(103 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 disc 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 510(k) summary (K113540) for the Reliance Lumbar IBF System describes performance criteria related to mechanical testing for substantial equivalence to predicate devices, rather than clinical acceptance criteria for a diagnostic or AI-driven device.
Here's the breakdown based on the information provided:
Acceptance Criteria and Device Performance (Mechanical Testing)
| Acceptance Criteria (Test Standard) | Reported Device Performance |
|---|---|
| Static Compression Testing (ASTM F2077-03) | Performed; found to be substantially equivalent to predicate devices. |
| Dynamic Compression Testing (ASTM F2077-03) | Performed; found to be substantially equivalent to predicate devices. |
| Subsidence Testing (ASTM F2267-04) | Performed; found to be substantially equivalent to predicate devices. |
| Static Push-out Testing (ASTM Draft F-04.25.02.02) | Performed; found to be substantially equivalent to predicate devices. |
Note: The document explicitly states that "The Reliance Lumbar IBF was found to be substantially equivalent to the predicate devices." This implies that the device met the performance benchmarks or passed the tests as per the predicate device's established performance or the industry standard.
The following information is not applicable or not provided in the given 510(k) summary for K113540, as this device is an intervertebral body fusion system and not a diagnostic or AI-powered device. Therefore, questions related to AI performance, expert ground truth, sample sizes for AI training/testing, or MRMC studies are not relevant to this submission.
2. Sample size used for the test set and the data provenance: Not applicable. The testing described is mechanical, not involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is established by mechanical testing standards, not expert consensus.
4. Adjudication method for the test set: Not applicable. Mechanical testing does not involve adjudication.
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. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used: For mechanical testing, the "ground truth" is defined by the specific parameters and failure modes outlined in the ASTM standards (F2077-03, F2267-04, and ASTM Draft F-04.25.02.02).
8. The sample size for the training set: Not applicable. Mechanical testing of a physical device does not use a "training set."
9. How the ground truth for the training set was established: Not applicable. See point 8.
§ 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.