InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.

Device Description

The InFill® interbody fusion device is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill® interbody fusion device is provided sterile, for single use only.

AI/ML Overview

The provided document is a 510(k) premarket notification from the FDA for the 'InFill® Interbody Fusion Devices'. It primarily discusses the substantial equivalence of the device to existing predicate devices, focusing on technical characteristics and intended use. The document does not contain information about acceptance criteria, device performance, or a study that proves the device meets specific performance criteria in the way a clinical trial or a detailed performance study for an AI/CADe device would.

Instead, the "Performance Data" section specifically states: "An FEA (Finite Element Analysis) was performed to assess the introduction of the new InFill device sizes into the existing product family. The worst case construct was identified and characterized. The results of the analysis demonstrated that no new mechanical testing is required. The analysis demonstrated the substantial equivalence of the new device sizes to the predicate device. The modified InFill® intervertebral body fusion device met all specified criteria and did not raise new safety or performance questions."

This means:

The study performed was a Finite Element Analysis (FEA), a computational modeling technique, not a human reader study or a standalone algorithm performance study with a test set and ground truth.
The purpose of the FEA was to compare the newly introduced sizes of the InFill device with the existing product family and predicate devices from a mechanical standpoint.
The "acceptance criteria" referred to are the unspecified "specified criteria" related to mechanical performance, which the FEA demonstrated the device met. The document does not explicitly list these criteria or their values.
There's no mention of sample sizes for test or training sets, data provenance, ground truth establishment, expert involvement, or adjudication methods, as these concepts are not applicable to the type of study (FEA) described.
No MRMC or standalone performance study in the context of an AI/CADe device was conducted or reported.

Therefore, I cannot populate the table or answer most of your specific questions because the provided document does not contain the type of AI/CADe performance study results you are asking for.

However, I can extract the relevant information regarding the "Performance Data" section.

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

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical performance suitable for interbody fusion devices.	"met all specified criteria"
Mechanical performance substantially equivalent to predicate devices.	"demonstrated the substantial equivalence of the new device sizes to the predicate device."
Does not raise new safety or performance questions.	"did not raise new safety or performance questions."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The study was a Finite Element Analysis (FEA), a computational simulation, not a study utilizing a "test set" of patient data.

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. No ground truth was established by experts for this FEA study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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 study was a Finite Element Analysis.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. The study was a Finite Element Analysis.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The FEA used computational models and simulations, not ground truth derived from clinical data.

8. The sample size for the training set
Not applicable. The study was a Finite Element Analysis.

9. How the ground truth for the training set was established
Not applicable. The study was a Finite Element Analysis.

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 a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized image of three human profiles facing to the right, stacked on top of each other.

July 14, 2015

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

Pinnacle Spine Group, LLC % Rebecca Pine Consultant 1601 Elm Street, Suite 300 Dallas, Texas 75201

Re: K151184

Trade/Device Name: Infill® Interbody Fusion Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: May 18, 2015 Received: May 19, 2015

Dear Ms. Pine:

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

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Page 2 - Ms. Rebecca Pine

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" (21CFR 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 vours.

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 SERVICESFood and Drug Administration
Indications for Use
	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)	K151184
Device Name	InFill® Interbody Fusion Devices
Indications for Use (Describe)	InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients.InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbodyfusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for thetreatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain ofdiscogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are tobe used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device isintended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbarspine. These implants may be implanted via a variety of open or minimally invasive approaches. These approachesinclude anterior, lateral and transforaminal.
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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This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT:	Pinnacle Spine Group, LLC
DATE PREPARED:	July 8, 2015
CONTACT PERSON:	Rebecca K Pine1601 Elm Street, Suite 300Dallas, TX 75201Phone: 760.809.5178Fax: 760.290.3216
TRADE NAME:	InFill® Interbody Fusion Devices
COMMON NAME:	Spinal Implant
CLASSIFICATION NAME:	Intervertebral Body Fusion Device
DEVICE CLASSIFICATION:	Class II, per 21 CFR 888.3080
PRODUCT CODE	MAX
PREDICATE DEVICES:	(primary) InFill® Interbody Fusion Device (K133721)ALIF STS Interbody Fusion Device (K112316)Interform Interbody Cage System (K131082)

Substantially Equivalent To:

The modified InFill® Interbody Fusion Device is substantially equivalent in intended use, principal of operation and technological characteristics to the InFill® Interbody Fusion Device cleared under premarket notification K133721 and the ALIF ST Interbody Fusion Device (K112316) and Interform Interbody Cage System (K131082).

Description of the Device Subject to Premarket Notification:

The InFill® interbody fusion device is provided sterile, for single use only.

Indication for Use:

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use at either one level or two contiguous levels in the lumbar spine. from L2 to S1. for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.

Technical Characteristics:

The modified InFill® intervertebral body fusion device has similar physical and technical characteristics to the predicate device. An additional length (26mm) has been added to the product family.

TechnicalCharacteristics	InFill® interbodyfusion devices,(60-ALIF)	InFill® interbodyfusion device (60-ALIF)(K133721)	ALIF STSInterbody FusionDevice(K112316)	InterformInterbody CageSystem(K131082)
Shape	Oval-shaped, bulletnose	Oval-shaped, bulletnose	Oval-shaped	Oval-shaped, bulletnose
Bone to implantsurface	Surface teeth	Surface teeth	Surface roughness	Surface teeth
Bone graftsupport feature	SAME	Centralfenestration	Centralfenestration	Centralfenestration
Primary implantmaterial	PEEK OPTIMALT1 ®	PEEK OPTIMALT1 ®	Titanium	PEEK
SurgicalApproach	SAME	Anterior	Anterior	ALIF
Lengths (mm)	25, 26, 28	25, 28	"small""medium""large"	24, 28, 30
Widths (mm)	32, 36, 39	36, 39	"small""medium""large"	30, 36, 39
Heights (mm)	8-18	10-18	8-17	10-20

Performance Data:

An FEA (Finite Element Analysis) was performed to assess the introduction of the new InFill device sizes into the existing product family. The worst case construct was identified and characterized. The results of the analysis demonstrated that no new mechanical testing is required. The analysis demonstrated the substantial equivalence of the new device sizes to the predicate device. The modified InFill® intervertebral body fusion device met all specified criteria and did not raise new safety or performance questions.

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Basis for Determination of Substantial Equivalence:

The Indication/Intended Use and the fundamental scientific technology of the modified device have not been changed and are the same as those described in the unmodified predicate device. The modified InFill® interbody fusion device is found to have a safety and effectiveness profile that is similar to the predicate device and is determined by Pinnacle Spine Group LLC, to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.