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IB3D™ PL Spinal System is indicated for use in lumbar spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2 contiguous levels from L2 to S1. DDD is defined as discogenic back pain 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. When used for these indications, the IB3D™ PL Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Additionally, the IB3D™ PL Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation.

All patients should be skeletally mature and have had at least 6 months of nonoperative treatment. The IB3D™ PL Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach. When implanting via posterior approach (PLIF), a minimum of two implants is required per spinal level.

The IB3D Universal Implant Inserter is IB3D™ PL Spinal System instrument made of stainless steel. The Reusable Instruments are designed for use in orthopedic procedures to facilitate the insertion and rotation of IB3D™ PL implants into the lumbar spine. These instruments enable placement of the interbody implant between two lumbar vertebral bodies by allowing the implant to be inserted and rotated into its final position. The inserter comprises a handle and a shaft that securely holds the implant, with rotation achieved via the handle. The implant device is constructed from titanium alloy.

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The ZSFab Lumbar Interbody System is intended for lumbar interbody

The ZSFab Lumbar Interbody System is intended for lumbar interbody

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The UniSpace® TPLIF Cage is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The UniSpace® TPLIF Cage is to be used with supplemental internal spinal fixation. Additionally, the UniSpace® TPLIF Cage is to be used with autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft.

The UniSpace® TPLIF Cage is a product for lumbar spinal column stability. The implants of the UniSpace® TPLIF Cage are made of ASTM F3001 titanium alloy (Ti6Al4V ELI) and manufactured using an additive manufacturing method (3D printing), specifically Direct Metal Laser Sintering (DMLS). The UniSpace® TPLIF Cage is available in various heights, widths, lengths, and lordotic angles, and features an open architecture designed to accommodate autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft. The cages are provided in a variety of sizes to accommodate individual patients' anatomical requirements. The implants of the UniSpace® TPLIF Cage are provided as a sterile pack. The UniSpace® TPLIF Cage is implanted by using instruments manufactured from stainless steel material (ASTM F899) and/or Ti6Al4V ELI (ASTM F136).

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The Spectrum Spine Expandable Titanium PLIF/TLIF System includes interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

Spectrum Spine Expandable Titanium PLIF/TLIF System implants are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

The Spectrum Spine Expandable Titanium PLIF/TLIF System consists of lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The Expandable Titanium PLIF/TLIF System implants are provided in various shapes to accommodate posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) surgical approaches. These implants can expand to a set height and lordosis as appropriate. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Expandable Titanium PLIF/TLIF System is to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

The Expandable Titanium PLIF/TLIF System is manufactured from titanium alloy per ASTM F136.

The system provides several footprints in multiple height and angle configurations. The cage's ability to be inserted at a nominal height and then expand to a set height and angle to fill the joint space once properly positioned minimizes damage to the bony end-plate caused by impaction.

The purpose of this special 510(k) is to gain clearance for modifications made to the Expandable Titanium PLIF/TLIF System.

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Mobarn 80:20 Lumbar Interbody Fusion System is intended for spinal fusion procedures to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had previous non-fusion spinal surgery at the involved spinal level(s) and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Mobarn 80:20 Lumbar Interbody Fusion System is to be combined with supplemental fixation.

The Mobarn 80:20 Lumbar Interbody Fusion System consists of a family of additively manufactured titanium (Ti6Al4V-ELI) lumbar intervertebral body fusion devices (LIBF) designed to facilitate lumbar spinal fusion through various surgical approaches, as listed below.

• Posterior Lumbar Interbody Fusion (PLIF)
• Transforaminal Lumbar Interbody Fusion (TLIF)
• Direct Lateral Lumbar Interbody Fusion (DLIF)
• Anterior Lumbar Interbody Fusion (ALIF)

The Mobarn 80:20 Lumbar Interbody Fusion System is intended for use in lumbar intervertebral fusion procedures. These devices are designed to provide structural support and stabilization to facilitate bony fusion in patients with degenerative disc disease (DDD) and other conditions requiring interbody fusion.

The design of the implants consists of an open architecture surrounded by a titanium frame to accommodate autograft and/or allogenic bone graft, comprised of cancellous and/or cortico-cancellous bone graft. Each implant is engineered with an 80% open area to accommodate autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft, maximizing bone graft contact and fusion potential, while maintaining mechanical integrity through a titanium frame that makes up the remaining 20% and offers structural support. The implants are available in a variety of footprints, heights, and lordotic angles to approximate anatomical variation in different vertebral levels and/or patient anatomy.

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Atlas Spine Project X Expandable Posterior Lumbar Interbody Spacers are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

Atlas Spine Project X Expandable Posterior Lumbar Interbody Spacers are to be filled with autogenous bone graft material. This device is intended to be used with supplemental fixation, such as the Apelo™ Pedicle Screw System.

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The provided FDA 510(k) clearance letter for the "Atlas Spine Project X Expandable Posterior Lumbar Interbody System" does not contain information on acceptance criteria or a study that proves the device meets specific performance criteria.

The letter is a regulatory document confirming that the device has been reviewed and found substantially equivalent to legally marketed predicate devices. It focuses on regulatory compliance, classification, and applicable regulations (such as Quality System regulations, UDI rules, and adverse event reporting).

Therefore, I cannot provide the requested information from the given input because the document does not contain details about:

1. Acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, or adjudication methods for any test set.
3. MRMC comparative effectiveness study results.
4. Standalone performance studies.
5. Type of ground truth used.
6. Training set sample size or how its ground truth was established.

The letter mentions the "Indications for Use" for the device, detailing the patient population and conditions for which it is intended, but this is distinct from performance criteria and study results.

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The PRADO™ Lumbar Interbody Fusion System is indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis and/or stenosis at the involved level(s). Additionally, the Prado™ Lumbar Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. It is indicated to be used with autograft bone and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate or a bone void filler cleared for use in intervertebral body fusion to facilitate fusion.

Additionally, the use of hyperlordotic devices (lordotic angle greater than 20°) are intended to be used exclusively with anterior supplemental fixation.

PRADO™ Lumbar Interbody Fusion System consists of a series of implants and device specific instruments. PRADO™ Lumbar Interbody devices are manufactured from polyetheretherketone (PEEK) or Hydroxyapatite (HA) filled Polyetheretherketone (PEEK). The superior and inferior surfaces of the implants have ridges to interface with the vertebral endplates to resist rotation and migration. Additionally, the cephalad / caudal opening of each implant is maximized to facilitate bone through growth. Lateral fenestrations are provided to encourage bone ingrowth. Tantalum markers (per ASTM F560) or titanium (per ASTM F136), are configured as rods at the extremes of the PRADO™ Lumbar Interbody Devices to allow for radiological confirmation of the positioning. The proximal face of each interbody has a threaded thru hole which is to be used to interface with the inserter.

PRADO™ Lumbar Interbody Devices are available in four footprints to coincide with the surgical approach and patient need: PRADO™ P, PRADO™ T, PRADO™ L and PRADO™ A. The implants are available in a range of sizes to accommodate variations in patient anatomy.

The provided FDA 510(k) clearance letter for the PRADO™ Lumbar Interbody Fusion System does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/ML-driven medical device.

The document describes a mechanical implant (intervertebral body fusion device) and discusses its physical characteristics, materials, and non-clinical mechanical testing (ASTM F2077-18 and ASTM F2267-04), which typically involve evaluating properties like static compression, dynamic compression, expulsion, and subsidence. The clearance is based on substantial equivalence to predicate devices for these mechanical properties.

The questions you've asked (regarding acceptance criteria, sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are highly relevant to the validation of AI/Machine Learning (ML) medical devices, particularly those that perform diagnostic or prognostic functions based on image analysis or other data.

Since the provided document is for a physical implant and not an AI/ML device, it naturally does not include the details pertinent to AI/ML validation studies. Therefore, I cannot extract the requested information from this text.

To answer your request, if this were an AI/ML device, the required information would typically be found in a separate section of the 510(k) submission, often within a "Performance Data" or "Clinical Performance Testing" section, specifically detailing the validation study for the AI algorithm.

If you intended to provide a document related to an AI/ML medical device, please provide that document, and I will be able to answer your questions.

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The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.

The MectaLIF 3D Metal are a line extension to the MectaLIF Oblique and Posterior PEEK implants (K110927, K131671, K181970 and K212831) and MectaLIF Oblique and Posterior TiPEEK implants (K133192, K181970 and K212831). Specifically, the purpose of this submission is to obtain the clearance of MectaLIF 3D Metal Posterior, Oblique and Oblique Dome additively manufactured from Ti6Al4V according to ASTM F2924-14. MectaLIF implants are used to replace a degenerative disc in order to restore the height of the spinal column structure. The devices are not intended to be coupled with other implants but are intended to be used with supplemental fixation and autogenous bone graft. The subject implants are provided individually packed, sterile and single-use.

This document is an FDA 510(k) clearance letter for a medical device called "MectaLIF 3D Metal." This type of document is a regulatory submission demonstrating that a new device is as safe and effective as a legally marketed predicate device. It does not generally contain acceptance criteria or detailed study results for AI/software-as-a-medical-device (SaMD), as it pertains to a physical implant.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from the provided text because it is not relevant to this type of device or submission.

The document details the following for a physical medical device (intervertebral body fusion device):

• Device Name: MectaLIF 3D Metal
• Regulation Number: 21 CFR 888.3080
• Regulation Name: Intervertebral Body Fusion Device
• Regulatory Class: Class II
• Product Code: MAX
• Indications for Use: The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion.
• Predicate Devices: MectaLIF Extension (K212831), MectaLIF Posterior Extension (K181970), MectaLIF TiPEEK (K133192), MectaLIF Extension (K131671), MectaLIF (K110927).
• References Devices: Mpact 3D Metal Implants – DMLS Technology (K202568), GMK 3D Metal Tibial Tray (K221850).
• Performance Data (Non-Clinical Studies): Mechanical standard tests (static and dynamic axial/shear compression, axial compressive subsidence), expulsion test, wear analysis, stereological evaluation, abrasion test, static tensile test, static shear test, pyrogenicity testing, biocompatibility assessment, and shelf-life evaluation. These tests are conducted according to various ASTM and ISO standards for intervertebral body fusion devices and implant materials.
• Clinical Studies: No clinical studies were conducted for this submission, as is often the case for 510(k) clearances when substantial equivalence can be demonstrated through non-clinical testing and comparison to predicates.

In summary, the provided text does not contain information about acceptance criteria or performance studies related to AI/software, as it describes the 510(k) clearance for a physical orthopedic implant.

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