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This device is intended for the disposal of various-sized contaminated medical sharps (including needles, syringes, slides, and ampoules) in clinical and laboratory healthcare settings.

The Demolizer # 47 One-Gallon Point of Generation Sharps Container is a single use, non-sterile, disposable, point of generation sharps container, constructed out of tin-plated steel. The device has a friction fit lid and black foam plastisol sealant for container closure. It is designed to hold contaminated disposable sharps, such as various-sized hypodermic, intravenous syringes or other medical needles, scalpel blades, disposable knives and lancets, and broken glass such as slides, slip covers and ampoules. The device is not a secondary container.

The sharps container is a three-piece construction, one-gallon metal drum with a friction fit lid and sealant used to close the container. The minimum nominal body wall thickness is .0094 inches, and the minimum nominal top/bottom thickness is .0097 inches. The container is opaque and measures 6-5/8 inches wide by 7-7/16 inches in height, with a 2-3/8 inch sharps inlet opening in the center of the top of the container. The lid is 2-3/4 inches in diameter, with a thickness of .0088 inches. Lining the perimeter of the posterior side of the lid is a black foam plastisol which acts as an additional safety seal; this foam ensures a closed container. A built-in vent port, approximately 1 mm in diameter, is located on the top of the sharps container.

The provided text does not contain detailed information about acceptance criteria or a specific study that proves the device meets acceptance criteria in the format requested. The document is a 510(k) premarket notification for a sharps container, focusing on its substantial equivalence to predicate devices.

However, based on the information available, I can infer some aspects related to "acceptance criteria" through the lens of regulatory submission for a medical device. In a 510(k) submission, the primary "acceptance criterion" is often demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use as a predicate, and has either the same technological characteristics or, if different technological characteristics, that they do not raise new questions of safety and effectiveness and are as safe and effective as the predicate.

Here's an attempt to structure the answer based on the provided text, acknowledging its limitations:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The document describes a 510(k) Premarket Notification process. In this context, the "study" is the submission itself, which presents information to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. It's not a traditional clinical study with patients or human readers.

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

This information is not applicable in the context of this 510(k) submission. There is no "test set" of patient data or images as one would find in an AI/diagnostic device study. The "test" for a sharps container typically involves engineering specifications and performance testing (e.g., leak resistance, sharps penetration resistance, drop tests, closure robustness), but details of these specific tests (sample sizes, results) are not provided in this summary. The data provenance would be from manufacturing and engineering specifications, likely in the USA where the manufacturer is located.

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

This information is not applicable. The ground truth for a sharps container's performance is established by engineering standards and regulatory requirements, not by expert medical assessment of patient data.

4. Adjudication Method:

This information is not applicable. There is no "adjudication" in the sense of reconciling expert opinions for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable. This type of study is relevant for diagnostic devices where human readers interpret medical images. The device in question is a physical container for sharps disposal.

6. Standalone (Algorithm Only) Performance:

This information is not applicable. The device is a physical product, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" in this context is based on engineering specifications, regulatory standards (e.g., for sharps containers to prevent injury and contain biohazardous waste), and a comparison to the design and performance of predicate devices. The claim is that the device is "as safe and effective" as its predicates.

8. Sample Size for the Training Set:

This information is not applicable. There is no "training set" in the machine learning sense for this type of device. The design and manufacturing process would involve prototypes and quality control checks, but these are not referred to as a "training set."

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

This information is not applicable. The design and manufacturing would be validated against established engineering principles and regulatory guidelines (e.g., FDA guidance for sharps containers), not from a "training set."

In summary: The provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device. It does not contain the detailed study design elements (like test sets, human readers, ground truth establishment for AI/diagnostic purposes) that would be found for more complex diagnostic or AI-powered devices. The "acceptance criteria" are implied by the regulatory hurdles of proving substantial equivalence, primarily based on intended use and technological characteristics compared to predicates.

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