(43 days)
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:
| Acceptance Criteria (Performance Standard) | Reported Device Performance |
|---|---|
| Puncture Resistance (ASTM F2132-01 (2008)) | Passed |
| Leak Resistance of bottom and sides (OSHA Specification 29CFR 1910:1030) | Passed |
| Overfill detection and Capacity | Passed |
| Needle unwinder (OSHA Compliance Directive, FDA guidance 1993) | Passed (only present on 2.2 quart model) |
| Impact resistance and safe handling (ISO 23907:2012) | Passed |
| Sharps access, closure | Passed |
| Stability (ISO 23907:2012) | Passed |
| Mounting Brackets usability and stability (ISO 23907:2012) | Passed (Applies only to 2.2 quart container, 1 and 2-gallon are free standing) |
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.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).