The AccuFit Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

Device Description

The AccuFit Lateral Plate System consists of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) rigid plates and bones screws of varying sizes and lengths. The plate attaches by means of screws to the lateral portion of the vertebral body of the thoracolumbar spine (T1-L5). The system includes instrumentation which assists in the surgical implantation of the devices. The Lateral Plate System implants and instruments are provided non-sterile. Thev require sterilization prior to use.

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for the AccuFit™ Lateral Plate System. It confirms that the device is substantially equivalent to legally marketed predicate devices.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

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

The document does not explicitly state "acceptance criteria" in a numerical or categorical format for specific performance metrics. Instead, it indicates that the device has undergone performance testing according to recognized ASTM standards and the results lead to a conclusion of substantial equivalence to predicate devices. This implies that the performance met the standards expected for such devices, which is to perform comparably to existing, legally marketed devices.

The performance testing mentioned are:

Acceptance Criteria (Implied)	Reported Device Performance
Static Axial Compression (per ASTM F1717 standards for equivalence)	Tested per ASTM F1717 (concluded substantially equivalent)
Static Torsion (per ASTM F1717 standards for equivalence)	Tested per ASTM F1717 (concluded substantially equivalent)
Dynamic Axial Compression (per ASTM F1717 standards for equivalence)	Tested per ASTM F1717 (concluded substantially equivalent)

The overarching acceptance criterion is achieving substantial equivalence to the predicate devices based on these mechanical tests.

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

The document mentions "Performance Testing Summary" which includes mechanical tests (Static Axial Compression, Static Torsion, Dynamic Axial Compression). These are typically benchtop mechanical tests performed on physical device samples, not human or patient data. The document does not specify the sample size (number of devices tested) for these mechanical tests. It also does not provide information about the country of origin or whether "data provenance" (as in, patient data) is relevant for these types of tests, as they are not clinical studies.

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 question is not applicable to the information provided. The "test set" here refers to the physical devices undergoing mechanical stress tests, not clinical data requiring expert human interpretation or ground truth establishment in a medical context.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations of medical data. The tests described are mechanical engineering tests, not clinical evaluations.

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

No, an MRMC comparative effectiveness study was not done. The device is a spinal plate system, a physical implant, not an AI-assisted diagnostic or imaging device.

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

No, a standalone (algorithm only) performance study was not done. The device is a physical spinal implant.

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

The "ground truth" for the mechanical performance tests would be the established scientific and engineering principles and the performance benchmarks set by the ASTM F1717 standard for spinal implants, as well as the performance characteristics of the predicate devices. There is no mention of "expert consensus, pathology, or outcomes data" being used as ground truth for these specific performance tests.

8. The sample size for the training set

This question is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The "training" for a mechanical device would involve engineering design, material selection, and manufacturing processes, not numerical data sets.

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

This question is not applicable for the reasons mentioned in point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

November 28, 2016

Precision Spine, Inc. % Mr. Kenneth C. Maxwell II Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K162211

Trade/Device Name: AccuFit™ Lateral Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 19, 2016 Received: October 20, 2016

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/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/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,

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 Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K162211

Device Name

AccuFit™ Lateral 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)
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)

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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."

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	510(K) SUMMARY
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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 Consulting719.291.6874
Date Summary was Prepared:	23 November 2016
Trade or Proprietary Name:	AccuFit™ Lateral Plate System
Common or Usual Name:	Appliance, Fixation, Spinal Intervertebral Body
Classification:	Class II per 21 CFR §888.3060
Product Code:	KWQ
Classification Panel:	Division of Orthopedic Devices

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

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510kNumber	Trade or Proprietary or Model Name	Manufacturer	Type
K133194	Black/Red Diamond Rattlesnake Lumbar PlatingSystem	Eminent Spine	Primary
K070922	Anterior Lumbar Plate System	Spinal USA	Additional
K020244	Thoracolumbar Spine Locking Plate (TSLP) System	Synthes	Additional

Table 5-1: Predicate Devices

TECHNOLOGICAL CHARACTERISTICS

The following technological characteristics are similar between the subject and predicate devices:

Indications for use
Implant materials
Principles of operation
. Sterility

Performance Testing Summary

The AccuFit Lateral Plate System has been tested in the following test modes:

Static Axial Compression per ASTM F1717
. Static Torsion per ASTM F1717
Dynamic Axial Compression per ASTM F1717

CONCLUSION

The subject AccuFit™ Lateral Plate System has similar intended uses, indications, technological characteristics, and principles of operation as the predicate devices. The differences raise no new safety or effectiveness questions. The overall technology characteristics and mechanical performance data lead to the conclusion that the AccuFit™ Lateral Plate System is substantially equivalent to the predicate devices.

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.