(30 days)
The FuseLOX Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
The FuseLOX Lumbar Interbody Fusion System is an intervertebral body fusion device for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments and promote fusion. The device is made from PEEK-Optima with tantalum or titanium markers. The devices are provided in lordotic and convex configurations with heights ranging from 7-14mm in 1mm increments. Each device has a hollow core to receive bone graft. Placement is achieved with a series of device specific instruments provided.
Here's an analysis of the provided 510(k) summary for the Captiva Spine FuseLOX Lumbar Interbody Fusion System, focusing on acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
This 510(k) pertains to a medical device (intervertebral body fusion device), not an AI/software as a medical device (SaMD). Therefore, the "acceptance criteria" and "reported device performance" are based on mechanical testing and substantial equivalence to a predicate device, rather than diagnostic accuracy metrics.
| Acceptance Criteria (Performance Goal) | Reported Device Performance (Method & Result) |
|---|---|
| Mechanical Performance | Subject device was shown to meet the requirements of relevant ASTM standards. |
- Static Compression: Performed according to ASTM F2077. Results were acceptable and comparable to the predicate device.
- Dynamic Compression: Performed according to ASTM F2077. Results were acceptable and comparable to the predicate device.
- Static Compression Shear: Performed according to ASTM F2077. Results were acceptable and comparable to the predicate device.
- Static Torsion: Performed according to ASTM F2077. Results were acceptable and comparable to the predicate device.
- Subsidence: Performed according to ASTM F2267. Results were acceptable and comparable to the predicate device. |
| Material Biocompatibility | Not explicitly detailed in this summary, but would refer to the PEEK-Optima material, which is a common and well-established biocompatible material for implantable devices. Assumed to be met by substantial equivalence to predicate devices using similar materials. |
| Design and Features | The changes in design and features (non-pivoting inserter, lordotic/convex configurations) were found not to introduce any new risks. - The design changes were assessed for their impact on mechanical function and safety and found to be substantially equivalent to the predicate. |
| Indications for Use | Identical to predicate device. - The device is indicated for intervertebral body fusion at one or two contiguous levels in the lumbar spine (L2-S1) for patients with DDD with up to Grade 1 spondylolisthesis, who are skeletally mature and have had six months of non-operative treatment. Designed for use with autograft and supplemental fixation systems. |
| Clinical Application | Similar to predicate device. Functionally comparable to the predicate device in its intended clinical use. |
Study Proving Acceptance Criteria Met:
The primary study that proves this device meets its acceptance criteria is a mechanical performance testing study conducted according to recognized ASTM standards (ASTM F2077 and ASTM F2267).
This is a Special 510(k) submission, which means the changes introduced (new marketing name, new configurations, new inserter/trial instrument designs, new tray design) are minor and do not significantly alter the fundamental scientific technology of the device or its intended use. Therefore, extensive new clinical trials or highly complex comparative studies are generally not required. The key is to demonstrate that the modified device remains as safe and effective as the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in terms of patient numbers. For mechanical testing, the "test set" would refer to the number of device samples (implants) subjected to each specific mechanical test (e.g., N samples for static compression, N samples for dynamic compression). These numbers are typically defined by the ASTM standards themselves, but are not provided in this summary.
- Data Provenance: The data is generated from laboratory mechanical testing of the device components, not from human patients. Therefore, terms like "country of origin" or "retrospective/prospective" are not applicable.
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)
- Number of Experts: Not applicable. For mechanical testing of an intervertebral body fusion device, "ground truth" is established by adherence to standardized testing protocols (e.g., ASTM F2077) and objective measurement of physical properties (e.g., load to failure, displacement). There are no human "experts" establishing a subjective ground truth in this context like there would be for an image classification SaMD.
- Qualifications of Experts: Not applicable. The "experts" would be the engineers and technicians performing and supervising the mechanical tests, ensuring adherence to the standards and accurate data collection.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies or image interpretation studies where there is subjective interpretation or discrepancies in expert opinions. In mechanical testing, results are objective measurements against defined criteria.
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
- MRMC Study: No. This is a physical medical device, not an AI/SaMD.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" for this device's performance is established by objective mechanical properties (e.g., strength, stiffness, resistance to subsidence) as defined by internationally recognized ASTM standards (ASTM F2077 and ASTM F2267). The "ground truth" for safety and effectiveness is ultimately demonstrated by substantial equivalence to an already cleared predicate device, meaning it performs similarly and presents no new safety risks.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
Summary Specific to this Device:
This 510(k) submission is for a modification to an existing, already-cleared interbody fusion system. The regulatory pathway of a Special 510(k) relies heavily on demonstrating that the changes do not introduce new questions of safety or effectiveness. The core of the "study" proving acceptance criteria here is robust mechanical testing against established ASTM standards and a direct comparison of the modified device's performance to its cleared predicate device(s). The FDA's determination of substantial equivalence (K122956) indicates that these demonstrations were sufficient.
§ 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.