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The D.A.R.T. Pro Handle and X-TRACTOR Tip are solely intended for use in the acquisition, removal and storage of darts projected from stun guns and lodged in human tissue and/or clothing. The device is not intended for use as a medical sharps container.

The reusable D.A.R.T. Pro Handle and detachable, single-use only X-TRACTOR Tip (including a safety cap) comprise the two components of the device. Each of these components is described generally below.

• D.A.R.T. Pro Handle: A reusable handle component that is uniquely designed for the secure attachment (and removal post-use) of the X-TRACTOR Tip. The D.A.R.T. Pro Handle allows the user to hold, control and position the assembled product as required for stun gun dart acquisition and removal within the X-TRACTOR Tip. The D.A.R.T. Pro Handle includes a switch at the top of the handle to activate an internal LED light source to illuminate the X-TRACTOR Tip to ease device use in darkened environments. The LED light requires only a standard 9-volt battery, which the user can easily replace as needed.
• X-TRACTOR Tip: A single-use, detachable stun gun dart containment tip specifically designed to securely house up to two stun gun darts. In use, the X-TRACTOR Tip is placed over the stun gun dart and advanced to lock the dart into a sliding tip collet. The D.A.R.T. Pro Handle is then pulled to remove the dart. The external button on the tip collet is then pressed to slide the tip collet and secure the removed dart within the X-TRACTOR Tip. Following removal of up to two stun gun darts, the safety cap is press-fit over the X-TRACTOR Tip to securely house the darts within the X-TRACTOR Tip. Once placed, the safety cap cannot be removed from the X-TRACTOR Tip. The capped X-TRACTOR Tip is then removed from the D.A.R.T. Pro Handle, placed within a zip-seal bag, and the zip-seal bag appropriately identified for provision to law enforcement personnel.

The D.A.R.T. (stun gun Dart-Acquiring and Removal Tool) Pro Kit acceptance criteria and performance are detailed in the provided 510(k) summary. Given that this is a Class II device (sharps container) and not an AI/ML powered device, the typical AI-specific questions are not applicable.

Here's the information parsed from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The device underwent performance testing focused on its sharps container functionality for the capped X-TRACTOR Tip, which houses removed stun gun darts.

Note: The formal acceptance criteria for each test are not explicitly stated as numerical values in this summary but are implicit in the "Pass" result, indicating the device met the requirements of the specified standards.

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: The document does not specify the exact sample size (number of units tested) for each performance test. It only states that "Performance testing... included the following sharps container tests conducted on the capped X-TRACTOR Tip".
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. These are standard engineering/product performance tests, likely conducted in a controlled laboratory environment.

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 question is not applicable. The D.A.R.T. Pro Kit is a physical medical device (specifically, a sharps container for stun gun darts), not an AI/ML or diagnostic imaging device that requires expert ground truth for performance evaluation. The "ground truth" for its performance is determined by meeting objective engineering standards (e.g., whether it leaks, punctures, or breaks under specific physical stresses).

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert consensus in evaluating subjective or complex diagnostic outputs, typically for AI/ML or imaging studies. For physical device performance tests, the outcome (pass/fail) is typically objective and determined by measurement against a standard, not expert consensus on an interpretation.

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 question is not applicable. MRMC studies are relevant for evaluating the performance of diagnostic systems, particularly those involving human interpretation, often in conjunction with AI. The D.A.R.T. Pro Kit is a physical tool for dart acquisition, removal, and containment, not a diagnostic or AI-powered system, and does not involve human "readers" in this context.

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

This question is not applicable. The D.A.R.T. Pro Kit is a physical device that is inherently used "human-in-the-loop" for its intended purpose (removing stun gun darts). It does not contain an algorithm or AI component that could be evaluated in a standalone manner.

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

The "ground truth" for the D.A.R.T. Pro Kit's performance is objective adherence to physical and mechanical standards for sharps containers, as defined by "Health Devices 22" and "49 CFR" standards. This involves direct measurement and observation of the device's physical properties (e.g., whether it punctures, leaks, or deforms) under specified test conditions, rather than expert consensus, pathology, or outcomes data typically used for diagnostic devices.

8. The sample size for the training set

This question is not applicable. The D.A.R.T. Pro Kit is a mechanical device, not an AI/ML system, and therefore does not have a "training set" in the computational sense. Its design and manufacturing process would involve engineering specifications and quality control, but not data-driven machine learning training.

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

This question is not applicable, as there is no training set for this type of mechanical device.

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