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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 Chena Cervical Peek Spacer System is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Chena Cervical Peek Spacer interior should be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The Chena Cervical Peek Spacer is intended to be used with supplemental fixation.

The Axis Chena Cervical PEEK Spacer System consists of a variety of footprints and heights of PEEK cervical interbody spacer implants to assist in interbody fusion.

The Axis Chena Cervical PEEK Spacer System implant components are fabricated from medical implant grade Polyetheretherketone and tantalum described by such standards as ASTM F2026-17 and ASTM F560-17. Axis Orthopaedics Corporation expressly warrants that these devices are fabricated from one of the foregoing material specifications.

Do not use any of the Axis Chena Cervical PEEK Spacer System implant components with components from any other system or manufacturer. As with all orthopaedic and neurosurgical implants, none of the Axis Chena Cervical PEEK Spacer System components should ever be reused under any circumstances.

The provided document is a 510(k) summary for the Axis Chena Cervical PEEK Spacer System and focuses on demonstrating substantial equivalence to predicate devices, primarily through performance testing rather than clinical studies or reader studies. Therefore, many of the requested categories related to human-in-the-loop performance, expert ground truth, and clinical efficacy will not be directly applicable or available in this specific document.

However, I can extract and infer information relevant to its acceptance criteria and the engineering performance testing showing it meets those criteria.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely based on demonstrating equivalence to predicate devices through mechanical performance testing according to established ASTM standards. The reported performance is that the device met these standards.

Study Details (as inferable from the document)

Because this is a 510(k) submission primarily relying on mechanical testing for substantial equivalence, clinical study details (like MRMC, human-in-the-loop, etc.) are not part of this submission and are therefore not available in the provided text.

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

   • Sample Size: Not explicitly stated for each test, but standard engineering protocols for ASTM testing would involve a sufficient number of samples (e.g., typically N=5-6 per test condition).
   • Data Provenance: The testing was performed by the manufacturer, Axis Orthopaedics, or a contracted lab. The document does not specify the country of origin for the testing or whether it was retrospective or prospective in a clinical sense. It's prospective in the sense that the tests were conducted specifically to support this 510(k) submission.

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

   • Not Applicable. For mechanical performance testing of an implant, "ground truth" is established by the well-defined parameters and methods outlined in the ASTM standards. There are no human experts "establishing ground truth" in the way clinical studies would. The device's performance is objectively measured against the standard's specifications.

3. Adjudication Method for the Test Set:

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used for clinical trials involving human interpretation of data. For mechanical testing, the results are quantitative and objective measurements against established criteria.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. An MRMC study is a type of clinical study involving human readers evaluating images or data. This 510(k) is based on mechanical testing, not a clinical MRMC study.

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

   • Not Applicable. This device is a passive mechanical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

6. The Type of Ground Truth Used:

   • Mechanical Test Standards and Predicate Performance: The "ground truth" for this submission is adherence to recognized industry standards (ASTM F2077-14 and F2267-11) for intervertebral body fusion devices, and demonstrating that the device performs equivalently to its legally marketed predicate devices under these conditions.

7. The Sample Size for the Training Set:

   • Not Applicable. The concept of a "training set" applies to machine learning algorithms. This device is a mechanical implant; therefore, no training set was used.

8. How the Ground Truth for the Training Set was Established:

   • Not Applicable. See point 7.

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The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion 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 or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. The hyperlordotic CASCADIA lumbar implants (i.e., ≥ 20°) should be used with anterior supplemental fixation (e.g., an anterior lumbar plate).

The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e., ≥ 10°) are required to be used with an anterior cervical plate as the form of supplemental fixation.

The implants consist of hollow tube structures additively manufactured from titanium allov. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The purpose of the subject submission is to incorporate additional lumbar implant sizes into the system.

Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar segments of the spine.

I am sorry, but based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria in the context of device performance metrics such as accuracy, sensitivity, specificity, AUC, human reader improvement, or FROC analysis.

The document is a 510(k) premarket notification from the FDA for the Cascadia Interbody System. It focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than providing detailed acceptance criteria and performance study results for a new or significantly re-engineered AI/imaging device.

Here's what the document does mention in relation to performance and comparison:

• Non-Clinical Performance Evaluation:
  • It states that "The worst case implants for the Cascadia Interbody System were previously tested and performed equally to or better than the predicate devices in static compression, dynamic compression (ASTM F2077), subsidence (ASTM F2267) and expulsion."
  • It also mentions "Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 is used for pyrogenicity testing to achieve the Endotoxin limit of

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Blustone Synergy lumbar implants (Basalt, Magma, Obsidian):

The Blustone Synergy lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion 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 or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy. Additionally, the Blustone Synergy lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Blustone Sysergy lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

Blustone Synergy cervical implants (Slate):

The Blustone Synergy cervical (Slate) implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The Blustone Synergy cervical implants are also to be used with supplemental fixation.

The Blustone Synergy Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:

• Blustone Synergy cervical interbody fusion device(s), which may be implanted as a single 1) device via an anterior approach.
• 2. Blustone Synegy lumbar interbody fusion device(s), which may be implanted
  • bi-laterally in pairs via a posterior (PLIF) approach;
  • as a single device via a transverse (T-PLIF) approach;
  • as a single device via a lateral (LLIF) approach;
  • as a single device via a transforaminal (TLIF) approach

The Blustone Synergy System implant components are made of polyether ether ketone (Zeniva ZA-500 PEEK) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.

This FDA 510(k) K171893 document describes the Blustone Synergy Interbody Fusion System, which includes both lumbar and cervical implants. However, it does not contain information about formal acceptance criteria, device performance metrics (like accuracy, sensitivity, specificity, etc.), or a study evaluating such performance for a device that fits the description of an AI/ML medical device.

The document is a premarket notification for an intervertebral body fusion device made of PEEK material, intended to be implanted surgically. The non-clinical testing mentioned focuses on mechanical performance of the physical implant itself (e.g., static and dynamic compression, torsion, subsidence, expulsion) to demonstrate structural integrity and safety. These tests are standard for physical implantable medical devices.

Therefore, I cannot fulfill the request to provide information based on the typical acceptance criteria and study design for an AI/ML device because this document does not pertain to such a device. The questions you've asked (about sample size, data provenance, experts, MRMC studies, standalone performance, ground truth establishment) are relevant to AI/ML device performance evaluation, but this document describes a traditional medical device (an implant).

To directly answer your request based on the provided document, the following points can be made regarding the physical implant's evaluation, though they don't align with an AI/ML context:

1. Table of acceptance criteria and reported device performance: This document does not provide a table with quantitative acceptance criteria for device performance in terms of clinical outcomes or diagnostic accuracy. Instead, it discusses mechanical testing standards. The "reported device performance" is essentially that the device performed equivalently to predicates in these mechanical tests.

   Acceptance Criteria (e.g., Mechanical Standard)	Reported Device Performance (as compared to predicates)
   ASTM F2077-14 (Static & Dynamic Compression)	Met, equivalent to predicates
   ASTM F2077-14 (Static & Dynamic Torsion)	Met, equivalent to predicates
   ASTM F2267-04(2011) (Subsidence)	Met, equivalent to predicates
   ASTM Draft Standard F-04.25.02.02 (Expulsion)	Met, equivalent to predicates

2. Sample size used for the test set and the data provenance: Not applicable in the context of AI/ML device evaluation. The "test set" here refers to the physical devices subjected to mechanical testing. The document does not specify the number of individual implants tested for each mechanical test, nor does it refer to "data provenance" in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would relate to the mechanical properties being measured, which are determined by physical tests and engineering standards, not expert clinical consensus.

4. Adjudication method: Not applicable. Adjudication is relevant for interpreting ambiguous or challenging cases in diagnostic AI, not for mechanical testing of an implant.

5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No. This type of study is for evaluating human interpretation with and without AI assistance, which is not relevant for a physical interbody fusion device.

6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used: For the mechanical tests, the "ground truth" would be the engineered specifications and the results obtained from standardized mechanical testing equipment. It's not expert consensus, pathology, or outcomes data in the AI/ML sense.

8. The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA document pertains to a physical interbody fusion device and details mechanical testing to establish substantial equivalence, not the performance of an AI/ML diagnostic or assistive device.

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