The Blackstone Medical Inc. "Classic" Anterior Cervical Plate is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include: a) degenerative disc disease (ddd)* * 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) pseudoarthrosis; h) revision of previous surgery

Device Description

The Blackstone™ "Classic" Anterior Cervical Plate is a titanium alloy; multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build an anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices.

AI/ML Overview

This document describes the Blackstone™ "Classic" Anterior Cervical Plate, a medical device for spinal fixation. It's a 510(k) premarket notification, which means the manufacturer is asserting substantial equivalence to previously cleared devices rather than providing a study demonstrating the device meets specific acceptance criteria through novel performance data.

Therefore, the requested information elements related to performance studies, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not applicable or cannot be extracted from this document directly. This type of submission relies on bench testing and comparison to predicate devices to demonstrate safety and effectiveness.

Here's a breakdown based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Not Explicitly Stated in terms of performance metrics.	Not Applicable (N/A). The submission asserts substantial equivalence based on design, materials, and intended use to predicate devices already cleared by the FDA. Performance is implicitly accepted if it matches the predicate.

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

Not applicable. This document does not describe a clinical performance study with a test set of patient data, but rather a submission for substantial equivalence based on design and comparison to predicate devices. The "tests" would be bench testing.
Data Provenance: Not applicable.

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)

Not applicable. Ground truth establishment for a patient-based test set is not described as this is not a study requiring such data.

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

Not applicable. No test set requiring adjudication 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

Not applicable. This device is a physical implant, not an AI diagnostic tool, and therefore an MRMC study is irrelevant.

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

Not applicable. This device is a physical implant, not an algorithm.

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

Not applicable. No ground truth in the context of clinical performance data is discussed. The "ground truth" for this submission is that predicate devices are considered safe and effective, and this device is substantially equivalent.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary of the "Study" (Basis for Substantial Equivalence):

The "study" or basis for clearance is a substantial equivalence comparison to two predicate devices:

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

The document states: "The Blackstone™ "Classic" Anterior Cervical Plate System by its very nature is substantially equivalent to the Blackstone™ III° Anterior Cervical Plating System (K012184) and the Blackstone™ Anterior Cervical Plate System (K974885). The FDA has cleared this device, for anterior fixation to the cervical spine from C2 to C7."

This means the manufacturer demonstrated that the new device has the same intended use, similar technological characteristics (e.g., titanium alloy, screws, plates), and is as safe and effective as the previously cleared predicate devices. The "performance" is inferred to be adequate because it is substantially equivalent to devices already on the market and considered safe and effective by the FDA.

Summary

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K 0 2 2 9 6 5

MAR 2 8 2003

Premarket Notification Blackstone Medical, Inc. Blackstone ™ "Classic" Anterior Cervical Plate Confidential

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:	Blackstone™ "Classic" Anterior Cervical Plate
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:

The Blackstone Medical Inc. "Classic" Anterior Cervical Plate is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

a) degenerative disc disease (ddd)*

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) pseudoarthrosis;
h) revision of previous surgery

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Premarket Notification Blackstone Medical, Inc. Blackstone ™ "Classic" Anterior Cervical Plate Confidential

BASIS OF SUBSTANTIAL EQUIVALENCE:

The Blackstone™ "Classic" Anterior Cervical Plate System by its very nature is substantially equivalent to the Blackstone™ III° Anterior Cervical Plating System (K012184) and the Blackstone™ Anterior Cervical Plate System (K974885). The FDA has cleared this device, for anterior fixation to the cervical spine from C2 to C7.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing, ribbon-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2003

Mr. Alan Lombardo Vice President, Product Development Blackstone Medical Incorporated 90 Brookdale Drive Springfield, Massachusetts 01104

Re: K022965

Trade Name: Blackstone "Classic" Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: January 2, 2003 Received: January 3, 2003

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. Iisting 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) 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- . . 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,

sincerely, yours,

Mark McMullen

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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KO22965 510(k) Number:

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);
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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Melkerson

Division of General. Rest ative and Neurological Devices

510(k) Number_

2296

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.