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NO-POKES™ is a disposable needle recapping aid that helps prevent recapping injury by providing repository for the needle cap (other than the user's hand) in which to place the cap while using the syringe. This keeps the user's hand away from the needle during uncapping and recapping.

The cap of the capped needle is placed in the NO-POKES™ . The "wax-like" substance in the NO-POKES™ holds the cap securely while the operator uses the needle. After the procedure, while the cap is secured in the NO-POKES™, the operator inserts the needle back into the cap without exposing his/her hand to the needle. The NO-POKES™ container has an adhesive on the base to hold it to the desired surface while in use.

NO-POKES™ is a disposable needle recapping aid that helps prevent recapping injury by providing repository for the needle cap (other than the user's hand) in which to place the cap while using the syringe. This keeps the user's hand away from the needle during uncapping and recapping.

The cap of the capped needle is placed in the NO-POKES™ . The "wax-like" substance in the NO-POKES™ holds the cap securely while the operator uses the needle. After the procedure, while the cap is secured in the NO-POKES™, the operator inserts the needle back into the cap without exposing his/her hand to the needle. The NO-POKES™ container has an adhesive on the base to hold it to the desired surface while in use.

The provided document is a 510(k) premarket notification letter from the FDA for a device called "No-Pokes Needle Safety Device (Recapper)". This document does not contain any information regarding acceptance criteria, study details, or performance data for the device.

Therefore, I cannot provide the requested information. The document focuses on the regulatory clearance of the device based on its substantial equivalence to a predicate device.

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The Demis Two Gallon Sharps Containers are designed for use in areas with controlled access such as labs and pharmacies. They contain features for both temporary and final closure. The Bemis Two Gallon Sharps Containers have a volume of 6 qt. and weigh 1 lb. 2 oz. with dimensions of 8.5"II x 11.5"W x 7.6"D. Two Gallon Sharps Containers are injection molded of polypropylene plastic and are available in translucent red and beige. These containers are NOT reusable. Bemis Two Gallon Sharps Containers are puncture resistant with integral sidewalls and bottom and have a typical wall thickness of .070". The containers are leakproof on the sides and bottom. The Two Gallon Sharps Containers are labeled with the Biohazard warning symbol that is 1½" in height. The label color is orange-red, with lettering and symbol in contrasting color in accordance with OSIIA regulations. The labels are attached directly to the conor in accordance will of a promanent adhesive. The labels boldly indicate fill level of shree-quarter capacity. Bemis Two Gallon Sharps Containers are translucent with clear lids, therefore, allowing visibility at all levels. The Demis Two Gallon Sharps Container is designed for use in areas with controlled access. There is no limitation to hand access for this container as the opening is designed to accept other objects such as butterfly needles, test tubes and vials. Following final closure, the container remains closed during normal handling. There are no features to bend, break, or shear the needle. The lid also incorporates a "needle key" which can be used to unscrew needles from blood collection tube holders. Two Gallon Sharps Containers lock on wall mounted brackets. A key that is unique to this bracket is used to unlock containers from the bracket. The containers are shipped in two pieces and require assembly by the user. Instructions are included in every case.

Here's a breakdown of the requested information based on the provided 510K Summary for the Bemis Two Gallon Sharps Container:

This document describes a physical medical device (sharps disposal container) rather than a software-based AI/ML device. Therefore, many of the requested fields related to AI/ML studies, ground truth, and expert evaluation are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test. For physical device testing, it is common to test a representative number of units from a production batch or engineering samples. The provenance of the data is internal testing by Bemis Manufacturing Company, likely conducted retrospectively for the purpose of demonstrating compliance. The country of origin of the data would be the USA (Wisconsin, where Bemis is located).

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

Not applicable. For physical device performance tests like puncture resistance, leak resistance, and impact resistance, the "ground truth" is established by the physical properties of the material and design, measured against objective, quantifiable criteria using laboratory equipment and established test methods (e.g., force gauges for puncture, visual inspection for leakage). No human experts are used to "establish ground truth" in the way they would for medical image interpretation.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert interpretations, typically in AI/ML performance studies. For physical device testing, the results are objective measurements or pass/fail outcomes based on predefined criteria.

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

No. MRMC studies are relevant for evaluating the impact of AI/ML systems on human readers (e.g., radiologists, pathologists). This document is for a physical medical device.

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

No. This is not an AI/ML device. The "standalone" performance here refers to the device's inherent physical properties and functionalities without human interpretation. The reported tests are essentially standalone performance evaluations of the physical container.

7. The Type of Ground Truth Used

The ground truth used for these tests is objective physical measurement and adherence to predefined performance standards (or proposed standards). This includes:

• Force measurements (for puncture resistance)
• Observation of leakage (for leak resistance)
• Observation of stability and contents retention (for freestanding capability)
• Observation of integrity after impact (for impact resistance)
• Visibility of contents (for overfill warning)

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. As there's no training set for an AI/ML model, there's no ground truth to establish for it.

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The Bemis Two Gallon Chemotherapy Container is a sharps disposal container. It is intended for the safe disposal of needles, syringes, and other chemotherapy waste in areas with controlled access. These areas, as defined by OSHA regulations 29 CFR 1910.1030 and 29 CFR 1910.1030, include nurse's stations, oncology, pharmacies, and chemotherapy treatment rooms.

The Bemis Two Gallon Chemotherapy Containers are designed for use in areas with controlled access, such as nurse's stations, oncology, pharmacies, and chemo treatment rooms. They feature a gasketed lid and screw-on plastic cap. The containers have a volume of 6 qt. and weigh 1 lb. The containers are injections of polypropylene plastic and are available in translucent white. These containers are NOT reusable. Bemis Two Gallon Chemotherapy Containers are puncture resistant with integral wall thickness of .070". The containers are leakproof on the sides and bottom. The lids are gasketed to guard against spills. The containers are labeled with the Biohazard warning symbol that is 1½" in height. The label color is orange-red and yellow, with lettering and symbol in contrasting color in accordance with OSHA regulations. The labels are attached directly to the surface of the container by a permanent adhesive. The labels boldly indicate fill level of three-quarter capacity. Bemis Two Gallon Chemotherapy Containers are translucent white, therefore, allowing visibility of fill level. The Bemis Two Gallon Chemotherapy Container is designed for use in areas with controlled access. The opening is designed to accept other objects related to hand access for this container as the opening is designed to accept other objects related to hand access for this container as the container remains closed during normal handling. The container should be stable in it's upright position when toppled to 20 degrees, and contents should not spill out when toppled. Containers, when in the final closure position and dropped from a distance of 24 inches, remain intact. There are no features to bend, break, or shear the needle. Two Gallon Chemotherapy Containers can be used freestanding or locked on wall mounted brackets. A key that is unique to this order is required to access and unlock containers from mounted brackets. The containers require assembly by the user. Instructions are included in every case.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Bemis Two Gallon Chemotherapy Container:

Device: Bemis Two Gallon Chemotherapy Container

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for any of the tests. The text refers to "Testing done on the Bemis Two Gallon Chemo Containers" or "Section Sharps Containers passed this requirement," implying that at least one (but likely more) container was tested for each criterion.
• Data Provenance: Retrospective testing on manufactured containers. No country of origin is specified for the data collection, but the manufacturing company is US-based (Sheboygan Falls, WI).

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

• This device is a physical sharps disposal container and does not involve subjective diagnostic interpretations. Therefore, there were no "experts" in the traditional sense (e.g., radiologists) used to establish ground truth for testing.
• The "ground truth" (acceptance criteria) was established by existing standards and criteria from organizations like ASTM, ECRI, OSHA, and CAN/CSA.

4. Adjudication Method for the Test Set

• Not applicable. The tests performed were objective physical/mechanical performance tests against established standards, not subjective assessments requiring adjudication among multiple human reviewers.

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 device is a physical sharps container, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

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

• Not applicable. This device is a physical container, not an algorithm.

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

• The ground truth for the performance tests was based on established industry standards and criteria from organizations such as:
  • ASTM (American Society for Testing and Materials) proposed standard for puncture resistance.
  • ECRI (Emergency Care Research Institute) criteria for Leakproofness, Overfill Warning, Closure Characteristics, and Freestanding Capability.
  • OSHA (Occupational Safety and Health Administration) regulations for Biohazard warnings.
  • CAN/CSA - Z310.6 on Impact Resistance (Canadian Standards Association/Canadian Standards Council).

8. The sample size for the training set

• Not applicable. This is a physical device, not a machine learning model, so there is no "training set."

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

• Not applicable. As there is no training set, this question is not relevant.

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The Bemis One Quart Phlebotomy Container is a sharps disposal container. It is intended for the safe disposal of needles and syringes in areas with or without controlled access. They are typically used in patient rooms, nurse's stations, doctors' and dentists' offices and on med carts.

The One Quart Phlebotomy Container has a volume of 1.0 gt. and weigh .0.2 1b (3.2oz.) with dimensions of 8 "H x 4.3"W x 4.3"D. One Quart Phlebotomy Containers are injection molded with polypropylene plastic in translucent red. These products are typically a .. 970" wall thickness. The One Quart Phlebotomy containers are NOT reusable.

The One Quart Phlebotomy Containers are puncture-resistant, injection-molded containers with integral sidewalls and bottom. They are leakproof on the sides and bottom.

They are labeled with the Biohazard warning symbol. The label color is orange-red, with lettering and symbol in contrasting color in accordance with OSHA regulations. The labels are attached directly to the surface of the container by a permanent adhesive.

The One Quart Phlebotomy Container is secured to a tray or table top in an adhesive-backed injection molded plastic base.

There are no features to bend, break, or shear the needle.

The lid incorporates a "needle key" which can be used to unscrew needles from blood collection tube holders. After blood collection, the needle is inserted into the slotted opening and slid forward until firmly seated, and turned to unscrew the needle from the tube holder.

The lid has two openings: one intended to accommodate blood tube needles only and the other, larger opening to accept larger sharps such as butterfly needles. Both openings have covers that may be temporarily closed during transportation. Each cover also has a tab that is inserted in slots for final locking closure for disposal.

This document describes a physical medical device (sharps disposal container), not a software or AI/ML-based device. Therefore, many of the requested categories related to AI/ML studies, data sets, and ground truth establishment are not applicable.

Here's the information that is applicable based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical or definitive pass/fail thresholds for each test. Instead, it presents a comparison to a predicate device, showing that the new device passed the same tests. The "acceptance criteria" are implied by the "PASS" outcome for each test.

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

The document does not specify the sample size for the tests conducted (e.g., how many containers were drop-tested for impact resistance). It also does not provide data provenance (e.g., country of origin, retrospective/prospective) for these physical tests.

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

Not applicable. This is a physical device subject to engineering and mechanical testing, not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method for the test set

Not applicable. Physical device testing generally involves objective measurements or observations against predefined standards, not 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 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

The "ground truth" for the physical tests would be the established engineering standards or test methods for evaluating medical sharps disposal containers (e.g., ASTM standards for puncture resistance, leak resistance, etc.), against which the device's performance was measured. However, the specific standards are not cited in the summary.

8. The sample size for the training set

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

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

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

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