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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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