(109 days)
The Blackstone Medical Surgical Mesh System is indicated for use in the thoraco-lumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Surgical Mesh is also indicated for treating fractures of the thoracic and lumbar spine.
The Surgical Mesh System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. It is recommended to pack bone graft material inside the mesh cage prior to implantation.
The Surgical Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used with the Surgical Mesh System is the Blackstone Medical Spinal Fixation System.
The Blackstone Medical, Inc. Surgical Mesh System is comprised of a hollow cylindrical tube made from commercially pure (CP) titanium conforming to ASTM F-67. The walls of the tube are perforated with evenly spaced diamond-shaped openings. These openings and the hollow core allow grafting material to be placed inside the device to help achieve solid fusion. Because of the construction, the angle and the length of the mesh can be reduced incrementally to adjust it to individual anatomical conditions. The end rings, standard ring and screws of the device are made of titanium alloy (6AL-4V ELI, per ASTM F136). The end rings, which are placed onto each end of the tube, feature spikes on the exterior sides that help prevent lateral movement of the device.
The provided text is a 510(k) Premarket Notification for the Blackstone™ Surgical Mesh System, primarily focused on establishing substantial equivalence to previously cleared devices. It does not contain information about a study proving the device meets specific acceptance criteria in terms of performance metrics based on a clinical or diagnostic study.
Instead, the submission demonstrates "substantial equivalence" through device description and intended use compared to predicate devices. This type of submission typically relies on non-clinical performance testing (e.g., mechanical, biocompatibility) rather than clinical studies with human subjects that would involve ground truth establishment and expert adjudication.
Therefore, many of the requested fields cannot be populated from the provided document.
Here's a breakdown of the available and unavailable information:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as performance metrics in a clinical study context. For a device like this, acceptance criteria would typically involve engineering specifications (e.g., material strength, fatigue life, dimensional accuracy) and regulatory standards (e.g., biocompatibility testing). These are generally detailed in the technical sections of the 510(k) that are not included here.
- Reported Device Performance: The document states the device is "designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period." This is a functional claim, not a quantifiable performance metric as would be reported from a clinical study.
| Acceptance Criteria | Reported Device Performance (from document) |
|---|---|
| Not specified in terms of clinical or diagnostic performance metrics within this document. | - Designed to restore biomechanical integrity of the anterior, middle, and posterior spinal column. |
| - Substantially equivalent to predicate devices for use in patients with tumor, trauma or fractures. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable as no clinical test set for performance evaluation is described.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable as no clinical test set with ground truth is described.
4. Adjudication Method for the Test Set:
- Not applicable.
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 medical implant, not an AI-powered diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a medical implant, not an algorithm.
7. The Type of Ground Truth Used:
- Not applicable as no clinical study requiring ground truth is described. The "ground truth" for this device's safety and effectiveness relies on its conformance to established material and design standards, and its substantial equivalence to predicate devices that have prior FDA clearance.
8. The Sample Size for the Training Set:
- Not applicable. This is a medical implant, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
Summary based on the provided document:
The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the Blackstone™ Surgical Mesh System to existing, legally marketed predicate devices (DePuy AcroMed™ Surgical Titanium Mesh System, Synthes SynMesh™ Spacer System, and Surgical Dynamics™ (SDI) Mesh Cage System). This is a regulatory pathway that relies on comparisons of intended use, technological characteristics, and performance data typically derived from non-clinical (e.g., mechanical, material) testing rather than human clinical trials involving test sets, expert adjudication, or ground truth establishment in the context of diagnostic accuracy. As such, the document does not describe a study involving patient data, "acceptance criteria" in the sense of clinical performance metrics, or "ground truth" as typically defined for diagnostic or AI-driven device evaluations.
§ 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.