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Maxcon Reusable Sharps Container is intended to be used for the collection and transportation of used medical sharps. The container is intended to be used in hospitals and clinics, operating rooms, and laboratories by technicians, doctors, dentists, and veterinarians. The device is only intended for use in areas with no unsupervised patient access.

Maxcon Reusable Sharps Container is of injection molded high density polyethylene plastic, and designed for a multiple-use of 250 cycles 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 non-sterile, puncture resistant, leak resistant on the sides and bottom, impact resistant, closable and stable. The recommended fill level is engraved onto the plastic and corresponds to the product identification label's level line. The container body is in the color of red, while the container lid is in the color of black. The products are supplied to waste management companies that are responsible for transporting, decanting, decontaminating, and destroying the containers. The black lid is used to slide across the container top. When in use, move the lid to show an opening with a size depending on the sharps waste to be dropped, and drop sharps waste into the container safely and effectively by gravitational force, allows easy disposal of sharps. After the sharps is deposited, slide the lid closed along the groove to recover the container body for temporary closure. When the content reaching to the fill line, use a 6" cable tie to lock together the lid and container body for final closure. The container is not for use in area with unsupervised patient access.

The provided text is a 510(k) Premarket Notification for a medical device: Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421. This document describes the device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices. It is crucial to understand that this is not an AI/ML-based medical device. Therefore, the questions related to AI/ML model performance, such as MRMC studies, training/test sets, ground truth establishment by experts, and adjudication methods, are not applicable to this submission.

The document focuses on the physical and functional performance of the reusable sharps container.

Here's a breakdown of the acceptance criteria and study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The non-clinical tests are summarized in a table on pages 12-14.

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

The document does not explicitly state the "sample size" in terms of number of units tested for each non-clinical test. Instead, it indicates that the container was subject to various process simulations over its intended life cycle, specifically "250 cycles" for process simulations (filling, closing, decanting, decontaminating). This implies a single or very small number of physical samples would undergo these cyclical tests.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective" in the context of device testing. The tests are "non-clinical" and likely conducted in a laboratory setting. The applicant is Ningbo Maxcon Medical Technology Co., Ltd. in China, so the testing would presumably be done in China or by a contracted lab that adheres to the stated ISO and CFR standards.

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):

This question is not applicable. This is a physical medical device (sharps container), not a diagnostic device relying on expert interpretation of data or images. Ground truth is established by objective physical measurements and functional performance against defined standards (e.g., "no rupture, leakage," "force needed to penetrate").

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

This question is not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. The testing results are objective pass/fail criteria based on physical and mechanical properties.

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:

This question is not applicable. This is not an AI/ML-based device, and therefore, no MRMC studies involving human readers and AI assistance were conducted.

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

This question is not applicable. This is not an algorithm-based device.

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

The "ground truth" for this device's performance is established by international and national standards (e.g., ISO 23907-2:2019, 49 CFR 178.606, 49 CFR 178.608) that define acceptable physical and functional performance for sharps containers. This includes objective measurements such as:

• Absence of rupture or leakage.
• Resistance to penetration (minimum force in Newtons).
• Container stability (not toppling).
• Handle integrity (not breaking or detaching).
• Legibility of labels after processing.
• Microbiological validation (no organism recovery).
• Usable capacity within a percentage deviation.
• Leak-proof property after soaking.

8. The sample size for the training set:

This question is not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

This question is not applicable. There is no training set as it's not an AI/ML model.

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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 Two Gallon Chemotherapy Container (Model, MC1321) is intended for safe collection and containment of trace chemotherapy waste including needles, syringes, and empty vials. The container is non-sterile, to be single-used in areas with controlled access, such as nurse's stations, pharmacies and chemo treatment rooms, and the target population is for trained health-care professionals.

Maxcon Two Gallon Chemotherapy Container (Model: MC1321) is of 2 gallon capability, weight about 470gram, size of 275.6mm (length) ×181.5mm (width)× 275mm (height), and the maximum allowable gross mass of the container defined by the company is 2 Kg.There is no feature to bend, break, or shear needle (includes blunting and melting of needle)in the containers.

The container is made of base+gasketed cap+screw-on cap. The plastic components are made of injection-moulded of Poly-propylene (PP). The pad and gasket are made of Ethylene Vinyl Acetate (EVA) foam.

The closure system is designed, comprising of 4 components: Gasketed lid, Lid gasket pad, Screw-on cap, Cap gasket.

The provided text describes the 510(k) premarket notification for the Maxcon Two Gallon Chemotherapy Container (Model, MC1321). This document focuses on demonstrating substantial equivalence to a predicate device (Bemis Two Gallon Chemotherapy Container, K964858) through non-clinical performance data.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a table format with pass/fail results for each criterion. Instead, it lists the tests performed and indicates that the device "Passed" each of them. The regulatory standards referenced effectively serve as the acceptance criteria.

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

• Sample size: The document does not specify the sample size (number of containers) used for each test.
• Data provenance: The tests were conducted by Ningbo Maxcon Medical Technology Co., Ltd in China, as indicated by the submitter's identification. The data is non-clinical performance data gathered for regulatory submission. It is not specified if the tests were conducted prospectively or retrospectively, though typically such performance testing is done prospectively for new device submissions.

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

This information is not applicable as the device is a physical chemotherapy waste container and the "ground truth" for its performance is established through adherence to engineering and safety standards (e.g., puncture resistance, leak resistance, stability) rather than expert interpretation of medical images or patient outcomes. The evaluation is based on objective measurements against established test methods.

4. Adjudication method for the test set:

This information is not applicable for this type of device and testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed to establish ground truth for subjective interpretations (e.g., medical image diagnosis). For physical device testing, the results are typically objective measurements against a defined standard.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. The Maxcon Two Gallon Chemotherapy Container is a physical medical waste container, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

This information is not applicable. As stated above, this device is a physical chemotherapy waste container, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's performance is established by objective measurements against recognized industry standards and regulatory requirements. This includes:

• ASTM F 2132-01 (2008) for puncture resistance.
• ISO 23907:2012 for container stability, drop/impact, and handle strength.
• 49CFR 178.606 for stacking and vibration tests.
• Internal testing for suitability with chemotherapy drugs and chemical resistance, and shelf-life studies.

8. The sample size for the training set:

This information is not applicable. This is a physical device 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 information is not applicable. As mentioned above, there is no "training set" for this type of device.

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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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