(31 days)
The OneLIF™ Interbody Fusion System is an interbody fusion device system indicated for use in skeletally mature patients at one or more levels of the lumbosacral spine (L2-S1), in patients with the following indications: degenerative disc disease (DDD) defined as back pain with degeneration of the disc confirmed by patient history and radiographic studies, spinal deformity (degenerative scoliosis or kyphosis), spondylolisthesis or retrolisthesis, and failed previous fusion (pseudoarthrosis). Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
The OneLIF™ Interbody Fusion System is intended to be used with or without the screws which accompany the implants. These devices are intended for stand-alone use in patients with DDD or degenerative spondylolisthesis at one or two contiguous levels only when used with at least three screws per implant (including at least one screw in each endplate) and when ≤ 20° lordotic implants are used. When used at more than 2 contiguous levels, or for treatment of conditions other than DDD or degenerative spondylolisthesis, or with fewer than 3 accompanying screws, or when using implants greater than a 20° lordotic angle, the system must be supplemented by posterior fixation (e.g., pedicle screw system) cleared for use in the lumbar spine.
The implants can be placed via a variety of open or minimally invasive approaches. These include anterior and oblique approaches. The implant is designed for use with autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft.
The OneLIF™ Interbody Fusion System includes interbody cages and retention plates designed for anterior or oblique insertion techniques. The purpose of this submission is to add additional implant sizes to the previously cleared system.
The provided text is a 510(k) clearance letter for a medical device called the OneLIF™ Interbody Fusion System. It does not contain information about acceptance criteria and a study proving device performance in the way typically observed for AI/ML-based devices.
Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is a common pathway for clearance of conventional medical devices like interbody fusion systems. The "performance data" mentioned refers to mechanical testing of the physical hardware, not a clinical performance study with human subjects, AI accuracy, or human-in-the-loop metrics.
Therefore, many of the requested categories cannot be populated from the provided text.
Here's a breakdown based on the given document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Mechanical performance per ASTM F2077 | "Previously tested per ASTM F2077 under K211769" |
| No new worst-cases with modified implant designs | "Dynamic testing per ASTM F2077 and engineering analysis was performed on the modified subject implant designs to confirm no new worst-cases" |
| Substantial equivalence to predicate device (K211769) | "Overall technology characteristics and mechanical performance data lead to the conclusion that the OneLIF™ Interbody Fusion System is substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not mentioned. The "test set" here refers to physical implant designs and their mechanical properties, not a clinical dataset of patients or images.
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)
- Not applicable / Not mentioned. Ground truth in this context would be related to the mechanical properties and compliance with ASTM standards, typically assessed by engineers or testing laboratories, not clinical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not mentioned. Adjudication methods are typically used for clinical endpoints or image interpretation studies.
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
- No. This is a hardware device (interbody fusion system), not an AI-assisted diagnostic or treatment system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not mentioned for clinical ground truth. For the mechanical testing, the "ground truth" would be established by the ASTM F2077 standard's specifications for mechanical behavior (e.g., strength, fatigue life) under specific loading conditions.
8. The sample size for the training set
- Not applicable / Not mentioned. This device does not use a training set in the context of AI/ML.
9. How the ground truth for the training set was established
- Not applicable / Not mentioned. This device does not use a training set.
§ 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.