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The SteriSharp™ 3-Gallon RSDC reusable containers are intended for use by healthcare providers (hospitals, laboratories, medical clinics, veterinary clinics, and other such areas and facilities where needles, sharps waste and other infectious waste is generated). The containers are designed to safely contain sharps waste prior to removal from generating facility and until ultimate treatment and disposal of waste. Containers are of such a design and material as to withstand emptying, unloading, washing and disinfecting for reuse.

The SteriSharp™ 3 is a reusable plastic sharps disposal container. It features a mail drop, torturous path tumbler lid for safe and easy disposal of sharps. Simply deposit syringes horizontally into the opening of the lid and they are deposited automatically into the container. When the container is full the tumbler will indicate that it is time to replace the unit. Just insert the locking tabs to secure the container in a closed position and replace it with a clean sanitized unit. Using our proprietary equipment, SteriLogic employees will empty and sanitize the unit and return it to your facility to use for the next switch out. The durable high-density polyethylene construction of the SteriSharp™ 3 makes it leak-proof, puncture resistant and stable. It meets or exceeds all OSHA recommendations for sharps containers, and because it is reusable, it is more environmentally friendly and less expensive than disposable alternatives.

Here's a breakdown of the acceptance criteria and study information for the SteriSharp™ 3-Gallon RSDC, based on the provided FDA 510(k) Notification:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: A "random sampling" of the SteriSharp™ 3 container was used for the simulated life-use testing and subsequent performance tests. The exact number of units in this random sampling is not specified in the document.
• Data Provenance: The tests were conducted by the manufacturer or a contracted testing laboratory ("Container Testing Laboratory, Inc."). The document does not specify a country of origin for the data that would imply a geographical bias for the test set. All testing described is prospective, as it was performed specifically for this 510(k) submission to demonstrate the device's performance.

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

• This information is not applicable as the device is not an AI/diagnostic device that relies on expert interpretation for ground truth. The acceptance criteria are based on objective physical performance standards. The "ground truth" for these tests is the direct measurement of the device's physical properties against established safety and performance standards.

4. Adjudication Method for the Test Set:

• This is not applicable as there are no expert interpretations or subjective assessments requiring adjudication. The tests involve objective measurements and pass/fail criteria.

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 where human readers interpret patient data (e.g., medical images) with and without AI assistance. The SteriSharp™ 3 is a physical sharps disposal container, so this type of study is not relevant to its evaluation.

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

• This is not applicable. The SteriSharp™ 3 is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used:

• The ground truth used for these tests is based on objective performance standards and regulations (e.g., Health Devices 22, 49 CFR 178.603, 178.608, 178.606). These standards define the acceptable physical properties and performance characteristics (puncture resistance, leak resistance, vibration resistance, drop resistance, stacking strength) for disposable medical sharps containers. For the simulated life-use, the ground truth was the observable absence of failure and satisfactory functional performance after 100 cycles.

8. The Sample Size for the Training Set:

• This is not applicable. The SteriSharp™ 3 is a physical medical device, not a machine learning model that requires a training set.

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

• This is not applicable for the same reasons as point 8.

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The SteriSharp™ 2.5 Gallon RSDC reusable containers are intended to be used by healthcare providers (hospitals, laboratories, medical clinics, veterinary clinics, and other such areas and facilities where needles, sharps waste and other infectious waste is generated). The containers are designed to safely contain sharps waste prior to removal from generating facility and ultimate treatment and disposal of waste. Containers are of such a design and material as to withstand emptying, unloading, washing and disinfecting for reuse according to 49 CFR Sections 178.603, 173.4465(d), 173.465(e) and 178.608.

REUSABLE PLASTIC SHARPS DISPOSAL CONTAINER; two components of the device include (a) a plastic mail-drop, torturous path tumbler lid (where needles and sharps waste is inserted) and (b) a rotationally molded plastic bottom (the container), leak-proof on four sides and bottom, where needles are dropped and stored until container unit is emptied and cleaned.

The provided text describes the acceptance criteria and the results of a study for the "SteriSharp™ 2.5-Gallon RSDC" reusable sharps disposal container.

Here's the breakdown of the information requested:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not specify a numerical sample size for the test set. For instance, for "Free Fall Drop," it states "5 drops," implying a small sample for that specific test, but a general sample size for the overall device testing isn't provided.

The data provenance is not explicitly stated in terms of country of origin, nor whether it was retrospective or prospective. Given the context of a 510(k) submission to the FDA, it is highly likely the testing was conducted in a U.S.-based lab and was a prospective evaluation of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The tests are engineering and performance-based, governed by specific regulations and standards (e.g., 49 CFR), rather than relying on human expert interpretation of results that would require "ground truth" establishment in the typical sense (e.g., for medical imaging). The 'ground truth' for these tests is defined by the passing criteria of the regulations themselves.

4. Adjudication method for the test set

This information is not applicable and not provided. The tests are objective, pass/fail evaluations based on defined physical criteria and regulations, not subjective assessments requiring adjudication among multiple observers.

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 section is not applicable. The device is a physical sharps disposal container, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related comparative effectiveness was performed.

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

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

7. The type of ground truth used

The ground truth for this device is based on regulatory standards and established test criteria. For example:

• Puncture: Defined by a specific needle penetration force.
• Vibration: Defined by "1 hour repetitive bounce" as per 49 CFR 178.608.
• Free Fall Drop: Defined by surviving "5 drops 1.2 meter" at "-18° C" as per 49 CFR 178.603.
• Stacking: Defined by withstanding "24 hrs. under 30 kg" as per 49 CFR 178.606.
• Penetration: Defined by resistance to a "7 kg steel rod - 1 meter" as per 49 CFR 178.609(h)(1).

The overall ground truth is that the container must visibly prevent loss or dispersal of contents under these tested conditions.

8. The sample size for the training set

This section is not applicable. This is a physical device, and the concept of a "training set" is typically associated with machine learning algorithms.

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

This section is not applicable for the same reasons as point 8.

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