The InFront Lumbar Interbody Fusion System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be use with autograft bone.

Device Description

The InFront Lumbar Interbody Fusion System consists of cages of various lengths, widths and heights, which can be inserted between two lumbar or lumbrosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The InFront Lumbar Interbody Fusion System is to be used with supplemental fixation. The leading edge consists of bullet nose. The cephalad/caudal opening is large to allow for bone through growth. In addition, there are 2 large holes on each side to facilitate bone and to aid in visualizing the fusion mass. The teeth are slanted away from the direction of insertion of the implant to minimize implant migration. The superior and inferior surfaces are convex to better fit the vertebral endplates.

The device is offered in 3 general configurations, specifically shaped for posterior, transforaminal or lateral surgical approaches. The posterior approach configuration is available in 508 possible sizes, with lengths from 22mm, widths from 8mm to11mm, heights from 7mm to 16mm and lordosis angles of 0°, 4° and 8°. The transforaminal approach configuration is available in 720 possible sizes, with lengths from 22mm to 36mm, widths from 9mm to 12mm, heights from 7mm to 18mm and lordosis angles of 0°, 4° and 8°. The lateral approach configuration is available in 330 possible sizes, with lengths from 40mm to 60mm, widths from 18mm to 22mm, heights from 8mm to 18mm and lordosis angles of 0°, 4° and 8°.

The InFront Lumbar Interbody Fusion devices are made from PEEK (Polyetheretherketone) per ASTM F2026, with radiographic markers made from tantalum per ASTM F560.

AI/ML Overview

This document is a 510(k) Pre-Market Notification from the FDA for the InFront Lumbar Interbody Fusion System. It does not describe a study involving an AI/Machine Learning device or any associated acceptance criteria, human reader studies, or ground truth establishment based on expert consensus, pathology, or outcomes data.

Instead, this document is for a traditional medical device (an intervertebral body fusion device) and focuses on demonstrating its substantial equivalence to currently marketed predicate devices. The "studies" mentioned are non-clinical tests designed to assess the mechanical properties of the device to ensure it meets performance standards typical for such implants.

Therefore, I cannot fulfill your request for the specific AI/Machine Learning-related information, as it is not present in the provided text.

Here's a breakdown of what is available regarding the device's assessment:

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

This document does not provide a table with quantitative acceptance criteria and reported device performance from a clinical study or AI performance evaluation. Instead, it states that the device was tested as described in "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" with specific ASTM standards. The conclusion is that the device is "substantially equivalent" to predicate devices, implying it met the necessary performance standards without explicitly listing them here.

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

Not applicable in the context of an AI/ML device. The "test set" here refers to the physical devices subjected to non-clinical mechanical testing, not a dataset of patient information. No patient data provenance is mentioned.

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

Not applicable. Ground truth as typically defined for AI/ML studies (e.g., expert labels, pathology results) is not relevant to this type of device submission. The "truth" in this context is adherence to engineering standards and substantial equivalence to existing devices.

4. Adjudication method for the test set:

Not applicable. There's no adjudication process described for the mechanical tests.

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. This is not an AI/ML device, so no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

No. This is not an AI/ML device.

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

Not applicable for AI/ML ground truth. The "ground truth" for this device's safety and effectiveness is established through its compliance with existing mechanical testing standards and demonstrated substantial equivalence to predicate devices already on the market and deemed safe and effective.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary of Device Assessment from the Document (Non-AI/ML context):

Acceptance Criteria (Implied): The device's mechanical properties (static compression, dynamic compression, subsidence, expulsion) must meet the performance standards outlined in ASTM F2077-11, ASTM F2267-04, and ASTM Draft F04.25.0202, and be "substantially equivalent" to legally marketed predicate devices.
Reported Device Performance: The document states, "Based on the results of the testing and comparisons performed, InFront believes that the subject InFront Interbody Fusion System is substantially equivalent to the predicate systems it was compared to." Specific quantitative results are not provided in this summary.
Study Description: The study involved non-clinical mechanical testing of the InFront Lumbar Interbody Fusion System according to established ASTM standards.
- Tests Performed:
  - Static Compression ASTM F2077-11
  - Dynamic Compression - ASTM F2077-11
  - Subsidence - ASTM F2267-04
  - Expulsion - Per ASTM Draft F04.25.0202
- Data Provenance: The "data" comes from engineering tests performed on the physical device, not patient data.
- Ground Truth: The "ground truth" is adherence to established engineering and material standards and demonstrated mechanical performance comparable to predicate devices.

Summary

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

August 28, 2014

InFront Medical, LLC Mr. John D. Kuczynski President 1033 U.S. Highway 46 East, Suite A202 Clifton, New Jersey 07013

Re: K141443

Trade/Device Name: InFront Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 21, 2014 Received: June 2, 2014

Dear Mr. Kuczynski:

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

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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/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 yours.

RonaldfødJean -S for

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

Enclosure

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Indications for Use Form

K141443 510(k) Number (if known):

Device Name: InFront Lumbar Interbody Fusion System

Indications for Use:

Prescription Use × (Per 21 CFR 801.109) Subpart D

AND / OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary

Prepared May 29, 2014

1. Company:	InFront Medical, LLC1033 US Highway 46 EastSuite A202Clifton, NJ 07013 USATel: (888) 515-2532FAX: 888-292-4691
2. Contact:	John KuczynskiPresidentInFront Medical, LLC1033 US Highway 46 EastSuite A202Clifton, NJ 07013Tel: 973-906-2891FAX: 888-292-4691
3. Proprietary Name:	InFront Lumbar Interbody Fusion System
4. Classification Name:	Intervertebral Body Fusion Device (21 CFR888.3080); Class II, Product Code MAX

5. Product Description:

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The InFront Lumbar Interbody Fusion devices are made from PEEK (Polyetheretherketone) per ASTM F2026, with radiographic markers made from tantalum per ASTM F560.

6. Indications for Use:

The InFront Lumbar Interbody Fusion System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of nonoperative treatment prior to treatment with the device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.

7. Summary of Technological Characteristics

The InFront Lumbar Interbody Fusion System consists of a series of PEEK lumbar cages. These cages are intended to be placed between two lumbar or a sacral and lumbar vertebrae using instruments provided. The proposed devices are the same as current interbody cages already on the market with the only difference being minor variations in the shape.

InFront has determined that the minor differences between the proposed interbody fusion cages and the predicate devices will not impact the safety or effectiveness of the interbody fusion cages for their intended use. Analysis has shown that the proposed lumbar cages are equivalent to the predicate lumbar cages.

8. Identification of Legally Marketed Predicate Device

Documentation was provided which demonstrates that the subject InFront Interbody Cage System is substantially equivalent to several predicate devices that are currently on the market in the US, including the following:

Sapphire Medical Group A-Wedge (K121693, December 27, 2012) Vertebron Interbody Fusion System (K073502, March 24, 2008) Synthes Opal and Oracle Spacer (K072791, December 26, 2007) Stryker AVS PL Spacer (K050624, April 11, 2005) Stryker AVS TL Spacer (K083661, February 27, 2009) Synthes TPAL Spacer (K100089, May 13, 2010) Stryker AVS ARIA Spacer (K101051 August 12, 2010)

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9. Brief Discussion of Non-Clinical Tests Submitted

The subject InFront Lumbar Interbody Fusion System and the predicate cage systems are identical in their indications for use, performance specifications and fundamental technological characteristics. The subject cage system was tested as described in "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" with the following tests being performed:

Static Compression ASTM F2077-11 ●
. Dynamic Compression - ASTM F2077-11
. Subsidence - ASTM F2267-04
. Expulsion - Per ASTM Draft F04.25.0202

10. Conclusions from Non-Clinical Tests

Based on the results of the testing and comparisons performed, InFront believes that the subject InFront Interbody Fusion System is substantially equivalent to the predicate systems it was compared to.

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.