(101 days)
The MOSS 100 Pedicle Screw System is a thoracolumbar pedicle for the following indications of use:
- Degenerative Disc Disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis
- Trauma (i.e. fractures or dislocations)
- Spinal Stenosis
- Curvatures (i.e. scoliosis, kyphoses and/ or lordosis)
- Tumor
- Pseudoarthrosis
- Failed previous fusion
The Biedermann Motech MOSS 100 Pedicle Screw System is a comprehensive thoracolumbar spinal system that offers posterior clinical solutions. The MOSS 100 System is a universal set of instruments and implants that are indicated for the treatment of significant mechanical instability or deformity of the spine which requires fusion with instrumentation.
The MOSS 100 System provides several options for stabilization of the spine. Therefore, the system includes the following implants:
- -Pedicle Screws Ø5-8mm, length 25-80mm
- -Rods Ø5.5mm, length 30-95mm, 300mm and 480mm
- Locking caps -
- Polyaxial Heads -
The Polyaxial Heads are mounted onto the Pedicle Screws intra-operatively. The implants of the MOSS 100 System are single-use only and the system is provided non sterile.
This document is a 510(k) Premarket Notification for a medical device called the "MOSS 100 Pedicle Screw System." It does not describe a study involving an AI/Machine Learning device or analytical performance metrics typically associated with such software. Instead, it focuses on the performance of a physical pedicle screw system through non-clinical bench testing.
Therefore, many of the requested elements for AI/ML device studies are not applicable to this document. I will extract the available information regarding acceptance criteria and performance for the pedicle screw system.
Here's the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Static Compression | ASTM F 1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) | The results indicate that the MOSS 100 system is substantially equivalent to the identified predicate device (Expedium Spine System, K041119). |
| Dynamic Compression | ASTM F 1717 | The results indicate that the MOSS 100 system is substantially equivalent to the identified predicate device (Expedium Spine System, K041119). |
| Static Torsion | ASTM F 1717 | The results indicate that the MOSS 100 system is substantially equivalent to the identified predicate device (Expedium Spine System, K041119). |
| Static axial pull-off | ASTM F 1798 (Standard Test Methods for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants) | The Biedermann Motech device has higher mechanical characteristics than the reference product (Synthes Matrix Spine, K092929), supporting substantial equivalence. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact number of samples (e.g., individual pedicle screw systems or components) used for each bench test. It refers to "worst case mechanical testing" for ASTM F 1717.
Data provenance: This refers to physical bench testing conducted by the manufacturer, Biedermann Motech GmbH & Co. KG, based in Villingen-Schwenningen, Germany.
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 physical device being evaluated through mechanical bench testing against established ASTM standards, not against human expert interpretation of data.
4. Adjudication method for the test set
Not applicable. This is a physical device being evaluated through mechanical bench testing against established ASTM standards. The results are compared to predicate devices and standards directly.
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 physical medical device, not an AI/ML software device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an AI/ML algorithm.
7. The type of ground truth used
The ground truth or reference for comparison is established by ASTM standards (ASTM F 1717 and ASTM F 1798) and the performance of identified predicate devices (Expedium Spine System, K041119, and Synthes Matrix Spine, K092929).
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is a physical product, not an AI/ML system.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a physical 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.