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The MedSource Sharps Datt is a non-sterile single-use disposable sharps container with a permanent closure system for a contaminated 1 ml or smaller syringe. Its intended use is by health care professionals in a setting where standard sharps containers are not accessible such as EMS, home healthcare, and laboratories. Its permanent closure system protects the user prior to disposal by incineration or decontamination by autoclave.

The MedSource Sharps Dart (MSD) sharps container consists of two injected molded parts-a tubular tapered cone and a polypropylene closure. Its small size of 0.6 L qualifies it as a pocket sharps container as defined by ISO 23907 First Edition 2012-09-01, Sharps injury protection-Requirements and test methods-Sharps containers. It is designed for the storage, such sharps as small syringes, blood needles, lancets, and angio-caths prior to disposal consideration. It's intended to be used in remote settings for sharps containers are not convenient and accessible such as EMS, home healthcare, etc. It is a single use device.

This document describes the MedSource Sharps Dart, a non-sterile, single-use disposable sharps container. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The provided document is a 510(k) summary for a medical device (MedSource Sharps Dart), which primarily demonstrates substantial equivalence to predicate devices rather than independent clinical study results for novel technology. Therefore, many of the requested details about typical AI/software studies are not applicable or not provided in this regulatory submission.

2. Sample Size Used for the Test Set and Data Provenance:

The document describes performance testing of a physical medical device (sharps container) against established engineering standards (ISO 23907, ASTM F2132-01). It does not involve a "test set" in the context of AI/machine learning data.
The testing was conducted on samples of the MedSource Sharps Dart. The exact number of units tested is not specified in the summary, but it would involve a sufficient sample size to demonstrate compliance with the referenced standards. The provenance of this "data" is the manufactured MedSource Sharps Dart devices. The testing is prospective in the sense that newly manufactured devices were tested against existing standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This is not applicable as the "ground truth" is defined by the technical specifications and performance criteria within the international and national standards (ISO 23907, ASTM F2132-01). These standards are developed by expert committees, but there is no explicit mention of experts establishing ground truth for a test set in the context of this device's performance testing.

4. Adjudication Method for the Test Set:

Not applicable. Device performance was assessed against defined criteria in the standards rather than human adjudication of results.

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 device is a physical sharps container, not an AI or software device that would involve human readers or AI assistance.

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

Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth is based on the objective performance criteria and test methods specified in the recognized international and national standards: ISO 23907 and ASTM F2132-01. These standards define the acceptable physical and mechanical properties for sharps containers, such as puncture resistance and leak resistance.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this physical device.

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