SMARTSHEARS by NUSCIENCE CONSULTING AND MANAGEMENT GROUP, LLC

SmartShears® is a 4-in-1 device used for the removal of bandages, splints, and clothes. The device consists of four configurations which include: the trauma shears, ruler, angle and reflex hammer.

Shears: Critical to the development of the SmartShears® for the cutting of bandages, splints or clothes

Ruler: The ruler is used for measuring the length of lacerations and the size of entrance/exit wounds, location of a fracture, and rash size.

Angle: The angle can be used to measure for angulation of bone fractures.

Reflex Hammer: The reflex hammer can be used during a reflex procedure when the cutting blades are closed for testing tendon reflexes and percussing both the abdominal and chest.

AI/ML Overview

This document describes a 510(k) submission for a manual surgical instrument called SmartShears®. Manual surgical instruments like the SmartShears® are Class I exempt devices, meaning they are inherently considered low-risk and do not require extensive clinical studies or performance data to demonstrate safety and effectiveness beyond what is shown through their substantial equivalence to a predicate device.

Therefore, most of the requested information regarding acceptance criteria and performance studies (like sample sizes, expert involvement, MRMC studies, standalone performance, and ground truth establishment) is not applicable to this type of device and submission.

Here's a breakdown based on the provided text, addressing the points where information is available or noting its inapplicability:

Acceptance Criteria and Device Performance Study (Not Applicable for this Device Type)

For Class I exempt devices like the SmartShears®, the performance criteria are primarily met by demonstrating substantial equivalence to a legally marketed predicate device. This typically involves comparing design, materials, intended use, and functional characteristics. Formal studies with quantitative acceptance criteria as typically seen for AI/software devices are not required.

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

Acceptance Criteria: For this Class I exempt manual surgical instrument, the primary "acceptance criterion" for market clearance is demonstrating substantial equivalence to a predicate device, showing it is as safe and effective. This is achieved by comparing its functional characteristics and safety profile to an existing, legally marketed device. Specific quantitative performance metrics (e.g., accuracy, sensitivity, precision) are not typically established or reported for such devices in a 510(k) summary, as their mechanism of action is well-understood and not algorithm-dependent.
Reported Device Performance: The submission states: "SmartShears® are essentially the same as the previously marketed predicate device in both function and indication of use. The SmartShears® and the listed predicate device Conphar, Inc. Lister Bandage Scissors (K821116) are similar in size with overall length and scissor blades (5 1/2"). The device utilizes the same material made up of medical grade stainless steel materials."
- This statement serves as the primary "performance" assertion – that it performs functionally similarly to a device already deemed safe and effective. No specific quantitative performance data (e.g., "cuts through X material in Y seconds") is provided or typically required for this device type.

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

Not Applicable. No formal "test set" or clinical data collection of this nature was conducted or required for this Class I exempt device. The evaluation is based on comparison to a predicate device and engineering design.

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. No "ground truth" establishment by experts in the context of a performance study was required. The "ground truth" for manual surgical instruments is their fundamental, well-understood mechanical function.

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

Not Applicable. No "test set" and thus no adjudication method was used.

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 is a manual surgical instrument, not an AI or imaging device. MRMC studies are not relevant.

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

Not Applicable. This is a manual, human-operated device, not an algorithm.

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

Not Applicable. The "ground truth" for a manual device like this is its physical properties, material science, and demonstrated basic mechanical function, compared to a known safe and effective predicate. No complex "ground truth" such as found in diagnostic AI studies is relevant.

8. The sample size for the training set

Not Applicable. This device does not involve machine learning or a "training set."

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

Not Applicable. This device does not involve machine learning or a "training set."

Summary of Device and Acceptance:

The SmartShears® is a manual surgical instrument. Its acceptance by the FDA (as indicated by the 510(k) clearance) is based on:

Substantial Equivalence: Demonstrating that it is "essentially the same" as a legally marketed predicate device (Conphar, Inc. Lister Bandage Scissors K821116) in terms of intended use, function, design, and materials (medical grade stainless steel, similar size).
Compliance with General Controls: As a Class I device, it is subject to general controls such as good manufacturing practices, proper labeling, and adverse event reporting.
Exemption from Premarket Notification: The FDA letter explicitly states it is "exempt from the premarket notification requirements," meaning it's a very low-risk device that does not require extensive pre-market testing beyond basic safety and functional assessment by comparison to a predicate.

The provided documentation clearly indicates that this device falls under a category that does not require the extensive performance studies and detailed acceptance criteria typically associated with higher-risk devices, especially those utilizing AI or complex diagnostic algorithms.

Summary

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510(k) SUMMARY

510(k) NUMBER:	K112400
SUBMISSION TYPE:	Traditional
SUBMITTED BY:	Medix, Inc.230 A1A NorthPonte Vedra, FL 32082Tel: 904-382-8026Fax: 866-871-3721
CONTACT PERSON:	Dan QuigglePresident & CEO
DATE OF PREPARATION:	June 1, 2011
NAME OF DEVICE:	SmartShears®
CLASSIFACTION NAME:	Surgical Devices; General and plastic surgery(Regulation Number 21 CFR 878.4800[FZT])
TRADE NAME:	Lister Bandage Scissors
PREDICATE DEVICE(S):	Conphar, Inc. (K821116)

INDICATIONS FOR USE: SmartShears® is a manual surgical instrument intended to be used in removing bandages, splints, and clothes in trauma situations.

DEVICE DESRIPTION: SmartShears® is a 4-in-1 device used for the removal of bandages, splints, and clothes. The device consists of four configurations which include: the trauma shears, ruler, angle and reflex hammer.

Shears: Critical to the development of the SmartShears® for the cutting of bandages, splints or clothes

Ruler: The ruler is used for measuring the length of lacerations and the size of entrance/exit wounds, location of a fracture, and rash size.

Angle: The angle can be used to measure for angulation of bone fractures.

Reflex Hammer: The reflex hammer can be used during a reflex procedure when the cutting blades are closed for testing tendon reflexes and percussing both the abdominal and chest.

PREDICATE DEVICE: The SmartShears® are essentially the same as the previously marketed predicate device in both function and indication of use. The SmartShears® and the listed predicate device Conphar, Inc. Lister Bandage Scissors (K821116) are similar in size with overall length and scissor blades (5 1/2"). The device utilizes the same material made up of medical grade stainless steel materials.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

NuScience Consulting and Management Group, LLC % Ms. Nikole Goldsmith PO Box 8507 Fleming Island, Florida 32006

SEP 1 2 2011

Re: K112400

Trade Name: SmartShears® Classification Regulation Name and Number: Manual surgical instruments for general use - 21 CFR 878.4800

Regulatory Class: Class I Exempt Product Code: FZT Dated: June 1, 2011 Received: August 19, 2011

Dear: Ms. Goldsmith:

We have reviewed your premarket notification submission and have found this device to be exempt from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (Act). Therefore, you may immediately begin marketing this device as described in your premarket notification.

The final classification regulation for your device appears in Title 21 of the Code of Federal Regulations (CFR) 878.4800. We suggest that you review this regulation since it may grant other exemptions from certain general controls of the Act. Your device classification regulation name, regulatory class, and product code are shown above. When listing your device with the Food and Drug Administration, please use this product code.

In the future, new but substantially equivalent devices which fall within the above classification regulation name and meet the classification criteria may be marketed without sending a premarket notification submission to the Food and Drug Administration. We suggest, however, that you review 21 CFR Section 878.9 to determine whether or not your new device (s) meets the limitations of exemption from Section 510(k) of the Act.

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If you have any questions regarding this letter, please contact Dwight Yen (301) 796-6401 or the Division of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (301) 796-7100, or at its Internet address "http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ucm142656.htm".

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K112400

Device Name: SmartShears®

Indications For Use: SmartShear® is a manual surgical instrument intended to be used in removing bandages, splints, and clothes in trauma situations.

Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ryden firmxm

(Division Sign-O Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K112400

Regulation Number and Section

§ 878.4800 Manual surgical instrument for general use.

(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.