(23 days)
When used as an anterior, thoracic/lumbar screw fixation system, the MOSS Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).
When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the MOSS Spinal System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The MOSS Spinal System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.
The MOS'S Spinal System is available in Stainless Steel. The following components are included in the system: threaded rods, monoaxial and polyaxial screws, hexnut, washers, and transverse rod stabilizers. The design, intended use, and material of these components have been cleared in previous 510(k) submissions.
The provided text describes a 510(k) submission for the DePuy AcroMed MOSS Spinal System. This submission focuses on establishing substantial equivalence to existing predicate devices, rather than conducting a de novo study with acceptance criteria and direct performance evaluation. Therefore, the device meets acceptance criteria by demonstrating it is as safe and effective as legally marketed predicate devices, not through a study proving specific performance metrics against a predefined set of criteria.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" and "reported device performance" as typically applied to a de novo study (e.g., sensitivity, specificity, accuracy) is not directly applicable here because this is a 510(k) submission based on substantial equivalence. The "acceptance criteria" for a 510(k) are met by demonstrating that the new device is as safe and effective as a predicate device.
Acceptance Criteria (for 510(k) Substantial Equivalence): The device is substantially equivalent to legally marketed predicate devices in terms of:
- Intended use
- Technological characteristics (materials, design, performance)
- Safety and effectiveness
Reported Device Performance: The submission states:
| Characteristic | DePuy AcroMed MOSS Spinal System | Predicate Device (DePuy Motech MOSS Spinal System - Pedicle Fixation, DePuy Motech Universal Spinal System and Transverse Rod Stabilizer) |
|---|---|---|
| Components | Threaded rods, monoaxial and polyaxial screws, hexnut, washers, and transverse rod stabilizers | Components as described for MOSS Spinal Systems (implied to be similar or identical) |
| Material | Stainless Steel | Not explicitly stated, but implied to be similar for substantial equivalence (e.g., Stainless Steel) |
| Design | Cleared in previous 510(k) submissions | Cleared in previous 510(k) submissions |
| Intended Use | Anterior, thoracic/lumbar screw fixation for scoliosis, kyphosis, lordosis, fracture, tumor, spinal stenosis, spondylolisthesis, failed fusion, degenerative disc disease. Pedicle screw fixation for degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion. Pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1. | Similar or identical intended uses as extensively described for MOSS Spinal Systems, including pedicle fixation use indications. |
The basis of substantial equivalence is explicitly stated as: "The components of the MOSS Spinal System are identical to the components of the other MOSS Spinal Systems which have been cleared by FDA for certain anterior and posterior uses and for pedicle fixation use indications."
This means the "performance" demonstrated is that its components and functionality are equivalent to previously cleared devices.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This 510(k) relies on demonstrating substantial equivalence to existing predicate devices rather than a new study with a "test set" of patients or data. The "data provenance" would refer to the regulatory history and technical specifications of the predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No "test set" requiring expert ground truth establishment for performance metrics was used in this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. No "test set" requiring adjudication was used.
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. This device is a spinal implant system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a spinal implant system, not an algorithm.
7. The Type of Ground Truth Used
For a 510(k) based on substantial equivalence, the "ground truth" is effectively the regulatory history and established safety and effectiveness of the predicate devices. The ground truth is that the predicate devices have been deemed safe and effective for their indicated uses by the FDA. The new device is then compared against this established "ground truth" of the predicate.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this 510(k) submission for a spinal implant. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No "training set" was used.
§ 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.