The Unity LX™ Anterolateral Lumbar Plate Fixation System is indicated for use as an anteriorly or anterolaterally placed supplemental fixation device for the lumbar region of the spine (L1-L5) above the bifurcation of the vascular structures. When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include:

Degenerative disc disease (defined as back pain of discogenic origin with 1) degenerative disc confirmed by history and radiographic studies)

1. Pseudoarthrosis
1. Spondylolysis
1. Spondylolisthesis
1. Fracture
1. Neoplastic disease
1. Unsuccessful previous fusion surgery
1. Lordotic deformities of the spine
1. Idiopathic thoracolumbar or lumbar scoliosis

Deformities (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or mvelomenigocele
Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity

Device Description

The Unity LX Anterolateral Lumbar Fixation Plate consists of:

1. A base plate
1. A cover plate with locking setscrew
1. Bone screws

AI/ML Overview

The provided text describes a 510(k) summary for the Blackstone Medical's Unity LX™ Anterolateral Lumbar Plate Fixation System. This is a medical device application for a spinal fixation system, which is typically cleared based on substantial equivalence to existing predicate devices, rather than a study with acceptance criteria in the manner of an AI/ML device.

Therefore, the information requested for AI/ML device performance (like sample size, ground truth, expert qualifications, etc.) is not applicable to this 510(k) summary. The "acceptance criteria" for this device are met by demonstrating substantial equivalence to predicate devices through mechanical testing.

Here's an interpretation based on the provided document:

Acceptance Criteria and Device Performance (in the context of a 510(k) for a physical medical device)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance
Similar Intended Use: The device should have the same intended purpose as legally marketed predicate devices.	The Unity LX Anterolateral Lumbar Plate Fixation System is indicated for use as an anteriorly or anterolaterally placed supplemental fixation device for the lumbar region of the spine (L1-L5) to provide temporary stabilization until solid spinal fusion develops. This is the same intended use as the predicate devices: Blackstone Medical, Inc. Unity™ Anterior Lumbar Plate Fixation System (K043548) and Synthes Anterior Tension Band System (K022791).
Similar Indications for Use: The conditions for which the device is used should be similar to those of predicate devices.	The Unity LX system's specific indications include Degenerative disc disease, Pseudoarthrosis, Spondylolysis, Spondylolisthesis, Fracture, Neoplastic disease, Unsuccessful previous fusion surgery, Lordotic deformities of the spine, Idiopathic thoracolumbar or lumbar scoliosis, Deformities associated with deficient posterior elements, and Neuromuscular deformity associated with pelvic obliquity. These mirror the indications of the predicate devices, confirming similar indications for use.
Similar Technological Characteristics: The design, materials, and operating principles should be similar to predicate devices, with any differences addressed.	The Unity LX Anterolateral Lumbar Fixation Plate consists of a base plate, a cover plate with a locking setscrew, and bone screws. The document states that the Unity LX and its predicates have "similar technological characteristics and principles of operation." The only technological differences are "minor dimensional characteristics" which were addressed.
No New Issues of Safety or Effectiveness: Any minor differences in design or technology must not raise new questions of safety or effectiveness compared to predicate devices.	"These differences [minor dimensional characteristics] do not present any new issues of safety or effectiveness, therefore, the Unity LX Anterolateral Lumbar Fixation Plate is substantially equivalent to its predicate devices." This statement directly addresses this criterion.
Mechanical Testing Demonstration: For physical devices, mechanical testing is used to affirm that the device performs equivalently to predicate devices under relevant conditions.	"Mechanical testing of the Blackstone Medical Unity LX Anterolateral Lumbar Fixation Plate System was conducted which demonstrates that the system is substantially equivalent to predicate devices..." This confirms that mechanical testing was performed to support the claim of substantial equivalence.

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

Not Applicable: This is a physical medical device, not an AI/ML system. "Test set" in the context of AI/ML refers to data used to evaluate the algorithm's performance. For this device, "testing" refers to mechanical stress and durability tests on physical prototypes/samples of the device itself. The document does not specify the number of individual devices or components tested, nor details on data provenance (country of origin, retrospective/prospective) for mechanical testing, as these are not standard reporting requirements for 510(k) summaries of this type of device.

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

Not Applicable: There is no "ground truth" established by human experts in the AI/ML sense for this physical device. The "truth" is determined by established engineering standards and material science principles during mechanical testing.

4. Adjudication method for the test set

Not Applicable: No adjudication method is described as there is no "test set" in the AI/ML sense, nor a need for human expert consensus on interpretations. Mechanical test results are objective measurements against predefined engineering specifications.

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 physical spinal implant, not an AI/ML diagnostic or assistive tool. MRMC studies are designed for evaluating the performance of imaging modalities or interpretation systems by human readers, often with and without AI assistance. This concept does not apply to a spinal fixation plate.

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

Not Applicable: This refers to the performance of an AI algorithm. The device is a physical implant.

7. The type of ground truth used

Engineering Standards and Reference Data: For this type of device, the "ground truth" for evaluating performance during mechanical testing would be established engineering standards, material properties, and comparison data from predicate devices. The goal is to show the new device performs within acceptable parameters and is at least as safe and effective as existing legally marketed devices.

8. The sample size for the training set

Not Applicable: This is specific to AI/ML devices. There is no "training set" for a physical medical device.

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

Not Applicable: As there is no training set, this question is not relevant.

Summary

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510(k) SUMMARY

Blackstone Medical's Unity LX™ Anterolateral Lumbar Plate Fixation System

SUBMITTER: Blackstone Medical, Inc.

ADDRESS: 1211 Hamburg Turnpike Suite 300 Wayne, NJ 07470

PHONE: (973) 406-2847 FAX: (973) 633-6811

CONTACT PERSON: Martin G. Sprunck Senior Regulatory Affairs Specialist

TRADE NAME: Unity LX™ Anterolateral Lumbar Plate Fixation System

COMMON NAME: Spinal Fixation System

CLASSIFICATION NAME: Spinal Intervertebral Body Fixation Orthosis, 21 CFR 888.3060

PRODUCT CODE: KWQ - Appliance, Fixation, Spinal Intervertebral Body

Blackstone Medical, Inc. Unity™ Anterior Lumbar Plate PREDICATE DEVICES: Fixation System, (K043548 SE 6-14- 2005) Synthes Anterior Tension Band System (K022791 SE 11-13-2002)

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Intended Use / Indications for Use

Degenerative disc disease (defined as back pain of discogenic origin with 1) degenerative disc confirmed by history and radiographic studies)

1. Pseudoarthrosis
1. Spondylolysis
1. Spondylolisthesis
1. Fracture
1. Neoplastic disease
1. Unsuccessful previous fusion surgery
1. Lordotic deformities of the spine
1. Idiopathic thoracolumbar or lumbar scoliosis

Deformities (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or mvelomenigocele
Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity

Technological Characteristics

The Unity LX Anterolateral Lumbar Fixation Plate consists of:

1. A base plate
1. A cover plate with locking setscrew
1. Bone screws

Performance Data

Mechanical testing of the Blackstone Medical Unity LX Anterolateral Lumbar Fixation Plate System was conducted which demonstrates that the system is substantially equivalent to predicate devices that have the same intended use, similar indications, technological characteristics and principles of operation.

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Substantial Equivalence

The Unity LX Anterolateral System, the Unity Anterior System and the Synthes ATB System have the same intended use and similar indications, technological characteristics and principles of operation. The only technological differences between the Unity LX Anterolateral Lumbar Fixation Plate and its predicates are minor dimensional characteristics and have been addressed with side-by-side mechanical verification testing. These differences do not present any new issues of safety or effectiveness, therefore, the Unity LX Anterolateral Lumbar Fixation Plate is substantially equivalent to its predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and three human figures. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES U.S.A."

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 2006

Mr. Martin Sprunck Senior Regulatory Affairs Specialist Blackstone Medical, Inc. 1211 Hamburg Turnpike, Suite 300 Wayne, New Jersey 07470

Re: K061229

Trade/Device Name: Unity LX Anterolateral Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Codes: K WQ Dated: July 19, 2006 Received: July 20, 2006

Dear Mr. Sprunck:

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

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Page 2 - Mr. Martin Sprunck

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. 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barlie Brenno

Mark N. Melke 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 Statement

K061229 510(k) Number (if known):

Unity LX™ Anterolateral Lumbar Plate Fixation System Device Name:

Indications for Use:

The Unity LX™ Anterolateral Lumbar Plate Fixation System is indicated for use as an anteriorly or anterolaterally placed supplemental fixation device for the lumbar region of the bifurcation of the vascular structures. When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include:

Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by 1) history and radiographic studies)
Pseudoarthrosis 2)
1. Spondylolysis
Spondylolisthesis 4)
Fracture ર)
Neoplastic disease ()
Unsuccessful previous fusion surgery 7)
Lordotic deformities of the spine 8)
Idiopathic thoracolumbar or lumbar scoliosis 9)
Deformities (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that 10) resulting from laminectomy, spina bifida, or myelomenigocele
Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity || |

Preseription Use × (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)

Rattari Brelim

Division of Gene and Neurological Devices

Page 1 of 1

510(k) Number K001229

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.