(106 days)
The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at the fifth lumbar first sacral vertebral (L5-S1) joint utilizing autologous bone graft and intended to be removed after solid fusion is attained.
The ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to the illium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed surgery.
As a whole, the ISOLA Spinal System is intended for T1-sacral fixation. Screw fixation is from L3-S1.
The two piece Twister connector design utilizes the attributes of the one piece slotted connectors. It consists of a slotted transverse member with splines which mate with the splines of the V Groove body. Together these two pieces create the slotted connector assembly. The spline connection or joint is the medium by which the screw/connector interface can be manipulated and secured. This two piece design allows for intraoperative sagittal alignment in 7° increments.
The slotted portion of each design provides further surgical latitude for placement of the screw. The machine threaded portion of the screw is locked to the connector with a nut.
All implant components are manufactured of ASTM F-138 stainless steel.
This document describes a 510(k) summary for the AcroMed ISOLA Twister Connector, a component of the ISOLA System, which is a spinal fixation device. The summary focuses on comparing the Twister Connector to previously cleared AcroMed Slotted Connectors and does not contain detailed acceptance criteria or a specific study proving the device meets particular numerical performance targets.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific numerical acceptance criteria or detailed performance metrics. It makes a general statement about consistency with previously cleared components.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "Static and fatigue testing shows the constructs of the ISOLA Twister Connector to perform consistently with previously cleared components." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the static and fatigue testing. It also does not provide information on the data provenance (country of origin, retrospective/prospective).
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 is a medical device for spinal fixation, not a diagnostic or AI-based device requiring expert ground truth for interpretation. Therefore, this information is not applicable and not present in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is a mechanical device performance test, not a diagnostic or interpretive study requiring expert adjudication.
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 is not an AI-assisted diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical devices like this, the "ground truth" would be established by engineering standards and validated testing protocols that simulate anatomical loads and conditions. The document refers to "Static and fatigue testing," implying these engineering tests were used. The "ground truth" here is the physical performance under specified conditions, measured against established benchmarks (previously cleared components).
8. The sample size for the training set
Not applicable. This is a mechanical device, not an AI or machine learning system that requires a "training set."
9. How the ground truth for the training set was established
Not applicable.
Summary of Device Performance Study:
The provided text states: "Static and fatigue testing shows the constructs of the ISOLA Twister Connector to perform consistently with previously cleared components."
This indicates that the study performed involved physical mechanical testing (static and fatigue) of the device. The acceptance criteria appear to be based on demonstrating "consistency" in performance with already cleared components from the same manufacturer (AcroMed Slotted Connectors). This "consistency" likely refers to meeting or exceeding the established performance benchmarks that allowed the previous devices to be cleared for market.
The document does not provide specific numerical details about:
- The loads applied during static testing.
- The number of cycles or load levels during fatigue testing.
- The specific failure points or deformation limits observed.
- The exact performance metrics of the previously cleared components that served as the benchmark.
In the context of 510(k) submissions, demonstrating substantial equivalence often relies on comparing performance to a predicate device. This statement suggests that the ISOLA Twister Connector's mechanical properties were evaluated against those of similar devices already on the market and found to be comparable, thereby supporting its safety and effectiveness for its intended use.
§ 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.