(65 days)
The SteriSpine™PS system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.
SteriSpine™PS System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.
SteriSpineTMPS system includes Pedicle Screws and Rods. Components of SteriSpineTMPS system are made of Titanium Ta6V Eli grade conforming to ASTM F136. Components added within this submission include multi-axial extended head screws and multi axial extended head cannulated screws Ø 5.5, 6.5 and 7.5 (length from 25 to 60 mm), additional lengths for straight and prebent rods ø5.5mm, additional surgical instruments (screw head breakage tip, set screw holder and racking compression pliers, Ratchet module).
The SteriSpineTMPS range of products is supplied sterile with a sterile single-use set of surgical instruments.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study details for the SteriSpine™PS Pedicle Screw:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device (SteriSpine™PS Pedicle Screw), the acceptance criteria are not presented in a quantitative, pass/fail manner. Instead, the study focuses on demonstrating substantial equivalence to predicate devices. The performance is reported in terms of comparability to established predicate devices under specific mechanical tests.
| Acceptance Criteria (Implied by Equivalence) | Reported Device Performance |
|---|---|
| Comparable mechanical properties to predicate devices (K112453, K121299, K130632) as per ASTM F1717 and ASTM F1798. | Results demonstrate comparable mechanical properties to the predicate device. |
| Compliance with Special Control for Pedicle Screw Spinal Systems and "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document". | SteriSpine™PS conforms to special control and the relevant guidance document. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of clinical trials or data analysis that would typically have a defined sample size and provenance. Instead, it refers to:
- Mechanical Testing: Performed on the device itself. The sample size for each specific mechanical test (e.g., number of constructs tested for static compression) is not specified.
- Cadaver Testing: Performed to validate the instrumentation. The number of cadavers or tests is not specified.
- Clinical Data: "Clinical data from a review of the literature has been presented in the class III summary." This indicates a retrospective literature review rather than a prospective clinical study with a defined sample size. The provenance of this literature data (e.g., country of origin) is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since there is no "test set" in the typical sense of human-reviewed data, and the primary assessment is mechanical and literature-based, this information is not applicable to this submission. Ground truth, if considered, would be derived from the mechanical standards and the documented performance of the predicate devices.
4. Adjudication Method for the Test Set
As there is no "test set" requiring human review or ground truth establishment in this context, the adjudication method is not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. The submission primarily relies on mechanical testing and a literature review for clinical data. This type of study would typically be relevant for imaging or diagnostic AI devices where human reader performance is being evaluated.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not done. This device is a physical pedicle screw system, not an algorithm or software-only device.
7. Type of Ground Truth Used
For the mechanical testing, the "ground truth" implicitly refers to:
- Engineering Standards: Adherence to ASTM F1717 and ASTM F1798.
- Reference Device Performance: The established mechanical properties of the legally marketed predicate devices (K112453, K121299, K130632).
For the clinical data, the "ground truth" is derived from:
- Clinical Literature: Published evidence regarding the performance and safety of similar pedicle screw systems.
8. Sample Size for the Training Set
This information is not applicable as the device is a physical implant, not an AI/ML algorithm that requires a training set. The term "training set" is typically used in the context of machine learning model development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 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.