(111 days)
The intended use of the Malibu System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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.
The indications for use are as follows:
-
degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
-
severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
-
trauma (i.e., fracture or dislocation),
-
spinal stenosis, ·
-
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
-
tumor,
-
pseudarthosis, and/or
-
failed previous fusion.
The intended use and indications of the Malibu™ Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows: -
degenerative disc disease (DDD) 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.
-
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
-
tumor,
-
pseudarthosis, and/or
-
failed previous fusion.
The Malibu Spinal System contains titanium alloy and cobalt alloy implants and surgical tools. This submission is intended to address line extensions for spinal rods of identical material composition and dimensional specifications but with a higher tensile strength and varying uni-planar pedicle screws. Additional documentation is submitted for a reduced sterilization time for the Malibu implants within the Daytona™ Deformity System.
The Malibu™ Spinal System with the Daytona™ Deformity System is a medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as ground truth, training set, test set, effect size, etc.) are not applicable.
This device is a Pedicle Screw Spinal System and a Spinal Interlaminal Fixation Orthosis, which are hardware components (spinal rods and pedicle screws) used in spinal fusion procedures. The submission is a "Special 510(k)" for line extensions.
Here's the information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (What the device needs to achieve) | Reported Device Performance (How the device performed in testing) |
|---|---|
| Substantially equivalent to predicate devices in terms of technological characteristics. | The spinal rod product line extension increases the ultimate strength of the existing cobalt alloy spinal rods while the varying uni-planar pedicle screws combine the features of the current pedicle screws including cannulated and non-cannulated with variable and limiting angles. These line item extensions to the system do not alter the fundamental scientific technologies of the previously cleared system; these devices have substantially equivalent technological characteristics as the predicate devices. |
| Compliance with ASTM F1717 (Static and Fatigue Compressive Bending, Static Torsion). | The subjective devices were compared to legally marketed predicated devices in regards to an array of testing per ASTM F1717 (static compressive bending, fatigue compressive bending, static torsion) and found to be equivalent. |
| Compliance with ASTM F1798 (Static AP testing). | The subjective devices were compared to legally marketed predicated devices in regards to an array of testing per ASTM F1798 (static AP) testing and found to be equivalent. |
| Compliance with design control procedure requirements as specified in 21 CFR §820.30. | The manufacturing facility is in conformance with the design control procedure requirements as specified in 21 CFR §820.30 and the records are available for review. |
| Reduced sterilization time for Malibu implants within the Daytona™ Deformity System is validated. | Additional documentation is submitted for a reduced sterilization time for the Malibu implants within the Daytona™ Deformity System. A re-validation to updated standards is included. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical sample size for a "test set" in the context of clinical data. The performance testing was based on mechanical testing of the devices themselves, comparing them to predicate devices.
- Data Provenance: The testing was mechanical/bench testing according to ASTM standards (F1717 and F1798) comparing the new device designs to existing predicate devices. This is laboratory-based data, not human patient data in this context.
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 medical device (spinal hardware) that undergoes mechanical testing, not an AI/ML device requiring expert consensus for image or clinical data.
4. Adjudication method for the test set:
- Not applicable. This is a medical device (spinal hardware) that undergoes mechanical testing, not an AI/ML device requiring adjudication of clinical or image data.
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 a medical device (spinal hardware), not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (spinal hardware), not an AI/ML algorithm.
7. The type of ground truth used:
- For mechanical performance, the "ground truth" is established by the performance characteristics of legally marketed predicate devices and the requirements of recognized industry standards (ASTM F1717 and F1798). The new devices are shown to be "equivalent" in these mechanical tests to their predicates.
8. The sample size for the training set:
- Not applicable. This is a medical device (spinal hardware), not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. This is a medical device (spinal hardware), not an AI/ML 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.