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 Blackstone™ III° Anterior Cervical Plating System 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

The provided text is a 510(k) summary for the Blackstone™ III° Anterior Cervical Plating System, a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a clinical study in the way an AI/ML device would. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment is not applicable to this document.

However, I can extract the relevant information from the provided text as it pertains to medical device approval, focusing on the substantial equivalence argument, which served as the "proof" for this device's acceptance.

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device 510(k) submission, "acceptance criteria" and "reported device performance" are primarily demonstrated through substantial equivalence to previously cleared predicate devices, rather than through specific performance metrics from a comparative clinical trial. The "performance" is implicitly accepted as being equivalent to the predicate devices.

Acceptance Criteria Category	Specific Criteria (Implicitly Met by Substantial Equivalence)	Reported Device Performance (as demonstrated by substantial equivalence)
Intended Use	Anterior fixation to the cervical spine from C2 to C7 for specified indications.	Intended use is identical to predicate devices.
Indications for Use	a) degenerative disc disease; b) spondylolisthesis; c) fracture; d) spinal stenosis; e) deformities; f) tumor; g) pseudarthrosis; h) revision of previous surgery.	Indications for use are identical to predicate devices.
Technological Characteristics	Material (titanium alloy), multiple component system, non-sterile, single use, screws, plates, associated instrumentation, attachment to anterior aspect of vertebral body.	Technological characteristics are sufficiently similar to predicate devices to allow for substantial equivalence.
Safety and Effectiveness	Device is as safe and effective as predicate devices.	No new safety or effectiveness concerns raised beyond those of predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

This information is N/A. The 510(k) submission for this device does not involve a "test set" in the context of an AI/ML device or a clinical trial with a defined sample size for performance evaluation. Substantial equivalence is based on comparison of design, materials, intended use, and indications to existing predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is N/A. There was no "test set" or "ground truth" to be established by experts in the context of a performance study for this 510(k) submission. The FDA, through its review division, acts as the ultimate body to agree with the claim of substantial equivalence.

4. Adjudication Method for the Test Set

This information is N/A. No "test set" requiring adjudication methods (like 2+1, 3+1) was part of this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not done. This type of study is typically associated with evaluating AI/ML diagnostic tools or specific clinical comparisons, which is not the nature of this device's submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This device is a surgical implant (anterior cervical plating system), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not applicable.

7. The Type of Ground Truth Used

This information is N/A in the context of a ground truth for a performance study. For a 510(k) submission, the "ground truth" for acceptance is essentially the established safety and effectiveness profile of the predicate devices to which the new device claims substantial equivalence. The predicate devices' long-standing clinical use and prior FDA clearance serve as the basis for this "truth."

8. The Sample Size for the Training Set

This information is N/A. There is no "training set" for this type of medical device submission. The device is a physical implant, not an AI/ML model that requires training data.

9. How the Ground Truth for the Training Set Was Established

This information is N/A. Since there is no "training set," there is no process for establishing its ground truth.

Summary of the "Study" (Basis for Acceptance) for the Blackstone™ III° Anterior Cervical Plating System:

The "study" in this context is the comparison to predicate devices to demonstrate substantial equivalence, as required by the 510(k) pathway.

Basis of Substantial Equivalence: The Blackstone™ III° Anterior Cervical Plating System was deemed substantially equivalent to four predicate devices:
- Aesculap® ABC Cervical Plating System (K000486)
- Blackstone™ Anterior Cervical Plate System (K974885)
- Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System (K971883)
- Danek ZEPHIR™ Anterior Cervical Plate System (K994239)
Core Argument: The new device shares the same intended use, indications for use, and similar technological characteristics (titanium alloy, components, screws, plates, instrumentation for anterior fixation from C2 to C7) as the predicate devices, which the FDA had previously cleared for marketing. The implication is that because the new device is substantially equivalent to these already-approved devices, it is considered equally safe and effective.
Evidence Presented: The 510(k) submission would have detailed comparisons of materials, design, manufacturing processes, and possibly some bench testing data to confirm functional equivalence (e.g., mechanical strength, corrosion resistance), but these are not explicitly detailed in the provided text. The text primarily focuses on the claim of equivalence and lists the predicate devices.

Summary

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K02184 P1/2

JAN 3 0 2002

Premarket Notification Blackstone Medical, Inc. Blackstone™ III® Anterior Cervical Plating System 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™ III° Anterior Cervical Plating System
Common Name:	Cervical Plating Instrumentation
Device Product Code& Classification:	KWQ 888.3060 - Spinal Intervertebral Body FixationOrthosis

Substantially

Equivalent Devices:

Aesculap® ABC Cervical Plating System (K000486) Blackstone™ Anterior Cervical Plate System (K974885) Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System (K971883) Danek ZEPHIR™ Anterior Cervical Plate System (K994239)

Device Description:

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

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K012184 p$\frac{4}{2}$

Premarket Notification Blackstone Medical, Inc. Blackstone™ III° Anterior Cervical Plating System Confidential

f) tumor;

g) pseudarthrosis;

h) revision of previous surgery

BASIS OF SUBSTANTIAL EQUIVALENCE:

The Blackstone™ III° Anterior Cervical Plating System by its very nature is The "Diackstone" - " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "

Aesculap® ABC Cervical Plating System (K000486) Accemap® Insterior Cervical Plate System (K974885) Blackstone ... Anterior Corvical Prate Systems (2) ... ) ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (K971883) (K971605)
Danek ZEPHIR™ Anterior Cervical Plate System (K994239)

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

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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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2002

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

Re: K012184

Device/Trade Name: Blackstone™ IIIo Anterior Cervical Plating System Regulatory Number: 21 CFR 888.3060 Regulatory Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 10, 2001 Received: June 12, 2001

Dear Mr. Lombardo:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 – Mr. Alan Lombardo

This letter will allow you to begin marketing your device as described in your 510(k) prematet I mis letter will anow you to begin marketing your device to a legally marketed notification. The PDA incing of successification 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 II you desire specific advice to your actives), please contact the Office of Compliance at additionally 809.10 for m Vito diagnostions on the promotion and advertising of your device, (301) 394-4039. Addinomally, for questions on as p-4639. Also, please note the regulation prease contact the Office of Compilance as (21 CFR 807.97). Other general entitled, "Misoranuming of received to pearned from the Act may be obtained from the Division of Small information on your responsibilities ander the rise may of 30-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

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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Page 1 of 1

market Notification Blackstone Medical, Inc. Blackstone™ III° Anterior Cervical Plating System Confidential

510(k) Number: ΚΟΙ 2 184

Device Name: Blackstone™ III° Anterior Cervical Plating System

Indications for Use:

Blackstone™ III° Anterior Cervical Plating System is intended for anterior fixation to Diaenovical 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)
c) fracture;
d) spinal stenosis;
deformities (i.e., scoliosis, kyphosis, and/or lordosis); e)
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)

for Mark N. Mulkern

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

510(k) Number K012184

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.