(119 days)
The VALEO® C+CSC with Lumen Interbody Fusion Device 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 or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.
Valeo® C+CSC with Lumen Interbody Fusion Device is used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space to the C7-T1 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
VALEO® C+CSC with Lumen Interbody Fusion Device is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
The Valeo® C+CSC with Lumen Interbody Fusion Device consists of cervical spine interbody fusion devices, as well as instrumentation designed specifically for the implantation of these implants. The Valeo C+CSC with Lumen is manufactured from Amedica's Silicon Nitride ceramic material and is provided sterile.
This document describes the Valeo® C+CSC with Lumen Interbody Fusion Device and its acceptance criteria, focusing on performance and biocompatibility testing to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test are implicitly set by the "PASS" result, meaning the device met all applicable requirements of the specified standards.
| Test / Biological Endpoint | Standard | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Mechanical Testing | |||
| Static Compression | ASTM F2077 | PASS (meet standard req.) | PASS |
| Dynamic Compression | ASTM F2077 | PASS (meet standard req.) | PASS |
| Static Torsion | ASTM F2077 | PASS (meet standard req.) | PASS |
| Dynamic Torsion | ASTM F2077 | PASS (meet standard req.) | PASS |
| Subsidence | ASTM F2267 | PASS (meet standard req.) | PASS |
| Expulsion | ASTM F2267 | PASS (meet standard req.) | PASS |
| Biocompatibility Evaluations | |||
| Cytotoxicity | ISO 10993-5:1999 | PASS (meet standard req.) | PASS |
| Maximization Sensitization | ISO 10993-10:2002 | PASS (meet standard req.) | PASS |
| ISO Intracutaneous Extract | ISO 10993-10:2002 | PASS (meet standard req.) | PASS |
| ISO Systemic Toxicity Study | ISO 10993-11:2006 | PASS (meet standard req.) | PASS |
| Genotoxicity | ISO 10993-3:2003 | PASS (meet standard req.) | PASS |
| ISO Muscle Implantation Study | ISO 10993-6:1994 | PASS (meet standard req.) | PASS |
| System Toxicity | ISO 10993-11:2006 | PASS (meet standard req.) | PASS |
| Bacterial Endotoxin Testing (LAL assay) | ANSI/AAMI ST72:2011 | PASS (meet standard req.) | PASS |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes used for each specific test in the performance testing. It only states that "Testing performed on this device indicates that the Valeo C+CsC with Lumen Device is substantially equivalent to the Valeo Spacer System-C devices cleared under K142264. ASTM F2077 and ASTM F2267 performance standards were adhered to and all applicable requirements were met. Any deviations to the standards are noted at appropriate sections." This implies that the sample sizes were in accordance with the specified ASTM and ISO standards for mechanical and biocompatibility testing, respectively.
Data provenance: The tests were conducted internally or by a contracted lab to meet regulatory requirements for a medical device cleared in the U.S.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of testing (mechanical and biocompatibility) does not typically involve human experts establishing "ground truth" in the same way clinical studies or diagnostic AI evaluation would. The "ground truth" is established by the specifications and acceptance criteria defined within the ASTM and ISO standards themselves. Compliance is verified by technical experts in materials science, biomechanics, and toxicology. The document does not specify the number or qualifications of these technical experts.
4. Adjudication Method for the Test Set
Not applicable for this type of performance and biocompatibility testing. Results are determined by adherence to established test protocols and comparison against pre-defined acceptance criteria within the standards.
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 a premarket notification for an interbody fusion device, not a diagnostic or AI-powered device that involves human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical implant, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance testing is based on:
- Engineering Standards: Established criteria within ASTM F2077 (for mechanical testing) and ASTM F2267 (for subsidence and expulsion).
- Biocompatibility Standards: Established criteria within ISO 10993 series (various parts) and ANSI/AAMI ST72:2011 (for bacterial endotoxin testing).
Compliance with these standards forms the basis for demonstrating safety and effectiveness for a physical implant.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical implant, not an AI model that requires 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.