The Ogmend® Implant Enhancement System is intended to augment pedicle screw fixation when a screw has lost purchase due to screw loosening, back-out, or breakage. The Ogmend® Implant Enhancement System is for use with rigid, thoracolumbar pedicle screw systems where a screw is inserted posteriorly, through the pedicle, and into the vertebral body. The Ogmend® Implant Enhancement System is for use in skeletally mature patients.

Device Description

The Ogmend® Implant Enhancement System is a sterile, single-use device intended to provide supplemental fixation to restore stability when the screw-to-bone interface becomes mechanically compromised. The Ogmend® Implant Enhancement System includes a permanently implanted sleeve ("Ogmend® Implant") and an inserter ("Ogmend® Inserter").

The Ogmend® Implant Enhancement System is designed to use the principles of interference fit, surface area contact, and pressure distribution to secure a screw to bone and achieve stability at the screw-to-bone interface to allow for subsequent healing.

The Ogmend® Implant is manufactured from polyethylene terephthalate (PET) monofilament fibers.

The Ogmend® Implant is offered in two sizes:

Medium: For use with screws ranging in diameter from 3.5mm - 6.5mm.
Large: For use with screws ranging in diameter from 6.5mm 10.5mm.

The Ogmend® Inserter is used to insert the Ogmend® Implant into the bone hole and can be used with both size Ogmend® Implants. The Ogmend® Inserter is a stainless-steel rod with beveled ends. It can be used to insert multiple sleeves within one operative procedure. It is provided sterile as a disposable, single-use device. The Inserter is compatible with sterilization by gamma radiation.

AI/ML Overview

Acceptance Criteria and Device Performance Study for Ogmend® Implant Enhancement System (K233223)

This response describes the acceptance criteria and study details for the Ogmend® Implant Enhancement System, based on the provided FDA 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for K233223 focuses on demonstrating substantial equivalence to a predicate device (K223075) through performance testing. The document states that the data presented "demonstrates that the proposed Ogmend® Implant is substantially equivalent... to the pre-determined acceptance criteria." While specific numerical acceptance criteria were not explicitly defined in the provided text (e.g., a specific pullout strength value), the underlying acceptance criterion is that the device's performance is comparable to or better than the predicate device (K223075) and suitable for its intended use.

The following table summarizes the performance tests conducted, with the understanding that "reported device performance" implies the device met the implicit acceptance criteria by demonstrating substantial equivalence to the predicate.

#	Performance Test	Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
1	Screw Axial Pullout	Demonstra te pullout strength comparable to or better than the predicate device (K223075) to ensure adequate fixation.	The study data was submitted to the FDA to support substantial equivalence, indicating that pullout strength met the acceptance criteria.
2	Sleeve Insertion Force	Demonstrate appropriate insertion force that allows for surgical usability without excessive force or material damage.	The study data was submitted to the FDA to support substantial equivalence, indicating that insertion force met the acceptance criteria.
3	Screw Insertion Torque	Demonstrate appropriate screw insertion torque within acceptable surgical ranges.	The study data was submitted to the FDA to support substantial equivalence, indicating that screw insertion torque met the acceptance criteria.
4	Screw Removal/Extraction Torque	Demonstrate appropriate screw removal/extraction torque without compromising the implant or surrounding bone.	The study data was submitted to the FDA to support substantial equivalence, indicating that screw removal/extraction torque met the acceptance criteria.
5	Sleeve End Closure Strength	Demonstrate sufficient integrity of the sleeve's end closure to prevent unraveling or failure during use.	The study data was submitted to the FDA to support substantial equivalence, indicating that sleeve end closure strength met the acceptance criteria.
6	Device Breakage - Sleeve Durability	Demonstrate sufficient durability of the sleeve to withstand the intended surgical and physiological stresses without breakage.	The study data was submitted to the FDA to support substantial equivalence, indicating that sleeve durability met the acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the exact sample sizes (number of tests or specimens) used for each performance test. It only lists the types of performance tests conducted.

The data provenance is from bench tests (in vitro testing) and is conducted by Woven Orthopedic Technologies, LLC. No information is given about country of origin of the data beyond the manufacturer's location in Manchester, CT, USA. The study design is inherently prospective for these bench tests, as they were specifically designed and executed to support the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable to this type of device and study. The studies described are bench tests evaluating mechanical properties, not diagnostic or interpretive tasks requiring human expert ground truth establishment. The "ground truth" for these tests is the objective measurement of physical properties.

4. Adjudication Method for the Test Set

This section is not applicable to the bench testing described. Adjudication methods (like 2+1, 3+1) are typically used for studies involving human interpretation or subjective assessments, which is not the case here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document does not mention any studies involving human readers or comparative effectiveness for diagnostic or clinical tasks.

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

This section is not applicable. The Ogmend® Implant Enhancement System is a mechanical device, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests conducted is based on objective physical measurements obtained through standardized mechanical testing methods for medical implants. For example, for "Screw Axial Pullout," the ground truth would be the force measured at which the screw pulls out, determined by test equipment. This is distinct from expert consensus, pathology, or outcomes data, which are typically associated with diagnostic or clinical studies.

8. The Sample Size for the Training Set

This section is not applicable. The Ogmend® Implant Enhancement System is a mechanical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set was Established

This section is not applicable for the same reason as above; there is no training set for this device.

Summary

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October 26, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

Woven Orthopedic Technologies Mr. Brandon Bendes President and CEO 63 Center Street, #3a Manchester, Connecticut 06040

Re: K233223

Trade/Device Name: Ogmend® Implant Enhancement System Regulation Number: 21 CFR 888.3043 Regulation Name: Screw Sleeve Bone Fixation Device Regulatory Class: Class II Product Code: QVI Dated: September 28, 2023 Received: September 28, 2023

Dear Mr. Bendes:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image contains the text "Colin O'neill -S-". The text is arranged vertically, with "Colin" on the top line, "O'neill" on the second line, and "-S-" on the third line. The text is in a simple, sans-serif font and is black in color. The background of the image is white.

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health 2

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

= $98$$%

Device Name

Ogmend® Implant Enhancement System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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510K Summary

MANUFACTURER IDENTIFICATION

Woven Orthopedic Technologies 63 Center Street #3a, Manchester, CT 06040 Phone: 860-259-1260 Establishment Registration #3017505709 Contact Person: Brandon Bendes, President and CEO

DEVICE IDENTIFICATION

Device Trade Name:	Ogmend® Implant Enhancement System
Device Common Name:	Screw Sleeve Bone Fixation Device
Classification Name:	Screw Sleeve Bone Fixation Device
Classification Number:	21 CFR 888.3043
Product Code:	QVI
Device Class:	Class II
Review Panel:	Orthopedic Devices
Date Summary Prepared:	September 28, 2023

INDICATIONS FOR USE

DEVICE DESCRIPTION

The Ogmend® Implant is manufactured from polyethylene terephthalate (PET) monofilament fibers.

The Ogmend® Implant is offered in two sizes:

Medium: For use with screws ranging in diameter from 3.5mm - 6.5mm.
Large: For use with screws ranging in diameter from 6.5mm 10.5mm. ●

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K233223 - Page 2 of 3

PRIMARY PREDICATE DEVICE

Ogmend® Implant Enhancement System (K223075).

Comparison of Technological Characteristics to Predicate

The subject Ogmend® Implant is identical to the primary predicate with respect to materials, design, principle of operation, sterilization method, inserter material, and shelf life as detailed below. The subject and predicate devices are also identical with respect to Intended Use and Indications for use.

Implant Material:	Polyethylene Terephthalate
Implant Design:	Braided PET Sleeve Implant
Principle or Operation:	Enhance Screw / Bone Interface
Sterilization Method:	Gamma Irradiation
Inserter Material:	Stainless Steel
Shelf Life:	36 Months

The distinguishing characteristics between the subject and predicate devices are detailed below:

TechnologicalCharacteristic	Medium Ogmend® Implant(K223075)	Large Ogmend® Implant(proposed)
Sleeve Diameter	6.5mm	8.5mm
Sleeve Length	100mm	150mm
CompatiblePedicle Screw Size Range	3.5mm - 6.5mm	6.5mm - 10.5mm

PERFORMANCE DATA

The bench tests listed below were performed to support the substantial equivalence of the subject device in addition to the bench tests were previously purposed on the primary predicate in K223075:

#	Performance Test
1	Screw Axial Pullout
2	Sleeve Insertion Force
3	Screw Insertion Torque
4	Screw Removal/Extraction Torque
5	Sleeve End Closure Strength
6	Device Breakage- Sleeve Durability

Woven Orthopedic Technologies, LLC | 63 E. Center Street, Manchester CT USA 06040 | +1 860.259.1260

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K233223 - Page 3 of 3

SUBSTANTIAL EQUIVALENT

The data presented in this submission demonstrates that the proposed Ogmend® Implant is substantially to intended use, technological characteristics, design, materials, principles of operation, and procedural steps, the pre-determined acceptance criteria, performance with respect to intended use.

Woven Orthopedic Technologies, LLC | 63 E. Center Street, Manchester CT USA 06040 | +1 860.259.1260

Regulation Number and Section

§ 888.3043 Screw sleeve bone fixation device.

(a)
Identification. A screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone and provides increased surface area to create an interference fit to restore stability of the implant construct.(b)
Classification. Class II (special controls). The special controls for this device are:(1) In vivo performance testing under anticipated conditions of use must demonstrate:
(i) The device provides sufficient stability to allow for fracture healing; and
(ii) A lack of adverse biologic response to the implant through histopathological and histomorphometric assessment.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must:
(i) Assess the stability of the device in a rescue screw scenario;
(ii) Demonstrate that the device can be inserted and removed without damage to the implant or associated hardware;
(iii) Demonstrate the device can withstand dynamic loading without device failure; and
(iv) Characterize wear particle generation.
(3) The device must be demonstrated to be biocompatible.
(4) The device must be demonstrated to be non-pyrogenic.
(5) Performance data must demonstrate the sterility of the device.
(6) Performance data must support the labeled shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the established shelf life.
(7) Labeling must include:
(i) A detailed summary of the device technical parameters;
(ii) Information describing all materials of the device;
(iii) Instructions for use, including device removal; and
(iv) A shelf life.