The AxCess® Expandable Interbody System is a lumbar intervertebral body fusion device and is indicated for spinal fusion procedures to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients. The devices are intended for use at either one or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies for surgery should be skeletally mature and have had six months of conservative treatment.

The device is not intended to be used as a stand-alone device. For all the above indications the devices must be used with supplemental internal spinal fixation system that have been cleared for use in the lumbar spine, including Pedicle Screw and Hook Systems, and Spinal Plate Systems.

Device Description

The AxCess® Expandable Interbody System consists of lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The AxCess® Expandable Interbody System implants are provided in various shapes to accommodate posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) surgical approaches. These implants can expand to the desired height and varying degrees of lordosis as appropriate per the patient's anatomical needs. AxCess® Expandable Interbody System implant is to be filled with autogenous bone graft and/or allograft.

The AxCess® Expandable Interbody System implants are manufactured from titanium alloy (Ti-6AI-4V ELI) components per ASTM F136 and cobalt chrome alloy (Co-28Cr-6Mo) components per ASTM F1537.

AI/ML Overview

Here's an analysis of the provided FDA 510(k) summary regarding the AxCess® Expandable Interbody System, based on your requested framework. It's important to note that this document is a summary and often details about specific acceptance criteria and study methodologies, especially for software or AI-driven devices, are abbreviated or not explicitly stated in this format.

Key Observation: The provided document is for a mechanical medical device (intervertebral body fusion device), not a software or AI-driven diagnostic device. Therefore, many of your requested criteria, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm only without human-in-the-loop performance)," "number of experts used to establish ground truth," and "training set size/ground truth," are not applicable to this type of device and are not mentioned in the submission. The acceptance criteria here relate to physical performance and safety, not diagnostic accuracy.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Static Axial Compression	Must meet or exceed the performance of legally marketed predicate devices per ASTM F2077, demonstrating sufficient strength for intended use.	"The results of this non-clinical testing show that the strength of the AxCess® [is] sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." (Specific numerical values for acceptance and performance are not detailed in this summary.)
Dynamic Axial Compression	Must meet or exceed the performance of legally marketed predicate devices per ASTM F2077, demonstrating sufficient strength for intended use.	"The results of this non-clinical testing show that the strength of the AxCess® [is] sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." (Specific numerical values for acceptance and performance are not detailed in this summary.)
Static Compression Shear	Must meet or exceed the performance of legally marketed predicate devices per ASTM F2077, demonstrating sufficient strength for intended use.	"The results of this non-clinical testing show that the strength of the AxCess® [is] sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." (Specific numerical values for acceptance and performance are not detailed in this summary.)
Dynamic Compression Shear	Must meet or exceed the performance of legally marketed predicate devices per ASTM F2077, demonstrating sufficient strength for intended use.	"The results of this non-clinical testing show that the strength of the AxCess® [is] sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." (Specific numerical values for acceptance and performance are not detailed in this summary.)
Subsidence	Must meet or exceed the performance of legally marketed predicate devices per ASTM F2267, demonstrating adequate resistance to sinkage into bone.	"The results of this non-clinical testing show that the strength of the AxCess® [is] sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." (Specific numerical values for acceptance and performance are not detailed in this summary.)
Biocompatibility	Device materials (Ti-6AI-4V ELI, Co-28Cr-6Mo) must meet established ASTM standards for biocompatibility.	Implied by use of materials (ASTM F136 and ASTM F1537) that are commonly accepted as biocompatible in similar predicate devices. (No specific study details are provided in this summary.)
Sterility	Device must be sterile.	"Sterility" is listed as a similar technological characteristic to predicate devices, implying compliance with established sterilization methods and validation. (No specific study details are provided in this summary.)

Study Proving Device Meets Acceptance Criteria:

The study referenced is "non-clinical testing" which includes:

Static and Dynamic Axial Compression per ASTM F2077
Static and Dynamic Compression Shear per ASTM F2077
Subsidence per ASTM F2267

The conclusion states that these tests demonstrate "the strength of the AxCess® [is] sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." The specific details of the individual test results (e.g., actual load values, fatigue cycles) are not provided in this public summary but would have been part of the full 510(k) submission.

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

Sample Size: Not explicitly stated. For mechanical testing, the "sample size" refers to the number of devices or components tested. This information is typically found in the full test report, not the summary.
Data Provenance: Not applicable in the context of clinical data for AI/software devices. The provenance here refers to the materials used (Titanium alloy and Cobalt Chrome alloy) and the application of engineering standards (ASTM). The testing itself is laboratory-based non-clinical testing.

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

This is not applicable as this is a mechanical device, not an AI/software diagnostic device that requires expert-established ground truth from medical images or clinical data. The "ground truth" for mechanical testing is defined by the ASTM standards and the physical properties of the materials and design.

4. Adjudication method for the test set:

Not applicable for mechanical device testing. Adjudication typically refers to the process of resolving discrepancies among human readers or between AI and human disagreement in diagnostic studies. Mechanical tests are typically performed to engineering specifications.

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 is a mechanical interbody fusion device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a mechanical device, not an algorithm. The "standalone performance" here would be its mechanical performance without human intervention, which is what the ASTM tests assess.

7. The type of ground truth used:

Engineering Standards and Specifications: The "ground truth" for this device's performance is established by recognized consensus standards like ASTM F2077 (Static and Dynamic Axial Compression) and ASTM F2267 (Subsidence). These standards define the test methods and performance requirements for intervertebral body fusion devices. The device's performance is compared against the performance of predicate devices tested to the same standards.

8. The sample size for the training set:

Not applicable. This is a mechanical device, not an AI/machine learning model that requires a training set.

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

Not applicable. (See #8)

Summary

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January 24, 2025

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, the FDA logo is displayed in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" written in a clear, sans-serif font. The overall design is clean and professional, reflecting the organization's role in public health and safety.

Elliquence LLC % Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K243739

Trade/Device Name: AxCess® Expandable Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: December 4, 2024 Received: December 4, 2024

Dear Mr. Wright:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Katherine D. Kavlock -S

for

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Expiration Date: 07/31/2026 See PRA Statement below.

Form Approved: OMB No. 0910-0120

Submission Number (if known)

K243739

Device Name

AxCess® Expandable Interbody System

Indications for Use (Describe)

The AxCess® Expandable Interbody System is a lumbar intervertebral body fusion device and is indicated for spinal fusion procedures to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients. The devices are intended for use at either one or two contiguous levels in the lumbar spine. from L2 to S1, for the treatment of degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies for surgery should be skeletally mature and have had six months of conservative treatment.

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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K243739 - 510(K) SUMMARY

Submitter's Name:	Elliquence LLC	Image: Elliquence logo
Submitter's Address:	2455 Grand AvenueBaldwin, New York 11510
Submitter's Telephone:	516-277-9000
Contact Person:	Nathan Wright, MS, RACEmpirical Technologies1-719-351-0248nwright@empiricaltech.com	Image: Empirical Technologies logo
Date Summary was Prepared:	December 4, 2024
Trade or Proprietary Name:	AxCess® Expandable Interbody System
Device Classification Name:	Intervertebral Fusion Device With Bone Graft, Lumbar
Classification & Regulation #:	Class II per 21 CFR §888.3080
Product Code:	MAX
Classification Panel:	Spinal Devices (DHT6B)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The AxCess® Expandable Interbody System implants are manufactured from titanium alloy (Ti-6AI-4V ELI) components per ASTM F136 and cobalt chrome alloy (Co-28Cr-6Mo) components per ASTM F1537.

INDICATIONS FOR USE

The AxCess® Expandable Interbody System is a lumbar intervertebral body fusion device and is indicated for spinal fusion procedures to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients. The devices are intended for use at two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment.

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. The predicates included in this submission were selected based on the best practices described in the FDA Draft Guidance document Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission. Specifically, the following characteristics are similar between the subject and predicates:

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Indications for Use ●
Structure and Function
Expandable Feature ●
Materials
Sterility ●
Sizes

Predicate Devices

510k Number	Trade or Proprietary or Model Name	Manufacturer	Product Code	Predicate Type
K182877	HALF DOME Posterior Lumbar Interbody System	Astura Medical, LLC	MAX	Primary
K213951	FORZA XP Expandable Spacer System	Orthofix US LLC	MAX	Additional

Performance Data

The AxCess® Expandable Interbody System has been tested in the following test modes:

Static and Dynamic Axial Compression per ASTM F2077 ●
Static and Dynamic Compression Shear per ASTM F2077
Subsidence per ASTM F2267 .

The results of this non-clinical testing show that the strength of the AxCess® 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 AxCess® Expandable Interbody System 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.