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The Intelligent Implant Systems Mediant™ Anterior Cervical Plating System is intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Intelligent Implant Systems' Mediant™ Anterior Cervical Plating System consists of bone screws (4.0 and 4.5 mm diameter) of various lengths and a series of plates for fusion of 1-. 2-. or 3- levels of the cervical spine (C2-T1). The device functions as follows: An appropriately sized plate is placed on the anterior aspect of the vertebral body of the cervical spine by inserting either a 4.0 mm or a 4.5 mm diameter bone screw through the cephalad and caudad holes and into the vertebral body. The device improves stability of the spine while supporting fusion. The Mediant™ cervical plates are provided in multiple lengths from 19 mm (one-level) through 78 mm (three-level) for one-, two- and three-level fusions. The thickness of all plates is 2.2 mm and the width is 19.0 mm. All plates interface with the same cervical bone screws. which are either 4.0 mm diameter or 4.5 mm diameter. The bone screws can best be described as semi-constrained, but can be inserted at any angle (within a ±18° angular variation) to the plate. A slider mechanism then locks the bone screws to the plate at the angle of insertion using the supplied locking pliers. The bone screw will remain fixed at the angle of insertion unless bone resorption results in high loading levels on the bone screws. If this occurs, due to the polyaxiality of the screw, the screw will re-position itself and re-lock at the new angle. All implant components of the Mediant™ Anterior Cervical Plating system are manufactured from Ti-6Al-4V ELI alloy, conforming to ASTM F136.

This document is a 510(k) summary for the Mediant™ Anterior Cervical Plating System. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing. It does not describe the acceptance criteria for a device, nor does it detail a study proving a device meets specific acceptance criteria in the way you've outlined for diagnostic AI/medical imaging systems.

Here's why the requested information cannot be extracted from this document:

• Device Type: This is a physical orthopedic implant (spinal plating system), not a diagnostic device or software (like an AI algorithm for medical imaging). The regulatory pathway and substantiation methods differ significantly.
• Performance Metrics: The performance data provided is mechanical testing (Static Compression Bending, Static Torsional Bending, Dynamic Compression Bending) to assess the strength and safety of the implant, not diagnostic accuracy metrics (sensitivity, specificity, AUC) or human reader performance.
• Clinical Study Absence: There is no mention of a human clinical study in the context you described (e.g., test set, ground truth, experts, MRMC studies) because it's not relevant to demonstrating substantial equivalence for this type of device based on mechanical properties.

Therefore, I cannot populate the table or answer the specific questions because the provided text pertains to a different type of medical device and a different kind of performance evaluation.

If you have a document related to a diagnostic AI or medical imaging device, I would be happy to analyze it according to your requested format.

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The Revolution™ Spinal Fixation System is intended for pedicle screw fixation of the noncervical, posterior spine in order 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 or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e., fracture or dislocation), (4) spinal stenosis, (5) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (6) tumor, (7) pseudoarthrosis, (8) failed previous fusion.

The previously cleared Intelligent Implant Systems' Revolution™ Spinal Fixation System consists of monoaxial bone screws of various lengths and diameters and a series of connector assemblies for connecting the bone screws. The standard (one level) Revolution™ Connectors are provided in various lengths and are used to connect the pedicle screws and create a rigid structure. To allow for variation in screw placement, each end of the connector allows for angular compensation. One end allows for full polyaxial angulation, similar to a typical polyaxial screw. The other end has a pivoting-slide that allows for angulation in only one plane along the long axis of the Connector while also sliding within an opening in the Connector. As the distance between two screws is always variable, the slide allows the Connector to compensate for this difference, minimizing inventory. In addition, the Connectors have a threaded locking nut built into each end and each nut fits over the top of a bone screw post. These locking nuts are turned clockwise to tighten. A calibrated torque wrench provides the correct setting for locking the nuts on the bone screw post with sufficient force. The system can be unlocked, if necessary, by turning the locking nuts counterclockwise. To allow for multiple level fusions, four additional components were added to the system (K160216): 1) Transition Bone Screws, 2) Transition Connectors, 3) Two-Post Connectors, and 4) Two-Post Bone Screws. These components provide two connector attachment posts with a single bone screw, which allows the attachment of two connectors (one superior, one inferior) to a single level of the spine. In the case of the Transition Connector, the Transition Bone Screw includes a connector attachment post. This 510(k) submission adds two types of components to the system: 1) Two-Level Connectors, and 2) Two-Level Bone Screws. These components, when utilized with the previously cleared, standard Revolution™ connectors and standard bone screws, allow stabilization of two levels of the spine. These new Two-Level components allow fusion of two spinal levels when the patient's inter-pedicular distances are very short, by allowing attachment of two connector interfaces to a single bone screw. Like the previously cleared Revolution™ bone screws, the Two-Level Bone Screws are available in diameters of 4.5 mm - 7.5 mm, and in lengths from 25 mm to 55 mm. All screw diameter sizes except for the 4.5mm are cannulated for use with a 1.4 mm k-wire. The Two-Level Bone Screws have a standard thread for interfacing bone and a partially threaded post designed to engage a standard (one level) connector and a Two-Level Connector. The Two-Level Connector uses the same technology (the pivoting-slide and the spherical bearing), and has a stepped central plate. The step in the plate allows two connectors to stack on top of each other, thus requiring less horizontal space to attach two connectors. All implant components of the Revolution™ Spinal Fixation System, including the additional components, are manufactured from Ti-6Al-4V ELI alloy, conforming to ASTM F136.

This document refers to the Revolution™ Spinal Fixation System which is a medical device, and therefore the "device performance" mentioned in the request refers to the structural and mechanical performance of the system rather than diagnostic accuracy.

Here's a breakdown of the requested information based on the provided text, focusing on the mechanical performance as that's what was evaluated for this device:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size (number of devices tested) for the mechanical performance tests. It mentions "testing was conducted" but no specific count of components or systems tested.

• Data Provenance: Retrospective, as the testing was conducted on samples of the device to demonstrate their properties. The origin of the data is from the manufacturer's internal testing.

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

Not applicable for this type of device and study. The ground truth for mechanical testing is established by recognized international standards (ASTM F1798-13 and ASTM F1717-15), not human expert consensus on images or outcomes.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing results are objective measurements against defined standard criteria, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is for evaluating observer performance, typically in diagnostic imaging, which is not relevant for this spinal fixation system, whose performance is determined by mechanical properties.

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

Not applicable. This device is a physical implant, not an algorithm or software. Its performance is entirely standalone in terms of its mechanical function without human interpretation.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device's performance was the established criteria and methodologies outlined in the ASTM F1798-13 and ASTM F1717-15 standards, along with pyrogenicity requirements. These standards define the expected static and dynamic mechanical properties (e.g., strength, bending, torsional resistance) for spinal implants.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for a physical medical device.

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The Revolution™ Spinal Fixation System is intended for pedicle screw fixation of the noncervical, posterior spine in order 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 or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e., fracture or dislocation), (4) spinal stenosis, (5) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (6) tumor, (7) pseudoarthrosis, (8) failed previous fusion.

The Intelligent Implant Systems' Revolution™ Spinal Fixation System consists of monoaxial bone screws of various lengths and diameters and a series of connector assemblies for connecting the bone screws. This 510(k) submission adds four types of components to the system: 1) Transition Connector, 2) Transition Bone Screws, 3) Two-Post Connector, and 4) Two-Post Bone Screws. These components, when utilized with the existing standard Revolution™ connectors and standard bone screws, allow stabilization of multiple levels of the spine. Like the existing bone screws, the Transition and Two-Post bone screws are available in diameters of 4.5 mm - 7.5 mm, and in lengths from 25 mm to 55 mm. All screw diameter sizes except for the 4.5mm are cannulated for use with a 1.4 mm k-wire. The Transition Bone Screws and Two-Post Bone Screws have a standard thread for interfacing bone and a partially threaded post designed to engage the Revolution™ Connectors. The Transition Connector and Two-Post Connector effectively create two threaded posts from a single bone screw. These threaded posts are utilized to connect to the Revolution™ Connectors. The standard Revolution™ Connectors are provided in various lengths and are used to connect the pedicle screws and create a rigid structure. To allow for variation in screw placement, each end of the connector allows for angular compensation. One end allows for full polyaxial angulation, similar to a typical polyaxial screw. The other end has a pivoting-slide that allows for angulation in only one plane along the long axis of the Connector while also sliding within an opening in the Connector. As the distance between two screws is always variable, the slide allows the Connector to compensate for this difference, minimizing inventory and eliminating the need to cut spinal rods. In addition, the Connectors have a threaded locking nut built into each end and each nut fits over the top of a bone screw post. These locking nuts are turned clockwise to tighten. A calibrated torque wrench provides the correct setting for locking the bone screw post with sufficient force. The system can be unlocked, if necessary, by turning the locking nuts counterclockwise. All implant components of the Revolution™ Spinal Fixation System. including the new multi-level components, are manufactured from Ti-6Al-4V ELI alloy, conforming to ASTM F136.

This document is a 510(k) premarket notification for the Revolution™ Spinal Fixation System, which is a medical device and not an AI/ML regulated device. Thus, the provided information does not contain the requested details on acceptance criteria and a study that proves a device meets them in the context of AI/ML performance.

Therefore, I cannot provide the requested information.

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The Revolution™ Spinal Fixation System is intended for pedicle screw fixation of the noncervical posterior spine in order to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e., fracture or dislocation), (4) spinal stenosis, (5) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (6) tumor, (7) pseudoarthrosis, (8) failed previous fusion.

The Intelligent Implant Systems' Revolution™ Spinal Fixation System consists of monoaxial bone screws of various lengths and diameters and a series of connector assemblies for connecting the bone screws. The Revolution™ Bone Screws have a standard thread for interfacing bone and a partially threaded post designed to engage the Revolution™ Connectors. Screws are available in 4.5mm major diameter and lengths from 25mm to 50mm and 5.5mm, 6.5mm, and 7.5mm major diameters and lengths from 25mm to 55mm. All screw diameter sizes except for the 4.5mm are cannulated for use with a 1.4 mm k-wire. To allow the surgeon to determine the height of the connector relative to the bone, screws with extended non-threaded collars are provided. These extended collars effectively provide built in spacers that prevent the bone screw from being driven too deep and control the overall height of the completed assembly. The Revolution™ Connectors are provided in various lengths and are used to connect the pedicle screws and create a rigid structure. To allow for variation in screw placement, each end of the connector allows for angular compensation. One end allows for full polyaxial angulation, similar to a typical polyaxial screw. The other end has a pivoting-slide that allows for angulation in only one plane along the long axis of the Connector while also sliding within an opening in the Connector. As the distance between two screws is always variable, the slide allows the Connector to compensate for this difference, minimizing inventory and eliminating the need to cut spinal rods. In addition, the Connectors have a threaded locking nut built into each end and each nut fits over the top of a bone screw post. These locking nuts are turned clockwise to tighten. A calibrated torque wrench provides the correct setting for locking the nuts on the bone screw post with sufficient force. The system can be unlocked, if necessary, by turning the locking nuts counterclockwise. All implant components of the Revolution™ Spinal Fixation System are manufactured from Ti-6Al-4V ELI alloy, conforming to ASTM F136.

This FDA 510(k) summary describes a spinal fixation system, not a device with AI components. Therefore, the questions related to AI performance, ground truth, experts, and training/test sets are not applicable.

The document focuses on the Revolution™ Spinal Fixation System, a mechanical implant. For such a device, acceptance criteria and testing revolve around its physical properties, material compatibility, and structural integrity under simulated physiological conditions.

Here's an analysis of the provided information, addressing the applicable questions and indicating when a question is not relevant to this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the testing was conducted "according to methods defined in ASTM F 1798-13, 'Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants', and ASTM F 1717-14, 'Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model'."

Since specific numerical acceptance criteria (e.g., minimum strength in Newtons) are not explicitly stated in this summary, the table below will reflect the type of tests performed and the general conclusion given in the document. The implicit acceptance criterion is that the device meets the requirements of these ASTM standards and performs comparably to predicate devices.

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

The document does not specify a "sample size used for the test set" in terms of patient data, as this is a mechanical device. Instead, it refers to mechanical testing. The sample size for mechanical testing (i.e., the number of devices or components tested) is not explicitly stated in this summary. The data provenance is mechanical testing conducted in a laboratory setting to validate the device's physical properties.

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

Not applicable. This device is not an AI/diagnostic system. Ground truth in this context refers to the physical properties measured against established engineering standards (ASTM).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically for clinical studies or AI algorithm outputs where multiple human reviewers assess data. Here, the "truth" is determined by standardized mechanical testing procedures.

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 is a mechanical spinal fixation system, not an AI or diagnostic device that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

For this mechanical device, the "ground truth" is defined by established engineering and material standards, specifically:

• ASTM F 1798-13: "Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants"
• ASTM F 1717-14: "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model"
• ASTM F-136: Standard for the Ti-6Al-4V ELI material.

The device's performance is compared against the requirements and typical performance values for devices conforming to these standards.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable. This device does not have a "training set" in the context of AI.

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The Marauder™ Cervical-Thoracic Spinal Fixation System implants are intended to be used as a temporary construct that assists in normal healing and are not intended to replace normal body structures. The system is intended to stabilize the spinal operative site during posterior fusion procedures, attaching to the spine by means of hooks and screws joined with spinal rods and should be removed after fusion.

The Marauder™ Cervical-Thoracic Spinal Fixation System is intended to promote fusion of the cervical and thoracic spine (C1-T3) for the following conditions: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; trauma (fracture/dislocation); failed previous fusion; and/or tumors.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (CI-T3) spine.

The use of screws is limited to placement in TI-T3 vertebrae for treating thoracic conditions only. Screws.are not intended to be placed in the cervical spine.

The Marauder™ Cervical-Thoracic Spinal Fixation System consists of a polyaxial bone screw with a spherical-shape head, and a standard thread for interfacing bone. Screws are available in 3.5 mm and 4.0 mm diameters and lengths from 10mm to 30mm.

In addition to polyaxial screws, hooks are provided for use in the cervical and thoracic spine. Three hook geometry variations are offered with the Marauder™ Cervical-Thoracic Spinal Fixation System. The hooks use the same rod locking means as the polyaxial screw implants.

Titanium rods are provided in various lengths and are used to connect pedicle screws and create a rigid structure. The rods are connected to the implants by interference with the rod saddle and held into position by the locking caps.

All implant components of the Marauder™ Cervical-Thoracic Spinal Fixation System are manufactured from Ti-6Al-4V alloy, conforming to ASTM F136.

The provided text describes a medical device, the "Marauder™ Cervical-Thoracic Spinal Fixation System," and its performance testing. However, it does not describe an AI/ML powered device or software. Therefore, many of the requested fields related to AI/ML device evaluations (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from the provided document.

The document discusses the mechanical performance testing of a physical spinal fixation system.

Here's an attempt to answer the applicable parts based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the testing was conducted according to methods defined in ASTM F 1798 and ASTM F 1717. It then lists the types of tests performed. The "acceptance criteria" are implied to be meeting the requirements of these standards, and the "reported device performance" is a general statement that the device performed "as expected" and "typical of competitive systems," and "functioned as intended." Specific numerical performance data or pass/fail thresholds for each test are not provided in this summary.

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 for Test Set: This refers to the number of physical components or constructs tested in the mechanical performance evaluations. The document does not specify the exact sample size for each test (e.g., "n=5 constructs for static flexion"). It only lists the types of tests performed.
• Data Provenance: Not applicable in the context of mechanical device testing for substantial equivalence. The tests are laboratory-based mechanical tests, not clinical or observational data.

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)

Not applicable. This is a mechanical device, not an AI/ML system requiring expert ground truth for image interpretation or diagnosis.

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

Not applicable. This is a mechanical device, not an AI/ML system requiring adjudication of expert interpretations.

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 is a mechanical device, not an AI/ML system, so no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

Not applicable. This is a mechanical device, not an algorithm.

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

The "ground truth" for the mechanical testing is defined by the ASTM F1798 and ASTM F1717 standards themselves, which specify test methods, fixtures, loading conditions, and acceptance criteria for spinal implant constructs. The device's direct performance against these standards constitutes the "ground truth" in this context.

8. The sample size for the training set

Not applicable. This is a mechanical device; there is no "training set" in the AI/ML sense.

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

Not applicable. As there's no AI/ML training set, the concept of establishing its ground truth does not apply.

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The ACTIVE TM Screw Bone Screw is intended for implantation into prepared bone during orthopaedic surgery when the surgeon determines the need for additional fixation: bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The ACTIVE™ Screw Bone Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The ACTIVE ™ Screw Bone Screws subjected to this premarket notification are 4.5 mm diameter screws available in 5 mm length increments from 20 to 50 mm. The screws are manufactured from titanium alloy and have an expandable thread crest. The implants are single use only devices.

The ACTIVE ™ Screw Bone Screw consists of a screw shank in conjunction with a spiral helical thread crest component. With the spiral helical thread component, the screw has the ability to expand an additional 1 mm after implantation.

The ACTIVE TM Screw Bone Screw is made of wrought titanium 6AI-4V ELI (ASTM F136) and is available in a 4.5 mm diameter size from 20 mm to 50 mm and will be provided non-sterile, and is to be steam sterilized by the end user. Resterilization of screws upon contamination is not recommended.

The provided document describes a 510(k) premarket notification for the "ACTIVE™ Screw Bone Screw" and contains information about its performance testing. However, it does not present acceptance criteria in a quantitative, pass/fail manner with specific numerical targets. Instead, it describes general compliance with existing standards and acceptable results.

Here's a breakdown of the information based on the request:

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria are not explicitly stated in the document, I will infer them from the reported testing methods and positive outcomes.

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

• Sample Size for Test Set: The document does not explicitly state the specific number of screws or tests conducted for each performance evaluation (torsion, pullout, torque in/out, bone interaction). It refers to "testing" as a general activity.
• Data Provenance: The studies were pre-clinical bench tests. The data is generated from laboratory testing of the device itself, not from human subjects or retrospective/prospective clinical data. Therefore, notions of "country of origin of the data" or "retrospective/prospective" do not apply in the typical sense; the tests were conducted by the manufacturer, Intelligent Implant Systems, LLC.

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

This question is not applicable to the type of safety and effectiveness testing described in the document. The "ground truth" for mechanical testing is established by engineering standards (e.g., ASTM F543-07) and objective physical measurements rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where subjective assessments (e.g., image interpretation) require reconciliation; this document describes objective mechanical performance testing.

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 question is not applicable. The device described is a bone screw, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or evaluation of AI assistance for human readers is irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a physical bone screw, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these performance tests is based on:

• Engineering Standards: Specifically, ASTM F543-07 for bone screw testing methods.
• Physical Measurements: Objective measurements of torsional strength, breaking angle, axial pullout strength, and force exerted.
• Comparative Performance to Predicate Devices: Damage from removal was compared directly to that of "traditional (predicate) bone screw[s]."

8. The Sample Size for the Training Set

This question is not applicable. As a physical medical device (bone screw), there is no "training set" in the context of machine learning or AI models. Performance is evaluated through physical testing.

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

This question is not applicable, as there is no training set for this device.

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