(114 days)
The SHILLATM Growth Guidance System is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth, who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early-onset deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome. The SHILLA™ Growth Guidance System is intended to be removed after skeletal maturity.
The SHILLA™ Growth Guidance System is intended to treat severe, progressive multi-planar spinal deformities such as early-onset scoliosis while allowing for skeletal growth. Severe, progressive early-onset scoliosis is defined as a greater than 40° Cobb angle or a rib-vertebral angle difference greater than 20°. The SHILLATM Growth Guidance System consists of a variety of shapes and sizes of steel rods, hooks, screws, CROSSLINK® Plates, and connecting components, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. All SHILLATM components are manufactured from medical grade stainless steel.
The provided text is a 510(k) summary for the SHILLA™ Growth Guidance System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific acceptance criteria in a study to prove device performance. It doesn't detail a study with acceptance criteria in the way you've outlined.
However, I can extract the information provided about the supporting data that was submitted to the FDA for the SHILLA™ Growth Guidance System:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not present a table of specific, pre-defined acceptance criteria (e.g., sensitivity, specificity, accuracy targets) and corresponding device performance values because it is a 510(k) summary. The "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device.
The reported "performance" is a general statement about clinical and mechanical equivalence:
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Surgical approaches, implant materials, surgical instruments, and sterilization methods are equivalent to the predicate CD HORIZON® Growth Rod Conversion Set. |
| Equivalent Clinical Outcomes | Retrospective clinical data demonstrated the SHILLA™ Growth Guidance System to be substantially equivalent to traditional growth rod systems when treating the same patient population. |
| Equivalent Mechanical Strength | Mechanical testing demonstrated the SHILLA™ Growth Guidance System to be substantially equivalent with regards to mechanical strength to the CD HORIZON® Growth Rod Conversion Set. |
| No New Potential Risks | Retrospective clinical data identified no new potential risks to patients. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "Retrospective clinical data for the subject device compared to traditional growth rod devices were provided." It does not specify the number of patients or cases included in this dataset.
- Data Provenance: Retrospective clinical data. The country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. Since the clinical data is "retrospective," it likely refers to outcomes observed from standard clinical practice rather than a controlled study with a dedicated expert panel for ground truth establishment for a specific AI-assisted device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided.
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:
This is not applicable. The SHILLA™ Growth Guidance System is a physical surgical implant system, not a software device involving human readers or AI assistance. Therefore, an MRMC study related to interpretation accuracy with or without AI is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The SHILLA™ Growth Guidance System is a physical surgical implant system, not an algorithm.
7. The type of ground truth used:
For the clinical data, the "ground truth" would be the observed patient outcomes (e.g., correction of deformity, continued growth, complications) obtained from standard clinical follow-up for patients treated with either the SHILLA™ system or traditional growth rods.
8. The sample size for the training set:
Not applicable. This device is a physical implant system, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, this device does not involve a training set for an AI/ML algorithm.
§ 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.