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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.

Not Found

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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PathLoc Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures 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. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. PathLoc Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The PathLoc Lumbar Interbody Fusion Cage System implants are interbody fusion devices intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). These hollow, rectangular implants are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies. The implants can be expanded in height after insertion in the unexpanded state using the system instrumentation. The implants have serrations on the superior and inferior surfaces designed for fixation.

• PathLoc – TM / BluEX-TM are to be implanted via transforaminal and posterior approach.

The provided FDA 510(k) clearance letter for the PathLoc Lumbar Interbody Fusion Cage System focuses on the mechanical testing and material composition of the device, rather than a clinical study evaluating its performance with human readers or AI assistance. Therefore, many of the requested criteria, particularly those related to AI algorithm performance, multi-reader multi-case (MRMC) studies, ground truth establishment for image datasets, and training/test set details for AI, are not applicable to this submission.

This document describes a medical device (an intervertebral body fusion cage) which is a hardware implant, not an AI/Software as a Medical Device (SaMD). The acceptance criteria and "study" described are focused on bench testing (mechanical performance) and material biocompatibility to prove substantial equivalence to existing predicate devices.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance (Mechanical Testing)

The "acceptance criteria" for this device are based on demonstrating mechanical performance that is either superior or equivalent to the predicate device and in compliance with specified ASTM standards. The "study" proving this involves a series of bench tests.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated as a number of devices or units. For mechanical bench testing, sample sizes are typically defined by the ASTM standards (e.g., n=5, n=6, etc.) but are not detailed in this summary. It would be a sample of the manufactured devices.
• Data Provenance: The "data" here refers to the mechanical test results from manufactured devices. This is not "data" in the sense of patient images or clinical outcomes. The device is manufactured in South Korea. The testing would have been conducted in a lab environment. The provenance is internal bench testing, not patient-derived data, and is not retrospective or prospective in the clinical sense.

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

• Not applicable. This is a hardware device; its performance is measured by mechanical properties according to engineering standards, not by human interpretation of images or clinical outcomes requiring expert consensus. The "ground truth" is established by the specified ASTM test methods.

4. Adjudication Method for the Test Set:

• Not applicable. As the "test set" is physical devices undergoing mechanical tests, there is no human adjudication process involved as there would be for, e.g., image interpretation. The machines measure and report data directly.

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

• No. An MRMC study is relevant for evaluating the performance of AI (or human readers) in interpreting medical images. This device is a physical implant, not an imaging or diagnostic AI tool.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) was Done:

• Not applicable. This is a hardware device, not an algorithm or software. "Standalone performance" here is interpreted as the device's mechanical performance in isolation, which is precisely what the bench tests measure.

7. The Type of Ground Truth Used:

• Engineering/Material Standards and Predicate Device Performance: The "ground truth" for this device's performance is its ability to meet predefined mechanical specifications outlined in ASTM standards and to demonstrate substantial equivalence (i.e., not inferior performance) to the predicate device. It's about physical properties, not clinical "truth" from patients.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" in the context of this traditional hardware device clearance. This term (training set) relates to machine learning models.

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

• Not applicable. As there is no training set for a machine learning model, this question is irrelevant to this device submission.

In summary: The FDA 510(k) clearance for the PathLoc Lumbar Interbody Fusion Cage System relies on non-clinical bench testing to demonstrate substantial equivalence to a predicate device in terms of design, materials, and mechanical performance. The framework of questions about AI algorithm performance, clinical ground truth establishment, and training/test datasets is not applicable to this type of medical device submission.

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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 aprevo® anterior and lateral lumbar interbody fusion devices are intended for interbody fusion in skeletally mature patients and are to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches may include anterior lumbar interbody fusion or lateral lumbar interbody fusion.

The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® anterior and lateral lumbar interbody fusion devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® transforaminal lumbar interbody fusion device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® transforaminal lumbar interbody fusion device is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® transforaminal lumbar interbody fusion device is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® transforaminal lumbar interbody fusion devices are to be filled with auto graft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended for interbody fusion in skeletally mature patients. The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone and/or corticocancellous bone and is to be used with supplemental fixation cleared for use in the lumbar spine. The device may be implanted via an open or minimally invasive approach.

The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis, kyphosis, or sagittal), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended for standalone use at one or two levels of the spine when used with the screws that accompany the implant and with implants less than or equal to 20° of lordosis. At more than two levels or with implants greater than 20° of lordosis, the aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended to be used with the screws that accompany the implant and with supplemental fixation. When used at more than one level in patients with degenerative scoliosis and/or sagittal deformity, the aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) must be used with the screws that accompany the implant and with supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine. These patients should be skeletally mature and have had at least six months of non-operative treatment. The device is to be filled with autograft bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. The device may be implanted via an open or minimally invasive approach.

The aprevo® TLIF-C Articulating System is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® TLIF-C Articulating System is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® TLIF-C Articulating System is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® TLIF-C Articulating System devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® Cervical ACDF lnterbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic 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) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. The aprevo® Cervical ACDF lnterbody System must be used with supplemental fixation systems. For hyperlordotic corrections (≥20° lordosis), the system must be used with at least an anterior cervical plate as supplemental fixation.

The aprevo® Cervical ACDF-X lnterbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic 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) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. When used as a standalone system, the aprevo® Cervical ACDF-X lnterbody implant with integrated screw fixation is intended for use at multiple contiguous levels, or up to two levels when used in trauma, deformity or failed previous fusions. Deformity procedures to correct coronal angulation or any use of hyperlordotic correction (≥20°) must include supplemental fixation such as posterior cervical screw fixation or anterior plating.

The aprevo® Lumbar Intervertebral Body Fusion Devices include ALIF, LLIF, TLIF, ALIF-X and TLIF-CA interbodies. The aprevo® lumbar interbody fusion devices are designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® device incorporates patient specific features to allow the surgeon to tailor the procedure to the individual needs of the patient and includes an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient CT scans. The aprevo® devices are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F3001, while the screws that accompany ALIF-X are machined from material per ASTM F136. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and instruments are provided as single use, sterile-packed product to the end user.

The aprevo® Cervical Intervertebral Body Fusion Devices include ACDF, ACDF-X and ACDF-X no cams. The aprevo® Cervical ACDF System, which includes the aprevo® Cervical ACDF Interbody, aprevo® Cervical ACDF-X Interbody, and the aprevo® Cervical ACDF-X (NO CAM) Interbody are designed to stabilize the cervical spinal column and facilitate fusion. The personalized aprevo® devices incorporate patient-specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient and include an aperture for the packing of bone graft. The aprevo® Cervical ACDF System interbodies are additively manufactured from Ti-6Al-4V ELI titanium alloy per F3001, while the screws are machined from Ti alloy per ASTM F136. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and the instruments are provided to the end-user as single use, sterile-packed products.

The purpose of this 510(k) is to extend the expiration of imaging used to create 3D surgical plans. There have been no changes made to the software used in the surgical planning process.

The provided FDA 510(k) clearance letter (K250827) for Carlsmed, Inc.'s "aprevo®" interbody fusion devices primarily concerns the renewal of previously cleared devices and the extension of the imaging expiration dating used for 3D surgical planning. Therefore, the document does not contain details of a clinical study assessing the performance of an AI-based device meeting acceptance criteria in the way one might expect for a novel AI/ML medical device submission.

Instead, the performance testing summary indicates that "Clinical data was used to evaluate imaging expiration. Expiration dating was validated using statistical analysis (DICE score) with an acceptance criterion of >0.80. Additionally, the performance was evaluated across key cohorts." This suggests that the "device" being evaluated for performance in this context is likely related to the software's ability to accurately segment or generate 3D models from imaging data over time, rather than the interbody fusion implants themselves. The clearance is for the physical implants, which are considered substantially equivalent to previously cleared predicates. The "performance testing" here seems to be an update or validation related to the software component of the surgical planning.

Given this context, I will extract information relevant to the software's performance, as that is the only "acceptance criteria" and "study" mentioned, even if it's not a typical AI model performance study against clinical outcomes.

Here's an interpretation based on the limited information provided, assuming the "device performance" refers to the imaging processing capabilities of the aprevo® system's software, specifically regarding the "expiration" of imaging data for 3D surgical plans:

Acceptance Criteria and Device Performance Study for Imaging Expiration

The context of this FDA 510(k) submission (K250827) indicates that the performance study was specifically undertaken to extend the expiration of imaging used to create 3D surgical plans. This suggests the "device performance" being assessed relates to the consistency and accuracy of the software's ability to process imaging data for surgical planning over time, implying that "aging" of the input imaging data does not degrade the software's output beyond an acceptable threshold.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only specifies the acceptance criterion. The specific numerical performance result (e.g., the exact DICE score achieved) is not provided in this public clearance letter. However, the clearance implies that the criterion was met.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not specified in the provided text.
• Data Provenance: "Clinical data was used." No details on the country of origin or whether the data was retrospective or prospective are provided.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. (e.g., 2+1, 3+1, none).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done?: No, an MRMC study comparing human readers with and without AI assistance is not mentioned or implied by the description of this performance evaluation, which focuses on "imaging expiration" and DICE score.

6. Standalone (Algorithm Only) Performance

• Standalone Performance Done?: Yes, the use of a "DICE score" for "imaging expiration" strongly suggests an algorithm-only performance evaluation, likely comparing the software's segmentation or 3D reconstruction output against a form of ground truth derived from the clinical data. The phrase "There have been no changes made to the software used in the surgical planning process" further indicates an assessment of the software's intrinsic capabilities.

7. Type of Ground Truth Used

• Type of Ground Truth: The use of "DICE score" typically implies that the ground truth involves expert-annotated segmentations or regions of interest within the medical images. The DICE score measures the spatial overlap between the algorithm's output and the ground truth. While not explicitly stated, it's highly probable that this ground truth was derived from expert consensus or manual annotation of anatomical structures on the clinical imaging data.

8. Sample Size for the Training Set

• Training Set Sample Size: Not mentioned. This submission is for an extension/validation of existing software, not the initial clearance of a newly developed AI model, so details on original training are not typically included here.

9. How Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not mentioned. As above, this document focuses on a validation study for imaging expiration, not the initial development or training of the AI algorithm.

Summary of Limitations Based on Provided Text:

The provided 510(k) summary (specifically the "Performance Testing Summary") is extremely concise regarding details of the study. It states that "Clinical data was used to evaluate imaging expiration" and that "Expiration dating was validated using statistical analysis (DICE score) with an acceptance criterion of >0.80. Additionally, the performance was evaluated across key cohorts."

Therefore, many typical details requested for robust AI/ML performance studies, such as specific sample sizes, expert qualifications, and adjudication methods, are not present in this public clearance letter. This is common for 510(k) summaries, which are often condensed versions of the full submission. The key takeaway is that the "performance testing" here addresses a specific aspect ("imaging expiration" for 3D surgical planning) of the software rather than a direct clinical efficacy study of the implant or a broad AI diagnostic/prognostic model.

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The aprevo® posterior/transforaminal lumbar interbody fusion device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® posterior/transforaminal lumbar interbody fusion device is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone. The device may be implanted via an open or minimally invasive approach.

The aprevo® posterior/transforaminal lumbar interbody fusion device is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six months of non-operative treatment. The aprevo® transforaminal lumbar interbody fusion device is to be filled with autograft bone and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone. The device is intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). The device may be implanted via an open or minimally invasive approach.

The aprevo® posterior/transforaminal intervertebral body fusion device is designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® device incorporates patient specific features and includes an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient radiological images.

The aprevo® posterior/transforaminal lumbar interbody fusion device is additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 and provided sterile. The associated instruments, which facilitate the placement, adjustment, and removal, if necessary, of the interbody device, are manufactured from stainless steel per ASTM A564 and provided sterile packaged for single use.

This FDA 510(k) clearance letter pertains to a physical medical device, specifically an intervertebral body fusion device, not a software-based AI device. Therefore, much of the information typically sought for AI/ML device acceptance criteria (e.g., ground truth establishment, training set details, multi-reader multi-case studies) is not applicable or present in this document.

However, I can extract the relevant information regarding acceptance criteria and the study that proves the device meets them based on the provided text.

Acceptance Criteria and Device Performance Study for aprevo® posterior/transforaminal lumbar interbody fusion device

This device is a physical implant designed for spinal fusion, and its acceptance criteria primarily revolve around mechanical performance and substantial equivalence to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not detail specific "test set" sample sizes in the context of clinical or evaluation studies as would be seen for AI/ML. For a physical device, testing is primarily non-clinical.

• Sample Sized for "Test Set": Not explicitly stated in terms of a population size. Non-clinical testing typically involves a sufficient number of device samples or test configurations to demonstrate mechanical performance according to the specified ASTM standards.
• Data Provenance: The mechanical testing references ASTM standards (e.g., ASTM F2077, ASTM F2267), indicating laboratory setting for mechanical performance evaluation. A "cadaveric validation" was also performed. Details on the number of cadavers are not provided. The data is thus derived from non-clinical (laboratory/engineering) studies and a cadaveric study.

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

This information is not applicable as the clearance is for a physical medical device, not a diagnostic or prognostic AI/ML device requiring expert ground truth for interpretation. Mechanical testing and cadaveric validation do not typically involve human experts establishing a "ground truth" in the same way an AI model's output would be compared to a consensus reading.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or prognostic devices to assess the impact of AI on human reader performance. This device is a physical implant.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable. This device is a physical implant and does not involve an "algorithm only" performance. Its performance is assessed through its mechanical properties and successful fusion in conjunction with human surgical intervention and bone graft.

7. The Type of Ground Truth Used

For the mechanical performance, the "ground truth" is established by adherence to engineering standards (ASTM F2077, ASTM F2267) and the performance characteristics of predicate devices against which the new device is compared for substantial equivalence. For the cadaveric validation, the "ground truth" would be the observed physical behavior and performance within the cadaveric model. There is no clinical ground truth (like pathology or outcomes data from human patients) presented in this 510(k) summary, as "Clinical Testing" is explicitly stated as "Not applicable."

8. The Sample Size for the Training Set

This information is not applicable. This refers to a training set for an AI/ML model, which is not relevant to this physical medical device.

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

This information is not applicable for the same reasons as point 8.

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The Testa™ TP Pivoting Spacer System with TiCell® Nano Advanced Surface Technology 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 L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Testa™ TP Pivoting Spacer System is to be used with autograft bone and/or allogenic bone graft composed of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Testa™ TP Pivoting Spacer System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The Testa™ TP Pivoting Spacer System consists of new interbody implants that are provided sterile and intended to be surgically implanted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar intervertebral body fusion. The system is provided in a range of sizes to accommodate the anatomic needs for range of patients and is designed with a central graft window to accommodate graft material. The implant features TiCell® Nano Advanced Surface Technology, a proprietary etched surface with micro and nano-scale features, on the superior and inferior latticed surfaces. This is intended to help with resistance to migration and to facilitate fusion. The components of the implant are fabricated from Titanium-6 Aluminum-4 Vanadium ELI (Ti-6Al-4V ELI) conforming to ASTM F3001 and ASTM F136.

The provided document, an FDA 510(k) Clearance Letter for the Testa TP Pivoting Spacer System, does not contain information regarding an AI/ML-based device. Instead, it describes a traditional medical device: an intervertebral body fusion device.

Therefore, many of the requests in your prompt, which are specific to the regulatory approval process for AI/ML medical devices (such as acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone AI performance, and AI ground truth establishment), cannot be answered from this document.

The document states: "Nonclinical testing was performed on the Testa™ TP Pivoting Spacer System to support substantial equivalence to the predicate device. The following testing was performed: Static and dynamic axial compression testing per ASTM F2077, Static and dynamic compression shear testing per ASTM F2077, Subsidence testing per ASTM F2267, Particulate and wear analysis per ASTM F1877. Clinical testing is not applicable." This indicates that the device was evaluated through bench testing and mechanical performance standards, not through AI/ML performance metrics or studies involving human readers or expert consensus on AI outputs.

Summary based on the provided document:

Since the device is a physical medical implant (intervertebral body fusion device) and not an AI/ML software, the requested information on AI-specific acceptance criteria and study methods is not applicable and is not present in the provided FDA 510(k) clearance letter. The document focuses on demonstrating physical and mechanical substantial equivalence to predicate devices through non-clinical bench testing.

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X-PAC® LLIF Expandable Lateral Cage System is indicated for intervertebral body fusion procedures 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. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are intended to be used with autograft and/or allograft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. X-PAC® LLIF Expandable Lateral Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

X-PAC® LLIF Expandable Lateral Cage System is a lumbar interbody fusion system comprised of a cage implant and surgical instruments. The implants are used to provide structural stability in skeletally mature individuals following discectomy, and the devices that are the subject of this 510(k) are placed via a lateral approach. The device is available in various sizes and footprints to accommodate varying anatomy and is designed to allow for intraoperative adjustment in the height of the cage. Surfaces of the upper plate and bottom housing that contact the vertebral endplates are "toothed" to provide stability within the intervertebral space. The outer surface teeth are designed to resist expulsion in all directions. The fenestrated cage contains openings to enhance bony ingrowth and has a bulleted nose for easier entry into the disc space. The implants are manufactured from medical grade titanium alloy per ASTM F136, and ASTM F1472. X-PAC® LLIF Expandable Lateral Cage System implants are single-use, provided non-sterile, and are intended to be steam sterilized before use. The surgical instruments are designed to facilitate precise placement of the device within the intervertebral disc body, and are re-usable, provided non-sterile, and are intended to be cleaned and steam sterilized before each use.

Here's an analysis of the provided FDA 510(k) clearance letter and submission summary for the X-PAC® LLIF Expandable Lateral Cage System, focusing on acceptance criteria and supporting studies, presented in the requested format:

Important Note: The provided document is a 510(k) clearance letter and accompanying summary. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical trials or extensive standalone performance studies in the way a PMA (Pre-Market Approval) might. Therefore, many of the requested details regarding human reader studies, expert qualifications for ground truth, and comprehensive clinical data are not typically found or required in a 510(k) for a device like an intervertebral cage system. The information below reflects what is available in the provided text.

1. Table of Acceptance Criteria and the Reported Device Performance

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

The provided document describes non-clinical mechanical testing based on recognized standards. It does not refer to a "test set" in the context of patient data or algorithm performance.

• Sample Size for Test Set: Not applicable, as this was mechanical testing of the device, not a data-driven study on patient data.
• Data Provenance: Not applicable. The testing was conducted in a laboratory setting per ASTM standards.

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

Not applicable. The "ground truth" for mechanical testing is established by adherence to the specified parameters and methodologies defined in the ASTM standards (e.g., force application, displacement measurement, wear rates). No human experts were involved in establishing "ground truth" for this type of testing.

4. Adjudication Method for the Test Set

Not applicable. This was mechanical testing following standardized protocols, not a study requiring adjudication of expert interpretations.

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. An MRMC comparative effectiveness study is not mentioned or applicable to this device, which is an intervertebral cage system. This type of study is more common for diagnostic AI software.

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

No. This device is a physical medical implant, not an algorithm or AI software. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" is defined by the established parameters and methodologies of the ASTM F2077-22 and ASTM F2267 standards. These standards define acceptable performance limits for mechanical properties (e.g., strength, durability, resistance to wear and expulsion) for intervertebral body fusion devices.

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant and does not involve AI or algorithms that require a "training set."

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

Not applicable. As there is no training set, there is no ground truth to establish for one.

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