(418 days)
Crystal®:
The Crystal® device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implanted via an open, anterior approach and packed with autogenous bone.
The Crystal® device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.
Mosaic®:
The Mosaic® device is an interbody fusion device intended for spinal fusion procedures at one level (C3-C7) in sketally mature patients with degenerative disc disease (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.
The implant is designed to accommodate two, three, or four screws. The maximum number of screws should be used to ensure adequate fixation of the implant.
Vertu®:
The Vertu® device is a stand-alone interbody fusion device intended for spinal fusion procedures at one level ( C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implanted via an open, anterior approach and packed with autogenous bone.
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.
The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.
Crystal:
Crystal is an intervertebral body fusion device for use in cervical spinal surgery. The device is generally box-shaped with various holes throughout its geometry to allow for the placement of autograft. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned.
Mosaic:
The Mosaic Spinal Implant System is composed of a device body and fixation screws. The body is a generally box-shaped device with various holes located throughout its geometry for the placement of graft material. Additionally, it has teeth on its superior and inferior external surfaces to keep the device from migrating once placed in its desired location. The box-shaped body has projections (or flanges) that encompass screw holes. Screws pass through screw holes and affix to bone to help prevent implant migration.
Vertu:
The Vertu Cervical Intervertebral Body Fusion System is composed of an implant body and fixation screws. The implant body is a generally box-shaped device with holes through its body for the placement of graft material. Additionally, it has teeth located on its superior and inferior external surfaces to help keep the device from migrating once placed in its desired location. There are also screw holes located in the implant body. Screws pass through screw holes of the implant body and affix to bone to help prevent implant migration.
Here's a breakdown of the acceptance criteria and study information for the Crystal®, Mosaic®, and Vertu® intervertebral body fusion devices, based on the provided FDA 510(k) summary:
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the same way a de novo or PMA application might. Therefore, the "acceptance criteria" here are essentially the performance metrics of the legally marketed predicate devices, and the "study" is the non-clinical testing performed to show equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for substantial equivalence, the "acceptance criteria" are implied to be the performance of the predicate devices. The "reported device performance" demonstrates that the subject devices perform comparably to these predicates.
| Test Type | Acceptance Criteria (Implied by Predicate) | Reported Device Performance |
|---|---|---|
| Material Biocompatibility | Biocompatibility in accordance with FDA Memorandum #G95-1 and ISO 10993-1 Part 1 for PEEK (Invibio MAF 1209) and commercially pure titanium (ASTM F 1580). | The PEEK material's biocompatibility is presented in Invibio device master file (MAF 1209). The titanium coating material is commercially pure titanium, in accordance with ASTM F 1580. No further testing required. |
| Dynamic Torsion Testing | Performance comparable to the predicate devices (Crystal®, Mosaic®, Vertu® Systems - K073351, K071833, K122771, and Calix PC - K112036). | Tested in accordance with ASTM F2077-03. Results used to support substantial equivalence. |
| Gravimetric Measurement for Wear Assessment | Performance comparable to the predicate devices. | Tested in accordance with ASTM F2025-06. Results used to support substantial equivalence. |
| Particle Characterization | Performance comparable to the predicate devices, specifically the wear debris data of predicate Calix PC (K112036). | Tested in accordance with ASTM F1877-89. Wear debris data (number of particulates and size) indicates the device coating performs similarly to predicate Calix PC (K112036). |
| Static Shear | Performance comparable to the predicate devices. | Tested in accordance with ASTM F1044-05. Results used to support substantial equivalence. |
| Static Tension | Performance comparable to the predicate devices. | Tested in accordance with ASTM F1147-05. Results used to support substantial equivalence. |
| Abrasion Resistance | Performance comparable to the predicate devices. | Tested in accordance with ASTM F1978-00. Results used to support substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes (e.g., number of units tested) for each mechanical test. The data provenance is derived from non-clinical bench testing conducted to support the substantial equivalence claim. There is no mention of country of origin for this testing, but it is typically conducted by the manufacturer or a contract research organization.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission relies on non-clinical bench testing and comparison to predicate device performance, not on expert-established ground truth from clinical data.
4. Adjudication Method for the Test Set
Not applicable for non-clinical bench testing focused on mechanical properties.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical Studies No clinical studies were performed."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device (intervertebral body fusion device) is a physical implant, not a software algorithm. The document explicitly states: "Software Verification and Validation Testing The device does not contain software. Therefore no software verification and validation testing were performed."
7. The Type of Ground Truth Used
The ground truth used is based on the established performance characteristics and safety profile of the predicate devices and recognized consensus standards (e.g., ASTM, ISO) for material and mechanical testing. For the wear debris, the ground truth for comparison was specifically the predicate Calix PC (K112036).
8. The Sample Size for the Training Set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
§ 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.