Search Results

The Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The Cervical Stand Alone System is used with autograft comprised of cancellous and/or corticocancellous bone graft and the two titanium alloy screws which accompany the implant.

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.

Cervical Stand Alone system is designed to provide the biomechanical strength to a traditional or minimal invasive ACDF procedure with less disruption of patient anatomy and preserve the anatomical profile. The Cervical Stand Alone system helps to preserve the natural sagittal anatomic profile of the cervical spine while providing anterior column support and stability. Cervical Stand Alone is a hybrid PEEK (ASTM F-2026) and Titanium (Ti-6Al-4V) spacer which incorporates Titanium Bone Screws (Ti-6Al-4V) and a Titanium Cover Plate (Ti-6Al-4V). The Cervical Stand Alone spacers are designed with a zero anterior profile and are implanted using an anterior approach.

The provided document describes a medical device, the "Cervical Stand Alone System," and its premarket notification (510(k)) for FDA clearance. However, this document does not contain information about the acceptance criteria or a study proving the device meets the acceptance criteria in the context of an AI/ML medical device.

The document primarily focuses on:

• Regulatory Clearance: It's an FDA 510(k) clearance letter for a Class II medical device (intervertebral body fusion device).
• Device Description: Details about the Cervical Stand Alone System, its materials (PEEK, Titanium), and its intended use for spinal fusion in the cervical spine for patients with degenerative disc disease.
• Predicate Devices: It compares the device to previously cleared predicate devices (K142152 and K150619) to establish substantial equivalence.
• Performance Data (Non-Clinical): It mentions mechanical testing (Static and Dynamic Axial Compression Test, Static Torsion Test, Static Compression Shear Test, Subsidence Test, and Expulsion Test) conducted according to ASTM standards (F2077-14, F2267-04, and ASTM Draft Standard F-04.25.02.02).

There is no mention of:

• An AI/ML component.
• Acceptance criteria for AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
• A clinical study involving human readers or AI assistance.
• Ground truth establishment in the context of diagnostic performance.
• Training or test set sizes for an AI model.

Therefore, I cannot populate the requested table and answer the specific questions related to AI/ML device performance and testing. The document describes a traditional medical device's mechanical and material performance testing for regulatory clearance, not the performance of an AI-powered diagnostic or assistive tool.

Ask a specific question about this device

The Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD), DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The Cervical Stand Alone System is used with autograft bone material and the two titanium alloy screws which accompany the implant.

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.

The Cervical Stand Alone device is a stand-alone spacer system designed to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacer is to be filled with autogenous bone graft material.

The Cervical Stand Alone spacer is manufactured from PEEK and Titanium with Titanium bone screws that allow intradiscal fixation to the vertebral body. The superior and inferior suffaces of the implant have a pattern of ridges that provide increased stability and help prevent migration of the device.

Here's an analysis of the provided text regarding the Cervical Stand Alone System, focusing on acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance for Cervical Stand Alone System

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document states that these tests were "conducted" in accordance with the specified ASTM standards. It does not provide specific numerical performance results or explicit pre-defined pass/fail criteria beyond the adherence to the standards. The basis of substantial equivalence is that the new device has "the same intended use, similar indications for use, the same technological characteristics and design, same materials and the same principles of operation as the predicate devices." Implied acceptance criteria are that the device's mechanical performance is equivalent to, or better than, the predicate devices when tested to these standards.

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not explicitly stated in the provided text. The document mentions "mechanical testing" but does not detail the number of units or repetitions used for each test.
• Data Provenance: Not applicable in the context of clinical data. This study is described as "Non-Clinical Test Conducted." Therefore, there is no country of origin for clinical data, nor is it retrospective or prospective clinical data.

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

• Not applicable. This was a non-clinical, mechanical performance study. There was no "ground truth" derived from expert interpretation of images or patient outcomes. The "ground truth" for these tests would be the established scientific principles of mechanical engineering and the specifications of the ASTM standards themselves.

4. Adjudication Method for the Test Set

• Not applicable. As this was a non-clinical mechanical test, there was no need for expert adjudication. The results were likely compared against predefined limits or against the performance of predicate devices as per the ASTM standards.

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

• No. The document describes non-clinical mechanical testing, not a clinical MRMC study involving human readers or AI assistance.

6. Standalone (Algorithm Only) Performance Study

• No. This device is a physical medical implant (intervertebral body fusion device), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

• The "ground truth" for this study was the mechanical performance specifications and methodologies outlined in the ASTM standards (ASTM F2077-11, ASTM F2267-04, and ASTM Draft Standard F-04.25.02.02). The device's performance was evaluated against the requirements, methods, and expected behaviors established by these engineering standards.

8. Sample Size for the Training Set

• Not applicable. Since this is a physical medical device undergoing mechanical testing, there is no "training set" in the context of machine learning or AI models. The design and manufacturing processes are informed by engineering principles and standards, but not by a data-driven training set.

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

• Not applicable, as there is no training set. The "ground truth" for the design and manufacturing of such a device is rooted in:
  • Biomechanical principles of the spine.
  • Material science properties of PEEK and Titanium.
  • Clinical experience with similar devices (as inferred by the predicate devices).
  • Engineering design specifications aiming to meet the performance requirements of the relevant ASTM standards.

Ask a specific question about this device