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The COMET Lumbar Interbody Fusion Cage is indicated for use in intervertebral body fusion of the Spine. The COMET Lumbar Interbody Fusion Cage is inserted via a transforaminal posterior lumbar fusion procedures in skeletally mature patients with degenerative disc disease (DDD defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) and intended for use with autogenous bone graft at one or two contiguous levels of the lumbosacral spine (L2-S1). The COMET Lumbar Interbody Fusion Cage is intended to be used with supplemental fixation systems cleared by the FDA for use in the lumbar spine. Patients should have at least six months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

The COMET Lumbar Interbody Fusion Cage is a hollow, bullet-shaped PEEK cage (per ASTM F2026) with three Tantalum marker pins (per ASTM F560). It is indicated for use in skeletally mature patients for the lumbar spine intervertebral fusion. It is angulated 4°to accommodate the lordotic curve (except for the smallest height of each footprint, which does not have a lordotic angle.) The Cage devices are offered in a variety of different sizes with varying footprint dimensions to accommodate a multitude of anatomical needs. The implant has serrations on the top and bottom for fixation and the hollow space of the implant is intended to hold autogenous bone graft for fusion purposes. The COMET Lumbar Interbody Fusion Cage is supplied "Sterile".

The document describes a 510(k) premarket notification for the "COMET Lumbar Interbody Fusion Cage" and references a predicate device, the "SYNTHES T-PAL SPACER" (K100089). This type of submission is for medical devices and typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to prove effectiveness or extensive AI performance studies.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies, does not directly apply in the context of this 510(k) submission.

Instead of clinical performance, the approval hinges on demonstrating:

• Identical Indications for Use.
• Similar technological characteristics, materials, and operational principles.
• Non-clinical testing to ensure the device meets established mechanical performance standards as outlined in relevant ASTM standards.

Here's a breakdown of the information that is available in the document, mapped against your request:

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

The document does not provide a table of acceptance criteria with specific numerical targets and the device's reported performance against them in the way clinical studies for AI algorithms might. Instead, it refers to non-clinical mechanical testing performed in accordance with specific ASTM standards. The "acceptance criteria" here are implied by compliance with these standards, meaning the device must withstand the forces outlined in the tests without failure.

The reported device "performance" is implicitly stated as having "provided in support of substantial equivalence," meaning it passed these tests.

The following non-clinical tests were performed:

• Static Compression per ASTM F2077
• Static Compression Shear per ASTM F2077
• Subsidence per ASTM F2267
• Expulsion
• Dynamic Compression per ASTM F2077
• Dynamic Compression Shear per ASTM F2077

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

This information is not applicable as this is a non-clinical, mechanical device submission, not an AI or diagnostic tool clinical study. The "test set" refers to physical samples of the device used for mechanical testing. The document states "The worst-case size for the COMET Lumbar Interbody Fusion Cage was conducted" for these tests, implying specific configurations of the device were tested. No data provenance in the context of patient data is relevant here.

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)

This information is not applicable. Ground truth, in the sense of expert radiological or pathological labels, is not relevant for a mechanical device submission. The "ground truth" for mechanical testing is defined by the ASTM standard test methods and the physical properties observed during testing.

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

This information is not applicable. Adjudication methods are typically for subjective clinical assessments or image interpretations, which are not part of this device submission.

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

This information is not applicable. No MRMC comparative effectiveness study was conducted as this is a mechanical interbody fusion cage, not an AI or imaging diagnostic device intended to assist human readers.

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

This information is not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device, in the context of its safety and effectiveness, is established through compliance with recognized mechanical testing standards (ASTM F2077, ASTM F2267). This demonstrates that the device has appropriate structural integrity and performance characteristics for its intended physical function.

8. The sample size for the training set

This information is not applicable. This is not an AI algorithm submission, so there is no "training set."

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

This information is not applicable. There is no "training set" or ground truth for it as this is a mechanical device.

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The INNESIS PEEK TL Cage is 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 I spondylolisthesis or retrolisthesis at the involved level. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The INNESIS PEEK TL Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Transforaminal Lumbar Interbody Fusion (T-LIF) technique. The INNESIS PEEK TL Cages are offered in a variety of heights, footprints and curved shapes. The device has ridges on both its inferior and superior surfaces, and two large graft windows which help facilitate bony integration. The device includes marker (pin) for radiological evaluation of the position and orientation of the radiolucent PEEK Cage. The INNESIS PEEK TL Cage components are manufactured from Polyetheretherketone (VESTAKEEP® 14 R, ASTM F2026). They contain marker made of medical grade titanium alloy (Ti6Al4V-ELI, ASTM F136). The INNESIS PEEK TL Cage and instrumentation set is sold non-sterile.

This document is a 510(k) premarket notification for a medical device, the INNESIS PEEK TL CAGE. It does not contain information about the acceptance criteria and study proving device performance in the context of an AI/human-in-the-loop study. Instead, it details the substantial equivalence of this intervertebral body fusion device to predicate devices based on materials, design, indications for use, operational principles, and mechanical testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for device performance related to AI or multi-reader multi-case studies, as that information is not present in the provided text.

The closest relevant information, regarding device performance in a general sense, is about mechanical testing to demonstrate substantial equivalence:

Summary of Mechanical Testing:

• Test Standards:
  • Static and dynamic axial compression test: ASTM F2077-11
  • Static compression shear test: ASTM F2077-11
  • Static and dynamic torsion test: ASTM F2077-11
  • Static subsidence test: ASTM F2267-04
  • Expulsion test: ASTM Draft Standard F04.25.02.02.
• Conclusion: The tests performed demonstrated that the INNESIS PEEK TL Cage met required mechanical strengths and that any minor geometric differences from predicate devices did not impact performance. The device was found substantially equivalent to the predicate devices.

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The EOI FLXfit Intervertebral body fusion device is indicated for interbody fusion in patients with degenerative disc disease (DDD) at one 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. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The EOI FLXfit device is intended to be used with supplemental spinal fixation system and with autogenous bone graft.

EOI FLXfit Intervertebral Body Fusion Device is made From Titanium (Ti6A14V-ELI per ASTM norm F136). This is an articulated-expanded device with height ranges from 8mm through 14mm. The device also expands in height to provide lordosis angle correction of up to 10°. The FLXfit components are manufactured from titanium alloy (ASTM F136). It is implanted via a Transforaminal approach and supplemented by posterior fixation. The device is made from two titanium segments that are serrated on the superior and inferior surfaces. The titanium segments are attached (linked) with titanium wedge pins that provide the means to form the implant into its final articulated shape.

The provided document is a 510(k) summary for the FLXfit Intervertebral Body Fusion Device, which focuses on demonstrating substantial equivalence to predicate devices through mechanical testing. It is not a study that evaluates the performance of a device using clinical or reader studies, especially for AI/ML devices. Therefore, a significant portion of the requested information, such as sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for clinical performance, is not applicable or available in this document.

However, I can extract the acceptance criteria and reported device performance from the provided mechanical testing data.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance data based on mechanical testing standards, rather than clinical efficacy. The acceptance criterion for this type of submission is typically "substantial equivalence" to predicate devices, meaning the device performs at least as well as or better than the predicate devices under the specified tests. The reported performance is that the device met these criteria.

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

• Test Set Sample Size: Not applicable. The "test set" here refers to physical devices undergoing mechanical testing, not a dataset of patient cases for an AI/ML device. The document does not specify the number of devices tested for each mechanical test.
• Data Provenance: The data comes from "non-clinical testing" and a "usability cadaveric study." No country of origin is specified, but it can be inferred to be from the manufacturer's testing facilities or contract labs. The nature is experimental, not retrospective or prospective clinical data.

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

Not applicable. For mechanical testing, "ground truth" is established by the specifications of the ASTM standards themselves, and the measurement of physical properties, not by expert consensus on clinical cases. The usability study involved cadavers, likely evaluated by surgical or biomechanical experts, but no details are provided on their number or qualifications.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies among human readers for establishing ground truth from patient data. This document describes mechanical testing.

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 a medical device (intervertebral body fusion device), not an AI/ML diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed or described.

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

Not applicable. As noted, this is a physical medical device, not an algorithm.

7. The type of ground truth used

• For Mechanical Testing: The ground truth is defined by the requirements of the ASTM standards (e.g., F2077, F2267) which specify acceptable load-bearing capacities, fatigue life, and other mechanical properties for intervertebral body fusion devices. Substantial equivalence to predicate devices also serves as a comparative "ground truth" for performance.
• For Usability Cadaveric Study: The ground truth would be the direct observation and evaluation of the device's clinical application, expansion mechanism, and intra-operative subsidence in a cadaveric model by qualified personnel (likely surgeons or biomechanical engineers).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of mechanical testing or regulatory submission for a physical medical device. This term applies to machine learning models.

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

Not applicable. There is no training set mentioned in this document.

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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 SYNSTER CERVICAL CAGE 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 disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system 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.

The SYNSTER (ALIF, PLIF, PTLIF and TLIF) CAGE is 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 I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:

• 1. Cervical Interbody Fusion Device (SYNSTER® CERVICAL CAGE), which may be implanted as a single device via an anterior approach.
• 2. Lumbar Interbody Fusion Device [SYNSTER® (ALIF, PLIF, PTLIF and TLIF) CAGE], which may be implanted
  • As a single device via an Anterior or Anterolateral or Lateral (ALIF) approach; ।
  • Bi-laterally via a posterior (PLIF) approach; ।
  • As a single device via a posterior transforaminal (PTLIF) approach; -
  • As a single device via a transforaminal (TLIF) approach. -

The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain titanium makers (ASTM F136) to assist the surgeon with proper placement of the device.

The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE is implanted by using the (SCCI, SACI, SPCI, SPTCI and STCI) instruments manufactured from stainless steel materials that conform to ASTM F899.

This submission describes the SYNSTER® CERVICAL CAGE and SYNSTER® (ALIF, PLIF, PTLIF and TLIF) CAGE, intervertebral body fusion devices. The devices are made of PEEK Optima LT1 with titanium markers and are intended for intervertebral body fusion in skeletally mature patients with degenerative disc disease. The testing described for these devices primarily focuses on mechanical performance rather than AI/software performance. Therefore, many of the typical AI/ML-related questions are not applicable to this submission.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in terms of number of devices tested, but the testing refers to "non-clinical tests" conducted in accordance with specific ASTM standards. These standards typically involve a defined number of samples for each test type. The document does not specify the exact number of units tested.
• Data Provenance: Not applicable in the context of clinical data. The data originates from benchtop mechanical testing performed according to ASTM standards. There is no information regarding country of origin or retrospective/prospective nature as it's not clinical data.

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 this type of device (mechanical performance) is established by adherence to recognized national/international standards (ASTM F2077-03, ASTM F2267-04, and ASTM Draft Standard F 04.25.02.02) and engineering principles, not by expert consensus on clinical interpretation. The "experts" would be materials scientists and mechanical engineers performing and interpreting the tests according to the standards.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of human interpretations. Mechanical test results are objective measurements compared against specified criteria from 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 submission is for a physical medical device (intervertebral cage), not an AI/ML software device.

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

Not applicable. This submission is for a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for demonstrating the device's acceptable performance is defined by the mechanical properties and criteria stipulated in the referenced ASTM standards. These standards provide objective measures and acceptance thresholds for static and dynamic compression, shear, torsion, subsidence, and expulsion.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; therefore, there is no training set in the conventional sense.

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

Not applicable. There is no training set for this physical medical device.

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