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The Sharps Plus 5 Gallon Reusable Container is used within healthcare settings for the collection of contaminated disposable sharps.

Sharps Plus 5 Gallon Reusable Containers are generally supplied to hospitals by medical waste transporters or medical treatment facilities.

Sharps Plus 5 Gallon Reusable Containers are used by healthcare providers at the point of disposal where potentially infectious sharps waste is generated.

The Sharps Plus 5 Gallon Reusable Container is substantially equivalent to the BioSystem The Sharps I result sharps container. The Sharps Plus 5 Gallon Reusable Container meets and exceed the primary design characteristics needed to comply with the OSHA Bloodborne Pathogens Standard as well as the American Society for Testing & Maserials. Data for the following tests have been provided; Free Fall Drop (ASTM DS276-944), Stacking (49 CFR 173.465(d), Penetration (49 CFR 173.465(e), Vibration (49 CFR 173.608, Puncture (Health Devices 22). In each of these tests, the Sharps Plus container passed the test criteria.

The Sharps Plus 5 Gallon Reusable Container has a wall thickness of . 125", approximately twice the thickness of most single use primary sharps containers ( 07" to .05"). The testing data illustrates the highly resilies of linear low-density polyethylene. The container is molded rotationally by building up layers of plastic. Each container is equipped with a needleunwinder. Containers remain locked within the Wall Safe when in use within the healthcare facility. Keys are kept with housekeeping and unit nursing station.

The Sharps Plus 5 Gallon Rousable Container is marketed to medical waste transporters and regional treatment facilities, handling the destruction of infectious waste. The Sharps Plus 5 Gallon Reusable Contamer is used solely as a primary container when being shipped over the road. It is common for these facilities to have a unique waste dumping/loading configuration. The Sharps Plus 5 Gallon Reusable Contamer is designed to be opened, emptied and cleaned mechanically, as per the OSHA Bloodborne Pathogens Standard. As with the prodicate device the lid is designed to slide on and off the container via a tongue and groove track. A mechanical arm is used to slide the lid off of the container. Regional treatment facilities handling reusable medical waste are required to use automated container washers. Containers are washed to remove gross contamination and disinfected with a low-level disinfectant. A "Reuse Tracking Label" is used to track the number of cycles and the length of time, containers are used in the field. The Tracking Label is marked after each wash out cycle. After 12 months of use the containers are discarded.

The use of a "horizontal drop" lid opening reduces exposure to needles improperly discarded. Needles are less likely to be onented with the needle face up towards the opening. Other products on the market, such as Devon Industries, Sage Products and Becon Dickinson, all feature a horizontal drop lid opening. The containers are manufactured with natural linear lowdensity polyethylene and are semi-translucent. This makes viewing the waste level through the cabinet window easier.

The provided document is a 510(k) summary for the Sharps Plus 5 Gallon Reusable Container, which is a medical device for the collection of contaminated disposable sharps. The document focuses on establishing substantial equivalence to a predicate device and demonstrating compliance with relevant standards through testing.

Here's an analysis of the acceptance criteria and study information contained in the document, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the Puncture test reference is "Health Devices 22". This is a less common standard reference than ASTM or CFR and its full title or specific criteria are not detailed in the provided text.

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

• Sample Size for Test Set: The document does not specify the exact number of containers tested for each individual test (Free Fall Drop, Stacking, Penetration, Vibration, Puncture). It only states that "Data for the following tests have been provided" and "In each of these tests, the Sharps Plus container passed the test criteria."
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective. Given it's a 510(k) submission to the FDA, it's highly likely the tests were conducted in the US (or according to US-recognized standards) and were prospective, specifically for this device's approval.

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

This type of information is not applicable to this document. The "ground truth" for the performance of a physical device like a sharps container is established by standardized engineering and material tests, not by expert consensus on clinical observations or images. The "experts" in this context would be the engineers and technicians performing the tests according to the specified ASTM or CFR standards. Their qualifications are assumed to be appropriate for conducting these technical tests.

4. Adjudication Method for the Test Set

This is not applicable to this type of device and testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving image interpretation or clinical outcomes where there might be disagreements among observers. For a physical device undergoing standardized performance tests, the outcome is typically a pass/fail based on objective measurements against predefined criteria, not an adjudication of human interpretations.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation (e.g., radiology AI tools), to assess the impact of the device on human reader performance. It is not applicable to a physical sharps container.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a broad sense, standalone performance was assessed. The "device" in this context is the physical container, and its performance was evaluated in isolation through the listed engineering tests (Free Fall Drop, Stacking, Penetration, Vibration, Puncture). These tests measure the container's inherent physical properties and ability to meet safety standards without direct human intervention during the test itself (though humans operate the testing equipment). This is analogous to "algorithm only" performance in that it evaluates the device's intrinsic capabilities.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective measurements against established engineering and safety standards. These standards (ASTM D5276-94, 49 CFR 173.465(d), 49 CFR 173.465(e), 49 CFR 173.465(f), and "Health Devices 22") define the physical limits and conditions the container must withstand to be considered safe and effective for its intended use. The "pass" result indicates the device met these objective, pre-defined criteria.

8. The Sample Size for the Training Set

This is not applicable. The Sharps Plus 5 Gallon Reusable Container is a physical medical device, not an AI, machine learning, or software-based device that requires a "training set" of data. Its design and manufacturing are based on engineering principles and material science, not statistical models trained on data.

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

This is not applicable for the same reasons as #8. There is no training set for this type of device.

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