Search Results

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

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.

Ask a specific question about this device