(305 days)
The Keos Anterior Cervical Interbody Fusion Devices (IBFDs) are in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Keos Anterior Cervical IBFD's are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autogenous bone graft. Keos Anterior Cervical IBFD's are intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The subject Keos Anterior Cervical Interbody Fusion Device (IBFD) System is composed of anterior cervical spacers and associated instruments. Keos Anterior Cervical IBFD cages are manufactured from polyetheretherketone (PEEK) according to ASTM F2026, as well as Hydroxyapaetite (HA) Enhanced PEEK. The subject device has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. Keos Anterior Cervical IBFD cages are offered in several adaptive sizes with varying footprints and lordotic angles to accommodate patient anatomy. Additionally, the device contains six (6) tantalum marker balls per ASTM F560 to provide imaging visibility for device positioning.
The Keos Anterior Cervical Interbody Fusion Device System implants are intended for single use only. All components of the Keos Anterior Cervical IBFD System are provided non-sterile, to be sterilized by the end user.
The provided text is a 510(k) summary for the Keos Anterior Cervical Interbody Fusion Device System. This document focuses on demonstrating substantial equivalence to previously cleared devices through performance testing, rather than an AI/ML device study. Therefore, most of the requested information about acceptance criteria, study method, sample sizes, ground truth establishment, and expert involvement is not applicable or cannot be extracted from this document, as it pertains to a different type of device evaluation.
However, I can provide the information available regarding the performance testing that was conducted.
Summary of Performance Testing for Keos Anterior Cervical Interbody Fusion Device System (K212450)
This device is a physical medical implant (Interbody Fusion Device), not an AI/ML-based diagnostic or therapeutic system. Therefore, the questions related to AI/ML device performance (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for training sets) are not relevant to this submission.
The acceptance criteria and device performance are related to mechanical and biocompatibility testing of the physical implant as per relevant ASTM standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|---|
| Mechanical Testing | Performance demonstrated to be substantially equivalent to predicate devices. Specific standards followed: ASTM F2077 (for static axial compression, dynamic axial compression shear, dynamic compression shear, static torsion, dynamic torsion, and subsidence) and ASTM F2267. This implies meeting or exceeding the mechanical performance characteristics of the predicate devices under these test conditions, ensuring structural integrity, stability, and resistance to subsidence or failure under physiological loads. Acceptance criteria would typically include thresholds for displacement, load to yield, fatigue life, and other mechanical parameters as defined within the ASTM standards and compared against predicate devices. | All tests confirmed that the product met the predetermined acceptance criteria. Non-clinical bench performance testing demonstrated that the Keos Anterior Cervical IBFDs are substantially equivalent to previously cleared devices based on mechanical performance. |
| Static Axial Compression | As per ASTM F2077, likely involves specific load-bearing capacity without permanent deformation. | Met criteria, demonstrating substantial equivalence. |
| Dynamic Axial Compression | As per ASTM F2077, likely involves fatigue life under cyclic axial loading. | Met criteria, demonstrating substantial equivalence. |
| Dynamic Compression Shear | As per ASTM F2077, likely involves fatigue life under cyclic shear loading. | Met criteria, demonstrating substantial equivalence. |
| Static Torsion | As per ASTM F2077, likely involves resistance to torsional forces without permanent deformation. | Met criteria, demonstrating substantial equivalence. |
| Dynamic Torsion | As per ASTM F2077, likely involves fatigue life under cyclic torsional loading. | Met criteria, demonstrating substantial equivalence. |
| Subsidence | As per ASTM F2077, likely involves resistance to sinking into vertebral bone under load. | Met criteria, demonstrating substantial equivalence. |
2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical implant testing, not an AI/ML-based study with a test set of data. The "test set" would be the number of physical devices tested according to the ASTM standards. The provenance is from bench testing in a laboratory setting. Specific numbers of devices tested are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in this context, is established by industry standards (ASTM) and engineering principles for mechanical performance, not expert consensus interpreting medical images or data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This term relates to human interpretation/review of data, which is not part of this type of device 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 is for AI/ML devices.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/ML devices.
7. The type of ground truth used:
- Mechanical Performance: Established by adherence to the requirements and methodologies outlined in ASTM F2077 and ASTM F2267 standards for intervertebral body fusion devices. The "ground truth" is therefore consistency with established engineering principles and performance benchmarks for such implants.
8. The sample size for the training set: Not applicable. This is for AI/ML devices.
9. How the ground truth for the training set was established: Not applicable. This is for AI/ML devices.
§ 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.