(59 days)
The Innovasis® Excella® Spinal System is intended for use in the non-cervical area of the spine.
The INNOVASIS® Excella® Spinal System, when used for pedicle screw fixation is intended only for patients: a) Having severe spondylolisthesis (Grade 3 & 4) at the L5-S1 joint; b) Who are receiving fusion using autogenous bone graft only; c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and d) Who are having the device removed after the development of a solid fusion mass.
The INNOVASIS® Excella® Spinal System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine: i. Degenerative spondylolisthesis with objective evidence of neurologic impairment; Fracture; Dislocation; iii. iv. Scoliosis; V. Kyphosis; Spinal tumor; and vi. vii. Previous failed fusion (pseudoarthrosis).
The INNOVASIS® Excella® Spinal System, when used for anterolateral non-pedicle fixation, is intended for the following indications: i. Degenerative disc disease* ii . Spinal stenosis; iii. Spondylolisthesis; Pseudoarthrosis V. vi. Tumor vii. Trauma (i.e. fracture or dislocation); and iv. Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis); viii. Previous failed fusion. *(defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
The INNOVASIS® Excella® Spinal System, when used for posterior non-pedicle screw fixation to the noncervical spine, is intended for the following indications: i. Degenerative disc disease; ii. Spinal stenosis; iii. Spondylolisthesis; V. Pseudoarthrosis Tumor: vi. vii. Trauma (i.e. fracture or dislocation); iv. Spinal deformities (i.e. scoliosis, kyphosis and/or lordosis); viii. Previous failed fusion. *(defined as back pain of disogenic origin with degenerative disc confirmed by patient history and radiographic studies).
The Excella IIM Spinal System consists of 6AL-4V Titanium alloy implants meant to be used in a system. The single use devices are offered in a variety of different lengths ranging from 25mm to 60mm as well as the following diameters, 4.75mm, 5.5mm, 6.5mm and 7.5mm, 8.5mm-and are sold non-sterile. The Excella II implants are cannulated and feature a multi-axial joint for free motion of the screw head to allow the physician greater flexibility when placing the screws, including use of a minimally invasive surgical procedure. The bone thread portion of the screws features a self-tapping, double lead with an aggressive thread.
The Excella II system utilizes 5.5mm Titanium rods in various lengths from 35mm to 460mm (straight) or 35mm to 85mm (bent). The rods are placed in the head of the screws and the system is locked in place with Titanium locking caps. The locking caps design includes a threaded locking screw attached to an alignment cap. Each locking cap includes a buttress thread design for axial strength and to prevent screw loosening. The alignment cap is attached to the bottom of the locking screw and rotates about the radial axis. This cap is intended to aid the alignment of the locking cap during insertion. The alignment cap also improves the rotational stiffness at the rod to locking cap interface.
The Excella II system also has available alignment caps with extended length head (reduction head) that can be broken off after installation. The available lengths go from 5 inches (12.7mm) to 4.72 inches (120mm). Primarily used in scoliosis correction, the reduction head allows easier use of longer rods that may be difficult to place in the standard head due to the anatomy of the patient and the curvature of the spine needing correction. A retaining ring is provided to prevent splay of the reduction head while tightening down the rod. Once the locking screw has been tightened in place, the ring is removed and 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 screw and locking cap assembly.
The cross connectors come in various adjustable lengths and 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.
The implants are machined from Medical Grade Titanium (6AL-4V) per ASTM F136-02a.
The provided text describes a 510(k) premarket notification for the Innovasis Excella II Spinal System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as might be seen for novel devices or PMAs. As such, the information you've requested regarding acceptance criteria and performance studies in the context of AI/software device evaluation (e.g., sample sizes, expert ground truth, MRMC studies) is largely not applicable to this document.
The "studies" performed for this submission are mechanical tests of the physical implant, and the "acceptance criteria" are the ability to perform in accordance with its intended use, based on these tests and comparison to a predicate device.
Here's an analysis of the provided text in relation to your request, highlighting what is and isn't present:
1. A table of acceptance criteria and the reported device performance
The document does not present specific quantitative acceptance criteria and device performance in a table format as would be expected for a software/AI clinical trial. Instead, it relies on demonstrating substantial equivalence through adherence to recognized ASTM standards and material specifications.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Specifications: | |
| Biocompatible materials | Use of biocompatible materials with a proven history of acceptable performance. |
| Adherence to ASTM F136-02a for Medical Grade Titanium (6AL-4V) | Material selection with certifications to ASTM F136. Additional biocompatibility testing verification (LAL, MEM analysis). |
| Mechanical Performance: | |
| Ability to perform in accordance with intended use (spinal fixation) | Performance testing per ASTM F543 (Standard Specification and Test Methods for Metallic Medical Bone Screws), ASTM F1717-09 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model), and ASTM F1798-97 (Reapproved 2008) (Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants) for: |
| - Static Compression Bend | - (Indicates satisfactory performance) |
| - Static Torsion | - (Indicates satisfactory performance) |
| - Dynamic Compression Bend | - (Indicates satisfactory performance) |
| - Axial Pullout Strength | - (Indicates satisfactory performance) |
| - Torque to Failure | - (Indicates satisfactory performance) |
| - Axial, Flexion and Torsional Grip | - (Indicates satisfactory performance) |
| Manufacturing & Design: | |
| Dimension verification to design | Dimension verification (inspection) to the design. |
| Process verification and validation | Process verification and validation. |
| Product verification and validation | Product verification and validation. |
| Physician evaluation | Physician evaluation. |
| Calibrated inspection systems | Calibrated inspection systems. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document as it pertains to a mechanical device and not a data-driven AI/software study. "Sample size" in this context would refer to the number of implants tested mechanically, but specific numbers for each test are not given, only the standards applied. The tests are non-clinical (physical testing of the device itself) and not related to patient data.
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)
This information is not applicable and therefore not provided. Ground truth for mechanical devices is established through adherence to engineering specifications and performance against recognized standards, not expert consensus on medical images or patient outcomes. The document mentions "Physician evaluation" but does not detail how this was conducted or for what specific purpose related to "ground truth" and test sets.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. Adjudication methods are relevant for clinical studies involving disagreement among human reviewers, which is not the type of study described here.
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
An MRMC study is not applicable and was not done. This type of study is for evaluating the impact of AI on human reader performance, which is completely outside the scope of a 510(k) for a spinal implant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
A standalone performance study is not applicable and was not done. This device is a physical pedicle screw system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is implicit in its ability to meet established engineering standards (ASTM F543, F1717, F1798) for mechanical strength, fatigue, and material composition. There is no biological or interpretative ground truth involved in its evaluation for substantial equivalence.
8. The sample size for the training set
This information is not applicable and therefore not provided. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided. There is no "training set" and therefore no ground truth established for it.
§ 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.