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 and lateral.

Device Description

The InFill® Interbody Fusion Device product family consists of radiolucent implantable devices manufactured from PEEK-OPTIMA® LT1 or PEEK-OPTIMA® HA Enhanced and contains tantalum (marker material). The implants are available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill® Interbody Fusion Device is provided sterile.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "InFill® Interbody Fusion Device." This submission aims to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, and as such, it does not involve a study to prove the device meets acceptance criteria in the typical sense of a clinical trial or AI/software validation.

Instead, the "acceptance criteria" here are based on the device's technological characteristics and mechanical performance data meeting established industry standards (ASTM) and being comparable to legally marketed predicate devices.

Let's break down the information requested in your prompt based on the provided document:

1. Table of acceptance criteria and the reported device performance

There isn't a direct "acceptance criteria" table with numerical performance targets in the context of an AI/software validation study. Instead, the acceptance is based on the device meeting established ASTM standards and being substantially equivalent to predicates.

Acceptance Criteria (Implicit from 510(k)	Reported Device Performance
Technological Characteristics:	"The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness."
- Indications for use identical to predicates	Identical to predicates
- Implant Materials conform to ASTM standards	Made from PEEK-OPTIMA® LT1 or PEEK-OPTIMA® HA Enhanced and contains tantalum (marker material) - materials conform to ASTM standards.
- Structural support mechanism identical to predicates	Identical to predicates
- Principles of operation identical to predicates	Identical to predicates
Mechanical Performance (Worst Case Device: InFill® V2 Lateral):	"The results of this non-clinical testing show that the strength of the InFill® V2 Lateral Device is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
- Static axial compression per ASTM F2077-14	Tested, results indicate sufficiency for intended use and substantial equivalence.
- Static subsidence per ASTM F2267-04	Tested, results indicate sufficiency for intended use and substantial equivalence.
- Static expulsion per ASTM F-04.25.02.02	Tested, results indicate sufficiency for intended use and substantial equivalence.
- Dynamic axial compression per ASTM F2077-14	Tested, results indicate sufficiency for intended use and substantial equivalence.

Note: The document explicitly states, "the minor differences do not raise any new issues of safety and effectiveness" and "The overall technology characteristics and mechanical performance data lead to the conclusion that the InFill® Interbody Fusion Device is substantially equivalent to the predicate device." This is the ultimate "acceptance" for a 510(k).

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

Sample Size for Test Set: Not applicable in the context of a clinical study with patients. The "test set" here refers to the physical devices undergoing mechanical testing. The document states "The InFill® V2 Lateral Device (worst case device) has been tested..." This implies a sample size of physical devices tested to ASTM standards. The exact number of physical devices tested for each mechanical test is not specified in this summary, but these are typically small sample sizes for engineering verification (e.g., n=5 or n=10 devices per test).
Data Provenance: The data comes from non-clinical mechanical testing performed on the physical device. The location of the testing is not specified but would typically be an accredited testing lab. This is a form of prospective testing of the manufactured devices, not retrospective clinical data.

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

Not applicable. This is a mechanical device submission, not an AI or diagnostic imaging device requiring expert ground truth for interpretation of images or patient data. The "ground truth" for mechanical testing is established by the ASTM standards themselves and the objective measurements of the device's physical properties under various loads.

4. Adjudication method for the test set

Not applicable. There is no human interpretation or adjudication involved in the mechanical testing of physical properties. The results are quantitative measurements against defined standards.

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 an implantable interbody fusion device, not an AI or software-as-a-medical-device (SaMD) for diagnostic assistance. Therefore, no MRMC study or AI-assisted human reader performance was conducted or reported.

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

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

7. The type of ground truth used

The "ground truth" for this submission is established by validated ASTM international standards for the mechanical testing of intervertebral body fusion devices (e.g., F2077, F2267). These standards define the acceptable range of mechanical performance for these types of implants. The comparison is also made against the mechanical performance of predicate devices already on the market.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/machine learning device.

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

Not applicable. As there is no training set, there is no ground truth established for one.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 14, 2017

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

Re: K172349

Trade/Device Name: InFill® Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 13, 2017 Received: November 15, 2017

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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	Form Approved: OMB No. 0910-0120
Food and Drug Administration		Expiration Date: January 31, 2017
	Indications for Use	See PRA Statement on last page.
510(k) Number (if known)	K172349
Device Name	InFill® Interbody Fusion Device
Indications for Use (Describe)
InFill® interbody fusion device is indicated for intervertebral body fusion of the spine inskeletally mature patients. InFill® interbody fusion device is designed for use with autogenousbone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either onelevel or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment ofdegenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as backpain of discogenic origin with degeneration of the disc confirmed by history and radiographicstudies. 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 supplementalinternal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. Theseimplants may be implanted via a variety of open or minimally invasive approaches. Theseapproaches include anterior and lateral.
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)

FORM FDA 3881 (9/13)	Page 1 of 2	PSC Publishing Services (301) 443-6740 EF

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Submitter's Name:	Pinnacle Spine Group, LLC
Submitter's Address:	2921 Canton St.Dallas TX, 75226
Submitter's Telephone:	214.466.1428
Contact Person:	Kenneth C. Maxwell IIEmpirical Testing Corp.719.291.6874kmaxwell@empiricalconsulting.com
Date Summary was Prepared:	13 November 2017
Trade or Proprietary Name:	InFill® Interbody Fusion Device
Common or Usual Name:	Intervertebral Fusion Device With Bone Graft, Lumbar
Classification:	Class II per 21 CFR §888.3080 Device Classification
Product Code:	MAX
Classification Panel:	Division of Orthopedic Devices

510(K) SUMMARY

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

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TECHNOLOGICAL CHARACTERISTICS

The InFill® V2 Lateral Device and InFill Anatomic ALIF are made from material that conforms to ASTM standards. 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
Implants Materials
Structural support mechanism
Principles of operation ●

Table 5-1: Predicate Devices

510kNumber	Trade or Proprietary or ModelName	Manufacturer	Predicate Type
K152259	InFill® V2 Lateral	Pinnacle Spine Group	Primary
K150206	InFill® Interbody Fusion Device	Pinnacle Spine Group	Additional
K133721	InFill® Interbody Fusion Device	Pinnacle Spine Group	Additional
K150321	EVOS Lumbar Interbody System	Cutting Edge Spine	Additional

PERFORMANCE DATA

The InFill® V2 Lateral Device (worst case device) has been tested in the following test modes:

Static axial compression per ASTM F2077-14 .
Static subsidence per ASTM F2267-04 ●
Static expulsion per ASTM F-04.25.02.02 ●
Dynamic axial compression per ASTM F2077-14 .

The results of this non-clinical testing show that the strength of the InFill® V2 Lateral Device 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 InFill® Interbody Fusion Device is substantially equivalent to the predicate device.

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.