(35 days)
When used with the integrated fixation and as a stand-alone system:
The Genesys Spine 3D Printed AIS-C II Cervical Interbody Fusion System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine 3D Printed AIS-C II Cervical Interbody Fusion System is to be used with autogenous bone graft and implanted via an anterior approach.
When used without the integrated fixation:
The Genesys Spine 3D Printed AIS-C II Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenc pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (i.e., cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.
The Genesys Spine 3DP Als-C II Cervical Interbody System includes 3D-Printed (3DP) titanium interbody System offers a stand-alone version as well as a traditional (Regular) interbody that requires supplemental fixation.
The interbody that utilizes supplemental fixation may be used as a stand-alone that is implanted with two (2) titanium alloy anchors. This version includes an integrated cam lock mechanism and various The cam lock mechanism may be used as a secondary aid in keeping the anchors from backing out of the interbody and vertebral bodies after anchor deployment. After anchor deployment, in order to engage the cam lock key instrument is used to turn the lock (counterclockwise direction) from an open to closed position. When closed, the wings of the cam lock slide over the anchor channels and provide a backing cover for the anchor and anchor channels.
Al interbodies and anchors are made from Ti-6Al-4V ELI titanium alloy. The cam lock is made out Ti-6Al-4V ELI titanium alloy with a PEEK washer.
The integrated fixation anchors may not provide adequate stability for all situations. The Surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g., anterior cervical screws) may be needed.
This FDA 510(k) summary for the Genesys Spine 3DP AIS-C II Cervical Interbody System does not contain information about acceptance criteria or a study proving the device meets those criteria. My analysis of the provided text is as follows:
The document is a 510(k) premarket notification letter and summary for a medical device. It focuses on demonstrating substantial equivalence to a legally marketed predicate device (K191489, Genesys Spine 3DP Cervical Interbody System), rather than detailing specific acceptance criteria and a study to prove meeting them.
The sections that might typically contain such information (Non-Clinical and/or Clinical Tests Summary & Conclusions) are explicitly marked as "N/A" or describe comparative testing against the predicate (e.g., "results proved superior to predicates"). This indicates that the regulatory pathway for this device did not require a standalone study to establish de novo performance against specified acceptance criteria. Instead, it leveraged the established safety and effectiveness of a predicate device.
Therefore, I cannot provide the requested information from the provided text.
Here's why each point cannot be addressed:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on comparing the new device to a predicate, not on defining and meeting specific performance acceptance criteria for a novel device.
- Sample size used for the test set and the data provenance: Not applicable as a standalone performance study against acceptance criteria is not described. The document mentions "Anchor Push-Out testing," "Biocompatibility analysis," "Sterilization/Cleaning analysis," "Design Validation testing," "mechanical performance... in accordance with ASTM F2077," and "Finite Element Analysis (FEA)." However, these are presented as comparative tests to the predicate or as engineering analyses, not as a study against a specific set of acceptance criteria with defined sample sizes for that purpose. No data provenance (country, retrospective/prospective) is stated for these tests beyond their comparative nature.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The document refers to "user feedback" for design validation but does not detail a process for establishing ground truth by experts in the context of a clinical performance study.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication is described.
- 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 an interbody fusion system, not an AI-powered diagnostic or assistive tool for human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable given the nature of the device and the lack of a clinical performance study described. The document discusses mechanical testing and design validation.
- The sample size for the training set: Not applicable. The device is not an AI/ML algorithm that requires a training set.
- 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.