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The Blackstone Medical PEEK Vertebral Body Replacement 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 PEEK VBR System is also indicated for treating fractures of the thoracic and lumbar spine. It is recommended that bone graft material be packed inside the system prior to implantation. The PEEK VBR System is intended to be used with supplemental internal fixation. Specifically, the supplemental internal fixation system that may be used with the PEEK VBR System is the Blackstone Medical Spinal Fixation System.

Blackstone Medical, Inc. PEEK Vertebral Body Replacement (VBR) System is comprised of a variety of components fabricated and manufactured from Polyetheretherketone (PEEK Optima LT) as described by ASTM F-2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred. Titanium markers are inserted into components to give surgeons a visual aid in determining the location of the implant both inter and postoperatively. The superior and inferior surfaces of the construct have a pattern of ripples to provide increased stability and help prevent lateral movement of the device.

The Lordotic Lateral Spacers restore the natural curvature of the spine.

This document describes a modification to an existing medical device, the Blackstone PEEK Vertebral Body Replacement (VBR) System, specifically the addition of Lordotic Lateral Spacers. As such, the submission focuses on demonstrating substantial equivalence to the previously cleared device, not on proving device performance for novel indications or a new device.

Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating the performance of a new device or a device with new clinical indications, are not applicable to this 510(k) submission.

The core of this submission is a claim of substantial equivalence to a predicate device (Blackstone PEEK Vertebral Body Replacement System, K033702). This means that the product is being presented as being as safe and effective as a legally marketed device.

Here's why each point you requested is not available in this document:

1. Table of acceptance criteria and reported device performance: Not applicable. Performance criteria and detailed performance data beyond a description of materials and design are not provided for a substantial equivalence claim where the functionality is largely unchanged.
2. Sample size for test set and data provenance: No new clinical or performance test studies are described that would require a test set. This is a modification to an existing, cleared device.
3. Number of experts and qualifications for ground truth: Not applicable. No new diagnostic or interpretative claims are being made that would require expert consensus for ground truth.
4. Adjudication method: Not applicable, as there's no diagnostic performance study or human reader evaluation described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study assesses human performance with and without AI assistance, which is not relevant to a device modification for a spinal implant.
6. Standalone (algorithm only) performance study: Not applicable. This device is a physical implant, not an AI algorithm.
7. Type of ground truth used: Not applicable, as no new performance studies are described that would establish a "ground truth" (e.g., pathology, outcomes data for effectiveness).
8. Sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
9. How ground truth for the training set was established: Not applicable.

Summary of the document's content relevant to device acceptance:

• Acceptance Criteria for a 510(k) of this nature: The primary acceptance criterion for this 510(k) is demonstrating substantial equivalence to a predicate device. This means showing that the new device (Lordotic Lateral Spacers) has the same intended use, technological characteristics, and safety/effectiveness profiles as the predicate device (Blackstone PEEK Vertebral Body Replacement System, K033702).
• Study Proving Acceptance: The "study" (or rather, the justification) provided is the comparison to the predicate device K033702. The document states: "The Blackstone™ PEEK Vertebral Body Replacement System Lordotic Lateral Spacers are substantially equivalent to the Blackstone™ PEEK Vertebral Body Replacement System (K033702), which has received market clearance by the FDA."
• Device Performance (as described for a substantial equivalence claim):
  • Material: PEEK Optima LT (ASTM F-2026), chosen for radiolucent properties.
  • Features: Titanium markers for visualization, ripples on superior/inferior surfaces for increased stability and to prevent lateral movement.
  • New Feature (modification): Lordotic Lateral Spacers restore the natural curvature of the spine.
  • Intended Use/Indications: Remain consistent with the predicate device – thoraco-lumbar spine (T1-L5) for vertebral body replacement due to tumors or fractures, to achieve decompression, restore height, and restore biomechanical integrity. Intended for use with bone graft and supplemental internal fixation (specifically Blackstone Medical Spinal Fixation System).

In essence, for this 510(k) modification, the "acceptance criteria" were met by providing a detailed comparison between the modified device and the predicate device, asserting that the changes do not raise new questions of safety or effectiveness and that the intended use remains the same. The FDA's clearance letter (K041939) confirms that this claim of substantial equivalence was accepted.

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The Blackstone Medical PEEK Vertebral Body Replacement System is indicated for use in the thoraco-lumbar spine (T1-L5) to replace a deseased 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 PEEK VBR System is also indicated for treating fractures of the thoracic and lumbar spine. It is recommended that bone graft material be packed inside the system prior to implantation. The PEEK VBR System is intended to be used with supplemental internal fixation. Specifically, the supplemental internal fixation system that may be used with the PEEK VBR System is the Blackstone Medical Spinal Fixation System.

Blackstone Medical, Inc. PEEK Vertebral Body Replacement (VBR) System is of a variety of components fabricated and manufactured from comprised Polyctheretherketone (PEEK Optima LT) as described by ASTM F-2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred. Titanium markers are inserted into components to give surgeons a visual aid in determining the location of the implant both inter and postoperatively. The superior and inferior surfaces of the construct have a pattern of ripples to provide increased stability and help prevent lateral movement of the device.

The provided document is a 510(k) summary for the Blackstone PEEK Vertebral Body Replacement System. It does not contain information about acceptance criteria or a study proving that a device meets those criteria.

Instead, it's a submission to the FDA for market clearance based on substantial equivalence to a previously cleared device. The document explicitly states:

• Basis of Substantial Equivalence: "By its very nature, the Blackstone™ PEEK Vertebral Body Replacement System is substantially equivalent to the Blackstone Surgical Titanium Mesh System (K030744), which has been cleared by FDA for use in patients with tumor, trauma or fractures."

This means the manufacturer is asserting their device is similar enough to an already approved device that it doesn't require new clinical trials or the establishment of new performance acceptance criteria. The FDA's letter confirms that they have determined the device is "substantially equivalent."

Therefore, I cannot provide the requested information, as it is not present in the provided text. The document focuses on regulatory clearance via substantial equivalence, not on a study demonstrating adherence to specific performance acceptance criteria.

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