The Interspinous Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. It is not intended for stand-alone use.

Device Description

The Precision Spine Interspinous Plate System consists of an ISP female plate and an ISP male plate for posterior fixation of the spine in order to achieve fusion. The ISP female plate and an ISP male plate are available in multiple sizes to accommodate various patient anatomies. The ISP female plate and an ISP male plate feature teeth to interface with the bone of the spinous processes. The ISP male plate is passed through the insert such that, in their final position, the ISP female plate and an ISP male plate surround the spinous processes on both sides, and fixation is achieved via compression of the two components onto the spinous processes.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Interspinous Plate System," a medical device. The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than a study with a test set, ground truth, or expert review typical for AI/software devices. Therefore, many of the requested categories are not applicable.

Here's an analysis of the provided text based on your prompt:

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

Acceptance Criteria (Test Mode)	Reported Device Performance (Conclusion)
Static axial compression	Sufficient for intended use, substantially equivalent to predicate devices.
Static torsion	Sufficient for intended use, substantially equivalent to predicate devices.
Dynamic axial compression	Sufficient for intended use, substantially equivalent to predicate devices.
Static axial pull-out	Sufficient for intended use, substantially equivalent to predicate devices.
Static plate dissociation	Sufficient for intended use, substantially equivalent to 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)

Sample Size: Not explicitly stated. The tests are for mechanical properties of the device, implying a small number of physical samples rather than patient data.
Data Provenance: Not applicable in the context of patient data. The testing appears to be laboratory-based mechanical testing.

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. This device is a mechanical implant, and its performance is evaluated through physical tests, not by human expert interpretation of data.

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

Not applicable. This device is a mechanical implant; human adjudication is not part of its performance evaluation.

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 not an AI or software device that involves human reader interpretation.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Ground Truth: The "ground truth" for the performance of this mechanical device is based on the established mechanical testing standards (e.g., ASTM F1717-13) and the comparative performance against legally marketed predicate devices. The "truth" is whether the device meets the mechanical strength and stability requirements for its intended use, as demonstrated through these physical tests.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/software device that requires a training set.

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

Not applicable. There is no training set for this type of device.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three stylized profiles facing to the right. The profiles are connected and flow together, creating a sense of unity and collaboration.

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

December 18, 2014

Precision Spine % Mr. Kenneth C. Maxwell II Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K142378

Trade/Device Name: Interspinous Plate System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: November 14, 2014 Received: November 20, 2014

Dear Mr. Maxwell:

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

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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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/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 Industry and Consumer Education 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 N. Melkerson -S

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

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug AdministrationIndications for Use	Expiration Date: January 31, 2017See PRA Statement on last page.
510(k) Number (if known)
K142378
Device Name
Interspinous Plate System
Indications for Use (Describe)
The Interspinous Plate System is a posterior, non-pedicle supplemental fixation device,intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. It is intended
for single level plate fixation/attachment to spinous process for the purpose of achievingsupplemental fusion in the following conditions: degenerative disc disease (defined as backpain of discogenic origin with degeneration of the disc confirmed by history and radiographic
studies), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. It is not intendedfor stand-alone use.







I ype of Use (Select one or both, as applicable)> Prescription Use (Part 21 CFR 801 Subpart D)
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)

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

This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration

Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

5.510(K) SUMMARY

Submitter's Name:	Precision Spine
Submitter's Address:	2050 Executive DrivePearl, MS 39208
Submitter's Telephone:	973-455-7150
Contact Person:	Kenneth C Maxwell IIEmpirical Testing Corp.904.392.7576
Date Summary was Prepared:	11 December 2014
Trade or Proprietary Name:	Precision Spine Interspinous Plate System
Common or Usual Name:	Spinous Process Plate
Classification:	Class II per 21 CFR §888.3050Spinal interlaminal fixation orthosis
Product Code:	PEK
Classification Panel:	87 Orthopedics

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

TECHNOLOGICAL CHARACTERISTICS

The Precision Spine Interspinous Plate System is manufactured from medical grade Titanium (Ti 6Al-4V) per ASTM F136. The implants are provided non-sterile with instructions for sterilization. The interspinous plates are designed in total heights of 35-55mm.

{5}------------------------------------------------

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

. Indications for Use
. Materials of manufacture
Structural support mechanism
Sterilization ●

Table 5-1: Primary Predicate Device

510k Number	Trade or Proprietary or Model Name	Manufacturer
K133363	InterBRIDGE Interspinous PosteriorFixation System	LDR Spine USA, Inc.

Table 5-2: Additional Predicate Devices

510k Number	Trade or Proprietary or Model Name	Manufacturer
K073278, K131238	Affix Spinous Process Plate System	NuVasive®
K123093	StabiLink™ MIS Spinal Fixation System	Southern Spine
K100354	PrimaLOK™ Interspinous Fusion System	OsteoMed
K122509	Spinous Process Fixation Plate	VertiFlex®

PERFORMANCE DATA

The Precision Spine Interspinous Plate System has been tested in the following test modes:

Static axial compression per ASTM F1717-13 ●
Static torsion per ASTM F1717-13 ●
Dynamic axial compression per ASTM F1717-13 ●
Static axial pull-out ●
Static plate dissociation

The results of this non-clinical testing show that the strength of the Interspinous Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Interspinous Plate System is substantially equivalent to the predicate device.

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.