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When used as an interbody fusion device, the TruLift® Lateral Expandable Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). 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 at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine. The TruLift® Lateral Expandable Spacer can also be connected to the Lateral Buttress Plate System by a set screw.

The Lateral Buttress Plate System is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The Lateral Buttress Plate System is not intended for use in load-bearing applications. The Lateral Buttress Plate System can also be connected to the TruLift® Lateral Spacer System by a set screw. It may be used with other anterior, anterolateral or posterior spinal systems.

The TruLift® Lateral Expandable Spacer System is available in a range of sizes and footprints and can expand to the desired height (8mm to 16mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.

The Lateral Buttress Plate System consists of plates and bone screws. The Lateral Buttress Plate System is also intended to provide stabilization and to assist in the development of a solid spinal fusion to the anterior portion of the lumbar vertebral body. The Lateral Buttress Plate System is intended to be used in conjunction with traditional supplemental fixation which includes other anterior, or anterolateral spinal systems made of compatible materials.

All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System components with components from any other system or manufacturer. The TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System components should never be reused under any circumstances.

The provided FDA 510(k) clearance letter for the TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document is a regulatory clearance letter, which confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It focuses on the administrative and regulatory aspects of the clearance, such as:

• Device Name: TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System
• Regulation Number & Name: 21 CFR 888.3080, Intervertebral Body Fusion Device
• Regulatory Class: Class II
• Product Code: ODP, KWQ
• Predicate Devices: Life Spine ProLift Lateral Expandable Cage System (K221806), Life Spine Trulift Lateral Modular 1-Hole Buttress Plate (K221806), Life Spine ProLift HELO Expandable Spacer (K210061), Astura Sirion Lateral Lumbar Plate System (K202495), Life Spine ProLift Lateral Fixated (K200338).
• Indications for Use: Detailed description of the conditions and patient types for which the device is intended.
• Technological Characteristics: States that the device is substantially equivalent in design, materials, indications for use, and sizing.
• Materials: Titanium alloy (Ti-6Al-4V ELI) as per ASTM F136.
• Performance Data: A brief statement indicating that mechanical performance has not changed and the worst-case scenario remains the same, implying equivalence to predicates.

Specifically, the document states:

"Through the Comparison Analysis it is determined that the mechanical performance has not change as the worst case is still the same and therefore is substantially equivalent to the Life Spine ProLift Lateral Expandable Cage System (K221806) & Life Spine Trulift Lateral Modular 1-Hole Buttress Plate (K221806)."

This statement implies that the device's performance was assessed by comparing it to the predicate devices, likely through mechanical testing or analysis, to demonstrate that its performance is equivalent and that it meets the existing performance standards met by the predicates. However, the document does not elaborate on:

• Specific acceptance criteria: What quantitative or qualitative metrics were used to define "acceptable" mechanical performance.
• Detailed study methodology: How the "Comparison Analysis" was conducted.
• Actual reported device performance data: No specific values or results are provided.

Therefore, I cannot extract the requested information from the provided text. The information you're looking for (detailed acceptance criteria, specific study results, sample sizes, ground truth establishment, expert qualifications, etc.) would typically be found in the full 510(k) submission itself, which is a much more comprehensive document than the clearance letter.

To answer your request, I would need a different type of document, such as the actual performance testing report or a detailed summary of the premarket submission that includes these specific study details.

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The SIRION Lateral Lumbar Interbody System Spacer, either used individually or assembled to the SIRION plate, is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). SIRION Spacers are to be used with autogenous bone graft and supplemental fixation. Approved supplemental fixation includes the Olympic Posterior Spinal Fixation System. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The SIRION Lateral Lumbar Interbody System Plate, in 2-hole and 4-hole configurations, is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The SIRION Lateral Lumbar Interbody System Plate, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications

Hyperlordotic interbody devices (>20° lordosis) must be used in conjunction with the SIRION plate for fixation.

SIRION X must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for use in the lumbar spine.

The Sirion Lateral Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis). The Sirion cages are designed to be used in conjunction with supplemental spinal fixation instrumentation.

The provided document, a 510(k) summary for the SIRION Lateral Lumbar Interbody System, does not contain information regarding a study that proves a device meets acceptance criteria related to an AI/ML medical device.

The document describes a medical device, an intervertebral body fusion system, and its substantial equivalence to previously cleared predicate devices. The "Non-clinical Test Summary" explicitly states that tests like Static and Dynamic compression/shear, Subsidence, and Expulsion were conducted, and a "Clinical Test Summary" explicitly states: "No clinical studies were performed."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets the acceptance criteria, as the document pertains to a traditional medical device (spinal implant) and not an AI/ML-driven diagnostic or treatment device that would typically involve the kind of performance evaluation you're asking about (e.g., sensitivity, specificity, human reader improvement).

The information you asked for, such as sample sizes for test sets, data provenance, expert consensus, adjudication methods, MRMC studies, standalone performance, and training set details, is relevant to AI/ML device evaluations, but is not present in this 510(k) submission for a physical implant.

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