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Disposable Urine Collection Tube is intended for the collection, transport and preservation of urine specimens from the collection site to the testing laboratory, urine specimens are processed using standard clinical laboratory operating procedures for the cultivation of uropathogenic bacteria and yeasts.

The Disposable Urine Collection Tubes for the collection, transport and preservation system consist of a safety rubber plug, a plastic cap and boric acid as an additive inside the tube. The tube is made of Polyethylene terephthalate (PET) and the safety plug is made of butvl-rubber while the disposable cap is made of Polyethylene (PE). The disposable tube device sustains the viability of organisms during transport for up to 48 hrs. at 2-4°C and 22-25°C.There are two main tube types (round and conical bottom), and four configurations by volume of urine for the round bottom tubes (4 ml, 7 ml, 8 ml, 10 ml). The conical bottom tubes only have one configuration by volume (8 ml). Each volume is available in yellow and white caps.

This document describes the premarket notification (510(k)) for the Disposable Urine Collection Tube, which is a Class I medical device. The information provided outlines the device's intended use, comparison to a predicate device, and performance data from analytical studies.

Here's an analysis of the provided text in relation to the requested information:

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

The document details performance studies, primarily for microbial recovery and fill volume impact.

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

• Microbial Recovery Studies:
  • Sample Size: "Three lots of the Disposable Urine Collection Tubes with three samples per lot were evaluated" (3 lots * 3 samples/lot = 9 total samples per condition/time point). The table indicates N=9 for average CFU/ml recovered.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The studies used "pooled human negative clinical urine matrix." The study is presented as part of a 510(k) submission to the US FDA by a Chinese manufacturer. It is a prospective analytical study comparing the device's performance over time.
• Fill Volume Impact Recovery Study:
  • Sample Size: "Three production lots were tested in three replicates with each urine samples spiked with E. coli, P. aeruginosa or P. mirabilis" (3 lots * 3 replicates/lot = 9 total samples per microorganism/fill volume/time point). The table indicates N=9 for average CFU/ml recovered.
  • Data Provenance: Similar to microbial recovery, not explicitly stated beyond being an analytical study supporting the device's performance from a Chinese manufacturer.
• Shelf Life Study:
  • Sample Size: "Six lots of varying production were used for the studies." Specific number of samples per lot or per test is not detailed beyond that.
  • Data Provenance: Not explicitly stated. This is a prospective real-time aging study.

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 device is a urine collection, transport, and preservation tube, not an AI or diagnostic imaging device that requires expert interpretation of output. The "ground truth" for its performance studies is established by quantitative microbiological methods (e.g., counting colony-forming units (CFU/ml) and comparing them to initial counts), and physical/chemical tests (e.g., vacuum, leak, strength, borid acid content). Therefore, the concept of "experts" in the context of radiologists or similar interpretive professionals establishing ground truth is not applicable here. The ground truth is objective, laboratory-derived data.

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

Not applicable. This is an analytical device where performance is measured objectively through laboratory tests (microbial culture, physical properties) rather than through subjective human interpretation or consensus. No adjudication method for "ground truth" is needed in this context.

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 a medical device for specimen collection and transport, not an AI-assisted diagnostic tool. No MRMC study or AI assistance evaluation was conducted.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The ground truth for this device's performance is:

• Microbiological Culture Counts (CFU/ml): For microbial recovery and fill volume impact studies, the "ground truth" is the quantitative measurement of viable microorganisms at different time points and conditions. This is an objective, laboratory-based measurement.
• Physical and Chemical Test Results: For shelf-life studies, the "ground truth" is determined by objective measurements of vacuum, leak integrity, mechanical strength, sterility, and boric acid content.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as 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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