IMPIX DLIF Lumbar Interbody Device 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 I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. IMPIX DLIF Lumbar Interbody Device 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 purpose of this submission is to submit the new Lumbar Interbody device: IMPIX-DLIF, or Dual Lateral Interbody Fusion, has a rectangular shape with a front beveled and has three areas inside for use with autogenous bone graft. This new device and IMPIX-L Interbody devices previously cleared in K072226 are manufactured in the same material, PEEK OPTIMA® LT1, and have the same Indications for use. The devices differ in geometry and approach.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the IMPIX DLIF Lumbar Interbody Device. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than clinical studies or specific acceptance criteria with defined performance metrics.

Based on the provided document, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define acceptance criteria as pass/fail thresholds for specific performance metrics in a way that would typically be seen in a clinical study report. Instead, it describes mechanical tests performed and implies that the device's performance in these tests was comparable to or within acceptable limits for similar predicate devices. The "reported device performance" is essentially the execution of these tests, with the conclusion that the device is "substantially equivalent."

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Resistance (e.g., Static axial Compression, compression-shear, torsion, subsidence) to allow fusion, maintain/restore intervertebral height, and provide stability.	Testing performed according to ASTM F2077 and ASTM F2267. Specific numerical results are not provided in this summary, but the conclusion is that the device is "substantially equivalent" to predicate devices in terms of mechanical safety and performance.
Use of recognized standard materials.	Lumbar cage: PEEK OPTIMA® LT1 (ASTM F2026). Pins markers: Tantalum (ISO 13782). This matches predicate devices.
Intended Use	Indicated for intervertebral body fusion in skeletally mature patients with DDD at L2-S1, to be used with autogenous bone graft and supplemental fixation. This matches predicate devices.

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

The document states:

Sample Size for Test Set: Not explicitly stated for specific numerical outcomes. For non-clinical tests, it's typically a small number of devices per test (e.g., n=5 or n=10 per test condition). The summary only mentions "The following tests were conducted," implying a standard set of tests for interbody fusion devices.
Data Provenance: The data is based on non-clinical laboratory testing performed in support of regulatory submission (510(k)). This is not human data (retrospective or prospective), but rather mechanical test data from the device itself. The country of origin for the testing is not specified, but the applicant is from France.

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

Experts: Not applicable for non-clinical mechanical testing. Ground truth for mechanical tests is established by objective measurements against engineering standards (ASTM F2077, ASTM F2267).
Qualifications: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Mechanical tests have objective, quantifiable outcomes which don't require expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: No. This device is an interbody fusion device (an implant), not a software algorithm or an AI-powered diagnostic tool. Therefore, the concept of "standalone performance" for an algorithm is not applicable.

7. The Type of Ground Truth Used

Ground Truth: For this device, the "ground truth" for demonstrating substantial equivalence relies on:
- Engineering Standards: Conformance to recognized ASTM standards (F2077, F2267) for mechanical properties.
- Material Specifications: Conformance to specified material standards (e.g., PEEK OPTIMA® LT1 (ASTM F2026), Tantalum (ISO 13782)).
- Comparison to Predicate Devices: Demonstrating similar design, materials, and intended use as legally marketed predicate devices.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

In summary, the provided document is a 510(k) summary for a physical medical implant. The "acceptance criteria" and "study" described are primarily related to non-clinical mechanical testing and material compatibility, demonstrating substantial equivalence to existing predicate devices rather than clinical performance against specific metrics with human data. Most of the requested information regarding AI performance, expert adjudication, or clinical study design is therefore not relevant or available in this context.

Summary

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K100544

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Image /page/0/Picture/2 description: The image shows the word "MEDICREA" in bold, black letters. The letters are capitalized and have a slightly blocky appearance. To the left of the word is a small, abstract graphic that appears to be a stylized representation of a medical symbol. The word and the graphic are enclosed in a rectangular border.

510(k) Summary for the IMPIX DLIF

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the IMPIX DLIF.

Date Prepared: June 14, 2010

1. Submitter:
  MEDICREA TECHNOLOGIES ZI CHEFDE BAIE LA ROCHELLE 17000 FR

Contact Person:

J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: 512-388-0199

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FDA CDRH DMC

1. Trade name: IMPIX DLIF LUMBAR Interbody Device Common Name: Intervetebral body fusion Classification Name: Intervertebral body fusion device - lumbar

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

The IMPIX-L Lumbar Cages (MEDICREA, K072226) .
The ORACLE Spacer (Synthes, K072797) .
. The CROSS-FUSE (Pioneer, K073177)
. The Vu-a-Pod (Theken spine, K080822)

Description of the device: র্ব

This new device and IMPIX-L Interbody devices previously cleared in K072226 are manufactured in the same material, PEEK OPTIMA® LT1, and have the same Indications for use. The devices differ in geometry and approach.

Materials: PEEK OPTIMA LT1

Function: The IMPIX DLIF was developed as an implant:

. to maintain and/or to restore the intervertebral height and the spinal curve (after discectomy)
. to promote bone fusion
to provide stability to ease fusion �
. to be mechanically resistant to allow the fusion of the operated level

5. Substantial equivalence claimed to predicate devices

IMPIX DLIF is substantially equivalent to the IMPIX-L in terms of intended use, materials used, mechanical safety and performances, and the ORACLE Spacer or the Cross-Fuse in terms of intended use, design, materials used, mechanical safety and performances. IMPIX DLIF 40mm is substantially equivalent to the Vu-a-Pod for an antero-lateral approach.

The table below compares the features and characteristics of the IMPIX DLIF to these predicate devices.

Device	IMPIX DLIF	IMPIX-LInterbody Device(MEDICREA)	ORACLE Spacer(SYNTHES)	Vu-a-Pod(Theken Spine)	CROSS-FUSE(Pioneer)
510(k)number	/	K072226	K072791	K080822	K073177
Intended use

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Device	IMPIX DLIF	IMPIX-LInterbody Device(MEDICREA)	ORACLE Spacer(SYNTHES)	Vu-a-Pod(Theken Spine)	CROSS-FUSE(Pioneer)
Lumbar spine	Yes	Yes,	Yes	Yes	Yes
AnterolateralApproach	Yes, only withthe 40mm DLIFcages	No	No	Yes	No
LateralApproach	Yes	No	Yes	No	Yes
Design
Bonegraftcavity	Yes	Yes	Yes	Yes	Yes
Teeth / ridges	Yes	Yes	Yes	Yes	Yes
X-Ray Markers	Yes	Yes	Yes	Yes	Yes
Shape	Rectangularshape	Rectangularshape	Oval shape	Rectangularshape	Rectangularshape
Materials
Lumbar cage	PEEK OPTIMA®LT1 (ASTMF2026)	PEEK OPTIMA®LT1 (ASTM F2026)	PEEK OPTIMA®LT1 (ASTM F2026)	PEEK OPTIMALT1 (ASTMF2026)	PEEK OPTIMA®LT1 (ASTM F2026)
Pins markers	Tantalum (ISO13782)	Tantalum (ISO13782)	Tantalum (ISO13782)	Titanium, Ti-6Al-4V ELI(ASTM F-136)	Tantalum (ISO13782)

દ. Intended Use:

IMPIX DLIF Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative 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 I spondvlolisthesis at the involved level(s). This device is to be used with autogenous bone graft. IMPIX DLIF Lumbar Interbody Device 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. Non-clinical Test Summary:

Testing was performed on the IMPIX DLF following the protocols outlined in ASTM F2077 "Test Methods for Intervertebral Body Fusion Devices" and ASTM F2267 "Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression".

The following tests were conducted:

. Static axial Compression results
. Static compression-shear results
. Static torsion results
Static subsidence results ●

8. Clinical Test Summary

No clinical studies were performed

ರು Conclusions Nonclinical and Clinical

IMPIX DLF is substantially equivalent to the predicate devices in terms of indications for use, design, material and function.

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Public Health Service

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

Medicrea Technologies % The OrthoMedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K100544

Trade/Device Name: IMPIX® DLIF Lumbar Interbody Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 18, 2010 Received: June 22, 2010

Dear Mr. Webb:

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

IJUL 2 2 2010

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Page 2 - Mr. J.D. Webb

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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bartare meins

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

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K100544 Device Name: IMPIX® DLIF Indications for Use:

IMPIX DLIF Lumbar Interbody Device 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.

Prescription Use(Part 21 CFR 801 Subpart D)	✓ AND/OR
Over-The-Counter Use(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KI00544 510(k) Number

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.