Blackstone™ III° Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
a) degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) spondylolisthesis;
c) fracture:
d) spinal stenosis;
e) deformities (i.e., scoliosis, kyphosis, and/or lordosis);
f) tumor;
g) pseudarthrosis;
h) revision of previous surgery

Device Description

The Plate Washer addition for the Blackstone™ III° Anterior Cervical Plating System is a titanium alloy (6AL-4V ELI, per ASTM F136) device which is a non-sterile, single use component. When used with the Blackstone™ III° Anterior Cervical Plating System a surgeon can build an anterior cervical implant construct. The system's design is intended to stabilize the cervical spinal operative site during the fusion process of a bone graft in the disc space.

AI/ML Overview

The given text describes a medical device, the "Blackstone™ III° Anterior Cervical Plating System Plate Washer (System Addition)," and its premarket notification to the FDA. However, the provided document does not contain any information regarding acceptance criteria, device performance metrics, or a study proving that the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices (K012184 and K974885) for the purpose of FDA clearance. It describes the device, its intended use, and indicates that it is substantially equivalent to existing devices through its nature, implying that similar performance would be expected.

Therefore, I cannot provide the requested information in a table format or answer the specific questions about sample size, ground truth, expert qualifications, adjudication methods, or MRMC studies, as this data is entirely absent from the provided text.

The closest relevant information, regarding the basis of substantial equivalence, is stated in Section 1 of the provided text:

"The Plate Washer addition for the Blackstone™ III° Anterior Cervical Plating System by its very nature is substantially equivalent to the predicate devices listed below:
Blackstone™ III° Anterior Cervical Plating System (K012184)
Blackstone™ Anterior Cervical Plate System (K974885)
The FDA has cleared each of these devices, for anterior fixation to the cervical spine from C2 to C7."

This indicates that the device's equivalence is based on its similarity in design and intended use to already cleared devices, rather than a new study with specific performance criteria.

Summary

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KLLo do p

MAY 22 2002

Premarket Notification Blackstone Medical, Inc. Blackstone™ III° Anterior Cervical Plating System Plate Washer (System Addition)

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Name of Firm:	Blackstone Medical, Inc.90 Brookdale DriveSpringfield, MA 01104
510(k) Contact:	Alan LombardoDirector of Engineering
Trade Name:	BlackstoneTM III° Anterior Cervical Plating System
Common Name:	Cervical Plating Instrumentation
Device Product Code& Classification:	KWQ 888.3060 - Spinal Intervertebral Body FixationOrthosis

Substantially Equivalent Devices:

Blackstone™ III° Anterior Cervical Plating System (K012184) Blackstone™ Anterior Cervical Plate System (K974885)

Device Description:

Intended Use / Indications for Use:

Blackstone™ III9 Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

a) degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) spondylolisthesis;
c) fracture:
d) spinal stenosis;
e) deformities (i.e., scoliosis, kyphosis, and/or lordosis);
tumor; f)
g) pseudarthrosis;
h) revision of previous surgery

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Ka2060C P²/2

Premarket Notification Blackstone Medical, Inc. Blackstone™ III° Anterior Cervical Plating System Plate Washer (System Addition)

BASIS OF SUBSTANTIAL EQUIVALENCE:

The Plate Washer addition for the Blackstone™ III° Anterior Cervical Plating System by its very nature is substantially equivalent to the predicate devices listed below:

Blackstone™ III° Anterior Cervical Plating System (K012184) Blackstone™ Anterior Cervical Plate System (K974885)

The FDA has cleared each of these devices, for anterior fixation to the cervical spine from C2 to C7.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three profiles facing right, representing people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2 2002

Mr. Alan Lombardo Director of Engineering Blackstone Medical, Inc. 90 Brookdale Drive Springfield, Massachusetts 01104

Re: K020600

Trade/Device Name: Blackstone" III° Anterior Cervical Plating System (Plate Washer) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: February 21, 2002 Received: February 22, 2002

Dear Mr. Lombardo:

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. Alan Lombardo

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter will and a your e FDA finding of substantial equivalence of your device to a legally premaince notification " racesults 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 and 11 you declie specific arrison of tor in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the O ther general 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 vours,

R. Mark A. Milkerson

Celia 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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Premarket Notification Blackstone Medical, Inc. Blackstone™ III° Anterior Cervical Plating System Plate Washer (System Addition)

510(k) Number: K OLOLOGO

Device Name: Blackstone™ III° Anterior Cervical Plating System

Indications for Use:

Blackstone™ III° Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

a) degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
spondylolisthesis; b)

fracture; c)

spinal stenosis; d)
deformities (i.e., scoliosis, kyphosis, and/or lordosis); e)

f) tumor;

g) pseudarthrosis;
h) revision of previous surgery

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Millhuser

incinn Ci. Division of General, Restorative and Neurological Devices

510(k) Num.

<020600

Regulation Number and Section

N/A