(49 days)
The intended use of the Sierra spinal system is to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). The indications for use are as follows:
- degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
- spondylolisthesis, .
- . trauma (i.e., fracture or dislocation),
- . spinal stenosis,
- . atlantoaxial fracture with instability.
- occipitocervical dislocation, .
- . revision of previous cervical spine surgery, and/or
- . spinal tumor.
The occipital bone screws are limited to occipital fixation only.
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The Sierra spinal system will include polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, crossbars, hooks, and components. All products are fabricated from titanium alloy, with the exception of the screws which have a cobalt alloy component, and are being offered in a wide variety of sizes. All product is supplied "NON-STERILE" and must be sterilized prior to use.
Sierra will also offer a wide variety of instruments that range from bone awls to occipital screwdrivers. These instruments will be made from various grades of stainless steel with Radel and aluminum alloy being used in a few handles. All items are supplied "NON-STERILE" and must be sterilized prior to use.
The provided document is a 510(k) Pre-Market Notification for the Sierra™ spinal system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving de novo safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics.
Therefore, many of the requested categories regarding acceptance criteria, study details, ground truth, and training sets are not applicable to this type of regulatory submission. The document explicitly states: "A financial certification and/or disclosure statement is not needed for this submission as no clinical studies have been undertaken in regards to the products under consideration."
Here's a breakdown of the available information:
Acceptance Criteria and Study Details for Sierra™ Spinal System
1. A table of acceptance criteria and the reported device performance:
Since no clinical studies were performed to establish specific performance metrics or acceptance criteria for clinical outcomes, this cannot be provided as it would for a device relying on de novo clinical data. Instead, the "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. The performance reported relates to mechanical strength per applicable standards.
| Feature | Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | Similar to predicate devices | Similar |
| Indications for Use | Similar to predicate devices | Similar |
| Design | Similar to predicate devices (Polyaxial screws, rods, etc.) | Similar |
| Polyaxial Screws | Similar to predicate devices (Various sizes) | Similar |
| Locking Cap | Similar to predicate devices (Various sizes) | Similar |
| Lateral Connectors | Similar to predicate devices (Various sizes) | Similar |
| Crossbars | Similar to predicate devices (Various sizes) | Similar |
| Occipital Plates | Similar to predicate devices (Various sizes) | Similar |
| Occipital Screws | Similar to predicate devices (Various sizes) | Similar |
| Hooks | Similar to predicate devices (Various sizes) | Similar |
| Rods | Similar to predicate devices (Various sizes) | Similar |
| Material | Similar to predicate devices (Titanium alloy and cobalt alloy) | Similar |
| Sterile | Non-sterile, similar to predicate devices | Non-sterile |
| Method of Sterilization | High-temperature steam, similar to predicate devices | Similar |
| Mechanical Strength | Passed testing per applicable standards | All products passed testing per applicable standards. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. No clinical test set or human data was used for this 510(k) submission. The evaluation was based on technological characteristics and mechanical testing.
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):
- Not Applicable. No ground truth was established by external experts in the context of clinical performance or diagnostic accuracy. The substantial equivalence argument relies on comparison to existing legally marketed devices.
4. Adjudication method (e.g. 2+1, 3+1, none) 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 is a medical device (spinal system implants and instruments), not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a medical device, not an algorithm. Therefore, no standalone performance study was conducted.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Applicable. As no clinical studies were performed, no ground truth based on clinical outcomes or expert consensus for a test set was established. The "ground truth" for the submission is the regulatory acceptance of the predicate devices whose characteristics the Sierra system mimics.
8. The sample size for the training set:
- Not Applicable. No machine learning or AI models were used, so there was no training set.
9. How the ground truth for the training set was established:
- Not Applicable. No machine learning or AI models were used, so there was no training set or ground truth establishment for such.
§ 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.