(409 days)
The Genesys Spine 3DP Lumbar Interbody System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis 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 radios. The system is designed for use with supplemental fixation and with autograft to facilitate fusion.
The Genesys Spine 3DP Lumbar Interbody System is comprised of additively manufactured lumbar intervertebral body fusion devices. They are designed to provide mechanical support to the lumbar spine while arthrodesis occurs. Numerous styles, footprints, and sizes of interbodies are offered including PLIFs, TLIFs, ALIFs, and LLIFs. The 3DP Lumbar Interbody System implants are manufactured from titanium Ti-6AL-4V ELI alloy.
This document, K182987, is an FDA 510(k) Premarket Notification for the Genesys Spine 3DP Lumbar Interbody System. It details the device's indications for use and a comparison to predicate devices, but it does not contain information about a study that proves the device meets specific acceptance criteria in terms of performance measures such as sensitivity, specificity, or accuracy, as would be relevant for an AI/ML-based medical device.
The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices based on design, materials, technological characteristics, and non-clinical performance evaluations (mechanical testing), not on clinical performance or diagnostic accuracy.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study to prove they are met, as this document does not describe such a study for this type of medical device (physical implant).
Specifically, the information you requested that is NOT present in this document includes:
- A table of acceptance criteria and the reported device performance: This document reports mechanical test results for "worst-case components" (static compression, static torsion, etc.) but does not list performance metrics like sensitivity or specificity.
- Sample size used for the test set and the data provenance: Not applicable, as no clinical test set for AI performance is described.
- Number of experts used to establish the ground truth... and qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
- The type of ground truth used: Not applicable (no ground truth for diagnostic performance).
- The sample size for the training set: Not applicable (no AI/ML training set is mentioned).
- How the ground truth for the training set was established: 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.