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The Invictus® Bands System consists of temporary implants 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:

• Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
• 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 and older, adult scoliosis, kyphosis, and spondylolisthesis;
• Spinal degenerative surgery, as an adjunct to spinal fusions;
• Use with a posterior spinal instrumentation construct when ligament augmentation is needed.

The Invictus® Bands System may also be used in conjunction with other medical implants made of commercially pure titanium, titanium alloy, or cobalt chrome whenever "wiring" may help secure the attachment of other implants.

The Invictus® Bands System is a sublaminar fixation and ligament augmentation system consisting of bands, sleeves, connectors, and set screws that mate with 4.5 – 5.0 mm and 5.5 – 6.0 mm diameter rods. The Invictus® Bands System sleeves, connectors, and set screws are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The bands are comprised of a polyethylene terephthalate (PET) braid with a stainless steel malleable tip and needle (leads) at the ends of the bands. The stainless steel leads are detached after insertion and are not intended to be implanted. Implants are available in a variety of sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient.

The Invictus® Bands System connectors accept various rod diameters and are appropriate for use with any 4.5 – 5.0 mm and 5.5 – 6.0 mm diameter rod-based spinal fixation system cleared by FDA.

The bands are for single use and are provided terminally sterile via gamma irradiation. The sleeves, connectors, and set screws are for single use and are provided non-sterile to be steam sterilized by the end user. The system includes class I, reusable surgical instruments made of stainless steel and other materials and are provided non-sterile to be cleaned and steam sterilized by the end user.

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Valence Robotic Navigation System is indicated for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan.

The Valence Robotic Navigation System is indicated for assisting surgeons in spinal procedures, such as:

• Pedicle screw placement
• Interbody device placement

Valence Robotic Navigation Instruments (for use with the StealthStation™):

The Valence Posterior Disc Prep Instruments are indicated to facilitate discectomy, bony resection, and implant selection during spinal surgery.

The Valence Posterior Fixation Instruments are intended to be used during the preparation and placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures.

Navigated instruments are specifically designed for use with the Medtronic® StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Valence Robotic Navigation System is an image guided system primarily comprised of a computer workstation, software, a trajectory system, including a targeting platform, a camera, and various image guided instruments intended for assisting the surgeon in placing pedicle screws and interbody implants in the thoracolumbar and sacral spine.

The system uses optical instrument tracking and registration to an intraoperative 3D scan to navigate patient anatomy across three independent workflows:

• Robotic assisted screw navigation
• Freehand screw navigation
• Freehand disc prep and interbody implant navigation

In addition to compatibility with the Valence Robotic Navigation System, select instruments referred to as Valence Robotic Navigation Instruments (for use with StealthStation™) are designed to be compatible with the Medtronic® StealthStation™ Surgical Navigation System. The navigated disc preparation instruments are intended to facilitate discectomy, and bony resection while the posterior fixation instruments are intended to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants.

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The SafeOp 3: Neural Informatix System is intended for use in monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, extracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open/percutaneous, lumbar, thoracic, and cervical surgical procedures.

SafeOp 3 Accessories: The SafeOp Accessories are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.

The SafeOp™ 3: Neural Informatix System (SafeOp 3 System), consists of the SafeOp patient interface with power supply and IV pole mount, the Alpha Informatix Tablet with docking station and power supply and a data transfer USB cable. Associated disposable accessories consists of an electrode harness, surface and/or subdermal needle electrodes, MEP Activator, Cranial Hub, Delta Dilators and Stimulating Probe and Delta Clip contained in various kits.

The subject device is intended for use by trained healthcare professionals, clinical neurophysiologists/technologists and appropriately trained non-clinical personnel. The subject device is intended for use in operating room environments of hospitals and surgical centers. System setup may be performed by both clinical and trained non-clinical personnel.

The provided FDA 510(k) clearance letter and summary for the SafeOp 3: Neural Informatix System (K252842) primarily describe the device's substantial equivalence to a predicate device (K234092) and outline a Predetermined Change Control Plan (PCCP) for future modifications. However, it does not include a detailed study proving the device meets specific acceptance criteria in the context of clinical performance or AI algorithm validation for the initial clearance.

The "Performance Data" section explicitly states: "Determination of substantial equivalence is not based on an assessment of clinical performance data." and refers to nonclinical performance testing (functional, system, software requirements) and usability testing.

Therefore, the following information is extracted and synthesized based on the available document, but a comprehensive study proving acceptance criteria for all aspects of neural informatic performance is not present. The document focuses on the future PCCP for algorithmic changes, which will have performance criteria.

Acceptance Criteria and Reported Device Performance

The core of the documentation for this 510(k) clearance is about demonstrating substantial equivalence to an existing predicate device (SafeOp 3™: Neural Informatix System, K234092). Therefore, the "acceptance criteria" for the cleared device itself are primarily its ability to match the predicate's performance and specifications, which is shown through a direct comparison.

The document does not report specific quantitative performance metrics for the SafeOp 3: Neural Informatix System for its initial clearance, as it relies on substantial equivalence.

However, the Predetermined Change Control Plan (PCCP) outlines future modifications to the SSEP Baseline Classification Algorithm and defines acceptance criteria for these future algorithmic changes. These are the only explicitly stated performance acceptance criteria in the document.

Table 1: Acceptance Criteria and Reported Device Performance (from PCCP for future algorithmic changes)

Study Details (Based on the document, for the initial clearance)

Because the 510(k) is based on substantial equivalence and explicitly states "Determination of substantial equivalence is not based on an assessment of clinical performance data," there is no detailed "study" proving the device meets acceptance criteria in the way a de novo or PMA submission might. The "study" mentioned below refers to the verification and validation activities conducted to demonstrate substantial equivalence and safety/effectiveness for the initial clearance, as described in the "Performance Data" section.

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

   • Not explicitly stated for clinical performance data for the initial clearance. The document mentions "nonclinical performance testing" for functional, system, and software requirements, and "usability testing." These typically involve controlled test cases and user interactions rather than a large clinical test set.
   • For the future PCCP modifications of the SSEP algorithm, it mentions "an independent, firewalled dataset" and "additional labeled data" for re-training and testing, but no sample size or provenance is specified within this document.

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

   • Not explicitly stated for the initial clearance. Since the clearance is based on substantial equivalence and does not assess clinical performance data, detailed expert ground truth establishment for a clinical test set is not described.

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

   • Not explicitly stated for the initial clearance. Not applicable given the reliance on substantial equivalence and lack of clinical performance data assessment.

4. 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. The document does not describe an MRMC study. The device is a neural informatic system, and while it involves signal processing, it's not positioned as an AI-assisted diagnostic tool that human readers would interpret with assistance in the traditional sense of an MRMC study. The SSEP algorithm mentioned in the PCCP appears to be a standalone classification, not a human-in-the-loop assistance tool subject to such a study.

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

   • For the initial clearance, the document refers to "nonclinical performance testing" demonstrating the system meets functional, system, and software requirements. This implies standalone testing of device functions.
   • For the future SSEP Baseline Classification Algorithm (PCCP Modification #1 & #4), the acceptance criteria (PPV, Accuracy, F1-score) clearly indicate standalone algorithm performance is intended to be evaluated. However, no such standalone performance data is provided for the initially cleared device.

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

   • Not explicitly stated for the initial clearance. For the "nonclinical performance testing" and "usability testing," ground truth would typically be established based on engineering specifications and validated operational procedures.
   • For the future SSEP Baseline Classification Algorithm (PCCP Modification #1 & #4), it refers to "labeled data," which implies a ground truth established by experts or other definitive methods, but the specific type is not detailed in this document.

7. The sample size for the training set:

   • Not explicitly stated for the initial clearance. No AI algorithms are reported as being evaluated for the initial clearance.
   • For the future SSEP Baseline Classification Algorithm (PCCP Modification #1 & #4), it mentions the algorithm "will be re-trained using site-specific data" and "periodically re-trained as additional labeled data become available," but no sample size is specified within this document.

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

   • Not explicitly stated for the initial clearance.
   • For the future SSEP Baseline Classification Algorithm (PCCP Modification #1 & #4), it refers to "labeled data," but the method of labeling (establishing ground truth) is not detailed in this document.

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IdentiTi II ALIF Standalone Interbody System

The IdentiTi II ALIF Standalone Interbody System is indicated for spinal fusion procedures from L2 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. When used with screws or blades, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.

Additionally, the IdentiTi II ALIF Standalone Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis (>Grade 1) and spinal stenosis at one or two adjacent levels, the IdentiTi II ALIF Standalone Interbody System must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine. The IdentiTi II ALIF Standalone Interbody System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

When used with three (3) screws, interbody implants of <=20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels without the need for supplemental fixation.

When used with three (3) blades, a combination of three (3) screws and blades, or less than three (3) screws and/or blades, interbody implants must always be used with supplemental fixation.

When used with or without screws and/or blades, interbody implants of >20° must always be used with supplemental fixation.

Transend ALIF Standalone Interbody System

The Transcend ALIF Standalone Interbody System is indicated for spinal fusion procedures from L2 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. When used with screws or blades, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.

Additionally, the Transcend ALIF Standalone Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis (>Grade 1) and spinal stenosis at one or two adjacent levels, the Transcend ALIF Standalone Interbody System must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine. The Transcend ALIF Standalone Interbody System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

When used with three (3) screws, interbody implants of <=20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels without the need for supplemental fixation.

When used with three (3) blades, a combination of three (3) screws and blades, or less than three (3) screws and/or blades, interbody implants must always be used with supplemental fixation.

When used with or without screws and/or blades, interbody implants of >20° must always be used with supplemental fixation.

The IdentiTi II and Transcend ALIF Standalone Interbody Systems are integrated intervertebral body fusion systems with integrated screw and/or blade fixation for use in anterior and anterolateral procedures. The subject IdentiTi II interbody spacers are additively manufactured via full-melt powder bed fusion (laser melting) from titanium alloy powder (Ti-6Al-4V ELI) conforming to ASTM F3001. The subject Transcend interbody spacers are an assembly of additively manufactured titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F3001, PEEK (polyetheretherketone) Optima LT1 per ASTM F2026, and titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136. The IdentiTi II and Transcend ALIF Standalone interbody spacers are offered in various widths, heights, lengths, lordotic, and anti-migration options to accommodate individual patient anatomy and surgeon preference. The IdentiTi II and Transcend interbody implants are not patient matched. All interbody implants feature an internal graft aperture for placement of graft material to promote fusion through the cage. The interbody spacers accept up to three integrated bone screws and/or blades. The screws and blades are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F136 in varying lengths and diameters, and they mitigate the risk of expulsion of the interbody spacers. To mitigate risk of expulsion, the interbody endplates consist of roughed anti-migration surfaces and teeth. Additionally, the additively manufactured portions of the IdentiTi II (full spacer) and Transcend (anterior faceplate) implants are offered with a microporous/macroporous lattice structure that spans the entirety of the implant and extends to the superior and inferior surfaces of the device for biological fixation. The interbody implants are provided terminally sterile via gamma irradiation while the bone screws, blades, and reusable instruments are provided non-sterile to be steam sterilized by the end user.

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The Proximity Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

The Segmental Plating System (SPS) is intended for anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

The subject Alphatec Plating Systems consists of two anterior cervical plate subsystems, Proximity Anterior Cervical Plate System and Segmental Plating System, intended for anterior fixation to the cervical spine. The Alphatec Plating Systems consist of a variety of sizes of plates and screws that are manufactured from titanium alloy conforming to ASTM F136. The systems offer instrumentation for the delivery of the plate and screw constructs. The instruments in this system are intended for use in surgical procedures. The Alphatec Plating Systems implants are provided either terminally sterile or non-sterile to be steam sterilized by the end user.

I apologize, but the provided text from the FDA 510(k) clearance letter for the Alphatec Spine Proximity™ Anterior Cervical Plate System does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria for software-based AI/ML devices.

The document details:

• Device Type: Spinal Intervertebral Body Fixation Orthosis (a physical implantable device, not a software/AI device).
• Regulations: Primarily related to medical devices, specifically orthopedic implants.
• Performance Data: Lists non-clinical (mechanical) testing based on ASTM standards (e.g., Static and Dynamic Compression Bending, Static Screw Push-out) and sterilization/packaging validations.
• Substantial Equivalence: Compares the mechanical design and indications for use of the Proximity™ system to predicate physical spinal fixation devices.

Therefore, I cannot extract the information required by your prompts (acceptance criteria table, sample sizes for AI test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) because these concepts are not applicable to the type of device described in this 510(k) clearance letter. The letter pertains to a traditional, physical Class II medical device, not a software-based or AI/ML-driven diagnostic or therapeutic tool.

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The IdentiTi™ II Cervical Interbody System is an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature 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 IdentiTi II Cervical Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft, allograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

The IdentiTi II Cervical Interbody System is a cervical intervertebral body fusion system designed to be inserted through an anterior surgical approach. The interbody implants are additively manufactured from titanium powder per ASTM F3001 using a powder bed fusion method. The IdentiTi II Cervical Interbody System includes the following subsystems: IdentiTi II Cervical and IdentiTi II Cervical Max Contact. The endplates of the interbody implants contain roughened surface features to mitigate the risk of expulsion. Additionally, the IdentiTi II Cervical implants are offered with a microporous/macroporous lattice structure that spans the entirety of the implant and extends to the superior and inferior surfaces of the device for biological fixation. The implants consist of various lengths, widths, heights and lordotic options to accommodate individual patient anatomy. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. The internal lattice structure provides additional space for graft packing.

The provided FDA 510(k) clearance letter and summary concern the IdentiTi II Cervical Interbody System, which is a medical device for spinal fusion. This document does not describe an AI/ML-based medical device. Therefore, it does not contain information about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement as typically required for AI/ML device clearances.

The performance data section (VII. PERFORMANCE DATA) specifically lists non-clinical testing for mechanical properties, material properties, and biocompatibility, as is standard for intervertebral body fusion devices. These tests include:

• ASTM F2077 static and dynamic axial compression, compression shear and torsion
• ASTM F2267 static subsidence
• ASTM F1714 gravimetric analysis
• ASTM F1877 particle analysis
• Static push-out
• ASTM F1854 stereological analysis
• Bacterial endotoxin testing per ANSI/AAMI ST72

Since the request is to "describe the acceptance criteria and the study that proves the device meets the acceptance criteria" as if it were an AI/ML device, and the provided text explicitly indicates it is a non-AI/ML medical device, I cannot fulfill the request directly with the given input. The information points to a traditional medical device clearance, not an AI/ML one.

To answer your question based on the provided document, I must state that the information requested (acceptance criteria for AI/ML performance, study details for AI/ML, human expert consensus, etc.) is not present because the device described is a physical intervertebral body fusion system, not an AI/ML algorithm.

The document confirms that this device is a Class II medical device (Product Code ODP: Intervertebral Body Fusion Device), and its clearance is based on substantial equivalence to predicate devices through engineering and material testing, not through AI/ML performance evaluation.

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The Calibrate CCX Interbody System is indicated for spinal fusion procedures from L1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the Calibrate CCX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Calibrate CCX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate and supplemental fixation systems that are cleared by FDA for use in the lumbar spine.

The Calibrate CCX Interbody System with advanced NanoTec surface treatment is indicated for spinal fusion procedures from L1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the Calibrate Nanotec CCX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Calibrate NanoTec CCX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate and supplemental fixation systems that are cleared by FDA for use in the lumbar spine.

The Calibrate PSX Interbody System is indicated for spinal fusion procedures from L1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the Calibrate PSX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Calibrate PSX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate and supplemental fixation systems that are cleared by FDA for use in the lumbar spine.

The Calibrate PSX Interbody System with advanced NanoTec surface treatment is indicated for spinal fusion procedures from L1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the Calibrate Nanotec PSX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Calibrate NanoTec PSX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograff bone with bone marrow aspirate and supplemental fixation systems that are cleared by FDA for use in the lumbar spine.

The subject Calibrate Interbody Systems (inclusive of Calibrate CCX Interbody System, Calibrate NanoTec CCX Interbody System, Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System) are expandable lumbar intervertebral body fusion systems designed to be inserted through a posterior or transforaminal surgical approach. The interbody spacers are manufactured from titanium alloy (Ti-6A1-4V ELI) per ASTM F136 and Polyetheretherketone (PEEK) Optima LT1 per ASTM F2026. The Calibrate Interbody Systems consist of a variety of shapes and sizes of interbody spacers, inserters, trials, and general instruments to create parallel expansion, restore sagittal alignment, and provide indirect decompression. Implants are offered with anti-migration teeth and grit-blast treatment on the bone-contacting endplate surfaces. The subject Calibrate NanoTec Interbody Systems interbody implant endplate surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents nano-scale topography on the endplate surface, in addition to macro-/micro-scale topography existing from prior to treatment.

This document is an FDA 510(k) clearance letter for the Calibrate Interbody Systems. The purpose of this type of submission is to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. This process typically relies heavily on bench testing (non-clinical performance data) and comparison of technical specifications, rather than clinical studies involving human subjects or AI performance metrics.

Therefore, the requested information about acceptance criteria, study methodologies, expert ground truth establishment, MRMC studies, standalone AI performance, and training/test set details for proving device performance are not present in this document. This letter confirms the device's substantial equivalence based on non-clinical testing, primarily mechanical performance, and comparisons to predicate devices.

Here's a breakdown of why each point cannot be addressed from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The document mentions standard ASTM tests (ASTM F2077, ASTM F2267) and static push-out. It states "The results demonstrate that the subject Calibrate Interbody Systems are substantially equivalent to other predicate devices for nonclinical testing," but does not list specific numerical acceptance criteria or performance values.

2. Sample sizes used for the test set and the data provenance: Not applicable in the context of device approval based on substantial equivalence and non-clinical testing. The "test set" here refers to physical devices or materials undergoing mechanical stress tests, not patient data for an AI/algorithm.

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 the context of AI or diagnostic devices, is established by human experts (e.g., radiologists, pathologists). This document refers to the mechanical performance of an interbody fusion device, where "ground truth" would be established by engineering standards and measurements, not medical expert consensus.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in clinical studies or expert reviews of data/images to resolve discrepancies or establish a definitive "ground truth." This is not relevant for non-clinical, mechanical 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: Not conducted. MRMC studies are specific to evaluating the clinical performance of diagnostic or AI-assisted devices where human readers are involved. This device is an implantable interbody fusion system, not a diagnostic imaging or AI-based device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the conventional sense. For mechanical testing, the "ground truth" is adherence to established engineering standards (e.g., ASTM) and physical measurements.

8. The sample size for the training set: Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set."

9. How the ground truth for the training set was established: Not applicable.

In summary, this FDA 510(k) clearance is based on the substantial equivalence of the Calibrate Interbody Systems to legally marketed predicate devices, supported by non-clinical performance data primarily demonstrating mechanical integrity and adherence to standardized testing protocols (e.g., ASTM F2077, ASTM F2267). The document explicitly states this in the "PERFORMANCE DATA" and "CONCLUSION" sections. The questions posed are highly relevant for AI/ML-based medical devices or diagnostic tools, but not for traditional implantable devices like the one described here.

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The IdentiTi Porous Ti Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Additionally, the IdentiTi Porous Ti System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The IdentiTi Porous Ti Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograff bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used with or without integrated fixation, the system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

AMP™ Anti-Migration Plate may be used with IdentiTi LIF interbody spacers to provide integrated fixation. IdentiTi LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation. IdentiTi ALIF interbody spacers with >20° lordosis must be used with an anterior plate as the form of supplemental fixation.

IdentiTi NanoTec Interbodv System

The IdentiTi Interbody System with advanced NanoTec surface treatment is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Additionally, the IdentiTi NanoTec Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The IdentiTi NanoTec Interbody System is intended for use on patients who have had at allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used with or without integrated fixation, the system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

AMP™ Anti-Migration Plate may be used with IdentiTi NanoTec LIF interbody spacers to provide integrated fixation. IdentiTi NanoTec LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation.

IdentiTi Cervical Porous Ti Interbody System

The IdentiTi Cervical Porous Ti Interbody System is an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature 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 ldentiTi Cervical Porous Ti Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft, allograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

ldentiTi NanoTec Cervical Interbody System

The IdentiTi Cervical Interbody System with advanced NanoTec surface treatment is an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi NanoTec Cervical Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft, allograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

IdentiTi Cervical Standalone Interbody System

The IdentiTi Cervical Standalone Interbody System is a stand-alone anterior cervical interbody fusion system intended for use in skeletally mature patients for the treatment of cervical 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 IdentiTi Cervical Standalone Interbody System is intended to be used with autograft, allograft comprised of cortical, cancellous, and/or cortico-cancellous bone graft, demineralized allograft with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

ldentiTi NanoTec Cervical Standalone Interbody System

The IdentiTi Cervical Standalone Interbody System with advanced NanoTec surface treatment is a stand-alone anterior cervical interbody fusion system intended for use in skeletally mature patients for the treatment of cervical degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi NanoTec Cervical Standalone Interbody System is intended to be used with autograft, allograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

ldentiTi ALIF Standalone Interbody System

The IdentiTi ALIF Standalone Interbody System is indicated for spinal fusion procedures from L2 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have up to Grade 1 spondylolisthesis at the involved levels.

Additionally, the IdentiTi ALIF Standalone Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis (>Grade 1) and spinal stenosis at one or two adjacent levels, the IdentiTi ALIF Standalone Interbody System must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine. The IdentiTi ALIF Standalone Interbody System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/ or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

The IdentiTi ALIF Standalone Interbody System implants of ≤20° are a standalone system. The ldentiTi ALIF Standalone Interbody System implants of >20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine.

The IdentiTi ALIF Standalone Interbody System implants of ≤20° are a standalone system. The ldentiTi ALIF Standalone Interbody System implants of >20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine.

ldentiTi NanoTec ALIF Standalone Interbody System

The IdentiTi ALIF Standalone Interbody System with advanced NanoTec surface treatment is indicated for spinal fusion procedures from L2 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and

radiographic studies. These patients may have up to Grade 1 spondylolisthesis at the involved levels.

Additionally, the IdentiTi NanoTec ALIF Standalone Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis (>Grade 1) and spinal stenosis at one or two adjacent levels, the IdentiTi Nanotec ALIF Standalone Interbody System must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The IdentiTi NanoTec ALIF Standalone Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

The IdentiTi NanoTec ALIF Standalone Interbody System implants of ≤20° are a standalone system. The IdentiTi NanoTec ALIF Standalone Interbody System implants of >20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

Transcend PEEK Interbody System

The Transcend PEEK Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Additionally, the Transcend PEEK Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The Transcend PEEK Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograff bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used with or without integrated fixation , the system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

AMP™ Anti-Migration Plate may be used with Transcend LIF interbody spacers to provide integrated fixation. Transcend LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation. Transcend ALIF interbody spacers with >20° lordosis must be used with an anterior plate as the form of supplemental fixation.

Transcend NanoTec Interbody System

The Transcend PEEK Interbody System with advanced NanoTec surface treatment is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Additionally, the Transcend NanoTec Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The Transcend NanoTec Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used with or without integrated fixation , the system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

AMP™ Anti-Migration Plate may be used with Transcend NanoTec LIF interbody spacers to provide integrated fixation. Transcend NanoTec LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation.

Transcend Cervical PEEK Interbody System

The Transcend PEEK Cervical Interbody System is an anterior cervical interbody fusion system intended for use in skeletally mature 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 Transcend PEEK Cervical Interbody System is intended for use with supplemental fixation system is designed for use with autograft, allograft comprised of cortical, cancellous and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

Transcend NanoTec Cervical Interbody System

The Transcend Cervical PEEK Interbody System with advanced NanoTec surface treatment is an anterior cervical interbody fusion system intended for use in skeletally mature 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 Transcend NanoTec Cervical Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft, allograft comprised of cortical, cancellous and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

The IdentiTi and Transcend Interbody Systems are cervical intervertebral body fusion systems designed to be inserted through an anterior surgical approach, and thoracolumbar intervertebral body fusion systems designed to be inserted through anterior and posterior surgical approaches. The interbody spacers are manufactured from PEEK (polyetheretherketone) Optima LT1 per ASTM F2026, tantalum per ASTM F560, titanium alloy (Ti-6Al-4V ELI), and commercially pure titanium (CPTi Grade 2) per ASTM F67. The interbody spacers are available in the following material options: (1) PEEK (polyetheretherketone) with tantalum and titanium alloy markers, or (2) commercially pure porous titanium (PTi), or (3) a combination of commercially pure porous titanium (CPTi Grade 2) per ASTM F67 and titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The subject IdentiTi and Transcend Interbody Systems implants consist of various lengths, widths, heights and lordotic options to accommodate individual patient anatomy. To mitigate risk of expulsion, the interbody endplates feature teeth. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. Additionally, the IdentiTi implants are offered with a microstructure due to the layering of material that forms the porous architecture. This porous geometry extends to the superior and inferior surfaces of the device for implant fixation.

The IdentiTi and Transcend NanoTec Interbody Systems implant surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface, in addition to macro-/micro-scale topography existing from prior to treatment.

The purpose of this Traditional 510(k) is to receive clearance for expanded indications for use of the IdentiTi and Transcend Interbody Systems with bone void filler cleared by FDA for use in intervertebral body fusion to facilitate fusion, and to add a nanotechnology claim in alignment with FDA's Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.

The provided text describes the 510(k) premarket notification for the IdentiTi and Transcend Interbody Systems, which are intervertebral body fusion devices. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving device safety and effectiveness through clinical studies with acceptance criteria in the typical sense of a novel device.

Therefore, many of the requested sections regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, and details on training/test sets are not applicable in this context, as the submission relies on non-clinical performance data and comparison to already cleared predicate devices.

However, I can extract information related to the device's performance in non-clinical testing and the rationale for the nanotechnology claim.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for substantial equivalence based on non-clinical testing and nanotechnology claims, explicit "acceptance criteria" in the sense of clinical performance endpoints are not provided. Instead, the document mentions "in vitro evaluations" for the nanotechnology claim and adherence to ASTM standards for mechanical testing. The reported performance is that these tests were "performed and included" or "referenced in predicate 510(k) submissions to support clearance." For the nanotechnology claim, the "reported device performance" is the demonstrated statistically significantly increased proliferation, alkaline phosphatase activity, and mineralization.

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

• Nanotechnology Test Set: The document mentions testing on "human mesenchymal stem cells (hMSCs) and human osteoblasts (hOBs)." No specific sample size (number of cell cultures, replicates, etc.) is provided in the document.
• Mechanical Testing Test Set: Not specified in terms of number of devices tested; references to ASTM standards imply that standard testing protocols were followed.
• Data Provenance: The in vitro evaluations for the NanoTec surface treatment are implied to be prospective studies conducted by the submitter. For other tests, they were "performed and included" or "referenced in predicate 510(k) submissions," suggesting a mix of new testing and reliance on previously cleared data. Country of origin is not specified, but the submitter is Alphatec Spine, Inc. in Carlsbad, CA, USA.

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

Not applicable. The non-clinical studies do not involve expert-established ground truth in the context of clinical image interpretation or diagnosis. The ground truth for cellular assays is laboratory-measured biological markers, and for mechanical tests, it's defined by the physical responses measured according to engineering standards.

4. Adjudication method for the test set

Not applicable. There is no human interpretation or adjudication involved in the reported non-clinical 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

Not applicable. This submission is for an intervertebral body fusion system, not an AI/imaging device, therefore MRMC studies are not relevant.

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

Not applicable. This submission is for a medical implant, not an algorithm.

7. The type of ground truth used

• Nanotechnology Claim: Laboratory measurements of cellular proliferation, alkaline phosphatase activity, and mineralization in cell cultures are used as "ground truth" to assess osteogenic differentiation.
• Mechanical Testing: Physical measurements obtained according to established ASTM standards (e.g., force, displacement, gravimetric changes) serve as the ground truth.

8. The sample size for the training set

Not applicable. There is no machine learning PAI involved, so no training set is used.

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

Not applicable. As there is no training set, this question is not relevant.

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The IdentiTi™ II Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Additionally, the IdentiTi II System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The IdentiTi II Interbody System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used with or without integrated fixation, the system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

AMP™ II Anti-Migration Plate may be used with IdentiTi II LIF interbody spacers to provide integrated fixation. IdentiTi II LIF spacers with >20° lordosis must be used with AMP II Anti-Migration Plate in addition to supplemental fixation.

The IdentiTi II Interbody System is a thoracolumbar intervertebral body fusion system designed to be inserted through anterior and posterior surgical approaches. The interbody implants are additively manufactured from titanium powder per ASTM F3001 using a powder bed fusion method. The endplates of the interbody implants contain roughened surface features to mitigate the risk of expulsion. Additionally, the IdentiTi II implants are offered with a microporous lattice structure that spans the entirety of the implant and extends to the superior and inferior surfaces of the device for biological fixation. The implants consist of various lengths, widths, heights and lordotic options to accommodate individual patient anatomy. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. The internal lattice structure provides additional space for graft packing. The IdentiTi II LIF implants may be used with the AMP II anti-migration plate and bone screws. The AMP II plate and bone screws are manufactured from titanium alloy per ASTM F136.

Based on the provided text, the document is a 510(k) clearance letter for a medical device (IdentiTi™ II Interbody System), not a study report proving the device meets specific acceptance criteria based on AI/software performance. Therefore, the information required for a study proving acceptance criteria for a device involving AI or complex algorithm performance is not present in this document.

The document discusses the substantial equivalence of the IdentiTi™ II Interbody System to existing predicate devices based on:

• Intended Use & Indications for Use: Spinal fusion procedures.
• Design, Function, and Technology: Specifically mentions additive manufacturing from titanium powder, roughened surface features, microporous lattice structure, and an anti-migration plate.
• Non-clinical Performance Data: Lists various ASTM standards for static and dynamic mechanical testing, gravimetric analysis, particle analysis, static push-out, stereological analysis, static screw push-out, and bacterial endotoxin testing. These are standard tests for intervertebral body fusion devices, not for AI or software performance.

Since this document is entirely focused on a traditional hardware medical device and its mechanical/biocompatibility testing, it lacks all the requested information pertaining to AI/software acceptance criteria and a study proving those criteria.

Therefore, I cannot fill out the requested table or answer the specific questions about AI/software performance, ground truth, expert adjudication, or MRMC studies.

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Calibrate LTX Interbody System

The Calibrate LTX Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of a symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Additionally, the Calibrate LTX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The Calibrate LTX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

Calibrate LTX spacers expanded greater than 20° have integrated fixation tabs and must be used with LTX bone screws in addition to supplemental fixation. Calibrate LTX spacers without integrated fixation tabs may be used with AMP-LTX System as integrated fixation in addition to supplemental fixation.

Calibrate NanoTec LTX Interbody System

The Calibrate LTX Interbody System with advanced NanoTec surface treatment is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of a symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/ or thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Additionally, the Calibrate NanoTec LTX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The Calibrate NanoTec LTX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

Calibrate NanoTec LTX spacers expanded greater than 20° have integrated fixation tabs and must be used with AMP-LTX bone screws in addition to supplemental fixation. Calibrate NanoTec LTX spacers without integrated fixation tabs may be used with AMP-LTX System as integrated fixation in addition to supplemental fixation.

The subject Calibrate LTX Interbody Systems are lordotic expandable thoracolumbar intervertebral body fusion systems designed to be inserted through a lateral or anterolateral surgical approach. The subject interbody spacers are manufactured from titanium alloy (Ti-6Al-4V ELD per ASTM F136. The subject Calibrate NanoTec LTX Interbody System interbody implant endplate surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The Calibrate LTX Interbody Systems consist of a variety of shapes and sizes of interbody spacers, inserters, trials, and general instruments to create lordotic expansion, restore sagittal alignment, and provide indirect decompression. Implants are offered with anti-migration teeth and grit-blast treatment on the bone-contacting endplate surfaces. Certain Calibrate LTX Interbody Systems' offerings also accept fixation bone screws manufactured from titanium alloy per ASTM F136.

The purpose of this Traditional 510(k) is to receive clearance for the new sizes of the modified design of the interbody spacer, including a sterile offering of interbody spacer with hydroxyapatite surface treatment, sterile offering of AMP-LTX anti-migration plate and expanded indications for use for the Calibrate LTX Interbody System, previously cleared in K223611.

This looks like a 510(k) clearance letter and summary for a medical device, specifically the "Calibrate LTX Interbody System" and "Calibrate NanoTec LTX Interbody System". This type of document declares substantial equivalence to predicate devices, meaning it doesn't typically include acceptance criteria or detailed study results for a new device's performance against specific metrics in the way a PMA application or a clinical trial report would.

Here's an explanation based on the provided text:

• No acceptance criteria or study data for the device's performance against predefined metrics are present in this document.
• The document explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This strongly indicates that a clinical study designed to test the device's performance against specific acceptance criteria (like sensitivity, specificity, accuracy, etc.) was not performed or submitted for this 510(k) clearance.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and study details.

Instead, I can explain why this information is absent in this document and what was used for clearance:

This 510(k) submission relies on "Substantial Equivalence" to previously cleared predicate devices. This means the manufacturer demonstrated that the new device (Calibrate LTX Interbody System) is as safe and effective as a legally marketed predicate device (e.g., NuVasive Thoracolumbar Interbody Systems and NuVasive Attrax Putty - K203714, among others).

The "performance data" section in the document, under "VII. PERFORMANCE DATA", states:

• "An engineering analysis was utilized to determine that no new worst-case implants are being introduced compared to the predicate devices to support clearance of Calibrate LTX Interbody Systems."
• "The engineering analysis demonstrates that the subject Calibrate LTX Interbody Systems are substantially equivalent to other predicate devices for nonclinical testing."

This implies that the clearance was based on:

1. Bench testing and non-clinical performance data: This would typically involve mechanical testing (e.g., static and fatigue strength, expulsion resistance), material characterization, and potentially biocompatibility testing to ensure the device meets established standards and performs comparably to or better than the predicate devices. The document refers to "engineering analysis" and "nonclinical testing" as the basis for demonstrating substantial equivalence. It does not provide specific acceptance criteria or results from these tests in this summary, but they would have been submitted to the FDA.
2. Comparison of technological characteristics: The document explicitly states, "The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function, and technology and it was demonstrated that they are substantially equivalent."

In summary, based on the provided document:

• No acceptance criteria or specific device performance data (like sensitivity, specificity, accuracy for an AI system) are detailed because this is a 510(k) clearance based on substantial equivalence, not a new clinical efficacy study.
• No information on sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies for clinical performance is available here. This type of data would be required for devices where clinical performance is a primary metric for safety and effectiveness, often under a PMA pathway or for novel AI/software as a medical device (SaMD) requiring significant de novo clinical validation.

This document focuses on the mechanical and material equivalence of spinal implants to existing ones, rather than the performance of a diagnostic or AI algorithm.

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