The LESPlasty™ Posterior Cervical Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The system is used to hold or buttress the allograft or autograft material in place in order to prevent the allograft or autograft material from expelling or impinging the spinal cord.

Device Description

The SpineFrontier® LESPlasty™ System consists of various sized plates and screws designed for a systematic posterior approach to cervical laminoplasty procedures. The plates have screw holes which allow for attachment to the lamina and the lateral mass. The system is provided with primary and recovery bone screws for fixation. Plates and screws are fabricated from medical grade titanium alloy (ASTM F136).

AI/ML Overview

The provided text describes the SpineFrontier® LESPlasty™ Posterior Cervical Laminoplasty System, a medical device. The information details the device's technical characteristics, indications for use, and performance data from non-clinical testing. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML algorithm or a multi-reader multi-case (MRMC) comparative effectiveness study.

The document discusses the substantial equivalence of the LESPlasty™ System to predicate devices based on mechanical performance tests, which are standard for implantable devices, not AI/ML systems. Therefore, I cannot fulfill all parts of your request as it pertains to AI/ML specific criteria.

Here's a breakdown of the available information, noting the absence of AI/ML specific details:

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

The document describes non-clinical mechanical testing, but does not explicitly state numerical acceptance criteria in the format of a table with pass/fail thresholds. Instead, it concludes the device's strength is sufficient and substantially equivalent to predicate devices.

Test Mode	Reported Device Performance	Acceptance Criteria (Not explicitly stated as numerical thresholds)
Static Axial Pullout	Sufficient for intended use; Substantially equivalent to predicate devices.	Strength comparable to legally marketed predicate devices.
Static Four-Point Bending	Sufficient for intended use; Substantially equivalent to predicate devices.	Strength comparable to legally marketed predicate devices.
Dynamic Four-Point Bending	Sufficient for intended use; Substantially equivalent to predicate devices.	Strength comparable to legally marketed 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):

This information is not provided in the document. The testing described is mechanical (material and device component testing), not related to clinical data or patient samples. The document focuses on the device itself rather than data used to train or evaluate an AI/ML model for diagnostic or predictive purposes.

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 and not provided in the document. The "ground truth" for the mechanical tests would be the physical properties and performance metrics measured according to specified ASTM standards. There is no mention of human experts establishing ground truth in the context of diagnostic interpretations or classifications for this type of device submission.

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

This information is not applicable and not provided. Adjudication methods are relevant for human interpretation tasks, especially in clinical studies or expert review of AI outputs. This document describes mechanical engineering tests.

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 and not provided. An MRMC study involves human readers evaluating cases, often to assess the impact of an AI tool. This submission is for an implantable medical device, not an AI/ML system.

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

This information is not applicable and not provided. This document pertains to the physical performance of a medical implant, not a standalone algorithm.

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

For the mechanical tests, the "ground truth" would be the direct measurements of material strength, fatigue resistance, and other physical properties as defined by the ASTM standards (ASTM F-543 for static axial pullout and ASTM F-2193 for static and dynamic four-point bending). There is no "expert consensus," "pathology," or "outcomes data" ground truth in this context.

8. The sample size for the training set:

This information is not applicable and not provided. There is no mention of a training set as this is not an AI/ML device.

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

This information is not applicable and not provided. There is no training set for this type of device.

In summary, the provided document is a 510(k) summary for a spinal implant system, focusing on its mechanical equivalency to predicate devices. It does not contain any information related to AI/ML performance, clinical evaluation with human readers, or ground truth establishment in the context of an algorithm.

Summary

{0}------------------------------------------------

Submitter's Name:	SpineFrontier, Inc.
Submitter's Address:	500 Cummings Center, Suite 3500Beverly, MA 01915, U.S.A.
Submitter's Telephone:	978.232.3990 x116
Contact Person:	Paul L. SpeidelRegulatory Affairs ManagerTel: 978.279.9272Fax: 978.232.3991
Prepared by:	Meredith L. May, MSEmpirical Testing Corp.719.337.7579
Date Summary wasPrepared:	August 30th, 2013
Trade or Proprietary Name:	SpineFrontier® LESPlasty™ Posterior CervicalLaminoplasty System
Common or Usual Name:	Orthosis, Spine, Plate, Laminoplasty, Metal
Classification:	Class II per 21 CFR §888.3050
Product Code:	NQW
Classification Panel:	Orthopedic and Rehabilitation Devices Panel
Predicate Devices:	Synthes Arch™ Fixation System (AFS) (K032534)MedtronicCenterpiece™ Plate Fixation System(K050082)

5.510(K) SUMMARY

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The LESPlasty™ Posterior Cervical Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The system is used to

SpineFrontier® LESPlasty™ Posterior Cervical Laminoplasty System

{1}------------------------------------------------

hold or buttress the allograft or autograft material in place in order to prevent the allograft or autograft material from expelling or impinging the spinal cord.

The indication for use for the SpineFrontier® LESPlasty™ System is similar to that of the Synthes Arch™ Fixation System (AFS) (K032534) and MedtronicCenterpiece™ Plate Fixation System (K050082).

TECHNICAL CHARACTERISTICS

All components are fabricated from medical grade titanium alloy (ASTM F136). Titanium alloys have a successful history of use in the spinal implant industry and use of it in these devices does not introduce any previously unaccepted patient risks. The Synthes Arch™ Fixation System (AFS) (K032534) and MedtronicCenterpiece™ Plate Fixation System (K050082) are manufactured from titanium or titanium alloy.

PERFORMANCE DATA

The LESPlasty™ Posterior Cervical Laminoplasty System has been tested in the following test modes:

. Static Axial Pullout (ASTM F-543)
Static Four-Point Bending (ASTM F-2193) .
Dynamic Four-Point Bending (ASTM F-2193) o

The results of this non-clinical testing show that the strength of the LESPlasty™ System is sufficient for its intended use and legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the LESPlastyTM System is substantially equivalent to the predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Contro! Center - WO66-G609 Silver Spring, MD 20993-0002

SpineFrontier, Incorporated . % Empirical Testing Corporation Meredith May, MS, RAC 4628 Northpark Drive Colorado Springs, Colorado 80918 November 26, 2013

Re: K132740

Trade/Device Name: SpineFrontier® LESPlasty™ Posterior Cervical Laminoplasty System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NQW Dated: November 21, 2013 Received: November 25, 2013

Dear Ms. May:

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 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

{3}------------------------------------------------

Page 2 - Mr. Justin Eggleton

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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/McdicalDevices/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/McdicalDevices/Safety/ReportalProblem/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 yours,

Mark Nielkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: December 31, 2013See PRA Statement on last page.
Indications for Use

510(k) Number (if known)	K132740
DEVICE NAME
SpineFrontier® LESPlasty™ Posterior Cervical Laminoplasty SystemIndications for Use (Describe)
The LESPlasty™ Posterior Cervical Laminoplasty System is intended for use in the lower cervical and upperthoracic spine (C3 to T3) in laminoplasty procedures. The system is used to hold or buttress the allograft orautograft material in place in order to prevent the allograft or autograft material from expelling or impingingthe spinal cord.

TYPE OF USE (SELECT ONE OR BOTH, AS APPLICABLE)
✔ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Ronald P. Jean -S

SpineFrontier® LESPlasty™ Posterior Cervical Laminoplasty System

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.