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The Karma® Fixation System is intended for bilateral facet stabilization for fusion as an adjunct to a 1-level interbody lumbar fusion from L1 to L5 with autogenous and/or allogenic bone graft. The Karma Fixation System must be accompanied by an FDA cleared intervertebral body fusion device implanted at the same spinal level. The Karma Fixation System is indicated for the treatment of patients with lumbar degenerative disc disease at a single level from L1 to L5 in skeletally mature patients who have failed conservative care.

The Karma® Fixation System is a system that provides adjunctive fixation. The system consists of a PEEK band. The Karma band consists of a strap manufactured from PEEK compounded with 7.5% barium sulphate for radiopacity. The leading tip of the device is comprised of a spherical feature followed by a tapered neck to allow for an instrument to assist in advancing the strap around the bony structures to be secured. The spherical tip of the device contains a tantalum insert for visualization when fluoroscopic imaging is used. The device has teeth along its length that interact with a latching mechanism at the opposite end of the strap. The latch allows a loop created by feeding the strap through the latch to be made consecutively shorter or taut by continuing to pull the strap through the latch. Prior to creating the loop, the spherical tip of the device is cut off and discarded to allow for the strap to pass through the latch. The latch resists the lengthening of the loop due to forces that would pull the strap in the opposite direction, thereby securing the bony structures. Once the desired loop length is reached, the unneeded portion of the strap may be cut off and discarded. An instrument, Tensioner, is provided and can be used fully tension the implant.

The provided FDA 510(k) clearance letter and summary for the Karma® Fixation System is for a medical device (spinal fixation system), not a software device or AI-powered system that would typically have acceptance criteria focused on algorithm performance metrics like sensitivity, specificity, or AUC. Therefore, the questions related to AI performance, such as sample size for test sets, expert adjudication, MRMC studies, standalone performance, and training set details, are not applicable to this submission.

The "acceptance criteria" for a medical device like the Karma® Fixation System are typically related to:

• Mechanical and Biomechanical Performance: Ensuring the device can withstand expected physiological loads and perform its intended structural function.
• Biocompatibility: Verifying that the materials used are safe for implantation in the human body.
• Sterilization: Confirming the device can be effectively sterilized.
• Labeling and Packaging: Ensuring proper information is provided.
• Substantial Equivalence: Demonstrating that the device is as safe and effective as a legally marketed predicate device.

The study that proves the device meets its acceptance criteria (i.e., its safety and effectiveness compared to a predicate) is discussed under "Performance Data" and "Clinical Data."

Here's an interpretation based on the information provided, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a spinal fixation system, the "acceptance criteria" are implied by the need to demonstrate substantial equivalence to a predicate device in terms of safety and effectiveness. The "reported device performance" refers to the studies conducted to support this equivalence. Specific numerical acceptance criteria (e.g., minimum load-bearing capacity, fatigue life) are often part of the detailed testing protocols submitted to the FDA but are not explicitly listed in this summary.

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

• Sample Size for Test Set:
  • Biomechanical studies: Not specified, but typically involves a small number of cadaveric spines.
  • Clinical Data: Not specified, but includes CT evaluations, adverse event data, and patient-reported outcomes at 12 and 24 months. The specific number of patients is not mentioned.
• Data Provenance: Not explicitly stated (e.g., country of origin). The nature of the clinical data (CT evaluations, adverse events, patient-reported outcomes at specific follow-up points) suggests a prospective or retrospective clinical study, but this is not definitively stated.

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

This question is not applicable to this type of device submission. The "ground truth" for a spinal fixation system is typically established through objective measurements in mechanical/biomechanical testing and clinical outcomes, rather than expert consensus on image interpretation. Clinical assessments would be performed by qualified medical professionals (e.g., surgeons, radiologists), but their specific number or qualifications for "ground truth establishment" are not relevant in the context of AI model evaluation.

4. Adjudication Method for the Test Set

This question is not applicable as it pertains to expert disagreement resolution in AI model evaluation, which is not relevant for musculoskeletal implants.

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

This question is not applicable. MRMC studies are specific to evaluating AI-assisted diagnostic or interpretative devices, not spinal fixation systems.

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

This question is not applicable. The Karma® Fixation System is a physical implant, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance assessment relies on a combination of:

• Biomechanical Data: Objective measurements from cadaveric testing (e.g., stability, stiffness).
• Computational Modeling: Results from Finite Element Analysis (FEA) predicting stress distribution and fatigue.
• Clinical Outcomes Data:
  • Imaging: CT evaluations at 12 and 24 months.
  • Adverse Event Data: Reported complications.
  • Patient-Reported Outcomes (PROs): Oswestry Disability Index (ODI) and visual analog scale (VAS) for back and leg pain.

8. The Sample Size for the Training Set

This question is not applicable. The Karma® Fixation System is a physical medical device, not an AI model that requires a "training set."

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

This question is not applicable. There is no "training set" for this type of device.

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The Primus Spinal Fixation System is intended to provide immobilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1-S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. This system is interior/ anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation 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, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Spinal Elements Primus Spinal Fixation System may be used in conjunction with the Spinal Elements Overwatch System. In order to achieve additional levels of fixation, the Primus or Overwatch Fixation Systems may be connected to the Lotus Posterior Cervical/Thoracic rod connectors. Transition rods with differing diameters may also be used to connect the Lotus Posterior Cervical/Thoracic Spinal System to the Primus or Overwatch Spinal Systems. Refer to the Lotus Posterior Cervical/Thoracic Spinal System package insert for a list of Lotus indications for use.

When used for posterior non-cervical pedicle screw fixation in pediative patients, the Primus and Overwatch implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach.

Spinal Elements' fenestrated screws are intended to be used with saline or radiopaque dye.

These devices are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Spinal Elements' Navigated Instruments are intended to be used during the preparation and placements' Primus 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 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.

Spinal Elements' Primus Spinal Fixation System is comprised of a variety of screws, hooks, rods, and connectors that are used for attachment to the non-cervical spine (the thoracic spine through the sacrum and in the ilium). A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and achieve fixation by the mechanical joining of the rods with screws.

Navigation instruments are non-sterile and are intended to be used with the Medtronic StealthStation® S7 and S8 System.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria. Instead, the document is a 510(k) premarket notification letter from the FDA regarding the "Primus Spinal Fixation System," stating its substantial equivalence to a legally marketed predicate device.

The document discusses:

• The FDA's review and determination of substantial equivalence.
• General controls and additional controls applicable to the device.
• Requirements for quality systems, reporting adverse events, and unique device identification.
• The indications for use of the Primus Spinal Fixation System.
• A 510(k) summary, including:
  • Submitter and device information.
  • Device description (screws, hooks, rods, connectors, navigation instruments).
  • Detailed indications for use.
  • Technological characteristics and comparison to a predicate device (Mercury® II Spinal System K222516).
  • Performance Data: This section only mentions mechanical testing (Static and Dynamic Compression Bending, Static Torsion, Tensile Dissociation, Neutral and Max Angle testing per ASTM standards) to demonstrate substantial equivalence to the predicate device. It explicitly states, "The subject device has the same performance characteristics as the previously cleared predicate device..." and "Testing conducted demonstrates substantial equivalence to the predicate device."

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them, as this information is not present in the provided text. The document focuses on regulatory clearance based on substantial equivalence, primarily supported by mechanical testing against established ASTM standards, not clinical performance studies with acceptance criteria as typically understood for AI/ML-driven medical devices (e.g., diagnostic accuracy, sensitivity, specificity, or human reader improvement).

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The Sapphire X3 Anterior Cervical Plate System is intended fixation (C2-T1) in skeletally mature patients as an adjunct to fusion for the following indications:

· Degenerative Disc Disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

• · Spondylolisthesis
• · Trauma (including fracture or dislocation)
• · Spinal stenosis
• · Deformities or Curvatures (kyphosis, lordosis or scoliosis)
• Tumor
• · Pseudoarthrosis
• · Failed previous fusion

The purpose of this submission is to seek clearance for additional implant sizes in the Sapphire X3 Anterior Cervical Plate System. The Spinal Elements' Sapphire X3 Anterior Cervical Plate System is comprised of plates and screws that are used for attachment to the anterior cervical spine. Both plates and screws are available in a variety of sizes to suit the individual pathology and anatomic conditions of the patient. Plates are pre-shaped with radial and lordotic curvature and have large windows for graft and end plate visualization. Plates range in length to accommodate one to five levels of fusion. Sapphire X3 plates accommodate larger angles for the distal screws in order to minimize plate overhang on the vertebral bodies.

All screws are equipped with an internal locking mechanism that is actuated by rotating a preassembled inset screw. Upon rotation, the insert screw interfaces with a clip in the head of the screw causing the clip to expand. The expansion of the clip prevents the screw from disassociating from the plate.

Screws are available in both fixed and variable angle designs. Fixed angle screws have a predetermined trajectory relative to the plate. The fixed angle screws have a neck diameter similar in size to the screw hole diameter of the plate.

Variable angle screws provide freedom in trajectory of the screws into the vertebral body. They allow 8° of angulation in any direction relative to the plate. The variable angle screws have a neck diameter that is smaller than the screw hole diameter of the plate. This difference in diameter allows the variable angle screws to be inserted at various angles relative to the plate.

The materials used for the system remain unchanged. The plates and screws are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3. The locking clips on the screws are manufactured from Nitinol conforming to ASTM F2063.

This document, K231593, describes the 510(k) premarket notification for the "Sapphire X3 Anterior Cervical Plate System". However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria for software or AI/ML-driven performance.

The document primarily focuses on:

• Regulatory Clearance: Announcing the FDA's decision to clear the device for market.
• Device Description: Details about the physical components, materials, and design of the Sapphire X3 Anterior Cervical Plate System (plates and screws for spinal fixation).
• Indications for Use: The medical conditions for which the device is intended (e.g., Degenerative Disc Disease, Trauma, Spinal Stenosis).
• Predicate Devices: Identifying previously cleared devices that are similar and establish substantial equivalence.
• Performance Data (Mechanical Testing): Mentioning that mechanical performance testing (static compression bending, static torsion, dynamic compression bending) was performed according to ASTM F1717, which is a standard for spinal implant constructs.

There is no mention of any AI/ML component, software performance, or a study involving human readers or ground truth for diagnostic purposes. The device is a physical spinal implant system, not a diagnostic AI tool.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment because this information is not present in the provided document. The questions posed are relevant for AI/ML medical devices, which this product is not.

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Ventana™ L intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). 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 or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

These devices are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

This device is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) months' non-operative treatment prior to being treated with this device.

The subject devices are intervertebral body fusion devices for use in lumbar spinal surgery. They may also be referred to as interbody fusion devices or interbody cages. The devices are generally box-shaped with various holes throughout their design to allow for the placement of autograft or allogenic bone graft. They include a lid which further facilitates installation of bone graft and which is shut prior to implantation. The exterior of the devices has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the devices from migrating once they are implanted.

The devices submitted herein are additively manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F3001.

The provided text describes the Ventana™ L Spinal System, an intervertebral body fusion device. However, it does not contain information about acceptance criteria for an AI/ML powered device, nor does it detail a study proving such a device meets acceptance criteria. The text focuses on the substantial equivalence of the Ventana™ L Spinal System to predicate devices based on design, indications for use, and mechanical performance testing (e.g., static and dynamic compression, shear, and subsidence tests).

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device based on the given input.

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Ventana™ C devices are intended for spinal fusion at one or two contiguous levels in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Implanted via an open, anterior approach for the C2-C3 disc space to the C7-T1 disc space and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with these devices.

The Spinal Elements' Ventana C Interbody System is an intervertebral body fusion device for use in cervical spine surgery. The device is generally box-shaped with various holes throughout its geometry to allow for the placement of autograft or allogenic bone graft. It includes a lid which further facilitates installation of bone graft, and which is shut prior to implantation. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is implanted.

The devices submitted herein are additively manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F3001.

The provided text describes a medical device submission (K222833) for the Ventana™ C Spinal System, an intervertebral body fusion device. This document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than reporting on the clinical performance of a novel AI/software device.

Therefore, the requested information regarding acceptance criteria and the study that proves the device meets the acceptance criteria (specifically pertaining to AI/software performance) cannot be extracted from this document, as it does not describe an AI or software as a medical device.

The "Performance Data" section lists various mechanical tests (Static/Dynamic Compression, Static/Dynamic Torsion, Subsidence per ASTM standards) to demonstrate the physical characteristics and safety of the implant itself, comparing it to predicate devices. It does not mention any software-related performance criteria, test sets, ground truth establishment, or human reader studies.

In summary, this document is about the physical characteristics and substantial equivalence of a spinal implant, not about the performance of an AI/software device. Therefore, I cannot provide the requested table and details related to AI/software performance.

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The Mercury® II Spinal System is intended to provide immobilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (TI-S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. This system is interior/anterolateral nonpedicle fixation, posterior non-pedicle fixation pedicle fixation 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, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Spinal Elements Mercury II Spinal System may be used in conjunction with the Spinal Elements Overwatch System. In order to achieve additional levels of fixation, the Mercury II or Overwatch Fixation Systems may be connected to the Lotus Posterior Cervical/Thoracic rod connectors. Transition rods with differing diameters may also be used to connect the Lotus Posterior Cervical/Thoracic Spinal System to the Mercury II or Overwatch Spinal Systems. Refer to the Lotus Posterior Cervical/Thoracic Spinal System package insert for a list of Lotus indications for use.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mercury II and Overwatch implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatic pedicle screw fixation is limited to a posterior approach.

Spinal Elements' fenestrated screws are intended to be used with saline or radiopaque dye.

These devices are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Spinal Elements' Navigated Instruments are intended to be used during the preparation and placements' Mercury® II 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.

Spinal Elements' Mercury II Spinal System is comprised of a variety of screws and rods that are used for attachment to the non-cervical spine (the thoracic spine through the sacrum and in the ilium). A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and achieve fixation by the mechanical joining of the rods with screws.

Screws and rods are made from titanium alloy (Ti-6A1-4V) conforming to ASTM F136 or ISO 5832-3. Additionally, some rods may be manufactured from cobalt-chrome alloy (Co-Cr) conforming to ASTM F1537 or ISO 5832-12.

Navigated instruments are surgical instruments manufactured from stainless steel, as specified in ASTM F899 or ASTM A564. Navigated instruments are non-sterile and are intended to be used with the Medtronic StealthStation® S7 and S8 System.

The provided text is a 510(k) premarket notification summary for the "Mercury® II Spinal System," a medical device. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets specific acceptance criteria through a clinical study or performance data related to an AI/Software as a Medical Device (SaMD).

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies that would be typical for an AI/SaMD product.

The performance data mentioned is related to mechanical testing of the spinal system (screws and rods), not to the performance of a diagnostic or interventional AI.

To answer your request, I must state that the provided text does not contain the necessary information. The document is a regulatory submission for a physical medical device (spinal system and instruments), not an AI/SaMD.

If you have a document describing an AI/SaMD for me to analyze, please provide it.

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Crystal® devices are intended for spinal fusion at one or two contiguous levels in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Implanted via an open, anterior approach for the C2-C3 disc space to the C7-T1 disc space and packed with autograft bone graft comprised of cancellous and/or corticocancellous bone graft.

The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with these devices.

Vertu® devices are stand-alone interbody fusion devices intended for spinal fusion procedures at one level from the C2/ C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Implants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.

The implant is designed to accommodate two screws should be used to ensure adequate fixation of the implant.

Lucent® are intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). 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 or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).

This device is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.

The Zeus® Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in sketally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level. The Zeus® Lumbar Interbody Fusion Devices are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Ceres®-C Stand-Alone Cervical System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Ceres@-C Stand-Alone Cervical implant is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted with an anterior approach.

The Omega XP device is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Omega XP device is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fration. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Spinal Elements' Crystal Cervical Interbody System is an intervertebral body fusion device for use in cervical spine surgery. The device is generally box-shaped with various holes throughout its geometry to allow for the placement of bone graft material. The exterior of the device has teeth or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned.

Spinal Elements' Vertu Cervical Interbody System is composed of an implant body and fixation screws. The implant body is generally a box-shaped device with holes through its body for the placement of graft material. Additionally, it has teeth located on its superior and inferior external surfaces to help keep the device from migrating once placed in its desired location. There are also screw holes located in the implant body. Each screw hole is lined in its internal surface with a titanium ring insert. Screws pass through screw holes of the implant body and affix to bone to help prevent implant migration. When fully seated, the screw head rests on the titanium insert of the screw hole.

The Lucent device is an interbody fusion device for use in lumbar spine surgery. Because PEEK is translucent, tantalum pins are placed in various locations of the PEEK device to serve as markers for radiographic visualization of the device orientation. The Lucent devices are of various shapes, heights, width, length and lordosis to suit patient anatomy.

The Zeus Interbody Fusion Devices are comprised of implants designed to treat the cervical and lumbar spine. The implants are available in a range of sizes and shapes to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

The Ceres-C Stand-Alone Cervical System includes a PEEK spacer with Tantalum markers, and a titanium interbody plate and screws. The spacer component is assembled to the interbody plate and implanted anteriorly. The endplate contacting surfaces of the spacer component include serrations, and the plate component includes two holes for inserting one bone screw in each vertebral body. The plate component also includes a screw lock at each hole. The bone screws are available in a variety of diameters and lengths. The interbody plate components are available in a variety of heights. The spacer components are available in a variety of depths, widths, and heights.

The Omega XP System devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion in the lumbar spine. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various sizes and are designed to expand in height intraoperatively to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

This document is a 510(k) Premarket Notification from the FDA regarding several spinal intervertebral body fusion devices manufactured by Spinal Elements, Inc. The document states that the devices are substantially equivalent to previously marketed predicate devices and therefore do not require a premarket approval application.

Critically, this document is a regulatory approval notice based on the substantial equivalence principle, not a study evaluating the performance of an AI/ML powered medical device. It explicitly states under "Performance Data" that: "No changes were made to the existing devices nor were any new components were added to the systems. Therefore, no additional testing was required or performed."

As such, this document does not contain the information required to answer the prompt regarding acceptance criteria and a study that proves the device meets those criteria for an AI/ML powered medical device. The device described (intervertebral body fusion devices) is a physical implant, not a software-based AI/ML product.

Therefore, I cannot provide the requested information based on this document.

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Lucent® 3D intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). 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 or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

These devices are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).

This device is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.

The subject devices are intervertebral body fusion devices for use in lumbar spinal surgery. They may also be referred to as interbody fusion devices or interbody cages. The devices are generally box-shaped with various holes throughout their design to allow for the placement of autograft or allogenic bone graft. They include a lid which further facilitates installation of bone graft and which is shut prior to implantation. The exterior of the devices has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the devices from migrating once they are implanted.

The devices submitted herein are additively manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F3001.

The provided text is a 510(k) summary for the Lucent® 3D Spinal System, a medical device for spinal fusion. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than proving the performance of an AI/ML-based device against specific acceptance criteria derived from a clinical study.

Therefore, the information required to answer your request (acceptance criteria for an AI/ML device, details of a study proving it meets them, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment) is not present in the provided text.

The document discusses:

• Device Description: Intervertebral body fusion devices, box-shaped with "teeth", made from titanium alloy.
• Indications for Use: Spinal fusion for degenerative disc disease (DDD) at L2-S1, with or without Grade 1 spondylolisthesis/retrolisthesis, requiring supplemental spinal fixation and bone graft.
• Substantial Equivalence: Comparison to predicate devices (Lucent® K150061, OmegaLIF K150395) based on indications, surgical technique, design, manufacturing, and materials.
• Performance Data: Lists various mechanical tests (Static Compression, Static Compression Shear, Dynamic Compression, Dynamic Compression Shear, Subsidence) performed according to ASTM standards, concluding that "All data indicates that the device will perform as intended."

In summary, the provided document does not contain the information requested about a study for an AI/ML device's acceptance criteria.

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Lucent® intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). 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 or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

These devices are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).

This device is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.

The subject devices are intervertebral body fusion devices for use in lumbar spinal surgery. They may also be referred to as an interbody device or interbody cage. The devices are generally box-shaped with various holes throughout their design to allow for the placement of autograft or allogenic bone graft. The exterior of the devices have "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the devices from migrating once they are surgically positioned.

The devices submitted herein may be manufactured from polyetheretherketone (PEEK) materials and titanium alloy (Ti-6A1-4V conforming to ASTM F 136 and ISO 5832-3 or ASTM F 1472) or PEEK material conforming to ASTM F 2026 with a plasma sprayed coating of commercially pure titanium (per ASTM F 1580) on their superior and inferior surfaces and titanium alloy (Ti-6Al-4V conforming to ASTM F 136 and ISO 5832-3 or ASTM F 1472). Because PEEK is radiolucent, tantalum (per ASTM F 560) pins are placed in various locations of the PEEK devices to serve as markers for radiographic visualization of device orientation.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called Lucent® XP Curved, an intervertebral body fusion device.

Based on the provided text, the device does not involve an AI/ML component or complex diagnostic performance. Therefore, a study demonstrating the device meets acceptance criteria related to AI/ML performance (e.g., accuracy, sensitivity, specificity, human-in-the-loop improvement, ground truth methodology) is NOT applicable here.

The acceptance criteria and supporting "study" are primarily focused on mechanical performance and material characteristics to demonstrate substantial equivalence to a previously cleared predicate device.

Here's a breakdown of the relevant information provided:

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

The document states: "All data indicates that the device will perform as intended." The "acceptance criteria" are implied by adherence to the referenced ASTM standards and the demonstration of "substantial equivalence" to the predicate. No numerical performance metrics are provided in a table format in this document, as the focus is on similarity to an already cleared device, not novel performance claims.

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

• Test Set Sample Size: Not explicitly stated as a number of 'cases' or 'patients'. The testing is mechanical (on the device itself) rather than clinical. The "sample" would refer to the number of devices or test coupons subjected to the specified ASTM mechanical tests. This information is typically detailed in the full test reports, not usually summarized in this 510(k) format.
• Data Provenance: The document does not specify country of origin for the mechanical testing data. It is inherently "retrospective" in the sense that the justification relies on the established performance of the predicate device.

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

• Not Applicable. This is a mechanical device, not one requiring expert human interpretation of medical images or data for ground truth establishment. The "ground truth" for this device's performance is objective mechanical testing per engineering standards (ASTM F 2077-18).

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

• Not Applicable. As no expert review or human interpretation is involved in establishing performance, no adjudication method is necessary.

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 does not involve AI or human readers for diagnostic assistance.

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

• Not Applicable. This device does not have a software algorithm component.

7. The type of ground truth used:

• For mechanical performance: Objective engineering standards and test results from the ASTM F 2077-18 standards.
• For biocompatibility: Identity to previously cleared materials and manufacturing processes from predicate device K182584.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this device does not utilize machine learning or AI.

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

• Not Applicable. As there is no training set.

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The Sapphire® Spinal System is intended for anterior (C2-T1) in skeletally mature patients as an adjunct to fusion for the following indications:
· Degenerative Disc Disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
· Spondylolisthesis
· Trauma (including fracture or dislocation)
· Spinal stenosis
· Deformities or Curvatures (kyphosis, lordosis or scoliosis)
Tumor
· Pseudoarthrosis
· Failed previous fusion

The Sapphire X Anterior Cervical Plate Spinal System is intended for anterior cervical fixation (C2-T1) in skettally mature patients as an adjunct to fusion for the following indications:
· Degenerative Disc Disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
· Spondylolisthesis
· Trauma (including fracture or dislocation)
· Spinal stenosis
· Deformities or Curvatures (kyphosis, lordosis or scoliosis)
Tumor
· Pseudoarthrosis
· Failed previous fusion

Elements' Spinal System System and System and Sapphire Sapphire S X S Anterior Spinal Cervical Plate Spinal System are comprised of plates and screws that are used for attachment to the anterior cervical spine. Both plates and screws are available in a variety of sizes to suit the individual pathology and anatomic conditions of the patient. Plates are pre-shaped with radial and lordotic curvature and have large windows for graft and end plate visualization. Plates range in length to accommodate one to five levels of fusion. Sapphire X Anterior Cervical Plates accommodate larger angles for the distal screws in order to minimize plate overhang on the vertebral bodies.

All screws are equipped with an internal locking mechanism that is actuated by rotating a preassembled inset screw. Upon rotation, the insert screw interfaces with a clip in the head of the screw causing the clip to expand. The expansion of the clip prevents the screw from disassociating from the plate. The same screws will be used for both the Sapphire® and Sapphire X Anterior Cervical Plate Systems.

Screws are available in both fixed and variable angle designs. Fixed angle screws have a predetermined trajectory relative to the plate. The fixed angle screws have a neck diameter similar in size to the screw hole diameter of the plate.

Variable angle screws provide freedom in trajectory of the screws into the vertebral body. They allow 8° of angulation in any direction relative to the plate. The variable angle screws have a neck diameter that is smaller than the screw hole diameter of the plate. This difference in diameters allows the variable angle screws to be inserted at various angles relative to the plate.

The materials used for the system remain unchanged. The plates and screws are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3. The locking clips on the screws are manufactured from Nitinol conforming to ASTM F2063.

This is a premarket notification for the Sapphire® Spinal System and Sapphire X Anterior Cervical Plate Spinal System. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results or acceptance criteria based on performance metrics like sensitivity, specificity, or F1-score for AI/ML devices.

Therefore, many of the requested fields cannot be answered directly from this document as they are not relevant to a 510(k) for a spinal fixation system. This document specifically covers mechanical performance testing, not AI/ML algorithm performance.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not applicable or not provided:

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

For a spinal fixation system, "acceptance criteria" are typically defined by recognized standards for mechanical testing to ensure the device's structural integrity and functionality. The document references ASTM F1717, which sets standards for such tests. The "reported device performance" is a qualitative statement of compliance.

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

This information is not provided in the document. For mechanical testing, sample size would refer to the number of devices tested. Data provenance is not typically specified in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is a spinal fixation system undergoing mechanical performance testing, not an AI/ML diagnostic tool requiring expert-established ground truth.

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

This is not applicable as the device is a spinal fixation system undergoing mechanical performance testing.

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

This is not applicable as the device is a spinal fixation system, not an AI-assisted diagnostic tool.

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

This is not applicable as the device is a spinal fixation system, not an AI/ML algorithm.

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

This is not applicable. For mechanical testing, the "ground truth" is adherence to the specified engineering standards and successful completion of the tests without failure.

8. The sample size for the training set

This is not applicable as the device is a spinal fixation system, not an AI/ML algorithm that requires a training set.

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

This is not applicable as the device is a spinal fixation system, not an AI/ML algorithm.

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