(448 days)
Double Medical Universal Spine System is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.
Double Medical Universal Spine System consists of pedicle screws, rods, transconnector and nut etc. It is made of Ti-6A1-4V ELI, which meets ASTM F 136 "Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications" and is widely used for surgical implants. The proposed devices are provided non-sterile but sterilized by the end user.
The provided document is a 510(k) premarket notification for a medical device called the "Double Medical Universal Spine System." This type of document is for a medical device that has been deemed substantially equivalent to a previously cleared device. It focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria like a novel AI/software medical device would.
Therefore, much of the requested information, such as multi-reader multi-case studies, standalone algorithm performance, number of experts for ground truth establishment, training set details, and adjudication methods, is not applicable to this type of traditional medical device submission.
Here's a breakdown of the relevant information from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Tests) | Reported Device Performance |
|---|---|
| ASTM F 1717-14 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model": | Demonstrated to meet design specifications and be substantially equivalent to the predicate device. Specific numerical results are not provided in this summary but would have been included in the full submission. |
| - Static compression bending test | (Met) |
| - Dynamic compression bending test | (Met) |
| - Static torsion test | (Met) |
| ASTM F 1798-13 "Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants": | Demonstrated to meet design specifications and be substantially equivalent to the predicate device. Specific numerical results are not provided in this summary but would have been included in the full submission. |
| - Axial gripping capacity test | (Met) |
| Technological Characteristics Equivalence: | The device incorporates the same technological characteristics as the predicate device (Trauson General Spinal System K082617). |
| - FDA Product Codes: MNI and MNH | MNI and MNH |
| - Equivalent intended uses | Indicated for posterior, non-cervical, pedicle fixation for specified spinal conditions. |
| - Components are manufactured from Ti-6Al-4V ELI as per ASTM F 136 | Made of Ti-6Al-4V ELI, meeting ASTM F 136. |
| - Polyaxial and monoaxial pedicle screws are used to attach to the vertebrae | Polyaxial and monoaxial pedicle screws are used. |
| - Same pedicle screw thread form configuration | Same pedicle screw thread form configuration. |
| - Construct support mechanism | Same construct support mechanism. |
| - Use of instrumentation to aid the placement of pedicle screws and rods | Uses instrumentation to aid placement. |
| - Mechanical performance | Mechanical performance shown to be equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set: For the bench tests (ASTM F 1717-14 and ASTM F 1798-13), the "sample size" refers to the number of physical devices or constructs tested. This information is not provided in the summary document. It would typically be detailed in the full test reports submitted to the FDA.
- Data Provenance: This refers to laboratory bench testing conducted to internationally recognized standards (ASTM standards). It is not clinical data, so concepts like "country of origin" or "retrospective/prospective" don't apply in the common sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. The "ground truth" for the bench tests is established by the specifications of the ASTM standards and the measurements of a testing laboratory, not by expert medical opinion. For a physical device like this, performance is measured against engineering and material science standards.
4. Adjudication Method for the Test Set
- Not Applicable. As the tests are based on objective physical measurements against established standards, an adjudication method by experts is not required.
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
- No. This is a hardware device (spine system), not an AI/software device. MRMC studies are used for evaluating diagnostic image interpretation by humans, often with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- No. This is a hardware device.
7. The Type of Ground Truth Used
- For the bench tests: Engineering specifications and material science standards as defined by the ASTM F 1717-14 and ASTM F 1798-13 standards.
- For the overall device: Substantial equivalence to a legally marketed predicate device (Trauson General Spinal System K082617) in terms of intended use, materials, function, sizes, and mechanical test results.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of this traditional hardware medical device submission. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.