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Oak Ridge Products Sharps containers are a single-use, disposable, non-sterile containers intended to be used for healthcare purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for trained healthcare professionals. All the containers are intended to be used in areas where there is no unsupervised patient access.

The Oak Ridge Products Sharps Containers are of injection molded polypropylene plastic, designed for a single-use by healthcare professionals. No part of the container is intended to come in contact with patients. The containers are designed to be puncture resistant. leak resistant on the sides and bottom, impact resistant, closable and stable. Large access openings allow for disposal of sharps with one hand use. The plastic used for the sharps containers are of a similar chemical formula as the comparable predicate devices and many of the sharps objects that will be placed within the container such as plastic syringe bodies. These containers are suitable for a terminal disposal by incineration and all materials used are fully consumable during incineration. The Oak Ridge Products Sharps Containers are made of three parts (a base, a lid, and a closure) that form a single unit. The lid and closure come preassembled with the base not attached. Parts are nested to together to reduce storage and shipping requirements. The healthcare facility performs the final assembly on-site by snapping the lid to the base. Lids and closures are uncolored translucent material allowing for a visual determination of fill level. The base is made from a high strength material to support the capacity of the container. The recommended fill level is engraved onto the plastic and corresponds to the fill level line on the product identification label.

After reviewing the provided document, it appears that the submission is for Sharps Containers, which are physical medical devices, not an AI/ML powered device. The document details bench testing for physical properties rather than algorithmic performance.

Therefore, many of the requested categories related to AI/ML device evaluations, such as "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "standalone performance," "training set size," and "ground truth for the training set," are not applicable to this submission.

However, I can extract information related to the acceptance criteria and the study that proves the device meets them based on the provided text, focusing on the physical performance of the sharps containers.

Here's the relevant information:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not specify the exact sample sizes used for each test. It mentions that puncture resistance testing was "Performed by an independent materials testing lab." All tests were "Performance Testing (Bench) - Product Testing." The provenance details (country of origin, retrospective/prospective) are not provided as it's not a data-driven AI study but rather physical goods testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. This is a physical device, and performance is determined by meeting established engineering and safety standards through bench testing, not expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is not a study requiring adjudication of expert opinions.

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 is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this device can be considered the established performance criteria outlined in recognized consensus standards and regulations:

• ASTM F2132-01 (reapproved 2008), "Standard Specifications for puncture Resistance of Materials Used for the Collection for Discarded Medical Needles and Other Sharps."
• OSHA Specification 29CFR 1910:1030
• ISO 23907 First Edition 2012-09-01, "Sharps injury protection – Requirements and test methods – Sharps containers."
• FDA guidance document, "Guidance on the Content and Format of Premarket Notification [510(k)] Submission for Sharps Collectors dated October 1993."

The device's performance is measured against these objective, predefined physical and safety requirements.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. There is no training set for a physical sharps container.

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Oak Ridge Products Sharps containers are a single-use, disposable, non-sterile containers intended to be used for healthcare purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for trained healthcare professionals.

The containers 0330-150S and 0370-1500 are intended to be used in areas where there is no unsupervised patient access.

The 0330-150M container with the counterbalanced closure is intended to be used in areas that have unsupervised patient access.

The Oak Ridge Products Sharps Containers are of injection molded polypropylene plastic, designed for a single-use by health care professionals. No part of the container is intended to come in contact with patients. The containers are designed to be puncture resistant. leak resistant on the sides and bottom, impact resistant, closable and stable. Large access openings allow for disposal of sharps with one hand use. The plastic used for the sharps containers are of a similar chemical formula as the comparable predicate devices and many of the sharps objects that will be placed within the container such as plastic syringe bodies. These containers are suitable for a terminal disposal by incineration and all materials used are fully consumable during incineration.

The Oak Ridge Products Sharps Containers are made of three parts (a base, a lid, and a closure) that form a single unit. The lid and closure come preassembled with the base not attached. Parts are nested to together to reduce storage and shipping requirements. The health care facility performs the final assembly on-site by snapping the lid to the base.

This document describes the Oak Ridge Products Multi-Purpose Sharps Container and its substantial equivalence to a predicate device. Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each test. It mentions that testing was performed by an independent materials testing lab (for Puncture Resistance). The data provenance is not specified beyond being "Product Testing" performed in the context of a 510(k) submission, implying it's prospective testing for this specific device model. No information is given about country of origin of data or whether it's retrospective or prospective for the actual test sets.

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

This information is not applicable. The device is a physical sharps container, and its performance is evaluated against engineering and safety standards, not against "ground truth" established by human experts in the context of medical imaging or diagnostic algorithms. The "ground truth" for these tests are the objective pass/fail criteria defined by the standards (e.g., no needle puncture, no leaks).

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert interpretation (e.g., medical image reading) where there might be disagreements in initial assessments. For physical product performance tests against objective standards, the outcomes are typically definitive (pass/fail).

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 information is not applicable. This device is a physical medical waste container, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and analysis of AI assistance effect size are irrelevant.

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

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests are the objective measurement criteria and pass/fail thresholds defined by recognized consensus standards such as ASTM F2132-01, ISO 23907:2012, and OSHA Specification 29CFR 1910:1030. These standards provide quantifiable metrics (e.g., puncture depth, leakage volume, stability under load) to determine if the device meets the safety and performance requirements.

8. The sample size for the training set

This information is not applicable. This is a physical product, not a machine learning model that requires a training set.

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

This information is not applicable. As explained above, there is no training set for a physical product.

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Oak Ridge Products Sharps containers are single-use, disposable, non-sterile containers intended to be used for healthcare purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for trained healthcare professionals.

The 1 quart Phlebotomy container is intended to be used with an appropriate mounting device.

The 5.4 quart is intended to be used with an appropriate mounting device.

The 2 gallon container is intended to be used in areas where there is no unsupervised patient access.

The Oak Ridge Products Sharps Containers are an injection molded polypropylene plastic designed for a single-use. The containers are puncture resistant, leak resistant on the sides and bottom, closable and stable. The products have engraved maximum fill lines on the containers and instructions for locking the container closed. Labels are white with black text and a black bio-hazard symbol printed on an orange-red background. Labels are adhered to the containers at the time of manufacture with the fill line warning matching the engraved fill line on the container.

The Oak Ridge Products Sharps Containers are made of three parts (a base, a lid, and a closure) that form a single unit. Parts are nested together to reduce storage and shipping requirements. The bases are offered in natural (translucent) or colored (red). These are available in three sizes; 1) 1 quart Phlebotomy, 2) 5.4 quart for Patient room and 3) 2 gallon containers. Lids and closures are uncolored translucent material. The translucent nature of the product allows for a visual determination of content level.

The acceptance criteria for the Oak Ridge Products Sharps Containers are based on recognized consensus standards and regulations. The study proving the device meets these criteria involved non-clinical performance bench testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size for each performance test. It only states that the products were tested by "appropriate methods" and involved "product performance testing." The data provenance can be inferred as being from internal company testing and an "independent materials testing lab" for puncture resistance. No specific country of origin for the data is mentioned, but the company is based in McHenry, Illinois, USA. The testing is non-clinical and would be considered prospective for the device being evaluated.

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

This section is not applicable as the study involved non-clinical bench testing of a physical device against established technical standards, rather than expert evaluation of data to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable as the study involved non-clinical bench testing and adherence to predefined pass/fail criteria from recognized standards, not subjective adjudication by experts.

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 container, not an AI-powered diagnostic or assistive tool.

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 sharps container, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on the objective, measurable pass/fail criteria defined within the recognized consensus standards: ASTM F2132-01, OSHA 29CFR 1910:1030, and ISO 23907. These standards define the acceptable performance limits for physical characteristics such as puncture resistance, leak resistance, stability, and proper function of access and closure mechanisms.

8. The sample size for the training set

This section is not applicable. The device is a physical product, not a machine learning model, so there is no training set in the conventional sense. The product design and manufacturing processes are likely informed by engineering principles and previous product iterations, but not a "training set."

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

This section is not applicable for the reasons mentioned above.

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