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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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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).

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 autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.

Lucent Magnum+ is an intervertebral body fusion device intended for spinal fusion procedure 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 nonfusion spinal surgery at the involved spinal level(s).

This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.

Crystal devices are intended for spinal fusion at one or two contiguous levels in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implanted via an open, anterior approach from 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 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 or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radies) of the cervical spine. 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. Two screws should be used to ensure adequate fixation of the implant.

Spinal Elements' Ti-Bond® is an additive plasma sprayed coating of commercially pure titanium conforming to ASTM F1580. Spinal Elements' devices are coated with Ti-Bond®f on their surfaces. Spinal Elements Ti-Bond® coating presents a macro-, a micro and a nano-surface structure.

This document is a 510(k) Premarket Notification for Spinal Elements Ti-Bond coated devices, stating that the coating does not change the previously cleared devices or their indications for use. Therefore, it does not contain the information requested about acceptance criteria and a study proving a device meets those criteria because the device being reviewed is a coating applied to existing devices, and the submission argues for substantial equivalence based on the coating not changing the previously cleared devices.

Here's why the requested information cannot be extracted directly from this document:

1. Nature of the submission: This is a 510(k) for a coating (Ti-Bond) for already cleared intervertebral body fusion devices. The core argument is that applying this coating does not alter the fundamental safety or effectiveness of the devices, and thus they remain substantially equivalent to their predicates. It's not a submission for a new device with new performance claims requiring extensive new clinical or performance studies to establish standalone acceptance criteria.
2. No New Performance Claims: The document explicitly states: "The indications for use of the devices coated with Ti-Bond® are not being modified from the ones cleared in their respective 510(k)..." and "There are no changes to the predicate devices coating. All technical characteristics remain identical." This means that the device is relying on the previous clearances of the predicate devices for performance, rather than providing new performance data for this specific 510(k) submission that would require detailed acceptance criteria and a study proving they are met.
3. Performance Data Section: The "Performance Data" section merely states: "In support of this 510(k) Premarket Notification, Spinal Elements has conducted nonclinical testing demonstrating that the Spinal Elements Ti-Bond® coating present a surface topography at a macro, a micro and a nano scale." This describes a characterization of the coating's physical properties, not a study against specific acceptance criteria related to a device's clinical performance (e.g., fusion rates, pain reduction, etc.).

Therefore, the document does not provide the specific details regarding acceptance criteria and a study to prove they are met as you've requested. The information you're looking for (acceptance criteria for clinical performance, sample sizes for test/training sets, expert qualifications, etc.) would typically be found in the original 510(k) submissions for the predicate devices themselves, or in a 510(k) for a novel device where new performance claims are being made.

If this were a submission for a new device, the "Performance Data" section would be much more extensive and detail specific studies (e.g., biomechanical testing, clinical trials, animal studies) conducted to demonstrate safety and effectiveness against predefined acceptance criteria for that device.

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The Mercury® 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 (T1-S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. This system is intended for anterior/ateral 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.

This system is intended to be used with bone graft.

Spinal Elements' Mercury Spinal System is comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine (the thoracic spine through the sacrum and into 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 hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Connectors are used to mechanically join one rod to another. Staples (when used) are placed under the screws to help distribute loads placed against the bone. Screws, hooks, rods, connectors, and staples are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F 136, ASTM F 1472 or ISO 5832-3. Additionally, some rods may be manufactured from cobalt chromium alloy (Co-Cr) conforming to ASTM F 1537 and ISO 5832-12.

This document describes the Mercury® Spinal System, a medical device, and its regulatory clearance. It does not contain information about an AI-powered device or a study involving human readers and AI assistance for medical image analysis. Therefore, I cannot provide an answer that addresses the requested points regarding acceptance criteria, study details, expert involvement, or AI performance metrics.

The provided text details the following:

• Device Name: Mercury® Spinal System
• Manufacturer: Spinal Elements Inc.
• Regulatory Clearance: K172967
• Device Type: Thoracolumbosacral pedicle screw system
• Intended Use: Immobilization and stabilization of the spine as an adjunct to fusion for various spinal conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion).
• Materials: Titanium alloy (Ti-6Al-4V) and Cobalt Chromium alloy (Co-Cr).
• Substantial Equivalence: Claimed to be substantially equivalent to previously cleared Mercury Spinal System predicate devices (K071914, K082353, K083230, K091587, K141372, K151215).
• Performance Data: States that performance testing included Static Axial Grip and Torsional Grip Interconnection Testing per ASTM F 1717 and ASTM F 1798, and Static and Dynamic Flexion/Extension Testing per ASTM F 1798. It concludes that "All data indicates that the device will perform as intended."

To reiterate, the original text does not contain the information required to answer your specific questions related to AI device performance evaluation.

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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).

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 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 Lucent® device is an intervertebral body fusion device for use in lumbar spinal surgery. It may also be referred to as an interbody device or interbody cage. The device is generally box-shaped with various holes throughout its design to allow for the placement of autograft. 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.

This document is a 510(k) summary for a medical device called Lucent®, an intervertebral body fusion device.

Here's an analysis of the provided text in the context of your request:

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

The document does not provide acceptance criteria or reported device performance in the typical sense of quantitative metrics for a study. This 510(k) pertains to line additions to an already cleared device, and the submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting new performance data against specific acceptance criteria.

The "Performance Data" section explicitly states: "No clinical testing was found to be necessary. Given the type of changes made to the Lucent device, no additional non-clinical testing was required or performed."

Therefore, I cannot generate a table of acceptance criteria and reported device performance from this document.

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

As stated above, no new performance data or clinical testing was conducted for this 510(k) submission. The device's substantial equivalence is based on its similarity to previously cleared devices. Therefore, there is no test set sample size or data provenance to report from this document.

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):

Since no new performance data or clinical testing was performed, there was no test set for which ground truth needed to be established by experts.

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

Not applicable, as no test set was used for new performance evaluation.

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 an intervertebral body fusion device (a physical implant), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study involving human readers and AI assistance is irrelevant to this submission.

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

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

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

Not applicable, as no new performance validation using a specific ground truth was conducted. The ground for substantial equivalence relies on comparison of design, materials, and indications for use with predicate devices.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

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

Summary of Device Acceptance and Study proving criteria:

The document describes the device, Lucent®, as an intervertebral body fusion device. This 510(k) submission is for line additions to an already cleared device. The primary method of demonstrating acceptance and meeting criteria is through substantial equivalence to legally marketed predicate devices.

The study that "proves" the device meets acceptance criteria, in this context, is the comparison to predicate devices. The submission argues that:

• The subject device is identical in indications for use, manufacturing method, raw material and operating principles to the predicate devices cleared in K122967 and K150061.
• It has equivalent technological characteristics to its predicates in areas including labeling/indications for use, general design features, function, material, manufacturing process, and instrumentation.

Therefore, the "proof" is based on the argument that because the device is sufficiently similar to devices already found safe and effective, no new performance studies are required.

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Vertu® & Vertu® Ti-Bond devices are stand-alone interbody fusion devices intended for spinal fusion procedures at one level from the C2/C3 disc space to the C7/T disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radies) of the cervical spine. 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. Two screws should be used to ensure adequate fixation of the implant.

Crystal® & Crystal® Ti-Bond devices are intended for spinal fusion at one or two contiguous levels in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implanted via an open, anterior approach from 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 non-operative treatment prior to being treated with these devices.

The Vertu and Vertu Ti-Bond Cervical Interbody System is composed of an implant body made from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3 or polyetheretherketone (PEEK-Optima®) conforming to ASTM F2026 or PEEK-Optima® coated with commercially pure titanium per ASTM F1580 and fixation screws made from Ti-6Al-4V per ASTM F136 or ISO 5832-3 with a Nitinol clip conforming to ASTM F2063. All implant bodies have a titanium insert lining the internal surface of the screw holes conforming to ASTM F136 or ISO 5832-3. The implant body is generally boxshaped 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. 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 Crystal and Crystal Ti-Bond Cervical Interbody devices are generally a box-shaped device with various holes located throughout its geometry to allow for packing of bone graft material. The body of the implant is made from titanium alloy (Ti-6A1-4V) conforming to ASTM F136 or ISO 5832-3 or polyetheretherketone (PEEK-Optima®) conforming to ASTM F2026 or PEEK-Optima® coated with commercially pure titanium per ASTM F1580. Superior and inferior surfaces of the device have teeth that help keep the device from migrating once placed in its desired location.

This FDA 510(k) Premarket Notification document (K153352) describes the Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody Systems. Per the document, "No changes were made to the existing Vertu. Vertu Ti-Bond. Crystal Ti-Bond devices nor were any new components added to the system. Therefore, no additional testing was required or performed." This implies that new acceptance criteria and a study to prove these devices meet those criteria were not established for this specific submission. Instead, the document relies on the substantial equivalence to previously cleared predicate devices.

Therefore, the following information cannot be directly extracted from the provided text for this specific K153352 submission:

1. A table of acceptance criteria and the reported device performance: Not explicitly stated as new criteria or performance data were generated for this submission. The device is determined to be substantially equivalent based on existing data and characteristics of predicate devices.
2. Sample size used for the test set and the data provenance: Not applicable as a new test set was not created for this submission. The submission references previous clearances (K122771, K133218, K073351) for the predicate devices, which would have had their own testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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. These are interbody fusion devices, not AI-assisted diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

The provided document (K153352) is a 510(k) premarket notification for expanded indications for the Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody Systems. The FDA determined the device is substantially equivalent to legally marketed predicate devices. The basis for this determination is that no changes were made to the existing devices, and no new components were added, thus no additional testing was required or performed for this specific submission. The substantial equivalence is argued based on a comparison of indications for use, technological characteristics, surgical technique, design features, and instrumentation to established predicate devices.

The acceptance criteria and performance data for the original clearances of these devices and their predicates would be found in the associated 510(k) submissions (K122771, K133218, K073351, K150053, K142264, K133653), which are not included in this document.

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Spinal Elements' Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. Spinal Elements' Spinous Process Plate System is not intended for stand-alone use.

Spinal Elements' Spinous Process Plate System is comprised of a static plate and a translating plate for posterior fixation of the spine in order to achieve fusion. The plates are available in multiple sizes to accommodate various patient anatomies. Both the static plate and the translating plate present spikes to interface with the bone of the spinous processes. The barrel of the static plate passes through the insert of the translating plate such that, in their final position, the plates surround the spinous processes on both sides, and fixation is achieved via compression of the two components onto the spinous processes. The spinous process plates are made from titanium alloy (Ti-6A1-4V) conforming to ASTM F136 with a nitinol spring conforming to ASTM F2063 and a coating of commercially pure titanium conforming to ASTM F1580. Additionally, the plates feature a titanium coating on their medial surfaces as well as the initial portion of the barrel.

This document is a 510(k) premarket notification decision letter and summary from the FDA for a medical device called "Spinal Elements' Spinous Process Plate System." It does not contain information about the acceptance criteria and study proving device performance as requested, because it is for a physical orthopedic implant, not an AI/software device.

The information provided (e.g., performance data, sample sizes, ground truth establishment) is specific to the evaluation of AI/software devices for regulatory purposes. This document details the regulatory review for a spinal implant, which relies on different types of testing.

Therefore, I cannot fulfill your request for acceptance criteria and study details for an AI/software device based on the provided text.

The document states:

• "No clinical testing was found to be necessary." This indicates that a study demonstrating device performance in a clinical setting (which is where metrics like sensitivity, specificity, or reader improvement would be measured) was not required for the clearance of this specific physical implant.
• Non-clinical performance testing included: Static Compression and Torsion testing per ASTM F 1717, Dynamic Compression Testing per ASTM F 1717, Plate Dissociation per ASTM F1798, Pullout Testing, Particulate Analysis per ASTM F1877, Corrosion testing per ASTM F2129, and Austenitic finish (Af) functional testing. These are engineering and material science tests relevant to a physical implant.

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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).

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 autogenous 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 Lucent® XP device is an intervertebral body fusion device for use in lumbar spinal surgery. It may also be referred to as an interbody device or interbody cage. The Lucent® XP device is comprised of two PEEK endplates with teeth for engaging the vertebral body endplates on the outside of the device and an internal titanium mechanism for expanding the PEEK endplates of the device. The device is generally box-shaped with various holes throughout its design to allow for the placement of autograft. 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. The device is made from PEEK-Optima® grade LT1 conforming to ASTM F2026 with or without a coating of commercially pure titanium conforming to ASTM F1580. The internal mechanism is made from titanium alloy conforming to ASTM F136.

This document describes the Lucent® Intervertebral Body Fusion Device (Lucent® XP and Lucent XP Ti-Bond®). However, it does not contain detailed acceptance criteria and a study proving a device meets them in the way typically seen for AI/ML-based medical devices.

Instead, this is a 510(k) Premarket Notification for a spinal implant, which relies on demonstrating substantial equivalence to a predicate device. The "performance data" section focuses on mechanical and physical testing rather than clinical performance or comparisons of human readers with and without AI assistance.

Therefore, I cannot provide all the requested information, specifically regarding AI-related aspects (like MRMC studies, standalone algorithm performance, AI training/test sets, expert qualifications for ground truth in an AI context).

Here's an breakdown of the available information based on your request, explicitly noting what is not applicable (N/A) or not provided (N/P) in this document for the requested AI-centric details:

Device Name: Lucent® Intervertebral Body Fusion Device (Lucent® XP and Lucent XP Ti-Bond®)

Device Type: Intervertebral Body Fusion Device (Spinal Implant)

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: For this type of device (spinal implant), acceptance criteria are primarily based on meeting the performance specifications outlined in relevant ASTM standards for mechanical integrity, rather than clinical efficacy metrics like sensitivity/specificity for an AI algorithm. The document states that "All data indicates that the device will perform as intended," implying successful adherence to these standards, but does not provide quantitative results or detailed pass/fail thresholds within this summary.

Regarding AI/ML-specific Study Information:

This document is for a physical medical device (spinal implant), not an AI/ML algorithm. Therefore, the following points are not applicable (N/A) or not provided (N/P) as they pertain to AI/ML device evaluations.

2. Sample size used for the test set and the data provenance: N/A (Not an AI/ML device)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Not an AI/ML device)
4. Adjudication method for the test set: N/A (Not an AI/ML device)
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: N/A (Not an AI/ML device)
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A (Not an AI/ML device)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (Not an AI/ML device; for spinal implants, "ground truth" would be related to physical properties and functionality confirmed by engineering tests and potentially predicate device history / clinical literature)
8. The sample size for the training set: N/A (Not an AI/ML device)
9. How the ground truth for the training set was established: N/A (Not an AI/ML device)

Summary of this Document's Approach:

This 510(k) submission leverages the concept of substantial equivalence. The manufacturer demonstrates that the Lucent® XP and Lucent XP Ti-Bond® device has the same indications for use, manufacturing method, raw materials, and operating principles as several legally marketed predicate devices. The "Performance Data" section confirms that the device has undergone standard mechanical tests (Static Compression, Dynamic Compression, Subsidence, Compression Shear) according to specific ASTM standards, and the results indicate it performs as intended. This type of testing is standard for implantable devices to ensure structural integrity and biocompatibility, rather than diagnostic accuracy as would be required for an AI/ML system.

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The Mercury® 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.

This system is intended to be used with bone graft.

Spinal Elements' Mercury Spinal System is comprised of a variety of screws, hooks, rods, connectors, and staples 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 hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Connectors are used to mechanically join one rod to another. Staples (when used) are placed under the head of the screws to help distribute loads placed against the bone.

Screws, hooks, rods, connectors, and staples are made from titanium alloy (Ti-6A1-4V) conforming to ASTM F 136 and ISO 5832-3 or ASTM F 1472. Additionally, some rods may be manufactured from cobalt chromium alloy (Co-Cr) conforming to ASTM F 1537 and ISO 5832-12.

This document describes the 510(k) premarket notification for the MERCURY® Spinal System, which is a medical device. The information provided is primarily focused on regulatory clearance and substantial equivalence to previously cleared devices. It does not contain specific acceptance criteria, detailed study results, or the other specific information requested about an AI device's performance study.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used and qualifications to establish ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone algorithm 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 provided text only mentions "Performance testing included: Static Axial Grip and Torsional Grip Interconnection Testing per ASTM F 1798" and "Static and Dynamic Flexion/Extension Testing per ASTM F 1798." It then states, "All data indicates that the device will perform as intended." This is a summary statement for a mechanical device's physical performance, not a detailed report of a study proving a diagnostic AI device's performance.

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Lucent® and Lucent Ti-Bond® are intervertebral body fusion devices 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).

These devices are intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with these devices.

The Lucent® device is an intervertebral body fusion device for use in lumbar spinal surgery. It may also be referred to as an interbody device or interbody cage. The device is generally box-shaped with various holes throughout its design to allow for the placement of autograft. 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.

The provided text is a 510(k) Premarket Notification for the LUCENT® and LUCENT Ti-BOND® intervertebral body fusion devices. It is a submission to the FDA seeking clearance to market a medical device, demonstrating its substantial equivalence to previously cleared predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify quantitative acceptance criteria in terms of performance metrics (e.g., a specific strength value that must be met). Instead, it relies on demonstrating that the device performs comparably to predicate devices under a set of established tests.

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

• Sample Size for Test Set: The document does not specify the exact sample size for the mechanical tests (Static Compression and Dynamic Compression). It simply states that "Non-clinical testing were used," and lists the types of tests.
• Data Provenance: The document does not provide details about the country of origin for the data or whether it was retrospective or prospective. Given that no animal or clinical studies were performed, the "data" primarily refers to the results of the benchtop mechanical, biocompatibility, and material characterization tests.

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

This information is not applicable in the context of this 510(k) submission for these types of mechanical and biocompatibility tests. "Ground truth" for mechanical testing is established by engineering standards and validated testing protocols. For biocompatibility, it's established by recognized standards (e.g., ISO 10993-1) and material master files. There's no mention of experts establishing ground truth in the way it would be for, say, a diagnostic imaging study.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies where human readers or evaluators make subjective assessments that need to be reconciled, such as in clinical trials or AI performance evaluations involving expert consensus. This document describes benchtop mechanical and material tests, which rely on objective measurements and adherence to standards rather than expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." Therefore, there is no effect size reported for human readers improving with or without AI assistance.

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

No, a standalone performance study was not done. The device is a physical intervertebral body fusion device, not a software algorithm. The document explicitly states: "The device does not contain software. Therefore no software verification and validation testing were performed."

7. The Type of Ground Truth Used

For the mechanical testing, the "ground truth" is adherence to established engineering standards and regulatory guidance. The document states that testing was performed "in accordance with the FDA guidance Class II Special Controls Guidance Document: Intervertebral Body Fusion Device." This guidance document would define acceptable ranges or performance attributes that the device must meet to demonstrate safety and effectiveness comparable to predicate devices.

For biocompatibility, the ground truth is established by recognized international standards (ISO 10993-1) and material master files (e.g., Invibio device master file MAF 1209, ASTM F 1580 for titanium).

8. The Sample Size for the Training Set

This is not applicable. As a physical medical device (intervertebral body fusion device) without software or AI components, there is no "training set" in the context of machine learning or algorithms.

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

This is not applicable for the reasons stated above (no training set for a physical device).

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