(261 days)
The PATHWAY ELIF device(s) is intended for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative Disc Diseases (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spiral surgery at the involved spinal level(s).
The PATHWAY ELIF device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rod systems, and anterior screw and rod systems. The device(s) is intended to be used with autogenous bone graft.
Patients must have undergone a regiment of at least (6) months of non-operative treatment prior to being treated with the PATHWAY ELIF device(s).
The PATHWAY ELIF device can be used in one of two methods:
Transforaminal Lumbar Interbody Fusion (TLIF)
Used as a TLIF, a single device is implanted in the appropriate location to provide support for a transforaminal approached surgery.
Posterior Lumbar Interbody Fusion (PLIF)
Used as a PLIF, two devices are implanted in the appropriate locations to provide support to the spine for a posterior surgery.
The PATHWAY ELIF implant features three prescribed lordotic angle / height positions and is available in two lengths for posterior lumbar fusion. It allows lordotic adaptability and height restoration to meet patient anatomy. It is comprised of upper and lower expandable surfaces preassembled with a posterior height maintenance component. The device can be expanded to fixed configurations of 0°, 8°, and 16° positions. Each position after 0° provides approximately 2mm of additional mid-body height increase. The superior and inferior surfaces of all components are coated with plasma sprayed titanium to provide a roughened finish.
This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the PATHWAY ELIF device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a table of acceptance criteria with specific numerical targets. Instead, it refers to compliance with established ASTM standards for intervertebral body fusion devices. The reported device performance is that the PATHWAY ELIF System demonstrated "equivalent performance to the predicate" by successfully passing these tests.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance (Static Axial Compression) | Demonstrated equivalent performance to the predicate per ASTM F2077. |
| Mechanical Performance (Dynamic Axial Compression Shear) | Demonstrated equivalent performance to the predicate per ASTM F2077. |
| Subsidence Resistance | Successful subsidence testing per ASTM F2267. |
| Expulsion Resistance | Successful expulsion testing per ASTM Draft F04.25.02.02. |
| Usability and Functionality | Demonstrated in a cadaver study. |
| Material Properties (Titanium Alloy) | Ti-6AI-4V ELI according to ISO 5832-3 and ASTM F136. |
| Coating Properties (Plasma Spray Titanium) | Conformity to ASTM F1580, F1854, F1044, F1147, F1160, F1978 (implied by listing standards). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for each mechanical test (static/dynamic compression, subsidence, expulsion). Instead, it states that "Testing was performed in accordance with the following standard(s):" and lists several ASTM standards. These standards typically define minimum sample sizes for such tests.
The document mentions a "cadaver study" for usability and functionality, but the sample size for this study is not provided.
The provenance of the data is retrospective, as it describes tests conducted to demonstrate the device's characteristics. No information on the country of origin for the data is provided, but given the US FDA submission, it's presumed to be from tests conducted by or on behalf of Custom Spine, Incorporated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable to the supplied document. The "ground truth" for this medical device submission is established through objective engineering and material testing standards (ASTM standards), rather than expert consensus on medical images or clinical outcomes. The evaluation is based on whether the device meets pre-defined mechanical and material specifications.
4. Adjudication Method for the Test Set:
This information is not applicable. The assessment is based on quantifiable engineering test results and adherence to material specifications, not on human interpretation that would require an adjudication method.
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 information is not applicable. The PATHWAY ELIF is an intervertebral body fusion device (an implant), not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable for the same reason as point 5. The device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The ground truth used for this device is based on:
- Engineering Standards: Compliance with recognized ASTM standards (e.g., F2077, F2267) for mechanical performance (static/dynamic compression, subsidence, expulsion).
- Material Specifications: Adherence to defined material standards for Titanium alloy (ISO 5832-3, ASTM F136) and coating properties (e.g., ASTM F1580, F1854).
- Cadaveric Demonstration: For usability and functionality, a cadaver study provided empirical evidence.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a physical implant, not an AI model that requires a "training set." The development would involve engineering design, finite element analysis, and physical prototyping, but not a data training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no "training set" in the context of this physical medical device.
§ 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.