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VEO is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. VEO is designed to be used with autogenous graft and supplemental spinal fixation that is cleared for use in the lumbar spine.

VEO is a radiolucent PEEK interbody fusion implant comprised of various heights to accommodate individual patient anatomy and graft material size. It also interfaces with Class I access instruments and disc preparation instruments. The lateral access technique allows a large cage to be implanted similar to marketed lateral lumbar interbody fusion sized cages. It is designed for use to provide structural stability in skeletally mature individuals.

Here's a breakdown of the acceptance criteria and study information for the TranS1 VEO device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes a medical device, the TranS1 VEO, which is an intervertebral fusion device, and details its mechanical testing. The acceptance criteria are defined by various ASTM standards for mechanical testing. The reported device performance is that it met or exceeded these requirements.

2. Sample Size Used for the Test Set and Data Provenance:

The document describes confirmatory mechanical testing and does not refer to clinical studies with patient data. Therefore, information regarding "sample size used for the test set" (in terms of patient numbers), "data provenance" (country of origin, retrospective/prospective) is not applicable in this context. The "test set" in this case refers to the physical devices undergoing mechanical tests. The specific number of devices tested for each mechanical test is not provided in the summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not applicable as the study is a mechanical engineering test on a medical device, not a diagnostic or AI-driven evaluation that would require human expert ground truthing. The "ground truth" for these tests is the physical performance of the device against established engineering standards.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as above. Adjudication methods are typically relevant for clinical studies or image interpretation, not for mechanical device testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable. The document describes mechanical testing of an intervertebral fusion device, not a diagnostic or interpretative AI system where human readers would be involved or assisted by AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This information is not applicable. The device is a physical implant, not an algorithm.

7. Type of Ground Truth Used:

The ground truth used for these tests is the established requirements and specifications within the referenced ASTM (American Society for Testing and Materials) standards. These are engineering benchmarks for material properties, structural integrity, and performance under various loads.

8. Sample Size for the Training Set:

This information is not applicable. There is no "training set" as this is not an AI/machine learning study or a clinical trial with a patient training cohort. The device's design and manufacturing are based on established engineering principles and materials science.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reasons as above. The "ground truth" for the device's design and manufacturing is derived from engineering principles and regulatory requirements for such implants.

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The TranS1™ Axial Fixation System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TranS1™ Axial Fixation System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 in conjunction with legally marketed pedicle screw systems.

The TranS1 Axial Fixation System is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. The following components are included: 3D Axial Fixation Threaded Rod/Screw, Axial Fixation Screw Plug, Axial Fixation Screw Driver, Material Inserter, and Axial Fixation Screw Plug Driver.

The provided text is a 510(k) summary for the TranS1 Axial Fixation System, a medical device for spinal fixation. It does not contain information about acceptance criteria, device performance testing, or study details as outlined in your request (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies).

The primary purpose of this document is to demonstrate "substantial equivalence" to a predicate device, which is a regulatory pathway for lower-risk medical devices in the United States. This pathway typically focuses on functional equivalence, material equivalence, and similar intended use, rather than extensive clinical efficacy studies with specific performance metrics and acceptance criteria as you've requested.

Therefore, I cannot populate the table or answer the specific questions about device performance and study details based on the information provided. The document focuses on regulatory classification, device description, and a comparison to a predicate device for market clearance.

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The intended use of the TranS1 Trans-Sacral Spinal Access and Preparation Device is for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy or for assistance in the performance of L5-S1 interbody fusion.

The Trans-Sacral Spinal Access and Preparation Device is for minimally invasive access to the anterior lower spine and consists of the following components: Guide Pin Introducer Guide Pins Dilators Dilators with sheath Guide Pin Steering Handle Twist Drills Cutters Brushs Exchange Rod Exchange Cannula Brush Delivery Sleeve Distraction Tool with driver Bone Graft Inserter Fibula Placement Tool

This document is a 510(k) summary for the TranS1 Trans-Sacral Spinal Access and Preparation Device, and thus does not contain information on acceptance criteria or a study proving device performance against such criteria.

The 510(k) summary states the following about the device:

• Device Name: TranS1 Trans-Sacral Spinal Access and Preparation Device (also referred to as TranS1 Trans-Sacral Spinal Access and Preparation Kit)
• Generic Name: Rigid Endoscope and Instrument Set
• Intended Use/Indications for Use: For minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy, or for assistance in the performance of L5-S1 interbody fusion.
• Technological Characteristics: Designed to gain a minimally invasive access tract to the anterior region of the lower spine and assist in the diagnosis and treatment of the area, enabling procedures such as biopsy, lumbar fusion, vertebroplasty, etc. Access up to L5 is possible.
• Predicate Devices:
  • AxiaMed, Inc., Trans-Sacral Spinal Access Device
  • Surgical Dynamics, Inc., 30K Working Channel Scope and instrument kit
  • Argus Medical Company Laparoscopic Discectomy Instrument System
  • Surgical Dynamics, Inc., Nucleotome Tissue Aspirator/Cutter
  • Surgical Dynamics, Inc., Nucleotome II Tissue Aspirator/cutter
  • Sofamor Danek Mfg., Inc., Danek Tissue Cutting and Removal System
  • United States Surgical, Auto Suture Spinal Elevator
  • Harrington Spinal Elevator
  • Karlin Technology, Inc., Cobb Spinal Elevator.

The document is primarily focused on demonstrating substantial equivalence to these predicate devices for market clearance, rather than presenting a performance study with defined acceptance criteria. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in this filing.

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