(239 days)
This anterolateral/anterior system consists of several vertebral screws, locking Inis allectuateraliances system of attachment are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5). This amerolateral verteoral boures of unilization during the development of a solid spinal fusion.
When used as an anterolateral/anterior spine plate and rod system, the MaCs™ modular anterior construct system is indicated for patients with:
- Degenerative disk disease defined as back pain of discogenic origin with degeneration of the . disc confirmed by history and radiographic studies
- Spondylolisthesis .
- Spondylolysis ◆
- Fracture
- . Spinal stenosis
- Spillar schools
Deformities (i.e., scoliosis, kyphosis, lordosis, whether neuromuscular or related to deficient . posterior elements) - Tumors (neoplastic disease) .
- Pseudarthrosis .
- Failed previous fusion surgery
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 eyetype 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.
The provided text describes a 510(k) premarket notification for the "macsTL modular anterior construct system," a spinal intervertebral body fixation orthosis. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the way a clinical study with performance metrics would.
Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the cornerstone of the 510(k) pathway for medical device approval. This means the device is considered safe and effective because it is similar to other devices already on the market.
Here's an analysis based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be found in a clinical study for software or diagnostic devices. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices, focusing on:
- Intended Use and Indications for Use: The macsTM system must have the same or similar indications as the predicate devices.
- Material Composition: It must be made of the same implant alloy.
- Design and Function: It must have similar form, function, components, instruments, dimensions, geometry, and features.
- Biomechanical Performance: It must demonstrate comparable performance (stiffness, fatigue endurance) to the predicate devices and existing standards.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (macsTL modular anterior construct system) |
|---|---|
| Same Intended Use and Indications for Use | SAME as Centaur™ Spinal System (K994347) and BodyForm® (K983622): |
- Degenerative disk disease
- Spondylolisthesis / Spondylolysis
- Fracture
- Spinal stenosis
- Deformities (scoliosis, kyphosis, lordosis)
- Tumors
- Pseudarthrosis
- Failed Previous Fusion Surgery |
| Same Material Composition | SAME as Centaur™ Spinal System and BodyForm®: Titanium alloy (ASTM F-136-96 titanium alloy [Ti6Al4V] mentioned for Centaur™). |
| Similar Design, Form, Function, Components, Geometry | Similar to Centaur™ Spinal System and BodyForm®: Plate, rod, nuts & cancellous bone screws. Profile
§ 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.