implants.

The implants of the OsteoMed ExtremiLOCK Wrist Plating System are made from Titanium per ASTM F-67 (Plates), Titanium Alloy per ASTM F-136 (plates, screws and washer), and Stainless Steel per ASTM F-138( K-wires). The dimensional modifications to the screws include the addition of flutes (for screw lengths ≤ 16mm), tapered tip, decrease in thread pitch, and of the system has already been cleared through OsteoMed wrist predicate 510(k) K152145.

This document is a 510(k) premarket notification for the OsteoMed ExtremiLOCK Wrist Plating System. It does not describe a study involving an AI/ML powered medical device. Instead, it details the substantial equivalence of a new version of a wrist plating system to a predicate device. Therefore, much of the requested information regarding AI/ML device studies, such as acceptance criteria tables, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance, is not applicable.

However, based on the provided text, I can infer the acceptance criteria and the nature of the "study" (verification testing) for this specific medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify the exact number of screws or plates tested. It broadly refers to "the screws (subject device)" as being part of the verification testing.
• Data Provenance: The testing was conducted internally by OsteoMed as part of their premarket notification process to demonstrate substantial equivalence. The document does not provide details on the country of origin of the data beyond "OsteoMed" (based in Addison, Texas, USA). This is prospective testing, specifically designed to evaluate the new device.

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

• This question is not applicable as the "ground truth" for this device is based on engineering standards (ASTM F543) and mechanical performance comparisons, not human expert interpretation of data. The ground truth is objective mechanical strength and performance.

4. Adjudication method for the test set:

• This is not applicable as the evaluation is based on objective mechanical testing against engineering standards rather than subjective assessments requiring adjudication.

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:

• This is not applicable. The device is a physical medical implant (wrist plating system), not an AI-powered diagnostic or assistive tool for human readers.

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

• This is not applicable. The device is a physical medical implant, not an algorithm.

7. The type of ground truth used:

• The ground truth used for this premarket notification's "performance characteristics & testing" is engineering standards (specifically ASTM F543) and direct mechanical performance comparison to a legally marketed predicate device.

8. The sample size for the training set:

• This is not applicable. There is no AI/ML training set mentioned or implied for a physical medical implant undergoing mechanical verification testing.

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

• This is not applicable, as there is no AI/ML training set.

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