(104 days)
The Slimplicity Anterior Cervical Plate System is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: degenerative disc disease (DDD) (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (including fractures or dislocations); spinal tumors; spinal stenosis; pseudarthrosis; and failed previous fusions.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The Slimplicity Anterior Cervical Plate System consists of various sizes of anterior cervical bone plates, locking rivets pre-assembled, and bone screws, which can be assembled with associated instruments to provide immobilization of the cervical spine. All components are made from medical grade titanium or titanium alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".
The provided text describes a 510(k) premarket notification for a medical device called the Slimplicity Anterior Cervical Plate System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the "acceptance criteria" and "device performance" in the context of this document refer to the ability of the device to perform equivalently to a predicate device in specific engineering tests, not clinical performance against defined metrics.
Here's a breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: For 510(k) submissions, "acceptance criteria" typically refers to meeting the performance characteristics of an equivalent device as demonstrated through standardized testing. The "reported device performance" is that the device meets or is equivalent to the predicate device in these tests. The document indicates that testing was performed to demonstrate substantial equivalence, implying the Slimplicity system met the performance standards set by the predicate devices.
| Acceptance Criteria (Standard Test) | Reported Device Performance |
|---|---|
| Performance demonstrated to be substantially equivalent to predicate devices as defined by ASTM F1717-04 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." | The Slimplicity Anterior Cervical Plate System demonstrates substantial equivalence to the following predicate devices when tested in accordance with ASTM F1717-04: |
- Deltaloc Anterior Cervical Plate System (K993513)
- Synthes Spine Anterior CSLP System (K030866)
- Reflex Anterior Cervical Plate System (K031702) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text. The ASTM F1717-04 standard would outline the specific sample size requirements for the mechanical testing of spinal implants.
- Data Provenance: Not specified, but generally, mechanical testing for 510(k) predicate comparison is conducted in a laboratory setting, not on patient data. It is a prospective test in the sense that the testing is performed specifically for this submission. The "country of origin" is not stated, but the submission is to the US FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this type of device submission or study. Ground truth in this context refers to the mechanical performance standards established by the ASTM F1717-04 standard, which is determined by a consensus body of experts in the field of medical device standards, not by individual clinical experts reviewing a "test set" of cases.
4. Adjudication Method for the Test Set
Not applicable. Mechanical tests for substantial equivalence do not involve adjudication by human experts. The results are quantitative and objective, based on physical measurements against a standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or algorithms that require human interpretation and would measure the improvement in human reader performance with or without AI assistance. The Slimplicity Anterior Cervical Plate System is a physical implant, and its evaluation for 510(k) clearance relies on mechanical and material properties, not reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not done. This concept is applicable to software algorithms or AI devices. The Slimplicity Anterior Cervical Plate System is a hardware device.
7. The Type of Ground Truth Used
The "ground truth" used is the performance characteristics of legally marketed predicate devices as measured by a recognized mechanical testing standard (ASTM F1717-04). This standard simulates physiological loading conditions to assess the structural integrity and stability of spinal implant constructs.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" for this kind of physical device and its associated mechanical testing for 510(k) clearance. Training sets are used in machine learning for AI algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this context.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.