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The MONDRIAN™ Lumbar Interbody Fusion Cage 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. The system is to be used with supplemental fixation cleared for use in the lumbar spine. Hyperlordotic cage offerings (>20°) require the use of anterior fixation. 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. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The MONDRIAN™ Lumbar Interbody Fusion Cage system is intended for use as an interbody fusion cage device to maintain lumbar intervertebral spacing and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of PEEK-OPTIMA LT1 –or- PEEK VESTAKEEP i-Grade with Tantalum marker pins; titanium alloy; or a combination of PEEK, Titanium Alloy, or both.

The MONDRIAN™ Lumbar Interbody Fusion Cage System consists of cages made out of PEEK with marker pins made of Tantalum or Titanium alloy, both of which are identical to its predicate device. All of the heights, lengths, and widths are similar and/or within ranges covered by its predicate devices.

This document describes the MONDRIAN™ Lumbar Interbody Fusion Cage System and its substantial equivalence to predicate devices, not an AI/ML powered medical device. Therefore, much of the requested information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable.

However, I can extract information related to the device's performance and the studies conducted to demonstrate its safety and effectiveness.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MONDRIAN™ Lumbar Interbody Fusion Cage System are based on demonstrating equivalent mechanical performance to predicate devices under the same test conditions. The "reported device performance" is that it met these criteria.

Study Details (as applicable to a physical medical device submission):

• Sample sized used for the test set and the data provenance: Not explicitly stated as a separate "test set" in the context of an AI/ML device. The "test set" here refers to the actual physical devices (MONDRIAN™ Lumbar Interbody Fusion Cage System) subjected to mechanical testing. The provenance of these devices would be their manufacturing origin (CTL Medical Corporation). The studies are in vitro mechanical tests.
• 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 engineering standards and measurements, not expert consensus.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Mechanical testing results are objective measurements against established standards and predicate device performance.
• 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 a physical interbody fusion cage, not an AI/ML diagnostic or assistive device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by established engineering and material standards (e.g., ASTM F2026, ASTM F136, ASTM F560, ASTM F899, ASTM B211, ASTM B221) and the demonstrated performance of the predicate devices.
• The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML algorithm.
• How the ground truth for the training set was established: Not applicable.

Summary of the Device's Basis for Clearance:

The MONDRIAN™ Lumbar Interbody Fusion Cage System received FDA clearance (K192863) based on substantial equivalence to existing predicate devices (primarily CEZANNE™ and CEZANNE-II™ Lumbar Interbody Fusion Cage Systems). This means its safety and effectiveness were demonstrated by showing it has:

• The same intended uses.
• Similar indications, technological characteristics, and principles of operation.
• No new issues of safety or effectiveness raised by its technological differences.
• Demonstrated equivalent mechanical performance to the cited predicate devices under the same test conditions in the types of tests listed (Static Axial Compression, Static Compression Shear, Dynamic Axial & Compression Shear, Expulsion, Subsidence).

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When used as an intervertebral body fusion device, the InterForm Lumbar Interbody Cage System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft to facilitate fusion. Additionally, the InterForm Lumbar Interbody Cage System is intended for use with supplemental spinal fixation systems cleared for use in the lumbar spine. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The InterForm PLIF Interbody Fusion Implants consists of cage footprint widths of 9, 11, 13mm , lengths of 20, 22, 24, 26, 30mm, ranging in height from 7mm to 14mm with lordosis of 5°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm PLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, posterior approach and used with supplemental fixation and autogenous bone graft.

The InterForm TLIF Interbody Fusion Implants consists of cage footprints widths of 9, 11, 13mm , lengths of 22, 24, 26, 28, 30, 32mm, ranging in height from 7mm to 14mm with lordosis of 5°, which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm TLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, transforaminal approach and used with supplemental fixation and autogenous bone graft.

The InterForm OTLIF Interbody Fusion Implants consists of cage footprint widths of 9, 11, 13mm , lengths of 20, 22, 24, 26, 30, 32, 34mm, ranging in height from 7mm to 14mm with lordosis of 0°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm OTLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, posterior or transforaminal approach and used with supplemental fixation and autogenous bone graft.

The InterForm LLIF Interbody Fusion Implants consists of cage footprint widths of 18, 20, 22, 24mm, lengths of 40, 45, 50, 55, 60mm, ranging in height from 8mm to 18mm with lordosis of 0° or 7°, which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm LLIF Interbody Fusion devices are intended to be implant via a lateral approach and used with supplemental fixation and autogenous bone graft.

The InterForm ALIF Interbody Fusion Implants consists of cage footprints of 30x24mm, and 39x30mm (DxW), ranging in height from 10mm to 20mm with lordosis of 0°, 7° or 12° which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm ALIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, anterior approach and used with supplemental fixation and autogenous bone graft.

All implants are packaged non-sterile to be sterilized at the hospital.

Materials:

PEEK Optima LT1 conforming to ASTM F2026. Unalloyed tantalum conforming to ASTM F560.

Function:

Maintain adequate disc space until fusion occurs.

The InterForm Interbody Cage System is intended for spinal fusion procedures.
Here's a breakdown of the acceptance criteria and the study done:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The documentation explicitly states that the device is considered "substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances." The acceptance criteria, while not explicitly numerical, are therefore met by demonstrating performance comparable to the already legally marketed predicate devices. The study concludes that the results indicate the InterForm Interbody Cage System is equivalent.

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

This information is not provided in the document. The studies listed are non-clinical tests (mechanical testing), not studies involving human or animal subjects that would generate a "test set" of data in the typical sense of evaluating AI or clinical outcomes. The provenance of the samples (e.g., specific batches of PEEK and tantalum used in testing) is not detailed, nor is it relevant given the mechanical nature of the tests.

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

This information is not applicable as the studies are non-clinical mechanical tests, not clinical evaluations requiring expert interpretation or ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical mechanical tests.

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 was not done. The document explicitly states: "No clinical studies were performed." This device is a physical medical implant, not an AI or imaging device that would typically involve human reader studies.

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

This information is not applicable as the device is a physical medical implant and not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be the established mechanical properties and performance standards outlined in the ASTM F2077 and ASTM F2267 standards, and the performance characteristics of the predicate devices. For mechanical tests, the ground truth is objectively measured physical properties and behaviors of the material and device under specific conditions.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical medical implant and would not have a "training set" in the context of machine learning or AI. For mechanical testing, the "samples" would be the manufactured devices or materials subjected to the tests. The exact number of units tested for each non-clinical test (static compression, dynamic compression, subsidence, expulsion) is not specified, but it would typically be a statistically significant number of physical samples to ensure reliability and reproducibility of the results according to the ASTM standards.

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

This information is not applicable for the same reasons as #8. The "ground truth" for material and device properties in mechanical testing is established through standardized testing procedures and validated measurement techniques, as defined by organizations like ASTM.

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The Phantom Plus Ceramic Cages-Lumbar are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six (6) months of nonoperative therapy.

The Phantom Plus Ceramic Cage System-Lumbar is to be filled with autogenous bone graft material. The Phantom Plus Ceramic Cages-Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System.

The Phantom Plus Ceramic Cages-Cervical are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level.

DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Phantom Plus Ceramic Cages-Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone.

The Phantom Plus Ceramic Cages-Cervical are to used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Phantom Plus Ceramic Cage System consists of a variety of hollow vertebral body spacers featuring convex, bullet nose design and an axial void designed to hold bone graft material. The subject device is offered in various lengths. The subject devices are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices range from 6mm to 22mm in height and 14mm to 45mm in length.

The provided text describes a 510(k) premarket notification for the Phantom Plus® Ceramic Cage System, which is an intervertebral body fusion device. The focus of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove the device meets those criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, as well as details about sample sizes, expert involvement, and ground truth establishment, cannot be directly extracted from the provided text because such a study was not presented.

Instead, the submission relies on demonstrating compliance with recognized performance standards and substantial equivalence to predicate devices.

Here's a summary of what can be gathered, addressing the spirit of the request as much as possible given the available information:

1. Table of acceptance criteria and the reported device performance

Since this is a 510(k) submission focused on substantial equivalence to predicate devices and compliance with existing standards, explicit acceptance criteria for a novel performance study are not defined or reported in the text. Instead, the device's performance is demonstrated by meeting the requirements of recognized ASTM and AAMI standards.

• Adherence to ASTM F2077 (for lumbar intervertebral body fusion devices)
• Adherence to ASTM F1839 (for ceramic materials for surgical implants)
• Adherence to ASTM F1877 (for intervertebral body fusion devices with integrated plate fixation) | "Testing and engineering analyses on this device indicate that the Phantom Plus Cage System is substantially equivalent to predicate devices... all applicable requirements were met." |
  | Material/Biocompatibility:
• Adherence to AAMI TIR 33 (Guidance for biocompatibility risk management)
• Same or equivalent materials as predicate devices (ceramic) | "Testing and engineering analyses on this device indicate that the Phantom Plus Cage System is substantially equivalent to predicate devices... all applicable requirements were met." |
  | Design and Function:
• Same or equivalent design and function as predicate devices (e.g., hollow vertebral body spacers, convex, bullet nose design, axial void for bone graft, angular teeth for expulsion resistance) | "The Phantom Plus Ceramic Cage System was shown to be substantially equivalent to previously cleared devices, including itself (K082801) and the Valeo® Spacer System (K091278), and has the same or equivalent indications for use, design, function, and materials used." |
  | Indications for Use:
• Equivalent indications for use as predicate devices (e.g., DDD patients with specific conditions, autogenous bone graft, supplemental fixation) | "The Phantom Plus Ceramic Cage System was shown to be substantially equivalent to previously cleared devices... and has the same or equivalent indications for use..." |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a clinical "test set" in the context of a prospective clinical trial. The "testing and engineering analyses" mentioned likely refer to bench testing and mechanical studies conducted in a laboratory setting, not human clinical trials. Therefore, information about sample size (patients), data provenance, or retrospective/prospective nature is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as a clinical test set with human subject data requiring expert ground truth establishment is not discussed in this 510(k) summary.

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

Not applicable.

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 device is an implant, not an AI-assisted diagnostic tool, and therefore MRMC studies are not relevant.

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

Not applicable.

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

Not applicable, as a clinical study requiring ground truth is not presented. The "ground truth" for this submission is adherence to recognized performance standards and demonstrated mechanical equivalence to predicates.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device requiring a training set. The "engineering analyses" would involve material samples and device prototypes.

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

Not applicable.

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