The Hallmark™ 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

Device Description

The Hallmarl™ 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, which assists in the surgical implantation of the devices.

AI/ML Overview

This document (K050892) is a 510(k) Premarket Notification for the Hallmark™ Anterior Cervical Plate System. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.

Crucially, this document is a 510(k) submission, which means it focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies or establishing independent acceptance criteria based on performance data.

Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics is not available in this type of regulatory submission. The 510(k) process generally relies on comparison to a device already on the market (the predicate) and does not typically require new clinical trials to prove safety and effectiveness from scratch if substantial equivalence can be demonstrated through design, material, and functional comparisons.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the document. The 510(k) process for this type of device usually relies on demonstrating that the new device meets the same design, material, and functional specifications as the predicate devices, rather than establishing new, quantifiable performance acceptance criteria.	Not reported in the document. Since specific acceptance criteria for performance are not outlined, there is no direct "reported device performance" against such criteria. The device is deemed substantially equivalent based on its comparison to predicate devices.

2. Sample size used for the test set and the data provenance

Not applicable / Not provided. This document does not describe a clinical study or a "test set" in the context of evaluating performance against specific acceptance criteria. The basis of substantial equivalence is a comparison to predicate devices, focusing on design, materials, and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable / Not provided. The substantial equivalence determination does not involve establishing ground truth from a test set of data by experts in the way a diagnostic AI study would.

4. Adjudication method for the test set

Not applicable / Not provided. No test set or expert 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

No. This is a medical device (spinal implant), not an AI diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

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

Not applicable / No. This is a physical medical implant, not an algorithm.

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

Not applicable / Not provided. The concept of "ground truth" for a spinal implant device in the context of a 510(k) submission is typically tied to demonstrating the device's ability to achieve its intended function (e.g., fixation) and safety profile in a way that is equivalent to already marketed devices. This is usually assessed through design analysis, material testing, and comparison with predicate devices, rather than establishing a new ground truth from clinical outcomes data for the purpose of a novel performance study.

8. The sample size for the training set

Not applicable / Not provided. This is not an AI/machine learning device that would require a training set.

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

Not applicable / Not provided. As above, no training set is involved.

Summary of the K050892 document regarding acceptance criteria and studies:

The Hallmark™ Anterior Cervical Plate System received 510(k) clearance based on its substantial equivalence to two predicate devices: the Blackstone™ Fusion Anterior Cervical Plate System (K030595) and the Blackstone™ III° Anterior Cervical Plating System (K012184).

The "study" in this context is the comparison of the new device's design, materials, manufacturing processes, and intended use to those of the predicate devices. The acceptance criteria for a 510(k) submission like this are implicitly that the new device is as safe and effective as the predicate device(s) and does not raise new questions of safety and effectiveness. This is demonstrated by showing that the new device shares the same fundamental scientific technology, has similar indications for use, and meets similar performance standards (often through bench testing or engineering analysis) as the predicates. Specific quantifiable performance metrics or a clinical study with a test set, ground truth, or expert adjudication are generally not required for a typical 510(k) for this type of implantable device.

Summary

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K050892

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

MAY 1 1 2005

510(K) SUMMARY

Name of Firm:	Blackstone Medical, Inc.90 Brookdale DriveSpringfield, MA 01104
510(k) Contact:	Dean E. CiporkinDirector, Regulatory Affairs and Quality Assurance
Trade Name:	Hallmark™ Anterior Cervical Plate System
Common Name:	Cervical Plating Instrumentation
Device Product Code& Classification:	KWQ - 888.3060 - Spinal Intervertebral Body Fixation Orthosis
SubstantiallyEquivalent Devices:	Blackstone™ Fusion Anterior Cervical Plate System (K030595)Blackstone™ III° Anterior Cervical Plating System (K012184)

Device Description:

The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices.

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

Intended Use / Indications for Use:

The Hallmark™ 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 Hallmark™ Anterior Cervical Plating System is substantially equivalent to the predicate devices, the Blackstone™ III° Anterior Cervical Plating System (K012184) and the Blackstone™ Fusion Anterior Cervical Plate System (K030595), which have been cleared by FDA for anterior fixation to the cervical spine.

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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 eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 11 2005

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

Re: K050892

Trade/Device Name: HALLMARK Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 7, 2005 Received: April 11, 2005

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.

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Page 2 – Mr. Dean E. Ciporkin

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc advised that I DTT o letting that your device complies with other requirements of the Act that I DA has made a aond regulations administered by other Federal agencies. You must or any i-cuclar statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY art 6077, and if your rail on (21 CFR Part 820); and if applicable, the electronic form in the quality of the (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation oonal of problem marketing your device as described in your Section 510(k) I mis letter will anow your to organismal equivalence of your device of your device to a legally prematics notification. The 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 If you desire specific aarroliance at (240) 276-0120. Also, please note the regulation entitled, Connact the Office of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micrinational 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/industry/support/index.html.

Sincerely yours,

Stpk Rhodes

Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

KOSO92 510(k) Number (if known): __

Device Name: Hallmark™ Anterior Cervical Plate System

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 Degonerative disc confirmed by patient history and radiographic studies);
.
b) Spondylolisthesis;
c) Fracture;
d) Spinal stenosis;
a) Opinarities (i.e., scoliosis, kyphosis, and/or lordosis)
Tumor; f)
g) Pseudoarthrosis;
h) Revision of previous surgery

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) nontrepode of CBRH, Office of Device Evaluation (ODE) Division Sign-Off) Division of General, Restorative. Page 1 of ____________________________________________________________________________________________________________________________________________________________________ and Neurological Devices

510(k) Number K050892

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.