(47 days)
The PSL Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7). These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system are: degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
The PSL Anterior Cervical Plate (ACP) System comprises plate and screw components in a variety of sizes and lengths. Three styles of plate, including fixed, variable and corpectomy, are available. Primary, self-drilling primary and rescue screws are offered.
This document describes a 510(k) premarket notification for the "PSL Anterior Cervical Plate System". It's a medical device, specifically a spinal implant, which means the "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to a predicate device, primarily through mechanical testing and comparison of characteristics, rather than clinical efficacy studies often associated with AI/software devices.
Here's an breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Result) |
|---|---|
| Mechanical Performance (according to ASTM F1717): | |
| Static Compression Bending | Performed "as well as the predicate device" |
| Static Torsion | Performed "as well as the predicate device" |
| Dynamic Compression Bending | Performed "as well as the predicate device" |
| Technological Characteristics: | |
| Intended Use | Identical to predicate device |
| Design (plate-based fixation, self-tapping screws) | Identical to predicate device |
| Material (titanium alloy) | Identical to predicate device |
| Sizes (plate and screw) | Identical to predicate device |
| Fundamental Scientific Technology | Same as previously cleared device |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Mechanical Testing: "worst-case, cervical plate construct" - The document does not specify the exact number of constructs tested, but implies a sufficient number for an engineering study to demonstrate performance against the predicate.
- Data Provenance: The mechanical tests were performed by the manufacturer (Precision Surgery Limited) or a contracted lab. This is a prospective engineering study, not involving human data. There is no country of origin of data in the same sense as clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This is not applicable in the context of this device. The "ground truth" for mechanical testing is established by engineering standards (ASTM F1717) and direct comparison to the predicate device, not by expert medical consensus on individual cases.
4. Adjudication Method for the Test Set
Not applicable. This is an engineering study, not a clinical study requiring adjudication of outcomes or diagnoses.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size.
No, an MRMC study was not done. This is a spinal implant, not an AI/software device that would typically involve human readers interpreting images.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used for demonstrating substantial equivalence was:
- Predicate Device Performance: The established mechanical performance of the legally marketed predicate device (Fixed, Variable & Corpectomy Cervical Plate System (K032815/K073708)).
- ASTM F1717 Standard: The performance criteria defined by the standard for spinal implant mechanical testing.
- Direct Comparison of Characteristics: Comparing the design, materials, intended use, and sizes directly to the predicate device.
8. The Sample Size for the Training Set
Not applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.