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The NuVasive X-CORE® Expandable VBR System is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The NuVasive X CORE® Expandable VBR System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft material may be used at the surgeon's discretion.

The NuVasive X-CORE® Mini Cervical Expandable VBR System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following Corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The NuVasive X-CORE® Mini Cervical Expandable VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.

These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The NuVasive X-CORE® Mini Cervical Expandable VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

X-Core Expandable VBR and X-Core Mini Cervical Expandable VBR devices are vertebral body replacement devices manufactured from Titanium alloy Ti6Al-4V ELI conforming to ASTM F136 and ISO 5832-3. Devices are offered in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The purpose of this 510(k) application is to add the sterile implants option to the previously cleared system.

I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study that proves a device meets such criteria. The document is an FDA clearance letter for a medical device (NuVasive X-Core® Expandable VBR System), outlining its indications for use, technological characteristics, and stating its substantial equivalence to predicate devices. It mentions performance data related to sterilization and packaging but does not include details on acceptance criteria or clinical/comparative studies involving device performance metrics as requested in your prompt.

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The NuVasive Modulus XLIF Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The NuVasive Modulus XLIF Interbody System is intended for use in interbody fusions in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and for use in the lumbar spine from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive Modulus XLIF Interbody System is also indicated for use in the treatment of multilevel degenerative scoliosis in the thoracolumbar spine.

The subject NuVasive Modulus XLIF Interbody System are interbody implants manufactured from from titanium alloy (Ti-6Al-4V ELI) powder conforming to ASTM F3001. The solid and porous structures are simultaneously built using a powder bed fusion method. The hollow core, or graft aperture, allows for packing of graft to aid in the promotion of a solid fusion. Similarly, the macroporous internal lattice structure provides additional space for graft packing. The microporous, textured surface on the superior and inferior ends of the device serves to grip the adjacent vertebrae to resist migration and expulsion of the device. The device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracolumbar spine.

The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The device is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

It looks like you've provided a 510(k) Summary for a medical device (NuVasive® Modulus XLIF Interbody System), but this document does not contain any information about acceptance criteria or a study that proves the device meets those criteria, particularly not in the context of an AI/ML-driven medical device.

The document explicitly states: "No clinical studies were conducted." and describes "Non-clinical testing" related to the physical properties of the implant (e.g., static/dynamic compression, shear, gravimetric analysis, etc.). This device is an interbody fusion device, which is a physical implant, not an AI/ML software device.

Therefore, I cannot extract the information you've requested regarding acceptance criteria and a study proving device performance for an AI/ML device from the provided text. The questions you've asked (about sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) are highly relevant to AI/ML device validation but are not addressed by this document.

If you can provide a different document that details the validation of an AI/ML medical device, I would be happy to help answer your questions.

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The Next Generation NVM5® System is a medical device that is intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surger and lower extremities. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMC), transcranial or lumbar motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates BendiniTM software used to locate spinal implant instrumentation for the placement of spinal rods. · XLIF (Detection) — The XLIF (Detection) function allows the surgeon to locate and evaltiate spinal nerves, and is used as a nerve avoidance tool.

· Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws.

· Free Run EMG - The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying alive stream waveform of any mechanically induced myotome contractions.

· Twitch Test (Train of Four) — The Twitch Test function allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.

· MEP - Transcranial or lumbar (i.e., conus in region ofLI-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The ME? function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury.

· SSEP - The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk.

• Remote Access - The remote monitoring and local wireless control provides real-time capabilities to the NG-NVM5 System for additional physicians.

· Bendini - The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.

The NG-NVM5 System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NG-NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. Moreover. a Twitch Test function is utilized to test the ability of the nerve to respond, or contract. following four stimulation pulses to determine the presence of neuromuscular block.

The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods as well as providing guidance to support the delivery of pedicle screws during EMG monitoring. Lastly, the system offers real-time control capabilities (local wireless control) to the NG-NVM5 System by additional monitoring physicians, in addition to remote monitoring capabilities.

In summary, the NG-NVM5 System includes the following five (5) software functionalities / modalities:

• 1. Electromyography (EMG)
• Motor Evoked Potential (MEP) 2.
• 3. Somatosensory Evoked Potential (SSEP)
• 4. Remote Access
• 5. Bendini

The NG-NVM5 System hardware consists of a Patient Module (PM) and computer, as well as accompanying accessory components which consist of an assortment of disposable conductive probes, electrodes, and electrode leads.

This document describes the NuVasive Next Generation NVM5 System, a medical device for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities.

The relevant information regarding acceptance criteria and study to prove device meets the acceptance criteria is detailed below:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly provide a table of acceptance criteria alongside reported device performance in distinct quantitative values. Instead, it states that "The results of these studies showed that the subject NG-NVM5® System meets the same acceptance criteria as the performance of the predicate device". The comparison table provided (Table 1 – Comparison of Technical Characteristics on page 6) focuses on technological characteristics and functionalities of the subject device against predicate devices, indicating equivalence rather than specific performance metrics against pre-defined thresholds.

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

The document mentions "Laboratory bench top testing" and "Verification and Validation Testing" but does not specify sample sizes for these tests, nor does it provide details on data provenance (e.g., country of origin, retrospective or prospective nature of data). This suggests that the studies were non-clinical in nature.

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 provided in the document. The studies described are non-clinical benchtop and verification/validation tests, not studies requiring expert interpretation for ground truth establishment.

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

This information is not applicable and not provided in the document, as the studies are non-clinical benchtop and verification/validation tests, not clinical studies requiring adjudication methods for ground truth establishment.

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

The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness studies. The device is for intraoperative neurophysiologic monitoring and spinal rod bending assistance, and the studies described are non-clinical verification and validation activities. There is no indication of AI assistance being evaluated in comparison with human readers.

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

The studies described are non-clinical benchtop and verification/validation tests focusing on the device's technical performance, including the accuracy of angle and offset measurement and the functionality of the GUI and system components. This implicitly evaluates some aspects of the device's standalone performance (e.g., the Bendini software's ability to locate instrumentation and generate bend instructions). However, the device is intended for intraoperative use, with direct information provided to the surgeon, indicating a human-in-the-loop context. The document does not explicitly delineate studies demonstrating "algorithm only without human-in-the-loop performance" as a separate category of evaluation beyond the aforementioned technical tests.

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

For the non-clinical benchtop tests, the "ground truth" would have been established by engineering specifications, calibrated measurement tools, and predefined functional requirements (e.g., ensuring a certain angle is measured correctly by the device against a known standard). This is implicit in "Laboratory bench top testing was performed to verify accuracy of angle and offset measurement and validate that the graphical user interface (GUI) and system components function as intended."

8. The sample size for the training set

The document describes non-clinical testing for verification and validation and does not mention training sets, as it is not an AI/machine learning device in the context of data-driven model training.

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

As no training set is mentioned for an AI/machine learning model, this information is not applicable. The device's validation is based on engineering specifications and direct performance measurements.

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The NuVasive CoRoent Small Interlock System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. The NuVasive CoRoent Small Interlock System (lordotic angles of 10° and 15°) is a standalone system. The NuVasive CoRoent Small Interlock System (lordotic angles of 20° to 30°) must be used with supplemental fixation cleared by the FDA. The System is intended to be used with autogenous or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

The NuVasive CoRoent Small Interlock System is a standalone anterior cervical interbody device consisting of a PEEK (polyetheretherkeytone) implant cage with titanium alloy and tantalum radiographic markers, titanium alloy washers, and three (3) titanium alloy bone fixation screws. The devices are manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, titanium alloy conforming to ASTM F136 and tantalum conforming to ASTM F560 or ISO 13782. The implants are available in a variety of sizes to accommodate anatomical conditions. The NuVasive CoRoent Small Interlock System is a standalone system intended to be used with the bone screws provided, and when used as such requires no additional supplementary fixation systems.

The provided document is a 510(k) premarket notification for a medical device called the NuVasive CoRoent Small Interlock System. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. This type of submission typically does not include the detailed multi-reader multi-case (MRMC) studies, standalone algorithm performance, or extensive ground truth establishment details that are common for AI/ML-based diagnostic devices. Therefore, much of the requested information regarding AI performance metrics, sample sizes for training/test sets, and expert adjudication methods is not applicable to this document.

However, I can extract the relevant information from the document that pertains to the device's performance and the studies conducted to show its acceptance.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The device's acceptance criteria are based on mechanical and material performance standards relevant to intervertebral body fusion devices. The study conducted to prove the device meets these criteria involved a series of non-clinical, bench-top tests:

• Static and dynamic compression testing per ASTM F2077
• Static and dynamic torsion testing per ASTM F2077
• Wear debris/mass change analysis during ASTM F2077, per ASTM F1877 and ASTM F1714
• Static push-out testing per ASTM Work Item Z8423Z
• Subsidence analysis per ASTM F2267

The results of these studies demonstrated that the NuVasive CoRoent Small Interlock System "meets or exceeds the performance of the predicate device and does not introduce any new risks." This conclusion signifies that the device performs adequately according to the established industry standards for its intended use, by showing substantial equivalence to already legally marketed devices.

Regarding the requested information that is not generally applicable to this type of 510(k) submission for a non-AI/ML device:

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

• Not applicable. This document describes non-clinical, bench-top mechanical testing, not a clinical study involving human patient data. The "test set" would consist of physical devices and test parameters. The provenance is the testing facility/laboratory.

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

• Not applicable. Ground truth in this context is established by the specifications of the ASTM standards and the measurements taken during the mechanical tests, not by expert interpretation of clinical data in the same way an AI model's output would be adjudicated.

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

• Not applicable. This is a non-clinical, objective measurement against engineering standards, not a subjective interpretation requiring adjudication among 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:

• Not applicable. This document is for a physical orthopedic implant. It does not involve AI or human readers for diagnostic interpretation.

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.

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

• For the non-clinical tests, the "ground truth" is defined by the objective measurement results according to the specified ASTM standards (e.g., force applied, displacement, wear quantification).

8. The sample size for the training set:

• Not applicable. This device does not involve a training set as it is not an AI/ML system.

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

• Not applicable. This device does not involve a training set.

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The Nu Vasive® TLX Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion.

The TLX Interbody System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to SI, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (0) months of non-operative treatment prior to being treated with the TLX Interbody System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The TLX Interbody intervertebral fusion device is designed to address lumbar pathologies utilizing interbody placement through a standard posterolateral approach. The NuVasive® TLX Interbody System is manufactured from titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 and ISO 5832-3, and nickel-cobalt-chromium-molybdenum (MP35N) conforming to ASTM F562. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The provided text is a 510(k) summary for the NuVasive® TLX Interbody System, which is a medical device for spinal fusion. This document describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices based on technological characteristics and performance data.

However, the document does not contain information about:

• Acceptance criteria for device performance. It only states that nonclinical testing was performed and "The results demonstrate that the subject TLX Interbody System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate." This implies the acceptance criteria were based on equivalence to the predicate devices' performance, but specific numerical criteria are not given.
• A study that proves the device meets specific acceptance criteria with reported device performance. The document mentions nonclinical testing (static and dynamic axial compression and compression shear testing per ASTM F2077, static push-out testing per ASTM draft standard F-04.25.02.02, and subsidence assessment), but it does not provide the results of these tests or compare them to any explicit acceptance criteria in a table. Instead, it concludes equivalence to predicate devices based on these tests.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is typically for AI-assisted diagnostic devices, which this medical implant is not.
• Standalone (algorithm only) performance. The device is a physical implant, not an algorithm.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Therefore, I cannot provide the requested information in the format requested based on the provided text. The document is focused on establishing substantial equivalence for regulatory clearance, rather than detailing the specifics of a performance study against predefined acceptance criteria for a novel AI or diagnostic device.

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The NVM5® System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), transcranial or lumbar motor evoked potential (MEP), or somatosensoty evoked potential (SSEP) responses of nerves. The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods.

· XLIF (Detection) - The XLIF (Detection) function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool.

· Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws.

· Free Run EMG - The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.

· Twitch Test (Train of Four) — The Twitch Test Function allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.

· MEP - Transcranial or lumbar (i.e., conus in region ofLI-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury.

· SSEP - The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk.

· Remote Reader - The Remote Reader function provides real time remote access to the NVM5 System for a monitoring physician outside of the operating room.

· Guidance - The Guidance function is intended as an aid for use in either open or percutaneous pedicle cannulation procedures in the lumbar and sacral spine (LI-SI) of adult patients, and when used in conjunction with radiographic imaging and EMG, allows the surgeon to assess the angulation of system accessories relative to patient spinal anatomy for the creation of a cannulation trajectory for bone screw placement.

· Bendini - The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.

The NVM5 System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. Moreover, a Twitch Test function is utilized to test the ability of the nerve to respond, or contract, following four stimulation pulses to determine the presence of neuromuscular block.

Additionally, the NVM5 System includes an integrated stereotactic guidance system (NVM5 Guidance) to support the delivery of pedicle screws during EMG monitoring. The System also integrates Bendini software used to locate spinal implant instrumentation for the placement of spinal rods. Lastly, the system also offers an optional screen sharing application to allow a secondary physician to remotely view the events represented on the NVM5 user interface. In summary, the NVM5 System includes the following six (6) software functionalities / modalities:

1. Electromyography (EMG)
2. Motor Evoked Potential (MEP)
3. Somatosensory Evoked Potential (SSEP)
4. Remote Reader
5. Guidance
6. Bendini

The NVM5 System hardware consists of a Patient Module (PM) and computer, as well as accompanying accessory components which consist of an assortment of disposable conductive probes, electrodes, and electrode leads.

The provided text describes the NuVasive NVM5 System, a medical device for intraoperative neurophysiologic monitoring during spinal surgery. The document is a 510(k) premarket notification and primarily focuses on demonstrating substantial equivalence to a predicate device (NuVasive NVM5 System K143641).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The provided text does not present a formal table of acceptance criteria with corresponding device performance metrics in a quantitative way for all functionalities. It lists "Performance Requirements" for its "Guidance" function.

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

The document states:

• "Nonclinical testing was performed..."
• "Laboratory bench top testing was performed to verify accuracy of angle and offset measurement and validate that the graphical user interface (GUI) and system components function as intended."

The text does not specify the sample size used for the test set or the data provenance (country of origin, retrospective or prospective). The testing described appears to be laboratory-based rather than involving patient 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)

The document does not mention the use of experts to establish ground truth for the test set. The testing described is nonclinical and laboratory-based.

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

The document does not describe any adjudication method. Given the nonclinical nature of the testing mentioned (laboratory bench top testing), it's unlikely an adjudication method for human interpretation would be relevant.

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 MRMC comparative effectiveness study is mentioned. The device is a "Surgical Nerve Stimulator/Locator" and "Neurological surgical monitor," which directly provides information to the surgeon. While it aids the surgeon, it's not described as an AI system that improves "human readers" in an MRMC study context. The "Remote Reader" function only provides remote access for a monitoring physician, not an AI assistance for image interpretation.

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

The document describes the device's performance in a standalone context (without a human interpreting the outputs of an AI algorithm, but with a human using the direct outputs of the device). The "nonclinical testing" and "laboratory bench top testing" were performed to verify and validate the system's performance against design specifications. The device provides "information directly to the surgeon," indicating its primary mode of operation is standalone in generating the direct neurophysiologic monitoring data.

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

For the "Guidance" function, the ground truth for angular and offset accuracy would likely be physical measurements against known standards or calibrated equipment during the benchtop testing. For the neurophysiologic monitoring functions (EMG, MEP, SSEP), the ground truth for verification and validation would likely involve electrical signal generation and measurement against known physiological parameters or simulated physiological responses. The text does not explicitly state the specific type of ground truth but implies it's based on technical specifications and device functionality.

8. The sample size for the training set

The document does not mention a training set or machine learning components that would necessitate a training set. The device's algorithms are described as largely "identical" to a predicate device or having "modified stimulation parameters" for MEP and "addition of baseline algorithm and optional view" for SSEP, suggesting rule-based or signal processing algorithms rather than trainable machine learning models.

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

Not applicable, as a training set is not mentioned.

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The Foundation-LL System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous nonfusion spinal surgery at the involved level(s). The Foundation-LL System is intended for use with autograft. The Foundation-LL System must be used with supplemental internal spinal fixation systems (i.e., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Foundation-LL System.

The NuVasive Foundation-LL System is an interfixated interbody system manufactured from PEEK-Optima LT-1 conforming to ASTM F2026, with commercially pure titanium coating conforming to ASTM F1580 and internal screw hole rings made of titanium allov (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3. The tantalum radiographic markers conform to ASTM F560. The bone screws are made of titanium allov (Ti-6AI-4V ELI) conforming to ASTM F136 and ISO 5832-3. The NuVasive Foundation-LL System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The Foundation-LL System consists of a PEEK interbody or PEEK interbody with a commercially pure titanium plasma coating, and three (3) titanium alloy bone screws. The Foundation-LL System must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets specific criteria for performance and effectiveness. The text discusses the FDA's 510(k) clearance for a medical device called the "NuVasive® Foundation-LL System," which is an intervertebral body fusion device.

The document primarily focuses on regulatory approval, indicating that the device is substantially equivalent to previously marketed predicate devices. It lists the device's indications for use, technological characteristics, and nonclinical performance testing conducted (e.g., static and dynamic compression testing, wear debris testing, push-out testing, subsidence testing). However, these tests are mentioned as having been performed to demonstrate substantial equivalence to predicate devices, and the document states that the results show the system meets or exceeds the performance of the predicate device and does not introduce any new risks.

It does not provide:

• A table of acceptance criteria and reported device performance against those criteria.
• Details about sample sizes, data provenance, number or qualifications of experts, adjudication methods, or ground truth for a test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance, as the device is a physical implant and not an AI or diagnostic software.
• Details on the sample size or ground truth establishment for a training set.

Therefore, I cannot provide the requested information for this specific document.

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When used as a pedicle screw fixation system, the Nu Vasive Reline System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Degenerative spondylolisthesis with objective evidence of neurologic impairment
3. Fracture
4. Dislocation
5. Scoliosis
6. Kyphosis
7. Spinal tumor and/or
8. Failed previous fusion (pseudoarthrosis)

When used for posterior non-cervical screw fixation in pediatric patients, Nu Vasive Reline System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the NuVasive Reline System is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

The Nu Vasive Reline System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Reline System is also intended for the following indications:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Spinal stenosis
3. Spondylolisthesis
4. Spinal deformities
5. Fracture
6. Pseudoarthosis
7. Tumor resection and/or
8. Failed previous fusion

In order to achieve additional levels of fixation, the Reline System rods may be connected to the Armada System.

The NuVasive Reline System is a pedicle screw system that consists of a variety screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. This 510(k) is to add new components to the Reline System.

I am unable to provide a description of the acceptance criteria and the study that proves the device meets them because the provided text describes a 510(k) premarket notification for the "NuVasive® Reline™ System" which is a pedicle screw spinal system.

The document is an FDA clearance letter and a 510(k) summary, and it primarily focuses on establishing substantial equivalence to existing predicate devices based on design, intended use, material composition, and function. The "Performance Data" section mentions nonclinical testing (e.g., dynamic compression bending per ASTM F1717) but does not provide quantitative acceptance criteria or detailed results that would allow me to populate a table of acceptance criteria and reported device performance.

Furthermore, this type of device (spinal fixation system) does not typically involve the kinds of studies (e.g., standalone algorithm performance, MRMC studies, expert consensus on image interpretation, training/test set data provenance, ground truth establishment for AI/diagnostics) that would be needed to answer the specific questions posed about device performance for an AI/diagnostic device. The information requested is relevant to AI/machine learning medical devices, which this product is not.

Therefore, I cannot fulfill the request as the provided text relates to a different type of medical device lacking the details you are asking for.

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