(91 days)
The Reliance LUMBAR IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.
The Reliance LUMBAR IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.
The Reliance Lumbar IBF System is comprised of implant and instrument components. The implant component, the Reliance Lumbar IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the lumbar spine. The spacer is made of PEEK OPTIMA LT1 with Tantalum markers.
The provided documents are a 510(k) Pre-market Notification from the FDA regarding the "Reliance Lumbar IBF System." This document primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study of its own performance against specific acceptance criteria.
Therefore, the requested information about acceptance criteria and a study proving the device meets them, particularly regarding AI or algorithm performance, cannot be extracted from this document because:
- The device is a physical medical implant (intervertebral body fusion device), not an AI/software device. This type of device does not have "acceptance criteria" in the sense of performance metrics for an algorithm (e.g., sensitivity, specificity, AUC). Its acceptance is based on meeting mechanical and material specifications, biocompatibility, and substantial equivalence to existing devices.
- The document describes "Non-Clinical Testing" which is Finite Element Analysis (FEA). This is a computational method to analyze the mechanical behavior of the additional components, ensuring they do not create a "new worst-case scenario" compared to the predicate device. It's not a study with a test set, ground truth, experts, or statistical performance metrics.
- There is no mention of an algorithm, AI, human readers, or any form of software performance evaluation.
The document does state:
- Device Name: Reliance Lumbar IBF System
- Regulation Number: 21 CFR 888.3080
- Regulation Name: Intervertebral body fusion device
- Product Code: MAX
- Predicate Devices: Reliance Lumbar IBF System (K113540) and Globus Patriot TransContinental System (K093242, K102313).
- Intended Use/Indications for Use: Intervertebral body fusion of the spine in skeletally mature patients, with autogenous bone graft, intended for the lumbar spine (L2 to S1) for treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.
- Device Description: Made of PEEK OPTIMA LT1 with Tantalum markers.
- Non-Clinical Testing: Finite Element Analysis (FEA) was performed on additional components using Solidworks software and compared to test results of already approved components per K113540. No new components create a new worst-case scenario.
In summary, none of the requested information regarding algorithm-specific acceptance criteria, study design parameters (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), or training set details can be provided from this document as it pertains to a physical implant and not an AI/software medical device.
§ 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.