The Nextremity Solutions InCore® Lapidus System is a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis (also known as Lapidus or First Tarsometatarsal Fusion).

Device Description

The InCore® Lapidus System consists of a post and two headless compression screws. Posts are available in 28mm and 32mm lengths and in right and left orientations. Screws are available in a 3.5mm diameter and lengths of 24 to 60mm. The post is inserted into the medial cuneiform and compression screws are inserted into the first metatarsal and into the post to maintain apposition of the bones during fusion. A post plug screw is threaded into the top of the post after all components have been implanted to prevent tissue ingrowth into the post and facilitate removal, if needed. All implants are manufactured from color anodized Ti-6Al-4V alloy conforming to ASTM F-136. The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.

AI/ML Overview

The provided text is a 510(k) summary for the InCore® Lapidus System, a medical device for internal fixation in foot surgery. It primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing.

Here's an analysis of the text in the context of your request:

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

The document does not explicitly state "acceptance criteria" as clear numerical thresholds for performance. Instead, it describes "Non-Clinical Testing" designed to "confirm that the strength of the InCore® Lapidus System is substantially equivalent to predicate devices with similar indications and is adequate for its intended use."

The reported device performance is qualitative rather than quantitative in this summary.

Acceptance Criteria (Implied)	Reported Device Performance
Strength equivalent to predicate devices for its intended use.	Axial pull-out strength, torque to failure, and 3-point bend tests were performed on worst-case compression screws.Torque to failure, static 3-point bend, and dynamic 3-point bend tests were performed on worst-case constructs.These tests confirmed that the strength of the InCore® Lapidus System is substantially equivalent to predicate devices with similar indications and is adequate for its intended use.
Acceptable bacterial endotoxin levels.	Bacterial endotoxin levels were measured using LAL testing. (No specific levels are reported, but the implication is that they were acceptable).

Acceptance Criteria (Implied)

Reported Device Performance

Strength equivalent to predicate devices for its intended use.

Axial pull-out strength, torque to failure, and 3-point bend tests were performed on worst-case compression screws.Torque to failure, static 3-point bend, and dynamic 3-point bend tests were performed on worst-case constructs.These tests confirmed that the strength of the InCore® Lapidus System is substantially equivalent to predicate devices with similar indications and is adequate for its intended use.

Acceptable bacterial endotoxin levels.

Bacterial endotoxin levels were measured using LAL testing. (No specific levels are reported, but the implication is that they were acceptable).

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

The document does not specify the exact sample sizes (number of screws or constructs) used for the non-clinical tests. It refers to testing "worst case compression screws" and "worst case constructs," implying a targeted selection, but not the quantity.

The data provenance is not mentioned. Given it's non-clinical (mechanical) testing, it would likely be conducted in a laboratory setting, not tied to a specific country of origin in the same way clinical data would be.

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 information is not applicable to the type of testing described. The "testing" here refers to mechanical and material performance tests, where a "ground truth" established by human experts in the context of diagnostic or interpretive tasks is not relevant. The "ground truth" would be objective measurements from testing equipment compared against engineering specifications or predicate device performance.

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

This is not applicable. Adjudication methods are typically used in clinical studies or expert review processes, especially for ambiguous cases in diagnostic tasks. The non-clinical tests are objective mechanical 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. The device is a "Bone Screw System" for internal fixation, not an AI or diagnostic imaging device. No MRMC study or AI assistance is mentioned or relevant to this 510(k) submission.

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

This is not applicable. The device is a physical implant, not an algorithm.

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

For the non-clinical tests, the "ground truth" would be established by:

Engineering specifications and standards: The device performance (strength, torque, bend) would be measured against predefined physical limits or industry standards for similar implants.
Predicate device performance data: The performance of the InCore® Lapidus System was compared to the known performance characteristics of the "substantially equivalent devices" (K121349 and K160304) to demonstrate equivalence.

8. The sample size for the training set:

This is not applicable because this document describes a physical medical device (implants), not a machine learning model that requires a "training set."

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

This is not applicable for the same reason as point 8; there is no training set for a physical implant.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the U.S. Food & Drug Administration logo is on the right. The FDA logo is blue and white and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".

April 25, 2018

Nextremity Solutions, Inc. Greg Denham Project Leader, Product Development 210 North Buffalo Street Warsaw, Indiana 46580

Re: K180257

Trade/Device Name: InCore® Lapidus System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: January 29, 2018 Received: January 30, 2018

Dear Greg Denham:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

{1}------------------------------------------------

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K180257

Device Name

InCore® Lapidus System

Indications for Use (Describe)

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

区Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

{3}------------------------------------------------

510(k) Summary
Prepared:	April 8, 2018
Submitter:	Nextremity Solutions, Inc.210 North Buffalo StreetWarsaw, IN 46580
Contact:	Greg DenhamProject Leader, Product Developmentgreg.denham@nextremity.comPhone: 732-383-7901FAX: 574-966-1396
Proprietary Name:	InCore® Lapidus System
Common Name:	Bone Screw System
Classification:	21 CFR §888.3040: Smooth or Threaded Metallic Bone Fixation Fastener;Class II
Product Code:	HWC
SubstantiallyEquivalent Devices:	Extremity Medical Screw and Washer System (IO FiX), K121349 – Primary Predicate Phalanx Innovations OsteoBullet Compression Screw, K160304

Nextremity Solutions Axi+Line Proximal Bunion Correction System, � K152548 - Reference Predicate

Device Description:

{4}------------------------------------------------

The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.

Intended Use / Indications:

Summary of Technologies, Similarities/Differences:

The InCore® Lapidus System is similar to the predicate devices in regards to its intended use and indications, material, design, sizes, and mechanical properties. Differences between the subject device system and the predicate device systems include a targeting guide and sub-cortical interlocking components. These differences do not rase new types of safety and effectiveness questions.

Non-Clinical Testing:

To evaluate the strength of the InCore® Lapidus System and components, axial pull-out strength, torque to failure and 3 point bend tests were performed on worst case compression screws. Torque to failure, static 3 point bend and dynamic 3 point bend tests were performed on worst case constructs. These tests confirmed that the strength of the InCore® Lapidus System is substantially equivalent to predicate devices with similar indications and is adequate for its intended use. In addition, bacterial endotoxin levels were measured using LAL testing.

Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the InCore® Lapidus System to the predicate device.

Conclusions / Substantial Equivalence:

Differences between the subject device system and the predicate device systems do not raise new types of safety and effectiveness questions. The InCore® Lapidus System is substantially equivalent to the predicate devices in regards to its intended use, material, design, sizes and mechanical properties.

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.