(218 days)
When used with the internal fixation and as a stand-alone system:
The Genesys Spine 3DP 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 3DP Cervical Interbody Fusion System is to be used with autogenous bone graft and implanted via an anterior approach.
When used without the internal fixation:
The Genesys Spine 3DP 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 discogenic 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 Cervical Interbody System includes 3D-Printed (3DP) titanium interbodies. The 3DP Cervical Interbody System offers a stand-alone version as well as a traditional (Regular) interbody that requires supplemental fixation. The version that utilizes integrated fixation may be used as a stand-alone cervical device that is implanted with two (2) titanium alloy anchors. All interbodies are made from Ti-6Al-4V ELI titanium alloy. The standalone version includes an integrated locking mechanism and various sizes of anchors which are all manufactured from Ti-6Al-4V ELI titanium alloy.
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 plate, posterior cervical screws) may be needed.
The provided text describes a 510(k) premarket notification for a medical device, the Genesys Spine 3DP Cervical Interbody System. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance evaluations, rather than providing a detailed study of the device's performance against specific acceptance criteria in a clinical setting.
Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment are not available in the provided text, as this type of information is typically part of clinical trials or specific performance studies, which are not detailed in a 510(k) summary focused on non-clinical equivalence.
Here's an assessment based on the available information:
1. A table of acceptance criteria and the reported device performance:
The document describes performance evaluations conducted on constructs against mechanical testing standards. It does not list quantitative acceptance criteria or specific reported numerical performance values in a table format. Instead, it makes a general statement of equivalency.
| Acceptance Criteria (Not explicitly stated with values in the document) | Reported Device Performance (General Conclusion) |
|---|---|
| Static compression (In accordance with ASTM F2077) | Substantially the same as predicate devices |
| Static torsion (In accordance with ASTM F2077) | Substantially the same as predicate devices |
| Static compression shear (In accordance with ASTM F2077) | Substantially the same as predicate devices |
| Dynamic compression (In accordance with ASTM F2077) | Substantially the same as predicate devices |
| Dynamic torsion (In accordance with ASTM F2077) | Substantially the same as predicate devices |
| Dynamic compression shear (In accordance with ASTM F2077) | Substantially the same as predicate devices |
| Subsidence (In accordance with ASTM F2267) | Substantially the same as predicate devices |
| Expulsion testing | Substantially the same as predicate devices |
| Force to overcome locking mechanism | Demonstrated equivalence |
| Cadaver testing | Demonstrated equivalence |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "constructs representing the worst-case components" for the non-clinical tests. Medical device mechanical testing typically uses a certain number of samples, but the exact count is not provided here.
- Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. No country of origin for clinical retrospective or prospective data is applicable or mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For mechanical and cadaveric testing of medical implants, "ground truth" as typically defined for AI/diagnostic studies (e.g., expert consensus on clinical images) does not apply. The "ground truth" in this context would be the objective measurements obtained during the mechanical tests themselves, compared against established industry standards (e.g., ASTM).
4. Adjudication method for the test set:
- Not applicable. An adjudication method, common in clinical studies involving human interpretation or subjective assessments, is not relevant for the described non-clinical mechanical performance evaluations.
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:
- No. The provided document details a 510(k) submission for an interbody fusion device, which is a physical implant, not an AI or diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This question pertains to AI algorithms. The device is a physical cervical interbody fusion system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical performance evaluation, the "ground truth" is implied to be adherence to scientifically established mechanical testing standards (e.g., ASTM F2077, ASTM F2267) and engineering principles. The document states "The Genesys Spine 3DP Cervical Interbody System was found to be substantially the same as predicate devices" based on these evaluations.
8. The sample size for the training set:
- Not applicable. There is no "training set" mentioned or implied, as this document describes the evaluation of a physical medical device, not an AI algorithm.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set mentioned, the establishment of its ground truth is also 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.