The JAWS® Nitinol Staple System implants are indicated for use in osteotomy, arthrodesis, and fragment fixation of the bones and joints of the foot including fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement) located in the long bones of the lower extremities such as the fibula and tibia.

Device Description

The JAWS® Nitinol Staple System are bone staples of various sizes to accommodate a variety of small bone applications. The implants and instruments are sold sterile.

AI/ML Overview

Please note that the provided document is a 510(k) summary for a medical device (JAWS® Nitinol Staple System) seeking substantial equivalence to a predicate device, not an AI/ML-enabled imaging device. Therefore, the information requested in your prompt regarding acceptance criteria and studies for an AI device (e.g., sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone performance) is not directly applicable or available in this document.

The document discusses performance testing in the context of demonstrating substantial equivalence for a physical medical implant, not an AI algorithm. The performance testing referred to here would typically involve mechanical, material, and functional tests of the staple itself, rather than diagnostic accuracy or effectiveness studies in the way you're asking for AI.

However, I can extract the information relevant to their definition of "acceptance criteria" and "study" as presented for this specific medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical/Functional	Not adversely affected by modifications compared to predicate device.	"original testing and subsequent performance is not adversely affected by the modifications"
MR Compatibility	Meets specified MR safety standards.	"Testing on MR compatibility...was also conducted." (Results implied to meet criteria)
Corrosion	Meets specified corrosion resistance standards.	"Testing on...corrosion was also conducted." (Results implied to meet criteria)

Note: The specific numerical acceptance criteria for mechanical properties, MR compatibility, or corrosion are not detailed in this summary document. The "results...demonstrated the modified designs are substantially equivalent to the predicate devices" implies that the device met internal and regulatory standards for these tests. "All performance testing conducted...met the predetermined acceptance criteria or were otherwise considered acceptable."

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 applicable and thus not provided in the document as it pertains to a physical medical device (staple) and not a software/AI device. The "test set" here refers to physical samples of the staple and its components.

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 this is not an AI/diagnostic device. Ground truth, in the context of a physical device, would relate to manufacturing specifications, material properties, and mechanical performance standards, which are evaluated by engineers and technical experts.

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

Not applicable as this is not an AI/diagnostic device. Adjudication methods are relevant for subjective interpretations, typically in diagnostic imaging or clinical trials.

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 device is a physical bone fixation staple, 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 document is for a physical medical device, not an algorithm.

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

For this physical device, the "ground truth" would be objective engineering specifications, material standards (e.g., ASTM, ISO), and performance benchmarks for mechanical strength, fatigue, corrosion resistance, and MR compatibility. These are established through scientific principles and standardized testing methodologies rather than expert consensus on medical images or pathology.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary

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May 11, 2023

Paragon 28 Inc Haylie Hertz Senior Regulatory Affairs Specialist 14445 Grasslands Drive Englewood, Colorado 80112

Re: K230550

Trade/Device Name: JAWS® Nitinol Staple System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR Dated: March 15, 2023 Received: March 15, 2023

Dear Haylie Hertz:

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

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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) 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 (QS) 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,

Limin Sun -S

Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty 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)

K230550

Device Name JAWS® Nitinol Staple System

Indications for Use (Describe)

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

510(k) Number:	K230550
Manufacturer:	Paragon 28, Inc.14445 Grasslands Dr.Englewood, CO 80112
Contact:	Haylie HertzAssociate Regulatory Affairs SpecialistParagon 28, Inc.14445 Grasslands Dr.Englewood, CO 80112Phone: 303-720-0017hhertz@paragon28.com
Date Prepared:	May 11, 2023
Device Trade Name:	JAWS® Nitinol Staple System
Device Class andCommon Name:Classification:	Class II, staple, fixation, bone21 CFR 888.3030: Single/multiple component metallic bonefixation appliances and accessories
Product Codes:	JDR
Indications for Use:	The JAWS® Nitinol Staple System implants are indicatedfor use in osteotomy, arthrodesis and fragment fixation ofbones and joint of the foot including fixation of small bonefragments (i.e., small fragments of bone which are notcomminuted to the extent to preclude staple placement)located in the long bones of the lower extremities such asthe fibula and tibia.
Device Description:	The JAWS® Nitinol Staple System are bone staples ofvarious sizes to accommodate a variety of small boneapplications. The implants and instruments are sold sterile.
Predicate Device:	JAWS® Nitinol Staple System (K223056)
SubstantialEquivalence:	The proposed JAWS® Nitinol Staple System is substantiallyequivalent to the predicate JAWS® Nitinol Staple System(K223056) with respect to indications, design, material andfunction.
Performance Testing:	Engineering analysis is presented to provide evidence that theoriginal testing and subsequent performance is not adverselyaffected by the modifications to the subject devices. Testingon MR compatibility and corrosion was also conducted. Theresults of this analysis and testing demonstrated the modifieddesigns are substantially equivalent to the predicate devices.
Conclusions:	The JAWS® Nitinol Staple System subject to this submissionpossesses the same intended use and technologicalcharacteristics as the predicate device system components.All performance testing conducted for the JAWS® NitinolStaple System met the predetermined acceptance criteria orwere otherwise considered acceptable. As such, the JAWS®Nitinol Staple System components are substantiallyequivalent to the predicate devices for the intended use.

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Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.