(97 days)
The Innovasis Excella III-D Spinal Deformity System, when used as a posterior 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 of the thoracic, lumbar and sacral spine: Degenerative disc disease (DDD-defined as discogenic back pain with disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
The Innovasis Excella III-D Spinal Deformity System, is also indicated for treatment of severe spondylolisthesis (Grades 3 & 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fision. Levels of pedicle screw fixation for these patients are L3-sacrum/illium.
When used as a posterior non-pedicle screw fixation system, the Innovasis Excella III-D Spinal Deformity System is intended for the treatment of degenerative disc disease (DDD-defined as discogenic back pain with degeneration of the disc confirmed by history and radios), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis, Schevermann's disease), fracture, pseudoarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are TI-sacrum/ilium.
When used as an anterolateral thoracolumbar system, the Innovasis Excella III-D Spinal Deformity System is intended for anterolateral screw fixation for the following indications: Degenerative disc disease (DDD-defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, turnor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.
The Excella (//-D) pedicle screws, hooks and connectors are an adjunct to the Excella II® Spinal System. Both the Excella II Spinal System and Excella III-D Spinal Deformity System consist of 6Al-4V titanium alloy implants meant to be used in a system. The single use devices are offered in a variety of different configurations, including screw lengths ranging from 25mm to 100mm in the following diameters, 4.0mm (new size), 4.75mm, 5.5mm, 6.5mm, 7.5mm and 8.5mm; and various hooks, rods, and connectors-and are sold nonsterile. The Excella II screw implants are cannulated or solid while the Excella III-D implants are solid only. All pedicle screws and iliac screws feature identical multi-axial ioints for free motion of the screw head to allow the physician greater flexibility when placing the screws. The bone thread portion of the screws feature a self-tapping, double lead with an aggressive thread.
The Excella II and Excella III-D systems utilize identical 5.5mm titanium rods in various lengths from 35mm to 500mm (straight) or 35mm to 125mm (bent). The rods are placed in the head of the screws and the system is locked in place with titanium locking caps. The locking cap design includes a threaded locking screw attached to an alignment cap ("tulip"). Each locking cap includes a buttress thread design for axial strength and to prevent screw loosening. Excella III-D also features 5.5mm rods made from medical grade Cobalt-28 Chromium-6 Molybdenum, available in 500mm and 600mm lengths.
The Excella ///-D titanium screws also have available alignment caps with extended length head (reduction head) that can be broken off after installation. Once the locking screw has been tightened in place. the added length on the alignment cap can be broken off at a tab. resulting in a final profile and assembly that is identical to a standard Excella II screw and locking cap assembly.
The Excella III-D Spinal Deformity System includes multiple sizes of hooks for use primarily in the thoracic region, and rod connectors for extension of existing constructs. The additional rod connectors (five versions) have been added to the Excella III-D system to allow end-to-end connection of rods. These connectors will fit both 5.5mm and 6.0mm rods. The identical locking cap is used on all Excella // and Excella III-D pedicle screws, hooks and lateral connectors. The Excella III-D Spinal Deformity System includes additional instrumentation to aid in de-rotation of the spine in deformity cases.
The Excella cross connectors come in 20, 25, 30 or 35mm fixed and various adjustable lengths from 39 to 81mm to allow for variation in perpendicular placement on two rods. Each cross connector features a clamping mechanism to grip the rods and stabilize the relation between the rods, and will work with 5.5mm and 6.0mm rods. The 20 and 25mm (shorter) sizes are new to the system.
The provided document describes the mechanical performance testing of the Excella III-D® Spinal Deformity System, focusing on non-clinical data. It does not contain information about a study involving human subjects, AI assistance, or expert consensus on medical images. Therefore, many of the requested categories are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|
| ASTM F1717-13 (Static Compression Bend) | Excella III-D Spinal Deformity System is capable of performing in accordance with its intended use. (Implied: Meets or exceeds the criteria of ASTM F1717 for this test) |
| ASTM F1717-13 (Static Torsion) | Excella III-D Spinal Deformity System is capable of performing in accordance with its intended use. (Implied: Meets or exceeds the criteria of ASTM F1717 for this test) |
| ASTM F1717-13 (Dynamic Compression Bend) | Excella III-D Spinal Deformity System is capable of performing in accordance with its intended use. (Implied: Meets or exceeds the criteria of ASTM F1717 for this test) |
| ASTM F1717-13 (Static Axial Compression Bend) | Excella III-D Spinal Deformity System is capable of performing in accordance with its intended use. (Implied: Meets or exceeds the criteria of ASTM F1717 for this test) |
| ASTM F1717-13 (Dynamic Axial Compression Bend) | Excella III-D Spinal Deformity System is capable of performing in accordance with its intended use. (Implied: Meets or exceeds the criteria of ASTM F1717 for this test) |
| ASTM F1717-13 (Axial Pullout Strength) | Excella III-D Spinal Deformity System is capable of performing in accordance with its intended use. (Implied: Meets or exceeds the criteria of ASTM F1717 for this test) |
| Risk analysis & Engineering analysis | Device shown to be substantially equivalent to K102248 Excella II Spinal System. |
| Materials (6Al-4V ELI titanium) | Equivalent to predicate devices. |
| Materials (Cobalt-28 Chromium-6 Molybdenum) | Substantially equivalent to predicate devices, utilized in long-term implants. |
| Biocompatibility requirements | Demonstrated. |
2. Sample size used for the test set and the data provenance
The document refers to non-clinical performance testing of a physical medical device (spinal system components), not a test set of data like in an AI/data-driven study. Therefore, "sample size" and "data provenance" in the context of clinical data/images are not applicable here. The testing was conducted according to ASTM standards, which would specify the number of physical samples (implants) to be tested. The origin for these physical tests would typically be an accredited testing laboratory.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a report about non-clinical mechanical performance testing of a physical device, not an AI or diagnostic study requiring expert ground truth for interpretation.
4. Adjudication method
Not applicable. This is a report about non-clinical mechanical performance 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 document does not describe a clinical study of AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is about a physical spinal implant system, not a medical algorithm.
7. The type of ground truth used
For the performance data, the "ground truth" is defined by the objective, quantifiable physical properties and performance metrics specified by the ASTM F1717 standard. The device's ability to withstand specific forces, torques, and maintain strength serves as the "ground truth" for its mechanical functionality and safety.
8. The sample size for the training set
Not applicable. This is a non-clinical device performance report, not an AI or machine learning study requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.