(520 days)
The Octane Elevate Spinal Implant is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S 1 in patients with Degenerative Disc Disease (DDD,) with up to Grade 1 spondvlolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature, and have had at least six (6) months of nonoperative treatment. The device is intended for use with autogenous bone graft, and with supplemental internal fixation systems (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) cleared for use in the lumbosacral spine.
This submission proposes a new lumbar interbody fusion system. The Octane Elevate Spinal Implant is designed to provide stability during intervertebral body fusion in the lumbrosacral spine.
The provided document is a 510(k) summary for a medical device (Exactech® Octane® Elevate™ Spinal Implant System) seeking clearance from the FDA. This type of document focuses on demonstrating substantial equivalence to existing legally marketed devices, primarily through engineering and performance testing, rather than clinical studies involving human patients or complex AI algorithms.
Therefore, many of the requested categories for AI/clinical study evaluation do not apply to this specific submission.
Here's an analysis based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating "substantial equivalence" in performance characteristics to predicate devices. This is achieved through mechanical testing.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: |
- Static compression
- Dynamic compression
- Static compressive shear
- Dynamic compression shear
- Subsidence yield force | Demonstrated substantially equivalent performance characteristics compared to cited predicates based on testing per ASTM F2077 and ASTM F2267 for all listed mechanical tests. The document states: "Mechanical testing results summarized in this 510(k) premarket notification demonstrate Octane Elevate devices have substantially equivalent performance characteristics compared to cited predicates." |
| Intended Use | Substantially equivalent to predicate devices (intervertebral fusion for DDD at L2-S1 with bone graft and supplemental fixation). |
| Materials | Substantially equivalent to predicate devices (PEEK-Optima and tantalum materials with demonstrably safe and effective use). |
| Dimensions | Substantially equivalent to predicate devices (similar size ranges). |
| Sterilization processes | Substantially equivalent to predicate devices (sterilized using processes conforming to recognized industry standards). |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not applicable in the context of clinical patient data. The "test set" here refers to the actual physical devices (exact number not specified but implied to be sufficient for ASTM testing standards).
- Data provenance: Not applicable for patient data. The data provenance is from mechanical testing performed on the devices themselves, adhering to recognized ASTM standards (F2077 and F2267). This is engineering data, not clinical or human subject 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" in this context is established by engineering standards and validated mechanical testing protocols, not by expert medical review of patient data. The "experts" would be engineers and scientists familiar with mechanical testing and relevant ASTM standards.
4. Adjudication method for the test set
Not applicable. There is no adjudication method in the sense of reviewing disagreements among human readers for image interpretation or patient outcomes. The "adjudication" is inherent in the standardized mechanical testing protocols and their interpretation by qualified engineers.
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 a physical spinal implant, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used
The "ground truth" for demonstrating substantial equivalence is based on established engineering standards and performance specifications for intervertebral body fusion devices, as defined by ASTM F2077 (Standard Test Method for Static and Dynamic Axial Interbody Fusion Device Compression Fatigue) and ASTM F2267 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression). The performance of the Octane Elevate system is compared directly to the physical performance characteristics of the predicate devices under these standardized tests.
8. The sample size for the training set
Not applicable. This is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI algorithm.
§ 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.