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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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It is intended to be used for health care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles.

The Sharps container is single-use, disposable, non-sterile containers intended to be used for health- care purposes for safe disposal of hazardous sharps such as needles, syringes, lancets and etc. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used. It is made of injection molded polypropylene plastic, and is composed of base, lid, closure and handle (except pocket collectors). 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 provided text is a 510(k) Summary for a Sharps Container. It describes the device, its intended use, and its similarities to a predicate device, along with performance testing. However, it does not contain information about an AI/ML-based medical device. Therefore, I cannot generate the requested information about acceptance criteria, study details, expert involvement, or AI-specific performance metrics.

The document discusses the following types of tests:

• ASTM F2132-01(2008): Standard Specification for a Sharps Containers
• ISO 23907-1: Sharps containers - Part 1: Requirements and test methods - Sharps containers for single use
• 49 CFR 178.606 Stacking: Regulations for stacking of packaging for hazardous materials.
• 49 CFR 178.608 Vibration: Regulations for vibration testing of packaging for hazardous materials.

These are physical performance tests for a sharps container, ensuring its safety and appropriate containment of hazardous waste, not tests related to an AI/ML algorithm's diagnostic or predictive performance.

Therefore, I am unable to fulfill your request as the provided input does not describe an AI/ML medical device.

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Tiger Reusable Sharps Containers and accessories are intended to be used in healthcare facilities including nursing stations, medication carts, laboratories, dental offices, emergency rooms, treatment rooms, emergency vehicles, veterinarian offices and other small quantity waste generators for the safe disposal, storage and transportation of hazardous sharps.

Tiger Reusable Sharps Containers are of injection-molded polypropylene plastic, designed for reusable 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.

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 product identification label's level line.

The device in question is the Tiger Reusable Sharps Container.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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 explicitly state the specific sample sizes used for each individual test or the data provenance (country of origin, retrospective/prospective). It generally refers to "test specimens" or "test samples" for each performance test. The performance testing was done to demonstrate compliance with recognized international and national 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 information is not applicable as the tests performed are physical, chemical, and biological performance tests for a medical device (sharps container), not diagnostic image analysis or clinical studies requiring expert ground truth establishment. The "ground truth" for these tests is defined by the technical specifications and acceptance criteria of the referenced standards.

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

This information is not applicable for the type of performance testing conducted. Adjudication methods are typically used in clinical trials or studies involving human assessment or interpretation, not for objective engineering or laboratory tests.

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 information is not applicable. The device is a physical sharps container and not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

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

This information is not applicable. The device does not involve an algorithm or AI.

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

The ground truth used for these performance tests is based on objective measurements and predefined thresholds established by the relevant national and international standards (e.g., ISO, ASTM, DOT CFR). For biological tests, the ground truth is based on the absence of cytotoxicity, sensitization, irritation, or successful disinfection/cleaning as per the specified methods and criteria. No expert consensus, pathology, or outcomes data were used to establish the ground truth for these device performance tests.

8. The sample size for the training set

This information is not applicable. The device is not an AI/machine learning model and therefore does not have a "training set."

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

This information is not applicable for the same reason as above; there is no training set for this type of device.

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Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal.

The Containers are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal of hazardous sharps such as needles, syringes, lancets and etc. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used.

Sharps container are used to collect hazardous sharps such as needles, syringes, lancets and etc. The containers are single-use, disposable, non-sterile containers.

The Sharps Container constructed of polypropylene plastic. 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.

The provided text describes the acceptance criteria and a study proving that Sharps Containers meet these criteria. Here's a breakdown of the requested information:

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 sample size used for each non-clinical test (e.g., how many sharps containers were subjected to each test).
The provenance of the data is not specified in terms of country of origin of the data or whether it was retrospective or prospective. These are lab tests conducted on the physical device.

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 described tests are non-clinical hardware performance tests, not studies requiring expert interpretation of results or ground truth establishment by medical professionals. The acceptance criteria are based on physical measurements and observations against established standards (ASTM F2132-01, ISO 23907, 49 CFR 178.606, 49 CFR 178.608).

4. Adjudication Method for the Test Set

This information is not applicable. The tests are objective measurements and observations against pre-defined acceptance criteria, not subjective assessments requiring adjudication by a panel of experts.

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 information is not applicable. The device is a Sharps Container, which is a physical medical device for waste disposal, not an AI or imaging diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are irrelevant.

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

This information is not applicable. The device is a physical Sharps Container, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the Sharps Containers is based on:

• Established International Standards: ASTM F2132-01 (Reapproved 2008e1), ISO 23907, and 49 CFR 178.606, 49 CFR 178.608. These standards define the test methods and performance requirements (acceptance criteria) for sharps containers.
• Direct Physical Measurement and Observation: The tests involve physical manipulation (e.g., dropping, stacking, vibrating, puncturing) of the containers and subsequent observation and measurement of specific parameters (e.g., puncture resistance in Newtons, absence of leakage, absence of deterioration, stability, integrity of handles).

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device as it is a physical product and not an AI/machine learning model.

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

This information is not applicable for the same reason as above.

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Tiger Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal.

The Containers are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal of hazardous 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 device models are not for use in areas with unsupervised patient access.

All device models only be used with appropriate mounting accessories.

Tiger Sharps Containers constructed of injection molded polypropylene plastic. They are designed for a single-use (disposable) 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.

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 level line on the product identification label.

The provided text describes the regulatory clearance of "Tiger Sharps Containers" and includes information about its performance testing. Here's a breakdown of the requested information:

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

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 sample size used for each performance test. It only states that "Performance testing was provided in support of the substantial equivalence determination." The provenance of the data (country of origin, retrospective/prospective) is also not mentioned.

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 information is not applicable as the device is a sharps container and the performance tests described are physical and mechanical tests, not clinical evaluations requiring expert interpretation of medical data. Therefore, there is no "ground truth" established by medical experts in this context.

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

This information is not applicable for the same reasons as #3. The performance tests are objective measurements against established standards.

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 information is not applicable. The device is a physical sharps container, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

This information is not applicable as the device is a physical sharps container and does not involve an algorithm.

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

The "ground truth" for the performance tests appears to be defined by the consensus standards (e.g., ASTM F2132-01(2008)e1, ISO 23907-2012, 49 CFR) themselves. These standards specify the test methods and the acceptable criteria for "passing" a test, rather than relying on expert clinical consensus, pathology, or outcomes data in a medical sense.

8. The sample size for the training set

This information is not applicable. The device is a physical product that undergoes engineering performance testing, not a machine learning model that requires a training set.

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

This information is not applicable as there is no training set for a machine learning model.

Ask a specific question about this device

Bluestone Medical, Inc. OWTSH-I Sharps Container is a single- use, disposable, non-sterile container intended to be used for health-care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for qualified personnel in health care facilities and in other facilities in which medical sharps may be used. The container is intended to be used in areas where there is no unsupervised patient access.

The OnSite Waste Sharps Container OWTSH-I is constructed using tinplate steel base with a Nylon and polypropylene restrictive lid system. The OnSite Waste Sharps Container OWTSH-I measures 10 1/2" wide x 4 3/4" deep, and tapers to a dimension of 9" wide x 3 1/8 deep. The height of the container is 8 1/4" in height. The OnSite Waste Sharps Container OWTSH-I is equipped with a locking lid that once closed, prevents anyone from opening it either before or after processing. Labels are on a red background with printed in black text and a bio-hazzard symbol. Labels are adhered to the container at the time of manufacture with the fill line warning printed on the label There is no feature to bend, break, or shear needle, includes blunting of needle in container.

This FDA 510(k) summary for the OnSite Waste Sharps Container (K182235) details the performance testing against established standards. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "There were no clinical testing required to support the medical device," meaning the acceptance criteria and performance are based solely on non-clinical (laboratory) tests.

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

The document does not explicitly state the sample size used for each non-clinical test. However, it indicates that the puncture resistance test was "Performed by an independent materials testing lab," suggesting the use of laboratory samples. The data provenance is non-clinical laboratory testing, likely conducted in the United States or at a facility accredited for these ISO/ASTM standards. The testing is retrospective in the sense that it evaluates the manufactured product's performance against pre-defined standards.

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

Not applicable. For non-clinical performance tests of a physical device like a sharps container, ground truth is established by objective measurements and adherence to specified testing standards (ASTM, ISO). Expert consensus is not typically involved in determining if a physical property (like puncture resistance or leak-proofness) meets a technical specification.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for subjective assessments, especially in clinical or image-based studies. For physical performance tests, the results are typically determined by direct measurement or observation against a predefined pass/fail criterion.

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 and does not involve AI, human readers, or image interpretation. Therefore, an MRMC comparative effectiveness study is not relevant.

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

Not applicable. This device is a physical sharps container and does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device is based on established objective technical standards and specifications. Specifically:

• Puncture Resistance: Defined by ASTM F2132-01 (2008).
• Leak Resistance: Defined by visual observation against a "no leakage" criterion over 24 hours.
• Impact Resistance: Defined by ISO 23907:2012.
• Stability: Defined by ISO 23907:2012.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device. It does not involve machine learning algorithms that require a "training set." The performance is evaluated based on material science and engineering principles.

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

Not applicable, as no training set is relevant 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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MAUSER PG II Sharps Container is intended to be used in healthcare facilities including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, veterinarian offices and other waste generators for the safe collection and disposal of hazardous sharps.

MAUSER PG II Sharps Container is designed for use on sites with no unsupervised patient access.

MAUSER PG II Sharps Container is a single-use device, which consist of rectangular body and available in three sizes 30 liter, 50 liter and 60 liter. Each container has two parts, the body and the lid, which assemble together to form a unit. Two lid styles are available: grip, and click with port hole.

MAUSER PG II Sharps Container is designed for use on sites with no unsupervised patient access.

Manufacturer offers a stainless steel pedal frame cart that offers a hands free collection process and integrates with all sizes of container and lid type.

The container is designed for safe collection and disposal of sharps, i.e. items that can cause puncture wounds, cuts or tears in skin or mucous membranes, including, but not limited to hypodermic, surgical, suture, and IV needles; Pasteur pipets, lancets, razors, scalpels, and other blades.

This document is a 510(k) summary for a medical device called the MAUSER PG II Sharps Container. It describes the device, its intended use, and the performance testing conducted to demonstrate its substantial equivalence to predicate devices. It is not a document describing the acceptance criteria and study proving a device meets acceptance criteria for an AI/ML powered medical device, which is what your request implies by asking about ground truth, training sets, adjudication, MRMC studies, and expert qualifications.

The provided text focuses on the physical and mechanical properties of a sharps container, not on an AI's performance. Therefore, I cannot extract the information required for an AI/ML device study, such as sample size for test sets (as there isn't one in the context of AI), data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth (outside of physical test results), training set size, or how ground truth for training was established.

However, I can extract the acceptance criteria and performance data for the physical device as presented in the document:

Acceptance Criteria and Device Performance for MAUSER PG II Sharps Container

The MAUSER PG II Sharps Container is a physical medical device designed for the safe collection and disposal of sharps. The performance data presented in the 510(k) summary focuses on demonstrating that the device meets physical and mechanical safety standards, primarily through various engineering tests. No AI/ML component is mentioned or evaluated in this document.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set:
  • Puncture Resistance: "Various sections of container" were tested. The exact number of sections or containers is not specified.
  • Drop Test: Six containers (each of the three sizes) were tested.
  • Leak Resistance: Individual containers were tested (number not specified).
  • Stack Test: Individual containers were tested (number not specified).
  • Vibration Test: Individual containers were tested (number not specified).
  • Stability: Individual containers were tested (number not specified).
  • Strength of Handles: Individual containers were tested (number not specified).
• Data Provenance: The tests were conducted internally by MAUSER USA, LLC. The document does not specify the country of origin of the data beyond the company's US address. The nature of these tests is clearly prospective, as they are performed to demonstrate compliance for a new device.

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 to the type of device and testing described. The "ground truth" here is established by standardized physical engineering test methods (ASTM, CFR, ISO), not by human expert consensus on medical images or diagnostic interpretations. The tests are objective measurements of physical properties.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication is typically relevant for subjective assessments, especially in clinical studies or for determining ground truth in image analysis. For objective physical tests, the results are based on direct measurement against predefined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This information is not applicable. An MRMC study is relevant for evaluating the impact of a new technology (like AI) on human performance in diagnostic tasks. This document describes a physical sharps container, not a diagnostic or AI-enabled device.

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

This information is not applicable. There is no algorithm or software component for which standalone performance would be relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective measurements derived from adherence to established engineering standards and regulations (ASTM F2132-01, DOT CFR Title 49, ISO 23907). For instance, for puncture resistance, the ground truth is the force measured in Newtons; for drop test, it's the observation of content release; for leak resistance, it's the observation of leakage.

8. The Sample Size for the Training Set

This information is not applicable. There is no AI/ML component described, and therefore no "training set" in the context of machine learning. The device's design is validated through the physical tests listed, not through a data-driven training process.

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

This information is not applicable as there is no training set for an AI/ML model. The "ground truth" for the device's design and manufacturing is derived from the established engineering standards and safe design principles for sharps containers.

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Red2Green Reusable Sharps Containers and accessories are intended to be used in healthcare facilities including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian offices and other small quantity waste generators for the safe disposal, storage and transportation of hazardous sharps.

Red2Green Reusable Sharps Containers are reusable sharps containers designed for disposal of sharps. The containers are intended for over-the-counter use for the safe disposal of sharps, i.e. articles that can penetrate human skin. This definition includes, but is not limited to needles, scalpels, syringes with needles, disposable scissors, suture needles, stylets, trocars and broken test tubes.

The provided document is a 510(k) premarket notification for a medical device, specifically the Red2Green Reusable Sharps Container. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical safety and efficacy through human trials. Therefore, the information requested in your prompt related to clinical studies, human readers, ground truth established by experts, etc., is not typically found in this kind of document for a device like a sharps container.

However, the document does detail non-clinical performance testing and acceptance criteria. Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Puncture Resistance: "All containers and lids were tested." (Specific number of units not given, but implies comprehensive testing across product variations).
• Impact with Leak: "All containers and lids were tested in each possible configuration." (Specific number of units not given, but implies comprehensive testing across product variations and configurations).
• Stability: "One container."
• Impact: "Five containers."
• Stacking: "Five containers."
• Vibration: "Three containers."
• Accessory Strength: "One of each of the respective wall mounted accessories." (Number depends on accessories available).
• Repeated Opening: "Three samples of the Horizontal Drop Lid."
• Life Cycle: "Five representative sharps containers." (One of these was then used for puncture resistance).

Data Provenance: This document describes non-clinical laboratory testing performed by the manufacturer, Triumvirate Environmental, Inc. The location of the testing is not explicitly stated but is assumed to be internal to the company or through a contracted lab. This is retrospective data collected specifically for this 510(k) submission. There is no information regarding country of origin of data for clinical data as none was performed.

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

This information is not applicable to this document. The ground truth for this device's performance is based on meeting engineering and performance standards outlined by ASTM, ISO, and CFR, not on expert clinical consensus.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of medical data by multiple experts. For this device, performance is measured against objective laboratory criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. without AI Assistance

This information is not applicable. This device is a physical sharps container and does not involve AI or human interpretation for its function.

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

This information is not applicable. This device is a physical sharps container and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the Red2Green Reusable Sharps Container is established by adherence to recognized national and international performance standards (e.g., ASTM F2132, ISO 23907, 49 CFR 178.603, 178.606, 178.608) and predetermined acceptance criteria set forth by the manufacturer to demonstrate substantial equivalence to predicate devices. These standards define objective, measurable physical properties expected of sharps containers.

8. The Sample Size for the Training Set

This information is not applicable. "Training set" refers to data used to train AI algorithms, which is not relevant for this physical device. The non-clinical tests described are performance verification tests.

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

This information is not applicable for the reason stated above.

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