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

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.

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.

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