(120 days)
When used as an intervertebral body fusion device, the ROI Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, 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.
When used as a vertebral body replacement device. The ROI System of implants is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system. These devices are intended to be used with autograft or allograft bone.
The ROI-A implants are intended to be implanted singularly.
The ROI-A System is part of the ROI Interbody Fusion System family, and is comprised of various sizes and configurations of implants to accommodate individual patient anatomy. The ROI-A is intended to be used for interbody fusion of the lumbar spine, and is also indicated for use as a partial vertebral body replacement of the thoraco-lumbar spine.
The provided text describes a 510(k) submission for the LDR Spine ROI Interbody Fusion System (ROI-A Implant System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through extensive clinical studies.
Based on the information provided in the document:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) submission for a spinal implant, the "acceptance criteria" and "reported device performance" are primarily focused on demonstrating substantial equivalence through non-clinical (laboratory) testing, rather than clinical performance metrics typically associated with AI/software devices. The document explicitly states:
| Acceptance Criteria (Implicit for 510(k) substantial equivalence with minor design changes) | Reported Device Performance |
|---|---|
| Maintain identical intended uses, indications, materials of manufacture, processing, packaging, and surgical technique after minor design modifications. | Minor design modifications were made. The Predicate and Proposed devices have identical intended uses, indications, materials of manufacture, processing, packaging, and surgical technique. |
| Provide reasonable assurance of safety and effectiveness post-design changes. | The results of non-clinical (laboratory) validation testing demonstrate that the proposed design changes provide reasonable assurance of safety and effectiveness. |
| Mechanical and biocompatibility performance equivalent to or better than the predicate device. | (Implicitly met through non-clinical validation testing, but specific metrics are not detailed in this summary.) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of clinical data for AI/software. The "test set" here refers to the physical devices undergoing laboratory testing. The document does not specify the number of implants used for non-clinical (laboratory) validation testing.
- Data Provenance: The data is from "non-clinical (laboratory) validation testing." The location of these labs or specific provenance of the materials used in testing is not detailed. There is no clinical data provenance as "Clinical performance data was not required to support this submission."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. There is no mention of human expert involvement for establishing ground truth as there were no clinical studies or human interpretation components discussed for this device's performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There was no clinical data or expert review process described 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:
Not applicable. This device is a physical spinal implant, not an AI or software-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable, as this is a physical medical device and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. For the non-clinical (laboratory) validation testing, the "ground truth" would be established by engineering specifications, material properties, and biomechanical standards, rather than clinical ground truth types like pathology or outcomes data.
8. The sample size for the training set:
Not applicable. As a physical device, there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable.
Study Proving Acceptance Criteria:
The study proving the acceptance criteria (which, in this 510(k) context, is primarily substantial equivalence and demonstration of safety and effectiveness through non-clinical means) is explicitly stated as:
- "Non-clinical (laboratory) validation testing"
The document indicates that "The results of non-clinical (laboratory) validation testing demonstrate that the proposed design changes provide reasonable assurance of safety and effectiveness." This testing aimed to ensure that the minor design modifications to the predicate device did not negatively impact its performance or safety, maintaining the "identical intended uses, indications, materials of manufacture, processing, packaging, and surgical technique." No further details about the specific tests conducted (e.g., fatigue testing, static compression, expulsion resistance) are provided in this summary.
§ 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.