(201 days)
ACURA Stabilization System is intended to help provide immobilization of spinal segments in skeletally mature patients (including small stature) and for pediatric patients as an adjunct to fusion using posterior pedicle screw fixation (T1-S2/Ilium), posterior hook fixation (T1-L5), or anterolateral fixation. These devices are indicated as an adjunct to fusion for the treatment of the following acute and chronic spinal instabilities or deformities:
- Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- Degenerative spondylolisthesis
- Trauma (fracture or dislocation)
- Curvatures (Scoliosis, Kyphosis and /or Lordosis, Scheuermann's disease)
- Spinal tumours
- Spinal Stenosis
- Pseudarthrosis
- Previous Failed Fusions
When used as an adjunct to fusion, ACURA Stabilization System is intended to be used with autograft and/or allograft. When used for posterior non-cervical pediation in pediatic patients, the ACURA Stabilization System is intended as an adjunct to fusion to treat adolescent idionathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach.
The ACURA Stabilization System is a single use implantable system consisting of connecting members (rods) and fixation members (screws, hooks). The hooks are available in different types based on the attachment points on the vertebra such as the Lamina and Transverse Process. The screws are available in multiple diameters and lengths based on variations in the spinal anatomy. Variants in screws are also available based on the surgical procedure requirement such as polyaxial screws, monoaxial screws, uniplanar screws, cannulated screws, fenestrated screws, long tab screws, dual outer diameter screws. Locking caps are available which lock the screw head onto the rods. These devices can be rigidly locked into a variety of configurations as per surgical conditions and are available in a variety of sizes to accommodate individual patient anatomy.
Screws mate with 5.5mm diameter rods. Screws, hooks and cross connectors are intended for posterior use only. Hooks are intended for posterior use only. Similarly, Screws, Rods and Cross-Connectors are intended for both posterior and lateral use.
The devices are made Medical Grade Titanium (Ti6Al4V per ASTM F136), with some rods and polyaxial screw heads also offered as cobalt chromium alloy (Co28Cr6Mo per ASTM F1537).
The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.
The provided text is a 510(k) summary for the ACURA Stabilization System, a medical device used for spinal stabilization. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for the mechanical tests. Instead, it states that "The results of this non-clinical testing show that the strength of the ACURA Stabilization System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the performance of the ACURA Stabilization System met or exceeded the performance of the predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical strength sufficient for intended use and substantially equivalent to legally marketed predicate devices. | The ACURA Stabilization System's static compression bending, static torsion, dynamic compression bending, axial grip, and torsional grip testing results demonstrate its strength is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the mechanical testing (e.g., number of constructs tested). It also does not mention the country of origin of the data or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to this type of device. The ACURA Stabilization System is a mechanical implant, and its performance is evaluated through engineering mechanical tests, not through expert-reviewed clinical data or ground truth labeling in the context of diagnostic AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this device relies on mechanical testing, not human-reviewed data with adjudication.
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. The ACURA Stabilization System is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established through standardized material and mechanical testing specifications (e.g., ASTM F136, ASTM F1537, ASTM F1717-18, ASTM F1798). The performance is compared against the known performance of legally marketed predicate devices in these tests.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not involve machine learning or a training set.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.