Search Results

AttraX Scaffold is an implant intended to fill bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space and pelvis). These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. AttraX Scaffold resorbs and is replaced with bone during the healing process. When used in the posterolateral spine, AttraX Scaffold must be used in combination with either autogenous bone or autogenous bone marrow aspirate. When used in intervertebral body fusion procedures, AttraX Scaffold must be used in combination with either autogenous bone or autogenous bone marrow aspirate and with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

AttraX Scaffold is an osteoconductive and resorbable bone void filler consisting of hydroxyapatite/tricalcium phosphate ceramic granules premixed with a highly purified type I bovine collagen that provides cohesion between the granules and acts as an absorbent matrix for fluids. The bone graft mimics the composition of natural bone and is biocompatible. AttraX Scaffold provides an osteoconductive environment for promoting new bone formation while resorbing at a rate consistent with bone healing. In situ, the collagen and ceramic components are resorbed and replaced by new bone, similar to the resorption and remodeling observed with autogenous bone.

The provided text is an FDA 510(k) clearance letter for a medical device called NuVasive AttraX Scaffold. This document does not describe a study proving the device meets acceptance criteria for an AI or software-related product. Instead, it details the substantial equivalence of a bone void filler to previously cleared predicate devices.

Therefore, I cannot extract the requested information about acceptance criteria, study details, ground truth establishment, or human-in-the-loop performance, as this information is not present in the provided document.

The document discusses:

• Device Name: NuVasive AttraX Scaffold
• Device Type: Resorbable Calcium Salt Bone Void Filler Device (Class II)
• Indications for Use: Filling bony voids or gaps in the skeletal system (posterolateral spine, intervertebral disc space, pelvis), to be used in combination with autogenous bone or bone marrow aspirate, and with an intervertebral body fusion device when used in intervertebral body fusion procedures.
• Premarket Notification (510(k)): K240507
• Predicate Devices: NuVasive AttraX Scaffold (K172497) and NuVasive AttraX Putty (K203714).
• Performance Data (for prior clearance K172497): Non-clinical testing including chemical composition, physical properties, sterilization, bacterial endotoxin, packaging performance and shelf life, biocompatibility, and animal testing.
• MR Safety: Declared "MR Safe" based on scientific rationale per ASTM F2503 and FDA guidance, rather than testing, as it's composed of nonconductive, nonmetallic, nonmagnetic materials.
• Substantial Equivalence Argument: The subject device is identical to the primary predicate (K172497) in most aspects and substantially equivalent to the additional predicate (K203714) concerning intended use, indications, design principles, and performance. The key point of this submission (K240507) is to expand the indications of the AttraX Scaffold for use in the intervertebral disc space, which the document states is supported by previously provided animal testing from K172497.

In summary, the document addresses a conventional medical device (bone void filler) and its regulatory clearance based on substantial equivalence, not an AI or software device that would have the type of "acceptance criteria" and "study" details you are requesting related to algorithmic performance.

Ask a specific question about this device

The NuVasive Modulus-C Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Modulus-C Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral fusion to facilitate fusion.

The subject NuVasive Modulus-C Interbody System is designed to address cervical pathologies utilizing interbody placement through an anterior surgical approach. The NuVasive Modulus-C Interbody System implants are porous, hollow, devices additively manufactured from Grade 23 titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F3001 Class C. Modulus-C has solid and porous structures which 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 body lattice structure provides additional space for graft packing. The microporous, textured surfaces on the superior and inferior ends of the subject device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Mod-C is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the cervical spine.

The provided FDA 510(k) document for the NuVasive® Modulus-C Interbody System does not contain information related to an AI/ML-based medical device study.

The document describes a medical device (intervertebral body fusion device) and its non-clinical performance testing. It focuses on demonstrating substantial equivalence to predicate devices based on mechanical properties and material composition.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies, as there is no AI/ML component or related study described in the provided text.

The document specifically states: "No clinical studies were conducted." and describes non-clinical testing focused on mechanical performance.

Ask a specific question about this device

The Simplify Disc Inserter FP is intended for the placement and positioning of the Simplify Cervical Artificial Disc.

The instrument set includes a number of surgical instruments designed to facilitate Simplify Cervical Artificial Disc implantation. The Simplify Disc Inserter FP enables the Simplify Disc to be held as a rigid construct in extension and to be inserted as a single unit into the disc space. The instrument set is intended to be used only with the Simplify Cervical Artificial Disc.

The purpose of the 510(k) submission is to improve usability of the Simplify Disc Inserter with an updated version referred to as Simplify Disc Inserter FP.

This document is a 510(k) summary for the Simplify Disc Inserter FP. It details the device's intended use and design modifications, but it does not contain the kind of detailed information about acceptance criteria, study design, or AI performance that you are requesting.

The document states:

• Performance Testing: "Testing included user testing, dimensional analysis, cleaning validation, and steam sterilization. All completed tests met the pre-determined acceptance criteria."

However, it does not provide any specific acceptance criteria or detailed results from these tests. It also does not mention any AI component or related studies (like MRMC or standalone performance studies).

Therefore, based on the provided text, I cannot extract the information you requested regarding:

1. A table of acceptance criteria and the reported device performance: This information is not detailed.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth and their qualifications: Not mentioned.
4. Adjudication method: Not mentioned.
5. MRMC comparative effectiveness study, effect size: Not applicable, as no AI component is mentioned.
6. Standalone (algorithm only) performance: Not applicable, as no AI component is mentioned.
7. Type of ground truth used: Not applicable, as no AI component or clinical evaluation requiring such ground truth is detailed.
8. Sample size for the training set: Not applicable, as no AI component is mentioned.
9. How the ground truth for the training set was established: Not applicable, as no AI component is mentioned.

This document pertains to regulatory approval for a physical medical instrument (the Disc Inserter) and not an AI/software as a medical device (SaMD).

Ask a specific question about this device

The NuVasive® VersaTie™ System is a temporary implant for use in orthopedic surgery. The System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.

The indications for use include the following applications:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;

2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis; 3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The VersaTie System may also be used in conjunction with other medical implants made of titanium alloy or cobaltchromium alloy whenever "wiring" may help secure the attachment of other implants.

The NuVasive VersaTie System is part of a spinal fixation system designed to provide an interface between spinal anatomy and a rod used in spinal surgery. The device is secured around posterior vertebral structures such as the lamina, facet, transverse processes, and spinous process from T1-L5. The system is comprised of braided bands and clamps designed to attach to titanium alloy or cobalt-chromium alloy rods. 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. The purpose of this submission is to introduce an additional surgical technique.

The provided text describes a 510(k) premarket notification for the NuVasive® VersaTie™ System, a temporary implant for use in orthopedic surgery. The document focuses on establishing substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study design for a novel device. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not found within this particular document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It generally states that the device was shown to be "substantially equivalent" to its predicate based on the nonclinical testing.

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

The document mentions "nonclinical testing" was performed, which typically refers to mechanical or bench testing. It does not refer to a "test set" in the context of patient data or clinical studies. Therefore, information about sample size for a test set (in terms of patient data) or data provenance (country of origin, retrospective/prospective) is not applicable as this was not a clinical study involving human subjects or patient data.

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

This information is not applicable as the document describes nonclinical (bench) testing, not a study involving human data or expert review for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes nonclinical (bench) testing, not a study involving human data or 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 information is not applicable. The device is a physical bone fixation system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant to this device.

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

This information is not applicable. The device is a physical bone fixation system, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the nonclinical testing, the "ground truth" would be the engineering specifications and established mechanical properties of the predicate device. The performance of the subject device (NuVasive® VersaTie™ System) was compared against these established characteristics of the predicate to demonstrate substantial equivalence. This is not "expert consensus, pathology, or outcomes data" in the typical clinical sense.

8. The Sample Size for the Training Set

This information is not applicable. The document describes nonclinical (bench) testing of a physical device, and does not involve a training set as would be relevant for machine learning or AI models.

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

This information is not applicable for the same reasons as point 8.

Summary of Study (Based on Provided Text):

The study described is a nonclinical performance study comparing the NuVasive® VersaTie™ System to a legally marketed predicate device (NuVasive VersaTie System cleared in K161265). The purpose was to demonstrate substantial equivalence for the new device.

The testing performed included:

• Static and dynamic Anterior-Posterior band pull-through testing
• Static and dynamic Caudal-Cranial band pull-through testing

Conclusion from the document: The results of this nonclinical testing demonstrated that the subject NuVasive® VersaTie™ System is substantially equivalent to the predicate. The "acceptance criteria" were implied to be performance characteristics (e.g., strength, durability, pull-through resistance) comparable to or better than the predicate device.

Ask a specific question about this device

The NuVasive CoRoent Lumbar 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 and supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. Patients with previous non-fusion spinal surgery at involved level may be treated with the devices are to be used in patients who have had at least six months of non-operative treatment.

The CoRoent Lumbar System (L and XL platforms) is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, 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.

The NuVasive® CoRoent System is manufactured from PEEK-OPTIMA® Optima LT1 (Polyether-ether-ketone) conforming to ASTM standard F2026, Ti-6Al-4V ELI conforming to ASTM standard F136/1472 or Tantalum conforming to ASTM standard F560 or ISO 13782. These implants are available in a variety of shapes and configurations for PLIF/TLIF, XLIF and ALIF approaches, with heights ranging from 6 - 24 mm, widths ranging from 9 - 42 mm, lengths ranging from 20-65 mm and lordotic angles ranging from 0° - 20°, to suit the individual pathology and anatomical conditions of the patient. The hollow aperture allows for packing of autogenous bone graft. Teeth on the superior and inferior surface of the implants provide resistance to expulsion.

Both the subject device and its accessory surgical instruments are packaged as non-sterile, to be sterilized by the end user. In addition, the implants are also offered in sterile packaged versions.

Here's a breakdown of the acceptance criteria and study information for the NuVasive® CoRoent® System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

This information is not applicable as no human clinical data was used for this 510(k) submission. The performance data was based on nonclinical testing.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This information is not applicable as ground truth related to human observation or clinical outcomes was not established for a test set in this submission. The "ground truth" for nonclinical testing would be the ASTM standards themselves and the inherent properties of the materials and design compared to predicate devices.

4. Adjudication Method (Test Set)

This information is not applicable as there was no human-reviewed test set requiring adjudication.

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

No, a multi-reader multi-case comparative effectiveness study was not done. The submission explicitly states, "No clinical studies were conducted."

6. Standalone (Algorithm Only) Performance Study

This information is not applicable as this is a medical device (intervertebral body fusion system) composed of physical materials, not an algorithm or software requiring standalone performance evaluation.

7. Type of Ground Truth Used

The ground truth used for demonstration of substantial equivalence was based on:

• ASTM Standards: F2077 (for static and dynamic axial compression and compression shear) and F2267 (for subsidence testing). These established engineering standards serve as the "ground truth" for mechanical performance of intervertebral body fusion devices.
• Predicate Device Performance: The "ground truth" was also implicitly derived from the established performance of legally marketed predicate devices. The NuVasive CoRoent System aimed to meet the same criteria as these already cleared devices.

8. Sample Size for the Training Set

This information is not applicable as there was no training set in the context of an algorithm or machine learning. The "training" in this context would be the design and engineering process to ensure the device met the specified ASTM standards and matched the characteristics of predicate devices.

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

This information is not applicable as there was no training set in the context of an algorithm or machine learning. The design and manufacturing process for the device was informed by material science, biomechanical engineering principles, and the performance characteristics of previously cleared predicate devices and established ASTM standards.

Ask a specific question about this device

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 or autograft material may be used at the surgeon's discretion.

The X-Core® Expandable VBR System is manufactured from Ti-6A1-4V ELI conforming to ASTM F136 and ISO 5832-3. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. This 510(k) covers design changes to NuVasive Expandable Lumbar Interbody System (K090176).

This document is a 510(k) premarket notification for a medical device (NuVasive X-CORE® Expandable VBR System). It asserts substantial equivalence to predicate devices based on non-clinical testing. It does not describe a study involving "acceptance criteria" and "device performance" in the way one would for an AI/CADe/CADx device that performs a diagnostic or predictive function.

Therefore, I cannot extract the requested information as it pertains to AI/CADe/CADx studies. The document describes a physical medical device (vertebral body replacement system) and its performance is evaluated through mechanical testing, not through analysis of data in the way an AI algorithm would be.

Specifically, the document states under "G. Performance Data": "Nonclinical testing was performed to demonstrate that the subject NuVasive X-CORE Expandable VBR System is substantially equivalent to other predicate devices... The results demonstrate that the subject NuVasive X-CORE Expandable VBR System is substantially equivalent to predicate devices. No non-clinical studies were conducted." This last sentence appears to be a typo, likely intending to say "No clinical studies were conducted" given the preceding description of nonclinical testing.

If you are looking for information about AI/CADe/CADx device studies, this document is not relevant.

Ask a specific question about this device

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 somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods.

• o 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 of L1-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 (L1-S1) 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 a 510(k) premarket notification for the NuVasive NVM5 System. It asserts substantial equivalence to a predicate device (NuVasive NVM5 System - 510(k) - K132694) based on indications for use, technological characteristics, and performance testing.

Here's an breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the 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)

The document mentions "nonclinical testing" including "laboratory bench top and cadaveric testing". It does not specify the sample size for these tests, nor the country of origin of the data, or if it was retrospective or prospective.

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 provide information on the number of experts used or their qualifications for establishing ground truth. The testing mentioned appears to be hardware/software verification and validation, not clinical performance evaluation with expert review.

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

The document does not describe an adjudication method, as the testing appears to be based on technical specifications and functional validations rather than subjective clinical assessment 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

No MRMC comparative effectiveness study is mentioned in the provided text. The device is a surgical monitoring system, not explicitly an AI-assisted diagnostic device, and the testing described is nonclinical.

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

The "Performance Data" section discusses "Verification and Validation Testing according to the Software Requirements Specifications" and "Laboratory bench top and cadaveric testing". This implies testing of the algorithm (software functionalities) and hardware system, which would largely be standalone performance testing to verify it meets design specifications. However, "human-in-the-loop" is a core aspect of the device's intended use (providing information directly to the surgeon), so the distinction might not be as clear-cut as with an independent AI diagnostic tool.

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

The ground truth for the nonclinical testing appears to be based on established engineering and physiological parameters (e.g., "pulse width and amplitude, current polarity, stimulation rates and response detection ranges," "boundary conditions, extreme values, and nominal entries displayed on the GUI," "proper bend instructions and/or calculated offsets"). No mention of clinical outcomes data, pathology, or expert consensus in relation to diagnostic ground truth is made for the described premarket notification testing.

8. The sample size for the training set

The document describes nonclinical verification and validation testing, not a machine learning model that would require a "training set." Therefore, no training set sample size is provided.

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

As described above, the document does not mention a training set, so no information regarding its ground truth establishment is provided.

Ask a specific question about this device

The NuVasive CoRoent Ti-C 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 CoRoent Ti-C System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, 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. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. The 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 NuVasive® CoRoent Ti-C System is manufactured from PEEK-OPTIMA® (Polyetherether-ketone) conforming to ASTM F2026, commercially pure titanium conforming to ASTM F1580, Ti-6Al-4V ELI conforming to ASTM F136/1472 or Tantalum (Ta) conforming to ASTM F560 or ISO 13782. 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 document is a 510(k) premarket notification for a medical device (CoRoent Ti-C System), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical or performance study results for achieving specific acceptance criteria.

Therefore, the document does not contain the information requested for acceptance criteria and the study proving the device meets those criteria, specifically:

• A table of acceptance criteria and the reported device performance: This information is not provided. The document states "no new worst-case for performance testing" but does not detail specific performance thresholds or results against them.
• Sample sized used for the test set and the data provenance: No test set is described in the context of clinical performance.
• Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable as no clinical test set/ground truth is discussed.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: The document explicitly states, "No non-clinical or clinical studies were conducted."
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical implant, not a software/algorithm device.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable, as no training set for an algorithm is described.
• How the ground truth for the training set was established: Not applicable.

The performance data mentioned in the document (Section G, Page 4) is limited to nonclinical testing primarily for demonstrating equivalence to predicate devices:

• Static and dynamic axial compression and compression shear per ASTM F2077
• Wear debris testing per ASTM F2077, ASTM F1714 and ASTM F1877

The conclusion drawn from this testing is that "the subject CoRoent Ti-C System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate." However, specific acceptance criteria values and the device's numerical performance against those values are not detailed in this submission.

Ask a specific question about this device

The NuVasive AP Expandable XLIF 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 AP Expandable XLIF System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, 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 (6) months of non-operative treatment prior to being treated with the AP Expandable XLIF System. The AP Expandable XLIF System is intended to be used with supplemental internal spinal fixation systems (e.g., pedicle screw/rod systems) that are cleared by the FDA for use in the lumbar spine.

The NuVasive AP Expandable XLIF System is manufactured from Ti-6AI-4V ELI conforming to ASTM F136 and ISO 5832-3 and Ti-6Al-4V conforming to ASTM 1472. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

This document is a 510(k) Summary for the NuVasive® AP Expandable XLIF System, an intervertebral body fusion device. The purpose of this summary is to demonstrate that the device is substantially equivalent to legally marketed predicate devices, not to establish performance criteria through a clinical study involving AI or human readers.

Therefore, the requested information components related to acceptance criteria, ground truth, sample sizes for test and training sets, expert adjudication, and multi-reader multi-case (MRMC) studies are not applicable to the content provided in this 510(k) summary. These components are typically associated with performance evaluations of AI/ML-driven devices or clinical trials, neither of which are described here.

The document focuses on demonstrating substantial equivalence through nonclinical testing and comparison to predicate devices, as is standard for many Class II medical devices seeking 510(k) clearance.

Here's the relevant information based on the provided text, addressing the request by noting the inapplicability of many points:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. No "test set" in the context of AI/ML or clinical data performance evaluation is described. The performance data refers to nonclinical (mechanical) testing of the physical device.

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

Not applicable. No "ground truth" derived from expert review of data is established for this type of nonclinical testing.

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

Not applicable. No "adjudication method" is described as there is no human review of data to establish ground truth.

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 physical implant, not an AI-driven diagnostic or assistive system. No MRMC study was performed or is relevant.

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.)

Not applicable. The "ground truth" for the performance data in this context is based on engineering specifications and physical measurements compliant with ASTM standards, not clinical ground truth like pathology or expert consensus. The comparison is against predicate devices and their established performance characteristics.

8. The sample size for the training set

Not applicable. There is no AI/ML model, and therefore no "training set."

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

Not applicable. There is no AI/ML model, and therefore no "training set" or corresponding ground truth establishment process.

Ask a specific question about this device

Intervertebral Body Fusion

The NuVasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical degenerative disc disease (DDD) at one level from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent SHL interbody device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is designed for use with autogenous 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.

Partial Vertebral Body Replacement

The NuVasive CoRoent Small Interbody System may also be used as a partial 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 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 or autograft material may be used at the surgeon's discretion.

The NuVasive CoRoent Small Interbody System is manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, and titanium alloy conforming to ASTM F136 and ISO 5832-3 or tantalum conforming to conforming to ASTM F560 or ISO 13782. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission describes the NuVasive CoRoent® Small Interbody System, which is an intervertebral body fusion device and a partial vertebral body replacement device. Since this is a medical implant, the "performance" is measured by its mechanical integrity and functional equivalence to predicate devices, rather than typical AI/software performance metrics like accuracy, sensitivity, or specificity.

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

This submission does not involve a "test set" in the context of AI or software performance evaluation. The "testing" refers to non-clinical mechanical and material properties testing. The submission does not specify a distinct "sample size" for specific mechanical tests beyond the implication of standard testing methodologies per the referenced ASTM and ISO standards. The data provenance is derived from these non-clinical laboratory tests.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable. This is a medical device (spinal implant) submission, not an AI/software submission. Ground truth for mechanical performance is established through standardized engineering tests, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. This is a medical device (spinal implant) submission, not an AI/software submission requiring adjudication of expert interpretations.

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

Not applicable. This is a medical device (spinal implant) submission. There is no AI component, and thus, no human readers or AI assistance to compare.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. This is a medical device (spinal implant) submission. The device is a physical implant, not an algorithm.

7. Type of Ground Truth Used

The ground truth used for this device's "performance" is based on engineering standards and specifications. This includes:

• Material specifications: ASTM F2026, ASTM F136, ISO 5832-3, ASTM F560, ISO 13782 for the PEEK-Optima LT-1, titanium alloy, and tantalum components.
• Mechanical testing standards: ASTM F2077 for static and dynamic axial compression and torsion, and ASTM F2267 for subsidence analysis.
• Comparative analysis: Demonstrated substantial equivalence to the performance of legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. This is a medical device (spinal implant) submission, not an AI/software submission. There is no "training set" for an algorithm. The design and manufacturing processes are informed by existing biomechanical knowledge, engineering principles, and the performance characteristics of predicate devices.

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

Not applicable. There is no training set as this is not an AI/software device. The underlying principles for the device's design and expected performance are established through decades of biomedical engineering research, material science, and clinical experience with similar devices, as well as adherence to recognized industry standards (ASTM, ISO).

Ask a specific question about this device