The Hallmark™ Anterior Cervical Plate 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

Device Description

The Hallmark Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy (6AL-4V ELI, per ASTM F136) components that allow a 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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device modification, specifically the "Hallmark Anterior Cervical Plate System Modification - Five-Level Cervical Plates." This document primarily focuses on demonstrating substantial equivalence to predicate devices through mechanical evaluations, rather than reporting on a clinical study with an AI component or complex performance metrics.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI-powered device or a study with detailed performance metrics are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is substantial equivalence to predicate devices. This is demonstrated through mechanical evaluations. While the document doesn't explicitly state quantitative acceptance values for these mechanical tests, the underlying assumption is that the modified device's performance in these tests is comparable to or better than previously cleared devices.
Reported Device Performance: The document states:

"Mechanical evaluations were conducted to demonstrate that the Hallmark Anterior Cervical Plate System with the addition of the Five-Level Cervical Plates is substantially equivalent to predicate devices and systems that have been cleared by FDA for the purpose of building a spinal implant construct in the cervical spine."

No specific numerical performance data from these mechanical evaluations (e.g., fatigue strength, pull-out strength, stiffness values) are provided in the summary. The "performance" is implicitly deemed acceptable because it met the substantial equivalence standard.

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 device is a mechanical implant. The "test set" would refer to physical prototypes or manufactured units subjected to mechanical testing. The document does not specify the number of devices tested or the provenance of any data (as no human data is involved). These would typically be lab-based mechanical tests.

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. As a mechanical implant, there is no "ground truth" in the diagnostic sense or expert review of images. Mechanical testing results are objective measurements.

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

Not applicable. No expert adjudication of data is mentioned or relevant for this type of submission.

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, not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned.

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 consensus, pathology, outcomes data, etc)

For mechanical devices undergoing engineering testing, the "ground truth" would be the objective measurements from the tests themselves, compared against established standards (e.g., ASTM standards for material properties or biomechanical performance) and existing predicate device data. The document does not explicitly detail the specific standards or predicate data used for comparison.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no "training set."

Summary of Study Type:

The "study" conducted for this 510(k) submission was a series of mechanical evaluations (laboratory tests) designed to demonstrate that the modified Hallmark Anterior Cervical Plate System (with Five-Level Cervical Plates) performs equivalently to predicate devices under specified conditions. The objective was to show substantial equivalence for regulatory clearance, not to evaluate clinical performance or an AI algorithm.

Summary

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Premarket Notification Special 510(k) Blackstone Medical, Inc. Hallmark Anterior Cervical Plate System Modification

510(k) SUMMARY

Hallmark Anterior Cervical Plate System Modification - Five-Level Cervical Plates

Darla Chew, Regulatory Affairs Director

Sponsor:

..............................................................................................................................................................................

Blackstone Medical, Inc. 1211 Hamburg Turnpike Suite 300 Wayne, NJ 07470

DarlaChew@Orthofix.com

Regulatory Affairs Manger

1720 Bray Central Dr. McKinney, TX 75069

3004606875

469-742-8824 469-742-2256

Martin Sprunck

Orthofix, Inc.

2183449

MAY - 4 2010

Registration Number:

Contact Person: Telephone Number: Fax Number: Email:

Submitter:

Manufacturer:

Registration Number:

Contract Manufacturer:

Structure Medical, Inc. 2975 S. Horseshoe Drive Naples, Florida 34104

System Name:

Trade Name (Component): Hallmark Five-Level Cervical Plates

Anterior Cervical Plate System Common Name (System):

Product Code: KWQ - Appliance, Fixation, Spinal Intervertebral Body

Class II Device, 888.3060 - Spinal intervertebral body Regulatory Classification: fixation orthosis

Hallmark Anterior Cervical Plate System

Orthopedic Device Panel Review Panel:

Predicate Devices:

Blackstone Hallmark Anterior Cervical Plate System (K050892 SE 5/11/05) Life Spine Kinetic-SL Anterior Cervical Plate System (K073479 SE 1/9/28)

Hallmark Anterior Cervical Plate System Modification - 510(k) Summary

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Intended Use / Indications for Use

The Hallmark™ Anterior Cervical Plate 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

Technological Characteristics

Basis of Substantial Equivalence

Mechanical evaluations were conducted to demonstrate that the Hallmark Anterior Cervical Plate System with the addition of the Five-Level Cervical Plates is substantially equivalent to predicate devices and systems that have been cleared by FDA for the purpose of building a spinal implant construct in the cervical spine.

Hallmark Anterior Cervical Plate System Modification - 510(k) Summary

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY - 4 2010

Blackstone Medical, Inc. % Ms. Darla Chew Regulatory Affairs Director 1211 Hamburg Turnpike, Suite 300 Wayne, New Jersey 07470

Re: K100614

Trade/Device Name: Hallmark Five-Level Cervical Plates Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 27, 2010 Received: April 28, 2010

Dear Ms. Chew:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Darla Chew

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours. Mark Melke

Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):

System Name: Hallmark Anterior Cervical Plate System Device Name: Hallmark Five-Level Cervical Plates

Indications for Use:

The Hallmark 151 Anterior Cervical Plate 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
Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1___ of 1___

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K 100614 510(k) Number_

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.