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This bag is intended for the collection of effluent during Automated Peritoneal Dialysis (APD) Therapy.

Baxter's Cycler Drainage Bag product line currently consists of a sterile 15L Cycler Drainage Bag (5C4145P). This 15 L Cycler Drainage Bag is a single use device intended for the collection of effluent during Automated Peritoneal Dialysis (APD) Therapy and can be used with Baxter's APD Sets with Cassette, Manifold Sets and Extension Sets. The purpose of this drain bag is to allow the collection of the spent effluent in the event that a patient does not have access to a drain from the location where APD therapy is performed. The basis for this submission is the addition of a non-sterile version of the 15L Cycler Drainage Bag to the current product line. The product line does not come into direct or indirect contact with the patient's body tissue. The intended use, material, design, and function of the proposed device will be the same as the currently marketed 15 L Cycler Drainage Bag.

The provided document describes a 510(k) premarket notification for a new non-sterile version of Baxter's 15L Cycler Drainage Bag (product code 5C4145NS), comparing it to the currently marketed sterile version (5C4145P) which serves as the predicate device. The primary difference is the sterility status.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states that "All results meet the acceptance criteria," therefore, the reported device performance for all listed criteria is implicitly "Met."

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

The document does not explicitly state the sample sizes for each specific test or the data provenance (e.g., country of origin) for the test sets. The tests are described as "design verification tests" conducted by Baxter Healthcare Corporation. It is implied these are internal company tests, so the data provenance would be internal to Baxter, likely in the US (where Baxter is headquartered). The studies appear to be prospective, as they were conducted to support the premarket notification for a new product configuration.

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

This information is not provided. The tests described are largely objective engineering and microbiological performance tests (e.g., leak tests, force measurements, bioburden, microbial travel), which typically rely on predefined specifications and instrumentation rather than expert consensus on a "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, the tests are objective performance evaluations against established engineering and safety specifications, not subjective assessments 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 device is a medical accessory (drainage bag), not a diagnostic imaging or AI-enabled device. Therefore, MRMC studies and AI-related effectiveness are not relevant.

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

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

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance tests outlined (Capacity/Leak, Drain Line Spike/Leak, Clamp forces, Bioburden, Microbial travel, Cycler System Level, Removal forces, Solvent Bond Leak Strength, Connection Duration) is based on engineering specifications, established industry standards (e.g., ISO, AAMI), and risk analyses. For biocompatibility, it's adherence to ISO-10993. For microbial travel, it's the lack of contamination reaching a critical point (APD cassette). These are objective, measurable criteria, not subjective human interpretations.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical accessory, not an AI/machine learning algorithm requiring a training set.

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

Not applicable. No training set is involved.

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Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:

1. Reduce ICP, e.g., pre-, intra- or postoperative.
2. Monitor CSF chemistry, cytology, and physiology.
3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
   Monitoring of ICP is indicated in selected patients with:
4. Severe head injury.
5. Subarachnoid hemorrhage graded III, IV or V preoperatively.
6. Reyes syndrome or similar encephalopathies.
7. Hydrocephalus.
8. Intracranial hemorrhage.
9. Miscellaneous problems when drainage is to be used as a therapeutic maneuver.
   Monitoring can also be used to evaluate the status pre- and postoperatively for space-occupying lesions.

The Exacta External Drainage and Monitoring System (EDMS) is provided as a complete closed system for the drainage and monitoring of cerebrospinal fluid (CSF) flow from the lateral ventricles or the lumbar subarachnoid space. The system is offered in various kit configurations for various clinical applications.
The Exacta EDMS product family is comprised of a single use drainage system, a reusable blue pole clamp and a laser level accessory. The single use drainage assembly is comprised of a patient line, main system stopcock, graduated cylinder and drainage bag. The single use drainage assembly is mounted on the reusable blue pole clamp. The reusable blue pole clamp secures the system to an I.V. pole and includes the system pressure scale and holds an optional laser level accessory. The optional laser level accessory assists the user in leveling the single use drainage system to the patient's Foramen of Monro or lumbar catheter exit site.

This document is a 510(k) summary for the Medtronic Exacta External Drainage and Monitoring System (EDMS). The submission focuses on changes to a laser level accessory and does not involve AI. Therefore, several requested sections, especially those related to AI model evaluation, are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are qualitative (e.g., "met the acceptance criteria") rather than quantitative thresholds.

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

The document does not specify the sample size for the test set used in the bench testing. It only states that the testing was performed, but not how many units were tested.

• Data Provenance: The tests were "design verification bench testing," implying they were conducted in a lab setting by the manufacturer, Medtronic, Inc., located in Irvine, California, USA. The data is retrospective in the sense that it was collected as part of the device development and submission process.

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

Not applicable. The testing described is bench testing of physical device characteristics (mechanical, laser performance, electrical safety) against established engineering and safety standards, not against clinical ground truth requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. This was bench testing against engineering specifications, not a clinical study requiring expert adjudication of results.

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 submission is for an External Drainage and Monitoring System and its laser level accessory. It is a physical medical device, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the bench testing was defined by engineering specifications and international standards for mechanical strength, beam uniformity, laser accuracy, laser safety (IEC/EN 60825-1:2014), electrical safety (IEC 60601-1:2005 + AMD1:2012), and EMC (IEC 60601-1-2:2014 / EN 60601-1-2:2015).

8. The Sample Size for the Training Set

Not applicable. This device does not use a training set as it is not an AI/machine learning product.

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

Not applicable.

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Draining CSF and monitoring CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:

• 1. Reduce intracranial pressure (ICP), e.g. pre-, intra- or postoperative.
• 2. Monitor CSF chemistry, cytology and physiology.
• 3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.

The monitoring of the intracranial pressure (ICP) is indicated in selected patients with:

• 1. Severe head injury
• 2. Subarachnoid hemorrhage graded III, IV or V preoperatively
• 3. Reye's syndrome or similar encephalopathies
• 4. Hydrocephalus
• 5. Intracranial hemorrhage
• 6. Miscellaneous problems when drainage is to be used as a therapeutic maneuver.

Monitoring can also be used to evaluate the status pre- and postoperative for space-occupying lesions.

The Medtronic External Drainage and Monitoring System EDMS is provided as a complete closed system for the drainage and monitoring of cerebrospinal fluid (CSF) flow from the lateral ventricles or the lumbar subarachnoid space. The system is offered in various kit configurations for various clinical applications. The EDMS Drainage Assembly is supplied pre-assembled, sterile and non-pyrogenic in a double wrap package system. A drainage bag with braided cord is also included with each EDMS kit.
The EDMS and components are intended for single (one time) use only and is not designed or intended to be re-used, re-processed, or re-sterilized. Some of the basic features include the following:

• . a patient line stopcock with latex-free injection site and non-distensible patient connection line:
• a graduated chamber and hanging bracket for I.V. pole suspension; ●
• a drainage bag connection line with two slide clamps and latex-free injection site;
• a removable vented drainage bag with approximate volumetric graduations and drainage port; ●
• pressure scale tape.

The provided text does not describe an AI medical device. It pertains to the Medtronic External Drainage and Monitoring System (EDMS), which is a physical device for draining and monitoring cerebrospinal fluid. Therefore, the questions related to AI device performance metrics, such as ground truth establishment with experts, MRMC studies, or standalone algorithm performance, are not applicable.

However, I can extract information related to the acceptance criteria and the study that proves the device meets those criteria for the Medtronic EDMS.

Acceptance Criteria and Performance for Medtronic External Drainage and Monitoring System (EDMS)

The Medtronic EDMS underwent bench testing to demonstrate its safety and effectiveness, particularly addressing changes made to the disposable drainage bag.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The text does not specify the exact sample size for each bench test conducted.
• The tests were bench tests (laboratory-based testing of the physical device or its components). Data provenance is internal to the manufacturer's testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This question is not applicable as the study involved bench testing of a physical medical device, not an AI algorithm requiring expert ground truth for image or data interpretation.

4. Adjudication method for the test set:

• This question is not applicable as there was no expert review or adjudication process for bench testing a physical device.

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 as the device is not an AI-assisted diagnostic or interpretive tool.

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

• This question is not applicable as the device is not a standalone algorithm.

7. The type of ground truth used:

• The ground truth for the bench tests was based on engineering specifications and established test methods designed to verify the physical properties and functionality of the device components (e.g., verifying volumetric graduations, absence of leaks, strength of seals).

8. The sample size for the training set:

• This question is not applicable as this is not an AI device that requires a training set.

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

• This question is not applicable as this is not an AI device that requires a training set.

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Drainage Bags are single use and shall be used by a urologist or a gastroenterologist in a healthcare setting to for nephrostomy, biliary, abscess and other drainage collection.

Drainage Bag

The provided document is a 510(k) clearance letter from the FDA for a Drainage Bag (K990428). This type of document is a regulatory approval and does not contain information about device acceptance criteria, performance studies, or AI performance metrics as requested in the prompt.

Therefore, I cannot provide the requested information based on the input document. The document primarily focuses on:

1. Confirming that the device is substantially equivalent to legally marketed predicate devices.
2. Outlining the regulatory requirements for marketing the device.
3. Stating the intended use of the device.

There is no data presented in this document about clinical studies, test sets, ground truth, or AI performance.

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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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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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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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