(37 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; 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.
This document is a 510(k) premarket notification for the Reform Pedicle Screw System and does not provide acceptance criteria and detailed study data for a device's performance against specific metrics. Instead, it focuses on demonstrating substantial equivalence to previously cleared predicate devices.
Therefore, many of the requested sections regarding detailed acceptance criteria, specific performance tables, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies cannot be answered from the provided text. This document is a regulatory submission, not a research paper detailing the performance of an AI/ML-based medical device.
However, I can extract information related to the device itself and the general nature of the evidence provided for substantial equivalence, as well as highlight what information is missing.
The device in question is the "Reform Pedicle Screw System," a spinal implant, not an AI/ML diagnostic or measurement device. The "performance data" mentioned refers to mechanical engineering analysis to demonstrate substantial equivalence, not clinical performance metrics in the way AI models are evaluated.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it is absent for AI/ML device evaluation:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail metrics for a specific performance study in the way an AI algorithm would have. The "acceptance" in this context is regulatory clearance based on substantial equivalence.
- Reported Device Performance: No specific numerical performance metrics (e.g., sensitivity, specificity, accuracy, precision) are reported for this device in the provided document. The performance is implied by its "substantial equivalence" to predicate devices, meaning it performs similarly in its mechanical function.
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. This document describes a mechanical device (pedicle screw system), not a software or AI device that would have a "test set" in the context of clinical data. The "tests" mentioned are mechanical analyses. The document does not specify details about these mechanical tests such as the number of devices tested or their origin, beyond stating "Analysis was performed."
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. As this is a mechanical spinal implant, there is no "ground truth" to be established by experts in the context of diagnostic accuracy. "Ground truth" for this device would relate to its physical properties, biocompatibility, and mechanical strength, typically evaluated through engineering standards and testing, not expert clinical interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication is described as the device is not based on interpreting clinical images or data that would require such a process.
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. This is a hardware device (pedicle screw system), not an AI-assisted diagnostic or treatment planning tool. Therefore, an MRMC study related to AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the AI/ML sense. For a physical device like a pedicle screw system, "ground truth" generally refers to adherence to established engineering standards (e.g., ASTM, ISO for materials and mechanical properties) and proven clinical performance of predicate devices. The document implies reliance on these standards and the known safety and efficacy of the predicate devices for achieving substantial equivalence.
8. The sample size for the training set
- Not applicable. This is a mechanical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. (See point 8)
Summary of what the document does describe (relevant to substantial equivalence):
The document K143248 describes the Reform Pedicle Screw System and its submission for 510(k) clearance by Precision Spine, Incorporated.
Device Description:
The Reform System is a top-loading, multiple component, posterior spinal fixation system consisting of pedicle screws, rods, cross-connectors, locking cap screws, hooks, domino connectors, and lateral offset connectors. Components are made from medical-grade stainless steel, cobalt chromium alloys, titanium, or titanium alloy conforming to standards like ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3. The implants are provided non-sterile with instructions for sterilization.
Change from Predicate:
The primary purpose of this specific 510(k) submission (K143248) is to:
- Make modifications to the indications for use.
- Add additional sizes to the already cleared PSS (Reform Pedicle Screw System) devices (referenced by K131343, K130279, K121172, K092128, K090033, K073240, and K071438).
Technological Characteristics for Substantial Equivalence:
The document states that the intended use and technological features of the modifications/additions do not substantially differ from the legally marketed predicate devices.
Specifically, the following characteristics are identical between the subject and predicates:
- Materials of manufacture
- Structural support mechanism
- Sterilization
Predicate Devices:
- Primary: PSS System (Reform Pedicle Screw System) from Precision Spine (Spinal USA) - multiple 510(k) numbers listed.
- Additional: Polaris Spinal System from Biomet Spine - K133746, K131615.
Performance Data (for Substantial Equivalence):
"Analysis was performed to show that the subject devices are substantially equivalent to the predicate devices and do not require additional mechanical testing." This implies that the engineering and material specifications of the new sizes and modifications were compared against the established mechanical performance of the predicate devices. This type of "performance data" is typically bench testing and material characterization to ensure the new components meet the safety and efficacy profiles of the established devices.
Conclusion:
The overall technology characteristics and mechanical engineering analysis led to the conclusion that the Reform Pedicle Screw System is substantially equivalent to the predicate device. This conclusion is a regulatory determination, not a clinical performance metric.
§ 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.