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Sharps Away Disposable Containers and accessories are intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian office and other small quantity waste generators for the safe disposal of hazardous sharps.

Sharps Away Disposable Containers are injection molded polypropylene plastic. The containers are closable, puncture resistant, leak proof on the sides and bottom and stable. The label, containing an overfill warning and an easily visible fill line, is adhered to the container at the factory. The containers are translucent and are red and yellows. The label is white with the biohazard warning fluorescent orange. Sharps Away Disposable Containers are available in a variety of sizes. Each product has two parts, which assemble together to form a unit. Assembly is easily visualized. They can be nested together to reduce storage space. Handles are present on the 2-quart, 5-quart, 2.5-gallon and the 6-gallon containers. They are strong, easy to grasp and permits control of the container with one hand. Wall brackets are available for the 2-quart, 5 quart and the 2.5-gallon size. A counter top holder is available for the 1-quart size.

This document describes the Sharps Away Disposable Containers, which are medical devices for the safe disposal of hazardous sharps. The submission is a 510(k) premarket notification, indicating the device is intended to be substantially equivalent to a legally marketed predicate device.

Here's an analysis based on your request, highlighting the limited information available from this specific 510(k) document regarding acceptance criteria and study details:

Executive Summary: Sharps Away Disposable Containers

This 510(k) submission (K072667) for the "Sharps Away Disposable Containers" focuses on establishing substantial equivalence to a predicate device ("B-D Guardian Nestable Sharps Collectors") rather than presenting a novel device requiring extensive clinical trials with human subjects. Therefore, many of the details you requested (like multi-reader, multi-case studies, expert adjudication for test sets, and detailed ground truth for training) are not applicable or not provided in this type of submission.

The "studies" are primarily performance testing of the device's physical properties against established safety standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of device are generally derived from regulatory standards (e.g., OSHA, CFR) and recognized ASTM standards for medical sharps containers. The document states a device "meets or exceeds OSHA recommendations." The reported device performance is simply a "Passed" status for each test, implying compliance with the relevant standard's requirements. Specific quantitative acceptance limits are not detailed in this summary.

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

The document does not specify the sample sizes used for the individual performance tests (e.g., how many containers were puncture tested, or how many underwent leak testing).

The "data provenance" for these performance tests is inherently from laboratory testing of the manufactured devices. There is no indication of country of origin for the data beyond the manufacturer being based in the USA, and these are not retrospective or prospective studies in the clinical sense.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This question is not applicable to this type of device and submission. "Ground truth" in the context of clinical studies with experts (e.g., radiologists interpreting images) is not relevant here. The "ground truth" for these physical performance tests is defined by the objective metrics and methods outlined in the cited ASTM and CFR standards, which are evaluated by laboratory technicians or engineers.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical studies where multiple human readers interpret data, and their disagreements need to be resolved to establish a definitive "ground truth." For physical performance tests of a sharps container, there are objective pass/fail criteria based on quantitative measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This question is not applicable. MRMC studies are used to evaluate the diagnostic performance of an AI system, often in comparison to human readers, typically in image interpretation or diagnostic tasks. This device is a physical sharps container, not a diagnostic AI system, and therefore, no MRMC study was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

This question is not applicable. This device is a physical product, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims of the Sharps Away Disposable Containers is based on:

• Objective physical measurements and observations according to established industry and regulatory standards.
• Compliance with specified performance criteria detailed in standards like ASTM F2132-01 for puncture resistance and 49 CFR 178.609(h)(2) for specific handling of hazardous materials.
• Engineering specifications for leak resistance, impact, and handle strength.

There is no "expert consensus," "pathology," or "outcomes data" in the typical clinical sense used for establishing ground truth for this device type.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of AI/machine learning for this physical device. The device itself is manufactured, and its performance is tested against standards, not "trained" on data.

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

This question is not applicable for the same reason as above. There is no training set for a physical sharps container. The manufacturing process and quality control ensure the device's characteristics, which are then verified through performance testing.

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