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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."

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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 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) (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, 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 scolosis. 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. The MOSS VRS 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 VRS System provides several options for stabilization of the spine. Therefore, the system includes the following implants:

• Pedicle Screws Ø4.35-9mm, length 20-100mm
• Rods Ø5,5mm and Ø6,0mm, length 30-95mm, 120-600mm
• Locking Caps
• Polyaxial Reductionheads

The implants of the MOSS VRS System are single-use only and the system is provided non sterile.

This appears to be a 510(k) Summary for a medical device (MOSS VRS Spinal System). The document describes the device, its indications for use, and a comparison to predicate devices, including performance data. However, it does not describe a study involving an AI/Machine Learning device or specific acceptance criteria for such a device in the way your prompt requests.

The performance data section (8.1 Non-Clinical Test Summary) details bench testing for mechanical properties of the physical spinal implant system. It explicitly states, "No clinical tests were performed" (8.2 Clinical Test Summary).

Therefore, I cannot provide the requested information for an AI/ML device because this submission focuses on a traditional medical device (a spinal implant system) and its mechanical performance, not an AI-powered diagnostic or therapeutic tool.

If this document were for an AI/ML device, the requested information would typically be found in dedicated sections outlining the algorithm's performance study.

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The TELIX K Interbody System is intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1).

Patients should have six months of non-operative treatment prior to surgery.

These implants are used to facilitate fusion in the lumbar spine and are placed via a TLIF approach using autogenous bone.

These implants are intended for use with Biedermann Motech supplemental internal fixation products.

The TELIX K Interbody System is intended for use as an intercorporal fusion cage in the lumbar region (L2-L5) and sacral region (S1). Therefore, the system includes the following implants:

The TELIX K Interbody System is comprised of slightly curved implants in lengths of 28, 32 and 36mm and heights ranging from 7 to 17mm.

Devices that are 7mm in thickness are only available with 0-degrees of lordosis and all other implants possess 5-degrees of lordosis.

The implants are introduced via a TLIF approach using autogenous bone. The TELIX K Interbody System must only be implanted in combination with supplemental fixation.

The implants of the TELIX K Interbody System are single-use only and the system is provided non sterile.

This document is a 510(k) premarket notification for a medical device (TELIX K Interbody System), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study of the device's performance against detailed acceptance criteria in the context of an AI/algorithm-based medical device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" (especially points 2, 3, 4, 5, 6, 7, 8, 9 which relate to data, ground truth establishment, and clinical studies) are not applicable or not present in this type of regulatory submission. This document describes a physical intervertebral body fusion device, not an AI or algorithm.

Here's an analysis based on the provided text, addressing only the applicable points:

1. A table of acceptance criteria and the reported device performance

Based on the document, the "acceptance criteria" are derived from relevant ASTM standards for intervertebral body fusion devices, and the "reported device performance" refers to the results of mechanical bench testing.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated for specific tests, but implies a sufficient number of samples were tested to meet ASTM standard requirements for substantiation.
• Data Provenance: Not applicable in terms of patient data. The data is from mechanical bench testing of the device components.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

• Not applicable. This relates to mechanical testing against standards, not expert-derived ground truth on patient data.

4. Adjudication method for the test set:

• Not applicable. This relates to mechanical testing governed by standardized protocols, not human adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This document refers to a physical implant and mechanical testing, not a diagnostic or AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an algorithm.

7. The type of ground truth used:

• For the mechanical bench testing, the "ground truth" is defined by the acceptance limits and methodologies of the ASTM standards (ASTM F2077-14 and ASTM F2267-04).

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is a physical device subject to mechanical testing, not an AI/algorithm.

9. How the ground truth for the training set was established:

• Not applicable. There is no "training set" or corresponding ground truth establishment process for this type of device.

Summary based on the document:

The provided document describes a 510(k) premarket notification for a physical medical device, the TELIX K Interbody System. The intent of this submission is to demonstrate substantial equivalence to an already legally marketed device, primarily through non-clinical bench testing to ensure mechanical performance aligns with established standards for intervertebral body fusion devices.

The "acceptance criteria" are implied by the referenced ASTM standards (ASTM F2077-14 and ASTM F2267-04), which dictate the performance requirements for such implants regarding static compression, dynamic compression, torsion, compression-shear, and subsidence. The study conducted was non-clinical bench testing, specifically mechanical tests. No clinical trials or studies involving human patients were performed or deemed necessary for this 510(k) submission ("No clinical tests were performed."). Therefore, concepts like data provenance from patient studies, expert consensus, MRMC studies, or training sets for AI algorithms are not relevant to this specific regulatory submission.

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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.

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