(68 days)
The MOSS Miami Spinal System is intended for non-cervical use in the spine.
When used with anterior screw fixation or posterior hook, non-pedicle screw fixation the MOSS Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed back surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).
When used with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.
The MOSS Miami Spinal System is available in either Stainless Steel or Titanium. The following components are currently available in Stainless Steel: 4 and 5mm diameter longitudinal rods. 5-7 mm diameter monoaxial screws. 5-7 mm diameter polyaxial screws, hooks, transverse connectors, axial connectors and staple washers. The following components are currently available in Titanium: 5.5 mm diameter longitudinal rods, 5-8 mm diameter monoaxial screws, 5-7 mm diameter polyaxial screws, hooks, tranverse connectors, axial connectors, washers and staple washers.
The products in this submission are additional components to the existing MOSS Miami Spinal System. The MOSS Miami 6 mm Sub-System consists of: 6 mm diameter longitudinal rods in lengths of 12, 30 and 48cm; axial and transverse connectors for joining longitudinal rods; 6mm and 7mm diameter mono- and polyaxial screws in various lengths, which are attached to the longitudinal rods with inner screws and outer nuts; and various hooks and other accessories. The design, intended use, and material of these components have been cleared in previous 510(k) submissions.
The provided text describes the DePuy Motech MOSS Miami Spinal System and its 6mm Sub-System, focusing on the basis of substantial equivalence for FDA clearance. However, it does not contain information regarding detailed acceptance criteria, a specific study proving device performance against those criteria, or most of the requested study design elements (sample size, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details).
The primary claim for equivalence is based on mechanical testing, indicating similar biomechanical performance to previously cleared MOSS Miami systems and competitive spinal systems.
Here's a breakdown of the available information and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
No specific quantitative acceptance criteria are provided in the document. The document states that "Mechanical testing shows that the biomechanical performance of the components and subconstructs of the MOSS Miami 6 mm Spinal System is expected to be similar to the performance of the other MOSS Miami Spinal Systems and competitive spinal systems." This implies a qualitative comparison rather than a detailed, measurable acceptance criterion.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biomechanical Performance | Not explicitly stated | Expected to be "similar" to other Moss Miami Spinal Systems and competitive spinal systems. |
| Material | Match predicate devices | Identical to predicate devices |
| Design | Match predicate devices | Similar to predicate devices (with diameter being the only difference) |
| Intended Use | Match predicate devices | Matched, with specific limitations for pedicle screw fixation. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document refers to "mechanical testing," which typically involves material and device component testing, not clinical patient data.
- Data Provenance: Not specified. As it's mechanical testing, it would likely be laboratory-generated data, not from human subjects directly.
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/Not specified. Mechanical testing does not typically involve human experts establishing ground truth in the way clinical studies do. The "ground truth" would be the measured physical properties and performance characteristics.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. This is not a clinical study involving human perception or diagnosis.
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 document pertains to a spinal implant system undergoing mechanical testing, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For mechanical testing, the "ground truth" would be the objective physical measurements (e.g., tensile strength, fatigue life, torsional resistance, stiffness) obtained from standardized biomechanical test methods. These are compared against established engineering and regulatory benchmarks for similar devices or predicate devices.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. There is no mention of a "training set" as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
- Ground Truth (Training Set): Not applicable.
Summary of what the document does state about the study/testing:
- Study Type: Mechanical testing.
- Purpose: To demonstrate that the biomechanical performance of the MOSS Miami 6 mm Spinal System is "similar to the performance of the other MOSS Miami Spinal Systems and competitive spinal systems."
- Basis of Equivalence: The primary basis relies on:
- Identical components (except for rod diameter) to previously cleared MOSS Miami systems.
- Mechanical testing results showing similar biomechanical performance.
- Key Difference: The only difference between the submitted device and predicate MOSS Miami systems is the 6mm diameter of the longitudinal rods, as opposed to the 5mm diameter of the predicate.
§ 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.