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The Silicone Urethral Catheter is passed through the urethra during urinary catheterization and into the bladder to drain urine, or for routine post-operative drainage and bladder irrigation. It is intended for use by male, female and pediatric patients (2 years old to less than 12 years old).

The Silicone Urethral Catheter is inserted through the urethra during urinary catheterization and goes into the bladder for urine drainage or irrigation. It consists of shaft, drainage funnel, inflation funnel, irrigation funnel (if present), balloon and valve. The balloon of the catheter can be inflated and fixed the catheter in place after being injected with a sterile liquid.

The device is made of silicone and available in different types (e.g., male, female, Tiemann, 2-way, 3-way etc.) and sizes for adult and pediatric use.

The device is for single use and provided with sterile. The indwelling time is no more than 30 days.

This document is a 510(k) clearance letter for a Silicone Urethral Catheter, a physical medical device. The request asks for details about acceptance criteria and a study proving the device meets those criteria, typically found in submissions for AI/ML-enabled medical devices.

Therefore, the provided document does not contain the information requested for an AI/ML-enabled medical device. It thoroughly details the non-clinical performance testing for a traditional, physical medical device, but there is no mention of an algorithm, AI, machine learning, or any form of data-driven performance metrics, ground truth establishment, or human-in-the-loop studies.

Here's a breakdown of why the requested information cannot be extracted from this document:

• No AI/ML Component: The device is a Silicone Urethral Catheter, which is a physical product for urine drainage. The 510(k) summary focuses on its material, dimensions, performance (e.g., flow rate, balloon integrity), biocompatibility, sterilization, and shelf-life. There's no indication of any software, algorithm, or AI component.
• Non-Clinical Testing Only: The "Summary of Non-Clinical Performance Testing" explicitly states the types of bench tests conducted (e.g., Balloon Size and Shaft Size, Flow Rate, Balloon Integrity, etc.) and biocompatibility tests.
• No Clinical/Animal Testing: Section 9, "Clinical Testing and animal testing," explicitly states: "Clinical and animal testing were not performed for Silicone Urethral Catheter as part of the premarket Notification requirements for this 510(k) submission and the subject of this premarket submission, Silicone Urethral Catheter, did not require clinical and animal studies to support substantial equivalence." This further confirms the absence of any studies involving human data or interpretations by experts for diagnostic purposes that would be relevant to AI/ML.

To answer your specific questions based on the absence of this information in the provided document:

1. Table of acceptance criteria and the reported device performance: Applicable to physical performance characteristics (e.g., flow rate, balloon volume), but not "AI performance" criteria like sensitivity, specificity, AUC.

   • Acceptance Criteria Examples (from document):
     • Meets all requirements of biocompatibility (tested per ISO 10993-1)
     • Meets pre-determined testing and acceptance criteria for bench tests (ASTM F623-19, ISO 20696:2018, FDA guidance 'Conventional Foley Catheters')
     • Sterilized in accordance with ISO 11135:2014
     • Maintains product and package integrity and device sterility throughout shelf-life.
   • Reported Device Performance: The document states that the testing "demonstrated that the Silicone Urethral Catheter meets all the pre-determined testing and acceptance criteria" and that "All evaluation acceptance criteria were met" for biocompatibility. Specific quantitative results are not provided in this summary but would be in the full submission.

2. Sample size used for the test set and the data provenance: Not applicable to an AI test set. This would refer to the number of units tested for physical properties (e.g., how many catheters were tested for flow rate). The document doesn't specify these sample sizes, nor does it mention data provenance as it's not a data-driven device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" as understood in AI/ML (e.g., expert labels for images) was established, as there's no diagnostic or analytical function.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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. No AI component, no human readers involved in a diagnostic workflow related to the device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to diagnostic ground truth. The "ground truth" for this device would be its physical specifications and performance against established standards (e.g., a catheter's flow rate must meet X ml/min, balloon must hold Y volume without rupture).

8. The sample size for the training set: Not applicable. No AI model to train.

9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA 510(k) clearance letter for the Silicone Urethral Catheter pertains to a conventional medical device and does not contain any information related to AI/ML device performance, acceptance criteria, or study methodologies.

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The InnoCare Specialty Foley Catheter is intended for urethral catheterization for urological bladder drainage. The device is indicated for adult use only with a maximum indwell time of no more than 30 days.

The InnoCare Specialty Foley Catheter is a 16 French, two-way silicone Foley catheter for urethral catheterization to drain urine from the bladder. The catheter is retained in the bladder by use of a retention balloon attached to the distal end of the catheter. The device is offered in a straight tip configuration and a Coude tip configuration. The inflation lumen of the catheter contains a secondary balloon deflation mechanism. This mechanism is designed to provide a fluid escape pathway to allow for balloon deflation in the event of a forced withdrawal or catheter pullout. The device is provided sterile and for single use.

The provided text describes a 510(k) premarket notification for a medical device, the InnoCare Specialty Foley Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing. It does not contain information about a clinical study involving human patients, nor does it detail acceptance criteria and a study proving device performance in a clinical setting as you've requested.

Specifically, the document states:

• "Performance testing was conducted on the subject device, and it was established that the differences in technological characteristics between the subject and the predicate do not raise different questions of safety or effectiveness."
• "Bench testing of the subject device included dimensional verification, functional and performance testing per ASTM F623:2019 requirements, simulated use testing of the secondary balloon deflation mechanism and Magnetic Resonance Compatibility testing per FDA Guidance (2023)..."
• "All pre-determined acceptance criteria were met."

Therefore, I cannot provide the detailed information requested regarding a clinical study and its various components (sample size, ground truth, expert qualifications, MRMC study, etc.) because the provided document does not contain this information. The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical bench testing, not a human-in-the-loop clinical trial or an AI algorithm study.

However, I can extract information about the non-clinical acceptance criteria implied by the tests performed.

Here's what can be inferred from the provided text regarding the non-clinical acceptance criteria and "study":

1. Table of Acceptance Criteria and Reported Device Performance:

• Cytotoxicity
• Sensitization
• Irritation
• Acute Systemic Toxicity
• Subacute Systemic Toxicity
• Genotoxicity
• Implantation | All tests demonstrated the subject device is biocompatible for its intended use. |
  | Dimensional Verification | Met pre-determined acceptance criteria. |
  | Functional and Performance (per ASTM F623:2019) | Met pre-determined acceptance criteria. |
  | Simulated Use Testing of Secondary Balloon Deflation Mechanism | Met pre-determined acceptance criteria. |
  | Magnetic Resonance (MR) Compatibility (per FDA Guidance 2023) | Met pre-determined acceptance criteria. |
  | Sterilization Validation (per ISO 11135:2014) | Validated to be sterilized using ethylene oxide. |
  | Shelf Life (including performance testing, package integrity after environmental conditioning, simulated distribution, and accelerated aging) | Data supports the claimed shelf life. |

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

• Sample Size: Not specified for any of the non-clinical tests. Medical device bench testing typically uses a small, statistically justified sample size, but the exact number isn't provided here.
• Data Provenance: The tests are laboratory-based ("bench testing," "biocompatibility testing," "sterilization validation"), implying they were conducted by the manufacturer or a contract research organization. There is no mention of country of origin of data in terms of patient data, as this is not a clinical study. The tests are prospective in nature as they are conducted specifically for this submission.

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

• Not Applicable. For non-clinical bench testing, "ground truth" is established by adherence to recognized standards (e.g., ISO, ASTM, FDA guidance) and validated test methods, not by human expert consensus or adjudication in the way it would be for a clinical AI study.

4. Adjudication method for the test set:

• Not Applicable. No adjudication method is mentioned as this pertains to human interpretation/reading, which is not part of this type of non-clinical device testing.

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:

• No. This is a non-clinical evaluation of a physical medical device (Foley catheter), not an AI-assisted diagnostic device, so an MRMC study is not relevant or performed.

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

• No. This is not an AI algorithm.

7. The type of ground truth used:

• Established Industry Standards and Specifications. For each test, the "ground truth" is defined by the requirements of the specified standards (e.g., ISO 10993-1:2018 for biocompatibility, ASTM F623:2019 for functional performance, ISO 11135:2014 for sterilization) and the device's own design specifications.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning model, so there is no training set.

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

• Not Applicable. This is not a machine learning model.

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2 Way Latex Foley Catheters

Indicated where routine drainage of the bladder is required ether postoperatively or for patients with conditions requiring urine drainage.

3 Way Latex Foley Catheter

Indicated where routine drainage of the bladder is required either postoperatively or for patients with conditions requiring urine drainage and for patients requiring bladder irrigation.

The Rüsch Latex Gold Foley Catheter is available as 2 Way catheter, with a proximal funnel, non-return inflation valve and bladder fixation balloon, and 3 Way catheter which includes an additional irrigation channel with proximal funnel. The catheter is manufactured of natural latex, provided sterile, single use, and disposable. The inflation valve is designed for use with Luer lock syringe tips. Balloon inflation volumes in millimeters, as well as shaft size in French gauge (Fr.), Charrière (Ch.), or millimeters (mm), are indicated on the funnel of each individual catheters are siliconized, or surface finished with Polytetrafluoroethylene (PTFE). The Gold Foley Catheter maximum use/indwelling period is less than 30 days. The device has different models of catheters namely PURE GOLD, Gold Pediatric, Gold, and the Gold Haematuria.

The provided text is an FDA 510(k) Premarket Notification for a medical device: the Rüsch Latex Gold Foley Catheter. This document largely focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It does not describe acceptance criteria for an AI/software as a medical device (SaMD) or a study proving its performance against such criteria. The document explicitly lists nonclinical testing conducted for the physical Foley catheter, such as biocompatibility, sterilization validation, accelerated aging, and performance/functional testing per ASTM standards for a physical medical device.

Therefore, I cannot extract the requested information regarding acceptance criteria for an AI/software device, its performance, sample sizes for test/training sets, expert qualifications, or details about MRMC studies, as these types of studies were not conducted or described in this document for the Rüsch Latex Gold Foley Catheter.

The document pertains to a physical medical device. The "acceptance criteria" discussed implicitly are related to the successful completion of the listed nonclinical tests and demonstrating substantial equivalence to the predicate device, YiKang Latex Foley Catheter (K173340), for FDA clearance. The "study that proves the device meets the acceptance criteria" refers to the nonclinical testing detailed in section 7 of the document.

Here's how I can answer based on the provided text, interpreting "acceptance criteria" and "study" in the context of a physical medical device:

Acceptance Criteria for the Rüsch Latex Gold Foley Catheter (Based on Nonclinical Testing):

Study Information (for a Physical Medical Device):

1. Sample sizes used for the test set and the data provenance: Not explicitly stated as numerical sample sizes. The document refers to "testing" and "assessment" for each standard. The data provenance is internal testing conducted by the manufacturer (Teleflex Medical, Inc.) to comply with FDA recognized standards. The data is retrospective in the sense that the tests were performed on manufactured devices.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are laboratory-based, objective performance tests on the physical device, not subjective expert reviews of data like in AI/SaMD studies. The "ground truth" is defined by the standards (e.g., successful sterilization, acceptable biocompatibility levels, functional performance specifications).
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Testing is objective and based on meeting specified numerical or qualitative limits defined by the standards.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a physical device, not an AI/SaMD.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a physical device, not an AI/SaMD.
6. The type of ground truth used:
   • Biocompatibility: In vitro and in vivo biological responses as defined by ISO 10993 series of standards (e.g., cell viability, skin irritation, systemic toxicity, tissue reaction on implantation).
   • Sterilization: Sterility assurance level (SAL) achieved through validated processes per ISO 11137.
   • Accelerated Aging: Functional performance of the device and integrity of the sterile barrier system after simulated aging.
   • Performance/Functional Testing: Physical and mechanical properties (e.g., balloon inflation, flow rate, material integrity) as specified by ASTM 623-19.
7. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML model.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) for a traditional medical device (Foley catheter) and does not contain the information requested for AI/SaMD performance studies.

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TraumaGuard Intra-abdominal Pressure Sensing System is intended for use in the drainage of urine for continuous measuring of intraabdominal pressure (IAP) and core body temperature (CBT). The measured IAP can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS).

The TraumaGuard Intra-abdominal Pressure Sensing System is comprised of a catheter and cable used to connect to standard biometric monitors. The catheter is a Foley catheter that provides continuous biometric monitoring of intra-abdominal pressure and core body temperature.

TraumaGuard (TG) is a silicone catheter with two polyurethane pressure sensing balloons used to detect changes in intra-abdominal pressure (IAP), the outer distal balloon and the inner sensing balloon. The outer balloon is filled with 2.0 - 2.5cc of sterile water to ensure contact with the bladder wall. The inner sensing balloon has a column of air that runs the entire length of the catheter from the middle of the outer sensing balloon to a connector on the hub.

Temperature can be displayed in Celsius or Fahrenheit and is accurate within ±1°C over a range of 25°C to 40°C (77°F to 104°F). Pressure displayed is between 0mmHg and 40mmHg.

The inflation, drainage and sensing ports of the catheter are color-coded and can be operated with a Luer Lock syringe tip.

Each TG is sterile and individually pouched. TG Cables are reusable. TG is a single use catheter intended for short-term use (no more than 30 days).

This document is a 510(k) Premarket Notification from the FDA regarding the "TraumaGuard Intra-abdominal Pressure Sensing System." It describes the device, its intended use, and its substantial equivalence to a previously cleared predicate device.

Based on the provided text, the acceptance criteria and study proving the device meets those criteria are primarily focused on bench testing and laboratory studies demonstrating functional and safety performance, particularly regarding MR compatibility, rather than a clinical study evaluating AI assistance or human reader improvement. The submission is for a new version of an existing device (K210570) with the primary modification being the addition of MR conditional labeling.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a neat table of acceptance criteria with corresponding performance values for all aspects. However, it lists the standards followed and the outcome of the testing. The core "acceptance criteria" here relate to demonstrating that the new device (with MR conditional labeling) performs equivalently to the predicate device for its original functions, and meets MR safety standards.

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

The document explicitly states that "Representative samples of the TraumaGuard device were tested." It does not specify the exact sample size for the functional, performance, or MRI safety testing.

• Data Provenance: The studies were laboratory and bench tests ("laboratory tests," "bench testing") rather than clinical studies with patient data. The origin would be the testing facility, likely in the US, as Sentinel Medical Technologies is based in Jacksonville, FL. The studies appear to be prospective as they were conducted to gather data for this submission.

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

This type of information is not applicable to the evidence provided in this 510(k) summary. The submission relies on physical and engineering bench testing, as well as computational modeling, against established international and ASTM standards for medical device performance and safety (e.g., MRI safety, biocompatibility, sterilization). There is no mention of "experts" establishing ground truth in the context of clinical interpretation or diagnosis, as there would be for an AI-based diagnostic device.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, especially those involving human interpretation of medical images or data, to resolve discrepancies or determine a definitive ground truth. As this submission focuses on bench testing and device performance against physical standards, there is no human interpretation or adjudication process described.

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

No, an MRMC comparative effectiveness study was not done. This submission is for a device that directly measures physical parameters (IAP and CBT) and is a catheter, not an AI or imaging diagnostic software that assists human readers. Therefore, the concept of human readers improving with AI assistance is not relevant to this device.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm-only performance study was not done in the context of AI. The device itself is the "algorithm" in a sense, as it provides direct measurements. The performance testing focuses on the accuracy and safety of these direct measurements and the device's physical properties. There is no AI component described in the device functionality.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Physical measurement standards: Ensured by calibrated equipment and methods defined in the listed ASTM and ISO standards for properties like temperature accuracy, pressure range, and MRI safety parameters (displacement, torque, heating, artifact).
• Biocompatibility standards: ISO 10993 series and associated GLP reports for non-pyrogenicity.
• Sterilization standards: Achieving a specified SAL.

Essentially, the "ground truth" is adherence to pre-defined, measurable engineering, physical, chemical, and biological safety standards for medical devices, rather than a clinical ground truth like pathology, expert consensus on images, or outcomes data.

8. The Sample Size for the Training Set

This is not applicable. This is a physical medical device that measures IAP and CBT; it does not involve machine learning or AI models that require training sets. The "training" for this device would be its manufacturing process and design, not data-driven algorithm training.

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

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

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Folysil catheters are intended for use up to 30 days in adult and pediatric populations for:

• Bladder drainage by urethral catheterization,

• Bladder drainage by suprapubic catheter replacement only (for non-grooved, straight 2-way Folysil catheters with a maximum balloon volume of 15mL).

• Bladder instillation of physiological saline solution.

Folysil catheters are thin, hollow tubes equipped with a balloon, funnel and valve, to be inserted into the bladder by the urethral or supra-pubic approach to drain urine into a urine collection bag. Folysil catheters are held in place within the bladder by the balloon, which is filled with sterile water or with aqua-glycerin solution.

The provided text describes a medical device, the Folysil® Silicone Catheter, seeking 510(k) clearance from the FDA. The submission focuses on demonstrating substantial equivalence to predicate devices through biocompatibility and bench testing. However, it does not include information about clinical studies involving human patients, multi-reader multi-case (MRMC) studies, or the use of AI. Therefore, most of the requested information regarding human-in-the-loop performance, expert consensus, and training/test set details cannot be extracted from this document.

Here's the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that "All pre-determined acceptance criteria were met for 14-24 Fr. catheters" for the bench tests conducted according to FDA recognized standards and guidance. For catheter sizes 6-12 Fr., "the protocol and acceptance criteria for these tests were scientifically adequate and clinically relevant, and the acceptance criteria were met for these tests as well."

The text lists the following bench tests performed:

Additionally, for biocompatibility testing:

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

• Sample Size: The document does not specify the exact sample sizes (number of devices) used for each individual test or for the overall test set. It refers to "14-24 Fr. catheters" and "6-12 Fr. catheter sizes."
• Data Provenance: The testing was presented by Coloplast, an international company with its legal manufacturer address in Humlebaek, Denmark. The testing appears to be internal company testing based on recognized standards and guidance documents. The data is retrospective in the sense that it's data collected from internal testing for the purpose of this submission, not a prospective clinical trial.

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 evaluation mentioned is based on objective bench tests and biocompatibility testing, not on human interpretation or clinical data requiring expert ground truth in the context of diagnostic accuracy.

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

This information is not applicable for objective bench and biocompatibility testing. The "ground truth" for these tests is defined by the physical or biological measurement outcomes against pre-defined quantitative or qualitative acceptance limits.

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 present in the document. The submission pertains to a physical medical device (catheter) and its substantial equivalence, not an AI-assisted diagnostic or therapeutic tool.

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

This information is not present in the document. The device is a physical catheter, not an algorithm.

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

The "ground truth" for this submission is established by:

• Physical measurements and performance criteria defined in recognized standards (ASTM F623-19, ISO 20696:2018) and FDA guidance documents for bench testing.
• Biological responses and cytotoxicity assessments defined in recognized standards (ISO 10993-1 and relevant sub-standards) for biocompatibility testing.

8. The sample size for the training set:

This information is not applicable. This is a submission for a physical medical device (catheter) based on bench and biocompatibility testing, not a machine learning model requiring a training set.

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

This information is not applicable for the reasons stated above.

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The 2-Way 100% Silicone ClearTract Catheter is intended for drainage of the urinary tract. Catheterization is accomplished by inserting the catheter through the urethra and into the bladder, but also suprapubic placement or by nephrostomy. Intended population is adults and pediatrics.

The 2-Way 100% Silicone ClearTract Catheter is a standard single-use 2-way Foley catheter that is constructed of medical grade silicone with a surface modification. It incorporates two (2) lumens, one for inflation/deflation of the balloon and the other for drainage of the urinary tract. The drainage inlet is located distal to the catheter's balloon. The connection between the catheter and the urinary bag is accomplished by using a standard non- interconnector. Catheterization is accomplished by inserting the catheter through the urethra. Drainage can also be accomplished by suprapubic placement or nephrostomy tract placement of the catheter.

The provided text is an FDA 510(k) clearance letter for a medical device: the "2-Way 100% Silicone Cleartract Catheter." This type of document primarily focuses on establishing substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and study results for software-based medical devices (like AI algorithms).

Therefore, the document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance for a software component.
• Sample sizes used for a test set or training set, or their provenance.
• Number of experts and their qualifications for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness study results or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for the training set was established.

The document states that "performance testing was conducted on the subject device," and "All pre-determined acceptance criteria were met" for various bench performance tests related to the physical catheter (flow rate, balloon integrity, etc.). These are physical and mechanical tests for the catheter itself, not a study evaluating software or AI performance.

In summary, this document describes the clearance of a physical medical device (a catheter) and not a software/AI-driven device, thus the specific information requested about acceptance criteria and study details for an AI/software component is not present in the provided text.

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2 Way SoftSimplastic Catheters:

Indicated where routine transurethral drainage of the bladder is required either postoperatively or for patients with conditions requiring transurethral urine drainage.

3 Way SoftSimplastic Catheters:

Indicated where routine transurethral drainage of the bladder is required either postoperatively, for patients with conditions requiring transurethral urine drainage and for patients requiring bladder irrigation.

The Rusch SoftSimplastic Foley Catheter is a balloon retention type catheter and is single use, disposable and sterile. The catheters are made of transparent PVC. They have a 2 lumen or 3 lumen shaft with proximal funnel, inflation valve and a distal retaining balloon made of latex. Balloon capacity is in ml and the shaft size in French gauge (Fr.) as indicated on the funnel of each individual catheter.

The provided text describes a 510(k) premarket notification for a medical device, the Rusch SoftSimplastic Foley Catheter, not an AI/ML medical device. Therefore, the information required to answer the prompt regarding acceptance criteria and studies for an AI/ML device (e.g., sample size for test/training sets, expert qualifications, ground truth establishment, MRMC studies) is not present in the document.

The document focuses on demonstrating substantial equivalence to a predicate device (Rusch Simplastic Foley Catheters) based on:

• Intended Use: Similar indications for use for bladder drainage and irrigation.
• Technological Characteristics: Similar balloon retention type, materials (PVC), sizes, lumens, sterilization method, single-use, and radiopacity. The key differences highlighted are a change in PVC plasticizer, extended shelf life, and slightly different size ranges.
• Non-Clinical Performance Testing: This includes:
  • Biocompatibility testing (e.g., cytotoxicity, sensitization, systemic toxicity, implantation) according to ISO 10993 standards.
  • Bench performance testing (e.g., visual inspections, strength, connector security, balloon safety, flow rate, kink stability, tensile force, radiopacity) according to ISO 20696, ASTM F623, and ASTM F640 standards.
  • Sterilization and Packaging validation according to ISO 11135-1, ISO 10993-7, ISO 11607, ASTM D4169, ASTM F1886, ASTM F88, EN 868-5, and ASTM F2096.

The document explicitly states: "Differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness." and "Performance test results demonstrate that the subject device is as safe and effective as the predicate device."

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device based on the provided text. The document pertains to a traditional medical device demonstrating substantial equivalence through non-clinical bench and biocompatibility testing, not an AI/ML algorithm requiring clinical performance studies against defined ground truth with human reader involvement.

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The FLUME catheter is intended for bladder drainage via urethral or suprapubic route.

The FLUME catheter is intended for the drainage of urine from the bladder. The FLUME catheter is a sterile indwelling urinary catheter intended for single use. The FLUME catheter is made using polyurethanebased polymers. The catheter has an inflatable retention balloon attached to the catheter shaft. The catheter has a dual lumen tube. The larger lumen is for urine drainage. The smaller lumen is used to inflate and deflate the balloon with sterile water. The distal end has two opposite eye holes, which are used for drainage. The product is available in standard sizes. The catheter may be placed following the institutions' standard practice for either urethral bladder drainage or via percutaneous suprapubic access to the bladder.

This document is a 510(k) summary for the FLUME catheter, which seeks to expand its indications for use to include suprapubic drainage. This is a special 510(k) submission, meaning it relies heavily on the predicate device (FLUME catheter K212151) as the current device has no changes in design, materials, or manufacturing processes.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics against specific criteria for the expanded indication of suprapubic use. Instead, it relies on the predicate device's established performance and extensive non-clinical testing.

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

The document does not describe a new "test set" in the traditional sense of a clinical or ex-vivo study with a defined sample size for the expanded indication.

• Sample Size: Not applicable/not provided for a specific test set related to the suprapubic indication as it's a Special 510(k) leveraging prior data.
• Data Provenance: The biocompatibility data is "leveraged from the predicate device." This suggests the data was generated previously for the predicate device, but its original provenance (e.g., country, retrospective/prospective) is not detailed in this summary.

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

Not applicable. This is not a study involving expert-established ground truth for a test set. The submission relies on non-clinical data and risk assessment.

4. Adjudication Method for the Test Set

Not applicable. There is no described test set requiring adjudication in this summary.

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

No. The document explicitly states "SUMMARY of NON-CLINICAL TESTING." There is no mention of an MRMC comparative effectiveness study.

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

Not applicable. This device is a physical urological catheter, not an algorithm or AI-based device.

7. The Type of Ground Truth Used

The "ground truth" for the safety aspects (biocompatibility, pyrogenicity) is based on standardized testing protocols (e.g., ISO 10993-1 for biocompatibility, bacterial endotoxin testing for pyrogenicity) and internal risk assessments concluding equivalence. For functional equivalence, the ground truth is the established performance of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System with the Accuryn Sensing Urinary Catheter (SmartFoley®) - IAP UO Temp is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The Accuryn Sensing Urinary Catheter is a single use device intended for short term use (less than 30 days).

The Accuryn Monitoring System consists of three components, the Accuryn Sensing Urinary Catheter, Accuryn Urine Collection Set or Accuryn SmartFoley Adapter, and the Accuryn Monitor.

The Accuryn Sensing Urinary Catheter is a single use, sterile, MR conditional, disposable (12F, 14F, and 16 F), two-way silicone urinary bladder catheter with two opposing drainage eyes and four lumens. The first lumen is for urine drainage, the second lumen for the retention balloon, the third lumen embedded with a thermistor, and the fourth lumen to measure intra-abdominal pressure (IAP).

The Accuryn SmartFoley® comes in three configurations:

• IAP, U/O, Temp (intra-abdominal pressure, urine output, and core temperature)
• U/O. Temp (urine output and core temperature) ●
• Adapter (that is compatible with commercially available Foley catheters between 6-24Fr)

The Accuryn Urine Collection Set is provided permanently pre-connected to the Accuryn Sensing Urinary Catheter's drainage lumen conveys urine to a urine measurement cassette. which connects to the Accuryn Monitor. The cassette feeds the urine collection bag. Potrero Medical also provides a configuration of the Accuryn Urine Collection Set that is not provided pre-connected to the catheter/foley. It is known as Accuryn SmartFoley Adapter and enables the user to connect a Foley catheter of their choice to the Accuryn Urine Collection Set. The Accuryn Urine Collection Set and Accuryn SmartFoley Adapter function in conjunction with the Accuryn Monitor to measure and display urine output is considered a 510(k) exempt device per 21 CFR 876.1800 (urine flow or volume measuring system, product code EXY).

The Accuryn Monitor is a portable electronic device which maintains urine flow from the foley through the Accuryn Urine Collection Set or Accuryn SmartFoley Adapter, measures the urine output volume in the measurement cassette, and displays the urine output. The Accuryn Monitor also measures and displays the temperature from the thermistor and intra-abdominal pressure (IAP) from the pressure lumen. The monitor contains software.

The provided text is a 510(k) summary for the Accuryn Monitoring System. This document focuses on demonstrating substantial equivalence to a predicate device rather than outright proving device performance against pre-defined acceptance criteria in the manner of a novel device. Therefore, the information typically found in a study proving acceptance criteria for a new AI/ML medical device (like MRMC studies, detailed ground truth establishment, training set provenance, etc.) is largely not present in this type of submission.

The "acceptance criteria" here are essentially that the new device configurations (smaller catheter sizes) perform comparably to the predicate device and don't introduce new safety or effectiveness concerns. The "study" proving this is a series of non-clinical performance tests designed to validate and verify the device's adherence to relevant standards and its functional characteristics.

Here's an attempt to answer your questions based on the provided text, highlighting where information is absent due to the nature of a 510(k) submission for substantial equivalence:

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

The document does not provide a specific table of quantitative acceptance criteria with corresponding performance values in the way one might expect for a novel AI/ML device. Instead, it summarily states that the device "met all acceptance criteria" and "Performance testing data has demonstrated that the Accuryn Monitoring System is safe and effective for its intended use."

The closest a comparison table comes to "acceptance criteria" is the "Comments" column in the Comparison of Technological Characteristics and Device Use with Predicate Device section, where "Same" indicates meeting the implicit criterion of being equivalent to the predicate.

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The 2-Way 100% Silicone ClearTract Catheter is intended for drainage of the urinary tract. Catheterization is generally accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic placement or other placement of the catheter, such as nephrostomy tract. Intended population is adults and pediatrics.

The 2-Way 100% Silicone ClearTract Catheter is a standard single-use 2-way Foley catheter that is constructed of medical grade silicone with a surface modification. It incorporates two (2) lumens, one for inflation/deflation of the balloon and the other for drainage of the urinary tract. The drainage inlet is located distal to the catheter's balloon. The connection to the urinary bag is a standard noninterconnectable connector.

The provided document is a 510(k) Premarket Notification from the FDA for a 2-Way 100% Silicone Cleartract Catheter. This document describes the device, its intended use, a comparison to predicate devices, and the non-clinical testing performed to support its substantial equivalence.

Crucially, this document is for a medical device (a catheter) and not for an AI/ML-based diagnostic or prognostic device. Therefore, many of the requested criteria related to AI/ML device performance (such as sensitivity, specificity, MRMC studies, human reader improvement, and ground truth establishment for training/test sets) are not applicable to this type of submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the regulatory requirements for medical device clearance (specifically, demonstrating substantial equivalence to a legally marketed predicate device) rather than performance metrics for an AI algorithm.

Here's a breakdown of the information that is applicable or inferred from the document, and why other points are not relevant:

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

For this medical device, "acceptance criteria" relate to demonstrating substantial equivalence to a predicate device in terms of indications for use, technological characteristics, and performance. The "performance" is assessed through non-clinical testing to ensure safety and effectiveness for the expanded indications.

• Type: Same as Predicate (2-Way Foley Catheter with inflation and drainage lumens)
• Size/Balloon: Same as Predicate (14Fr/10cc, 16Fr/5cc, 18Fr/10cc)
• Materials of Construction: Same as Predicate (Silicone, Medical Grade)
• Zwitterionic Polymer Surface Modification: Same as Predicate (Yes)
• Performance Standard: Same as Predicate (ASTM F623)
• Indwelling Time: Same as Predicate (Up to 30 days)
• Single Use? Same as Predicate (Yes)
• Prescription Use? Same as Predicate (Yes)
• Sterile? Same as Predicate (Yes)
• Sterilization Method: Same as Predicate (Ethylene Oxide Gas)

Conclusion: Technologically identical to the predicate device. |
| Safety and Biocompatibility (for new indications) | Non-Clinical Testing Performed:

• Biocompatibility: Genotoxicity Study per ISO 10993-3:2014, Biological Evaluation of Medical Devices, Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
• Bacterial Endotoxins Test (BET) / LAL Test: per USP .

Conclusion: "All testing was successfully completed and provided objective evidence to demonstrate the ClearTract catheter is substantially equivalent to the predicate device." The submission states "the proposed additions to the indications for use do not change or add new risks to the ClearTract catheter." |
| Compliance with Design Control Regulations | "All changes [the updated IFU] were made in compliance with 21 CFR 820.30 for design controls." |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable in the context of this 510(k) submission. There is no "test set" of patient data in the sense of an AI/ML algorithm evaluation. The testing involved controlled laboratory studies for biocompatibility and endotoxins, not clinical sample data.

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. There is no "test set" requiring ground truth establishment by clinical experts, as this is a physical medical device, not an AI diagnostic.

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

Not applicable. No clinical test set requiring adjudication was used.

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 pertains to AI-assisted diagnostic devices. This submission is for a physical medical catheter.

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

Not applicable. This pertains to AI diagnostic algorithms.

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

Not applicable. There is no "ground truth" in the clinical data sense required for this type of device. The "ground truth" for device performance is established through adherence to quality standards (e.g., ASTM F623), biocompatibility testing (ISO 10993-3), and endotoxin testing (USP ).

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning.

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

Not applicable. This device does not have a "training set" or "ground truth" in the machine learning sense.

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