The Blackstone Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impingement of the spinal cord.

Device Description

The Blackstone Laminoplasty Fixation System is a device comprised of non-sterile, single use, titanium and titanium allov components. The specially shaped plates, made of commercially pure (CP) titanium, are designed to fit the anatomy of the dorsally elevated lamina. The plates have screw holes on both ends, which allow for attachment to the vertebral body, and a screw hole in the center for attachment to the allograft.

The screws, made of titanium alloy (6AL-4V ELI, per ASTM F-136), are available in variety of lengths and diameters in order to meet individual anatomical requirements.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for the Blackstone™ Laminoplasty Fixation System. It establishes substantial equivalence to a predicate device, the Synthes Arch™ Fixation System (K032534), rather than presenting a study demonstrating that the device meets specific acceptance criteria through a clinical or performance study of the device itself.

Therefore, most of the requested information regarding acceptance criteria, performance data, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies cannot be extracted from this document as it serves a different purpose in the regulatory pathway.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be extracted. This document focuses on demonstrating substantial equivalence to a predicate device, not on presenting specific performance acceptance criteria for the Blackstone Laminoplasty Fixation System itself, nor results from a study showing it meets such criteria. Regulatory submissions for devices relying on substantial equivalence typically reference the predicate device's performance or established standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be extracted. No test set or associated sample size is described for the Blackstone Laminoplasty Fixation System.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be extracted. No ground truth establishment related to a test set for this device is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be extracted. No test set or adjudication method is described.

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

Cannot be extracted. This is a medical device for spinal fixation, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is not applicable and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Cannot be extracted. This is a medical device for spinal fixation, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be extracted. No ground truth data for a specific study of this device is presented.

8. The sample size for the training set

Cannot be extracted. No training set is described.

9. How the ground truth for the training set was established

Cannot be extracted. No training set or ground truth establishment for it is described.

Summary of Relevant Information from the Document:

While the document doesn't fit the requested structure directly (as it's a 510(k) for substantial equivalence), here's what it does provide:

Device Name: Blackstone™ Laminoplasty Fixation System
Intended Use/Indications for Use: For use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty to hold or buttress an allograft, preventing its expulsion or spinal cord impingement.
Device Description: Non-sterile, single-use components made of titanium and titanium alloy. Comprises specially shaped plates (CP titanium) with screw holes (for attachment to vertebral body and allograft) and screws (titanium alloy, 6AL-4V ELI) in various lengths/diameters.
Predicate Device: Synthes Arch™ Fixation System (K032534). The Blackstone system is considered substantially equivalent to this predicate. This substantial equivalence is the "proof" for regulatory clearance, relying on the predicate device's established safety and effectiveness.

Summary

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Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone TM Laminoplasty Fixation System.

FEB 1 8 2005

K043338 age ( of )

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™ Laminoplasty Fixation System
Common Name:	Interlaminal Fixation Appliance
Device Product Code& Classification:	NQW- 888.3050 -Orthosis, Spine, Plate, Laminoplasty, Metal
SubstantiallyEquivalent Devices:	Synthes Arch™ Fixation System (K032534)

Device Description:

The screws, made of titanium alloy (6AL-4V ELI, per ASTM F-136), are available in variety of lengths and diameters in order to meet individual anatomical requirements.

Intended Use / Indications for Use:

Basis of Substantial Equivalence:

The Blackstone Laminoplasty Fixation System is substantially equivalent to the Synthes Arch™ Fixation System (K032534), which has been cleared by FDA for use as a laminoplasty fixation device.

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Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 2005

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

Re: K043338

Trade/Device Name: Blackstone ™ Laminoplasty Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: NQW Dated: January 28, 2005 Received: February 1, 2005

Dear Mr. Ciporkin:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave a row a ma have determined the device is substantially equivalent (for the indications ferenced above and har sure) to legally marketed predicate devices marketed in interstate for use starsa in the encrease. 976, the enactment date of the Medical Device Amendments. or to conniner of the 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 r ou may, morely mains of the Act include requirements for annual registration, listing of general oblines pro rise first 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 n your device 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 I hat FDA has made a determination that your device complies with other requirements of the Act or any Fedcral 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. 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.html.

Sincercly yours,

Sincerery yours,

Mark R. Milbers

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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Indications for Use

510(k) Number (if known):

Device Name: Blackstone™ Laminoplasty Fixation System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

338

Mark A Milhous

Peter Live. and Neure

Page 1 of

510(k) Number

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.