(221 days)
The Stable-L Standalone Lumbar Interbody System is indicated for spinal fusion procedures in skeletally mature patients. Stable-L is designed for use with autogenous and/or allogenic bone graft comprised of cancellous bone graft. The devices are to be used in patients who have had at least six months of non-operative treatment. Stable-L is intended for use in interbody fusions in the lumbar spine from L2 to S1 at one or two adjacent levels in the treatment of symptomatic degenerative disc disease (DDD). The DDD patients may also have up to Grade 1 spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Each interbody fusion device having a lordotic angle 20° or less is intended to be used with the bone screws provided and requires no additional fixation. However, for hyperlordotic devices (> 20° lordosis), due to the increased risk of anterior migration with hyperlordotic implants, the devices should be used with the bone screws provided and supplemental fixation such as posterior fixation.
The Stable-L™ Standalone Interbody System is made of Ti-6A1-4V. The implant is offered in various angles, widths, heights, and lengths, and with various lengths of screws, to meet patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.
This document is a 510(k) premarket notification summary for the Stable-L Standalone Lumbar Interbody System. It describes the device, its intended use, and provides a statement of technological comparison and performance data. However, it does not contain any information about acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, expert involvement, ground truth establishment, or specific performance metrics related to AI/algorithm performance.
The content focuses on the regulatory clearance process for a medical device (an intervertebral body fusion device), asserting its substantial equivalence to previously cleared predicate devices through mechanical performance testing. It does not involve any AI or algorithmic components that would require the kind of data and studies requested in the prompt.
Therefore, I cannot fulfill the request using the provided text as it does not contain the necessary information regarding:
- Table of acceptance criteria and reported device performance: Not present. The document mentions mechanical testing (Static and dynamic compression and compression shear testing per ASTM F2077, screw pushout testing, and implant expulsion testing) but doesn't provide specific acceptance criteria or results.
- Sample sizes for test set and data provenance: No information on this.
- Number of experts and qualifications: Not applicable, as this is a mechanical device, not one requiring expert interpretation of output.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable as there's no mention of AI or human-in-the-loop performance.
- Standalone (algorithm only) performance: Not applicable as there's no algorithm.
- Type of ground truth used: Not applicable.
- Training set sample size: Not applicable.
- Ground truth establishment for training set: Not applicable.
§ 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.