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PureWay Compliance 1.4 Quart Sharps Collector Container is single-use, disposable, non-sterile and intended to be used for healthcare purposes for safe containment and disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target user is for healthcare professionals.

The PureWay Sharps Collector is injection molded with High Density Polyethylene plastic (HDPE). Designed for single use, the container is puncture resistant, leak resistant on the sides and bottom, closable and stable. The container is labeled with a fill line and instructions for snapping the container lid closed. "Do Not Overfill" to prevent overfill. The label is white and blue with white text and a black biohazard symbol is printed on a red background. The container is made of two parts, (Base and Lid) that form a single unit. The red colored base is conical shaped, and the lid is a clamshell design snapped in place for a tight seal when the container is full. The device is a non-sterile, single use, disposable infectious waste container and is designed to contain and hold sharps such as angio-caths, blood needles, lancets, cap needles, and various sized syringes. The shape of the container is conical which allows for one hand disposal of sharps and a clamshell lid for means of closure.

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

1. No evidence that the performance or function of the container has been compromised.
2. Container's temporary closure shall remain intact. | Pass |
   | Resistance to damage or leakage after toppling | ISO 23907-1:2019 Section 5.5 | There shall be no evidence of breach of the sharps containment area. Minimum five minutes after each topple, the following points shall be visually checked:
3. There shall be no evidence that the performance or function of the container has been compromised.
4. The container's temporary closure shall remain intact. | Pass |
   | Fill line indicator | ISO 23907-1:2019 Section 4.2.7 | 1. Fill line shall be determined by the design of the container, taking into account the risk of sharps extending above the fill line, and shall be at a level no greater than 85% of the total volume of the container.
5. Fill line feature helps prevent overfilling and is a critical safety feature of a sharps container.
6. It shall be possible to ensure the sharps are not above the fill line. This can be achieved either visually or mechanically. | Pass |
   | Strength of Handles | ISO 23907-1:2019 4.2.2 and 5.2 | 1. All sharps containers shall be provided with one or several handles.
7. The handle/carrying feature shall not break or detach during testing.
8. The position of the handles(s), finger recesses, protrusions or flanges shall not interfere with the normal use of the container.
9. Fill the container with a mass equivalent to 150% of manufacturer's maximum allowable gross mass. Suspend the container by its handles(s) at the intended carrying points(s) from a rigid support for 1 h at a temperature of (23+/- 5) degrees Celsius. Remove the container from the support and inspect the handles for integrity and for any evidence of detachment of the handles(s) from the container. | Pass, no evidence of detachment of the handles(s) from the container. (Note: Predicate Device listed as N/A - No Handles) |

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

The document does not explicitly state the sample size (number of sharps containers) used for the non-clinical tests. It refers to the tests performed "when tested," implying a defined test protocol, but the specific number of units tested for each criterion is not provided.

The data provenance is from non-clinical bench testing performed by PureWay Compliance Inc., as indicated by the "Summary of Non-Clinical Performance Data" section and the overall context of a 510(k) submission for a medical device. The tests were performed to ISO 23907-1:2019 standards, which are international standards. The country of origin for the testing itself is not explicitly stated, but the company headquarters is in Carson, CA, USA. The data is prospective in the sense that these tests were conducted specifically to support this 510(k) submission.

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

This section is not applicable as the "study" described is entirely non-clinical (bench testing) of a physical product (sharps collector). There is no "ground truth" to be established by human experts in the context of diagnostic or interpretive performance.

4. Adjudication Method for the Test Set

This section is not applicable as the "study" is non-clinical bench testing and does not involve human interpretation or adjudication for establishing ground truth. The results are based on objective physical measurements and observations against pre-defined engineering 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

An MRMC comparative effectiveness study was not done. This device is a physical sharps collector and does not involve AI or human readers for diagnostic or interpretive purposes.

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

This section is not applicable. The device is a physical sharps collector and does not involve any algorithms or software for standalone performance evaluation.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of this device is defined by the acceptance criteria specified in the international standard ISO 23907-1:2019 for "Sharps containers – Part 1: Requirements for sharps containers for single-use." These are objective, measurable physical properties and functional requirements for the sharps collector.

8. The Sample Size for the Training Set

This section is not applicable. This is a physical medical device, not a machine learning or AI model. Therefore, there is no "training set" in the context of data-driven model development.

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

This section is not applicable for the same reason as point 8.

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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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The Qlicksmart BladeFlask PLUS is a single-use sharps container with a scalpel blade removal function intended to permit the safe removal of scalpel blades from most currently available scalpel handles and contain the blade immediately upon removal to eliminate the need for further handling prior to be disposed as medical waste while allowing the user to monitor its use to see when it is becoming full and will need changing. Scalpel handles compatible with the Qlicksmart BladeFlask PLUS include:

• Swann Morton sizes 3. 4. 5. 6. 7. 8. and 9
• Lawton size 4
• Martin sizes 3, 4, and 7
• Aesculap sizes 3. 4. 6. and 7
• Sayco sizes 3, 4, and 5
• Smic sizes 3 and 4
• Nopa sizes 3 and 4
• AB Stainless size 4
• Lance sizes 3 and 4
• Pro-Med sizes 3 and 4
• Paragon sizes 3 and 4
• Rocket size 5
• Conqueror size 3
• Feather sizes 3. 4. and 7
• LRI sizes 3 and 4
• Generic handle size 4
• L-dent
• Medesy size 5
• Jakobi size 4
• CS size 5
• Helmut Zepf

Scalpel handles known to be incompatible with the Qlicksmart BladeFlask PLUS include:

• Beaver type handles
• Disposable handles

The Qlicksmart BladeFlask PLUS is a single-use sharps container with a scalpel blade removal function that is used under non-sterile conditions. The Qlicksmart BladeFlask PLUS removes scalpel blades from scalpel handles in a single-handed action and then immediately contains the used scalpel blade inside the Qlicksmart BladeFlask PLUS. The handle is intended to be used to dispose the entire container as hazardous waste when full (100 removed blades and shut-off system is activated) and the device is not intended to be reprocessed.

The Qlicksmart BladeFlask PLUS combines a hard plastic sharps container with an internal blade remover mechanism made of hard plastic and hardened steel parts.

It is approximately (13.5 cm) tall by (9.1 cm) wide by (12.3 cm) deep. It weighs less than 250gm per unit when empty. It is red in color. It is labelled as shown on the samples provided with this application.

This document is a 510(k) Summary for the Qlicksmart BladeFlask PLUS, a medical device intended for safe scalpel blade removal and containment. The summary outlines the device's characteristics, intended use, and most importantly, the performance testing conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the provided information, structured to answer your questions regarding acceptance criteria and study proving device performance:

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

The document provides a detailed table within the "TECHNOLOGICAL CHARACTERISTICS COMPARISON OF WITH THE VI. PREDICATE DEVICE" section under "Performance Specifications." This table, along with the "Mechanical and Functional Tests" and "Transportation Tests" sections, outlines the acceptance criteria and corresponding results.

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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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Nitta M&T Safety Boxes are 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, syringes, and blood needles by qualified personnel in health care facilities and other facilities in which medical sharps may be used. The device is not in contact with or available to the patient in normal use.

Nitta M&T Safety Boxes are disposable and non-sterile sharps container and its lid are made of puncture resistant, leak proof polypropylene. These containers are offered in various volumes, sizes, and lid styles. Mounting accessories (brackets) are available for use with 1.0L, 1.5L, 3.2L and 7.6L containers in locking and non-locking variations. Equipped with visible final lock mechanism. A design that allows you to determine and clearly differentiate the permanent and temporary closure engagement by the position of final lock claws.

The document describes the Nitta M&T Safety Box, a disposable and non-sterile sharps container, and its compliance with relevant standards. 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 explicitly state the sample size used for each test. The testing was performed on the "subject device" (Nitta M&T Safety Box) which comprises various models. The data provenance is not explicitly mentioned with respect to country of origin, but Nitta M&T (Thailand) Co., Ltd. is based in Thailand. The studies appear to be prospective, laboratory-based performance tests as opposed to retrospective data analysis.

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 is a physical medical device (sharps container), not an AI or diagnostic device that requires expert evaluation for ground truth. The acceptance criteria are based on objective, quantifiable metrics defined by international standards (ISO 23907-1:2019). Therefore, expert consensus for ground truth is not applicable in this context.

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

Not applicable, as this is objective performance testing against a standard, not a subjective evaluation requiring 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 or diagnostic device.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for this device is conformance to the objective, measurable requirements outlined in the international standard ISO 23907-1:2019. This involves physical measurements and observations of the device's behavior under specific test conditions.

8. The sample size for the training set

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

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

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

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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.

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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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