(137 days)
The Reform Pedicle Screw System is intended to provide immobilization and stabilization of spinal seqments 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 disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); spinal tumor; pseudarthrosis; 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.
When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the G21 and Precision Spine Cement Cannula for mixing and injection of bone cements, the fenestrated Reform pedicle screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The fenestrated Reform pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
The Reform Pedicle Screw System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks, dominoes, and lateral offsets. All of the components are available in a variety of sizes to match more closely the patient's anatomy. All components are made from medical grade stainless steel, cobalt chromium alloys, titanium alloy described by such standards as ASTM F158, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3. The products are supplied clean and "non-sterile". The Fenestrated Screws allow the augmentation of PMMA bone cement to the insertion site. These modular Fenestrated Screws are assembled during surgery with the Reform Standard Modular Tulips or the Reform Reduction Modular Tulips which were cleared under K150856 and their compatible rods and set screws. The Fenestrated Screws are to be used with the G21 V-Fast Bone Cement or V-Steady Bone Cement cleared under K150408. Bone Cement is delivered into the pedicle screw and bone through the delivery instrumentation.
The provided text is a 510(k) summary for the Reform Pedicle Screw System. This document focuses on the mechanical testing and equivalence of a medical device, specifically a pedicle screw system, rather than a diagnostic AI/ML device that would have acceptance criteria related to classification metrics (e.g., sensitivity, specificity, AUC).
Therefore, the typical acceptance criteria and study design elements you're asking for (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) for an AI/ML device are not applicable to this submission.
Instead, the performance data provided is entirely about mechanical and material testing to demonstrate the physical characteristics and safety of the implanted device.
Here's a breakdown of the relevant information from the provided text, framed within the context of a traditional medical device submission, recognizing that it doesn't fit the AI/ML paradigm:
1. A table of acceptance criteria and the reported device performance:
The document describes performance testing rather than specific acceptance criteria in a tabular format with quantitative metrics for a pass/fail. However, it states the following tests were conducted:
| Test Mode | Description/Reported Performance |
|---|---|
| Dynamic Compression Bending | Performed per ASTM F1717 standard. The results "show that the performance of the Reform Pedicle Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." |
| Bone Cement Injection Testing | Performed with the subject fenestrated screws. The testing "demonstrated successful injection of bone cement through the fenestrations." This test was conducted because of "difference in fenestration diameters and differences in quantity of fenestrations at the screw tip" compared to predicates, to ensure these differences "do not raise questions for safety and efficacy." |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified in the summary. For mechanical testing, this would typically involve a specific number of test articles (e.g., screws, constructs) for each test.
- Data Provenance: The "study" is non-clinical mechanical bench testing performed according to ASTM standards. It's not human-centric data, so concepts like "country of origin" or "retrospective/prospective" studies are not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context is established by engineering specifications, standard ASTM testing methodologies, and objective mechanical measurements. It does not involve expert readers reviewing images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication is relevant for subjective expert reviews, not for objective mechanical testing.
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 physical implant, not an AI-powered diagnostic tool. MRMC studies are used to evaluate the diagnostic performance of AI or imaging modalities.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm or AI component in this device. The testing is entirely for the physical device's characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this type of device is established by engineering standards and physical test methodologies (e.g., ASTM F1717 for spinal implant constructs). The performance is measured against these established standards and compared to legally marketed predicate devices.
8. The sample size for the training set:
- Not applicable. This device does not involve machine learning; therefore, there is no training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device.
In summary, the provided document details the substantial equivalence of a physical medical implant through mechanical testing, not the performance claims or evaluation of an AI-powered diagnostic 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.