The Ali Interbody Fusion System is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L1-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. The Ali Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Ali Interbody Fusion is to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft, and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

Device Description

The Ali Interbody Fusion System is used to provide structural stability and maintain disc space distraction during intervertebral body fusion in the lumbosacral spine. The Subject Device implants are fabricated from PEEK (ASTM F2026) or Titanium (ASTM F136) with Titanium endplates. The Ali Interbody Fusion System implants are available in a range of sizes and shapes, and are designed to accommodate variations in surqical approach and patient anatomy. Each cage assembly has a hollow center to allow placement of autograft and/or allograft. Fixation ridges on the superior and inferior endplates of the device help to grip the endplates and prevent expulsion.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Ali Interbody Fusion System, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving device performance against those criteria.

Therefore, many of the requested details related to acceptance criteria, specific performance metrics, sample sizes for testing and training, expert qualifications, and ground truth establishment are not explicitly present in the provided text.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the nature of a 510(k) submission for an intervertebral body fusion device, the acceptance criteria are generally related to demonstrating similar mechanical and material properties to a predicate device, as well as adherence to specific ASTM standards for the materials used and device design. The "reported device performance" in this context refers to the demonstration that the subject device meets these established characteristics compared to the predicate.

Acceptance Criterion (Implied by 510(k) Process for this device)	Reported Device Performance (as stated in the document)
Material Composition Equivalence	Subject Device implants are fabricated from PEEK (ASTM F2026) or Titanium (ASTM F136) with Titanium endplates, similar to predicate.
Design Characteristics Equivalence	Available in a range of sizes and shapes to accommodate variations in surgical approach and patient anatomy. Hollow center for graft. Fixation ridges on endplates to grip and prevent expulsion.
Intended Use Equivalence	Indicated for intervertebral body spinal fusion in skeletally mature patients with DDD at one or two contiguous levels (L1-S1), up to Grade I spondylolisthesis/retrolisthesis, and as an adjunct for degenerative scoliosis. To be used with autograft/allograft and supplemental fixation, after 6 months non-operative treatment. (Identical to predicate's stated indications)
Mechanical Performance Equivalence	"Engineering analysis was performed for the Subject Device. Evaluation demonstrated the Subject Device is substantially equivalent to the predicate device." (Implies mechanical testing results were comparable).
Safety and Effectiveness	Demonstrated through substantial equivalence to the legally marketed predicate device.

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

Sample Size: Not specified in the provided text. The term "engineering analysis" suggests a series of tests on manufactured devices, but the number of units tested is not mentioned.
Data Provenance: Not specified. The "engineering analysis" would typically be conducted in a laboratory setting by the manufacturer or a contract testing facility.

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

Not applicable/Not specified. This type of information is usually relevant for AI/ML device studies where expert consensus is used to label data. For a mechanical device like an interbody fusion system, ground truth is established through engineering and material science principles (e.g., destructive testing, fatigue testing, static compression tests), not expert interpretation of outputs.

4. Adjudication method for the test set:

Not applicable/Not specified. Adjudication methods (e.g., 2+1, 3+1) are common in studies involving human interpretation (e.g., radiology reads) to establish consensus on "ground truth." This is not relevant for the type of engineering performance testing described.

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 study is not mentioned and is not relevant for this type of mechanical interbody fusion device. This device is 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 device is an implanted medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device, inferred from the "engineering analysis" and "comparison of characteristics," would be based on:
- Material specifications: Adherence to ASTM standards (e.g., F2026 for PEEK, F136 for Titanium).
- Mechanical performance standards: Comparison to the known, acceptable mechanical performance characteristics of the predicate device (e.g., strength, fatigue resistance, subsidence resistance) which are established through standardized biomechanical testing.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML device that requires a training set.

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

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

Summary

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January 15, 2021

Raed M. Ali, M.D., Inc. % Kristen Allen Founder and Principal Consultant AllenBridge Consulting 2221 Oleander Drive Wilmington, North Carolina 28403

Re: K203308

Trade/Device Name: Ali Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 10, 2020 Received: December 16, 2020

Dear Kristen Allen:

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.

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

510(k) Number (if known) K203308

Device Name

Ali Lumbar Interbody Fusion System

Indications for Use (Describe)

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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510(k) Summary

Ali Interbody Fusion System

Submitter:	Raed M. Ali, M.D., Inc.6 StarcatcherNewport Coast, CA 92657
Contact Person:	Kristen AllenFounder and Principal Consultant, AllenBridge Consulting910-612-4153 (P)Kristen@allenbridgeconsulting.com
Date Prepared:	December 16, 2020
Trade Name:	Ali Interbody Fusion System
Common Name:	Intervertebral body fusion device
Device Product Codeand Classification:	Regulation Number: 21 CFR 888.3080MAX, Class II, Intervertebral Fusion Device with Bone Graft,Lumbar
Primary Predicate:	Ali Interbody Fusion System (K191516)

Device Description:

Indications and Intended use:

The Ali Interbody Fusion System is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L1-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. The Ali Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Ali Interbody Fusion System is to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft, and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

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K203308 Page 2 of 2

Summary of Technological Characteristics:

The subject devices are substantially equivalent to the predicate device as well as other similar devices cleared by FDA for commercial distribution in the United States. The Subject Device was shown to have the same technological characteristics as its predicate devices through comparison of characteristics including design, intended use, performance specifications and function.

Summary of Performance Testing:

Engineering analysis was performed for the Subject Device. Evaluation demonstrated the Subject Device is substantially equivalent to the predicate device.

Conclusion:

Based on the comparison to predicate device, the Subject Device has been shown to be substantially equivalent to the legally marketed 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.