LOSPA IS PLIF/T-PLIF & ALIF & TLIF & DLIF Cages are indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) With up to Grade I spondylolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non-operative treatment. Devices are intended to be implanted via an open, posterior or anterior approach and used with autogenous bone and supplemental fixation.

Device Description

LOSPA IS TLIF & DLIF Interbody fusion devices are available in various heights and Lordotic configurations with an open architecture to accept packing of bone graft material. The design features are common with the design features of the predicate devices. Straight and wedge / Lordotic designs to match vertebral anatomy, Large interior graft space for optimal bony integration, Superior and inferior ridges designed to prevent implant migration, PEEK Cages with Tantalum markers for optimum fluoroscopic placement and post operative examination, Available in multitude of similar sizes to suit the individual pathology and anatomic condition of the patient. It is made of PEEK (ASTM F2026) & Tantalum (ASTM F560).

LOSPA IS TLIF Cage is available in

. Two versions are available according to the lordotic angles (0° & 7°).
It has various heights (8~16 mm) and lengths (24, 29, 32, 35 mm).
Two shapes, LOSPA IS TLIF Cage & LOSPA IS TLIF Cage B type.

LOSPA IS DLIF Cage is available in

Four versions are available according to the lordotic angles (0°, 6°, 12° & 18°). ●
It has various heights (8~16 mm), widths (18 & 22 mm) and lengths (40, 45, 50, 55, 60 mm).

AI/ML Overview

The provided text is a 510(k) summary for the LOSPA IS TLIF & DLIF Cages. This document primarily focuses on establishing substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting detailed acceptance criteria and a study report with performance metrics for software or AI devices.

Therefore, many of the requested categories for acceptance criteria and a study proving device meets those criteria are not applicable or cannot be extracted from this particular document. The device in question is an intervertebral body fusion device, a physical implant, not a software or AI diagnostic tool.

Here's a breakdown of what can and cannot be extracted from the provided text according to your request:

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

Acceptance Criteria Category	Reported Device Performance (or N/A)	Notes
Mechanical Performance	Demonstrated through static axial compression and static compression shear testing.	The document states, "The static results demonstrated that the subject devices are expected to be as safe and as effective as the predicate devices." Specific numerical acceptance criteria or performance values are not provided.
Material Biocompatibility	Made of PEEK (ASTM F2026) & Tantalum (ASTM F560). Parts of instruments made of stainless steel and polymers. All materials are biocompatible and cleared for use in PMN.	Compliance with established ASTM standards for materials.
Sterilization	Steam sterilization validated as per ISO 17665-1 for non-sterile devices. Gamma sterilization validated as per ISO 11137-1 & ISO 11137-2 for sterile components.	Compliance with ISO standards.
Packaging & Shelf Life	Packaging subjected to sterile barrier testing to validate a shelf life of 5 years as per ISO & ASTM standards (accelerated aging as per ASTM F1980).	Compliance with ISO and ASTM standards.
Pyrogenicity	Pyrogen Testing performed.	Test was conducted; specific results not detailed but implied to meet requirements for safety.
Indications for Use (Clinical Equivalence)	"LOSPA IS PLIF/T-PLIF & ALIF & TLIF & DLIF Cages are indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) With up to Grade I spondylolisthesis at the involved level(s)."	This is the intended use for which substantial equivalence was sought and granted. The performance testing supports this.

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

Not Applicable. This document describes mechanical and sterilization testing of a physical medical device, not a diagnostic or AI device that would utilize a "test set" of patient data. The "test set" refers to the physical devices (e.g., specific cage sizes/configurations) subjected to mechanical, sterilization, and pyrogenicity tests. The document does not specify a numerical sample size for these hardware tests, stating "performance testing was carried out." There is no patient data provenance as it's not a clinical study on patient data.

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 not a study requiring expert readers or ground truth establishment in the context of diagnostic performance. Technical experts would have designed and critically reviewed the engineering, material, and sterilization tests, but their number and specific qualifications are not detailed in this regulatory summary.

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

Not Applicable. Adjudication methods are relevant for clinical studies or diagnostic performance evaluations where disagreement among experts needs resolution. This document describes physical device testing.

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. This is not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not Applicable. This is not an algorithm or software device.

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

The "ground truth" for this type of device is primarily defined by engineering specifications, material science standards (e.g., ASTM), and regulatory standards (e.g., ISO for sterilization). For example, for mechanical testing, the ground truth is the specified load a device must withstand. For material composition, it's the chemical and physical properties required by the ASTM standard. For sterilization, it's the Sterility Assurance Level (SAL) defined by ISO standards. It's not a clinical "ground truth" derived from patient outcomes or expert consensus on images.

8. The sample size for the training set

Not Applicable. This is not a machine learning or AI device that utilizes a "training set."

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

Not Applicable. As there is no training set, there is no ground truth establishment for one.

Summary

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March 31, 2017

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

Corentec Co., Ltd J.S. Daniel Associate Director - Global RA&OA 8F Chungho Tower. 483. Gangnam-daero Seocho Gu. Seoul. 06541 Korea

Re: K170243

Trade/Device Name: LOSPA IS TLIF & DLIF Cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 23, 2017 Received: March 24, 2017

Dear Mr. Daniel:

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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-

Image /page/0/Picture/10 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized image of three human profiles facing right, arranged in a cascading manner. The profiles are connected by flowing lines, creating a sense of unity and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central image.

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related 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)

K170243

Device Name

LOSPA IS TLIF & DLIF Cages

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)|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

Corentec Co., Ltd.

LOSPA IS TLIF & DLIF Cages

20th March, 2017

ADMINISTRATIVE INFORMATION

Manufacturer	Corentec Co., Ltd.12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-GuCheonan-si, Chungchongnam-do, 06541, South KoreaTelephone: +82-41-585-7114Fax: +82-41-585-7113
Official Contact	J.S. DanielAssociate Director – Global RA/QACorentec Co., Ltd8F Chungho Tower, 483, Gangnam-daero,Seocho Gu, Seoul, Korea 31056Ph: +82 70 4393 3819Fax: +82 2 3445 5467Email: jsdaniel@corentec.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	LOSPA IS TLIF & DLIF Cages
Common Name:	Inter body Fusion Cage
Classification Regulations:	21 CFR 888.3080
Regulatory Class:	2
Product Codes:	MAX
Regulation Medical Specialty:	Orthopedic
Reviewing Panel:	Orthopedic

INDICATIONS FOR USE

LOSPA IS PLIF/T-PLIF & ALIF & TLIF & DLIF Cage is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) With up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

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DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Patients should be skeletally mature and have had six months of non-operative treatment. Devices are intended to be implanted via an open, posterior or anterior approach and used with autogenous bone and supplemental fixation.

DEVICE DESCRIPTION

LOSPA IS TLIF Cage is available in

. Two versions are available according to the lordotic angles (0° & 7°).
It has various heights (8~16 mm) and lengths (24, 29, 32, 35 mm).
Two shapes, LOSPA IS TLIF Cage & LOSPA IS TLIF Cage B type.

LOSPA IS DLIF Cage is available in

Four versions are available according to the lordotic angles (0°, 6°, 12° & 18°). ●
It has various heights (8~16 mm), widths (18 & 22 mm) and lengths (40, 45, 50, 55, 60 mm).

LOSPA IS SPINAL SYSTEM INSTRUMENTATION

LOSPA IS Spinal Fixation System Instrumentation which includes instruments for subject devices LOSPA IS TLIF & DLIF Cages consisting of set of accessories to be used with LOSPA IS TLIF & DLIF Cages. The instruments are designed to be simple, conventional, and accurate and all parts of which are used for their respective procedures by qualified orthopedic surgeons. The parts of the instruments are made of stainless steel and polymers which are biocompatible and have been used in the medical industry for over a decade. All the materials used are cleared for use in PMN.

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SUBSTANTIAL EQUIVALENCE

The LOSPA IS TLIF & DLIF Cages are similar to the 510(k) cleared devices as mentioned below with respect to indications, design, operating principles and material.

Subject Devices	PredicateCategory	Manufacturer	Trade Name	510(k)
LOSPA ISSpinal SystemsTLIF Cages	Primary	Corentec Co.Ltd.	LOSPA IS SpinalSystems(PLIF/ALIF/ACIF)	K151408
	Additional	Biomet Spine(Zimmer)	Zyston CurveInterbody Spacer	K110650
		K7 LLC	K7 Lumbar Spacers	K133126
LOSPA ISSpinal SystemsDLIF Cages	Primary	Corentec Co.Ltd.	LOSPA IS SpinalSystems(PLIF/ALIF/ACIF)	K151408
	Additional	Medtronic	CLYDESDALESpinal System	K100175
		DePuy Synthes	ORACLE CageSystem	K072791

The LOSPA IS Spinal Systems consisting of TLIF & DLIF Interbody fusion devices and all the predicate devices have same intended use and similar indications for use.

The LOSPA IS TLIF Cages has a kidney bean shape similar with predicate Zyston Curve Interbody Spacer [K110650] and K7 Lumbar Spacers [K133126], with central canal to receive bone graft and has either straight shaped designs or wedge/Lordotic designs to match the vertebral anatomy. The overall design and dimensional specification of LOSPA IS TLIF Cages is similar to its predicate devices.

The LOSPA IS DLIF Cage has a convex & bullet nosed shaped interbody fusion device similar with predicate CLYDESDALE Spinal System [K100175] and ORACLE Cage System [K072791], with central canal to receive bone graft and has either straight shaped designs or wedge/Lordotic designs to match the vertebral anatomy. The overall design and dimensional specification of LOSPA IS DLIF Cages is similar to its predicate devices.

The design features of the LOSPA IS Spinal Systems consisting of LOSPA IS TLIF & DLIF Cages are common with of all the predicate devices as described in the device description.

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At a high level, the LOSPA IS Spinal Systems consisting of TLIF & DLIF Interbody fusion devices has the following similarities to the predicate devices:

has the same intended use, o
o has the similar indications for use,
uses the similar operating principles, O
incorporates similar basic designs, O
incorporates same materials, and O
is supplied Sterile and Non Sterile o

PERFORMANCE DATA

LOSPA IS TLIF & DLIF Cages, performance testing was carried out to demonstrate substantial equivalence and included methods described in the standard ASTM F2077 & AAMI ST72. Testing of the subject devices consisted of static axial compression, static compression shear and Pyrogen Testing.

The static results demonstrated that the subject devices are expected to be as safe and as effective as the predicate devices. Any differences in technological characteristic between the subject and predicate devices do not raise new issues of safety or efficacy.

STERILIZATION & PACKAGING

Similar to the predicate devices, the LOSPA IS TLIF & DLIF Cages are packaged in pouch and supplied sterile and non sterile.

The non sterile implants and all instruments used in the surgery must be sterilized by the end user, prior to use, as mentioned in the IFU. Steam sterilization validation for the subject non sterile devices was conducted as per, ISO 17665-1.

For the sterile components, following to gamma sterilization, packaging was subjected to sterile barrier testing to validate a shelf life of 5 years as per ISO & ASTM standards confirms the stability and effectiveness of packaging of the sterilized product during the shelf-life, by evaluating changes by accelerated aging, as per ASTM F1980.

Gamma sterilization validation for the subject sterile devices was conducted as per, ISO 11137-1 & ISO 11137-2.

CONCLUSION

Overall, the LOSPA IS TLIF & DLIF Cages are similar to the identified primary predicate device and additional predicates. Any differences in technological characteristic between the subject and primary predicate device and additional predicate do not raise new issues of safety or efficacy and has been adequately addressed in this premarket notification.

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.