PathLoc Lumbar Interbody Fusion 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. PathLoc Lumbar Interbody Fusion 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 PathLoc Lumbar Interbody Fusion Cage System 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

This document is a 510(k) Premarket Notification from the FDA regarding the "PathLoc Lumbar Interbody Fusion Cage System." It outlines the regulatory approval process and describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to previously approved devices.

Here's an analysis of the provided information concerning acceptance criteria and study proof:

Important Note: The provided document is for a lumbar interbody fusion cage system, which is a mechanical implant. The questions posed (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance) was done," "ground truth used (expert concensus, pathology, outcomes data, etc.)" with specific numbers of experts and adjudication methods) are typical questions for the validation of AI/ML-based medical devices for image analysis or diagnostics. These types of studies are not applicable to a mechanical orthopedic implant like the PathLoc Lumbar Interbody Fusion Cage System.

The "studies" described in this document are bench testing to assess the mechanical properties and biocompatibility of the implant, demonstrating its structural integrity and safety for implantation. There are no "human readers," "AI assistance," or "ground truth based on expert consensus" in the context of this device's validation.

Therefore, many of the requested points in your prompt cannot be answered from the provided text because they pertain to a different type of medical device (e.g., AI diagnostic software) and not a physical implant.

Let's address what is available in the document:

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

The document does not provide a specific table of acceptance criteria with numerical targets and the exact reported performance values. Instead, it states:

Acceptance Criteria (General Description)	Reported Device Performance (General Statement)
"The PathLoc Lumbar Interbody Fusion Cage System met all pre-defined acceptance criteria"	"Bench testing to evaluate the mechanical properties of the PathLoc Lumbar Interbody Fusion Cage System showed a higher or similar mechanical value than predicate marketed devices."
Compliance with ASTM F2077, ASTM F2267 standards for static and dynamic mechanical properties.	Testing was performed for: Static Axial Compression, Static Compression-Shear, Static Torsion, Static Subsidence, Dynamic Axial Compression, Dynamic Compression-Shear. The results supported substantial equivalence.
Use of Ti-6Al-4V ELI titanium alloy (ASTM F136) for material composition.	"The device is made of Titanium 6AL-4V Alloy conforming ASTM F136 and is manufactured in an identical manner to the predicate device." "This this is the same material used in the predicate devices."

The "acceptance criteria" are implied to be meeting or exceeding the performance of the legally marketed predicate devices and conforming to relevant ASTM standards. The detailed numerical values of these tests are not provided in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: This refers to the number of physical samples (implants) tested in the mechanical bench studies. The document does not specify the exact number of samples tested for each mechanical test. Standard ASTM test methods typically prescribe a minimum number of samples (e.g., 5 or 6 per test condition), but this detail is not present.
Data Provenance: Not applicable in the context of clinical patient data. This is bench testing of manufactured devices. The manufacturer is L&K BioMed Co., Ltd. from South Korea. The testing was reported as "non-clinical testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This is a mechanical device. "Ground truth" in this context is established by standardized mechanical testing methods (ASTM standards) and engineering principles, not by medical experts interpreting data like images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. See point 3.

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. See point 3. This device is not an AI diagnostic tool and does not involve human readers interpreting cases.

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

Not Applicable. See point 3. This is not an algorithm.

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

Type of "Ground Truth": For this mechanical device, the "ground truth" or standard for evaluation is:
- ASTM Standard Methods: Compliance with the mechanical testing specifications outlined in ASTM F2077 and ASTM F2267.
- Predicate Device Performance: Demonstrating mechanical performance (e.g., static and dynamic strength, subsidence) that is "higher or similar" to the legally marketed predicate devices.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of a mechanical implant. This term applies to machine learning models.

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

Not Applicable. See point 8.

In summary, the provided document details the regulatory clearance for a physical medical implant. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for such a device primarily revolve around mechanical performance bench testing (to ensure it can withstand forces in the body without failure) and biocompatibility (to ensure it doesn't cause adverse reactions when in contact with human tissue). The questions you've posed are highly relevant for digital health devices, particularly those involving AI/ML for diagnostics or image analysis, but they do not align with the type of device described in this FDA 510(k) summary.

Summary

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March 9, 2022

L&K BioMed Co., Ltd. Kang-Keun Lee Director of Regulatory Affairs #101, 201, 202 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu Yongin-si, Gyeonggi-do 17015 South Korea

Re: K213441

Trade/Device Name: PathLoc 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: January 25, 2022 Received: January 28, 2022

Dear Kang-Keun Lee:

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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Indications for Use

510(k) Number (if known) K213441

Device Name

PathLoc Lumbar Interbody Fusion Cage System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X 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:	Keun Ju ParkL&K BIOMED Co., Ltd.#101, 201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si, Gyeonggi-do, 17015, KoreaPhone. 82-2-6717-1983/ FAX .82-2-6717-1949
Date Prepared	October 7, 2020
Contact Person:	Kang-Keun Leekangkeun.lee@lnkbiomed.com/ ra@lnkbiomed.com

2. Device Identification

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

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

The PathLoc Lumbar Interbody Fusion Cage System is undergone a comprehensive battery of non-clinical testing, including chemical and physical testing. The PathLoc Lumbar Interbody Fusion Cage System met all pre-defined acceptance criteria and, in tests where it was compared to either PathLoc Lumbar Interbody Fusion Cage System the predicate or reference device, 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, materials, intended use, operational principles and indications for use for the subject device 'PathLoc Lumbar Interbody Fusion Cage System' is substantially equivalent to the following predicate(s);

Primary Predicate Device: RISE® Spacer (K113447) 1)
Additional Predicate Devices: 2)
LnK Lumbar Interbody Fusion Cage System (K110783, K120063, K121096, K151140, K181380)

The subject and predicate devices are substantially equivalent in the areas of materials, design, indications for use, intended use and operational principles.

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4 Materials

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

ട്. Description of the Device

PathLoc - TM is to be implanted via transforaminal and posterior approach.

6. Intended use

PathLoc Lumbar Interbody Fusion 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. PathLoc Lumbar Interbody Fusion System is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

7. Performance -Bench testing

The PathLoc Lumbar Interbody Fusion Cage System was tested according to the ASTM F

2077, ASTMF 2267

Static compression, dynamic compression, static and dynamic shear testing according to

ASTM F2077, was presented to demonstrate the substantial equivalency of the PathLoc

Lumbar Interbody Fusion Cage System to the predicate devices.

Static Axial Compression Test ASTM F 2077 -18
. Static Compression-Shear Test - ASTM F 2077 -18
" Static Torsion Test - ASTM F 2077 -18
Static Subsidence Test ASTM F 2267 04 (Reapproved 2018)/F 2077-18 "
Dynamic Axial Compression Test- ASTM F 2077 -18 .
. Dynamic Compression-Shear Test - ASTM F 2077 -18

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

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8. Summary of Technology Characteristics

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

9. Biocompatibility

The device is made of Titanium 6AL-4V Alloy conforming ASTM F136 and is manufactured in an identical manner to the predicate device.

10. Substantial Equivalence:

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

11. Conclusion

The information presented demonstrates the substantial equivalency of the PathLoc Lumbar Interbody Fusion 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.