(58 days)
The Blackstone™ Fusion 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) Pseudoarthrosis;
h) Revision of previous surgery
The Blackstone Fusion 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.
This excerpt is not focused on the acceptance criteria or a study proving device performance as typically understood for AI/ML or diagnostic devices. Instead, it's a 510(k) premarket notification for a traditional medical device: the Blackstone™ Fusion Anterior Cervical Plating System.
The document primarily establishes substantial equivalence to previously cleared predicate devices, which is the regulatory pathway for this type of device. Therefore, the questions related to AI/ML device performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable in this context.
Here's how to address the provided information based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not specify formal "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy that would be found for a diagnostic or AI device. For this type of device (a spinal plating system), the "criteria" for market clearance are primarily established through demonstrating substantial equivalence to pre-existing, legally marketed devices.
The "reported device performance" is not quantified in the way an AI/ML device's performance would be. Instead, it relies on the established safety and effectiveness of the predicate devices.
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 is a traditional mechanical implant, not an AI/ML or diagnostic device that requires a test set of data for performance evaluation in the described manner.
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. There is no "ground truth" establishment in this context as there is no diagnostic output or classification being generated.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's clearance is its physical and material properties, design, and intended use being substantially equivalent to legally marketed predicate devices, which have already demonstrated safety and effectiveness through their own regulatory pathways (e.g., clinical experience, previous testing, etc.).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
{0}------------------------------------------------
Premarket Novification 510(k) Blackstone Medical, Inc. Blackstone™ Fusion Anterior Cervica! Plating System Confidential
APR 2 4 2003
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| 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™ Fusion Anterior Cervical Plating System |
| Common Name: | Cervical Plating Instrumentation |
| Device Product Code& Classification: | KWQ - 888.3060 - Spinal Intervertebral Body FixationOrthosis |
| SubstantiallyEquivalent Devices: | Blackstone™ III° Anterior Cervical Plating System (K012184)Aesculap® ABC Cervical Plating System (K000486)Synthes Spine Small Stature Anterior Cervical VertebraePlate System (K971883)Danek ZEPHIR™ Anterior Cervical Plate System (K994239) |
Device Description:
The Blackstone Fusion 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.
{1}------------------------------------------------
Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone™ Fusion Anterior Cervical Plating System Confidential
Intended Use / Indications for Use:
The Blackstone Fusion 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) Pseudoarthrosis;
- h) Revision of previous surgery
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Blackstone Fusion Anterior Cervical Plating System is, by its very nature, substantially equivalent to the predicate devices listed below:
Blackstone™ III° Anterior Cervical Plating System (K012184) Aesculap® ABC Cervical Plating System (K000486) Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System (K971883) 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.
{2}------------------------------------------------
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 is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 2003
Mr. Dean E. Ciporkin Director, Regulatory Affairs and Quality Assurance Blackstone Medical, Incorporated 90 Brookdale Drive Springfield, Massachusetts 01104
Re: K030595
Trade Name: Blackstone™Fusion Anterior Cervical Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWO Dated: February 24, 2003 Received: February 25, 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
{3}------------------------------------------------
Page 2 - Mr. Dean E. Ciporkin
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
Mark N Milliman
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
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): K030595
Device Name:
Blackstone Fusion Anterior Cervical Platin System
Indications For Use:
The Blackstone™ Fusion Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from the C2 to C7. The specific indications include:
- degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed a) by patient history and radiographic studies);
- b) spondylolisthesis;
- c) fracture;
- spinal stenosis; ರ)
- deformities (i.e., scoliosis, kyphosis, and/or lordosis); e)
- () tumor:
- pseudoarthrosis; g)
- revision of previous surgery h)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Mark N. Milliman
Restorative
510(k) Number: __K030595
(Optional Format 3-10-98)
§ 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.