(94 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),
- spondylolisthesis,
- trauma (i.e., fracture or dislocation),
- spinal stenosis,
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- spinal tumor,
- pseudoarthrosis, and/or
- failed previous fusion.
- The intended use and indications of the Malibu system, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System or Sublaminar Wire 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 system contains titanium alloy and cobalt alloy implants. This submission is intended to address the line extensions including titanium and cobalt alloy spinal rods, cap, set screw, and a sublaminar wire. All devices are supplied non-sterile. These devices are not compatible with stainless steel implants.
The SeaSpine Malibu Spinal System line additions (titanium and cobalt alloy spinal rods, cap, set screw, and a sublaminar wire) do not have specific acceptance criteria or a detailed clinical study described in the provided document that proves the device meets such criteria.
Instead, the submission relies on the concept of substantial equivalence to predicate devices. This means that the manufacturer demonstrates that the new line additions are as safe, as effective, and perform as well as or better than existing, legally marketed predicate devices.
Here's an analysis based on the provided text, addressing your points:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Properties Comparable to Predicate Devices | "The devices were justified or mechanically tested to substantiate comparable mechanical properties to the predicate devices." |
| Technological Characteristics Equivalent to Predicate Devices | "Equivalent technological characteristics include design, operating principle, materials of construction, intended use and sterilization methods." |
| Safety | "The analysis indicates that the line additions are as safe...as the predicate devices." |
| Effectiveness | "The analysis indicates that the line additions are...as effective...as the predicate devices." |
| Performance | "The analysis indicates that the line additions are...perform as well as or better than the predicate devices." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. No clinical test set or human study data is described. The performance data focuses on mechanical testing and comparison to predicates.
- Data Provenance: Not applicable. The data primarily stems from mechanical testing and a comparison of design, materials, and intended use to existing predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. No human expert "ground truth" or clinical efficacy/safety study requiring expert assessment is described.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No clinical test set or human study data requiring adjudication is described.
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
- MRMC Study: No. This submission is for spinal implants and does not involve AI or diagnostic imaging interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This submission is for physical spinal implants, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For the purpose of establishing substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the predicate devices. The mechanical testing data aims to demonstrate that the new devices perform comparably to these known predicates. No clinical outcomes data for the new device is presented.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. No training set for an algorithm is described.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. No training set for an algorithm is described.
In summary: The provided document is a 510(k) summary for line additions to an existing spinal system. The primary method for demonstrating safety and effectiveness is through proving substantial equivalence to previously cleared predicate devices, supported by mechanical testing rather than clinical trials with human subjects. Therefore, many of the questions related to clinical study design, expert evaluation, and AI performance are not applicable to this type of submission.
§ 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.