Search Results

IVA-C (ACIF):
The IVA-C Cage System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

AEON-C (ACIF):
The AEON-C Cage System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C Cage System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device. If the device is being used without the provided screws, supplemental fixation must be used.

IVA-L (ALIF, PLIF, DLIF, TLIF) & AEON-L (ALIF):
The IVA-L Cage System and AEON-L Cage System are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AEON-L Cage System is designed for use with or without the bone screws, depending on the surgeon's discretion. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The IVA & AEON Cervical and Lumbar Cage System are cervical and lumbar intervertebral fusion cages that are implanted in the disc space between the intervertebral bodies to obtain fusion and mechanical stability. The cages are manufactured via Selective Laser Melting (SLM) 3D printing technology using a medical grade metal powder and/or by machining (CNC method). The cages are manufactured from titanium alloy powder per ASTM F3001 or titanium alloy per ASTM F136 or PEEK per ASTM F2026. The screws are manufactured from titanium alloy per ASTM F136. They are provided non-sterile to the end user. The patient contacting portion of all instruments is made from Stainless Steel per ASTM F899 and all instruments are provided non-sterile and intended to be sterilized by the end user prior to use.

This FDA 510(k) Clearance Letter is for the IVA & AEON Cervical and Lumbar Cage System, which are intervertebral body fusion devices. It is a Class II device.

Crucially, this document focuses on the substantial equivalence of a physical medical device (intervertebral cages) based on engineering performance tests, materials, and design features, not on the performance of an AI/ML software.

Therefore, most of the requested information regarding AI/ML device performance (acceptance criteria table, study details, human reader improvement, ground truth, training set, etc.) is not applicable to this specific submission.

The document states:

• "Summary of Performance Data (Nonclinical and/or Clinical):" and then lists "Non-Clinical Tests" such as Static/Dynamic Compression Bending, Static/Dynamic Compression Shear Bending, Static/Dynamic Torsion, and Subsidence, all referencing ASTM standards.
• "Clinical Tests: - N/A"

This means that the device was cleared based on non-clinical (laboratory/mechanical) testing, not on clinical performance studies involving patient data or AI/ML algorithm evaluation.

To answer your specific questions in the context of this document:

1. A table of acceptance criteria and the reported device performance:

   • Not Applicable (N/A) for AI/ML performance.
   • For the physical device, the acceptance criteria would be defined by the referenced ASTM standards (e.g., ASTM F2077, ASTM F2267) for specific mechanical properties (e.g., strength, durability, resistance to subsidence). The document states that the "Results of the non-clinical tests indicate that the device will perform within the intended uses," implying these criteria were met, but specific numerical performance data is not provided in this public summary.

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

   • N/A for AI/ML performance.
   • For the mechanical tests, the "sample size" would refer to the number of physical devices tested to ASTM standards. This information is not provided in this summary. Data provenance is also N/A as it's not patient data.

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

   • N/A. Ground truth establishment by experts is relevant for diagnostic or AI/ML interpretation performance, not for the mechanical testing of a physical implant.

4. Adjudication method:

   • N/A. Adjudication is relevant for expert consensus in AI/ML or clinical studies.

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:

   • N/A. This is a physical implant, not an AI-assisted diagnostic tool.

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

   • N/A. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • N/A for AI/ML. For the device, the "ground truth" would be established mechanical properties as defined by the ASTM standards (e.g., material properties, structural integrity under load).

8. The sample size for the training set:

   • N/A. There is no training set as no AI/ML algorithm is involved.

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

   • N/A. There is no training set.

In summary, the provided FDA 510(k) clearance letter pertains to a surgical implant, not an AI/ML software. Therefore, the questions related to AI/ML device performance and associated studies are not applicable to this document. The clearance is based on the substantial equivalence to predicate devices and adherence to mechanical performance standards, as indicated by the non-clinical tests section.

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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 Elevation Spine Saber-C System is a cervical interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) and is for use in one or two adjacent spinal levels. DDD 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. The SABER-C Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The SABER-C Spacer is intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and screws, the plate-spacer-screw assembly can be used as a stand-alone device with the SABER-C Anterior Cervical Plate acting as the supplemental fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and spikes, the plate-spacer-spike assembly should be used with additional supplemental fixation such as posterior cervical screw fixation.

The SABER-C Anterior Cervical Plate, when used without the spacer component and with screws, is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The Anterior Cervical Plate is not to be used with spikes when used without the Spacer component.

The SABER-C System is a cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The SABER-C System is inserted through an anterior cervical approach and is available in various geometric and material options to fit the clinical needs of the patient. The SABER-C System Anterior Cervical Plate is an anterior cervical fixation device this is available in various geometric and fixation options and can be used with various types of interbody spacers.
The previously cleared SABER-C interbody devices are offered manufactured from titanium alloy per ASTM F136 or titanium-coated radiolucent polyether ether ketone (PEEK), with titanium alloy or tantalum markers, as specified in ASTM F2026, ASTM F136, ASTM F1295, and ASTM F560. The SABER-C Anterior Cervical Plate and two fixation options, spikes or screws, are manufactured from titanium alloy, as specified in ASTM F136 and ASTM F1295. The plate is not to be used with spikes when used without the Spacer component.
The subject submission seeks to expand size offerings and gain clearance for expanded indications and minor design modifications to the previously cleared devices.

The provided text is a 510(k) clearance letter for the SABER-C System, an intervertebral body fusion device. It details the regulatory clearance, indications for use, device description, and a brief summary of performance testing.

However, the document does not contain information related to a study proving the device meets acceptance criteria specific to an AI/ML algorithm, nor does it specify any AI/ML components within the SABER-C System. The performance testing listed is entirely mechanical/physical bench testing for a physical implant (Axial Screw Pullout, Insertion Torque, plate pushoff), which is standard for orthopedic devices.

Therefore, it is not possible to complete the requested table and answer questions about AI/ML acceptance criteria, study design, sample sizes for AI, expert involvement for AI ground truth, MRMC studies, or standalone algorithm performance based on the provided text. The document is for a traditional medical device, not a software as a medical device (SaMD) or an AI-enabled device.

To address the prompt directly based on the provided text, the answer is that the document does not contain the information requested, as the device is a physical implant and not an AI/ML enabled medical device.

Summary of missing information directly related to AI/ML acceptance criteria and study:

• No AI/ML Component: The document describes a physical interbody fusion device and its associated plates and screws. There is no mention of any AI or machine learning functionality.
• Acceptance Criteria for AI/ML: Since there's no AI component, there are no acceptance criteria related to AI performance metrics (e.g., accuracy, sensitivity, specificity, AUC).
• Study Proving AI Compliance: There is no study described that would evaluate AI performance. The performance testing mentioned is purely mechanical (bench testing).
• Sample Size (AI): Not applicable, as there's no AI component.
• Data Provenance (AI): Not applicable.
• Experts for Ground Truth (AI): Not applicable.
• Adjudication Method (AI): Not applicable.
• MRMC Study: Not applicable.
• Standalone Performance (AI): Not applicable.
• Type of Ground Truth (AI): Not applicable.
• Training Set Sample Size (AI): Not applicable.
• Training Set Ground Truth (AI): Not applicable.

If the prompt assumed an AI/ML component was present and requested how one would describe these aspects for a hypothetical AI/ML device in a similar FDA clearance, I would construct a general example. However, as the instruction is to describe "the study that proves the device meets the acceptance criteria" based on the input, and the input clearly does not describe an AI/ML device, the direct answer is that the information is not present.

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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 Stabilis SA Cervical Stand-Alone System is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device system is designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space.

The Stabilis SA Cervical Stand-Alone System is intended for use at either one level or two contiguous levels in the cervical spine, from C2 to T1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Stabilis SA Cervical Stand-Alone System cages may be used as a stand-alone device when two (2) vertebral body bone screws are used. Stabilis SA Cervical Stand-Alone System cages with four (4) screw holes may be used as a stand-alone device when at least two (2) vertebral body bone screws are utilized with one inferior and one superior screw trajectory on opposite sides of the cage. If the physician chooses to use Stabilis SA Cervical Stand-Alone System cages with fewer than two (2) screws, then an additional supplemental spinal fixation system cleared for use in the cervical spine must be used.

Stabilis SA Cervical Stand-Alone System cages with four (4) screw holes may only be used at contiguous levels if at least two (2) vertebral body bone screws are utilized in each cage with one inferior and one superior screw trajectory on opposite sides of the cage, such that no more than two (2) vertebral body bone screws are implanted at the shared vertebral body with one inferior and one superior screw trajectory on opposite sides of the cages. Additionally, a cage with four (4) screw holes and a cage with two (2) screw holes can be implanted contiguously only if the cage with four (4) screw holes uses at least (2) vertebral body bone screws with one inferior screw on the left side of the cage and one superior screw on the right side of the cage.

The Stabilis SA cages are intervertebral body fusion devices intended for cervical interbody fusion using an anterior approach. The devices are intended to improve stability of the spine while supporting fusion. Stabilis SA constructs are intended for use at one or two contiguous levels in the cervical spine (C2-T1). The components are offered in different shapes and sizes to meet the requirements of the individual patient anatomy.

Stabilis SA Cervical Stand-Alone System cages are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion. All cages are manufactured using the L-PBF (laser powder bed fusion) additive manufacturing method. L-PBF allows for the formation of solid, non-porous cages with a layered porous lattice structure on the surfaces of the components, including the surfaces of the interior graft window. This intricate structure facilitates bone in-growth by providing a larger surface of implant/bone contact than a buffed surface. The cages are also titanium anodized to allow for identification of various heights by color. The Stabilis SA Cervical Stand-Alone System cages are secured on the vertebral bodies using bone screws. The bone screws are machined from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and passivated according to ASTM F86 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants.

Stabilis Ti SA 2 Interbody, Stabilis Ti SA 2 Interbody, Curved, Stabilis Ti SA 4 Interbody, Stabilis Ti SA 4 Interbody, Curved, Stabilis Ti ZP Interbody, Stabilis Ti ZP Interbody, Curved cages, and bone screws are also available with a hydroxyapatite coating to increase implant anchoring by facilitating osseointegration and enhancing early bone growth. All Stabilis SA Cervical Stand-Alone implants are only available sterile packaged.

Non-sterile, reusable surgical instruments to support implantation of the system are provided for use with Stabilis SA Cervical Stand-Alone devices are provided in steam sterilization trays.

Here's an analysis of the provided FDA 510(k) clearance letter for the Stabilis SA Cervical Stand-Alone System, focusing on the acceptance criteria and study information:

This document describes the mechanical testing performed on an intervertebral body fusion device and does not involve AI. Therefore, many of the typical questions regarding AI device studies are not applicable.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Device: Stabilis SA Cervical Stand-Alone System (Intervertebral Body Fusion Device)

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

The document does not specify the exact sample size for the mechanical performance testing (e.g., number of devices tested for each mechanical test). It refers to the tests as being conducted on "the worst-case subject device" and "new implant sizes and configurations."

The data provenance is from non-clinical (mechanical and material) testing performed on the physical device, not patient data. Therefore, concepts like country of origin or retrospective/prospective do not apply in the typical sense for clinical studies.

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

This question is not applicable as this is a non-clinical device clearance for an intervertebral body fusion device, not an AI/software device requiring "ground truth" derived from expert interpretation of clinical data. The "ground truth" here is the adherence to established mechanical and material standards and the performance equivalence to predicate devices.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to how expert disagreements are resolved when establishing ground truth in clinical data interpretation studies. This document describes mechanical and material testing, not clinical data assessment.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or prognostic AI/software devices where human reader performance is being evaluated with and without AI assistance. This document pertains to the mechanical and material safety and effectiveness of a physical implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This device is a physical implant, not an algorithm. Standalone performance typically refers to the diagnostic or predictive capability of an AI algorithm without human input or modification of the output.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Adherence to recognized industry standards: ASTM F2077 (Test Methods for Intervertebral Body Fusion Devices), ASTM F2267 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Devices Under Static Axial Compression), ASTM F3001 (Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI), ASTM F136 (Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy), and ASTM F86 (Practice for Surface Preparation and Marking of Metallic Surgical Implants).
• Performance equivalence to previously cleared predicate devices, as demonstrated through mechanical and material testing.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" as this is not an AI/machine learning device. The "training" for the device's design is based on engineering principles, material science, and the performance characteristics of previously cleared predicate devices.

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

Not Applicable. As there is no training set in the context of AI/ML, there is no ground truth established for it. The standards and predicate devices guide the design and manufacturing, but this is a different concept than ground truth for machine learning.

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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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The CONDUIT™ SYNFIX™ Evolution Secured Spacer System is a stand-alone anterior interbody fusion device with a microscope roughened surface and micro and nano-scale features indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the CONDUIT SYNFIX Evolution can be packed with autograft. If used with less than the four integrated bone screws, or for hyperlordotic implants (>20Deg), implants must be used with supplemental fixation systems cleared by the FDA for use in the lumbosacral spine.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The CONDUIT SYNFIX Evolution Secured Spacers are intervertebral body fusion devices intended for lumbar interbody fusion (ALIF). Four Screws are inserted through the anteriorly-located Plate into the adjacent vertebral bodies. The Screws lock securely to the Plate using a tapered-thread locking mechanism.

The CONDUIT SYNFIX Evolution Secured Spacer System is available as non-assembled Cage and Plate components in various heights and geometries to suit individual pathology and anatomical conditions. The Cage and Plate components are intended to be assembled at the point of use prior to implantation.

The CONDUIT SYNFIX Evolution Cages are made from Ti-6Al-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

The 3D Printed Conduit Cellular Titanium Cages have a microscopic roughened surface with micro and nano-scale features. The micro and nano features are on all surfaces of the Cage, including the superior, inferior, and peripheral surfaces, as well as each member of the internal cell structure.

The provided text is a 510(k) clearance letter for a medical device called the "CONDUIT™ SYNFIX™ Evolution Secured Spacer System," which is an intervertebral body fusion device.

Crucially, this document is for a traditional medical device (an implantable hardware system), not an Artificial Intelligence (AI) or software-as-a-medical-device (SaMD) product.

Therefore, the information requested in the prompt, such as acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC), sample sizes for test/training sets for AI, expert adjudication of AI ground truth, MRMC studies for AI, or standalone AI performance, is not applicable to this submission.

The acceptance criteria and study proving the device meets them, as described in this 510(k), relate to the mechanical performance, material properties, and biocompatibility of the physical interbody fusion device, not an AI algorithm.

Here's an analysis of the provided information relevant to the device's acceptance criteria and studies:

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

The document mentions that mechanical testing was performed to "allow comparison with established acceptance criteria." While the specific numerical acceptance criteria (e.g., minimum load to failure, maximum displacement) are not explicitly detailed in the publicly available summary (which is common for 510(k) summaries), the types of tests conducted and the general conclusion indicate that the device met these criteria.

1. Table of Acceptance Criteria and Reported Device Performance (as inferred for a physical device):

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

• Sample Size: Not specified in the summary document. For mechanical testing of medical devices, "sample size" refers to the number of physical device units tested for each configuration or stress condition. These studies are typically conducted in a laboratory setting.
• Data Provenance: Laboratory testing (mechanical, MR compatibility). The country of origin of the data is not specified but is typically internal lab data or contracted third-party lab data.
• Retrospective or Prospective: Not applicable in the traditional sense for physical device testing. The tests are designed to assess the device's properties under simulated conditions.

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

• Not Applicable. This pertains to AI/software performance evaluation. For physical device testing, "ground truth" is established by calibrated measuring equipment and standardized test methods (e.g., ASTM standards). The "experts" are typically engineers and technicians responsible for conducting the tests and interpreting the results against pre-defined engineering acceptance criteria.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. This relates to human expert consensus for AI ground truth labeling. For mechanical testing, the results are objective measurements from testing equipment validated against industry standards.

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:

• Not Applicable. This is specific to AI/software for diagnostic or image-interpretation tasks. No such study was conducted or required for this physical device.

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

• Not Applicable. This is specific to AI/software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For mechanical testing, the "ground truth" is derived from standardized test methods (e.g., ASTM F2077, F2267) that define specific performance thresholds based on mechanical properties (e.g., ultimate strength, displacement within limits) and material science. The goal is to demonstrate that the device performs equivalently to predicate devices under defined mechanical loads and environmental conditions.

8. The sample size for the training set:

• Not Applicable. This pertains to AI model development.

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

• Not Applicable. This pertains to AI model development.

Conclusion from the 510(k) Summary:

The manufacturer "demonstrated substantial equivalence" by showing that their device performs mechanically and in terms of MR compatibility similarly to legally marketed predicate devices, and that the materials and design are appropriate for the intended use. The reliance on established ASTM standards and comparison to predicate devices are the primary methods for demonstrating safety and effectiveness for this type of medical implant.
The summary explicitly states: "No clinical data was necessary to demonstrate substantial equivalence, nor safety and effectiveness of this system." This further confirms that the evaluation was based on non-clinical (mechanical, material, and MR compatibility) testing and comparison to predicates.

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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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