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The Evolution Spine navigation instruments are indicated for use during the preparation and placement of Whistler Modular Pedicle Screw System polyaxial screws or Stowe Pedicle Screw System polyaxial screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The navigation instruments are intended to be used with the Medtronic® StealthStation® S8 Navigation System (Software Version 1.3.0)., 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 Evolution Spine Navigation Instruments are reusable surgical instruments for use with the Medtronic® StealthStation® S8 Navigation System. The system is designed to assist surgeons in the precise localization of anatomical structures, preparation and placement of pedicle screw implants during spinal procedures.

The Evolution Spine navigation Instruments include awls, probes, taps and drivers. The navigated instruments are to be used with Whistler Modular Pedicle Screw System (K182478) and Stowe Pedicle Screw System (K181554).

All instruments are made of stainless steel per ASTM F899. The Evolution Spine navigation Instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic® StealthStation® S8 Navigation System hardware and software.

The provided FDA 510(k) clearance letter for the Evolution Spine Navigation Instruments focuses on establishing substantial equivalence to predicate devices, primarily through non-clinical performance testing. It indicates that clinical testing was not performed. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted to assess human reader improvement with AI assistance, nor was a standalone algorithm performance study performed as part of this submission for establishing substantial equivalence.

The submission relies on a non-clinical test to demonstrate performance, specifically focusing on positional accuracy of the instruments when used with a specific navigation system.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The exact numerical values for positional accuracy criteria from ASTM F2554-18 and Rampimura et al. are not explicitly stated in the provided text. The document only confirms that the device "meets and exceeds" these established benchmarks.

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: The document does not specify a numerical "sample size" in terms of cases or patients. Instead, it refers to "the worst-case instruments constructs" being tested. This implies a limited number of physical instrument configurations were chosen for rigorous testing, representing the most challenging scenarios for accuracy.
   • Data Provenance: The study described is a non-clinical, laboratory-based performance test. This means the "data" is derived from controlled measurements in a lab setting, not from human subjects or clinical data. Therefore, concepts like "country of origin" or "retrospective/prospective" do not apply in the typical sense; it's an engineering test.

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

   • This is a non-clinical performance test of a physical device's accuracy. "Ground truth" in this context refers to the engineering specifications and established test methods (ASTM F2554-18 and Rampimura et al. reference values) for positional accuracy. No human experts (e.g., radiologists) were used to establish the ground truth for this performance test. The "truth" is an objective, measurable accuracy.

3. Adjudication Method for the Test Set:

   • Not applicable as this was a non-clinical instrument performance test, not a subjective assessment requiring human adjudication. The results are quantitative measurements against established engineering standards.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. The document explicitly states: "Clinical testing was not necessary to demonstrate the substantial equivalence of the subject devices." This implies that an MRMC study involving human readers and AI assistance was not performed or submitted for this specific clearance.

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

   • No. The device is a set of "navigation instruments" used with a navigation system (Medtronic® StealthStation® S8). It's a physical instrument, not an AI algorithm. Its performance is evaluated in conjunction with the navigation system, but the focus is on the instrument's mechanical and tracking accuracy.

6. The Type of Ground Truth Used:

   • Engineering Specifications / Established Test Standards: The ground truth for this non-clinical study was defined by the performance criteria established in:
     • ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems"
     • Rampimura et al: "Accurate pedicle screw insertion under the control of a computer-assisted guiding system: Laboratory test and clinical study"
   • These are recognized industry standards and published research that define acceptable accuracy limits for such devices.

7. The Sample Size for the Training Set:

   • Not applicable. This is a physical medical device (surgical instruments), not an AI/machine learning algorithm that requires a "training set" of data.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as there is no "training set" for this type of device.

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E3D™ C Interbody System includes interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical degenerative disc disease (DD), instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondy lotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osterior vertebral endplates producing symptomatic nerve root and/or spinal confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

E3D™ C Static Interbodies are intended to be used with supplemental fixation (e.g. cervical posterior fixation).

E3D™ C Integrated Interbodies are intended to be used with screws or anchors. When used with two screws, these devices are stand-alone interbody fusion devices. When anchors, or without screws, these devices are intended to be used with supplemental fixation (e.g. cervical plates or cervical posterior fixation).

The E3D™-C Interbody System provides interbody fusion devices designed to provide structural stability during spinal fusion. The E3D™-C Interbody System consists of Interbodies offered in various sizes to accommodate surgical needs and anatomic requirements. The E3D™-C Interbodies were designed to be placed via an anterior approach. All Interbodies in the system are additively manufactured from titanium alloy powder, per ASTM F3001. The System offers both Static and Integrated Interbodies. The Integrated version is to be used in conjunction with two (2) screws that are subtractively manufactured from titanium alloy, per ASTM F136 or two (2) anchors that are additively manufactured from titanium alloy powder, per ASTM F3001.

Integrated Interbodies were designed to accept two bone screws or anchors which are used to fixate into the adjacent vertebral bodies. When appropriate, the Integrated Interbodies may be used as a standalone system when used with screws. The Titanium Alloy (Ti-6Al-4V ELI) Interbodies are manufactured using an additive Direct Metal Laser Sintering (DMLS) 3D-printing process which enables the creation of the system's double lattice architecture. The double lattice architecture was designed to encourage bone growth on and through the cage. The Integrated Interbody has two screw holes as well as an integral cam locking mechanism to prevent screw back-out.

The E3D™-C Interbody System's implants are available with and without HA"® Surface®, a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface.

This document is a 510(k) clearance letter and summary for a medical device called the E3D™-C Interbody System. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria or proving device performance through a clinical study with human readers or AI.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from this document because it is not a study report relevant to AI/CADe applications.

The "Performance Data" section solely refers to mechanical testing (static compression, static torsion, dynamic compression, dynamic shear, dynamic torsion per ASTM F2077; wear debris analysis per ASTM F1877; expulsion and subsidence per ASTM F2267) to ensure the physical device meets safety and performance standards for an intervertebral body fusion device. This is distinct from the type of performance data typically associated with AI/CADe devices, which would involve diagnostic accuracy metrics on image datasets.

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E3D™-A Static Interbody Devices are thoraco-lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12- L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondvlolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. Devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation.

E3D™-A Integrated Interbody Devices are integrated lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with three screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g., facet screws or posterior fixation). Hyperlordotic implants (>20° lordosis) are intended for use with supplemental fixation (e.g., facet screws or posterior fixation). When used without screws or anchors, these devices are intended for use with supplemental fixation (e.g., facet screws or posterior fixation).

When used for multilevel degenerative scoliosis or sagittal deformity, supplemental fixation that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) must be used.

The E3D™ -A Interbody System provides interbody fusion devices designed to provide structural stability during spinal fusion. The E3D™-A Interbody System consists of Interbodies offered in various sizes to accommodate surgical needs and anatomic requirements. The E3D™-A Interbodies were designed to be placed via an anterior approach. All Interbodies in the system are additively manufactured from titanium alloy powder, per ASTM F3001. The System offers both Static and Integrated Interbodies. The Integrated version is to be used in conjunction with three (3) screws that are subtractively manufactured from titanium alloy, per ASTM F136; or three (3) Anchors that are additively manufactured from titanium alloy per ASTM F3001.

The E3D™-A Interbody System's implants are available with and without HAnano Surface®, a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface.

The purpose of this submission is to add larger footprints and Anchors.

This document is a 510(k) summary for the E3D™-A Interbody System, a medical device used for spinal fusion. The information provided heavily focuses on regulatory aspects and comparisons to predicate devices, rather than a detailed study proving the device meets specific acceptance criteria based on clinical performance. Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from this text, as specific quantitative performance metrics and acceptance thresholds for clinical efficacy are not detailed.

However, I can extract information related to performance testing that supports the device's substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, the document does not contain a typical table of clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) and reported device performance. It instead describes mechanical performance testing against predicate devices and standards.

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

The document mentions "worst-case implants" for mechanical testing, but does not specify the sample size (number of implants tested) for the test set. It does not mention clinical data or studies with human subjects, so there is no information on data provenance (country of origin, retrospective/prospective). This submission is for substantial equivalence based on technological characteristics and mechanical testing, not clinical performance.

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

Not applicable. The document does not describe a clinical study or expert review for establishing ground truth, as the submission focuses on mechanical and design equivalence.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of adjudication, as no clinical ground truth assessment or expert review is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical intervertebral body fusion device, not an AI or software-based diagnostic tool, so an MRMC study is not relevant.

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

Not applicable. This device is a physical implant, not an algorithm.

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

For the mechanical testing, the "ground truth" would be the established performance standards of ASTM F2077 and the performance of the predicate devices. For the HAnano Surface®, the "ground truth" was established by Promimic's protocols accepted by FDA (reference K232432).

8. The Sample Size for the Training Set

Not applicable. This document describes a physical medical device and its regulatory submission, not a machine learning model, so there is no "training set."

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

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

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E3D™ -A Static Interbody Devices are thoraco-lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12- L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. Devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

E3D™ -A Integrated Interbody Devices are integrated lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with three screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g., facet screws or posterior fixation). Hyperlordotic implants (≥20° lordosis) are intended for use with supplemental fixation (e.g., facet screws or posterior fixation). When used without screws or anchors, these devices are intended for use with supplemental fixation (e.g., facet screws or posterior fixation).

When used for multilevel degenerative scoliosis or sagittal deformity, supplemental fixation that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) must be used.

The E3D™ -A Interbody System provides interbody fusion devices designed to provide structural stability during spinal fusion. The E3D™-A Interbody System consists of interbodies offered in various sizes to accommodate surgical needs and anatomic requirements. The E3D-A Interbodies were designed to be placed via an anterior approach. All interbodies in the system are additively manufactured from titanium alloy powder, per ASTM F3001. The System offers both Static and Integrated Interbodies. The Integrated version is to be used in conjunction with three (3) screws that are subtractively manufactured from titanium alloy, per ASTM F136.

The E3D-A Interbody System's implants are available with and without HA®®º Surface®, a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface.

The provided text describes a medical device, the E3D™-A Interbody System, and its clearance by the FDA based on substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria through clinical performance or AI/software analysis.

Therefore, the information required to answer the prompt (acceptance criteria for device performance, sample sizes, expert involvement, ground truth, etc.) is not present in the provided text. The document focuses on regulatory clearance for an interbody fusion device, primarily detailing its physical characteristics, indications for use, and comparison to existing similar devices.

Specifically:

• No acceptance criteria or device performance report is provided in the context of a study for clinical efficacy or AI performance. The "Performance Data" section solely refers to physical and material testing (ASTM F2077 for dynamic compression shear testing and Promimic's protocols for the HA surface treatment), not clinical outcomes or AI model performance.
• No mention of a test set, training set, or data provenance for any AI/software component. The device is an interbody fusion system, a physical implant.
• No information on experts, ground truth, or adjudication methods as these are not relevant to the type of regulatory submission described (510(k) for a physical implant based on substantial equivalence).
• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned, as this device does not involve human readers interpreting images with or without AI assistance.
• No standalone algorithm performance is mentioned, as there is no algorithm described.

In summary, the provided document is a 510(k) clearance letter and summary for a physical medical device (an interbody fusion system), not a document detailing the performance evaluation of an AI or software device.

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Evolution Spine Static Interbody Devices are thoraco-lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12- L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. Devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

Evolution Spine Integrated Interbody Devices are integrated lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Devices are to be filled with autograff bone and/or allogenic bone graft composed of cancellous bone. These devices are intended to be used with three screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). When used without screws or anchors, these devices are with supplemental fixation (e.g. facet screws or posterior fixation).

When used for multilevel degenerative scolical deformity, supplemental fixation that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems) must be used.

The EVOLUTION SPINE Interbody System provides interbody fusion devices designed to provide structural stability during spinal fusion. The EVOLUTION SPINE Interbody System consists of interbodies offered in various sizes to accommodate surgical needs and anatomic requirements. The EVOLUTION SPINE Interbodies were designed to be placed via an anterior approach. All interbodies in the system are additively manufactured from titanium alloy powder, per ASTM F3001. The System offers both Static and Integrated Interbodies. The Integrated version is to be used in conjunction with three (3) screws that are subtractively manufactured from titanium alloy, per ASTM F136.

The provided document, an FDA 510(k) clearance letter for the "EVOLUTION SPINE Interbody System," does not contain the information requested about acceptance criteria and a study proving the device meets those criteria.

This document serves to demonstrate that the device is "substantially equivalent" to legally marketed predicate devices, primarily through engineering and performance testing of the device itself (e.g., static compression, dynamic shear, wear debris analysis). It does not describe a study involving human readers, AI assistance, or the establishment of ground truth in a clinical or image-based diagnostic context.

Therefore, I cannot fulfill the request for information regarding:

1. A table of acceptance criteria and reported device performance (in a clinical/AI context).
2. Sample sizes used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study or its effect size.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document's "Performance Data" section (Page 6) refers to mechanical testing (e.g., ASTM F2077, ASTM F1877, ASTM F2267) to establish the device's physical properties and demonstrate substantial equivalence, not the performance of an AI or diagnostic system.

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The EMERGE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors (primary and metastatic), deformity (kyphosis, lordosis), failed previous fusions (pseudarthrosis), spondylolisthesis, and spinal stenosis. The EMERGE™ Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The EMERGE™ Anterior Cervical Plate System consists of cervical plates offered in various sizes to accommodate surgical needs and anatomic requirements. The plate attaches to the anterior portion of the vertebral body of the cervical spine. The plates can be used with fixed angle screws. The system is comprised of a Titanium Alloy (Ti-6Al-4V ELI) plates and bone screws. The subject 510(k) adds additional 3-screw plates to the system.

This document describes the FDA's 510(k) clearance for the EMERGE™ Anterior Cervical Plate System. It details the device's indications for use, its substantial equivalence to predicate devices, and the performance testing conducted.

However, the provided text does not contain information related to an AI/ML-driven medical device. It describes a traditional implanted medical device (a spinal plate system). Therefore, it is not possible to answer the specific questions about acceptance criteria, study design, ground truth, expert adjudication, or MRMC studies for an AI/ML device, as these concepts are not applicable to the information given in the document.

The document focuses on:

• Device Type: Anterior Cervical Plate System (a mechanical implant).
• Purpose: Spinal fixation.
• Regulatory Pathway: 510(k) clearance, establishing substantial equivalence to existing predicate devices.
• Performance Data: Mechanical testing (static compression, static torsion, dynamic compression) according to ASTM F1717, demonstrating compliance with performance criteria for Spinal Plating Systems.

In summary, this document does not provide the information needed to answer your questions about the acceptance criteria and study proving an AI/ML device meets those criteria.

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The EMERGE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors (primary and metastatic), deformity (kyphosis, lordosis), failed previous fusions (pseudarthrosis), spondylolisthesis, and spinal stenosis. The EMERGE™ Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The EMERGE™ Anterior Cervical Plate System consists of cervical plates offered in various sizes to accommodate a variety of spinal levels based on surgical need and anatomic requirements. The plate attaches to the anterior portion of the vertebral body of the cervical spine. The plates can be used with fixed angle or variable angle screws. The system is comprised of a Titanium Alloy (Ti-6Al-4V ELI) plates and bone screws.

The provided text describes a 510(k) premarket notification for the EMERGE™ Anterior Cervical Plate System, a spinal intervertebral body fixation orthosis. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device based on indications, design, materials, function, manufacturing, and performance.

However, the document does not contain any information about an AI/ML-based device, nor does it mention any studies involving acceptance criteria and performance metrics for such a device. The device described is a physical medical implant (a cervical plate system) designed for surgical use. Therefore, it's not possible to answer your specific questions relating to AI/ML device performance, ground truth, expert adjudication, or MRMC studies from the provided text.

The closest relevant information is contained in the "Performance Data" section on page 5, which states:

"Testing on the EMERGE™ Anterior Cervical Plate System included static compression, static torsion, and dynamic compression per ASTM F1717. The results demonstrate that the EMERGE™ Anterior Cervical Plate is substantially equivalent to the performance criteria identified in Spinal Plating Systems -Performance Criteria for Safety and Performance Based Pathway Guidance document; FDA-2019-D-1647."

This indicates that the performance of the physical device was evaluated against established engineering standards (ASTM F1717) and FDA guidance for spinal plating systems. However, these are mechanical and material performance tests, not AI/ML model performance evaluations.

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The Whistler Modular Pedicle Screw System is intended 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 thoracic, lumbar, and sacral spine: 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.

The Whistler Modular Pedicle Screw System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods, and locking cap set screws. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All implant components are made from titanium alloy (ASTM F136). The Whistler Modular Pedicle Screw System is provided in both non-sterile and sterile forms. All implants are intended for single use only.

The provided document is a 510(k) Premarket Notification from the FDA for the Whistler Modular Pedicle Screw System. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information regarding an AI/ML-driven device or studies proving its performance against acceptance criteria in the context of diagnostic accuracy, image analysis, or similar AI-related applications.

Instead, this document focuses on a physical medical device (pedicle screw system) and its mechanical performance testing to demonstrate substantial equivalence to existing devices. The performance data listed (Static Axial Compression Bending, Static Torsion, Dynamic Axial Compression Bending, Static A-P load) are standard mechanical tests for spinal implants, not AI performance metrics.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves a device meets acceptance criteria in an AI/ML context using the provided text. The document is entirely about a hardware implant.

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The Vail ALIF Buttress Plate System in conjunction with tradition is intended for use in spinal fusion procedures of the thoracolumbar to S1 spinal region as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.

The Vail ALIF Buttress Plate System is an anterior non-load bearing plate system manufactured from Titanium Alloy 6AL-4V ELI per ASTM F136. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The Vail ALIF Buttress Plate System is provided non-sterile, for single use only.

This is a 510(k) premarket notification for a medical device (Vail ALIF Buttress Plate System), not a study evaluating software or AI performance. Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment, which are typical for studies of AI/software devices, is not available in this document.

The document describes the device, its intended use, and compares it to predicate devices based on design and material. It also mentions "performance data" but these refer to mechanical tests of the physical implant, not clinical or algorithmic performance from a study.

Here's a breakdown of what is provided regarding "performance data" in this document:

• Acceptance Criteria and Reported Device Performance: This section is not applicable in the context of an AI/software device. The document states:
  • Acceptance Criteria for the Vail ALIF Buttress Plate System: "met all specified criteria" for "Static Cantilever Bending" and "Dynamic Cantilever Bending." The specific numerical criteria are not detailed in this summary but would have been part of the full 510(k) submission.
  • Reported Device Performance: The device withstood static and dynamic cantilever bending without failure, demonstrating "a safety and effectiveness profile that is equivalent to the predicate device."
• Study That Proves the Device Meets the Acceptance Criteria: The study mentioned is a series of mechanical performance tests, specifically:
  • Static Cantilever Bending
  • Dynamic Cantilever Bending
  • No details about the sample size (number of devices tested), data provenance, or explicit ground truth are provided, as these are material and mechanical tests, not clinical efficacy studies or AI performance evaluations.

The remaining requested information (2-9) is not applicable or present in this 510(k) summary because it pertains to the evaluation of AI/software performance, which this device is not.

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The Anterior Cervical Plate System is indicated for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the following indications; degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The Anterior Cervical Plate System consists of self-tapping screws and plates. Screws are available in a variety of diameter-length combination. Plates are available in a variety of lengths.

This document is a 510(k) premarket notification for a medical device called the Anterior Cervical Plate System. It is focused on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information regarding AI/algorithm performance, detailed study design, and expert review is not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. This was a bench testing study, not a clinical study with patient data. The "sample size" would refer to the number of physical constructs tested, but this specific number is not provided, only that the "worst case" construct was tested.
• Data Provenance: Not applicable. This refers to bench test results in a lab environment.

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

• Not applicable. This was a mechanical bench test against a standard, not a study requiring expert clinical ground truth.

4. Adjudication method for the test set

• Not applicable. No clinical test set to adjudicate.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI/algorithm-driven device. It is a physical implant.

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

• Not applicable. This is not an AI/algorithm-driven device.

7. The type of ground truth used

• Mechanical Performance Standards: The ground truth for performance was established by recognized mechanical testing standards (ASTM F1717) and comparison to the predicate device's established performance.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm-driven device. There is no "training set."

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

• Not applicable.

Summary of the Study:

The study proving the device meets the acceptance criteria was a bench testing study. The purpose of this study was to demonstrate substantial equivalence of the Anterior Cervical Plate System to a legally marketed predicate device (Synthes Anterior CSLP System, K030866).

• Acceptance Criteria for Substantial Equivalence: The primary acceptance criterion was that the mechanical performance of the subject device, when tested according to ASTM F1717 (covering static compression bending, torsion, and dynamic compression bending), would be comparable or equivalent to the predicate device.
• Device Performance: The study reported that "The mechanical test results demonstrated that the Subject device is substantially equivalent to the predicate devices."
• Test Conduct: The testing was performed on the "worst case Anterior Cervical Plate construct."
• Ground Truth: The "ground truth" for the mechanical performance comparison was the established performance characteristics of the predicate device and the requirements of the ASTM F1717 standard.
• Purpose: The overall conclusion was that the Anterior Cervical Plate System has the same intended use, identical indications for use, similar technological characteristics and materials as its predicate(s), and minor differences do not raise new safety or efficacy concerns after bench testing.

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