(170 days)
When used with the integrated fixation and as a standalone system:
The Genesys Spine AIS-C II Cervical Interbody Fusion System is a standalone 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 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 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 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 AIS-C II Cervical Interbody Fusion will be offered in various device configurations based on surgical approach and patient anatomy. The AIS-C II System has two interbody options: Regular or Standalone.
The Regular Cervical Interbody System does not require the use of Anchors but is designed for use with supplemental fixation (i.e., cleared cervical plating system).
The Standalone Cervical Interbody System requires the use of Anchors for integrated fixation. This version includes an integrated cam lock mechanism and various sizes of anchors. 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, a cam lock key is used to turn the lockwise) to engage the cam lock and secure the anchors. When engaged (closed), the wings of the cam lock cover the anchor channels and provide a backing plate for the anchors.
The subject and predicate devices are based on the same technological characteristics: Integrated fixation anchors provide additional biomechanical support to the interbody. lmplant materials are identical: PEEK, Titanium 6AL-4V ELI alloy, and tantalum. A single inserter can be used to position the interbody and deploy the anchors.
The provided text is a 510(k) summary for the Genesys Spine AIS-C II Cervical Interbody Fusion System. It describes the device, its indications for use, and a comparison to predicate devices, focusing on technological characteristics and mechanical testing. However, the document does not contain information related to software, artificial intelligence (AI), or clinical studies involving human readers or expert ground truth adjudication.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance related to AI or software.
- Sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for test sets.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Details on standalone algorithm performance.
- Type of ground truth used for AI/software evaluation.
- Sample size for the training set or how ground truth was established for a training set.
The document focuses on the mechanical performance of a physical medical implant (intervertebral body fusion device) and demonstrates substantial equivalence to predicate devices through non-clinical mechanical testing.
Here's the relevant information that is present in the document regarding the device's acceptance criteria and the study proving it:
1. Acceptance Criteria and Reported Device Performance (Mechanical Testing)
The acceptance criteria are implicitly defined by the guidance documents and consensus standards listed, aiming to demonstrate the mechanical performance of the device is equivalent or superior to predicate devices and generally accepted standards for intervertebral body fusion devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Meets or exceeds performance data referenced by predicate submissions or aggregated mechanical test data from previously cleared Intervertebral Body Fusion Devices (IBFDs). | "Nonclinical mechanical testing demonstrates that the [device] exceeds performance data referenced by the predicate submission or aggregated mechanical test data from IBFDs previously cleared by the U.S. Food and Drug Administration through the 510(k) process. Data of previously cleared devices is cited in "Mechanical performance of cervical intervertebral body fusion devices: A systematic analysis of data submitted to the Food and Drug Administration" (Journal of Biomechanics, 2007) and ISO 23089-2:2021 Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices." |
| Conforms to relevant ASTM and ISO consensus standards for intervertebral body fusion devices. | Mechanical testing was performed per ASTM F2267-22, ASTM F2077-22, ASTM F1877-16, ASTM F04.25.02.02 (Draft), ASTM F3292-19, and ISO 23089-2:2021. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified in the provided text. Mechanical testing typically involves a number of devices or components to establish statistical significance for properties like strength, fatigue, and subsidence, but the exact number is not detailed here.
- Data provenance: Not applicable in the context of human data or AI. The "data" refers to the results of in vitro mechanical tests conducted on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a physical device; its mechanical performance is measured directly by adherence to engineering standards and comparison to established benchmarks from other devices, not by expert consensus on clinical cases.
4. Adjudication method for the test set:
- Not applicable. Mechanical testing results are objective measurements against defined parameters.
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 document explicitly states: "Clinical testing is not required." This device is not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical surgical implant, not a standalone algorithm.
7. The type of ground truth used:
- Not applicable in the AI/software sense. The "ground truth" for this device's performance is established through internationally recognized engineering standards (ASTM, ISO) for static and dynamic mechanical properties, and comparative data from previously cleared devices, as measured in a laboratory setting.
8. The sample size for the training set:
- Not applicable. This device is not an AI/software product, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI/software product, so there is no training set or ground truth establishment relevant to AI.
§ 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.