(29 days)
Crescent: The Spineology PEEK 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 I 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.
These devices may be implanted via an open or a minimally invasive transforaminal approach.
The Spineology PEEK Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
Bullets: The Spineology PEEK Bullet 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 I 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.
These devices may be implanted singly or in pairs via an open or a minimally invasive posterior or transforaminal approach.
The Spineology PEEK Bullet Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
The Spineology PEEK 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 device is available in a range of lengths and heights. The device and associated instruments are provided non-sterile.
This document describes a 510(k) summary for the Spineology PEEK Lumbar Interbody Fusion Devices, specifically a modification to add tantalum markers. The information provided does not detail a study proving the device meets acceptance criteria in the context of an AI/algorithm-based medical device. Instead, it focuses on demonstrating substantial equivalence to predicate devices for a physical medical implant.
Based on the provided text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or performance metrics in terms of accuracy, sensitivity, specificity, etc., are provided for an AI or algorithm. The document states:
"No testing was required for this change. The results of a risk analysis showed that the device was substantially equivalent to the identified predicate devices."
The "performance" criteria for this submission are based on the device's substantial equivalence to predicate devices in its intended use, materials, configuration, and performance characteristics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (K110933, K111880, K113030) in intended use, materials, configuration, and performance characteristics for PEEK Lumbar Interbody Fusion Devices. | The device is shown to be substantially equivalent to the intended use, materials, configuration, and performance characteristics of the predicate products. A risk analysis supported this conclusion. |
| Safety and effectiveness based on established predicate devices. | The FDA reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No test set involving patient data or images was used for this submission, as "No testing was required for this change." The submission is for a modification (adding tantalum markers) to an already cleared device, relying on substantial equivalence arguments rather than new clinical or performance data.
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)
Not applicable. No ground truth establishment by experts was performed for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication was performed for this submission.
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 submission is for a physical medical implant modification, not an AI/algorithm-based diagnostic or assistive device. Therefore, no MRMC study comparing human readers with and without AI assistance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is for a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this specific submission, the "ground truth" equivalent would be the established safety and performance of the predicate physical devices. The substantial equivalence argument relies on the existing approval of the predicate devices, not new ground truth generated for an algorithm.
8. The sample size for the training set
Not applicable. There is no algorithm being "trained" in this submission.
9. How the ground truth for the training set was established
Not applicable. There is no algorithm being trained.
§ 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.