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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 non-operative treatment prior to treatment with an intervertebral cage.

The Integrity Spine Core System is a cervical interbody fusion system comprised of 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. The devices are plasma spray coated with titanium that conforms to ASTM F1580. Additionally, the devices contain tantalum markers that conform to 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 that conforms to ASTM F899.

The provided text describes a 510(k) premarket notification for a medical device called "The Integrity Spine Core System." This submission is for an intervertebral body fusion device and is primarily focused on demonstrating substantial equivalence to previously cleared predicate devices.

The document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in terms of analytical or clinical performance of an AI/ML algorithm. Instead, it describes non-clinical engineering tests conducted to ensure the physical and mechanical properties of the implant device meet established standards.

Therefore, many of the requested items (e.g., sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of device submission as it is not an AI/ML product.

Here's the relevant information based on the provided text:

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

The document lists non-clinical mechanical tests to ensure the device's structural integrity and performance in vitro. It states these tests were "conducted in accordance with" specific ASTM standards, implying that the device successfully met the requirements of these standards. The acceptance criteria are implicitly those defined by the ASTM standards, but specific numerical thresholds and results are not provided in this summary.

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

This is not applicable to the non-clinical mechanical testing described. The "test set" here refers to the physical devices subjected to mechanical loads, not a dataset for an AI/ML algorithm. No information on data provenance is provided or expected for this type of testing.

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)

This is not applicable. The "ground truth" for mechanical testing is defined by the physical properties and performance against established engineering standards (ASTM). No human experts are involved in establishing this "ground truth."

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

This is not applicable. No adjudication method is relevant for objective mechanical testing.

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 is not applicable. This is a medical implant, not an AI/ML diagnostic or assistive device.

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

This is not applicable. This is a medical implant, not an AI/ML algorithm.

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

The "ground truth" for the mechanical testing is based on objective measurements against the performance criteria specified in the referenced ASTM (American Society for Testing and Materials) standards. These standards define the acceptable mechanical properties and failure modes for intervertebral body fusion devices.

8. The sample size for the training set

This is not applicable. This is a medical implant undergoing mechanical testing, not an AI/ML algorithm.

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

This is not applicable. There is no "training set" or "ground truth" in the context of AI/ML for this device.

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The Integrity Spine Lumbar Interbody Fusion 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 I spondylolisthesis or retrolisthesis 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. These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Integrity Spine Lumbar Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy. The Integrity Spine lumbar interbody fusion device(s) may be implanted:

• bi-laterally in pairs via a posterior (PLIF) approach;
• as a single device via an oblique (OLIF) approach:
• as a single device via a transforaminal (TLIF) approach; or
• as as a single device via an anterior or anterolateral (ALIF) approach.
  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.
  The 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.

This document is a 510(k) premarket notification for the Integrity Spine Lumbar Interbody Fusion System. It is an FDA clearance letter and a 510(k) summary, not a study report proving a device meets acceptance criteria. As such, it does not contain the specific information requested in the prompt regarding acceptance criteria, study details, ground truth, or expert involvement for evaluating device performance in the context of AI or diagnostic accuracy studies.

The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and non-clinical mechanical testing for safety and performance in a physical device context (interbody fusion).

Therefore, I cannot extract the requested information from this document. The document discusses:

• Device Name: Integrity Spine Lumbar Interbody Fusion System (Page 2)
• Intended Use: Intervertebral body fusion of the lumbar spine, from L2 to S1, for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis, for skeletally mature patients who have had six months of non-operative treatment. (Page 2)
• Testing: Non-clinical mechanical testing including static and dynamic compression, static and dynamic torsion, subsidence, and expulsion testing. These tests were conducted according to ASTM standards (F2077-11, F2267-04, and a Draft Standard F-04.25.02.02). (Page 5)
• Conclusion: The device is substantially equivalent to predicate devices based on shared intended use, implant design, material, and non-clinical mechanical test results. (Page 5)

The prompt asks for acceptance criteria and study details that are typically found in studies evaluating diagnostic devices, AI algorithms, or clinical performance. This document pertains to a surgical implant and its mechanical properties.

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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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