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Maxcon Sharps containers (1 QT Sharps Container, MA1112; 5.4 QT Sharp Container MA1212 ; 5.4 QT Sharps Container MA1213; 7 Liter Sharps Container MA1324) are single-use, disposable, non-sterile containers, intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The device is intended to be used for safe disposal of hazardous sharps such as hypodermic needles, and blood needles by qualified personnel in health care facilities in which medical sharps may be used. All device models are not in contact with or available to the patient in normal use, and all device models are not for use in areas with unsupervised patient access.

Maxcon Sharps Containers are of injection molded polypropylene plastic, and designed for a single-use by qualified personnel in health care facilities and other facilities in which medical sharps may be used. 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 polypropylene , the same as that of the comparable predicate devices. Labels are printed in black text and a black bio-hazard symbol. Labels are adhered to the containers at the time of the manufacture with a fill line warning not to fill above this line. The cover base and the lid (closure) come pre-assembled with the body not attached. Components are nested together to reduce room occupation in storage and shipping. The final on-site assembly is performed in health care facility by snapping the cover to the body. There is no feature to bend, break, or shear needle ,includes blunting and melting of needle in the containers.

Acceptance Criteria and Device Performance Study for Maxcon Sharps Containers

This document outlines the acceptance criteria for Maxcon Sharps Containers and summarizes the non-clinical test study demonstrating the device meets these criteria.

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 number of units (sample size) for each test set. However, for "Resistance to Penetration," it mentions cutting the external surface of "the container" into 24 approximately equal sized areas, implying at least one container was used per test. For "Stacking Test" and "Vibration Test," it mentions using "Three sample packagings" selected at random.

The data provenance is not specified in terms of country of origin. The study appears to be a retrospective non-clinical test conducted by the manufacturer, Ningbo Maxcon Medical Technology Co., Ltd.

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

This information is not applicable as the tests performed are non-clinical (physical and mechanical tests) and do not involve human interpretation or subjective assessment by experts to establish ground truth. The results are based on objective measurement and observation against predefined criteria in relevant standards.

4. Adjudication Method for the Test Set

This information is not applicable as there is no human interpretation or subjective assessment that would require adjudication. The tests involve quantifiable measurements and observations of physical performance.

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

There was no MRMC comparative effectiveness study conducted. The device is a physical sharps container and does not involve AI or human reader interpretation.

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

This is not applicable as the device is a physical sharps container and does not involve any algorithm or AI.

7. The type of ground truth used

The ground truth for these non-clinical tests is established by fulfilling the objective, quantifiable criteria defined by recognized international and national standards, specifically:

• ISO 23907-1:2019 (Sharps injury protection — Part 1: Requirements and test methods for sharps containers)
• 49CFR 178.606 (US Department of Transportation hazardous materials regulations for drumming and packaging – specifically related to stacking tests)
• 49CFR 178.608 (US Department of Transportation hazardous materials regulations for drumming and packaging – specifically related to vibration tests)
• OSHA Regulations (Standards - 29 CFR) Bloodborne Pathogens. 1910.1030, (d)(2)(viii)(C) (for leak proof testing)

These standards define the methodologies and acceptable performance limits.

8. The sample size for the training set

This is not applicable as the device is a physical product and does not involve any machine learning models that require a training set.

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

This is not applicable as the device is a physical product and does not involve any machine learning models or training sets.

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Maxcon Sharps containers(2.2QTSharpsContainer,MA1122;2GSharps Container MA1321;2GSharp Container MA1221; 8GSharps Container MA1352) are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal ofhazardous sharps such as hypodermic needles, syringes, lancets and blood needles.The target population is for qualified personnel in health care facilities in which medical sharps may be used. All the containers are intended to be used in areas where is no unsupervised patient access.

Maxcon Sharps Containers are made of injection molded polypropylene plastic, and designed for a single-use by qualified personnel in health care facilities and other facilities in which medical sharps may be used, the same as that of the comparable predicate devices.

Maxcon Sharps Containers are composed of 3 parts (base+lid+closure).No part of the container is intended to come in contact with patients and the sharps objects that will be placed within the containers. The lid and the closure come pre-assembled with the base not attached. Components are nested together to reduce room occupation in storage and shipping. The final on-site assembly is performed in health care facility by snapping the lid to the base.

Labels are on a red background with printed in black text and a black bio-hazard symbol. Labels are adhered to the containers at the time of the manufacture with the fill line warning matching the engraved fill line on the container.

There is no feature to bend, break, or shear needle ,includes blunting and melting of needle in the containers.

The provided document details the 510(k) submission for the Maxcon Sharps Container. Since this is for a medical device (sharps container) and not an AI/ML-driven diagnostic or therapeutic device, the concepts of "acceptance criteria," "device performance," "sample sizes," "ground truth," "experts," and "MRMC studies" are applied differently than described in the prompt, which is more suited for AI/ML outputs.

Instead, the acceptance criteria are based on established performance standards for sharps containers, and the "study" is a series of non-clinical tests demonstrating the device's adherence to these standards.

Here's the information adapted to the context of a sharps container:

1. Table of Acceptance Criteria and the Reported Device Performance

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

The document does not specify the exact sample sizes (number of units tested) for each non-clinical test. It only states that the tests were successfully passed ("Passed"). The data provenance is through the manufacturer's internal testing as part of their 510(k) submission, confirming compliance with international and US standards. This is prospective testing performed on the final device design. The country of origin of the device and testing is implied to be China (Ningbo Maxcon Medical Technology Co., Ltd. is based in China), under the guidance of US FDA recognized consensus standards.

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

This concept is not directly applicable to the evaluation of a sharps container. The "ground truth" for a sharps container's performance is defined by established engineering and safety standards (e.g., ASTM, ISO, CFR). The "experts" in this context would be the engineers and technicians performing the tests according to the specified methodologies and the regulatory bodies (like FDA) that define and enforce these standards. There is no mention of external clinical experts retrospectively reviewing test results for "ground truth" establishment in the way it applies to diagnostic algorithms.

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

Adjudication methods like 2+1 or 3+1 (common in clinical trials or AI performance evaluations involving human readers) are not applicable here. The assessment of whether a sharp container "passed" a test is based on objective measurements and predefined pass/fail criteria outlined in the standardized test protocols (e.g., did the container resist puncture up to a certain force, did it leak after a drop, etc.).

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

An MRMC study is not applicable to a sharps container. This type of study is designed to evaluate the performance of diagnostic imaging devices or AI algorithms by having multiple human readers interpret cases, often comparing performance with and without AI assistance. The Maxcon Sharps Container is a physical medical device for waste disposal, not an imaging or diagnostic tool.

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

This concept is not applicable. The Maxcon Sharps Container is a physical product, not an algorithm. Its performance is inherent in its physical design and materials, and it functions independently, although it is used by humans.

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

The "ground truth" used for evaluating the Maxcon Sharps Container is defined by adherence to established international and national performance standards (e.g., ASTM F2132-01, ISO 23907:2012, 49 CFR 178.606, OSHA 29 CFR 1910.1030). These standards themselves represent a consensus of expert engineering and safety knowledge that defines what constitutes a safe and effective sharps container. There is no "pathology" or "outcomes data" in the sense of clinical disease diagnosis.

8. The sample size for the training set

This concept is not applicable. Sharps containers are physical devices manufactured through injection molding. They do not involve "training sets" in the context of machine learning. The design and manufacturing processes are refined through engineering principles, material science, and iterative prototype testing, not data-driven algorithm training.

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

Not applicable, as there is no "training set" for an algorithm. The "ground truth" for the design and manufacturing of the sharps container is the adherence to the performance requirements stipulated by the aforementioned safety and engineering standards. Manufacturing processes are validated to consistently produce devices that meet these specifications.

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