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The Kodiak C Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine (C2-T1). The Kodiak C Cervical Cages are intended to be used with autograft and/or allograft bone (allogenic bone graft comprised of cancellous and/or corticocancellous bone graft). The Kodiak C Cervical Cages are intended to be used with an FDA cleared cervical supplemental fixation system. Patients should receive 6 weeks of nonoperative treatment prior to treatment.

The Kodiak C Corpectomy Cages are indicated for use in the thoracolumbar spine (T1-L5) for partial or total replacement of a damaged, collapsed, or unstable vertebral body due to trauma/fracture or tumor, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Kodiak C Corpectomy Cages are intended to be used with autograft and/or allograft bone. The Kodiak C Corpectomy Cages are intended to be used with an FDA cleared supplemental fixation device such as a lumbar pedicle screw system.

The Met One Technologies Kodiak C Cervical Cage is a cervical intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The cervical cages have a central cavity to permit the packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces to resist expulsion, and lattice windows for radiographic visualization. The implants are additively manufactured from Ti-6A1-4V ELI and are available in a variety of height, footprints, and lordotic configurations to suit individual patient anatomy.
The Met One Technologies Kodiak C Corpectomy Cage is a thoracolumbar vertebral body replacement device (VBR) that is implanted to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body. The corpectomy cages have a central cavity to permit the packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces to resist expulsion, and lattice windows for radiographic visualization. The implants are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy.

This document is a 510(k) Summary for the Kodiak C Spinal Implant System, a medical device. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving performance against specific acceptance criteria in the context of AI/ML or diagnostic performance.

Therefore, the information requested regarding acceptance criteria, study details (sample size, data provenance, expert qualification, adjudication, MRMC, standalone performance, ground truth), training set sample size, and ground truth establishment cannot be fully provided from the given document. This document describes mechanical and material testing, not diagnostic or AI performance.

Here's an attempt to answer based on the provided text, highlighting what is present and what is missing:

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

The document lists performance tests conducted, but it does not explicitly state quantitative acceptance criteria or reported numerical performance values for these tests. It only states that the device "demonstrated substantial equivalence" to predicate devices, implying that the results met relevant industry standards (e.g., ASTM standards) but without providing the actual data or specific thresholds.

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

• Test set sample size: Not specified. The document refers to "the following test modes" and implies mechanical testing of devices, not clinical studies with patient data.
• Data provenance: Not applicable in the context of mechanical device testing. The tests are likely performed in a lab setting.

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. This is a medical device approval involving mechanical properties and material composition, not diagnostic interpretation by experts. Ground truth in this context would refer to material specifications and engineering standards, not expert medical opinions.

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

• Not applicable. Adjudication methods are relevant for subjective interpretations of data, not for objective mechanical test results.

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. This document does not mention any MRMC study or AI assistance. The device is a physical spinal implant.

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

• No. This document does not pertain to an algorithm or AI.

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

• The "ground truth" for this type of device (spinal implant) would be established by engineering specifications, material standards (e.g., ASTM F3001 for Ti-6Al-4V ELI), and biomechanical testing standards (e.g., ASTM F2077, ASTM F2267). The device's performance is compared against these known, objective standards to demonstrate substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. This document does not describe an AI/ML device that requires a training set.

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

• Not applicable. This document does not describe an AI/ML device.

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The Camber Spine Technologies SPIRA-C Integrated Fixation System consists of a stand-alone interbody device indicated for use at one or two contiguous levels in the cervical spine, from C2-C3 disc to the C7-T1 disc, in skeletally mature patients who have had six weeks of non-operative treatment for the cervical disk disease is defined as intractable radiculopathy and/or myelopathy with hermiated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The SPIRA-C Integrated Fixation System must be used with internal screw fixation. The Camber Spine Technologies SPIRA-C Integrated Fixation System must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.

The SPIRA®-C Integrated Fixation System consists of a stand-alone interbody fusion device with internal screw fixation. The SPIRA®-C Integrated Fixation System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one or two levels from the C2-C3 disc to the C7-T1 disc. The system is comprised of a Titanium Alloy (Ti-6Al-AV ELI) interbody cage and screws. The SPIRA®-C Integrated Fixation System cages are provided in 7 degrees of lordosis, 6-12mm heights, 14-20mm widths and 13-16mm depths. This device must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The SPIRA® C Integrated Fixation System is that has spiral supports to allow chamber to permit packing with autogenous and/ or allogenic bone to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. The titanium alloy interbody cage also comes preassembled with a titanium alloy, built-in rotary locking mechanism. The bone screws used with this device are provided in self-tapping options, along with variable angle and fixed angle trajectories, and are manufactured from medical grade titanium alloy. The bone screws are provided in 3.5mm and 4.0mm diameters and 12-18mm lengths.

This document describes the SPIRA-C Integrated Fixation System, an intervertebral body fusion device. The acceptance criteria and the study proving the device meets these criteria are outlined in the "Performance Testing Summary" section.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "Testing performed" and "The results demonstrate" but does not specify the sample size for the mechanical tests. The data provenance is not explicitly stated as retrospective or prospective, but given the nature of mechanical testing for a medical device, it would be prospective laboratory testing conducted specifically for this submission. The "country of origin of the data" is not stated, but the submission is to the U.S. FDA, implying the data would be generated in a manner acceptable for U.S. regulatory standards.

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

This is a mechanical device test, not an AI or diagnostic imaging study. Therefore, the concept of "ground truth established by experts" in the clinical sense (e.g., radiologists interpreting images) does not apply. The "ground truth" here is based on engineering standards (ASTM) and performance relative to predicate devices. The expertise would lie in the engineers and technicians conducting and interpreting the mechanical tests according to these standards. The document does not specify the number or qualifications of the personnel who performed these tests.

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

Not applicable. This is a mechanical device test, not a clinical study involving human interpretation or adjudication.

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 document pertains to the mechanical safety and effectiveness of an intervertebral body fusion device, not an AI or diagnostic imaging system.

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

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 mechanical device testing is based on:

• Established ASTM standards (F2077-18 and F2267-04): These standards define methodologies and criteria for evaluating spinal implant performance.
• Performance of legally marketed predicate devices: The device's performance is accepted if it is "as mechanically sound as predicate devices." This implies that the 'ground truth' for acceptable performance is benchmarked against the established performance of existing, cleared devices.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

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

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SPIRA Open Matrix ALIF: The Camber Spine Technologies SPIRA™ Open Matrix ALIF 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 radios. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine Technologies SPIRA™ Open Matrix ALIF is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine Technologies SPIRA™ Open Matrix ALIF system must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

SPIRA Open Matrix LLIF: The Camber Spine Technologies SPIRA Open Matrix LLIF 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 radios. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine Technologies SPIRA Open Matrix LLF is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine Technologies SPIRA Open Matrix LLIF system must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

SPIRA Open Matrix ALIF is an interbody fusion device with an open matrix design consisting primarily of arched support members to permit bone growth (i.e., interbody fusion) throughout the implant, SPIRA Open Matrix ALIF. With the exception of the perimeter, all surfaces have a roughened texture to help prevent movement of the device.

SPIRA Open Matrix LLIF is an interbody fusion device with an open matrix design consisting primarily of spiral support members to permit bone growth (i.e., interbody fusion) throughout the implant, SPIRA-L Open Matrix LLIF.

The purpose of this submission is the addition of the allogenic bone graft indication to both SPIRA ALIF and SPIRA LLIF devices that have been cleared under K162986 and K180724 respectively.

The provided text is a 510(k) summary for a medical device (SPIRA Open Matrix ALIF and LLIF) and does NOT contain information about acceptance criteria or a study proving that a device meets those criteria, particularly in the context of an AI/algorithm-driven device.

The document describes the device, its indications for use, and a comparison to predicate devices for substantial equivalence. It briefly mentions "Performance Data" but this refers to a Finite Element Analysis (FEA) performed to evaluate the effects of design changes on the implant, not an AI or algorithm's performance against clinical endpoints or ground truth.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text, as this information is not present. The questions you posed are typically relevant for AI/ML-driven medical devices, which this submission is not.

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The Camber Spine Technologies SPIRA-VTM Open Matrix Corpectomy Cage is indicated for use in the Thoracolumbar Spine (T1-L5) to replace collapsed, or an unstable vertebral body due to tumor or trauma (i.e., fracture). The Camber Spine Technologies SPIRA-VTM Open Matrix Corpectomy is intended to be used with additional FDA-cleared supplementary fixation systems.

The Camber Spine Technologies SPIRA-VTM Open Matrix Corpectomy Cage system must be used with autogenous graft material.

The Camber Spine Technologies SPIRA-VIM Open Matrix Corpectomy Cage is a device that has spiral supports to allow for a hollow chamber to permit packing with autogenous bone to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place.

The provided document is a 510(k) premarket notification letter for a medical device called the "Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage." This document focuses on demonstrating that the new device is substantially equivalent to existing, legally marketed predicate devices. It does not describe an AI medical device or a study involving human readers or AI assistance.

Therefore, many of the requested criteria related to AI performance, human expert evaluation, and multi-reader multi-case studies are not applicable to this document.

However, I can extract information related to the device's performance testing and acceptance criteria as described in the summary:

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

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

• This document describes mechanical testing of a physical device, not an AI model or clinical data.
• The "test set" in this context refers to the physical samples of the SPIRA-V™ Open Matrix Corpectomy Cage that underwent mechanical testing. The exact number of samples tested for each criterion is not specified in the provided text.
• "Data provenance" is not applicable in the sense of patient data origin; instead, it would relate to how the physical test specimens were manufactured and handled, which is not detailed here.

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

• Not applicable. This is a mechanical device, not an AI system requiring expert interpretation for ground truth establishment.

4. Adjudication method for the test set:

• Not applicable. No adjudication of human interpretations is involved as it's mechanical testing. The "ground truth" for mechanical properties is determined by the physical measurements themselves against established 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 not an AI device.

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

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

• For the mechanical tests, the "ground truth" is established through physical measurements against validated ASTM (American Society for Testing and Materials) standards and comparison to the mechanical performance of legally marketed predicate devices. The aim is to show the device is "as mechanically sound as predicate devices."

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI model requiring a training set.

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

• Not applicable.

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