AccelFix Lumbar Expandable Cage System is indicated for intervertebral body fusion procedures 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. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. AccelFix Lumbar Expandable Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Description

The AccelFix Lumbar Expandable Cage System's implants are interbody fusion devices intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). These hollow, rectangular implants are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies. The implants can be expanded in height after insertion in the unexpanded state using the system instrumentation. The implants have serrations on the superior and inferior surfaces designed for fixation.

AI/ML Overview

The provided text, a 510(k) summary for the "AccelFix Lumbar Expandable Cage System," describes a medical device, specifically an intervertebral body fusion device.

The questions you've asked are typical for the validation of an Artificial Intelligence / Machine Learning (AI/ML) powered medical device, particularly those involved in diagnostic imaging or similar applications where performance metrics like sensitivity, specificity, and reader studies are crucial.

This document, however, does not describe an AI/ML device. It's a traditional medical device (an implantable cage) and its clearance is based on bench testing to demonstrate mechanical properties and substantial equivalence to existing predicate devices.

Therefore, many of the questions you've posed, such as those related to:

Data provenance, sample sizes for training/test sets
Number of experts for ground truth establishment, expert qualifications
Adjudication methods
MRMC studies, effect size of human reader improvement with AI
Standalone algorithm performance
Ground truth type (expert consensus, pathology, outcome data)

...are not applicable to the content provided in this 510(k) summary. The "study" proving the device meets acceptance criteria here refers to mechanical bench testing, not a clinical study involving human readers or AI.

Here's what can be extracted from the text relevant to the device validation:

Study Description: Bench Testing for Mechanical Properties

The study conducted to prove the device meets acceptance criteria was a series of bench tests evaluating the mechanical properties of the AccelFix Lumbar Expandable Cage System.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the "AccelFix Lumbar Expandable Cage System met all pre-defined acceptance criteria." While the specific numerical acceptance criteria values are not explicitly listed, the types of tests performed and the general outcome are provided.

Test Type	Acceptance Criteria (Implicit)	Reported Device Performance
Static Axial Compression Test (ASTM F 2077)	To demonstrate substantial equivalence to predicate devices (meeting or exceeding their performance/safety thresholds)	Showed a higher or similar mechanical value than predicate devices.
Static Compression-Shear Test (ASTM F 2077)	To demonstrate substantial equivalence to predicate devices	Showed a higher or similar mechanical value than predicate devices.
Static Torsion Test (ASTM F 2077)	To demonstrate substantial equivalence to predicate devices	Showed a higher or similar mechanical value than predicate devices.
Static Expulsion Test	To demonstrate substantial equivalence to predicate devices	Showed a higher or similar mechanical value than predicate devices.
Static Subsidence Test (ASTM F 2267/F 2077)	To demonstrate substantial equivalence to predicate devices	Showed a higher or similar mechanical value than predicate devices.
Dynamic Axial Compression Test (ASTM F 2077)	To demonstrate substantial equivalence to predicate devices (meeting or exceeding their performance/safety thresholds)	Showed a higher or similar mechanical value than predicate devices.
Dynamic Compression-Shear Test (ASTM F 2077)	To demonstrate substantial equivalence to predicate devices	Showed a higher or similar mechanical value than predicate devices.
Chemical and Physical Testing (general)	Demonstrates device is as safe and effective for its intended use as a predicate device and supports substantial equivalence	Yes, testing has shown this.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not explicitly stated in terms of number of devices tested. It refers to "battery of non-clinical testing" and details the types of mechanical tests. For mechanical testing of medical devices, sample size typically refers to the number of individual units or specimens tested for each specific test, which is not detailed here.
Data Provenance: The tests are "non-clinical testing" and are laboratory-based bench tests performed by the manufacturer, L&K Biomed Co., Ltd., Republic of Korea. It is a retrospective summary of completed tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

N/A. This information is for AI/ML validation or clinical studies. For mechanical bench testing, "ground truth" is established by the specified ASTM standards and the physics of the tests, with results measured by instrumentation. The experts are mechanical engineers or testing technicians performing the lab tests, not clinical experts establishing disease presence.

4. Adjudication Method for the Test Set:

N/A. This is relevant for human reader studies or expert consensus. For mechanical testing, results are typically objective measurements against predefined pass/fail criteria from the ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This is not an AI/ML device or a diagnostic device evaluated with human readers.

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

No. This is not an algorithm.

7. The Type of Ground Truth Used:

N/A (in the context of clinical "ground truth"). The "ground truth" for these tests are the established ASTM (American Society for Testing and Materials) standards (F 2077, F 2267) which define the methodologies and expected performance characteristics for intervertebral body fusion devices. The device's performance is measured against these standard requirements and compared to predicate devices, not against clinical outcomes or pathology.

8. The Sample Size for the Training Set:

N/A. This device does not use a training set as it is not an AI/ML product.

9. How the Ground Truth for the Training Set was Established:

N/A. No training set exists.

In summary, the provided document focuses on the mechanical and material verification of an implantable medical device, not the diagnostic performance of an AI/ML system.

Summary

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September 16, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

L&K Biomed Co., Ltd. Kihyang Kim RA Vice President #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu Yongin-si, Republic of Korea

Re: K190708

Trade/Device Name: AccelFix Lumbar Interbody Fusion Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 13, 2019 Received: August 15, 2019

Dear Kihyang Kim:

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.

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

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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 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).

Sincerely,

for Melissa Hall 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) K190708

Device Name

AccelFix Lumbar Expandable Cage 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

The following 510(k) summary is being submitted as required by 21 CFR 807.92:

1 Manufacturer

Submitter:	Gook Jin Kang
	L&K BIOMED Co., Ltd.
	#201, 202 16-25, Dongbaekjungang-ro 16 beon-gil
	Giheung-gu, Yongin-si, Gyeonggi-do, 17015, Korea
	Phone. 82-2-6717-1983/ FAX .82-2-6717-1949
Contact Person:	Kihyang Kim
	khkim@lnkbiomed.com/ khkim3747@gmail.com

2. Device Identification

Trade Name:	AccelFix Lumbar Expandable Cage System
Common Name:	Intervertebral Body Fusion Cage
Product Code:	MAX
Classification:	Class II
Classification Name:	Intervertebral body fusion device
Regulation No.	21 CFR 888.3080
Classification Pane	Orthopedic

3. Predicate or legally marketed devices which are substantially equivalent.

The AccelFix Lumbar Expandable Cage System has undergone a comprehensive battery of non-clinical testing, including chemical and physical testing. Testing has shows the device is as safe and effective for its intended use as a predicate device and supports a determination of substantial equivalence.

The AccelFix Lumbar Expandable Cage System met all pre-defined acceptance criteria and, in tests where it was compared to either AccelFix Lumbar Expandable Cage System the predicate devices, was found to not represent a new worst case.

Overall, the results of the performance bench tests support the substantial equivalence of the Subject device.

The design feature and indications for use for the subject device 'AccelFix Lumbar Expandable Cage System' is substantially equivalent to the following predicate(s);

Primary Predicate Device: ProLift® Expandable System (K173182) 1)
1. Additional Predicate Devices: Concorde Lift Expandable Cage(171425) LnK Lumbar Interbody Fusion Cage System (K110783, K120063, K121096, K151140, K181380)

4 Materials

AccelFix Lumbar Expandable Cage System is manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136). This this is the same material used in the predicate devices.

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5. Description of the Device

AccelFix-XT Expandable Cage is to be implanted via transforaminal and posterior approach.
AccelFix-XTP Expandable Cage is to be implanted via Anterior to Psoas approach. ।
AccelFix-XL Expandable Cage is to be implanted via lateral approach. ।

6. Intended use

AccelFix Lumbar Expandable Cage System is indicated for intervertebral body fusion procedures 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. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. AccelFix Lumbar Expandable Cage System is to be used with supplemental fixation systems. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

7. Performance -Bench testing

The AccelFix Lumbar Expandable Cage System was tested according to the ASTM F 2077, and ASTM F 2267 as noted below;

Static compression, dynamic compression, static and dynamic shear testing according to ASTM F2077, was presented to demonstrate the substantial equivalency of the AccelFix Lumbar Expandable Cage System to the predicate devices.

Static Axial Compression Test ASTM F 2077 -17 .
. Static Compression-Shear Test - ASTM F 2077 -17
" Static Torsion Test - ASTM F 2077 -17
. Static Expulsion Test
. Static Subsidence Test - ASTM F 2267 - 04 (Reapproved 2018)/F 2077-17
. Dynamic Axial Compression Test- ASTM F 2077 -17
יי Dynamic Compression-Shear Test - ASTM F 2077 -17

Bench testing to evaluate the mechanical properties of the AccelFix Lumbar Expandable Cage System showed a higher or similar mechanical value than predicate marketed devices.

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8. Summary of Technology Characteristics

AccelFix Lumbar Expandable Cage System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.

9. Substantial Equivalence:

AccelFix Lumbar Expandable Cage System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance.

10. Conclusion

The information presented demonstrates the substantial equivalency of the AccelFix Lumbar Expandable Cage System to the predicate devices.

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.