(25 days)
The SteriSpine™PS system is intended to provide immobilization 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.
The cleared range of SteriSpineTM PS system include multiaxial screws and cannulated multiaxial screws with or without extended head (ø5.5, 6.5 and 7.5mm, lengths from 25 to 60 mm) and straight and prebent rods (ø 5.5, 6.5 and 7.5mm, lengths from 30 to 380 mm). Components of SteriSpineTM PS system are made of Titanium Ta6V Eli grade conforming to ASTM F136. The SteriSpineTM PS range of products is supplied sterile with a sterile single-use set of surgical instruments. The Percutaneous Ancillary Kit added within this submission include (trocar needle, dilators, rod measurer, protection sleeve, funnel body, funnel shaft and funnel impactor). These instruments are supplied as a sterile single-use set to be used with the previously cleared Ancillary Kits.
This document is a 510(k) premarket notification for a medical device called the SteriSpine™ PS Pedicle Screw. It seeks to establish substantial equivalence to a previously cleared predicate device.
Based on the provided text, there is NO study described that proves the device meets specific acceptance criteria in terms of performance (e.g., diagnostic accuracy, efficacy).
The "Discussion of Testing" explicitly states: "No testing has been performed for the added components."
This 510(k) submission is for the addition of a "Percutaneous Ancillary Kit" to an already cleared SteriSpine™ PS product range. The submission argues for substantial equivalence based on the intended use, material, design, mechanical properties, and function being similar to the predicate device, not on new performance studies for the added components.
Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from this document, as such studies were not conducted or reported for this specific submission.
Here's an attempt to answer the questions based only on the provided text, acknowledging the significant limitations:
1. A table of acceptance criteria and the reported device performance
This information is not present in the document. The document states "No testing has been performed for the added components," meaning no performance criteria have been tested or reported for the new ancillary kit.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No performance testing involving a test set was conducted or reported for the added components.
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 performance testing was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No performance testing was conducted.
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 pedicle screw system and an ancillary kit, not an AI-based diagnostic tool. No MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a pedicle screw system and an ancillary kit, not an algorithm. No standalone performance study was conducted or reported.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No performance testing was conducted.
8. The sample size for the training set
Not applicable. This device is a pedicle screw system and an ancillary kit, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a pedicle screw system and an ancillary kit, not an AI/ML model.
§ 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.