The Lumfuse-TP cage is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the Lumfuse-TP cage is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These patients should be skeletally mature and have had six months of nonoperative treatment. The Lumfuse-TP cage is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

Device Description

The Lumfuse-TP cage consists of PEEK cages of various lengths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are made from PEEK radiolucent material (ASTM F2026) with embedded tantalum x-ray markers (ASTM F560 or ISO 13782).

AI/ML Overview

This FDA 510(k) summary is for a medical device (LumFuse-TP, an intervertebral body fusion device) and therefore primarily focuses on substantial equivalence to a predicate device based on mechanical and material properties, rather than AI model performance. As such, the requested information regarding AI model acceptance criteria, study details, and expert involvement is largely not applicable in this context.

However, I can extract the relevant information regarding the device itself and explain why the AI-related questions are not addressed by this document.

Device: LumFuse-TP (Intervertebral Body Fusion Device)

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

Acceptance Criteria (Test Standard)	Reported Device Performance
Static Axial Compression (ASTM F2077-14)	Evaluated on worst-case devices
Dynamic Axial Compression (ASTM F2077-14)	Evaluated on worst-case devices
Static Compression-Shear (ASTM F2077-14)	Evaluated on worst-case devices
Subsidence (ASTM F2267-04 (2011))	Evaluated on worst-case devices
End-user Cleaning and Sterilization	Evaluated
Implantable Device Biocompatibility Endpoints	Evaluated

Note: The document states that "The worst case devices were evaluated for mechanical performance...". While it lists the standards, it does not provide specific numerical acceptance criteria or performance values. This is typical for a 510(k) summary, which generally affirms compliance to standards rather than detailing raw test results.

The following questions are NOT APPLICABLE as this document describes a physical medical device (intervertebral body fusion cage) and its mechanical/biocompatibility testing, not an AI/software as a medical device (SaMD).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable for this device. (Relates to AI/software validation)

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 for this device. (Relates to AI/software validation)

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable for this device. (Relates to AI/software validation)

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 for this device. (Relates to AI/software validation)

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable for this device. (Relates to AI/software validation)

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable for this device. For physical devices, "ground truth" generally refers to validated test standards and material specifications.

8. The sample size for the training set
Not Applicable for this device. (Relates to AI/software development)

9. How the ground truth for the training set was established
Not Applicable for this device. (Relates to AI/software development)

Summary from the document:

Clinical Testing: "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." This reinforces that the evaluation was based on non-clinical (mechanical, material, sterilization, biocompatibility) testing.
Purpose: The submission's purpose was to gain initial marketing authorization by demonstrating substantial equivalence to an existing predicate device (Medtronic® CAPSTONE).
Conclusion: "Based on the information provided in this premarket notification, we believe that the subject Lumfuse-TP demonstrates substantial equivalence to the identified predicate device."

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

PRECIFIT MEDICAL LTD % Mr. Kellen Hills Quality and Regulatory Consultant Orchid Design 4600 East Shelby Drive. Suite 1 Memphis, Tennessee 38118

July 25, 2017

Re: K171630

Trade/Device Name: LumFuse-TP Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: May 22, 2017 Received: June 2, 2017

Dear Mr. Hills:

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. 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K171630

Device Name Lumfuse-TP

Indications for Use (Describe)

The Lumfuse-TP cage is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the Lumfuse-TP cage is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These patients should be skeletally mature and have had six months of nonoperative treatment. The Lumfuse-TP cage is intended to be used with autograft and lor allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

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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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Sun

[As Required by 21 CFR 8

(a)(1) Submitted By: Address:

Phone: Date: Contact Persons Primary: Secondary:

Proprietary Name: (a)(2) Common Name:

Classification Name and Reference:

Product Code:

(a)(3) Predicate Devices: Primary:

PRECIFIT MEDICAL LTD 951 Aviation Pkwy Ste 100, Morrisville, NORTH CAROLINA, 27560 901-433-1990 July 21, 2017

Kellen Hills (Orchid Design Consulting) Eric Wu (Precifit Medical Ltd)

Lumfuse-TP Lumbar interbody fusion device, interbody cage 21 CFR 888.3080: Intervertebral Fusion Device With Bone Graft, Lumbar MAX

Medtronic® CAPSTONE (K151128);

(a)(4) Device Description:

The Lumfuse-TP cage consists of PEEK cages of various lengths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are made from PEEK radiolucent material (ASTM F2026) with embedded tantalum x-ray markers (ASTM F560 or ISO 13782).

The purpose of this submission is to gain initial marketing authorization in the United States.

(a)(5) Indications for Use:
The Lumfuse-TP cage is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the Lumfuse-TP cage is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These patients should be skeletally mature and have had six months of nonoperative treatment. The Lumfuse-TP cage is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.
(a)(6) Comparison of Technological Characteristics: The Lumfuse-TP has the same intended use and is similar in basic shape, material and performance characteristics to the predicate device. The technological characteristics do not raise any new questions of safety and efficacy.
(b)(1) Non-clinical testing:

The worst case devices were evaluated for mechanical performance in static and dynamic axial compression and compression-shear per ASTM F2077-14 and subsidence per ASTM F2267-04 (2011). End-user cleaning and sterilization as well as implantable device biocompatibility endpoints were also evaluated.

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(b)(2) Clinical testing:

Clinical testing was not required to demonstrate substantial equivalence in this premarket notification.

Conclusions: (b)(3)
Based on the information provided in this premarket notification, we believe that the subject Lumfuse-TP demonstrates substantial equivalence to the identified 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.