(137 days)
The Kepler II is 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 neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. These patients should have had 6 weeks of non-operative treatment. The Kepler II implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The Kepler II Cervical Cage is to be used with supplemental fixation.
The Kepler II Cervical Cage consists of cervical spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Kepler II Cervical Cage is manufactured from PEEK-OPTIMA LT1 polymer and contains tantalum radiopaque markers. The Kepler II Cervical Cage is for single level anterior spinal use from the C2-C3 to C7-T1 disc levels.
This document is a 510(k) premarket notification for the Kepler II Intervertebral Body Fusion Device, manufactured by Orbbo Surgical, LLC. The FDA has determined the device to be substantially equivalent to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Static Compression | ASTM F2077-14 | Met original performance requirements |
| Static Compression Shear | ASTM F2077-14 | Met original performance requirements |
| Static Torsion | ASTM F2077-14 | Met original performance requirements |
| Dynamic Compression | ASTM F2077-14 | Met original performance requirements |
| Dynamic Compression Shear | ASTM F2077-14 | Met original performance requirements |
| Dynamic Torsion | ASTM F2077-14 | Met original performance requirements |
| Subsidence | ASTM F2267-04 (reapproved 2011) | Met original performance requirements |
| Expulsion | Recognized industry norm | Met original performance requirements |
| Bacterial Endotoxin | USP34 and NF 29 | Not explicitly stated as "met" but implied through general "performance testing" |
| Material-mediated Pyrogenicity | ISO 10993-11 (2006) and ASTM F750-87 (2007) | Not explicitly stated as "met" but implied through general "performance testing" |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "mechanical testing" and "performance testing" of the device itself and its material, not a "test set" of patient data.
- Data Provenance: Not applicable as no clinical data or patient test sets were used. The testing was mechanical and material-based.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Mechanical and material testing standards (e.g., ASTM, ISO, USP) establish the 'ground truth' for performance rather than expert consensus on clinical cases.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical intervertebral body fusion device, not an AI or imaging diagnostic tool that would typically undergo such a study.
6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)
- Not applicable. The Kepler II is a physical medical implant, not a software algorithm.
7. Type of Ground Truth Used
- The ground truth used was established engineering and material science standards (e.g., ASTM, ISO, USP) for mechanical performance, biocompatibility, and sterilization. These standards objectively define acceptable performance for the device.
8. Sample Size for the Training Set
- Not applicable. The Kepler II is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set was used.
§ 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.