(48 days)
The PrimaLIFTM LLIF Unitary PEEK Lateral Lumbar Interbody Fusion System (PrimaLIFTM LLIF) is indicated for intervertebral body fusion of the lumbar spine to be used with autogenous bone graft, 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 level or two contiguous levels for the treatment of degenerative disc disease (DDD) and these patients may have up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation systems such as PrimaLOK™ SP and PrimaLOK™ FF which have been cleared for use in the lumbar spine.
The PrimaLIFTM LLIF implants are intended for single use only.
The PrimaLIFTM LLIF Unitary PEEK Lateral Lumbar Interbody Fusion System is a comprehensive interbody cage system that provides structural stability of the anterior column. It is comprised of unitary PEEK interbody cages of various sizes. The instruments provided with the system include osteoteomes, implant trials, and an inserter to facilitate placement of the interbody device.
The provided document is a 510(k) Summary for the OsteoMed PrimaLIF™ LLIF Unitary PEEK Lateral Lumbar Interbody Fusion System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.
Based on the content, this device is a physical intervertebral body fusion system, not an AI/ML-driven solution. Therefore, many of the requested categories (like sample size for test/training set, ground truth, experts, MRMC studies, standalone performance) are not applicable to the information provided.
The "Performance/Clinical Data" section states: "The PrimaLIF™ LLIF device has been tested in static and dynamic axial compression per ASTM F2077 and static subsidence per ASTM F2267. The intended use of the device is the same as the predicate devices. Clinical testing is not required to support substantial equivalence." This indicates that the regulatory pathway for this device relied on demonstrating mechanical equivalence and material biocompatibility to predicate devices, rather than clinical performance studies using human data or AI-specific evaluations.
Therefore, an AI system is not applicable to the provided information as the device is a physical medical device.
If this were an AI medical device, the following would be how I would format the response if the information was available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| (Not Applicable to this device) | (Not Applicable) | (Not Applicable) |
2. Sample size used for the test set and the data provenance
(Not Applicable - no test set for an AI/ML device was used as this is a physical medical implant)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
(Not Applicable - no ground truth development for an AI/ML device was required)
4. Adjudication method for the test set
(Not Applicable - no test set for an AI/ML device was used)
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 - no MRMC study conducted as this is a physical medical implant)
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
(Not Applicable - no standalone algorithm performance evaluated as this is a physical medical implant)
7. The type of ground truth used
(Not Applicable - no ground truth developed as this is a physical medical implant)
8. The sample size for the training set
(Not Applicable - no training set for an AI/ML device was used as this is a physical medical implant)
9. How the ground truth for the training set was established
(Not Applicable - no ground truth for an AI/ML device was established as this is a physical medical implant)
§ 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.