When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone™ Posterior Cervical System is indicated for:
a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
b) spondylolisthesis
c) spinal stenosis
d) fracture/dislocation
e) atlantoaxial fracture with instability
f) occipito-cervical dislocation
g) revision of previous cervical spine surgery
h) tumors

The occipital bone screws are limited to occipital fixation only.

The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Songer Cable System to be used with the Blackstone™ Posterior Cervical System allows for wire/cable attachment to the posterior cervical spine.

Device Description

The Blackstone™ Posterior Cervical System is a titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The Blackstone™ Posterior Cervical System consists of an assortment of rods, set-screws, cross connectors, multi-axial screws, plates, bone screws and Songer Cables.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Blackstone™ Posterior Cervical System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the way one would for a diagnostic or AI-driven aid.

Therefore, many of the requested categories (e.g., acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

The primary "study" presented here is a comparison to a predicate device to establish substantial equivalence.

Here's a breakdown of the information that is available or can be inferred, and where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence: The device must be as safe and effective as a legally marketed predicate device.	The Blackstone™ Posterior Cervical System is deemed "substantially equivalent" to the DePuy AcroMed™, Summit (OTC) Spinal System (K002733).
Intended Use/Indications for Use: The device must align with the intended use of the predicate device.	The indications for use match those cleared for the predicate device: promoting fusion in the cervical spine and occipito-cervico-thoracic junction for conditions like degenerative disc disease, spondylolisthesis, spinal stenosis, fracture/dislocation, atlantoaxial fracture with instability, occipito-cervical dislocation, revision surgery, and tumors. Specific limitations for occipital bone screws and multi-axial screws are noted.
Device Description/Design: The device's components and materials should be comparable to the predicate.	The device is a "titanium alloy, multiple component system comprised of a variety of non-sterile, single use components" including rods, set-screws, cross connectors, multi-axial screws, plates, bone screws, and Songer Cables. This design allows it to function similarly to 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 submission is for a medical device (spinal implant) and relies on substantial equivalence to a predicate device, not on a clinical "test set" of patients or data in the context of a diagnostic or AI study. The "test" is a comparison of design, materials, and intended use against an already cleared device.

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. No "ground truth" establishment by external experts for a test set is described in this type of submission for a spinal implant. The FDA itself (specifically, the Division of General, Restorative and Neurological Devices) reviews the submission and determines substantial equivalence based on the provided documentation, which details the device's characteristics and comparison to the predicate.

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

Not Applicable. No adjudication method for a test set is described. The determination of substantial equivalence is made by the FDA reviewer(s) based on the submitted materials.

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 mechanical device (spinal implant), not a diagnostic tool or AI-assisted system. MRMC studies are irrelevant here.

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

Not Applicable. This is a mechanical device, not an algorithm.

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

Not Applicable. For this type of submission, the "ground truth" for demonstrating safety and effectiveness is largely established by the predicate device's prior FDA clearance and its demonstrated history of safe and effective use. The new device then needs to demonstrate that it is sufficiently similar in design, materials, intended use, and performance characteristics to the predicate.

8. The sample size for the training set:

Not Applicable. This is a mechanical device, not an AI or diagnostic system that requires a "training set."

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

Not Applicable. See point 8.

Summary

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JUN 1 2 2003

Premarket Notification Blackstone Medical, Inc. Blackstone™ Posterior Cervical System Confidential

1630197 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Name of Firm:	Blackstone Medical, Inc. 90 Brookdale Drive Springfield, MA 01104
510(k) Contact:	Contact Person: Dean Ciporkin Director of Regulatory Affairs & Quality Assurance
Trade Name:	Blackstone™ Posterior Cervical System
Common Name:	Rod and screw spinal instrumentation
Device Product Code& Classification:	MNI - 888.3070 - Pedicle Screw Spinal System KWP - 888.3050 - Spinal Interlaminal Fixation Orthosis
SubstantiallyEquivalent Devices:	DePuy AcroMed™, Summit (OTC) Spinal System (K002733

Device Description:

Intended Use / Indications for Use:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone™ Posterior Cervical System is indicated for:

a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
b) spondylolisthesis
c) spinal stenosis
d) fracture/dislocation
e) atlantoaxial fracture with instability
occipito-cervical dislocation f)
g) revision of previous cervical spine surgery
h) tumors

The occipital bone screws are limited to occipital fixation only.

Summary

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Premarket Notification Blackstone Medical, Inc. Blackstone™ Posterior Cervical System Confidential

The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Songer Cable System to be used with the Blackstone™ Posterior Cervical System allows for wire/cable attachment to the posterior cervical spine.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The Blackstone™ Posterior Thoracic System by its very nature is substantially equivalent to the DePuy AcroMed™, Summit (OTC) Spinal System (K002733) which has been cleared by FDA for posterior fixation applications to the occipito-cervico-thoracic junction (occiput -T3).

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized human profiles facing to the right, stacked on top of each other.

JUN 1 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030197

Trade Name: Blackstone™ Posterior Cervical System Regulation Number: 21 CFR 888.3050, 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWP, MNI Dated: May 14, 2003 Received: May 15, 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 vours.

Sincerely yours,

Mark N. Millman

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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030197

510(k) Number: 022220000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

Device Name: Blackstone™ Posterior Cervical System

Indications for Use:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic When Intended to promote fusion of the oce near ophis and overple of hos on

a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
b) spondylolisthesis
c) spinal stenosis
d) fracture/dislocation
e) atlantoaxial fracture with instability
occipito-cervical dislocation f)
g) revision of previous cervical spine surgery
h) tumors

The occipital bone screws are limited to occipital fixation only.

The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Songer Cable System to be used with the Blackstone™ Posterior Cervical System allows for wire/cable attachment to the posterior cervical spine.

Concurrence of CDRH, Office of device Evaluation

Signature

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number	K030197
---------------	---------

Prescription Use	OR	Over-The-Counter Use
------------------	----	----------------------

(Per 21 CFR801.109)

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.