(159 days)
InFill™ TLIF Oblique is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ TLIF Oblique is designed for use with autogenous bone graft to facilitate fusion. InFill™ TLIF Oblique is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, 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 lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill™ TLIF Oblique is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
The InFill™ TLIF Oblique is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill™ TLIF Oblique is provided sterile, for single use only.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static/Dynamic Compression (ASTM F2077) | Meets the requirements for intervertebral body fusion devices | "All necessary performance testing... has been completed" to assure substantial equivalence to predicate devices. |
| Static Subsidence (ASTM F2267) | Meets the requirements for intervertebral body fusion devices | "All necessary performance testing... has been completed" to assure substantial equivalence to predicate devices. |
| Expulsion | Meets the requirements for intervertebral body fusion devices | "All necessary performance testing... has been completed" to assure substantial equivalence to predicate devices. |
| Technical Characteristics (Shape) | Substantially equivalent to predicate devices (Box-shaped, bullet nose) | SAME as predicate devices |
| Technical Characteristics (Bone to implant surface) | Substantially equivalent to predicate devices (Surface teeth) | SAME as predicate devices |
| Technical Characteristics (Bone graft support feature) | Substantially equivalent to predicate devices (Central fenestration) | SAME as predicate devices |
| Technical Characteristics (Primary implant material) | Substantially equivalent to predicate devices (PEEK OPTIMA ®) | SAME as predicate devices |
| Technical Characteristics (Surgical Approach) | Substantially equivalent to relevant predicate devices (Transforaminal) for the specific device type | Transforaminal |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of clinical data. The performance data is based on material and mechanical testing, not a clinical study involving patients. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The "test set" here refers to physical and mechanical testing of the device, not a human-interpreted dataset. Therefore, no experts were used to establish ground truth in this context.
4. Adjudication Method for the Test Set
Not applicable, as no human-interpreted test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on substantial equivalence through technical and mechanical performance data, not a clinical comparison of human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is an intervertebral body fusion device (an implant), not an AI algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The Type of Ground Truth Used
For the performance data, the ground truth is established by validated mechanical testing standards (ASTM F2077, ASTM F2267) and engineering specifications for the material properties and design characteristics of the device and its predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is a medical implant device, not an AI or imaging device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 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.