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Lucent® and Lucent Magnum® are intervertebral body fusion devices intended for spinal fusion procedures at one or two contiguous levels (T1-L5) 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, anterior plate 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.

This product is an intervertebral body fusion device, manufactured from titanium (Ti-6Al-4V) or PEEK-Optima®, 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 modification seeks clearance for the addition of PEEK devices coated with a plasma-sprayed titanium coating.

The provided text describes a 510(k) premarket notification for a medical device, specifically an intervertebral body fusion device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than independently proving safety and effectiveness through clinical trials. Therefore, the information requested in your prompt regarding acceptance criteria, study details, and ground truth establishment, which are typical for studies validating AI/ML models or novel devices requiring extensive clinical data, is not directly applicable in the context of this 510(k) submission.

Here's an explanation based on the provided document and why most of your requested fields cannot be filled:

1. Nature of the Device: The Lucent® and Lucent Magnum® are physical intervertebral body fusion devices, not AI/ML systems or diagnostic tools. Their performance is assessed through mechanical testing against established ASTM standards and comparison to predicate devices, not through clinical studies with "test sets," "ground truth experts," or "AI assistance effect sizes."

2. 510(k) Process: A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predecessor. The primary method for proving this "substantial equivalence" is through comparison of material specifications, design features, intended use, and performance data (often mechanical testing for implants) against predicate devices. Clinical efficacy studies as you've described for AI models are generally not required for 510(k)s unless the device raises new safety or effectiveness questions not addressed by predicates.

Therefore, many of your specific questions are not addressed in this type of regulatory document. I will fill in what can be inferred or directly stated from the text.

Acceptance Criteria and Device Performance (for a physical medical device)

The "acceptance criteria" for this device are implicitly tied to demonstrating performance at least as good as the predicate devices, as measured by standard mechanical tests. The "reported device performance" is a statement that the device did meet these criteria.

Study Details and Ground Truth Establishment

Given the nature of a 510(k) for a physical implant, the following information is not applicable or not provided in the document as it would be for an AI/ML diagnostic device study:

• Sample size for the test set: Not applicable. Performance was assessed through mechanical testing of the device itself and components, not a "test set" of clinical cases.
• Data provenance: Not applicable. Mechanical test results do not have "provenance" in the sense of clinical data (country or retrospective/prospective).
• Number of experts used to establish the ground truth for the test set & qualifications: Not applicable. There is no "ground truth" to be established by experts for a mechanical device in this context.
• Adjudication method: Not applicable.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This device is not an AI algorithm assisting human readers.
• Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
• Type of ground truth used: Not applicable in the sense of clinical ground truth (e.g., pathology). The "ground truth" for mechanical performance is defined by the ASTM standards and the performance of the predicate device.
• Sample size for the training set: Not applicable. This is a physical device, not an AI model.
• How the ground truth for the training set was established: Not applicable.

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Magnum+ is a stand alone device intended to be used with bone screws. If the physician chooses to use fewer than the maximum number of screws accommodated by the device, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability.

When used as a vertebral body replacement:
When used as a vertebral body replacement, the device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
The interior of the spacer can be packed with allograft or autograft.

When used as an intervertebral body fusion device:
Lucent Magnum+ is an intervertebral body fusion device 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 autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

Spinal Elements' Lucent Magnum+ device is composed of a main device body (spacer) and fixation screws. The spacer is generally oval-shaped with various holes throughout its geometry. The superior and inferior surfaces of the spacer have engagement members to help prevent migration once surgically positioned. The spacer has holes through it that allow for the passage of bone screws that affix to bone to help prevent migration.
Devices are available in a multitude of sizes. The spacer may be made from titanium alloy (Ti-6Al-4V) conforming to ASTM F 136 or ISO 5832-3 or polyetheretherketone (PEEK-OPTIMA LTI, provided by Invibio) conforming to ASTM F 2026. Because PEEK is radiolucent, tantalum (per ASTM F 560) pins are embedded into PEEK spacers to serve as markers for radiographic visualization of spacer orientation. Screws are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F 136 or ISO 5832-3. All implants are intended for single use only and should not be reused under any circumstances. Components from this system should not be used in conjunction with components from other systems.

This document is a 510(k) Premarket Notification for a medical device called Lucent® Magnum+. It describes the device, its intended uses, and claims substantial equivalence to previously cleared devices.

There is no information in this document about acceptance criteria, device performance metrics, or a study to prove the device meets acceptance criteria.

The document is a regulatory submission for premarket clearance, which typically focuses on demonstrating equivalence to existing legally marketed devices rather than presenting detailed performance studies against specific acceptance criteria for a novel AI device. The device itself is a physical intervertebral body fusion device and not an AI/ML powered device. Therefore, a study proving device performance against acceptance criteria as might be done for software or AI medical devices is not applicable here.

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When used as a vertebral body replacement, the device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.

When used as an intervertebral body fusion device is 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, anterior plate 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 of non-operative treatment prior to being treated with the device.

Spinal Elements' Lucent Magnum+ device is composed of a main device body and fixation screws. The main device body is generally oval-shaped with various holes throughout its geometry. The superior and inferior surfaces of the device have engagement members to prevent migration once surgically positioned. The main implant body has holes through it that allow for the passage of bone screws that affix to bone to help prevent migration.

Devices are available in a multitude of sizes. Device bodies are made from either titanium alloy (Ti-6Al-4V), conforming to ASTM F 136 or ISO 5832-3, or polyetheretherketone (PEEK-Optimal), conforming to ASTM F 2026. Screws are made from titanium alloy (Ti-6Al-4V), conforming to ASTM F 136 or ISO 5832-3. All implants are intended for single use only and should not be reused under any circumstances. Components from this system should not be used in conjunction with components from other systems.

The provided text describes a medical device, the Lucent® Magnum+, and its intended use, but it does not contain any information about acceptance criteria or a study proving the device meets any specific performance criteria.

The document is a 510(k) summary for a medical device cleared by the FDA. Such documents primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria.

Therefore, I cannot provide the requested information. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or its data provenance.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about a standalone performance study.
7. The type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

The document primarily focuses on:

• Device Description: What the device is made of and its general shape.
• Intended Use: The medical conditions and anatomical locations for which the device is designed (e.g., vertebral body replacement, intervertebral body fusion).
• Substantial Equivalence: Listing predicate devices to which the Lucent® Magnum+ is considered equivalent based on indications for use, design, function, and materials.

In the context of 510(k) clearance, the "study" is often a comparison to a predicate device, focusing on equivalence rather than independent performance metrics against predefined acceptance criteria.

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When used as a vertebral body replacement:

When used as a vertebral body replacement, the Lucent Magnum device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.

When used as an intervertebral body fusion device:

When used as an intervertebral body fusion device, the Lucent Magnum device is 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, anterior plate 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 of non-operative treatment prior to being treated with the Lucent Magnum device.

Spinal Elements' Lucent Magnum device is a generally oval-shaped device with various holes located throughout its geometry and teeth on the superior and inferior surfaces.

The device body may be made from titanium alloy (Ti-6A1-4V) or polyetheretherketone (PEEK).

Devices are available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient.

The Lucent® Magnum device is a medical implant, and its acceptance criteria are based on mechanical performance demonstrating substantial equivalence to predicate devices, rather than a clinical study with human readers or AI.

1. Table of Acceptance Criteria and the Reported Device Performance:

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

• Sample Size: Not applicable. The "study" referenced is mechanical testing, not a clinical trial with a test set of patient data.
• Data Provenance: Not applicable.

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

• Not applicable as the assessment is based on mechanical testing and comparison to predicate devices, not expert human interpretation of medical data.

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:

• No MRMC study was performed or is relevant to this device. This device is an implant, not an AI-powered diagnostic tool.

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

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

• The "ground truth" for the Lucent® Magnum's acceptance is based on established engineering principles and benchmarks for mechanical strength and durability of similar intervertebral body fusion devices, as demonstrated through mechanical testing. The comparison against legally marketed predicate devices serves as the standard for substantial equivalence.

8. The sample size for the training set:

• Not applicable. This is not an AI device that requires a training set.

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

• Not applicable.

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