(89 days)
The Vertebral Spacer Ti is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vertebral Spacer Ti is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix, USS and Small Stature USS. The interior of the spacer component of the Ti Spacer System can be packed with bone.
The Vertebral Spacer Ti is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The Vertebral Spacer Ti is a titanium vertebral body replacement device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy and consists of:
- vertebral body replacement devices comprised of a variety . of fixed heights and cross-sections.
- supplemental fixation currently cleared for use in treating . patients for tumor, trauma or fractures of the vertebral body and
- manual surgical instrumentation used to prepare the . anatomy and implant the Vertebral Spacer Ti.
There are no unique surgical instruments required for implantation of the submitted device system.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Synthes Vertebral Spacer Ti:
The provided document is a 510(k) premarket notification for a medical device. These types of submissions typically focus on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trials with detailed acceptance criteria and standalone performance studies for novel devices.
Based on the provided text, the information available is limited regarding explicit acceptance criteria and a detailed study report. However, we can extract some relevant points.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Mechanical Stability/Strength | "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', September 27, 2000 was presented." |
| Material Biocompatibility | "All components... manufactured from commercially pure titanium (ASTM F67) or titanium alloy Ti6Al7Nb (ASTM F1295)." (Implies meeting ASTM standards for biocompatible materials) |
| Substantial Equivalence to Predicate Device | "The Vertebral Spacer Ti implants are similar to the predicate Synthes SynMesh vertebral body replacement device(s), (K003275) with respect to technical characteristics and performance." |
| Anterior Spinal Column Support | "The Vertebral Spacer Ti is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period." (This is a design intent rather than a measured performance metric in the document) |
| Intended Use Compliance | The device is intended for use in "thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture)." The 510(k) cleared this indication. |
Explanation: In 510(k) submissions, acceptance criteria are often framed implicitly by the substantial equivalence argument and adherence to recognized standards. For mechanical devices like spinal implants, the "Guidance for Spinal System 510(k)s" would outline specific mechanical tests (e.g., compression, fatigue, subsidence) and acceptable performance limits, likely referencing ASTM or ISO standards. The document only confirms that such testing was presented, not the specific results or the predefined acceptance values.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document refers to "Mechanical testing," which implies laboratory-based, non-clinical tests. There is no mention of a human test set or clinical data for this specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/not provided. As "mechanical testing" was performed, the "ground truth" would be established by engineering standards and measurements, not medical expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes.
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
This information is not applicable. The device is a physical spinal implant, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical spinal implant, not an algorithm.
7. The Type of Ground Truth Used
For the "Performance Data" section, the ground truth was based on engineering standards and measurements from mechanical testing. The document states that testing was "in accordance with the 'Guidance for Spinal System 510(k)s', September 27, 2000." This guidance would specify the appropriate methods for determining the mechanical properties and performance (e.g., strength, stiffness, fatigue life) of spinal implants.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This device is not an AI/ML product that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided.
Summary of the Study Mentioned:
The primary "study" mentioned for the Vertebral Spacer Ti is mechanical testing. This testing was conducted:
- In accordance with: "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000.
- Purpose: To demonstrate the device's mechanical performance and support the claim of substantial equivalence to the predicate device (Synthes SynMesh System, K003275).
- Basis of Substantial Equivalence: The filing argues that the new device's "technical characteristics and performance" are similar to the predicate device. This implies that the mechanical testing results were comparable or met the same performance expectations as the predicate device and the relevant guidance.
It's crucial to understand that for a 510(k) substantial equivalence submission for a physical implant, the focus is largely on non-clinical performance (like mechanical testing, material biocompatibility, and sterilization) and a comparison of design and indications for use to a previously cleared device. Extensive clinical studies with defined acceptance criteria for patient outcomes, expert consensus on images, or AI performance metrics are typically not required for this regulatory pathway unless the device presents novel technology or significant differences from a predicate.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.