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The Advantage-C PEEK Cervical Interbody Fusion Device is a cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disease (DDD) with / without radicular symptoms at one level 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 Advantage-C PEEK Cervical Interbody Fusion Device is intended for use with supplemental fixation systems and with autogenous bone graft.. The Advantage-C PEEK Cervical Interbody Fusion Device is supplied sterile and is intended for one-time use.

The proposed Intelivation Advantage-C Cervical Interbody Fusion Device is a sterile, single use implant grade polyetheretherketone (PEEK; ASTM F2026) device and Tantalum (ASTM F560), available in varied footprints and heights, designed for supplemental stabilization of the cervical spinal column in anterior cervical discectomy and fusion (ACDF) procedures. The device is intended for spinal fusion procedures at one level in skeletally mature patients with degenerative disc disease (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. The implant should be used with supplemental spinal fixation systems and with autogenous bone graft.

The provided text describes a 510(k) premarket notification for the "Advantage-C PEEK Cervical Interbody Fusion Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy studies typically required for a new device. Therefore, the information provided for acceptance criteria and studies will be geared towards non-clinical performance and biological compatibility.

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

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

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

Notes on Acceptance Criteria: For some tests (like subsidence), a "characterization" is performed, implying that the results are within expected limits for the material and design, even if an explicit "Pass" is not stated in the summary. The core acceptance criterion for a 510(k) is often "substantial equivalence" to a predicate device, which these non-clinical tests help to demonstrate.

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

• Sample Size for Test Set: Not explicitly stated for any of the non-clinical tests. The document refers to "the proposed device" and "this testing" which implies standard sample sizes for each test method as per the referenced ASTM and ISO standards would have been used, but specific numbers are not given.
• Data Provenance: The studies are non-clinical (laboratory tests). No country of origin is mentioned for the data, but the submitter is Intelivation, LLC, based in Saint Simons Island, Georgia, USA. The studies are prospective in the sense that they were conducted specifically for this submission.

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

This question is not applicable to the non-clinical performance and sterilization tests described. Ground truth, in the clinical sense, is not established for these types of engineering and material property tests. The "ground truth" for these tests is defined by the objective measurement criteria and methodologies specified in the referenced ASTM and ISO standards.

4. Adjudication method for the test set:

Not applicable. The tests are objective, laboratory-based physical and chemical evaluations following standardized protocols. There is no human adjudication process involved as there would be with clinical image interpretation or diagnosis.

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 a physical interbody fusion implant, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was conducted or is relevant for this product.

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

Not applicable. This device is an implantable medical device, not an algorithm or software.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is based on the objective measurements and performance specifications defined by the referenced industry standards (ASTM, ISO). For example, for strength tests, the ground truth is the measured yield/ultimate force or fatigue resistance compared against a predefined standard. For wear particle analysis, it's the measured size, shape, and distribution. For sterilization, it's the achievement of a specific sterility assurance level (SAL).

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" for physical medical device performance testing in this context. The manufacturing process and quality control would involve internal testing, but not a "training set" in the machine learning sense.

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

Not applicable, as there is no "training set" for these non-clinical tests.

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When used as a lumbar intervertebral body fusion device, the Republic Spine Restore Interbody Fusion System 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 either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). 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 Republic Spine Restore Intervertebral Body Fixation System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Republic Spine lumbar intervertebral body fusion device, which may be implanted as a single device via an anterior, posterior, transforaminal or lateral approach.

The Republic Spine Restore Intervertebral Body Fusion System implant components are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F136 or polyether ether ketone (Evonik Vestakeep® i4R) that conforms to ASTM F2026 with tantalum markers (ASTM F560) to assist the surgeon with the proper placement of the device.

The provided document describes a 510(k) premarket notification for the "Republic Spine Restore Intervertebral Body Fusion System," which is a Class II medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to establish safety and efficacy from scratch.

Therefore, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the traditional sense of a clinical trial for a novel device. Instead, it focuses on demonstrating that the new device is as safe and effective as existing predicate devices.

Here's how to interpret the available information according to your request categories:

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

The acceptance criteria for a 510(k) submission are generally that the device performs at least as well as (or is substantially equivalent to) the predicate device in relevant performance tests. The "reported device performance" are the results from these comparative tests.

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

• Sample Size for Mechanical Bench Tests: Not explicitly stated as a number of devices (e.g., N=5 per test). It mentions "the subject PEEK device is considered worst case and therefore, was utilized during design verification mechanical bench tests." This implies a representative number of units for each test type was used, as is standard for ASTM testing, but the exact count is not provided.
• Data Provenance: The data is from bench testing conducted by the manufacturer, Republic Spine, LLC, to compare their device to predicate devices. This is not human data (no country of origin or retrospective/prospective designation applies).

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

This information is not applicable as this is a medical device 510(k) submission based on mechanical bench testing and substantial equivalence, not a study involving human subjects or expert image review. There is no concept of "ground truth" derived from expert consensus in this context.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3.

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. This is a physical medical device (intervertebral body fusion system), not an AI imaging or diagnostic algorithm. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

This information is not applicable as 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 standards and specifications (e.g., ASTM F2077, ASTM F2267) and the performance characteristics of the predicate devices. The device is considered to meet "ground truth" if its mechanical properties are comparable to or better than the predicate devices and meet the relevant ASTM standards for intervertebral body fusion devices.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/machine learning model. The mechanical tests are "verification" tests against standards and predicate performance.

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

This information is not applicable as there is no training set for this type of device submission.

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