CAPTIVATE® Compression Screws are indicated for use in adult and pediatric patients, for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.

CAPTIVATE® VL Compression Screws are indicated for use in adult and pediatric patients, for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of the phalanges, metacarpals, carpals, metatarsals, midfoot, hind foot, ankle, fibula, distal tibia, proximal tibia, radius, ulna, humerus, and clavicle.

Device Description

CAPTIVATE® Compression Screws consist of bone screws designed to compact juxtaposed bone for reconstruction and enhanced arthrodesis. The implants are available in various diameters and lengths to accommodate patient anatomy, with headless, partially or fully threaded, solid or cannulated, and variable length (VL) options. CAPTIVATE® implants are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F1537, and F138.

AI/ML Overview

The provided document describes the FDA 510(k) clearance for Globus Medical Inc.'s CAPTIVATE® Compression Screws. This is a medical device submission, and the document focuses on demonstrating substantial equivalence to predicate devices through performance testing rather than a study involving human subjects or AI algorithms assessing medical images.

Therefore, many of the requested criteria (e.g., acceptance criteria for AI algorithms, sample size for test sets, expert ground truth, MRMC studies, training set details) are not applicable to this type of regulatory submission. The information provided heavily emphasizes the mechanical and material performance of the screws.

Here's an analysis of the provided information based on your request, highlighting what is present and what is not:

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

The document describes performance testing to demonstrate substantial equivalence, rather than setting specific clinical acceptance criteria in terms of accuracy or sensitivity/specificity for an AI. The performance criteria are mechanical, comparing the new screws to existing predicates.

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Static Torsion	Demonstrate equivalence to predicate devices (K162825, K140891, K190586)	Conducted to demonstrate substantial equivalence. (Specific values not provided in this summary)
Insertion/Removal	Demonstrate equivalence to predicate devices	Conducted to demonstrate substantial equivalence. (Specific values not provided in this summary)
Axial Pullout	Demonstrate equivalence to predicate devices	Conducted to demonstrate substantial equivalence. (Specific values not provided in this summary)
Cantilever Bending	Demonstrate equivalence to predicate devices	Conducted to demonstrate substantial equivalence. (Specific values not provided in this summary)
Biocompatibility	Materials meet applicable standards (ASTM F136, F1295, F1472, F1537, F138) or are used in 510(k) cleared devices.	Demonstrated by using materials meeting standards or previously cleared devices (K162825, K212433).

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

This information is not provided in the summary. For mechanical testing, "sample size" would refer to the number of screws tested for each mechanical property. Data provenance would refer to the lab where the testing was conducted. This is typically found in the detailed test reports submitted to the FDA, not in the 510(k) summary.

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)

This is not applicable. The "ground truth" for a bone screw is its physical and mechanical properties, not an assessment made by human experts on an image or clinical case. The ground truth is established through standardized laboratory testing.

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

This is not applicable. As this is mechanical testing, there is no human "adjudication" in the sense of clinical agreement. Lab testing results are objective measurements.

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

This is not applicable. This document describes a medical device (bone screws), not an AI-assisted diagnostic tool. Therefore, no MRMC study was conducted or relevant.

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

This is not applicable. This describes a physical medical device, not an algorithm.

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

The "ground truth" in this context is established via standardized mechanical and material property testing according to ASTM standards (ASTM F543, ASTM F2193) and FDA guidance for orthopedic non-spinal metallic bone screws. This is objective laboratory-measured data, not clinical ground truth.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable.

Summary of Device Performance Study:

The study proving the device meets the (implied) acceptance criteria is a series of mechanical and biocompatibility tests performed according to recognized industry standards (ASTM) and FDA guidance.

Test Performed: Static torsion, insertion/removal force, axial pullout strength, and cantilever bending strength. Biocompatibility was also assessed by confirming material compliance with standards and prior FDA clearances.
Purpose: To demonstrate substantial equivalence of the CAPTIVATE® Compression Screws to legally marketed predicate devices (CAPTIVATE® Compression Screws K162825, Zimmer Biomet Cannulated Screw System K140891, Paragon 28 Monster® Screw System K190586).
Result: The performance data supported the claim of substantial equivalence, indicating the device performs comparably to existing devices in terms of its mechanical properties and material safety.

In essence, this document is a regulatory submission for a physical medical device, and the "study" is a collection of engineering and material science tests, not
a clinical efficacy or AI performance study.

Summary

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September 8, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.

Globus Medical, Inc. Jennifer Antonacci Group Manager, Regulatory Affairs Valley Forge Business Center 2560 General Armistead Ave. Audubon, Pennsylvania 19403

Re: K222409

Trade/Device Name: CAPTIVATE® Compression Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: August 9, 2022 Received: August 10, 2022

Dear Jennifer Antonacci:

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. 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 located 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.

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

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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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K222409

Device Name CAPTIVATE® Compression Screws

Indications for Use (Describe)

CAPTIVATE® VL Compression Screws are indicated for use in adult and pediatic patients. for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of the phalanges, metacarpals, midfoot, hind foot, ankle, fibula, distal tibia, proximal tibia, radius, ulna, humerus, and clavicle.

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)

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510(k) Summary: CAPTIVATE® Compression Screws

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
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Contact: Jennifer Antonacci, Ph.D. Group Manager, Regulatory Affairs
September 8, 2022 Date Prepared:
CAPTIVATE® Compression Screws Device Name:
Common Name: Bone screws
Classification: Per 21 CFR as follows: §888.3040 Smooth or threaded metallic bone fixation fastener Product Code: HWC Regulatory Class: II

Primary Predicate: CAPTIVATE® Compression Screws (K162825)

Other Predicates: Zimmer Biomet Cannulated Screw System (K140891) Paragon 28 Monster® Screw System (K190586)
Reference Device: ANTHEM® Fracture System (K212433)

Purpose:

The purpose of this submission is to request clearance for new implants and changes for CAPTIVATE® Compression Screws.

Device Description:

Indications for Use:

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Performance Data:

Performance of the CAPTIVATE® Compression Screws was evaluated in accordance with ASTM F543. ASTM F2193. and the FDA quidance Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway. Static torsion, insertion/removal, axial pullout, and cantilever bending testing was conducted to demonstrate substantial equivalence to the predicate devices.

Biocompatibility of patient-contacting materials was demonstrated by using materials that meet applicable standards or are used in 510(k) cleared devices (K162825, K212433).

Technoloqical Characteristics:

Subject CAPTIVATE® implants have similar technological characteristics as the predicate devices including overall design, intended use, material composition, function, and range of sizes. New material specifications for existing screws are in accordance with the same material standards.

Basis of Substantial Equivalence:

The subject CAPTIVATE® Compression Screws have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided supports substantial equivalence to the predicate devices.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.