(253 days)
The MOSS VRS Spinal System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The MOSS VRS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications:
- degenerative disc disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.)
- spondylolisthesis
- trauma (i. e., fracture or dislocation)
- spinal stenosis
- curvatures (i. i., scoliosis, kyphosis and/or lordosis)
- tumor
- pseudoarthrosis
- failed previous fusion
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MOSS VRS System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The MOSS VRS System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Biedermann Motech MOSS VRS Spinal System is a comprehensive thoracolumbosacral spinal system that offers posterior clinical solutions and is indicated for the treatment of significant mechanical instability or deformity of the spine which requires fusion with instrumentation.
The MOSS VRS System consists of a variety of screws, polyaxial heads, rods, locking caps, connectors, hooks and associated general instruments. The implant components are available in a variety of sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The purpose of this submission is to add components like additional polyaxial heads, cannulated screws, fenestrated screws, screws with larger diameters and lengths and hooks and connectors to the MOSS VRS Spinal System (see K181821).
The safety and effectiveness of the fenestrated screws has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.
All implants of the MOSS VRS System are sinqle-use only and the system is provided non sterile.
The provided text is a 510(k) Summary for the MOSS VRS Spinal System. It details the device, its intended use, and the performance data for its substantial equivalence determination. However, it does not describe specific acceptance criteria with numerical thresholds or report the device's performance against such criteria in a detailed table format. Instead, it states that mechanical testing was performed to "support system related performance under consideration of well-established acceptance criteria" and that the "results demonstrate that the MOSS VRS Spinal System is substantially equivalent to the identified predicate devices."
Therefore, I cannot provide a table of acceptance criteria and reported device performance as requested, nor can I provide specific details about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or training set details as these are not present in the provided document.
Here's an overview of the information that is available related to performance, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (General Statement): The document states that testing was performed "under consideration of well-established acceptance criteria." However, it does not specify what those criteria are (e.g., "withstanding X N of force," "less than Y degrees of angular deformation," "surviving Z cycles").
- Reported Device Performance (General Statement): The document concludes that "The results demonstrate that the MOSS VRS Spinal System is substantially equivalent to the identified predicate devices." It does not provide numerical performance outcomes against specific benchmarks.
2. Sample Sized used for the test set and the data provenance:
- Missing: The document does not specify the sample size (number of constructs or tests) used for the mechanical bench testing.
- Data Provenance: The tests are "Bench testing - mechanical," indicating an engineered laboratory setting, not patient data (retrospective or prospective). The location of testing is not specified, but the manufacturer is based in Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical assessments) where expert consensus establishes a "ground truth." For mechanical bench testing, ground truth is based on physical measurements and engineering standards, not expert interpretation in the clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: As above, adjudication methods are for resolving discrepancies in expert interpretations, which is not relevant to mechanical bench testing.
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 document describes a spinal implant system and its mechanical testing for substantial equivalence, not an AI-assisted diagnostic or therapeutic device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This document is not about an algorithm or AI device.
7. The type of ground truth used:
- Ground Truth: For mechanical testing, the "ground truth" is typically defined by the specified test methods (ASTM F1717 and ASTM F1798) and the physical properties and failure modes observed under controlled laboratory conditions, compared against the performance of predicate devices.
- Type: Engineering standards and physical measurements.
8. The sample size for the training set:
- Not Applicable: This document does not describe a machine learning algorithm or AI model, thus there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable: As there is no training set, this question is not relevant.
Summary of what is present:
- Study Type: Mechanical bench testing.
- Standards Used: ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) and ASTM F1798 (Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants).
- Tests Performed:
- ASTM F1717: Static Compression, Dynamic Compression, Static Torsion.
- ASTM F1798: Static Flexion Extension, Dynamic Flexion Extension, Static Axial Grip, Static Axial Pull-Off.
- Conclusion: The tests demonstrated that the MOSS VRS Spinal System is "substantially equivalent to the identified predicate devices."
§ 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.