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The INTESS™ Cervical Cage is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with supplemental internal fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cage.

The INTESS™ Cervical Cage was developed as implants for the stabilization of the cervical column. The INTESS™ implants have graft windows which help facilitate bony integration. The INTESS™ implants have ridges on both their inferior and superior surfaces. X-ray markers are integrated for visualization of the implants during and after surgery.

Materials:
Zeniva ZA500 PEEK conforming to ASTM F2026. Unalloyed tantalum conforming to ASTM F560.

Function:
Maintain adequate disc space until fusion occurs.

The provided document is a 510(k) Summary for the INTESS™ Cervical Cage. This type of document is a premarket notification to the FDA to demonstrate that the device to be marketed is substantially equivalent to a legally marketed predicate device.

It's important to understand that a 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with defined performance metrics like a typical AI/software device. For a traditional medical device like the INTESS™ Cervical Cage, "acceptance criteria" are usually met by demonstrating that the device's functional and safety characteristics are comparable (substantially equivalent) to already approved devices.

Therefore, the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software device (with details like sample sizes, expert ground truth, MRMC studies, etc.) does not directly apply to this 510(k) submission for a physical implant.

However, I can extract the information relevant to the equivalence demonstration for the INTESS™ Cervical Cage:

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

Since this is a 510(k) to demonstrate substantial equivalence, "acceptance criteria" are implied by the performance of the predicate devices. The "reported device performance" is a demonstration that the INTESS™ Cervical Cage performs comparably to these predicates in non-clinical tests.

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

• Sample Size for Test Set: Not applicable in the context of human data. For mechanical testing, the "sample size" refers to the number of physical devices tested. This information is typically detailed in the test reports referenced by the ASTM standards, but not usually in the 510(k) summary itself. The document states "The following tests were conducted," implying a sufficient number of devices were tested to meet the ASTM standards.
• Data Provenance: Not applicable for a non-clinical mechanical test summary.

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. Ground truth from human experts is not used for mechanical testing of a physical implant. The "ground truth" for mechanical performance is established through adherence to recognized ASTM standards and the associated testing methodologies.

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

Not applicable. This device's evaluation did not involve human adjudication of test results in the way an AI/software device would. The mechanical tests have pass/fail criteria based on engineering specifications.

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 is a physical implant, not an AI/software device. No MRMC study was performed.

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

No. This is a physical implant.

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

The "ground truth" for the non-clinical tests is based on established engineering and materials standards (ASTM F2077, ASTM F2267, ASTM F2026, ASTM F560) and the performance characteristics of the legally marketed predicate devices.

8. The sample size for the training set:

Not applicable. There is no training set for a physical implant.

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

Not applicable. There is no training set for a physical implant.

Summary of the Study (Equivalence Demonstration):

The study conducted to support the INTESS™ Cervical Cage was a series of non-clinical bench tests designed to demonstrate the device's mechanical integrity and material properties.

• Tests Performed:
  • Static and dynamic compression per ASTM F2077
  • Static and dynamic torsion per ASTM F2077
  • Subsidence per ASTM F2267
• Materials Conformance: Zeniva ZA500 PEEK conforming to ASTM F2026 and Unalloyed tantalum conforming to ASTM F560.
• Conclusion: The results of this testing indicated that the INTESS™ Cervical Cage is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety, and performances.
• Clinical Studies: No clinical studies were performed.

In essence, for this device, "acceptance criteria" are met by demonstrating that its physical and mechanical properties, as measured by standard engineering tests, are comparable to those of already approved predicate devices.

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When used as a cervical intervertebral body fusion device, the Integrity Spine Core System 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 nonoperative treatment prior to treatment with an intervertebral cage.

The Integrity Spine Core System is a cervical intervertebral body fusion system comprised of parallel and lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach.

The Integrity Spine Core System implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

The Integrity Spine Core System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.

The provided text describes a 510(k) Premarket Notification for the Integrity Spine Core System, an intervertebral body fusion device. The focus of this submission is to demonstrate substantial equivalence to previously cleared predicate devices through non-clinical mechanical testing, rather than a clinical study evaluating device performance in humans.

Therefore, many of the requested items related to clinical study design, such as acceptance criteria based on human performance, sample size for test sets (in a clinical context), expert ground truth establishment for diagnostic performance, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, are not applicable to this 510(k) submission.

This submission primarily relies on bench testing to show mechanical equivalence.

Here's the information that can be extracted and a clear indication of what is not applicable:

1. Table of acceptance criteria and the reported device performance

Explanation of Acceptance Criteria: The acceptance criteria for this 510(k) submission are implicitly defined as demonstrating "substantially equivalent results" in non-clinical mechanical testing compared to the identified predicate devices. This means the Integrity Spine Core System's mechanical performance in these standardized tests must fall within expected ranges relative to the predicates, indicating no new questions of safety or effectiveness are raised.

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

• Sample Size for Test Set: Not applicable in the context of human data. For the mechanical tests, the sample sizes would be determined by the ASTM standards (e.g., number of constructs tested for compression, torsion, subsidence, and expulsion). The document does not specify these exact numbers, but it states the tests were "conducted in accordance with" the respective ASTM standards.
• Data Provenance: Not applicable as this submission is based on non-clinical (bench) testing, not human data. The tests were performed in a lab setting to assess the device's physical properties.

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 the sense of expert diagnosis or outcome labeling from human data, is not established for this type of non-clinical mechanical testing. The "ground truth" here is the adherence to mechanical performance standards and comparison to predicate devices.

4. Adjudication method for the test set

• Not Applicable. This is relevant for studies involving human data where there might be disagreements in interpretation (e.g., reading medical images). For mechanical testing, outcomes are typically measured objectively based on physical properties.

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 an intervertebral body fusion device, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.

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

• Not Applicable. This is a physical medical implant, not an algorithm or AI system.

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

• Not Applicable / Bench Test Standards. The "ground truth" for this submission are the established ASTM standards for mechanical testing of spinal implants (F2077-11 for static and dynamic mechanical testing, F2267-04 for subsidence, and ASTM Draft Standard F-04.25.02.02 for expulsion) and the performance characteristics of the predicate devices. The aim is to demonstrate that the new device performs equivalently in these controlled mechanical environments.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this 510(k) submission for a physical implant device. This concept applies to machine learning algorithms.

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

• Not Applicable. As there is no training set, there is no corresponding ground truth to establish.

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