The stand-alone intersomatic IMPIX ALIF S/A implants are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine 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 at the involved level(s).

This device is to be used with autogenous bone graft.

Patients should have a satisfactory course of conservative treatment (usually at least six (6) months of non-operative treatment) prior to treatment with an IMPIX-ALIF-S/A stand-alone cage.

The IMPIX ALIF S/A devices should be used with the three (3) bone screws (Small Footprint) or four (4) bone screws (Medium. Large Footprints) accompanying the device. Otherwise, an additional fixation system (e.g., pedicle screw system) should be implanted.

Device Description

The MEDICREA® IMPIX ALIF S/A is an intervertebral fusion device with integrated fixation use as an adjunct to fusion. The implant is composed of:

one PEEK cage with tantalum markers
either 3 or 4 IMPIX ALIF S/A screws , depending on the footprint of cage considered.

The IMPIX ALIF S/A screw is manufactured from titanium alloy (Ti-6Al-4V) meeting ASTM F136 and ISO 5832-3 standards, and the PEEK cage is manufactured from PEEK OPTIMA® LT1 meeting the ASTM F 2026.The tantalum markers are manufactured from tantalum meeting the ASTMF560 and ISO 13782 standards.

Materials: Titanium alloy (Ti-6Al-4V) and PEEK OPTIMA® LT1 and tantalum

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (IMPIX ALIF S/A), primarily focusing on demonstrating substantial equivalence to predicate devices for regulatory clearance. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically expected for an AI/ML powered device, or a clinical trial showing efficacy.

The "performance data" section in the document refers to biocompatibility and mechanical testing, which are standard for implantable medical devices, not for assessing the performance of an AI model against specific acceptance criteria.

Therefore, for the requested information regarding acceptance criteria and a study proving the device meets those criteria, most of the fields cannot be filled from the provided text as they are not applicable to the type of regulatory submission presented.

Here's a breakdown of what can be extracted and why other parts cannot be:

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

Acceptance Criteria	Reported Device Performance
Biocompatibility	Conforms to ISO 10993-1, ASTM F136, ISO 5832-3, ASTM F2026, ASTM F560, ISO 13782 standards. Tests included Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Pyrogen Testing.
Mechanical Testing	Demonstrated substantially equivalent performance to identified predicate device systems. Tests included FEA, static/dynamic axial compression (ASTM F2077-11), static/dynamic compression shear (ASTM F2077-11), Subsidence (ASTM F2267-04), Expulsion (ASTM Draft Standard F-04.25.02.02), Screw clip-out evaluation.

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. The "performance data" refers to engineering and laboratory tests of the physical device, not performance on a dataset of 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 information is irrelevant for the mechanical and biocompatibility testing of a physical implant.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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. The device is an intervertebral fusion device, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For biocompatibility: Adherence to established ISO and ASTM standards for materials and biological reaction.
For mechanical testing: Adherence to established ASTM standards for mechanical properties.
No clinical ground truth (like pathology or outcomes data) was used or provided as no clinical studies were performed.

8. The sample size for the training set
Not applicable. This document describes a physical medical device, not an AI/ML algorithm that would have a "training set."

9. How the ground truth for the training set was established
Not applicable.

Summary of what the document confirms regarding performance:

No clinical studies were performed.
No animal studies were performed.
The device's performance was assessed through biocompatibility testing and mechanical testing against relevant ISO and ASTM standards, demonstrating compliance and substantial equivalence to predicate devices.
The biocompatibility testing included cytotoxicity, sensitization, irritation, systemic toxicity, and pyrogen testing.
The mechanical testing included FEA, static and dynamic axial compression, static and dynamic compression shear, subsidence, expulsion, and screw clip-out evaluation, all performed in compliance with FDA guidance and ASTM standards for intervertebral body fusion devices.

This document specifically highlights that the "performance data" provided was sufficient to establish "substantial equivalence" for regulatory approval without human or animal clinical studies, or any data-driven AI/ML performance evaluation.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with outstretched arms, which is meant to represent the department's mission of protecting the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the figure.

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

January 15, 2015

Medicrea International S.A. Mr. David Ryan Marketing & Product Development Director 14 Porte Du Grand Lyon 01700 Neyron France

Re: K141187

Trade/Device Name: IMPIX ALIF S/A Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX Dated: December 17, 2014 Received: December 19, 2014

Dear Mr. Ryan:

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

{1}------------------------------------------------

Page 2 – Mr. David Ryan

(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 (OS) 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/Resourcesfor You/Industry/default.htm. 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 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,

Mark N. Melkerson -S

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

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K141187

Device Name IMPIX ALIF S/A

Indications for Use (Describe)

This device is to be used with autogenous bone graft.

Patients should have a satisfactory course of conservative treatment (usually at least six (6) months of non-operative treatment) prior to treatment with an IMPIX-ALIF-S/A stand-alone cage.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

1. DEVICE SUBMITTER

MEDICREA® INTERNATIONAL S.A. 14 Porte Du Grand Lyon 01700 NEYRON- France

Phone: +33 4 72 01 87 87 Fax: +33 4 72 01 87 88

Contact Person: David Ryan VP Product Development and Marketing dryan@medicrea.com

Date Prepared: 12/01/2015

DEVICE

Name of Device: IMPIX ALIF S/A

Common or Usual Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar Intervertebral Fusion Device With Bone Graft, Lumbar

Classification Name: Intervertebral Body Fusion Device

Regulatory Class: 21 CFR 888.3080- Intervertebral Body Fusion Device Product Code: OVD; MAX

3. PREDICATE DEVICE

The primary predicate used in this 510(k) notice is:

The STALIF MIDLINE (Centinel Spine, K101301)
The additional predicates are:
The IMPIX ALIF Lumbar IBF (MEDICREA TECHNOLOGIE, K083798) ●
. The IMPIX L (MEDICREA TECHNOLOGIE, K072226)
The SYNFIX LR (Synthes Spine, K062083)
. The STALIF TT (Surgigraft Limited,K073109)

These predicates have not been subject to a design-related recall.

{4}------------------------------------------------

4. DEVICE DESCRIPTION

The MEDICREA® IMPIX ALIF S/A is an intervertebral fusion device with integrated fixation use as an adjunct to fusion. The implant is composed of:

one PEEK cage with tantalum markers
either 3 or 4 IMPIX ALIF S/A screws , depending on the footprint of cage considered.

Materials: Titanium alloy (Ti-6Al-4V) and PEEK OPTIMA® LT1 and tantalum

5. INDICATIONS FOR USE

The stand-alone intersomatic IMPIX ALIF S/A implants are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine from L2-S1. DDD is defined as discogenic back pain with deqeneration 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.

Patients should have a satisfactory course of conservative treatment (usually at least six (6) months of non-operative treatment) prior to treatment with an IMPIX-ALIF-S/A stand-alone cage.

The IMPIX ALIF S/A devices should be used with the three (3) bone screws (Small Footprint) or four (4) bone screws (Medium, Large Footprints) accompanying the device. Otherwise, an additional fixation system (e.g., pedicle screw system) should be implanted.

{5}------------------------------------------------

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The table below compares the features and characteristics of the IMPIX ALIF SA to its predicate device.

Device	IMPIXALIF SA -New	IMPIX ALIFLumbar IBF	IMPIX L	STALIFMIDLINE	STALIF TT	SYNFIX LR
510(k)number	K062083	K083798	K072226	K101301	K073109	K062083
Lumbar	Yes	Yes	Yes	Yes	Yes	Yes
AnteriorApproach	Yes	Yes	No	Yes	Yes	Yes
Design
Anchoragemean	3 or 4screws	No	No	3 screws	3 screws	4 screws
Securityfeatures	Screwsheadclippedwithin thecage	No	No	Titaniumring on thescrewsclippedinthe cage	No	Screw headthreaded ina titaniumplate
Shape	Anatomicalshape	Anatomicalshape	Rectangularshape	Semi-cylindricalshape	Semi-cylindricalshape	Rectangularshape
Standalonedevice	Yes	No	No	Yes	Yes	Yes
Materials
Ti-6Al 4V	Yes	No	No	Yes	Yes	No
Titaniumalloy(TAN)	No	No	No	No	No	Yes
Tatalum	Yes	Yes	Yes	Yes	Yes	Yes
PEEKOPTIMA®LT1	Yes	Yes	Yes	Yes	Yes	Yes

Material composition is identical to other MEDICREA® INTERNATIONAL products that have been cleared via the 510(k) process.

{6}------------------------------------------------

7. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for the IMPIX ALIF S/A system was conducted in accordance with the FDA blue book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

く Cytotoxicity
V Sensitization
V Irritation
V Systemic toxicity
V Pyrogen Testing

According to the standard ISO 10993-1, the IMPIX ALIF S/A System is defined as implantable device

in contact with tissue and bone and as a permanent contact with the patient.

For chemical composition, the material conform to Ti-6Al-4V ELI, following ASTM F136 and ISO 5832-3 standards, PEEK OPTIMA LT1 following ASTM F2026 standard and Tantalum following ASTM F560 and ISO 13782 standards.

Mechanical testinq

Testing in compliance with the FDA's June 12, 2007 "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device was performed for the IMPIX ALIF S/A system and demonstrated substantially equivalent performance to the identified predicate device systems.

The following Mechanical tests were performed:

. FEA testing to determine worst case
Static and dynamic axial compression (per ASTM F2077-11) ●
Static and dynamic compression shear (per ASTM F2077-11) ●
Subsidence (per ASTM F2267-04) ●
Expulsion (per ASTM Draft Standard F-04.25.02.02) ●
Screw clip-out evaluation o

Clinical study

No clinical studies were performed.

Animal study

No animal studies were performed.

8. CONCLUSION

MEDICREA® INTERNATIONAL S.A. IMPIX ALIF S/A Spinal System - additional components are substantially equivalent to the already cleared STALIF MIDLINE(Centinel Spine, K101301); STALIF TT (Surgigraft Limited.K073109); SYNFIX LR (Synthes Spine, K062083); IMPIX ALIF Lumbar IBF (MEDICREA TECHNOLOGIE, K083798); IMPIX L (MEDICREA TECHNOLOGIE, K072226) in terms of intended use, materials used, sterilization, mechanical safety and performances

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.