Search Results

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.

Ask a specific question about this device

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