The SALVATION™ Midfoot Reconstruction System is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: intramedullary medial column fusion and lateral column fusion resulting from neuropathic osteoarthropathy (Charcot).

Device Description

The SALVATION Midfoot Reconstruction System, introduced as SALVATION Beams and Bolts in K140741, is being expanded to include the SALVATION Midfoot Nail. Designed to address the demands of advanced midfoot reconstruction, the subject nail features proximal threads and a distal cross screw to ensure fixation and rotational stability.

AI/ML Overview

The provided text is a 510(k) summary for the "SALVATION Midfoot Reconstruction System - Midfoot Nail Line Extension," a medical device. This document does not describe a study that involves software, AI, or diagnostic performance and therefore does not have the information requested in points 1-9 of the prompt.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical evidence (material, design, and mechanical testing) for a physical orthopedic implant.

Here's a breakdown of why the requested information cannot be provided from this document:

No AI/Software Component: The device is a physical "Smooth Or Threaded Metallic Bone Fixation Fastener" (midfoot nail). There is no mention of any AI component, software, or diagnostic function.
No Performance Metrics for AI: Consequently, there are no acceptance criteria, reported device performance (in terms of sensitivity, specificity, accuracy, etc., typically associated with diagnostic AI), sample sizes for test sets, expert ground truth establishment, or adjudication methods described for AI performance.
No MRMC or Standalone Studies for AI: Since there's no AI, there are no multi-reader multi-case studies or standalone algorithm performance studies.
No Ground Truth for AI: The concept of "ground truth" (expert consensus, pathology, outcomes data) as it applies to evaluating AI diagnostic performance is not relevant to this physical implant.
No Training Set: As there's no AI model, there's no training set or ground truth establishment for a training set.

Instead, the document details:

Device Name: SALVATION Midfoot Reconstruction System - Midfoot Nail Line Extension
Intended Use: Fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of bones in the foot and ankle, including treatment for neuropathic osteoarthropathy (Charcot).
Predicate Device: SALVATION Beams and Bolts (K140741)
Technological Characteristics Comparison (Table 1): Compares material (Type II Anodized Titanium Alloy), central shaft design (cannulated or solid core), and size offerings between the subject device and the predicate.
Non-Clinical Evidence (b)(1): Static Bend Testing, Construct Fatigue Testing, and Pyrogenicity Testing were conducted. These are mechanical and biocompatibility tests for physical implants, not performance studies for AI.
Clinical Evidence (b)(2): N/A (Not Applicable), indicating no human clinical trials were deemed necessary to demonstrate substantial equivalence for this device.
Conclusion: The device is substantially equivalent to the predicate based on non-clinical evidence, with no new questions of safety or effectiveness.

Summary

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Wright Medical Technology, Inc. Alayne Melancon Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117

July 11, 2018

Re: K180024

Trade/Device Name: SALVATION Midfoot Nail Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: June 6, 2018 Received: June 8, 2018

Dear Alayne Melancon:

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. Iisting 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

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

510(k) Number (if known)

K180024

Device Name

SALVATION Midfoot Reconstruction System - Midfoot Nail Line Extension

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K180024 Page 1 of 2

Headquarters Wright Medical Technology, Inc.

1023 Cherry Road Membhis. TN 38117

901 867 997' mt.com

510(k) SUMMARY

In accordance with the Food and Drug Administration rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the SALVATION Midfoot Reconstruction System – Midfoot Nail Line Extension.

(a)(1) MANUFACTURER IDENTIFICATION

Submitted By:

Contact Person:

Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117

Date:

December 20, 2017

Alayne Melancon Regulatory Affairs Specialist Office: (901)290-5986 Fax: (901)867-4190

(a)(2) SUBJECT DEVICE INFORMATION

Proprietary Name:

Common Name: Classification Name & Reference: Device Product Code & Panel:

SALVATION™ Midfoot Reconstruction System -Midfoot Nail Line Extension Smooth or Threaded Metallic Bone Fixation Fastener 21 CFR 888.3040 - Class II HWC - Orthopedic

(a)(3) PREDICATE DEVICE INFORMATION

SALVATION Beams and Bolts

K140741

(a)(4) DEVICE DESCRIPTON

Image /page/3/Picture/21 description: The image contains the logo for Wright, a company that focuses on excellence. The logo features two overlapping trapezoids, one red and one orange, to the left of the word "WRIGHT" in red, bold letters. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in a smaller, gray font.

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(a)(5) INTENDED USE

(a)(6) TECHNOLOGICAL CHARACTERISTICS COMPARISON

The subject was designed with the same basic design features (material, geometry, and principle of operation) as the predicate device. A comparison of technological characteristics is shown below in Table 1.

SUBJECT	PREDICATES
	SALVATION Midfoot Nail	SALVATION Beams and BoltsSystem(K140741)
Material:	Type II Anodized TitaniumAlloy per ASTM F136	Type II Anodized TitaniumAlloy per ASTM F136
Central ShaftDesign:	Cannulated or Solid Core	Cannulated or Solid Core
Size Offerings:	Diameters:8.0 mmLengths:60-160 mm	Diameters:5.0 mm, 6.5 mm, 7.0 mmLengths:50-200 mm

(b)(1) SUBSTANTIAL EQUIVALENCE - NON-CLINICAL EVIDENCE

The following evaluations were conducted to support the safety and efficacy of the SALVATION Midfoot Nail:

Static Bend Testing
-Construct Fatigue Testing
-Pyrogencity Testing

(b)(2) SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE N/A

(b)(3) SUBSTANTIAL EQUIVALENCE - CONCLUSIONS

The design characteristics of the subject device do not raise any new types of questions of safety or effectiveness and testing shows no new worst case. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate systems and are substantially equivalent.

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.