(142 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 Lumbar Interbody System is a stand-alone lumbar interbody system including an interbody cage additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 and associated bone screws manufactured from titanium alloy per ASTM F136. The device is offered in a variety of sizes to accommodate patient anatomy. Stable-L Interbody devices are provided nonsterile and are expected to be sterilized by the end-user prior to use. The subject submission seeks to gain clearance for design changes to the previously cleared devices, as well as expand the screw offerings of the system.
The provided text is a 510(k) summary for the Stable-L Standalone Lumbar Interbody System. This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about studies involving AI or human readers, or detailed clinical performance criteria typically found in studies for diagnostic devices. Therefore, I cannot provide all the requested information.
Based on the provided text, here is what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) that would be relevant for an AI-powered diagnostic device. Instead, it refers to substantial equivalence to a predicate device based on design, indications for use, materials, and mechanical performance testing.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Confirmatory Bench Testing) |
|---|---|
| Design, Indications for Use, Materials are substantially equivalent to predicate. | Design changes (screw offerings, slight geometry differences) demonstrated to be substantially equivalent to the predicate. |
| Mechanical performance (e.g., screw insertion torque, static compression, static compression shear, screw pull out) is equivalent to predicate. | Confirmatory screw insertion torque performed on new screws. |
| Confirmatory static compression and static compression shear performed on interbody device changes. | |
| Confirmatory screw pull out testing conducted on cover plates. | |
| Device does not raise new questions of safety and effectiveness. | Testing confirmed that proposed design changes do not raise new issues of safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes bench performance testing for a medical implant (lumbar interbody system), not a diagnostic AI device using a "test set" of clinical data. Therefore, this information is not applicable and not provided. The testing involves physical devices.
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)
This information is relevant for studies validating diagnostic devices. As this document describes testing for a spinal implant, there is no mention of "experts" establishing a "ground truth" for a test set in the context of clinical interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is relevant for studies validating diagnostic devices, particularly when there are discrepancies in expert interpretations. As this document describes testing for a spinal implant, there is no mention of adjudication methods.
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 such study was conducted or is mentioned in the document. This type of study is for evaluating AI-assisted diagnostic tools, not for medical implants.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the performance of an AI algorithm without human involvement. As described, this device is a physical medical implant, not an AI algorithm. Therefore, this is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical performance testing conducted, the "ground truth" would be established by engineering standards and measurements. The document does not explicitly state the specific "ground truth" criteria (e.g., specific torque values, force limits) but implies adherence to established mechanical testing methodologies to ensure equivalence to the predicate device.
8. The sample size for the training set
The document does not describe the development of an AI algorithm, and therefore there is no "training set."
9. How the ground truth for the training set was established
As there is no AI algorithm or training set, this information is 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.