The PASS Anterior Spinal System is an anterolateral screw fixation system intended to provide immobilization and stabilization of spinal segments from T4 to L5 in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic and lumbar spine:

Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
· Traumatism (ex: fracture, dislocation)
· Tumor
· Spinal deformation such as scoliosis or kyphosis
· Failed previous fusion (Pseudoarthrosis)

Device Description

The Medicrea PASS Anterior Spinal System consists of screws, rods, plates, staples, connection and locking devices. It can be used for single or multiple level fixations, with one or two rods. This system has been developed to accommodate a left or right anterior approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ISO 5832-3 specifications and ASTM F136 specifications.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called the "PASS Anterior Spinal System." It is a spinal intervertebral body fixation orthosis. The document focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than providing detailed acceptance criteria and a study to prove performance in the context of an AI/machine learning device.

Therefore, most of the requested information for an AI/ML device's acceptance criteria and study proving performance is not applicable to this document.

However, I can extract what is provided regarding non-clinical testing and the overall conclusion.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a mechanical spinal implant, the "acceptance criteria" are based on mechanical performance tests, and "reported device performance" refers to the device passing these tests.

Acceptance Criteria Category	Specific Test	Reported Device Performance (PASS Anterior Spinal System)
Mechanical Performance	Static testing in axial compression bending	Test conducted in a load to failure mode (Passed/Met)
Mechanical Performance	Static testing in torsion	Test conducted in a load to failure mode (Passed/Met)
Mechanical Performance	Cyclical axial compression bending testing	Test conducted (Passed/Met)

Note: The document states "The following tests were conducted according to ASTM F1717," implying successful completion and meeting relevant standards for spinal implants. However, specific numerical acceptance thresholds or results (e.g., "device withstood X N-m," or "deformation less than Y mm") are not provided in this summary.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable in the context of an AI/ML test set. For mechanical testing, the "sample size" would refer to the number of devices tested. This information is not explicitly stated in the summary, but typically multiple units are tested per configuration to ensure reproducibility and statistical significance.
Data Provenance: Not applicable for AI/ML specific data provenance. The testing is non-clinical, done in a laboratory environment according to ASTM F1717.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a mechanical device, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.

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

Not applicable. Adjudication methods are relevant for clinical studies or AI/ML evaluations, not mechanical 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 a mechanical spinal implant, not an AI-assisted diagnostic tool.

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

Not applicable. This is a mechanical spinal implant.

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

For the mechanical tests, the "ground truth" would be the engineering specifications and performance standards defined by ASTM F1717 for spinal implant constructs. The device's ability to withstand certain loads and cycles without failure or exceeding deformation limits constitutes meeting the "ground truth" for mechanical integrity.

8. The sample size for the training set

Not applicable. There is no AI/ML training set for this mechanical device.

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

Not applicable. There is no AI/ML training set for this mechanical device.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the provided document):

The provided document describes a Non-Clinical Test Summary which details mechanical testing performed according to ASTM F1717. These tests included:

Static testing in a load to failure mode in axial compression bending.
Static testing in a load to failure mode in torsion.
Cyclical axial compression bending testing.

The conclusion drawn from these tests is that "The PASS Anterior Spinal System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function." This implies that the device successfully met the mechanical performance requirements defined by the ASTM standard, thereby demonstrating its safety and effectiveness comparable to existing, legally marketed devices.

No clinical studies were performed as the substantial equivalence was established through design, material comparison, and non-clinical mechanical testing, which is common for spinal fixation systems.

Summary

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

510(K) SUMMARY

AUG 2 3 2011

GENERAL INFORMATION

Trade Name	PASS Anterior Spinal System
Common Name	• Anterolateral screw system• Anterolateral plate
Classification Name	Spinal intervertebral body fixation orthosis per KWQ 888.3060
Class	II
Product Code	KWQ
CFR section	888.3060
Device panel	Orthopedic
Legally marketed predicate devices	Colorado II Spinal System (Medtronic Sofamor Danek) = K991031Expedium Anterior Spine System (Depuy Spine) = K041205Moss Miami (DePuy Spine) = K964024 / K982011PWB (Cross Medical) = K920116Synergy VLS (Interpore Cross) = K012871ISOLA (Acromed) = K980485Halm Zielke Instrumentation System (Micomed Ortho) = K024125
Date prepared	May 16, 2011
Submitter	MEDICREA® INTERNATIONAL14 Porte du Grand Lyon01700 NEYRON, France
Contact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199E-Mail: ortho.medix@sbcglobal.net

DEVICE DESCRIPTION

INTENDED USE

Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
· Traumatism (ex: fracture, dislocation)
· Tumor
· Spinal deformation such as scoliosis or kyphosis
· Failed previous fusion (Pseudoarthrosis)

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

SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES

The PASS Anterior Spinal System is similar to the Moss Miami and the Halm Zielke Instrumentation System.

DeviceNameItems	PASS Anterior SpinalSystem	Moss Miami	Halm ZielkeInstrumentation System
510(k) number	/	K982011	K024125
Sponsor	Medicrea	Depuy Spine	Micomed
DeviceClassificationName	Spinal intervertebral bodyfixation orthosis	888.3060/ Spinalintervertebral bodyfixation orthosis	888.3060/ Spinalintervertebral bodyfixation orthosis
Product Code	KWQ	KWQ	KWQ
Intended use	Per KWQ	Per KWQ	Per KWQ
Material	Ti6Al4V alloy per ASTMF-136 or ISO 5832-3	Manufactured frombiocompatible StainlessSteel or Titanium	Manufactured frombiocompatible StainlessSteel (316 LS) accordingto ASTM F1314 orTitanium (Ti 6Al 4V)according to ASTM F136
Components	- simple screws Ø5.5,6.5 or 7.2mm, L=25 to50mm- rods Ø5.5, L=60 to280mm- staples- plates- nuts- dual connectors	The MOSS Miami iscomposed of the followingmajor components: rod,screws and bolts.	The HALM ZIELKEInstrumentation system iscomposed of the followedmajor components: rod,screws and nuts,

NON-CLINICAL TEST SUMMARY

The following tests were conducted according to ASTM F1717:

Static testing in a load to failure mode in axial compression bending 1.
1. Static testing in a load to failure mode in torsion
Cyclical axial compression bending testing ని.

CLINICAL TEST SUMMARY

No clinical studies were performed.

CONCLUSIONS: NON-CLINICAL AND CLINICAL

The PASS Anterior Spinal System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

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

AUG 2 3 2011

Re: K102406

Trade/Device Name: Pass Anterior Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal invertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 27, 2011 Received: August 02, 2011

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

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

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/CDRHQffices/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 vours.

Sincerely, yours,

Euin Keith

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

. :

Device Name: PASS Anterior Spinal System

Indications for use:

The PASS Anterior Spinal Systems is an anterolateral screw fixation system intended to provide ime 1 ASS hillization of spinal segments from T4 to L5 in skeletally mature patients as inningbination and callery of the following acute and chronic instabilities or deformities of thoracic and lumbar spine:

Degenerative disc disease {DDD} (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
Traumatism (ex: fracture, dislocation)
Tumor
Spinal deformation such as scoliosis or kyphosis
= Failed previous fusion (Pseudoarthrosis)

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

510(k) Number K102406

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.