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 current submission adds disposable instruments to the InCore® Lapidus System. The disposable instruments are packaged in sterile kits with the 28mm post and post plug screw implant. The implant components of the system are unchanged aside from the change in packaging of the 28mm posts and post plug screws.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called "InCore® Lapidus Sterile Kits". Based on the provided text, the device is a bone fixation fastener used for First Metatarsocuneiform arthrodesis. The document states that clinical testing was not necessary to demonstrate substantial equivalence, meaning a study proving the device meets acceptance criteria as typically understood for AI/ML devices or clinical trials was not conducted or required.

The submission is primarily focused on demonstrating substantial equivalence to a predicate device, specifically regarding a change from re-usable, non-sterile instruments to disposable, sterile instruments packaged with the implants.

Therefore, the requested information cannot be fully provided in the context of a typical acceptance criteria study for device performance (e.g., sensitivity, specificity, accuracy). However, I can extract the relevant information from the document regarding the non-clinical testing performed to support the substantial equivalence claim for the instrument change.

Here's an adaptation of the requested information based on the provided 510(k) summary:

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

Since this is a substantial equivalence submission primarily for a change in instruments and packaging, the "acceptance criteria" are related to biocompatibility, sterility, and endotoxin levels for the new disposable instruments and packaging, rather than clinical performance metrics. The document implies acceptable results for these non-clinical tests.

Acceptance Criteria Category	Reported Device Performance (Non-Clinical)
Biocompatibility	A biocompatibility risk assessment was completed for the new instruments. (Implies acceptable assessment).
Packaging Validation	Packaging validation was completed for the new instruments. (Implies satisfactory validation of the sterile packaging).
Endotoxin Levels	Endotoxin testing using the Limulus amebocyte lysate (LAL) has been completed. The endotoxin limit is <10 EU total. (Implies testing confirmed levels were below this limit, establishing safety for the new sterile components).

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

Sample Size: Not specified for biocompatibility, packaging validation, or endotoxin testing. These types of tests typically follow established standards that dictate sample sizes based on lot size or statistical confidence, but the specific numbers are not in this summary.
Data Provenance: Not specified, but generally, non-clinical tests for medical devices are performed in controlled laboratory environments.

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. This is not a study requiring expert clinical assessment for ground truth. Biocompatibility and endotoxin testing rely on laboratory analyses and adherence to standardized protocols.

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

Not applicable. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data where consensus among experts is needed.

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

No, an MRMC comparative effectiveness study was not conducted. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the InCore® Lapidus Sterile Kits to the predicate device." This device is not an AI/ML-driven diagnostic or assistive tool for human readers.

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

No, a standalone performance study was not conducted as the device is a physical bone fixation fastener, not an algorithm.

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

For the non-clinical tests mentioned:

Biocompatibility: Ground truth is established by adherence to ISO 10993 series standards, assessing biological responses to medical devices.
Packaging Validation: Ground truth is established by demonstrating the ability of the packaging to maintain sterility over a defined shelf life and withstand shipping realities, often using standards like ISO 11607.
Endotoxin Testing: Ground truth is established by reference standards for endotoxin and validated analytical methods (e.g., LAL assay).

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device requiring a training set.

Summary

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May 24, 2019

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

Re: K190231

Trade/Device Name: InCore® Lapidus Sterile Kits Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: April 1, 2019 Received: April 1, 2019

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

Shumaya Ali, MPH Assistant Director DHT6C: Division of Stereotaxic, Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190231

Device Name InCore® Lapidus Sterile Kits

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary
Prepared:	February 4, 2019
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 Sterile Kits
Common Name:	Bone Screw System
Classification:	21 CFR §888.3040: Smooth or Threaded Metallic Bone Fixation Fastener;Class II
Product Code:	HWC
Substantially

Equivalent Devices:

Device Description:

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Intended Use / Indications:

Summary of Technologies, Similarities/Differences:

The InCore® Lapidus Sterile Kits are substantially equivalent to the predicate device in regards to their intended use and indications, material, design, sizes, and mechanical properties. The implant components of the subject device system are identical to those of the predicate device. While the predicate device was provided with re-usable, non-sterile instruments, the current device system is provided with disposable instruments which are packaged in sterile kits with the 28mm post plug implants.

Non-Clinical Testing:

The implant components of the InCore® Lapidus Sterile Kits are identical to the implant components This submission includes additional, disposable instruments. of the predicate device. A biocompatibility risk assessment and packaging validation was completed for the new instruments. Endotoxin testing using the Limulus amebocyte lysate (LAL) has been completed. The endotoxin limit is <10 EU total.

Clinical Testing:

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

Conclusions / Substantial Equivalence:

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

Regulation Number and Section

N/A