The Amplify Surgical DualXSLIM® T/PLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are to be used in patients who have had at least six months of non-operative treatment. The Amplify Surgical DualXSLIM® T/PLIF is indicated for unilateral or bilateral implantation. The DualXSLIM® T/PLIF implants are intended for single use.

Device Description

The purpose of this 510(k) is to offer the DualXSLIM® T/PLIF as additional sizes and lordosis options to the previously cleared DualX (K181397). The DualX implants are a family of expandable interbody fusion devices that expand sequentially in lateral and then vertical directions. The implants are designed to be used in minimally invasive spine surgery. The DualXSLIM® T/PLIF implants are offered in a variety of sizes to accommodate patient anatomical needs. All implant components are manufactured from Ti-6A1-4V ELI per ASTM F136.

AI/ML Overview

This document is a 510(k) summary for the Amplify Surgical DualXSLIM® T/PLIF intervertebral body fusion device. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed study of the device's diagnostic performance against specific acceptance criteria relevant to an AI/ML powered medical device.

Therefore, the information requested about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies for an AI/ML device is not applicable or available in this document.

This document describes a traditional medical device (implant) and its mechanical performance testing, not a diagnostic AI/ML device.

Here's a breakdown of why each requested point is not applicable:

A table of acceptance criteria and the reported device performance: Not applicable. This document is for a physical implant, not an AI/ML diagnosis. It focuses on mechanical testing relative to standards (ASTM F2077, F2267) rather than diagnostic performance metrics (e.g., sensitivity, specificity).
Sample size used for the test set and the data provenance: Not applicable. This refers to physical "tests" (e.g., static/dynamic compression) on the device, not a test set for an algorithm. The "test sets" would be the manufactured devices themselves.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no concept of "ground truth" established by experts in the context of mechanical testing for an implantable medical device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This relates to expert consensus for diagnostic ground truth, which is not relevant here.
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 for AI-assisted diagnostic devices.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not have a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. For mechanical tests, the "truth" is determined by the physical properties measured against engineering standards.
The sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set.
How the ground truth for the training set was established: Not applicable, for the same reason as above.

In summary, this 510(k) document is for an intervertebral body fusion device and details mechanical performance testing, not the diagnostic performance of an AI/ML algorithm. Therefore, the specific questions related to AI/ML device performance and validation cannot be answered from this provided text.

Summary

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October 18, 2022

Amplify Surgical, Inc. % Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K222203

Trade/Device Name: DualXSLIM® T/PLIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 10, 2022 Received: August 10, 2022

Dear Nathan 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 (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 located 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.

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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) for

devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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).

Sincerely.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K22203

Device Name DualXSLIM® T/PLIF

Indications for Use (Describe)

Type of Use (Select one or both, as applicable) 図 Prescription Use (Part 21 CFR 801 Subpart D)

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

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Submitter's Name:	Amplify Surgical, Inc.
Submitter's Address:	9272 Jeronimo Rd., Suite 107BIrvine, California 92618
Submitter's Telephone:	949-698-4854
Contact Person:	Nathan Wright MSEmpirical Technologies719-351-0248nwright@empiricaltech.com
Date Summary was Prepared:	August 10, 2022
Trade or Proprietary Name:	DualXSLIM® T/PLIF
Common or Usual Name:	Intervertebral Fusion Device with Bone Graft, Lumbar
Classification:	Class II per 21 CFR §888.3080
Product Code:	MAX
Classification Panel:	Orthopedic Devices - Spinal Devices (DHT6B)

K22203 - 510(K) SUMMARY

Description of the Device Subject to Premarket Notification:

The purpose of this 510(k) is to offer the DualXSLIM® T/PLIF as additional sizes and lordosis options to the previously cleared DualX (K181397).

The DualX implants are a family of expandable interbody fusion devices that expand sequentially in lateral and then vertical directions. The implants are designed to be used in minimally invasive spine surgery. The DualXSLIM® T/PLIF implants are offered in a variety of sizes to accommodate patient anatomical needs. All implant components are manufactured from Ti-6A1-4V ELI per ASTM F136.

INDICATIONS FOR USE

The DualXSLIM® T/PLIF implants are intended for single use.

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 same to predicate device in the following ways:

Indications for Use
Structural support mechanism ●

Amplify Surgical, Inc. DualXSLIM® T/PLIF

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Expansion mechanism
Material
Manufacturing and Biocompatibility ●
Sizes

Predicate Devices

510k Number	Trade or Proprietary or Model Name	Manufacturer	Predicate Type
K181397	DualX™	Innovasive, Inc.	Primary
K171633	NuVasive® TLX Interbody System	NuVasive, Inc.	Additional
K152475	FORZA® PTC Spacer System	Orthofix Inc.	Additional

PERFORMANCE DATA

The DualXSLIM® T/PLIF has been tested in the following test modes:

Static & Dynamic Axial Compression per ASTM F2077 ●
Static & Dynamic Compression Shear per ASTM F2077 ●
Subsidence per ASTM F2267 ●

The results of this non-clinical testing show that the strength of the DualXSLIM® T/PLIF is sufficient for its intended use and that the DualXSLIM® T/PLIF is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the DualXSLIM® T/PLIF 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.