IMPIX 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 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 IMPIX Lumbar Cage is bi-convex in the sagittal plane. It possesses teeth on both superior and inferior surfaces that assist in the anchorage and stability of the device to the bone of the vertebrae. The upper and lower aspects of the IMPIX-L are open, to allow the surgeon to pack the device with bone graft prior to insertion. Lateral holes exist to allow bone growth through the device. In order to the varying morphology of patients, the IMPIX Lumbar Cages are available in various sizes. The IMPIX Lumbar Cage is machined from PEEK OPTIMA LT1.

AI/ML Overview

The provided text describes a 510(k) premarket notification for IMPIX Lumbar Interbody Devices. This submission focuses on establishing substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness through extensive clinical trials. Therefore, the information typically found in acceptance criteria and detailed study descriptions for a device that demonstrates performance against specific metrics with human involvement (like AI-assisted diagnostics) is not present.

Here's an analysis based on the available text:

A table of acceptance criteria and the reported device performance

Acceptance Criteria: The primary acceptance criterion for this type of device (intervertebral body fusion device) is demonstrating substantial equivalence to a predicate device, primarily through mechanical testing and material equivalence. The text mentions "required mechanical strengths" as the benchmark.

Reported Device Performance:

Performance Aspect	Reported Performance
Mechanical Strength	"IMPIX Lumbar Interbody Fusion devices meet required mechanical strengths."
Material	Manufactured from PEEK OPTIMA LT1 (same as predicate).
Indications for Use	Same as predicate device.
Design (IMPIX-LA, IMPIX-LAD, IMPIX-TLIF)	Different from the predicate in design, but still deemed substantially equivalent based on testing.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated for mechanical tests. The "cadaver trial" would have involved a small number of cadavers, but the exact count is not provided.
- Data Provenance: Not specified for the mechanical tests. The cadaver trial likely took place where the manufacturer (MEDICREA Technologies, France) or its contact (Donald W. GUTHNER, PA, USA) conducted R&D.
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 as this is a mechanical device submission, not a diagnostic device requiring expert interpretation of images. The "ground truth" here is mechanical integrity and adherence to ASTM standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. The "test set" primarily refers to mechanical testing according to ASTM standards, which are objective measurements, not subjective evaluations by experts needing adjudication.
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, not an AI-powered diagnostic device. 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 medical implant, not an AI or algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is based on engineering standards and mechanical testing results (e.g., meeting requirements for axial compression, compressive shear, resistance to subsidence, and expulsion as defined by ASTM F2077 & ASTM F2267). For substantial equivalence, the "ground truth" is also the performance characteristics of the legally marketed predicate device.
The sample size for the training set
- Not applicable. This device does not use machine learning or AI, so there is no "training set."
How the ground truth for the training set was established
- Not applicable. There is no training set for this type of device.

In summary, the 510(k) submission for IMPIX Lumbar Interbody Devices relies on demonstrating that the new devices are substantially equivalent to a previously cleared predicate device (IMPIX Lumbar Interbody Device, K072226) through mechanical testing and material similarity, as opposed to extensive clinical testing with patient outcomes or expert reviews.

Summary

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510(K) SUMMARY

MAY 1 9 2010

1. GENERAL INFORMATION

Date Submitted	December 18, 2008
Trade Name	IMPIX-ALIF LUMBAR Interbody Device (Model IMPIX-LA)IMPIX-ALIF D LUMBAR Interbody Device (Model IMPIX-LAD)IMPIX-TLIF LUMBAR Interbody Device (Model IMPIX-TLIF)
Common Name	intervertebral body fusion device
Classification Name	intervertebral body fusion device - lumbar
Class	II
Product Code	MAX
CFR section	888.3080
Device panel	Orthopedic
Legally marketedpredicate devices	IMPIX Lumbar Interbody Device, MAX (K072226)
Submitter	MEDICREA TechnologiesZ.I. Chef de Baie17000 La Rochelle, France
Contact	Donald W. GUTHNER111 Hill RoadDouglasville, PA 19518

2. PREDICATE DEVICE DESCRIPTION

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3. DESCRIPTION OF DEVICE MODIFICATION

The purpose of this submission is to submit three new Lumbar Interbody devices:

IMPIX-LA
IMPIX-LAD -
IMPIX-TLIF -

Those three new devices and previously cleared in K072226 IMPIX-L Interbody devices are manufactured in the same material, PEEK OPTIMA® LT1, and have the same Indications for use. The devices differ only in design.

4. INTENDED USE

IMPIX 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.

5. PERFORMANCE DATA

Tests performed, according to ASTM F2077 & ASTM F2267, indicate that the IMPIX Lumbar Interbody Fusion devices meet required mechanical strengths. Tests conducted included axial compression, compressive shear, resistance to subsidence and resistance to expulsion.

In addition, a cadaver trial was performed to demonstrate implantation technique.

6. CLINICAL TESTING

Not applicable to this device

7. CONCLUSIONS

Based on the 510(k) Summary and the information provided herein, we conclude that the IMPIX LUMBAR Interbody Fusion Devices are substantially equivalent to the existing legally marketed device under the Federal Food, Drug and Cosmetic Act.

8. Additional Information

No additional information.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAY 1 9 2010

Medicrea Technologies % Donald W. Guthner Orgenix, LLC 111 Hill Road Douglassville, PA 19518

Re: K083798

rcoos770
Trade/Device Name: Impix ALIF Lumbar IBF, ALIF-D Lumbar IBF, TLIF Lumbar IBF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 12, 2010 Received: May 13, 2010

Dear Mr. Guthner:

We have reviewed your Section 510(k) premarket notification of intent to market the device we ferenced 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 connivelo phor the 2011-170, the accordance with the provisions of the Federal Food, Drug, teches hat fa vo occh rocation require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 on may, morely inams of the Act include requirements for annual registration, listing of general controls provisions of vactice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability acanceration. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see aboye) into either class II (Special Controls) or class III (PMA), it If your device to additional controls. Existing major regulations affecting your device can be may be subject to attentions. 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 r loase of the rised that I Dr o losean that your device complies with other requirements of the Act that + 2 . deval statutes and regulations administered by other Federal agencies. You must or any I 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 - Mr. Donald W. Guthner

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/ucm11.5809.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.

Barbara Buchner

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

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

Device Name: IMPIX Lumbar Interbody Devices

Indications for Use

IMPIX 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X : (Part 21 CFR 801 Subpart D)

AND/OR

ANNER FRID CUTATION WALL BARN AND ART ART ART ARE ARM AND ARM AND AND AND AND AND AND AND AND A

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

Signature

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

K083798 510(k) Number_

Page i

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.