OptiMesh 500E is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal or tibial plateau in hip stem and total knee replacement.

OptiMesh 500E is not intended for use in spinal indications.

Device Description

OptiMesh 500E is an implantable PET device indicated for use as a cement restrictor in the femur and tibia. OptiMesh 500E is manufactured from polyethylene terephthalate (PET). The device is provided pre-loaded, for ease of handling, on a disposable holder made of stainless steel. The device is available in a variety of different sizes to suit the individual pathology and anatomical conditions of the patient.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called OptiMesh 500E Cement Restrictor. This document establishes that the device is substantially equivalent to legally marketed predicate devices. However, it does not include information about specific acceptance criteria and a study proving those criteria are met in the way typically found for AI/ML-based devices with quantitative performance metrics.

The document is for a physical medical device (cement restrictor) and its clearance is based on substantial equivalence to existing predicate devices, not on meeting specific performance acceptance criteria from a clinical study with quantitative outcomes.

Therefore, the requested information elements related to AI/ML device performance (like sample size for test set, provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details) are not applicable to this type of device submission as described in the provided text.

Here's an analysis of what is available:

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

Acceptance Criteria: The primary "acceptance criterion" for this type of device, as per the document, is demonstrating substantial equivalence to existing predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.
Reported Device Performance: Instead of performance metrics from a clinical study, the "performance" demonstrated is that the device is identical in materials and similar in configuration and principles of use to predicate devices. Configurational differences were addressed through testing, which found "no new questions of safety or effectiveness."

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Summary)
Intended Use Equivalence to Predicate Devices	OptiMesh 500E intended use is equivalent to the intended use for other bone cement restrictors (e.g., in orthopedic surgeries such as those involving the femoral canal or tibial plateau in hip stem and total knee replacement).
Material Equivalence to Predicate Devices (specifically OptiMesh)	The OptiMesh 500E material is identical to the previously cleared OptiMesh device material (Polyethylene terephthalate - PET).
Similar Configuration and Principles of Use to Predicate Devices	OptiMesh 500E is similar in configuration and principles of use to other devices used to contain orthopedic reconstruction materials.
No New Questions of Safety or Effectiveness compared to Predicate Devices (after testing)	Configurational differences between OptiMesh 500E and predicate devices were addressed through testing. The testing resulted in "no new questions of safety or effectiveness for a bone cement restrictor." (Specific test details are not provided in this summary).

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. This is a physical device submission focused on substantial equivalence through material and design comparison, supported by internal testing (not clinical trials with human participant test sets).

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. Ground truth as typically defined for AI/ML models is not relevant here.

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. This is not an AI-assisted device.

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

Not applicable. This is a physical device.

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

For this type of device, the "ground truth" would be related to engineering specifications, material properties, and mechanical performance demonstrated through non-clinical testing, rather than clinical outcomes or diagnostic accuracy. The text indicates "configurational differences... were addressed through testing," which implies mechanical or bench testing.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires training data in that sense.

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

Not applicable.

In summary, the provided document relates to a traditional medical device (cement restrictor) seeking 510(k) clearance based on demonstrating substantial equivalence to already cleared predicate devices. The study that "proves" the device meets acceptance criteria primarily involves bench testing and comparison to predicate device specifications rather than clinical study data and performance metrics typically associated with AI/ML or efficacy trials.

Summary

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510(k) Summary (as required by 21 CFR 807.92c)

Submitter Information	Manufacturer's Contact Person
Spineology Inc.	Pamela R. Snyder
1815 Northwestern Ave.	Director of Clinical and Regulatory Affairs
Stillwater MN 55082	Phone: 651-351-1011
Establishment registration number: 2135156	Fax: 651-351-0712
	e-mail: psnyder@spineology.com

Device Names

Proprietary Name	OptiMesh 500E Cement Restrictor
Common/Usual Name	Cement restrictor
Classification Name	Prosthesis, Hip, Cement Restrictor
Regulatory Classification	Class II, 878.3300 Surgical Mesh
Device Product Code	JDK

Predicate Devices

The subject device is substantially equivalent to similar previously cleared predicate devices, RABEA Cement Restrictor, K020836, ImproVise Absorbable Cement Flow Restrictor, K011943 and OptiMesh, K014200.

Device Description

Intended Use

OptiMesh 500E is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal or tibial plateau in hip stem and total knee replacement.

WARNING: This device is not intended for use in spinal applications. The safety and effectiveness of this device when implanted in the spine have not been established.

Technological Characteristic Comparison

The OptiMesh 500E cement restrictor is identical in materials and similar in configuration and principles of use to other devices used to contain orthopedic reconstruction materials, including bone cement and bone graft. The OptiMesh 500E intended use is equivalent to the intended use for other bone cement restrictors. The OptiMesh 500E material is identical to the previously cleared OptiMesh device material. Configurational differences between OptiMesh 500E and the predicate bone cement restrictors were addressed through testing. No new questions of safety or effectiveness for a bone cement restrictor were raised during the testing and evaluation of OptiMesh 500E. OptiMesh 500E is, therefore, substantially equivalent to the named predicate devices.

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Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo features a stylized bird in flight, composed of three curved lines that suggest movement and wings. Encircling the bird is text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES - USA'. The text is arranged along the circumference of the circle, with the bird positioned in the center.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 6 2004

Ms. Pamela Snyder Director of Clinical and Regulatory Affairs Spineology, Inc. 1815 Northwestern Avenue Stillwater, Minnesota 55082-6500

Re: K033953

Optimesh 500E Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: April 16, 2004 Received: April 19, 2004

Dear Ms. Snyder:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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 (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's package insert and also as a Warning on the product label:

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WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS.

THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 (21 CFR Part 807); labeling (21 CFR Part 801); 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.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

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Page 3 – Ms. Pamela Snyder

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address: http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Naletta

Donna-Bea Tillman, Ph.D. Acting Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment

ATTACHMENT 1: INTENDED USE STATEMENT

Page 1 of 1

510(k) Number (if known):

Device Name: OptiMesh 500E Cement Restrictor

OptiMesh 500E is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal or tibial plateau in hip stem and total knee replacement.

OptiMesh 500E is not intended for use in spinal indications.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

V. Olet Tule

Division of General, Restorative. and Neurological Devices

510(k) Number_Ko33953

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.