ALLEZ SPINE CROSS CONNECTORS by ALLEZ SPINE, LLC

The ALLEZ SPINE Cross Connectors are intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space in conjunction with the Allez Spine Laguna Polyaxial Pedicle Screw System. The ALLEZ SPINE Cross Connectors are intended for posterior, non-cervical fixation in conjunction with the Allez Spine Laguna Pedicle Screw System for the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e.fracture or dislocation); spinal stenosis; curvatures (i.e.scoliosis, kyphosis and/or lordosis); tumor pseudarthrosis; and/or failed previous fusion.

Device Description

The ALLEZ SPINE Cross Connectors are intended to help provide and Characteristics: correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space in conjunction with the Allez Spine Laguna Polyaxial Pedicle Screw System. The Laguna Spinal System consists of a variety of rods and screws. which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. The Allez Spine Laguna Polyaxial Pedicle Screw System (K050060) was cleared for marketing on May 4, 2005. The ALLEZ SPINE Cross Connectors are available in three sizes: small (37 mm), medium (50 mm) and large (80 mm) and are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3 or 5832-2.

AI/ML Overview

The provided text describes a 510(k) submission for the ALLEZ SPINE Cross Connectors. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through novel studies. Therefore, many of the requested elements are not applicable to a 510(k) summary focused on substantial equivalence.

Here's an analysis based on the provided text, highlighting where information is available and where it is not, or not relevant to this type of regulatory submission:

1. A table of acceptance criteria and the reported device performance

This information is not applicable in the context of a 510(k) summary that relies on substantial equivalence. A 510(k) submission primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, without necessarily establishing new, specific performance acceptance criteria beyond what is inherent in the predicate.

The document states: "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading." However, it does not provide specific numerical acceptance criteria or the detailed results of these biomechanical tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable for device performance testing in a 510(k) submission focused on substantial equivalence. The "test set" and "data provenance" as implied in the question are typically relevant for clinical studies, which are not detailed or required for this type of submission.

The biomechanical tests mentioned would have their own sample sizes for the laboratory setups, but these are not provided in this summary.

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)

This information is not applicable. The concept of "ground truth" and expert consensus is typically associated with clinical studies, especially those involving image analysis or diagnostic accuracy, which are not the focus of this 510(k) submission for a spinal fixation device.

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

This information is not applicable for the same reasons as point 3.

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

This information is not applicable. An MRMC study is relevant for evaluating the performance of AI-powered diagnostic or decision support systems. The ALLEZ SPINE Cross Connectors are mechanical implants, not AI-driven diagnostic tools.

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

This information is not applicable. This question is relevant for AI algorithms. The device in question is a mechanical implant.

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

This information is not applicable for the reasons mentioned in point 3. The primary "ground truth" in this context is the performance of the legally marketed predicate device, to which the new device is compared. For mechanical devices, performance is usually assessed through bench testing (e.g., fatigue, static loading) rather than clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set

This information is not applicable. The concept of a "training set" is relevant for machine learning algorithms. The ALLEZ SPINE Cross Connectors are a physical medical device.

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

This information is not applicable for the same reasons as point 8.

Summary

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510(k) Summary of Safety and Effectiveness

[in accordance with SMDA of 1990, 21 CFR 807.92(c)]

070460 Mr. Hartmut Loch, RAC Contact: Regulatory Consultant Official FDA Correspondent c/o Allez Spine, LLC. JUN 1 1 2007 2301 DuPont Drive, Suite 510 Irvine, CA 92612 ALLEZ SPINE Cross Connectors Trade name: Spinal Fixation Cross Connector Common name: Appliance, Fixation, Spinal Intervertebral - § 888.3060 (KWQ, KWP) Classification Orthosis, Spinal Pedicle Fixation - § 888.3070 (MNI, NKB) name: Orthosis, SpondylolisthesisSpinal Fixation - § 888.3070 (MNH) Class III, Orthopedic Device Panel 87 KWQ, MNI, KVVP, NKB & MNH Product Code: Device Description The ALLEZ SPINE Cross Connectors are intended to help provide and Characteristics: correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space in conjunction with the Allez Spine Laguna Polyaxial Pedicle Screw System. The Laguna Spinal System consists of a variety of rods and screws. which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. The Allez Spine Laguna Polyaxial Pedicle Screw System (K050060) was cleared for marketing on May 4, 2005. The ALLEZ SPINE Cross Connectors are available in three sizes: small (37 mm), medium (50 mm) and large (80 mm) and are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3 or 5832-2. Allez Spine ALLEZ SPINE Cross Connectors is substantially equivalent to Equivalence: the Blackstone Spinal Fixation System, Second-Generation Cross-Connector K003735 S/E May 8, 2001 The ALLEZ SPINE Cross Connectors are intended for posterior, non-Indications: cervical fixation in conjunction with the Allez Spine Laguna Pedicle Screw System for the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e.fracture or dislocation); spinal stenosis; curvatures (i.e.scoliosis, kyphosis and/or lordosis); tumor pseudarthrosis; and/or failed previous fusion. Biomechanical tests have been performed. The test results were equivalent Performance data: to other similar implants and are sufficient for in vivo loading.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Allez Spine, L.L.C. c/o Mr. Hartmut Loch Regulatory Consultant 2301 Dupont Drive, Suite 510 Irvine, California 92612

JUN 1 1 2007

Re: K070460

Trade/Device Name: Allez Spine Cross Connectors Regulation Number: 21 CFR §888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP and KWQ Dated: April 24, 2007 Received: April 27, 2007

Dear Mr. Loch:

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. Hartmut Loch

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 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,

Mark N. Melkerson

Mark N. Melkerson 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 ______________________________________________________________________________________________________________________________________________________________________

510(k) Number: K070460

Device Name(s):

ALLEZ SPINE Cross Connectors

Indications for Use:

The LAGUNA SPINAL SYSTEM is intended for posterior, non-cervical pedicle fixation for the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc (confirmed by history and radiographic studies); spondylolisthesis; connimed by filetery or dislocation), spinal stenosis; curvatures trauma (1.0.huotare failed previous fusion.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

(Optional format 1-2-96)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

ign-Ull

Division of General, Restorative, and Neurological Devices

510(k) Number L070466

Regulation Number and Section

N/A