Search Results

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.

Ask a specific question about this device