(239 days)
When used as an intervertebral body fusion device, the ROI-A Implant 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 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.
The ROI- A Oblique implant is intended for use as an interbody fusion device in the lumbar spine. The device is manufactured from medical grade PEEK OPTIMA® LT1 in accordance with ASTM F2026 and has tantalum markers conforming to ASTM F560 embedded in the implant extremities to facilitate visibility in x-ray imaging. The subject device is designed for placement using an anterolateral approach with an approximate offset angle of 25° from the straight anterior axis.
The provided document describes the LDR Spine ROI-A® Implant System, an intervertebral body fusion device. The acceptance criteria and the studies that prove the device meets these criteria are outlined as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Static Shear Compression | Performance comparable to the legally marketed predicate device (LDR Spine ROI Implant System, K082262, K090507) as specified by ASTM F2077. | "The results of this testing demonstrate that the performance of the LDR Spine ROI-A Oblique implant, when compared with its legally marketed predicate, is substantially equivalent." |
| Dynamic Axial Compression | Performance comparable to the legally marketed predicate device as specified by ASTM F2077. | "The results of this testing demonstrate that the performance of the LDR Spine ROI-A Oblique implant, when compared with its legally marketed predicate, is substantially equivalent." |
| Dynamic Bending | Performance comparable to the legally marketed predicate device as specified by ASTM F2077. | "The results of this testing demonstrate that the performance of the LDR Spine ROI-A Oblique implant, when compared with its legally marketed predicate, is substantially equivalent." |
| Expulsion | Performance comparable to the legally marketed predicate device as specified by ASTM F-04.25.02.02. | "The results of this testing demonstrate that the performance of the LDR Spine ROI-A Oblique implant, when compared with its legally marketed predicate, is substantially equivalent." |
| Wear Debris Analysis | Performance comparable to the legally marketed predicate device as specified by ASTM F1877. This typically involves demonstrating that wear debris generation is within acceptable limits or comparable to the predicate. | "The results of this testing demonstrate that the performance of the LDR Spine ROI-A Oblique implant, when compared with its legally marketed predicate, is substantially equivalent." |
| Low Cycle Cadaver Testing | Clinical stability and absence of device expulsion/pull-out comparable to the legally marketed predicate device under low cycle conditions. This would imply demonstrating the device maintains its position and stability. | "The results of this testing demonstrate that the performance of the LDR Spine ROI-A Oblique implant, when compared with its legally marketed predicate, is substantially equivalent." (This statement implicitly covers the cadaver testing results by reaffirming substantial equivalence to the predicate in overall performance.) |
| High Cycle Cadaver Testing | Absence of device loosening or migration, blade back-out, and vertebral body damage comparable to the legally marketed predicate device under high cycle conditions. This would imply demonstrating long-term stability and integrity. | "The results of this testing demonstrate that the performance of the LDR Spine ROI-A Oblique implant, when compared with its legally marketed predicate, is substantially equivalent." (This statement implicitly covers the cadaver testing results by reaffirming substantial equivalence to the predicate in overall performance.) |
| Biocompatibility | The device is manufactured from medical grade PEEK OPTIMA® LT1 in accordance with ASTM F2026. This implies the material meets biocompatibility standards. The document doesn't explicitly state biocompatibility testing results, but the material choice and standard compliance address this. | The device is manufactured from medical grade PEEK OPTIMA® LT1 in accordance with ASTM F2026. |
| Radiographic Visibility | The device has tantalum markers conforming to ASTM F560 embedded in the implant extremities to facilitate visibility in x-ray imaging. This implies the device is adequately visible for post-operative assessment. | "[...] and has tantalum markers conforming to ASTM F560 embedded in the implant extremities to facilitate visibility in x-ray imaging." |
| Indications for Use | The device must be suitable for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients with six months of non-operative treatment, for one or two contiguous levels, treating DDD with up to Grade I spondylolisthesis, and used with supplemental fixation and autograft, equivalent to the predicate. | The device's stated Indications for Use are identical to those implicitly accepted for the predicate, showing equivalence in intended clinical application. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical performance data primarily involving in-vitro mechanical and cadaveric testing. It does not refer to a "test set" in the context of clinical data, as it is not a clinical study assessing patient outcomes.
- Sample Size for Mechanical Testing: Not explicitly stated for each test (static, dynamic, expulsion, wear debris). Standard practice for such tests involves using a statistically significant number of samples, but the exact count is not given.
- Sample Size for Cadaver Testing: Not explicitly stated for low cycle and high cycle cadaver testing.
- Data Provenance: Not applicable in the context of "country of origin of the data" or "retrospective or prospective" as these are non-clinical biomechanical and material tests, not patient studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of study presented. The studies are non-clinical engineering and biomechanical tests, where "ground truth" is established by physical measurements, material properties, and adherence to ASTM standards, rather than expert interpretation of patient data.
4. Adjudication Method for the Test Set
This information is not applicable as there is no "test set" of clinical data requiring expert adjudication. The study involves objective engineering and biomechanical testing.
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 device is an intervertebral fusion implant, not an AI-powered diagnostic or decision support system. Therefore, no MRMC study or AI assistance evaluation was performed or described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical performance studies, the "ground truth" is based on:
- Physical Measurements and Mechanical Properties: Measured forces, displacements, wear rates, and other biomechanical parameters.
- ASTM Standards: Adherence to established industry standards like ASTM F2077, ASTM F-04.25.02.02, ASTM F1877, ASTM F2026, and ASTM F560.
- Predicate Device Performance: The established performance characteristics of the legally marketed predicate device (LDR Spine ROI Implant System, K082262, K090507), against which the new device is compared for substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not a machine learning or AI-based study.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no "training set" or corresponding ground truth establishment process in the context of this device's evaluation.
Summary of the Study:
The study performed was a series of non-clinical bench and cadaveric tests designed to demonstrate the mechanical and functional substantial equivalence of the LDR Spine ROI-A® Implant System to its legally marketed predicate device. The tests covered static and dynamic mechanical properties, expulsion resistance, wear debris, and cadaveric stability and migration. The primary conclusion was that the new device's performance is substantially equivalent to that of the predicate, thus satisfying the requirements for 510(k) clearance.
§ 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.