(85 days)
The Reform Pedicle Screw System is 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The Reform Pedicle Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The Reform Pedicle Screw System is also intended for non-cervical pedicle screw fixation (T1-S1/ilium) for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; kyphosis; and/or lordosis); spinal tumor; degenerative disc disease (DDD); pseudoarthrosis; and failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Reform Pedicle Screw System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Reform System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks, domino connectors, and lateral offset connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from medical grade stainless steel, cobalt chromium alloys, titanium or titanium alloy described by such standards as ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3. The pedicle screws are included with or without hydroxyapatite (HA) coating.
This document is a 510(k) premarket notification for the "Reform Pedicle Screw System" by Precision Spine, Inc. It seeks to add hydroxyapatite (HA) coated pedicle screws to an already cleared system. As such, the document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a novel study evaluating the performance against specific acceptance criteria.
Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria are not present in this document. This submission relies on substantial equivalence and clinical literature assessment, not a dedicated performance study with specific acceptance criteria.
However, I can extract and infer some information based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not present specific acceptance criteria in the typical sense (e.g., a specific numerical threshold for a performance metric). Instead, the "acceptance criteria" for a 510(k) submission is substantial equivalence to legally marketed predicate devices. The "reported device performance" in this context is the assertion that the device is substantially equivalent based on its technological characteristics and a clinical literature assessment.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance |
|---|---|
| Technological Characteristics: The subject device must have sufficiently similar technological characteristics to the predicate device(s) such that any differences do not raise new questions of safety or effectiveness. | "The intended use and technological features of the modifications/additions to the components of the PSS System (Reform Pedicle Screw System) do not substantially differ from the legally marketed predicate devices..." |
| "The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness." | |
| Specifically, identical indications for use, materials of manufacture, structural support mechanism, and sterilization are cited. | |
| Performance Data: If performance data is used to demonstrate equivalency, it must support the claim that the device is as safe and effective as the predicate. | "Analysis was performed to show that the subject devices are substantially equivalent to the predicate devices and do not require additional mechanical testing." |
| "To support substantial equivalence, a clinical literature assessment was conducted using published clinical data for pedicle screw fixation. The assessment concluded that pedicle screw fixation is safe and effective for use in pediatric patients." | |
| Indications for Use: The subject device must have the same or similar indications for use as the predicate device(s). | "Indications for Use" are listed and stated as identical between the subject and predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This submission relies on a "clinical literature assessment" and "mechanical engineering analysis" to demonstrate substantial equivalence, not a specific test set. The literature assessment would draw from numerous studies, each with its own sample size.
- Data Provenance: The general provenance of the data would be from "published clinical data for pedicle screw fixation." The specific country of origin or whether it's retrospective or prospective is not detailed in this document, as it refers to a broad body of existing literature.
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 "test set" and no "ground truth" were established by experts for this submission in the context of a performance study. The expertise involved would be in the "clinical literature assessment" but the number and qualifications of those performing that assessment are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No "test set" or adjudication method described for performance evaluation.
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 not an AI-assisted device, and no MRMC study was conducted. This is a spinal implant system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm, but a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable to a performance study with a test set. The "ground truth" for the submission's argument of substantial equivalence rests upon:
- The known safety and effectiveness of the predicate devices.
- The conclusion drawn from the "clinical literature assessment" that "pedicle screw fixation is safe and effective for use in pediatric patients" (which would be based on outcomes data, expert consensus, etc., from the reviewed literature).
8. The sample size for the training set
Not applicable. No "training set" is relevant here, as this is not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. No "training set" is relevant here.
§ 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.