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The North American Rescue Sharps Shuttle is a molded polypropylene, non-sterile, single use, portable transportable sharps container. Its permanent closure system protects the user prior to disposal via incineration.

The North American Rescue Sharps Shuttle is approximately 6.41" in length, with a sharps aperture of approximately 1" in diameter.

The North American Rescue Sharps Shuttle are injected or blow molded single use, non-sterile disposable, transportable sharps collectors and transport containers intended for use where standard sharps containers are not conveniently accessible. The North American Rescue Sharps Shuttle is a portable collector that provides an alternate to resheathing a needle with its original protective cover. The North American Rescue Sharps Shuttle is designed to safely hold small low volume sharps such as blood needles, lancets, and small syringes.

The North American Rescue Sharps Shuttle is cylindrical, with a conical taper and a temporary closure capability, which can be reopened for the storage of additional sharps prior to terminal disposal via incineration. In addition to the temporary closing mechanism, the North American Rescue Sharps Shuttle has a locking mechanism designed with a locking tab to permanently close the container.

The North American Rescue Sharps Shuttle is a non colored, translucent plastic and is approximately 6.41 inches long by 1 inch in diameter. The cap is red opaque plastic with a hinged cap, which is snapped and locked close contains the biohazardous sharps. Each North American Rescue Sharps Shuttle is individually labeled with a biohazard symbol and fill line. The North American Rescue Sharps Shuttle is available as a single device or as a kit of six (6).

This document is a 510(k) Summary for a medical device called the "North American Rescue Sharps Shuttle." This type of document is generally for substantial equivalence determinations, not for proving a device meets specific clinical acceptance criteria in the same way an AI/ML algorithm might. Instead, it demonstrates that the new device is as safe and effective as a legally marketed predicate device.

Therefore, the following information about acceptance criteria and study design is interpreted within the context of a 510(k) submission for a non-active medical device (a sharps container), rather than an AI/ML diagnostic tool.

1. Table of Acceptance Criteria and Reported Device Performance

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The Sharps Shuttle and Sharp Shuttle with Locking Mechanism are single use, Sharps transport containers intended for use in any setting where standard sharps containers are not conveniently accessible, such as EMS, home health care, etc..

The Sharps Shuttle and Sharps Shuttle with Locking Mechanism are injection or blow molded, single use, non-sterile, disposable, sharps transport containers intended for use in any setting where standard sharps containers are not conveniently accessible, such as EMS, home health care, etc. The Sharps Shuttles may be viewed as a portable sharps containment device that provides an alternative to the procedure of resheathing a needle with its original protective cover which is not a recommended practice or disposing of the sharp in a non-sharps container. The products are designed to hold sharps such as angio-caths, blood needles, lancets and small syringes.

The container is cylindrical for rigidness and has a conical taper. The product body is non colored translucent plastic and is approximately 6 inches long by 1 inch in diameter. The cap is red opaque plastic with a hinged cap which when snapped closed contains the biohazardous sharps for safe conveyance.

Locking and non locking versions are available. Both versions have a temporary closure which can be reopened for the placement of additional sharps prior to terminal disposal. In addition to the temporary closure, the locking Sharps Shuttle with Locking Mechanism can be permanently locked by engaging the locking tab.

Each unit is individually labeled with a biohazard label. Sharps Shuttles are available singly or packaged in a dispenser with an attached carrying handle for easy transport of unused containers. The dispenser is available for the storage of the device prior use. The dispenser does not function as an accessory for use, nor, is it intended to transport containers with biohazardous waste.

The provided document, a 510(k) summary for the Sharps Shuttle, describes the device and its intended use, but does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for a medical AI/software device.

This 510(k) is for a physical medical device (a sharps container) and thus its "acceptance criteria" are related to product performance and safety, demonstrated through physical tests rather than a study with a test set, ground truth, or statistical performance metrics.

Therefore, many of the requested elements for an AI/software device study are not applicable to this document. I will extract the relevant information where possible and indicate when information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Design Features" and their "Safety and Effectiveness Basis." These "Design Features" serve as the de facto acceptance criteria for this physical device, outlined by reference to OSHA regulations and general safety principles. The document describes the features but does not provide specific quantitative acceptance criteria values or detailed test results, only the basis for needing these features.

Details of the "Study" (as applicable to a physical device 510(k)):

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

  • Sample size: Not specified. For a physical device, this would typically involve testing a sample of manufactured units. The document only lists design features and their safety basis.
  • Data provenance: Not applicable. This is not a data-driven device; its performance is assessed via physical testing against FDA/OSHA requirements for sharps containers. The document originates from Sage Products Inc. (Crystal Lake, IL, USA) and is a pre-market notification to the FDA in the USA.

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

  • Not applicable. "Ground truth" in this context refers to the regulatory requirements for sharps containers (OSHA Bloodborne Pathogens Standard, 21 CFR 1910.1030), rather than expert consensus on interpretive data. The document implies compliance with these established regulations.

• 4. Adjudication method for the test set:

  • Not applicable. Performance is likely determined by meeting defined physical test specifications, not by subjective expert adjudication.

• 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 a physical device, not an AI/software device.

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

  • Not applicable. This is a physical device, not an AI/software device.

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

  • The "ground truth" for the requirements of this device is based on regulatory standards and safety guidelines (specifically OSHA Bloodborne Pathogens Standard, 21 CFR 1910.1030) for physical sharps containers.

• 8. The sample size for the training set:

  • Not applicable. This is a physical device, not an AI/software device that requires a training set.

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

  • Not applicable. This is a physical device, not an AI/software device.

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