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This device is intended to measure/ display collected urine volume. It detects fill level and temperature.

iBag™ is a urine management system that includes bladder and temperature measurement for catheterized patients who desire to be fully mobile. · iBag™ provides accurate, real-time assistive data. It does this through use of a calibrated drainage bag integrated with a Future Path Medical sensor, a base transmitter unit called Wi-Mitter™ for wireless transmission of urine bag fill and bladder temperature information. Once the Wi-Mitter™ is snapped in place, the container is polled and the measurement of fluid level begins and this data is then transmitted to the patient, the care provider (an aid) a family member, or even to the hospital's base station. Data is transmitted via traditional data networking and may be interpreted and displayed on a user's laptop computer, and other types monitors. Since the data from the Wi-Mitter™ is time and date stamped, time of fill level may be automatically calculated, noted and threshold values used for fill level alarming.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study conducted for the iBag™ Urine Management System:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The predicate device's specifications for volume accuracy and temperature range are used as a proxy for acceptance criteria where the iBag™ device states "SAME" or explicitly meets/exceeds them. For other tests, the text indicates that the testing was "successfully conducted" or that the device meets the respective standard.

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set: The document does not specify the sample sizes for the "Fill level accuracy" or "Temperature measurement accuracy" tests, nor for the "User Feedback Study" or "Simulated Use Testing."
• Data Provenance: The document does not provide details on the country of origin of the data or whether the studies were retrospective or prospective. It only states that "Bench and test laboratory results indicate that the new device is as safe and effective as the predicate device" and lists the tests conducted.

3. Number and Qualifications of Experts for Ground Truth

The document does not provide any information about the number or qualifications of experts used to establish ground truth for any of the tests.

4. Adjudication Method for the Test Set

The document does not specify any adjudication methods for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being done, or any effect size related to human readers improving with or without AI assistance. This device is not an AI-based system.

6. Standalone Performance (Algorithm Only)

The document primarily focuses on the device's mechanical and electronic performance, not on an algorithm's standalone performance. It states that "iBag™ provides accurate, real-time assistive data" and "Software is designed to be used with little or no training," but does not detail an algorithm's standalone performance separate from the hardware.

7. Type of Ground Truth Used

Based on the provided information, the ground truth for volume and temperature accuracy would likely be established through:

• Reference measurements: Using highly accurate, calibrated instruments to measure actual urine volume and temperature.
• Bench testing: Controlled laboratory conditions for precise measurements.

For other tests like electrical safety, EMC, leak testing, and sterility, the ground truth would be defined by the relevant industry standards (e.g., IEC 60601-1, IEC 60601-1-2) and their specific test protocols.

8. Sample Size for the Training Set

No information is provided about a "training set" as this device is not an AI/ML-based system requiring a training phase in the typical sense. The testing described is for performance validation, not algorithm training.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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The basics of the intended use has not changed. The Maersk Medical 4L drainage bag continue to be intended for collection of fluid which is on its way away from the body. The 4L drainage bag can be used in different treatment procedures within areas as urology and dialysis, but in any case the intended use is the same. The device label will state the following: A: "Peritoned Dialysis Drainage bag" B: "Collection bag fer urine"

The general description, operation, construction and use of the Maersk Medical 4L drainage bag has not changed as a result of the modifications. The 4L drainage bag contains basically the same features as the device described in K843480 and the manufacturing process is identical. However the 4L drainage bags will hold 4000 ml. compared to 2000 ml. for the device described in K843480. On a few points features has been added to the 4L drainage bag, but they are all added to improve patient and healthcare personnel comfort.

The provided text describes a 510(k) premarket notification for a medical device, specifically a 4L drainage bag. The core of this submission is to demonstrate substantial equivalence to an existing legally marketed predicate device (K843480), rather than establishing new performance criteria through a detailed clinical study.

Therefore, the input requests for acceptance criteria, study details, and related metrics often found in a de novo or PMA submission are not directly applicable in the same way for this 510(k). The "performance data" mentioned focuses on demonstrating equivalence to the predicate, not on setting and meeting new, specific performance thresholds against a defined clinical outcome.

Here's an analysis based on the provided text, addressing the requested points where information is available or noting when it's not applicable in the context of a 510(k) for substantial equivalence:

Description of Acceptance Criteria and Study to Prove Device Meets Them

The Maersk Medical 4L drainage bag's acceptance criteria and the "study" to prove it meets them are primarily framed around demonstrating substantial equivalence to a previously cleared predicate device (K843480). This means the acceptance criteria are implicitly that the 4L drainage bag performs at least as safely and effectively as the predicate device for its intended use, despite minor modifications (increased volume and added comfort features). The "study" largely consists of functional and quality testing to support this claim of equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a 510(k) for substantial equivalence, the "acceptance criteria" are not explicitly quantitative performance metrics in the way one might see for a novel device. Instead, they relate to maintaining the functional and quality characteristics of the predicate.

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

The document does not specify a "test set" in the context of a clinical trial or large-scale data analysis. The "performance data" mentioned refers to functional and quality testing, which typically involves a sample of manufactured devices. The specific sample size for these engineering tests is not provided.

• Data Provenance: The testing would have been conducted by Maersk Medical A/S in Denmark (manufacturing facility location). The data is retrospective in the sense that it evaluates the modified device's performance against the established performance of the predicate device, and prospective in that the specific tests were conducted on the newly manufactured 4L bags.

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

Not applicable or not specified in this 510(k) submission. "Ground truth" in the context of expert consensus or clinical diagnosis is not relevant for demonstrating substantial equivalence of a drainage bag. The "ground truth" here is the established safety and effectiveness of the predicate device, as determined by the FDA during its original clearance. The "experts" involved would be the engineers and quality assurance personnel at Maersk Medical conducting the functional and quality tests.

4. Adjudication Method for the Test Set

Not applicable or not specified. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and their discrepancies need to be resolved. This is not the type of study presented for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. MRMC studies are used to evaluate diagnostic systems, often AI-assisted, and are not relevant for a drainage bag that collects fluid.

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

Not applicable. This device is a passive medical device (a drainage bag), not an algorithm or an AI-enabled system. There is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for this submission is implicitly the established safety and effectiveness profile of the predicate device (K843480). The modifications to the 4L drainage bag are demonstrated to align with this established profile through functional and quality testing. There is no clinical "ground truth" (e.g., pathology, clinical outcomes) generated for this specific submission, as it relies on the predicate's clearance.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of machine learning or AI for this device.

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

Not applicable. As there is no training set, there is no ground truth to establish for it.

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These devices are indicated for use by incontinent persons with other medical conditions that warrant the use of a leg bag and are intended to collect urine. They may be connected to either an indwelling or non-indwelling catheter.

Medline Leo Bags are vinyl pouches with sterile fluid paths and adjustable comfort straps. This device is attached to the leg of an incontinent person and used to collect urine. This device may be used with an indwelling catheter or an external catheter. A leg bag provides the catheterized person with greater mobility and are usually worn during the day and are replaced at night with a standard urinary drainage bag.

The provided document is a 510(k) summary for a medical device: "Urine Collection Leg Bag for External Use Premium Leg Bag, Fabric-Bac Leg Bag, Urinary Leg Bag" by Medline Industries, Inc.

This document explicitly states: "There are no clinical studies that have been performed on these devices, both for the predicate and the new devices."

Therefore, based on the provided text, there is no study described that proves the device meets specific acceptance criteria as it relates to clinical performance. The submission rather relies on substantial equivalence to a predicate device already on the market, and the only difference noted is in the labeling.

Given this information, it is not possible to fill out the requested table and answer the study-related questions.

However, I can extract the information explicitly available:

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):
Not applicable, as no clinical studies were performed.

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):
Not applicable, as no clinical studies were performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical studies were performed.

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, as no clinical studies were performed, and the device is a urine collection bag, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable, as no clinical studies were performed, and the device is a urine collection bag, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no clinical studies were performed. The basis for approval is substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set:
Not applicable, as no clinical studies were performed.

9. How the ground truth for the training set was established:
Not applicable, as no clinical studies were performed.

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The BeSECURE External Urinary Collection System is an external urine collection system for the incontinent patient.

Not Found

The provided text is a letter from the FDA regarding a 510(k) submission for the "BeSECURE External Urinary Collection System," and an "Indications for Use" statement.

Unfortunately, this document does not provide any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The letter is a regulatory approval document stating that the device is substantially equivalent to legally marketed devices, implying that it has met certain regulatory requirements, but it does not detail the technical performance studies and their results.

Therefore, I cannot fulfill your request for the specific information about:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method
5. Whether a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
6. Whether a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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Amsino Urinary Leg Bag is a device intended to collect urine.

Not Found

The provided text is a legally binding letter from the FDA to AMSINO International, Inc. regarding their Urinary Leg Bag, confirming its substantial equivalence to previously marketed devices. This document does not contain any information regarding acceptance criteria, device performance, sample sizes, expert qualifications, or study methodologies that you've requested.

Therefore, I cannot extract the requested information from the provided text. The document is a regulatory approval letter, not a technical report or study summary.

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The Welcon Hue-Vu™ Urinary drainage Bag is indicated for use for the collection of urine when used with an indwelling catheter.

The Welcon Hue-Vu™ Urinary Drainage Bag is a 2000 ml capacity vented vinyl urine collection receptacle intended to be used with an indwelling catheter. The bag has a hanging hook at the top, and is equipped with a sampling port near the catheter connector. The inlet tubing has an anti-reflux valve to prevent backflow. A vent allows air to escape the bag as urine enters. A Hue-Vu™ color strip label is affixed to the front of the bag, and is used to compare and record the color of the urine collected in the bag.

The provided document is a 510(k) premarket notification for the Welcon Hue-Vu™ Urinary Drainage Bag. It explicitly states that no performance or safety data was included in this submission. Therefore, it is not possible to describe acceptance criteria or a study proving the device meets those criteria from the information given.

The document states:
"Substantial equivalence for this device was based solely on design and performance characteristics; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the Welcon Hue-Vu™ device are identical to those of the predicate devices."

As a result, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance study
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

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The Liberty Valve is intended to allow individuals in a wheelchair to empty their own urine collection leg bag, which may be connected to either an indwelling or non-indwelling catheter, provided the individual possesses the ability to make gross arm and hand movements.

The Liberty Valve consists of a switch box, a solenoid valve with electrical connection, a fuse, battery leads with wiring, and tubing with the necessary connections for attachment to the leg bag and valve. The device is to be mounted to the wheelchair permanently with the clamps and wire ties provided. The switch box regulates the power from the battery which opens the solenoid valve the urine collection leg bag to drain.

Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

• At 0 °C: 1 minute 53 seconds to drain 500 mL.
• At 23 °C: 1 minute 49 seconds to drain 500 mL.
• At 70 °C: 1 minute 45 seconds to drain 500 mL.
  All tests drained 500 mL from a urine collection bag held ten inches above the valve in less than two minutes. |
  | Operating Temperature Range | The device should operate effectively across a suitable temperature range. | Tests conducted at 0 °C, 23 °C, and 70 °C showed the valve required less than two minutes to drain 500 mL at all these temperatures.
  Recommended: Use at temperatures between 0 °C and 70 °C. |

Note regarding Acceptance Criteria: The provided document does not explicitly state numerical acceptance criteria for current leaks (e.g., "current leaks must be

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Both devices are indicated for use in the collection of free flowing urinary drainage. Both devices function in the same manner: they collect and contain urine.

ProSys™ Bedside Drainage Bag (Sterile) is available with a 2000 ml volume capacity. Each stèrile bag is fitted with a permanently welded 55 inch inlet tube containing a universal connector which connects to an indwelling or external catheter. The Bedside Drainage Bag (Sterile) has a T-tap drainage valve. The inlet tube contains an anti-reflux valve to reduce the risk of urine backflow and infection and, a sample port used for urine sampling is integrated into the universal connecter.

The provided text is a 510(k) summary for a medical device called the "ProSys™ Bedside Drainage Bag (Sterile)". It describes the device, its intended use, and claims substantial equivalence to a predicate device.

However, the information required to answer your specific questions about acceptance criteria, device performance, and study details (sample size, experts, ground truth, MRMC, standalone performance, training set details) is not present in this document.

This 510(k) summary focuses on general device description, biocompatibility, and process validation testing, but it does not provide the detailed study results or specific quantitative performance metrics that would be typically found in a clinical study report or a more comprehensive technical document.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer your specific questions about sample sizes, experts, ground truth, or MRMC/standalone studies, as this information is not available in the provided text.

The document mentions "Process validation testing performed on ProSys™ Bedside Drainage Bag (Sterile) included tests for resistance to bursting, resistance to impact, and for leakage. Additionally, the anti-reflux valve, tensile strength and outline weld integrity were also tested. All components performed at an acceptable level and the test results appear in Item 5a."

This indicates that some testing was done, and that the results were deemed "acceptable," but it does not provide the quantitative acceptance criteria or the reported performance values. It also refers to "Item 5a" for the test results, which is not included in the provided text.

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