The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are designed for use with autograft bone to facilitate fusion and are intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Device Description

The PLIF Lite and TLIF Lite Lumbar Interbody Fusion Devices are made from PEEK. The PLIF Lite implants are available in lordotic and non-lordotic form, while the TLIF implants are provided with 7 degrees of lordosis only. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile, and a set of instrument for implantation is provided to facilitate implantation. Three radiographic markers made of titanium alloy (ASTM F-136) are included in each implant to allow radiographic visualization.

AI/ML Overview

The provided text describes the 510(k) summary for Sintea Plustek's PLIF Lite and TLIF Lite Interbody Fusion system, which is a medical device for spinal fusion. This specific document focuses on demonstrating substantial equivalence to existing predicate devices based on mechanical performance and design, rather than conducting a clinical study to establish new performance criteria. Therefore, the information requested for a clinical study assessing device performance against acceptance criteria is largely not applicable in this context.

Here's an analysis based on the provided text, highlighting what is available and what is not:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance: - Static axial compression - Dynamic axial compression - Static compression shear - Dynamic compression shear - Static torsion - Subsidence - Expulsion	"Test results demonstrate that the PLIF Lite and TLIF Lite devices are substantially equivalent to the predicate devices" in regards to "Mechanical testing".
Material: PEEK and Titanium alloy (for markers)	"Substantially equivalent to the predicate devices" in regards to "Materials".
Dimensions: Variety of heights and lengths	"Substantially equivalent to the predicate devices" in regards to "Dimensions".
Function: Facilitate fusion with autograft bone; use with supplemental fixation	"Substantially equivalent to the predicate devices" in regards to "Function".
Indications for Use: Intervertebral body fusion at L2-S1 for DDD with up to Grade 1 spondylolisthesis in skeletally mature patients after 6 months non-operative treatment.	"Substantially equivalent to the predicate devices" in regards to "Indications for Use".

Explanation: In a 510(k) submission for substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the new device performs as well as, or better than, the legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. The core "study" here is the performance testing conducted according to recognized ASTM standards (ASTM F2077 and ASTM F2267) to show mechanical equivalence.

Study Details (as far as applicable to a 510(k) for substantial equivalence)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document refers to "Performance Testing" according to ASTM F2077 and ASTM F2267, which are mechanical testing standards. These standards typically involve a specific number of samples (e.g., 5 or 6 per test condition) of the device to be tested. The exact number of samples is not explicitly stated in this summary.
- Data provenance: Not specified, but generally, such bench testing is conducted in a controlled laboratory environment by the manufacturer or a contracted testing facility. It is prospective in the sense that the tests are planned and executed to evaluate the new device. Country of origin is Miami, FL, implying the sponsor is U.S.-based.
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 device's evaluation is based on mechanical testing, not clinical or diagnostic performance that would require expert adjudication of "ground truth" for patient data. The "ground truth" for mechanical testing is established by the test procedures and measurements themselves, compared against the predicate device's performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for mechanical testing. Adjudication methods are typically relevant for clinical studies or studies involving human interpretation (e.g., image reading).
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 a medical implant device, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the mechanical performance testing, the "ground truth" is derived from the established mechanical properties and performance of the predicate devices as demonstrated through their own testing and regulatory clearance, and the adherence to the relevant ASTM standards for intervertebral body fusion devices. The goal is to show the new device meets or exceeds these established benchmarks.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of mechanical performance testing for a spinal implant device. This terminology relates to machine learning or AI algorithm development.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device submission.

In summary: The provided document is a 510(k) submission establishing substantial equivalence for a spinal implant. This process primarily relies on benchtop mechanical testing against recognized industry standards (ASTM F2077, ASTM F2267) and comparison to predicate devices, rather than clinical trials involving patient data, human reader performance, or AI algorithms. Therefore, many of the requested details about study design and ground truth establishment, which are typical for clinical performance studies, are not present or applicable.

Summary

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510(k) SUMMARY Sintea Plustek's PLIF Lite and TLIF Lite Interbody Fusion system

JUL 2 4 2014

Date: ·

September 16, 2013

Contact:

Sintea Plustek Guido Zorzoli 305-673-6226 407 Lincoln Road Suite 10/L Miami, FL 33139

PLIF Lite and TLIF Lite (PLIF Lite and TLIF Lite Interbody Fusion system) Trade Name: Common Name: Intervertebral Body Fusion Device Product Class: Class II Classification: 888.3080 Product Code: MAX Panel Code: 87

Name of Sponsor

Sintea Plustek, LLC 407 Lincoln Road Suite 10/L Miami, FL 33139 305-673-6226

Device Description

Predicate Device

The PLIF Lite and TLIF Lite Interbody Fusion system is substantially equivalent to legally marketed predicate devices. The predicate devices are the Stryker (formerly Surgical Dynamics) Ray TFC Cage (P950019a), the Depuy Spine Lumbar I/F Cage Implant System (P960025), the Zimmer (formerly Spinal Concept) Fidji PEEK Lumbar Cage (K042714) and the R Tree Innovations Epicage (K092901).

Intended Use / Indications for Use

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and are intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Performance Testing

The PLIF Lite and TLIF Lite Lumbar Interbody devices were tested according to ASTM F2077 and ASTM F2267. Testing included static and dynamic axial compression, static and dynamic compression shear, static torsion, subsidence and expulsion. Test results demonstrate that the PLIF Lite and TLIF Lite devices are substantially equivalent to the predicate devices.

Summary:

The PLF Lite and TLIF Lite Interbody Fusion system is substantially equivalent to the predicate devices in regards to:

Indications for Use .
Materials .
. Dimensions
Function .
. Mechanical testing

There are no significant differences in technological characteristics compared to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 24, 2014

Sintea Plustek, LLC % Rich Jansen, Pharm.D. Silver Pine Consulting. LLC 11821 Bramble Cove Drive Fort Myers, Florida 33905

Re: K132907

Trade/Device Name: PLIF Lite and TLIF Lite Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 23, 2014 Received: June 26, 2014

Dear Dr. Jansen:

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 vour device is classified (sec 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Rich Jansen, Pharm.D.

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 yours,

Ronald P. Jean -S for

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) K132907

Device Name

PLIF Lite and TLIF Lite Interbody Fusion System

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

Katherine D. Kavlock, PhD

Division of Orthopedic Devices

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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.