The ENDURAMESH is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autograft. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference.

Device Description

The ENDURAMESH is a vertebral body replacement system which provides structural support of the vertebral bodies following an anterior or far lateral corpectomy, aiding in spinal fusion. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference.

The ENDURAMESH vertebral body replacement system consists of a single cylindrically shaped titanium mesh cage. The hollow core of the cage allows for packing bone graft and the circular holes throughout the device promote bone fusions. Various diameters and heights are available to accommodate variability among patients.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called ENDURAMESH, a spinal intervertebral body fixation orthosis. Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets specific performance criteria in a clinical or AI-assisted context.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (DePuy Harms Mesh Cage (K003043)) through non-clinical mechanical testing.

Therefore, many of the requested information points cannot be extracted from the given text.

Here's a breakdown of what can and cannot be answered:

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

Cannot be provided: The document does not define specific clinical acceptance criteria (e.g., success rates, complication rates, image quality metrics) or report performance against such criteria. The "performance" reported refers solely to mechanical testing results comparing it to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable / Cannot be determined: There is no clinical "test set" in the traditional sense described. The "testing" referred to is mechanical testing of the physical device, not a study involving 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: As there's no clinical test set or diagnostic task, there's no ground truth established by experts.

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

Not applicable: No clinical test set.

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:

No: This is a submission for a physical medical implant, not an AI/software device. Therefore, no MRMC study or AI assistance is relevant here.

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

No: This device is a physical implant, not an algorithm.

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

Not applicable: No clinical ground truth is established for this mechanical device submission.

8. The sample size for the training set:

Not applicable: No AI algorithm or training set is mentioned as this is a physical implant.

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

Not applicable: No AI algorithm or training set is mentioned.

Summary of Non-Clinical Tests (from the document):

The only "studies" mentioned are non-clinical mechanical tests to demonstrate substantial equivalence to the predicate device.

Tests Performed: Static Compression, Dynamic Compression, Static Torsion, Dynamic Torsion, Subsidence, and Expulsion.
Standards Used: ASTM F2077 and ASTM F2267.
Outcome: "The device functioned as intended and the performance results show that the ENDURAMESH is substantially equivalent to the predicate device."

Conclusion:

The provided K093207 submission for the ENDURAMESH device is a 510(k) Pre-market Notification focusing on demonstrating substantial equivalence to a predicate device through non-clinical mechanical testing. It does not involve AI, clinical efficacy studies with human subjects, or the establishment of ground truth for diagnostic purposes. Therefore, the majority of the requested information points, which are typically relevant for AI/diagnostic device submissions, are not present in this document.

Summary

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K093207

510(k) Summary

Summary of 510(k) Safety and Effectiveness

Submitted By:	Lucero Medical, LLC.PO Box 67Richfield, OH 44286	APR 2 6 2010
Date:	April 22, 2010
Contact Person:	Jennifer PalinchikProject Manager
Contact Telephone:	(440) 808-9995
Device Trade Name:	ENDURAMESH
Device Classification Name:	Spinal intervertebral body fixation orthosis
Device Classification:	Class II
Reviewing Panel:	Orthopedic/87
Regulation Number:	888.3060
Product Code:	MQP
Predicate Devices:	DePuy Harms Mesh Cage (K003043)

Device Description:

Indications for Use:

The ENDURAMESH is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference.

Substantial Equivalence Information:

The design features, material, and indications for use of the ENDURAMESH system are substantially equivalent to the predicate devices listed above. The safety and effectiveness is adequately supported by the substantial equivalence, material information, and analysis data provided within this Premarket Notification.

Summary of Non-Clinical Tests:

The following mechanical testing was performed per ASTM F2077 and ASTM F2267 to demonstrate substantial equivalence of the subject device to the predicate device: Static Compression, Dynamic Compression, Static Torsion, Dynamic Torsion, Subsidence, and Expulsion. The device functioned as intended and the performance results show that the ENDURAMESH is substantially equivalent to the predicate device.

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three wing-like shapes, symbolizing health, services, and human needs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

APR 2 6 2010

Lucero Medical, LLC % Ms. Jennifer Palinchik Project Manager P.O. Box 67 Richfield, Ohio 44286

Re: K093207

Trade/Device Name: Enduramesh Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: April 12, 2010 Received: April 16, 2010

Dear Ms. Palinchik:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 910(x) premained issubstantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manietics promotive Americal Device Amendments, or to commerce prov to May 28, 1976, the enactiven assist of the Federal Food, Drug, devices that have been recuired in aver approval of a premarket approval application and Cosmetic Act (Act) market the device, subject to the general controls provisions of the (PMA). You may, therefore, market the Act include requirements for annual registration,
Act. The general controls provisions of the Act include requirements for annual regist Act. The general controls provisions of the rice habeling, and prohibitions against misbranding ilsting of devices, good manufacturing practice, in county in - information related to contract itability. and adulteration. Frease note: CDICI Goos not ovation must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or classics on be If your device is classified (see above) into than major regulations affecting your device can be may be subject to additional confrols. "Entraling and on 898. In addition, FDA may found in the Code of I each resgurerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA's issualled of a bacession with other requirements of the Act
that FDA has made a determination that your device complies with one and on anyat inal FDA has made a deciermination and your acceral by other Federal agencies. You must and ligit of any Federal statules and regulations administered of Callerial of registration and listing (21

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Page 2 - Ms. Jennifer Palinchik

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI'N Fat 607), adoming (21 OFR 803); good manufacturing proctice requirements as set de vice-related adverse orents) (2) CFR Part 820); and if applicable, the electronic forth in the quality by crems (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (1 CFR Patt 801), please IT you ucsire specific advice to: your conters Offices/CDRH/CDRHOffices/ucm115809.htm for go to nttp://www.lua.goff.rRadiological Health's (CDRH's) Office of Compliance. Also, please the Conter to: Doviete and , "Misbranding by reference to premarket notification" (21CFR Part note the regulations 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 r ou may obtain other general memational 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Barbara Buekus

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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Indications for Use

510(k) Number (if known): K093207

Device Name: ENDURAMESH

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

K093207 510(k) Number_

Page 1 of 1

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.