(91 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-L5. 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. The device 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. 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.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance" in the context of clinical outcomes or specific metrics for an AI/device performance study. Instead, it refers to performance testing standards that the device has met.
| Acceptance Criteria (Performance Standard) | Reported Device Performance (Compliance) |
|---|---|
| ASTM F2077 - Static and dynamic axial compression | Met/Compliant |
| ASTM F2077 - Static and dynamic compression shear | Met/Compliant |
| ASTM F2077 - Static torsion | Met/Compliant |
| ASTM F2267-04 - Subsidence Testing | Met/Compliant |
| ASTM F2119 - MR Image Artifact | Met/Compliant |
| ASTM F2052 - MR Induced Displacement Force | Met/Compliant |
| ASTM F2213 - MR Induced Torque | Met/Compliant |
| ASTM F2182 - MR Induced Heating | Met/Compliant |
| Expulsion testing per accepted industry standard | Met/Compliant |
Note: The document refers to the successful completion of these tests as evidence of "substantial equivalence" to predicate devices, rather than a clinical performance study with specific metrics like sensitivity/specificity for disease detection.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document describes a medical device (Lateral Spinal Truss System (LSTS) Interbody Fusion Device), not an AI algorithm or diagnostic tool that would typically involve a "test set" of patient data for performance evaluation in the context of AI. The performance testing mentioned relates to the device's physical and material properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided as the document describes a physical medical device and its mechanical/material testing, not a diagnostic AI system requiring expert-established ground truth from a test set.
4. Adjudication Method for the Test Set
This information is not provided as it's not relevant to the type of device and testing described in the document.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
This information is not provided. The document describes a physical interbody fusion device, not a diagnostic or assistive AI system that would typically undergo an MRMC study.
6. Standalone (Algorithm Only) Performance Study
This information is not provided. The document is about a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The concept of "ground truth" as typically understood in AI/diagnostic studies (e.g., pathology, expert consensus, outcomes data) is not applicable to the performance testing described. The "ground truth" for the device's performance would be the physical and mechanical properties measured against established engineering standards (ASTM).
8. Sample Size for the Training Set
This information is not provided as the document describes a physical medical device, not an AI system that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not provided as it's not relevant to the device described.
§ 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.