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The container is intended for use in healthcare settings. The container is designed to safely contain sharps prior to removal from the generating facility, during transportation and until ultimate treatment and disposal of the sharps.

The Sharpsology 2 is a reusable plastic sharps disposal container. The container is a nonsterile device for nonsterile applications. The container is intended to be used in an appropriate wall mount unit, wall bracket or stand alone tray. It features a canteen style, vertical drop lid and a mailbox style, vertical drop lid for safe and easy disposal of sharps. Simply deposit syringes vertically into the opening of the lid, and they are deposited automatically into the container. Container is easily identified as full by looking at both the fill line on the container and biohazard label attached to container. When the canteen style lid is being used and the container is full, the supplied cap is attached to the lid by turning clockwise until it snaps into place for transport. When using the mailbox style lid and the container is full, pull the rotating portion of lid forward and snap lock the rotating portion into the two locking tabs located on the front of the lid. The Sharpsology 2 has a hole in one end of the lid and container that match, a plastic cable wire tie is inserted to look the lid to the container for transportation. Then just replace it with a clean sanitized unit, Using proper cleaning and sterilizing equipment, cleaning facility will empty and sanitize the unit and return it to the user facility to use for the next switch out. The durable high-density polypropylene specialty impact copolymer construction of the Sharpsology 2 makes it leak resistant, 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. The projected life expectancy of the device is at least (5) five years. Other sharps containers using the same material for the same purpose have remained in use over (5) five years without showing failure. The container is intended to be used in healthcare settings. The container is designed to safely contain sharps prior to removal from the generating facility, during transportation and until ultimate treatment and disposal of the sharps.

The Sharpsology 2 container is inserted into a wall mount unit available from Industrial Water Solutions, Inc. that is lockable and allows access to the opening of the lid of the Sharpsology 2 container for needle disposal. Healthcare personnel drop used sharps into the opening of the lid of the container, Sharps drop to the bottom of the container. When the container is full or up to the "Fill Line" of the container, the container is then taken out of the wall mount or bracket on the wall. The label on the container has very visible "Fill Line" imprinted on the outside. The container also has a very visible fill line, as well. A new container or one that has been sanitized for reuse is then put back into the wall mount or bracket for use. The container is then ready for transport to the cleaning facility for sanitation.

A label will be attached to the container specifying the intended use of the container. A sample of this label is attached at the end of this document. (See Attachment 1)

The Sharpsology 2 container is a reusable two gallon sharps container used for the collection of sharps at the healthcare facility. The container is housed in a wall mount or bracket attached to the wall. Healthcare personnel simply drop used sharps into the vertical drop opening on top of the lid and release. The used sharps deposited into the container and drop to the bottom of the container. The container is used until it is deemed to be full by visually inspecting to see if the sharps level is up to the "Fill Line". Once the container is deemed to be full, it is then removed from the wall mount or bracket and gotten ready for transport. A new container or a used, sanitized container is then placed in the wall mount or bracket for use, The Sharpsology 2 container has no handles, but is easily picked up by placing hands on either side of the container and lifting. The average weight of the container plus sharps inside a full container will average five and seven pounds. The used or full containers are then transported to the cleaning and sanitizing facility for sanitation, inspection, packaging, and made ready for reuse. The container is lockable. Each container has a bayonet style lid closure that horizontally slides into place and is removed mechanically for emptying and cleaning. The lid features a wire tie to further help hold the lid in place.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes and Data Provenance:

• Simulated Life-Use Test: 30 containers (15 with canteen-style lids, 15 with mailbox-style lids). The containers were red-colored Sharpsology 2 containers from the same lot tested by Arama Package and Container Testing Services, Inc. in July 2013 (Test report dated July 24, 2013). This appears to be prospective testing conducted by the manufacturer or a contracted lab.
• Free Fall Drop Test: Five (5) filled packages.
• Vibration Test: Three (3) samples.
• Stacking Test: Three (3) containers.
• Leak Resistance: Three (3) containers.
• Puncture Resistance: "A sample of several sections of containers," including the thinnest areas.
• Freestanding Capability: Not explicitly stated but implied to be sufficient for assessment.

The data provenance for most tests appears to be from laboratory testing conducted specifically for the 510(k) submission, likely in the United States, given the reference to U.S. regulations (49 CFR, OSHA) and a U.S. testing laboratory (Container Testing Laboratory, Inc.).

3. Number of Experts and Qualifications:

Not applicable. This device is a reusable sharps disposal container, and the tests performed are physical and mechanical performance tests, not clinical evaluations requiring expert interpretation of results (e.g., medical image analysis).

4. Adjudication Method:

Not applicable, as the tests involve objective physical measurements and observations (e.g., presence of leakage, damage, puncture force, stability) rather than subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is a physical device, not an AI or diagnostic tool that would involve human readers or AI assistance.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is a physical device; there is no embedded algorithm.

7. Type of Ground Truth Used:

The ground truth for these tests is defined by the objective pass/fail criteria established by the referenced standards and regulations (e.g., 49 CFR 178.603, 49 CFR 178.606, 49 CFR 178.608, Health Devices 22, OSHA specifications). These are engineering and performance standards for packaging and safe handling of hazardous materials.

8. Sample Size for the Training Set:

Not applicable. This is a physical device, not a machine learning model.

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

Not applicable. There is no training set for a physical device.

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The container is intended for use by healthcare providers, such as hospitals, laboratories, medical clinics, veterinary clinics and other facilities where needles are generated. The container is designed to safely contain sharps prior to removal from the generating facility, during transportation and until ultimate treatment and disposal of the sharps.

The Enviro Sharp Solutions 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, Sci-Med Waste employees will empty and sanitize the unit and return it to the facility to use for the next switch out. The durable high-density polyethylene construction of the Enviro Sharp Solutions 3 makes it leakproof, 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 an analysis of the provided text regarding the acceptance criteria and study for the Enviro Sharp Solutions 3 device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a precise numerical sample size for the "random sampling" of containers subjected to simulated life-use or for the individual performance tests (Puncture, Leak, Vibration, Free Fall Drop, Stacking). It refers to "all components of a random sampling" for the simulated life-use.
• Data Provenance: The data is retrospective, generated from testing performed on the device components. The country of origin is not explicitly stated but is implied to be within the US given the FDA submission and US regulatory standards cited (e.g., OSHA, CFR). The testing occurred over "a two-day period from November 5, 2008 to November 7, 2008."

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

• The document does not describe the use of human experts to establish ground truth for the performance tests. The "ground truth" for these tests is based on objective measurements and observations against established engineering and regulatory standards (Health Devices 22, 49 CFR).
• The final assessment for the performance tests is reported by "Container Testing Laboratory, Inc.," indicating an accredited testing facility, but individual expert qualifications are not detailed.

4. Adjudication Method for the Test Set

• No human adjudication method (like 2+1 or 3+1) is mentioned or implied for the performance tests. The tests involve objective measurements against pass/fail criteria from regulatory standards.

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

• No, an MRMC comparative effectiveness study was not done. This device is a physical sharps disposal container and not an AI-assisted diagnostic or decision support tool that would involve human readers.

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

• This question is not applicable. The device is a physical product, not an algorithm or software. The performance tests are by definition "standalone" in the sense that they evaluate the physical product's characteristics against objective criteria.

7. The Type of Ground Truth Used

• The ground truth used for the performance tests is derived from established engineering and regulatory standards. For example, the "Pass" for Puncture, Leak, Vibration, Free Fall Drop, and Stacking implies that the device performance met the quantitative or qualitative criteria specified within Health Devices 22 and various sections of 49 CFR. For the simulated life-use, the ground truth was the absence of visible signs of failure.

8. The Sample Size for the Training Set

• This question is not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI.

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

• This question is not applicable, as there is no training set for this device.

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