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.

Device Description

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.

AI/ML Overview

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.

Summary

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KD32744

Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone™ Surgical Mesh System Confidential

JUN 2 7 2003

510(k) SUMMARY

Name of Firm:	Blackstone Medical, Inc.90 Brookdale DriveSpringfield, MA 01104
510(k) Contact:	Dean E. CiporkinDirector, Regulatory Affairs and Quality Assurance
Trade Name:	Blackstone™ Surgical Mesh System
Common Name:	Spinal Vertebral Body Replacement Device
Device Product Code& Classification:	MQP- 888.3060 - Spinal Vertebral Body Replacement Device
SubstantiallyEquivalent Devices:	DePuy AcroMed™ Surgical Titanium Mesh System (K003043)Synthes SynMesh™ Spacer System (K003275)Surgical Dynamics™ (SDI) Mesh Cage System (K003709)

Device Description:

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Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone™ Surgical Mesh System Confidential

Intended Use / Indications for Use:

BASIS OF SUBSTANTIAL EQUIVALENCE:

By its very nature, the Blackstone™ Surgical Mesh System is substantially equivalent to the DePuy AcroMed Surgical Titanium Mesh™ System (K003043), Synthes SynMesh™ Spacer System (K003275), and the Surgical Dynamics™ (SDI) Mesh Cage System (K003709), which have been cleared by FDA for use in patients with tumor, trauma or fractures.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it. The text is arranged in a circular fashion, following the contour of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2003

Mr. Dean E. Ciporkin Director, Regulatory Affairs and Quality Assurance Blackstone Medical, Inc. 90 Brookdale Drive Springfield, Massachusetts 01104

Re: K030744

Trade Name: Blackstone™ Surgical Titanium Mesh System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP (Vertebral Body Replacement Device) Dated: May 27, 2003 Received: May 28, 2003

Dear Mr. Ciporkin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Dean E. Ciporkin

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Mark A. Mulhearn

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) # K030744:

Device Name: Blackstone™ Surgical Titanium Mesh System

Indications for Use:

The Blackstone Medical Surgical Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of turnors, 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.

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

for Mark N. Mulkerson

Division Sign-Off) Division of General. Rest rative and Neurological Devices

510"""\N... K030744

Regulation Number and Section

§ 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.