(92 days)
The Lateral Spine Truss System (LSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. All LSTS Interbody Fusion Devices must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Interbodies with 18° lordosis or greater must be used with the 4WEB Lumbar Spine Truss System Plating Solution (LSTS-PS) with integrated fixation. If using the 1-hole 4WEB LSTS-PS with integrated fixation, additional supplemental fixation is required (e.g. posterior fixation). These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy.
The device is available in a variety of sizes and lordotic angles to accommodate the patient's anatomy.
This document is a 510(k) summary for the 4WEB Lateral Spine Truss System (LSTS) Interbody Fusion Device. It focuses on the mechanical performance of the device rather than the performance of an AI/ML diagnostic algorithm. Therefore, the questions regarding acceptance criteria and studies for AI/ML performance metrics are not directly applicable to this submission.
However, I can extract the information related to the device's performance testing based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Standard) | Reported Device Performance |
|---|---|
| No introduction of new worst-case compared to previously cleared 4WEB Lumbar Interbody Fusion Devices for mechanical properties. | Validated finite element analysis demonstrated that the product line extension for the Lateral Spine Truss System (LSTS) Interbody Fusion Device does not introduce a new worst-case compared to the previously cleared 4WEB Lumbar Interbody Fusion Devices for mechanical properties of the device. |
| Sufficient strength for intended use and substantial equivalence to legally marketed predicate devices. | The results of non-clinical testing show that the strength of the LSTS Interbody Fusion Device and LSTS Plating Solution is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. |
Specific tests performed to demonstrate compliance:
- Axial screw pushout per ASTM F543
- Static axial compression per ASTM F2077
- Static compression shear per ASTM F2077
- Dynamic axial compression fatigue per ASTM F2077
- Dynamic compression shear fatigue per ASTM F2077
- Expulsion testing
- MR Conditional testing
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable. The device is a surgical implant, and its performance is evaluated through mechanical testing and finite element analysis, not through a test set with patient data.
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. Ground truth for a physical device's mechanical properties is established through adherence to engineering standards (ASTM) and scientific principles, not expert consensus on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Mechanical testing does not involve adjudication.
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 device (interbody fusion device), not an AI/ML diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document is about a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by engineering standards (e.g., ASTM F543, ASTM F2077), which define the methods and criteria for evaluating mechanical properties like strength, fatigue, and expulsion. Finite element analysis (FEA) is also used to simulate mechanical behavior and establish "ground truth" in terms of predicted performance under various conditions, validated against established engineering principles.
8. The sample size for the training set
This is not applicable. The document discusses a physical medical device, not an AI/ML algorithm. Finite Element Analysis (FEA) is a computational method that doesn't involve a 'training set' in the machine learning sense.
9. How the ground truth for the training set was established
This is not applicable. As stated above, this is about a physical device and not an AI/ML algorithm.
§ 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.