(56 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.
system includes Pedicle Screws and Rods. Components SteriSpine™PS of SteriSpine™PS system are made of Titanium Ta6V Eli grade conforming to ASTM F136. SteriSpine™PS components are supplied sterile with a single-use set of surgical instruments. Components added within this submission include multi-axial pedicle screws with extended head and associated instruments.
This document describes a 510(k) premarket notification for a medical device, the "SteriSpine™ PS (Pedicle Screw) System." It is a class III device, which means it carries a higher risk than class I or II devices. The submission concerns a modification to an existing device (K112453 and K121299). The information provided is not for an AI/ML powered device, but rather a traditional medical device (pedicle screw spinal system). Therefore, several of the requested sections related to AI/ML device performance criteria, data provenance, expert ground truthing, and MRMC studies are not applicable.
Here's the breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|
| Conforms to special control established for Pedicle screw spinal system | Met |
| Conforms to «Spinal System 510(k)s - Guidance for Industry and FDA Staff Document» issued on: May 3, 2004 | Met |
| Mechanical testing per ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model): Static Compression | Results demonstrate comparable mechanical properties to the predicate device. |
| Mechanical testing per ASTM F1717: Static Torsion | Results demonstrate comparable mechanical properties to the predicate device. |
| Mechanical testing per ASTM F1717: Dynamic Compression | Results demonstrate comparable mechanical properties to the predicate device. |
| Mechanical testing per ASTM F1798 (Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants): Static slipping | Results demonstrate comparable mechanical properties to the predicate device. |
| Mechanical testing per ASTM F1798: Static bending | Results demonstrate comparable mechanical properties to the predicate device. |
| Mechanical testing per ASTM F1798: Static rotation | Results demonstrate comparable mechanical properties to the predicate device. |
| Validation of instrumentation via Cadaver testing | Performed and presented |
| Verification Activity and Validation Activity for added components | Demonstrated that added components are as safe, effective, and perform at least as safely and effectively as predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified for mechanical or cadaver testing. For the clinical data, it states "Clinical data from a review of the literature has been presented in the class III summary," but no specific sample size from this literature review is provided in the extract.
- Data Provenance:
- Mechanical Testing: Not specified (country of origin). This is typically performed in a lab setting.
- Cadaver Testing: Not specified (country of origin).
- Clinical Data: "a review of the literature" implies retrospective data, but the specific origins are not detailed.
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. This is a traditional mechanical device, not one that relies on expert interpretation for ground truth. The "ground truth" here is adherence to mechanical standards and performance comparable to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of expert interpretations.
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
No, an MRMC comparative effectiveness study was not done. This is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm. The performance is the mechanical integrity of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established through:
- Mechanical Standards: Adherence to ASTM F1717 and ASTM F1798 standards.
- Predicate Device Performance: Direct comparison of mechanical properties to the legally marketed predicate devices (SteriSpine™ PS K112453 and K121299).
- Cadaver Testing: Validation of instrumentation.
8. The sample size for the training set
Not applicable. This device does not use a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
§ 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.