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The Atlas Spine Expandable Cervical Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Atlas Spine Expandable Cervical Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The Atlas Spine Expandable Cervical Interbody System consists of various size and style options to address the clinical and anatomic needs of individual patients. The implant is rectangular in its general shape with the capability to expand in height. The implant incorporates bone graft cavities through the superior and inferior surfaces to allow fusion between adjacent vertebral bodies. The implants incorporate a textured bone contacting surface to resist migration/expulsion of the implant post operatively. Additionally, the implant incorporates an opening posteriorly to allow the addition of bone graft post expansion.

The implants components are manufactured from implantable grade Ti6AI4V per ASTM F136 alloy and Peek Optima LT1 delivered in the pre-assembled, unexpanded state.

The provided documentation describes a medical device, the "Atlas Spine Expandable Cervical Interbody System," and its 510(k) premarket notification for substantial equivalence, not an AI/ML device. Therefore, the specific questions regarding acceptance criteria, study details, and performance metrics for AI/ML devices are not applicable.

However, I can extract the relevant information from the document concerning the device's evaluation and its deemed "acceptance criteria" for regulatory clearance based on substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, "acceptance criteria" are not reported as quantitative performance metrics for an AI/ML algorithm. Instead, they refer to the device meeting the requirements for substantial equivalence to predicate devices. The performance is demonstrated through non-clinical (bench) testing.

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

Not applicable for this type of medical device (physical implant). The "test set" refers to the specific implants tested during the non-clinical bench studies. The document does not specify the exact number of implants tested, only the types of tests performed. Data provenance is not mentioned beyond the tests being conducted according to ASTM standards.

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

Not applicable. Ground truth as typically defined for AI/ML studies by experts is not relevant here. The "ground truth" for a physical implant's mechanical properties is derived from the physical testing against established ASTM standards.

4. Adjudication method for the test set

Not applicable. Adjudication methods are typically used to resolve discrepancies in expert labeling or diagnoses for AI/ML ground truth.

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/ML device that assists human readers.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for this device's performance is established by physical mechanical testing against recognized industry standards (ASTM F2077 and ASTM F2267), demonstrating that the device meets or exceeds the performance criteria for intervertebral body fusion devices, and is comparable to predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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The INNESIS PEEK Cervical Cages 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 (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. INNESIS PEEK Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach and packed with autogenous bone. INNESIS PEEK Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The INNESIS PEEK Cervical Cage is an implant for the anterior stabilization of the cervical spinal column using an Anterior Cervical Desectorny and Fusion (ACDF) surgery. The INNESIS PEEK Cervical Cages are offered in a variety of heights, footprints and curved shapes. The INNESIS PEEK Cervical Cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft. The INNESIS PEEK Cervical Cage includes spikes and marker (pin) for radiological evaluation of the position and orientation of the radiolucent PEEK Cage

Here's a breakdown of the acceptance criteria and study information for the INNESIS PEEK Cervical Cage, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to predicate devices and the mechanical performance of the INNESIS PEEK Cervical Cage. The acceptance criteria are based on established ASTM standards for intervertebral body fusion devices.

Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Testing results are for the following:" followed by the list of tests and standards. It then concludes by saying "These materials are both recognized as suitable biomaterials for this intended use and predicate devices have previously been cleared by FDA for this same intended use. Endotoxin testing has demonstrated that the process does not introduce endotoxins as a bi-product of the manufacturing and cleaning process." While it directly states biocompatibility and endotoxin results, for the mechanical tests, it implicitly suggests that the device met the requirements of the standards by stating testing was conducted in accordance with them, which is the typical approach for demonstrating substantial equivalence for mechanical properties.

Study Details

The provided text describes pre-clinical, often benchtop, testing rather than a clinical study. Therefore, some of the requested information regarding clinical study design (e.g., sample size for test sets, expert ground truth, MRMC studies) is not applicable.

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

   • Sample Size: Not specified for individual tests. For mechanical testing of medical devices, samples are typically physical units of the device tested under controlled laboratory conditions.
   • Data Provenance: Not explicitly stated, but implied to be from laboratory testing performed by BK Meditech Co, Ltd. or a contracted testing facility, likely in the Republic of Korea given the company's origin. The data is retrospective in the sense that it's generated for regulatory submission after device development.

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

   • This is not applicable as the testing described is mechanical, material, and chemical (endotoxin) in nature, not based on expert interpretation of clinical data or images. The "ground truth" here is the adherence to the specified ASTM standards and the validated properties of the materials.

3. Adjudication method for the test set:

   • Not applicable for the type of testing performed. Mechanical and material tests have objective pass/fail criteria based on quantitative measurements against a standard.

4. 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 implantable medical device (cervical cage), not an AI diagnostic or image interpretation tool. Therefore, no MRMC study or AI assistance is relevant.

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

   • Not applicable. This device does not involve an algorithm or AI.

6. The type of ground truth used:

   • For mechanical, material, and chemical tests: The ground truth is the performance specification defined by recognized industry standards (ASTM) and accepted material properties for biomaterials. For endotoxin testing, the ground truth is the absence of endotoxins at or below detectable levels.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of an AI/machine learning model for this type of device submission. The device design and materials are based on established engineering principles and prior art (predicate devices), not machine learning.

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

   • Not applicable, as there is no training set for an AI/machine learning model. The analogous "ground truth" for the device's design and manufacturing is based on established engineering and materials science principles, industry standards, and the performance history of similar predicate devices.

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