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.

The screws are available in multiple variations of fixed or variable angle. All lengths are provided in Ø4.0mm for primary use, or Ø4.5 mm rescue use. They have self-drilling and selftapping threads. The screws are type II anodized in varying colors depending on the length and diameter. The plate has a tear drop shaped anti-back out mechanism to prevent the screws from backing out. The variable screw has a 4.5 degree cone angulation (9.0 degree total sweep) within the plate. The use of the screws is optional and the intent is to add further fixation to stop implant dislocation/ migration.

AI/ML Overview

This document describes the Precision Spine Interspinous Plate System, a medical device. As such, acceptance criteria and performance data are related to the mechanical and biomechanical properties of the device, not to an AI/ML algorithm. Therefore, many of the requested categories in your prompt are not applicable.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria for biomechanical tests. Instead, it states that the device's strength was found to be "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the acceptance criteria are implicitly met by demonstrating substantial equivalence to the performance of predicate devices.

Acceptance Criteria Category	Reported Device Performance
Biomechanical Static Strength	Sufficient for intended use; substantially equivalent to predicate devices.
Biomechanical Dynamic Strength	Sufficient for intended use; substantially equivalent to predicate devices.

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

Sample Size: Not specified for the biomechanical tests.
Data Provenance: The tests were conducted internally by Precision Spine or a contracted lab, as it falls under "Performance Data" from the manufacturer. It is a prospective study design as the tests are conducted to demonstrate performance of the new device. The country of origin of the data is not specified, but the manufacturer is based in Pearl, MS, USA.

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

Not Applicable. This device is a physical implant, and its performance is evaluated through engineering tests (static and dynamic biomechanical testing), not through expert clinical interpretation or ground truth derived from expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set:

Not Applicable. As above, this is a physical device subject to engineering and biomechanical testing, not clinical adjudication of interpretations.

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 device is a physical implant, not an AI/ML algorithm.

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

Not Applicable. This device is a physical implant, not an AI/ML algorithm.

7. The type of ground truth used:

Engineering/Biomechanical Testing Standards: The "ground truth" for the device's performance is established by the results of standardized biomechanical static and dynamic testing. The implicit "ground truth" for substantial equivalence is the performance observed in predicate devices, which likely also underwent similar testing against established standards.

8. The sample size for the training set:

Not Applicable. This document describes a physical medical device, not an AI/ML model that requires a training set.

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

Not Applicable. This document describes a physical medical device, not an AI/ML model that requires a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is a stylized representation of human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

May 4, 2016

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

Precision Spine, Incorporated Mr. Michael C. Dawson Senior Director of Regulatory Affairs/Deputy General Counsel 2050 Executive Drive Pearl, Mississippi 39208

Re: K160568

Trade/Device Name: Precision Spine Interspinous Plate System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: February 29, 2016 Received: February 29, 2016

Dear Mr. Dawson:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: January 31, 2017See PRA Statement on last page.

Indications for Use

510(k) Number ( if known )	K160568
Device Name	Precision Spine Interspinous Plate System
Indications for Use (Describe)

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)
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CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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:

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FORM FDA 3881 (8/14)

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5.510(K) SUMMARY

Submitter's Name:	Precision Spine
Submitter's Address:	2050 Executive DrivePearl, MS 39208
Submitter's Telephone:	601-420-4244 ext. 128
Contact Person:	Michael C. Dawson
Date Summary was Prepared:	February 25, 2016
Trade or Proprietary Name:	Precision Spine Interspinous Plate System
Common or Usual Name:	Spinous Process Plate
Classification:	Class II per 21 CFR §888.3050 – Spinal interlaminalfixation orthosis
Product Code:	PEK
Classification Panel:	Orthopedic

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

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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 28-55mm.

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: Predicate Devices

510k Number	Trade or Proprietary or Model Name	Manufacturer	Predicate
K151863, K142378	Interspinous Plate System	Precision Spine	Primary
K093438, K112595	Coflex-F Implant System	Paradigm Spine, LLC

The subject device differs from the previously cleared version of the device in that optional screw fixation can be employed in addition to the spikes (which are unchanged) to attach the plate to the spinous process. The screws are available in fixed or variable angles in lengths of 10, 12, 14, and 16mm. All lengths are provided in Ø4.0mm diameter for primary use, or Ø4.5 mm rescue use. They have self-drilling and self-tapping threads. The screws are type II anodized in varving colors depending on the length and diameter. The plate has a tear drop shaped antiback out mechanism to prevent the screws from backing out. The variable screw has a 4.5 degree cone angulation (9.0 degree total sweep) within the plate. The use of the screws is optional and the intent is to add further fixation

PERFORMANCE DATA

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

Biomechanical static testing
. Biomechanical dynamic testing

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.