(43 days)
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
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Static and Dynamic Compression (ASTM F2077) | Met, demonstrates substantial equivalence to predicate devices. |
| Static and Dynamic Torsion (ASTM F2077) | Met, demonstrates substantial equivalence to predicate devices. |
| Subsidence Properties (ASTM F2267) | Met, demonstrates substantial equivalence to predicate devices. |
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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.