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EFFORTMED CERVICAL PEEK CAGES are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. CERVICAL PEEK CAGES facilitate intervertebral body fusion in the cervical spine and are placed via the anterior approach and packed with autograft/autologous bone graft. Patients should have received at least six (6) months of prior non-operative treatment. EFFORTMED CERVICAL PEEK CAGES are to be used with supplemental fixation.

The EFFORTMED LUMBAR PEEK CAGES are indicated for intervertebral body fusion at one or two contiguous levels in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) of lumbar spine with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received at least six (6) months of prior non-operative treatment. The devices are designed to be used with supplemental fixation and autograft/autologous bone graft to facilitate fusion for each spinal region.

The EFFORTMED ORIZABA CERVICAL CORPECTOMY CAGE is intended for use in skeletally mature patients in the cervical spine (C2-T1) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The EFFORTMED COTOPAXI LUMBAR CORPECTOMY CAGE is intended for use in skeletally mature patients in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The ORIZABA and COTOPAXI CORPECTOMY CAGES are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

ORIZABA and COTOPAXI CORPECTOMY CAGES are intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material is optional.

The EffortMed spinal interbody cage system includes cervical intervertebral body fusion (IBFD), transforaminal lumbar interbody fusion (TLIF), and posterior lateral interbody fusion (PLIF) devices. The cervical cage models are the EffortMed Pacaya Cervical PEEK Cage and Masaya Augmented Cervical PEEK cage. The lumbar cage models are the EffortMed TLIF PEEK Cage, Effortmed TLIF PEEK Cage 4° Angled, Effortmed PLIF PEEK Cage, EffortMed PLIF PEEK Cage 5° Angled, and EffortMed Expandable PLIF PEEK Cage. The system was designed to restore height and lordotic angle in the spine. The main role of the cages is to help maintain the cleared disc space stable and intact, until a healthy bony fusion occurs between the adjoining vertebrae. To help achieve this, the inner chamber of the cage body is filled with bone graft before implantation.

The system also includes cervical and corpectomy cages (identified as used in cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to, tumors, fractures, and infections. The corpectomy cage models are the EffortMed Orizaba Cervical Corpectomy cage and EffortMed Cotopaxi Lumbar Corpectomy cage.

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

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Universal Spinal System is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Universal Spinal System is intended to treat pediatric patients diagnosed with spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The HOBBIT Growth Connectors are indicated in patients under 10 years of age with potential for additional spinal growth who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis, as part of a growing rod construct.

Universal Spinal System includes the HOBBIT 4.75 Spine System, HOBBIT 5.5/6.0 Spine System, HOBBIT MIS Spine System, HOBBIT 5.5/6.0 HA coated spine system and Anterior Thoracic-lumbar Spine System. Universal Spinal System consists of a variety of structures and sizes of pedicle screws, nut, rods, connectors, hook, transconnectors.

Universal Spinal System is made from Ti-6Al-4V ELI following ASTM F136 or Ti-6Al-4V following ASTM F1472 or Co-Cr-Mo following ASTM F1537.

The implants are provided as sterile or non-sterile, while the instruments are provided as non-sterile.

The implants are intended for single-use only, while the instruments are reusable.

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The Atlas Spine HiRISE™ Expandable Cervical Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2-T1). The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion.

When used in the cervical spine (C2-T1), Atlas Spine HiRISE™ Expandable Cervical Corpectomy System spacers are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in the cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine.

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The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 - S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.

To achieve additional levels of fixation, CD Horizon™ Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of the Vertex™ indications of use.

The CD Horizon™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, Crosslink™ Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

A subset of CD Horizon™ Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, Crosslink™ plates, and connecting components. Similar to the CD Horizon™ implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

Certain components within the CD Horizon™ Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods and Spire™ plates. Screws used in pediatric cases are only cleared for use via a posterior approach. All components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, and medical grade cobalt-chromium-molybdenum alloy.

Certain implant components from other Medtronic spinal systems can be used with the CD Horizon™ Spinal System in non-pediatric cases. These components include TSRH™ rods, hooks, screws, plates; Crosslink™ plates, connectors, staples, and washers; GDLH™ rods, hooks, and connectors; Crosslink™ bar and connectors and Medtronic multi-axial rods and screws.

Note that certain components are specifically designed to connect to specific rod diameters, while other components can connect to multiple rod diameters. Care should be taken so the correct components are used in the spinal construct.

CD Horizon™ hooks are intended for posterior use only. CD Horizon™ staples and associated screws are intended for anterior use only. However, for patients of smaller stature and pediatric patients, CD Horizon™ 4.5mm rods and associated components may be used posteriorly.

CD Horizon™ Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobalt-chromium-molybdenum alloy, or medical grade PEEK Optima-LT1. Certain CD Horizon™ Spinal System components may be coated with hydroxyapatite. No warranties, expressed or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.

Never use stainless steel and titanium implant components in the same construct.

Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt chromium-molybdenum alloy with stainless steel in the same construct.

PEEK Optima-LT1 implants may be used with titanium or cobalt-chromium-molybdenum alloy implants. CD Horizon™ PEEK rods are not to be used in pediatric patients. PEEK rods are only to be used with the associated pedicle screws as well as interbody fusion devices in the anterior spinal column.

To achieve best results, do not use CD Horizon™ Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document.

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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 Resolve Anterior Cervical Plate System is intended for anterior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. Specific indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Resolve Anterior Cervical Plate (ACP) System is intended for anterior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. The system consists of non-sterile, single use plates and screws that are manufactured from titanium alloy (Ti-6Al-4V). The plates have an integrated active locking mechanism, are offered in various lengths, and accommodate constrained and variable screws. The system includes non-sterile, reusable instruments designed to facilitate proper implantation/explantation of the plates and screws.

The provided FDA document, K251436, describes the Resolve Anterior Cervical Plate System, a medical device. The document states that the substantial equivalence of the device was demonstrated through performance criteria identified in the FDA guidance document "Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway".

While the document confirms that non-clinical mechanical tests were performed and met acceptance criteria, it does not provide the specific numerical acceptance criteria or the reported device performance in a table format. Nor does it detail a clinical study with human readers or specific ground truth methodologies. The information focuses on non-clinical mechanical testing for spinal plating systems.

Therefore, the following information is extracted and inferred based only on the provided document:

Acceptance Criteria and Device Performance Study (as per provided document)

1. Table of Acceptance Criteria and Reported Device Performance

The FDA document states that the device "meets or exceeds the acceptance criteria stated in the 'Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway' guidance document." However, the specific numerical acceptance criteria from this guidance document and the precise numerical results of the Resolve Anterior Cervical Plate System are not provided in this submission.

2. Sample Size for the Test Set and Data Provenance

The document describes non-clinical mechanical testing, not a clinical study involving a test set of human subjects or patient data.

• Sample Size: Not applicable in the context of human data. For mechanical testing, the "worst-case configuration" was tested. The specific number of mechanical test samples is not detailed.
• Data Provenance: Not applicable as it refers to non-clinical, laboratory-based mechanical testing.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The "ground truth" here is adherence to mechanical performance standards, not expert clinical interpretation.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving reader agreement. This describes non-clinical mechanical testing.

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

• Was an MRMC study done? No. The document describes non-clinical mechanical tests for a spinal implant, not an AI/imaging device requiring human-in-the-loop evaluation.
• Effect size of human readers with AI vs without AI assistance: Not applicable.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical spinal implant, not an algorithm or AI software. Therefore, there is no standalone algorithm performance.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established by meeting predetermined mechanical performance specifications outlined in the FDA guidance document "Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway" and relevant ASTM standards (ASTM F1717 for mechanical tests; ASTM F2052, ASTM F2213, ASTM F2182 for MR safety).

8. Sample Size for the Training Set

Not applicable. This refers to non-clinical mechanical testing of a physical device, not an AI model requiring a training set.

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

Not applicable. No training set for an algorithm was involved.

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When used as an interbody fusion device, the TruLift® Lateral Expandable Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine. The TruLift® Lateral Expandable Spacer can also be connected to the Lateral Buttress Plate System by a set screw.

The Lateral Buttress Plate System is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The Lateral Buttress Plate System is not intended for use in load-bearing applications. The Lateral Buttress Plate System can also be connected to the TruLift® Lateral Spacer System by a set screw. It may be used with other anterior, anterolateral or posterior spinal systems.

The TruLift® Lateral Expandable Spacer System is available in a range of sizes and footprints and can expand to the desired height (8mm to 16mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

The Lateral Buttress Plate System consists of plates and bone screws. The Lateral Buttress Plate System is also intended to provide stabilization and to assist in the development of a solid spinal fusion to the anterior portion of the lumbar vertebral body. The Lateral Buttress Plate System is intended to be used in conjunction with traditional supplemental fixation which includes other anterior, or anterolateral spinal systems made of compatible materials.

All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System components with components from any other system or manufacturer. The TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System components should never be reused under any circumstances.

The provided FDA 510(k) clearance letter for the TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document is a regulatory clearance letter, which confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It focuses on the administrative and regulatory aspects of the clearance, such as:

• Device Name: TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System
• Regulation Number & Name: 21 CFR 888.3080, Intervertebral Body Fusion Device
• Regulatory Class: Class II
• Product Code: ODP, KWQ
• Predicate Devices: Life Spine ProLift Lateral Expandable Cage System (K221806), Life Spine Trulift Lateral Modular 1-Hole Buttress Plate (K221806), Life Spine ProLift HELO Expandable Spacer (K210061), Astura Sirion Lateral Lumbar Plate System (K202495), Life Spine ProLift Lateral Fixated (K200338).
• Indications for Use: Detailed description of the conditions and patient types for which the device is intended.
• Technological Characteristics: States that the device is substantially equivalent in design, materials, indications for use, and sizing.
• Materials: Titanium alloy (Ti-6Al-4V ELI) as per ASTM F136.
• Performance Data: A brief statement indicating that mechanical performance has not changed and the worst-case scenario remains the same, implying equivalence to predicates.

Specifically, the document states:

"Through the Comparison Analysis it is determined that the mechanical performance has not change as the worst case is still the same and therefore is substantially equivalent to the Life Spine ProLift Lateral Expandable Cage System (K221806) & Life Spine Trulift Lateral Modular 1-Hole Buttress Plate (K221806)."

This statement implies that the device's performance was assessed by comparing it to the predicate devices, likely through mechanical testing or analysis, to demonstrate that its performance is equivalent and that it meets the existing performance standards met by the predicates. However, the document does not elaborate on:

• Specific acceptance criteria: What quantitative or qualitative metrics were used to define "acceptable" mechanical performance.
• Detailed study methodology: How the "Comparison Analysis" was conducted.
• Actual reported device performance data: No specific values or results are provided.

Therefore, I cannot extract the requested information from the provided text. The information you're looking for (detailed acceptance criteria, specific study results, sample sizes, ground truth establishment, expert qualifications, etc.) would typically be found in the full 510(k) submission itself, which is a much more comprehensive document than the clearance letter.

To answer your request, I would need a different type of document, such as the actual performance testing report or a detailed summary of the premarket submission that includes these specific study details.

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The intended use of the Virata Spinal Fixation System in a posterior or anterolateral approach is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The indications for use are as follows:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
• spondylolisthesis,
• trauma (i.e., fracture or dislocation),
• spinal stenosis,
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• spinal tumor,
• pseudarthrosis, and/or
• failed previous fusion.

When used for posterior non-cervical screw fixation in pediatric patients, the Virata Spinal Fixation System is also indicated as adjunct to fusion to treat:

• Adolescent Idiopathic Scoliosis (AIS)
• Neuromuscular scoliosis
• Congenital scoliosis

The Virata Spinal Fixation System can be used with components of the Mariner and Malibu Systems such as rods and connectors. The Virata Spinal Fixation System is intended to be used with autograft or allograft.

Virata Spinal Fixation Navigated Instruments:
The Virata Spinal Fixation Navigated Instruments are intended to be used in the preparation and placement of Virata screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are 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 a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Virata Spinal Fixation System is a pedicle screw-based system that utilizes modular and preassembled screws. The modular screw shanks and the shanks of the preassembled screws are available in solid and cannulated configurations, in a variety of length and diameter size options. The rods are provided in a variety of lengths, diameters, and material options in both straight and pre-contoured configurations that can also be bent with instrumentation to more optimally accommodate the anatomy.

The Virata Spinal Fixation System consists of single-use implants intended to build constructs within the body to act as a temporary or permanent posterior, non-cervical pedicle fixation system, or an anterolateral fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

Screws are placed in the pedicles of the vertebral body using a posterior approach. The construct is connected using rods to span across screws implanted at various levels. The construct is secured using a set screw tightened to a predetermined torque value which is threaded into the top of the screw to secure the rod. All modular tulips and the tulips of preassembled screws of the system are designed to accept a rod through the opening in the top of the tulip, except the closed polyaxial modular tulip and the tulip of closed preassembled screws for which the rod is passed through an opening on the side of the tulip. The Virata Spinal Fixation System implants are manufactured from titanium alloy Ti-6Al-4V ELI (per ASTM F136), and cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537).

The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components. Non-sterile instruments also include instrumentation compatible with navigation arrays to allow for navigated implant placement.

The provided document, an FDA 510(k) clearance letter for the Virata Spinal Fixation System, is for a medical device (spinal implant) and not an AI/software-as-a-medical-device (SaMD). Therefore, the information typically required for describing acceptance criteria and a study proving a digital device meets those criteria (such as analysis of test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training data) is not applicable or present in this document.

Instead, the document focuses on the mechanical performance and substantial equivalence of the physical spinal fixation system to existing predicate devices.

Here's the relevant information that can be extracted from the provided text, adapted to the context of a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

For the Virata Spinal Fixation System, acceptance criteria are generally implied by demonstrating safe and effective mechanical performance as compared to predicate devices, typically by meeting or exceeding standards outlined in ASTM (American Society for Testing and Materials) standards. The document doesn't explicitly list numerical acceptance criteria values or specific reported device performance metrics beyond stating that testing was conducted and the device was found substantially equivalent.

However, the types of tests performed indicate the areas where mechanical performance was evaluated:

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

• Sample Size: The document does not specify the exact number of test samples (e.g., screws, rods, constructs) used for each mechanical test. Mechanical testing typically involves a sufficient number of samples to ensure statistical validity for the properties being evaluated, as per the ASTM standards.
• Data Provenance: Not applicable in the context of mechanical testing of a physical implant. The "test set" here refers to the physical devices manufactured for testing. The testing was conducted by SeaSpine Orthopedics Corporation as part of their 510(k) submission.

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

Not applicable. For mechanical testing of a physical device, "ground truth" is established by the physical properties and performance characteristics measured according to standardized test methods (e.g., ASTM standards), not by human expert opinion or interpretation in the way it is for digital health technologies.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for reconciling differing expert opinions in clinical or diagnostic assessments, not for objective mechanical performance tests.

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

No. An MRMC study is relevant for evaluating the impact of an assist device (like AI) on human diagnostic performance. The Virata Spinal Fixation System is a physical implant, not a diagnostic or AI-assisted device. While it includes "Navigated Instruments," these are physical tools designed for use with a separate "Medtronic StealthStation® System" (a stereotactic surgery system), and the testing presented here focuses on the mechanical performance of the fixation system itself, not a comparative effectiveness study involving human readers' diagnostic accuracy.

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

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used

For the mechanical performance testing, the "ground truth" is defined by the objective physical measurements and adherence to the specified performance parameters and failure modes outlined within the respective ASTM standards (F1717 and F1798). Compatibility and substantial equivalence to existing predicate devices (SeaSpine Mariner Pedicle Screw System, NuVasive GSB Global Spinal Balance System) also serve as a form of "ground truth" benchmark.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of mechanical testing for a physical implant.

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

Not applicable. There is no "training set" or "ground truth" establishment in this context.

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The Xenix Medical RIVA Posterior Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system or anterolateral fixation, in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine:

• Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
• Spondylolisthesis
• Trauma (i.e. fracture or dislocation).
• Spinal Stenosis
• Deformities or curvatures (i.e scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudoarthrosis
• Failed previous fusion

Xenix Medical fenestrated screws are intended to be used with saline or radiopaque dye.

Xenix Medical RIVA Posterior Fixation System Navigation Instruments are intended to be used with the Xenix Medical RIVA Posterior Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic® StealthStation™ S8 System, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Xenix Medical RIVA Posterior Fixation System is a non-cervical spinal fixation system used to build constructs within the body to act as temporary or permanent non-cervical spinal fixation devices and is intended for use as a posterior pedicle screw fixation system, and/or an anterolateral fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur.

The Xenix Medical RIVA Posterior Fixation System includes a variety of single-use implants manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562) and is comprised of polyaxial pedicle screws, as well as connecting spinal rods, connectors, crossbars, and a separate set screw locking element. The instruments included in the Xenix Medical RIVA Posterior Fixation System facilitate the placement, adjustment, final locking, and removal, if necessary, of the system implants, and accessories to the system include trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

This document, a 510(k) Clearance Letter for the RIVA Posterior Fixation System, is a submission for a physical medical device (pedicle screw system and navigation instruments), not a software or AI-driven medical device. Therefore, the specific information requested in your prompt regarding acceptance criteria and study proving performance for AI/software-based devices (such as statistical metrics, test/training sets, expert consensus, MRMC studies) cannot be directly derived from this document.

The document focuses on proving substantial equivalence to existing predicate devices, primarily through mechanical performance testing for the physical implants and accuracy testing for the navigation instruments. It does not describe a clinical study in the way an AI/software device would.

However, I can extract and interpret the available information to best fit your requested structure, making assumptions where necessary based on typical 510(k) submissions for physical devices:

Analysis of Acceptance Criteria and Performance for RIVA Posterior Fixation System

Given that the RIVA Posterior Fixation System is a physical medical device (spinal implant and surgical instruments), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" differ significantly from those for an AI/software device. For physical devices like this, acceptance is primarily based on meeting mechanical performance standards and demonstrating substantial equivalence to existing legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact number of devices or components tested for mechanical or accuracy performance. For mechanical testing, samples typically involve multiple units of each component type (e.g., screws, rods, connectors) to ensure statistical validity across batches. For navigation instrument accuracy, it would involve a certain number of instrument uses with the navigation system.
• Data Provenance: The data provenance is from laboratory testing (mechanical and accuracy testing) performed by the manufacturer, HT Medical d.b.a. Xenix Medical. This is not patient data; it's engineering test data.
  • Country of Origin: Not specified, but generally performed at the manufacturer's R&D facilities or contracted testing labs, typically in the country of manufacture or where submission is being sought (implied US, given FDA 510(k)).
  • Retrospective or Prospective: This is not applicable in the context of laboratory mechanical/accuracy testing.

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

This section is not applicable in the context of this device and submission type. "Ground truth" as defined for AI/software (e.g., expert consensus on medical images) is not relevant here. The "truth" is established by the physical and mechanical properties of the device and its ability to function as intended in a controlled laboratory environment according to established engineering standards (ASTM). The "experts" involved would be engineers, material scientists, and quality assurance personnel conducting the tests and interpreting the results against the ASTM standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used for resolving disagreements in labeling or classifying data, typically by human experts reviewing complex medical images or clinical cases. For mechanical testing, the "adjudication" is against the pre-defined ASTM standards and the performance of the predicate device. Test results are quantitative and either meet or do not meet the criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described in this 510(k) submission. MRMC studies are typically done for diagnostic imaging devices or AI tools that assist human readers in making clinical decisions. This device is a surgical implant and navigation system, not a diagnostic tool requiring MRMC.

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

Not Applicable. This concept applies to AI algorithms. The "RIVA Posterior Fixation System" is a physical implant and surgical navigation instrumentation. There is no standalone "algorithm" to evaluate in this context. The navigation instruments are designed for "human-in-the-loop" use with a surgeon and the Medtronic StealthStation system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance assessment is based on accepted engineering standards (ASTM F1717, ASTM F1798) and the established performance of the predicate devices. This means:

• Mechanical Integrity: The ability to withstand specified static and dynamic forces as defined by ASTM standards.
• Functional Accuracy: For the navigation instruments, the ability to register and provide accurate location information within the Medtronic StealthStation system, demonstrated through bench testing.
• Material Conformity: Conformance to specified biocompatible material standards.

It is not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic tool would be validated. Clinical outcomes data would typically be gathered in post-market surveillance or specific clinical trials for PMA devices, which this is not.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning. There is no algorithm being trained.

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

Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for one. The "truth" for the design and manufacturing of this physical device is based on engineering principles, material science, and established manufacturing processes.

Summary Caveat:

It is crucial to understand that the provided document is a 510(k) clearance letter for a traditional physical medical device (implant and instruments). The questions in your prompt are specifically tailored towards the validation of Artificial Intelligence (AI) or software as a medical device (SaMD). Therefore, many of the requested details (like ground truth establishment from experts, MRMC studies, training/test sets for algorithms) are not relevant to this type of device and are consequently not found in the 510(k) clearance letter. The FDA's assessment for this device focuses on substantial equivalence in terms of intended use, indications for use, design, materials, function, manufacturing, and most importantly, mechanical performance as demonstrated through rigorous engineering bench testing.

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The Frida™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine in skeletally mature patients, serving as an adjunct to fusion of the cervical spine (C2 - T1). The system is intended for the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: 1) degenerative disc disease (as defined as neck pain of discogenic origin and confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) spinal stenosis, 4) trauma, 5) failed previous fusions, 6) tumors, 7) curvature deformities (kyphosis, lordosis, or scoliosis), and/or 8) pseudoarthrosis.

The Frida™ Anterior Cervical Plate System is an anterior cervical plating system that consists of single-use plates and screws, along with manual instruments for implant insertion. The plates are manufactured from titanium (Ti-6Al-4V ELI) per ASTM F136 and come in a variety of lengths to accommodate individual pathology and anatomical conditions of the patient. Plates incorporate a graft window for intraoperative visualization. Screws are manufactured from titanium (Ti-6Al-4V ELI) per ASTM F136 and are available in self-tapping and self-drilling options. Screws are available in a fixed or variable configuration, with a range of sizes to accommodate individual pathology. Plates and screws are available in single-use sterile packaging.

The provided FDA 510(k) clearance letter for the Frida™ Anterior Cervical Plate System does not contain the detailed information typically found in an AI/Software as a Medical Device (SaMD) submission regarding acceptance criteria and study results.

This document is for a traditional medical device (a mechanical implant), not a software-based device. Therefore, the "acceptance criteria" and "study proving the device meets the acceptance criteria" are related to mechanical performance and biocompatibility, not algorithmic performance or clinical effectiveness in a human-computer interaction context.

Here's how to interpret the available information based on your request, and what information is missing due to the nature of this particular device:

Device Type: This is a physical, implantable medical device (Anterior Cervical Plate System), not an AI/SaMD. The "studies" described are primarily mechanical performance tests.

Acceptance Criteria & Device Performance (as much as can be inferred for a mechanical device):

Missing Information (Crucial for an AI/SaMD, but not applicable/provided for this physical device):

The following points are specifically geared towards AI/SaMD and are not found in the provided document because it pertains to a physical, mechanical medical device:

1. Sample size used for the test set and data provenance: Not applicable. The "test set" here refers to physical samples of the device undergoing mechanical testing, not a dataset of patient information.
2. Number of experts used to establish ground truth: Not applicable. Ground truth for a spinal plate is its mechanical performance and material properties.
3. Adjudication method: Not applicable.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is for evaluating AI-assisted human performance, not relevant for a physical implant.
5. Standalone (algorithm only) performance: Not applicable.
6. Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/SaMD sense. The ground truth here is the objective measurement of mechanical properties compared to established standards and predicate devices.
7. Sample size for the training set: Not applicable. This device does not have a "training set" in the machine learning sense. Its design and manufacturing are based on engineering principles and material science.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (based on the provided text):

• Study Type: Non-clinical mechanical performance testing.
• Tests Performed:
  • Static compression testing
  • Dynamic compression testing
  • Static torsion testing
• Standards Used: ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model)
• Comparison Basis: The device's performance was compared to "legally marketed predicate devices."
• Conclusion: The tests demonstrated that the "worst-case constructs were substantially equivalent to legally marketed devices." This implies that the Frida™ Anterior Cervical Plate System's mechanical characteristics, such as strength and durability, are comparable to or better than existing devices on the market, thereby demonstrating its safety and effectiveness for its intended use.

In essence, while the prompt asks for information typically found in AI/SaMD submissions, the provided document details the regulatory clearance for a traditional orthopedic implant, focusing on mechanical and material equivalence rather than data-driven algorithmic performance.

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