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The XIPHOS™ ZFUZE™ 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 I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion.

The XIPHOS™ ZFUZE™ Interbody Fusion System is a single use sterile- packed permanent implant identical to that of the construct in the cleared XIPHOS™ Interbody Fusion system (K100042). The DiFUSION Technologies XIPHOS™ ZFUZE™ Interbody Fusion System is comprised of various sizes and configurations to accommodate individual patient anatomy. The configurations are designed to provide the surgeon with different surgical approach options. The XIPHOS™ ZFUZE™ Interbody Fusion System will be offered in two (2) configurations of various sizes like its predicate XIPHOS™. The configurations are designed based on indicated spinal implant level and surgical approach, and consist of: 1) XIPHOS™ ZFUZE™ PLIF, posterior lumbar approach and 2) XIPHOSTM ZFUZE™ TLIF, transforaminal lumbar approach.

XIPHOS™ ZFUZE™ Interbody Fusion System implants consist of bullet shaped (PLIF) and banana shaped (TLIF) blocks in a parallel configuration of various heights. Large bone graft windows are located through the body of the device to allow for placement of bone graft to facilitate fusion. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants.

Additionally, the device contains four (4) radiolucent tantalum markers in the PLIF configuration and five (5) radiolucent tantalum markers in TLIF configuration to assist the surgeon with proper placement of the device. The PLIF device may be implanted singularly or in pairs via a posterior approach while The TLIF device may be implanted singularly via a transforaminal approach.

The XIPHOS™ ZFUZE™ Interbody Fusion System is made of Ketaspire PEEK (KT1211FP) and Type 4A Zeolite. In addition tantalum beads are embedded in the spacers to allow radiographic visualization. These permanent implants are available for prescription use only.

This document is a 510(k) premarket notification for a medical device, specifically an intervertebral body fusion system. It does not contain information about acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets acceptance criteria.

The document describes the XIPHOS™ ZFUZE™ Interbody Fusion System, which is a physical implant used for spinal fusion. The "performance data" section clearly states that the testing was mechanical testing (e.g., Static Compression, Dynamic Compression, Wear Debris) and biocompatibility assessment for the physical device, not an AI algorithm.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device (AI/SaMD) performance, as this information is not present in the provided text.

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When used as an intervertebral body fusion device, the DiFUSION Technologies XIPHOS 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 I spondvlolisthesis. 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.

When used as a vertebral body replacement device, the DiFUSION Technologies XIPHOS System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The XIPHOS System is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The DiFUSION Technologies XIPHOS System is intended to be used with autograft or allograft bone.

The XIPHOSTM ALIF is a lumbar PEEK interbody fusion device. These implants can be described as an oval structural column having a central strut. The superior and inferior surfaces are open with parallel serrations. The implants are available in an assortment of height, depth, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements.

The provided text is a 510(k) Summary for a medical device called XIPHOSTM ALIF, an intervertebral body fusion and vertebral body replacement device. It details the device's description, intended use, materials, and a declaration of substantial equivalence to predicate devices based on mechanical performance.

Here's an analysis of the acceptance criteria and study information based on the provided document:

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

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

The document mentions "Mechanical testing of the worst case XIPHOS™ ALIF." However, it does not specify the sample size used for these mechanical tests. The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective, but it's generated internally by the manufacturer for regulatory submission.

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 product is a physical medical device (spinal implant), not an AI/software device that requires human expert interpretation for "ground truth" establishment in a test set. The "ground truth" for its performance is its physical and mechanical properties, assessed through standardized ASTM tests. Therefore, these sections are not applicable in their usual sense for this type of device.

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

Not applicable. As noted above, this is a physical device being evaluated by mechanical testing against established ASTM standards, not an AI/software requiring human adjudication of 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

Not applicable. This is not an AI-assisted diagnostic or imaging interpretation device.

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

Not applicable. This is not an AI/software device with an algorithm.

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

The "ground truth" for this device's performance is derived from established mechanical testing standards (ASTM F2077 and ASTM F2267) and the comparison of its properties to predicate devices that have already been cleared by the FDA. The performance is assessed against these known standards and characteristics of existing safe and effective devices.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

Not applicable. As established above, there is no "training set" for this type of medical device submission.

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Intervertebral Body Fusion Device: The DiFUSION Technologies XIPHOS Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to Sl, 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. 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.

Vertebral Body Replacement Device: The DiFUSION Technologies XIPHOS System of implants is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The XIPHOS System is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone.

The DiFUSION Technologies XIPHOS Interbody Fusion System is comprised of various sizes and configurations to accommodate individual patient anatomy. The configurations are designed to provide the surgeon with different surgical approach options. The XIPHOS System will be offered in two (2) configurations of various sizes. The configurations are designed based on indicated spinal implant level and surgical approach, and consist of: 1) XIPHOS PLIF, posterior lumbar approach and 2) XIPHOS TLIF, transforaminal lumbar approach. The XIPHOS System implants are manufactured from PEEK Zeniva ZA-500 (ASTM F-2026) with Tantalum alloy position markers (ASTM F-560).

The provided document is a 510(k) Premarket Notification for the DiFUSION Technologies XIPHOS Interbody Fusion System. It details the device description, indications for use, and a summary of technological characteristics, primarily focusing on non-clinical mechanical testing to demonstrate substantial equivalence to predicate devices.

However, the document does not describe acceptance criteria for an AI-powered device, nor does it detail a study involving human readers, ground truth establishment by experts, or any AI-specific performance metrics.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves an AI device meets acceptance criteria based on this document. The document describes a medical device (interbody fusion system), not an AI device.

If you intended to ask about the acceptance criteria and study for the medical device itself, I can extract information related to its mechanical testing.

Based on the provided document, here is what can be inferred about the medical device's performance criteria and evaluation:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical targets in a table format. Instead, it refers to demonstrating "substantially equivalent results" to predicate devices based on non-clinical mechanical testing standards. The reported performance is that the XIPHOS System meets these standards and shows similar characteristics to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the sample size (number of devices/implants) used for the non-clinical mechanical tests. These tests typically involve a defined number of samples to ensure statistical validity, but the exact count is not disclosed here.
• Data Provenance: The tests are "non-clinical tests" conducted on the device components themselves, following ASTM standards. This implies laboratory testing rather than data from human or animal subjects. There is no country of origin for "data" in the sense of patient data, as this is a physical device test.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• This question is not applicable to the type of premarket notification and testing described. "Ground truth" established by experts typically refers to clinical data interpretation or pathological findings for diagnostic/AI devices. For a physical interbody fusion system, performance is assessed through standardized mechanical tests, not expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

• Not applicable. As the "test set" refers to mechanical testing of physical implants, there is no adjudication method involving expert review as understood in clinical studies. Test results are compared against standard specifications or predicate device performance.

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 document is for a medical implant (DiFUSION Technologies XIPHOS Interbody Fusion System), not an AI device or a diagnostic tool that involves human readers. Therefore, an MRMC study related to AI assistance would not be part of this submission.

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

• Not applicable. This relates to AI algorithms, which are not the subject of this document.

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

• Not applicable in the context of clinical ground truth. For the mechanical testing, the "ground truth" or reference for performance is defined by the technical specifications within the ASTM standards (e.g., F2077-03, F2267-04, F1877) and the performance characteristics of legally marketed predicate devices. The goal is to demonstrate equivalence, not to achieve a "diagnosis" or "outcome" based on typical ground truth definitions.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI device where machine learning models are trained.

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

• Not applicable. Same reason as above.

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