(125 days)
The KG2 implant is indicated for transforaminal and posterior interbody fusion of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The KG2 implant is used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The interbody fusion devices are intended to be used with FDA-cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment with an interbody fusion device.
The Kleiner KG2 is a cage intended for lumbar intervertebral fusion (PLIF/TLIF approach). The design contains both solid and porous structures formed as a diamond mesh, and it contains a bone grafting hole. The cage is additively manufactured from titanium alloy. The KG2 cage may be used with coverplate.
The sterile Kleiner KG2 implant comes pre-assembled on the inserter and includes pre-packaged sterile, single-use instrumentation for primary insertion, graft passing, and cover plate insertion. A reusable set of instruments are included for disc preparation, trial sizing, and repositioning/removal.
This document, an FDA 510(k) clearance letter for the Kleiner KG2 System, does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria. The provided text is a summary of the device's substantial equivalence to predicate devices, focusing on regulatory compliance rather than a comprehensive performance study report.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set, data provenance, ground truth establishment, or expert details for any such test set.
- Information about multi-reader multi-case (MRMC) studies, standalone algorithm performance, or training set details.
The document primarily focuses on substantiating equivalence through general performance characteristics and adherence to industry standards, rather than detailing a specific clinical or AI-driven performance study.
However, based on Section 7, "Summary of Performance Data," some aspects related to device performance evaluation can be inferred.
Inferred Information from the Document:
While a formal "acceptance criteria" table is not present, the Summary of Performance Data implicitly states that the Kleiner KG2 System underwent various tests to demonstrate its performance and safety, thereby meeting the necessary regulatory requirements for substantial equivalence. The document indicates that by demonstrating equivalence in these tests to predicate devices, the Kleiner KG2 System meets the implied acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a specific table with numerical acceptance criteria and corresponding reported device performance values. Instead, it lists the types of tests conducted and generally states that the device demonstrated equivalent or stronger performance compared to predicate devices.
| Acceptance Criteria (Inferred from Standards & Equivalence) | Reported Device Performance |
|---|---|
| Mechanical Performance (ASTM F2077 & ASTM F2267): | Confirmed equivalent performance to cited predicate device; implants are stronger compared to previously cleared devices. |
| - Static compression | Demonstrated satisfactory performance (implied by equivalence). |
| - Static compression-shear | Demonstrated satisfactory performance (implied by equivalence). |
| - Dynamic compression | Demonstrated satisfactory performance (implied by equivalence). |
| - Dynamic compression-shear | Demonstrated satisfactory performance (implied by equivalence). |
| - Subsidence | Demonstrated satisfactory performance (implied by equivalence). |
| Packaging Integrity (ISO 11607, parts 1 & 2): | Satisfactory packaging integrity for terminally sterilized medical devices. |
| Biocompatibility (ISO 10993-1): | Biocompatibility evaluated in accordance with FDA Guidance. (Implied |
to be satisfactory). |
| Sterilization (ISO 11137-1 & ISO 11137-2): | Sterilization testing conducted; reusable instruments conform to SAL 10-6 steam sterilization. (Implied to be satisfactory). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify sample sizes for mechanical testing or other non-clinical tests. It refers to established ASTM and ISO standards (e.g., ASTM F2077, ASTM F2267, ISO 11607, ISO 10993-1, ISO 11137) which typically detail the number of samples required for such tests.
Data provenance is implicitly from laboratory testing (e.g., mechanical, packaging, biocompatibility labs), likely conducted by or for the manufacturer. The document does not specify countries of origin, but the manufacturer is based in the Netherlands. These are prospective tests performed for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable in this context. The "ground truth" for mechanical and material performance is established by the specifications and methodologies within the cited ASTM and ISO standards, evaluated by qualified engineers and technicians performing the tests.
4. Adjudication Method for the Test Set:
Not applicable. This concept typically applies to clinical studies or assessments requiring human interpretation of data (e.g., image-based diagnosis). Performance under engineering standards is typically objective and measured directly.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC study was not done. This device is an intervertebral body fusion device (an implant), not a diagnostic device requiring human interpretation of medical images or data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, this device is a physical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used:
For the performance data mentioned:
- Mechanical Testing: Ground truth is defined by the objective physical measurements and failure modes specified in standards like ASTM F2077 and F2267, compared against predefined thresholds or performance of predicate devices.
- Biocompatibility: Ground truth is established by the cellular and tissue responses observed in standardized tests, evaluated against criteria from ISO 10993-1.
- Sterilization & Packaging: Ground truth is defined by the sterility assurance level (SAL) and packaging integrity requirements outlined in ISO 11607 and ISO 11137.
8. The Sample Size for the Training Set:
Not applicable, as this is an implantable medical device, not an AI/ML algorithm requiring a training set.
9. 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.