Search Results

Luja Coudé is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

The product is for male patients only (adults and pediatric above the age of 1 years).

The Luja Coude is a single-use, sterile, hydrophilic coated catheter for intermittent urinary catheterization. The catheter has a flexible tip which contains several small holes (micro holes) by the tip creating a drainage zone which allows the urine to flow from the bladder through the catheter. The drainage end of the device has an outlet to which a urine bag with a suitable connector can be connected. The catheter also contains a hydrophilic-coating and is sterilized by irradiation.

The primary packaging provides the sterile barrier and contains a proof of seal for identification of opened products.

The Luja Coude is available in one length (33cm) with a flexible tip and diameters of 8 Fr, 10 Fr, 12 Fr, 14 Fr, 16 Fr, and 18 Fr.

The provided FDA 510(k) clearance letter and supporting Traditional 510(k) summary pertain to a urological catheter (Luja Coudé) and its substantial equivalence to a predicate device. This document focuses on the mechanical and material properties of the catheter, not on an AI/software as a medical device (SaMD) or diagnostic imaging device.

Therefore, many of the requested details, such as MRMC comparative effectiveness studies, standalone algorithm performance, AI training/test sets, expert ground truth establishment, and complex adjudication methods, are not applicable to this type of medical device submission. These elements are typically required for AI/ML-based diagnostic devices where performance is measured in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC) and reader improvement.

The provided information focuses on bench testing (non-clinical performance) to demonstrate the device's physical and biological properties meet established standards and are equivalent to the predicate.

Here's an analysis of the provided text in relation to your questions, highlighting what is available and what is not:

Analysis of Acceptance Criteria and Study Proof for Luja Coudé Catheter

Based on the provided FDA 510(k) clearance letter and Traditional 510(k) summary, the Luja Coudé catheter demonstrates its performance through non-clinical (bench) testing and biocompatibility assessments, rather than clinical studies or AI/ML performance evaluations involving human readers.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Biocompatibility and bench performance testing were conducted to verify the proposed subject devices with modified hydrophilic coating met the pre-determined acceptance criteria per specified requirements." It also states, "The subject devices met the pre-determined acceptance criteria after simulated shipping distribution and aging cycle per specified performance requirements."

However, the specific numerical acceptance criteria or the exact reported performance values are not detailed in this public summary. Instead, the summary lists the tests conducted and confirms that the device met the criteria.

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

• Sample Size for Test Set: The document does not specify exact sample sizes for each non-clinical test (e.g., number of catheters tested for friction, kink, etc.). It only states that "Testing was performed on final, finished, and sterilized devices." This is typical for bench testing where the number of units tested is governed by standard protocols (e.g., ISO, ASTM, internal methods) to achieve statistical confidence for manufacturing and design verification, but individual numbers are not usually disclosed in 510(k) summaries unless a specific, novel statistical method for performance testing is employed.
• Data Provenance: The studies are "non-clinical" (bench testing). Therefore, concepts like "country of origin of the data" or "retrospective/prospective" studies do not apply in the context of human subject data. The device is manufactured by Coloplast A/S in Humlebæk, Denmark, and the tests would have been performed in a controlled laboratory environment.

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

• Not Applicable. For this type of device (a physical urological catheter), "ground truth" is established through physical measurements, chemical analysis, and standardized biological assessments in a lab setting, not by human experts interpreting clinical data (like radiologists interpreting images). The "experts" involved would be engineers, material scientists, and microbiologists conducting the tests.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies among human readers/experts in diagnostic studies, typically for AI/ML device validation. This is not relevant for the bench testing of a physical catheter.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• No. An MRMC study is relevant for AI/ML-driven diagnostic devices where the AI assists human readers. This device is a physical medical instrument, not an AI diagnostic tool.

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

• No. This question applies to AI algorithms. The Luja Coudé is a physical catheter designed for direct patient use via insertion, not an algorithm.

7. The Type of Ground Truth Used

• For this device, the "ground truth" is based on:
  • Standardized Bench Test Measurements: Objective physical properties (e.g., friction coefficients, kink resistance, dimensions, pH, osmolality) measured against international and proprietary Coloplast standards (ISO 20696, Coloplast TMs).
  • Biocompatibility Testing: Laboratory assays and in-vivo animal models (for systemic toxicity, irritation, sensitization) that demonstrate the material's safety in a biological environment, conforming to ISO 10993 standards.
  • Sterility Assurance Level (SAL): Defined by microbial inactivation standards (SAL 10⁻⁶).

8. The Sample Size for the Training Set

• Not Applicable. The concept of a "training set" is for AI/ML models. This device does not use an AI/ML model. The design and manufacturing process for the catheter would involve extensive development and testing, but not in the sense of an "AI training set."

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

• Not Applicable. As there is no AI training set, there is no ground truth to establish for it. The development of the catheter relies on established engineering principles, material science, and manufacturing quality control.

Summary: The provided document is a 510(k) summary for a physical medical device (catheter) that relies on non-clinical bench testing and biocompatibility assessments to demonstrate substantial equivalence and safety/effectiveness. It does not involve AI/ML technology or human reader studies. Therefore, many of the questions related to AI/ML device validation are not applicable.

Ask a specific question about this device

Luja Set is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

The product is indicated for male patients only (adults and pediatric above the age of 1 years).

The medical device is an intermittent, ready-to-use, sterile, hydrophilic-coated catheter with integrated urine bag. It contains a catheter with a flexible tip that facilitates passage through the sphincter in the urethra. The catheter is shielded by a sleeve, which serves as protection from the user's hands during insertion. Several small holes (micro-holes) by the straight tip, create a draining zone, which allow the urine to flow from the bladder out through the catheter to a urine bag. The drainage end of the catheter is attached to a urine bag with a tear off section to open the bag for emptying. The catheter is sterilized by radiation. The Luja Set is available in sizes: CH10, CH12, CH14, and CH16.

The provided FDA 510(k) Clearance Letter for the Luja Set indicates that it is a Special 510(k) Notification. This type of submission is used when a modification is made to a manufacturer's own legally marketed device (the predicate device) where the modification does not require a new intended use and the methods for evaluating the changes are well-established.

Crucially, the provided document describes the device itself (a urological catheter), its intended use, and its similarities/differences to a predicate device (Luja Coudé) and a reference device (SpeediCath Flex Set). It details the non-clinical performance testing performed (flow rate and kink stability), but it DOES NOT contain the actual acceptance criteria or the specific results proving those criteria were met.

The document states: "Bench performance testing was conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements. Testing was performed on final, finished, and sterilized devices as described in the applicable submission sessions." However, the "applicable submission sessions" are not included in this document.

Therefore,Based on the provided document, I cannot fulfill most of the detailed requests regarding acceptance criteria and study particulars because the document does not contain the acceptance criteria or the specific performance data.

Here's what I can extract and state based only on the provided text, along with what cannot be determined:

Acceptance Criteria and Device Performance

• Acceptance Criteria: Not explicitly stated in the provided document. The document only mentions that "the proposed subject devices met the pre-determined acceptance criteria per specified requirements."
• Reported Device Performance: Not explicitly stated in the provided document. The document mentions that "Risk assessment was conducted, and two performance risks were identified: flow rate and kink stability. To support the flow rate and kink stability testing, the SpeediCath Flex Set (K222059) was used as a reference device." However, the actual performance data (e.g., specific flow rates achieved, quantitative kink stability metrics) are not provided.

Study Details (Based on available information and inferences from a 510(k) for a physical medical device)

The information provided is for a physical medical device (urological catheter), not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical questions regarding AI/ML clinical validation studies (like multi-reader multi-case studies, expert adjudication, ground truth establishment for AI models, training set details) are not applicable to this type of device and submission.

Here's a breakdown based on the context of the device:

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

   • Acceptance Criteria: Not listed in the provided document.
   • Reported Device Performance: Not listed in the provided document. The document only states that testing was performed for "flow rate and kink stability."

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

   • Sample Size: Not specified.
   • Data Provenance: Not applicable in the context of a physical device's non-clinical bench testing. This typically refers to clinical data. The testing mentioned (flow rate, kink stability) is bench testing on the device itself.

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

   • Not Applicable. This question is relevant for AI/ML or imaging-based devices where human expert readings establish ground truth. For a physical device like a catheter, "ground truth" is established through standardized physical measurements and engineering specifications, not expert consensus interpreting data.

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

   • Not Applicable. See point 3.

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 physical medical device, not an AI/SaMD. MRMC studies are not relevant here.

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

   • Not Applicable. This is a physical medical device.

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

   • For this device, "ground truth" for non-clinical testing is based on engineering specifications, physical measurements, and adherence to international standards (e.g., ISO 20696:2018 for urethral catheters, ASTM F623-19 for Foley Catheters, as cited). It's not a diagnostic ground truth from patient data like pathology or expert consensus.

8. The sample size for the training set

   • Not Applicable. This device does not involve 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 involve a "training set" in the context of machine learning.

Ask a specific question about this device

The product is intended for use in male, female, and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.

SureCath Set is a sterile, single-use hydrophilic coated intermittent catheter with integrated urine bag. An ampoule of saline solution is provided inside the urine bag. This saline solution from the ampoule is poured over the catheter to activate the coating before use.

Here's an analysis of the provided text regarding acceptance criteria and the study:

The document (K242049) is a Traditional 510(k) Summary for the Coloplast SureCath Set, a sterile, single-use hydrophilic coated intermittent catheter with an integrated urine bag. It demonstrates substantial equivalence to predicate devices. The information provided primarily focuses on non-clinical performance testing rather than human clinical studies involving AI assistance.

Based on the provided text, the device SureCath Set is a medical device, not an AI/ML powered device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study, effect size of human readers with/without AI, or standalone algorithm performance are not applicable.

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

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

The document broadly states that "Bench performance testing and usability testing were conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements." It also mentions various ISO and ASTM standards to which the device was tested. However, it does not explicitly list specific quantitative acceptance criteria or detailed reported performance values for each test. It only states that the device "met the pre-determined acceptance criteria."

Implicit Acceptance Criteria (based on standards and test descriptions):

• Strength of connection between catheter and urine bag.
• Aseptic insertion (non-touch approach) of catheter through urine bag.
• Water amount of 20 ml in ampoule must activate coating on catheter.
• Friction of the coated catheter after 30 seconds activation time.
• Tearing and emptying of the urine bag.
• Volume of the urine bag.
• Strength of the urine bag. |
  | Usability | Met acceptance criteria per EN/IEC 62366-1. |
  | Packaging Integrity | Met acceptance criteria per ISO 11607-1, DS EN ISO 20696, ASTM D4169-22 for maintenance of sterile barrier and impact of transportation. |
  | Shelf Life/Aging Stability | Met acceptance criteria after accelerated aging per ASTM F1980-21, demonstrating stability for the defined shelf life (24 months at time of submission, planned 36 months). |

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

The document does not specify the exact sample sizes used for each non-clinical test. It states "Testing was performed on final, finished, and sterilized devices." The provenance of the data is from Coloplast A/S, Denmark. The tests are non-clinical, bench performance tests, so the concepts of "retrospective or prospective" human data don't directly apply here.

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

This information is not applicable to this type of non-clinical device testing. There are no "experts" establishing a "ground truth" for a test set in the way it would be for an AI/ML clinical study (e.g., radiologists interpreting images). The "ground truth" for non-clinical tests is based on objective measurements against established engineering and biological standards.

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

This information is not applicable. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish ground truth for ambiguous cases. Non-clinical bench tests rely on objective measurements against defined standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not conducted. The device is a physical medical device (intermittent catheter), not an AI-powered diagnostic or assistive tool. Therefore, there is no "AI assistance" for human readers to improve upon.

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. The device is not an algorithm or software requiring human-in-the-loop performance.

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

The "ground truth" for the non-clinical tests is based on:

• Compliance with recognized international standards (ISO, ASTM, EN/IEC).
• Pre-determined acceptance criteria defined by Coloplast for specific performance aspects (e.g., strength, friction, volume, activation).
• Objective measurements of physical and chemical properties.

8. The sample size for the training set

This information is not applicable. "Training set" is a concept for AI/ML models. This document describes testing for a physical medical device.

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

This information is not applicable, as there is no training set for a physical medical device.

Ask a specific question about this device

Luja Coudé is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

The product is indicated for male patients only (adults and pediatric above the age of 1 years).

Luja Coude is a single-use, sterile, hydrophilic coated catheter for intermittent urinary catheterization. The catheter has a flexible tip which contains several small holes (micro holes) by the tip creating a drainage zone which allows the urine to flow from the bladder through the catheter. The drainage end of the device has an outlet to which a urine bag with a suitable connector can be connected. The catheter also contains a hydrophilic-coating and is sterilized by irradiation.

The primary packaging provides the sterile barrier and contains a proof of seal for identification of opened products.

Luja Coude is available in one length (33cm) with a flexible tip and diameters of 8 Fr, 10 Fr, 12 Fr, 14 Fr, 16 Fr, and 18 Fr.

The provided text is a 510(k) summary for a medical device (Luja Coude catheter) and outlines its substantial equivalence to a predicate device. However, it does not contain information about a study that proves the device meets specific acceptance criteria based on AI/ML performance metrics. The document focuses on non-clinical performance testing (bench testing, biocompatibility, packaging, aging) and usability testing relevant to catheter functionality and safety.

Therefore, I cannot extract the information required for your request, as the document does not describe:

• AI/ML performance metrics (e.g., accuracy, sensitivity, specificity).
• A test set or training set for an AI/ML model.
• Ground truth experts or adjudication methods for AI/ML performance.
• MRMC studies comparing human readers with and without AI assistance.
• Standalone algorithm performance.

The document states: "Bench performance testing and usability testing were conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements. Testing was performed on final, finished, and sterilized devices as described in the applicable submission sessions." This refers to standard medical device performance and safety testing, not AI/ML model validation.

In summary, the provided text does not contain the type of study and data required to answer your prompt about an AI/ML device's acceptance criteria and performance.

Ask a specific question about this device

To establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.

The ReTrace Ureteral Access Sheath is a sterile, single use device that is inserted over a guidewire into the upper or lower urinary tract of patients requiring ureteroscopic procedure sin a hospital environment. The ReTrace Ureteral Access Sheath consists of:

• Reinforced tube/sheath
• Introducer/dilator
• Connector
• Clip

The reinforced polymeric introducer sheath includes a hydrophilic coating on the exterior and a lubricious inner surface. The sheath is reinforced to provide kink resistance. The distal tip of the sheath is fitted with a radiopaque ring. A white connector is fitted on the proximal end of the sheath and an orange connector is on the proximal end of the introducer to allow the two components to be attached.

The dilator is fitted with a Luer connector on the proximal end and has a hydrophilic coating on the distal end. A guidewire entry and exit eye and exit holes for fluid delivery are located at the distal end of the introducer. The dilator protrudes out the distal end and allows for a gradual enlargement of the passage if needed and improves trackability along the guidewire. Once in the desired location, the dilator is removed to establish a hollow conduit for insertion of endoscopes and other instruments into and out of the urinary tract.

The ReTrace Ureteral Access Sheaths are available in two diameters 10/12 Fr and 12/14 Fr. Lengths range between 28 and 55 cm.

This submission is for modifications to device materials, labeling, packaging, and connector design.

Here's a breakdown of the acceptance criteria and study information based solely on the provided text.

Crucial Note: The provided document is a 510(k) summary for a medical device (Ureteral Access Sheath) that underwent modifications. This means the primary argument for clearance is substantial equivalence to a previously cleared predicate device, rather than proving efficacy from scratch with a new device. Therefore, the details requested in your prompt regarding AI/ML models (e.g., training/test sets, human reader studies, ground truth establishment by experts) are generally not applicable to this type of device clearance. The performance data focuses on demonstrating that the modifications do not negatively impact the device's basic safety and function compared to the original cleared version.

Acceptance Criteria and Reported Device Performance

Given this is a 510(k) for a modified device, the "acceptance criteria" are implicitly that the modified device performs comparably to the predicate device in relevant mechanical, biocompatibility, and sterilization tests, and the modifications do not raise new questions of safety or effectiveness. The reported performance is that the device met these criteria.

Study Details (Based on Provided Text)

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

   • Sample Size: Not explicitly stated as a number of devices for each test. The document lists types of mechanical tests performed (e.g., tensile strength, friction tests) which implicitly involve testing multiple samples, but the exact quantity is not given.
   • Data Provenance: Not specified regarding country of origin. The studies are non-clinical testing (mechanical, biocompatibility, sterilization, packaging) and not human subject data. Thus, the concept of "retrospective or prospective" human data does not apply here.

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

   • Not Applicable. This document describes the clearance of a physical medical device (Ureteral Access Sheath) through non-clinical performance testing for substantial equivalence after modifications. It is not an AI/ML device that requires expert-established ground truth for a test set. The "ground truth" for these tests is defined by the technical specifications, standards (like ISO 10993-1), and acceptable performance parameters for the device.

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

   • Not Applicable. Again, this pertains to expert review of data, typically in AI/ML performance studies. Here, the "adjudication" is whether the device passed specific engineering and performance tests, which would be determined by laboratory results and quality system procedures, not expert consensus on ambiguous data.

4. 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 type of study (MRMC, human readers with/without AI) is specifically for AI-powered diagnostic/interpretive devices. The Retrace Ureteral Access Sheath is a physical, mechanical medical device.

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

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

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

   • The "ground truth" for this device's performance testing is defined by engineering specifications, industry standards (e.g., ISO 10993-1), and established test methodologies to ensure the device's physical and functional properties meet design requirements and maintain equivalency to the predicate device.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device with a training set.

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

   • Not Applicable. As above, no training set for an AI/ML model.

Summary of why AI/ML related questions are not addressed:

The provided text is a 510(k) summary for a physical, mechanical medical device (a Ureteral Access Sheath) that underwent modifications. The FDA clearance pathway for such devices, especially when arguing substantial equivalence, relies heavily on non-clinical performance testing (biocompatibility, mechanical integrity, sterilization validation, packaging) to demonstrate that the device is as safe and effective as a legally marketed predicate device. It does not involve AI/ML components, diagnostic interpretation, or human reader studies. Therefore, many of the questions asked in your prompt are not relevant to the content of this specific FDA submission.

Ask a specific question about this device

The Altis Single Incision Sling System is indicated for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The Aris Transobturator Kit consists of the Aris implantable midurethral support sling and disposable introducers. The Aris sling and introducers are indicated for the surgical treatment of all types of stress urinary incontinence (SUI) and for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Supris Retropubic Kit consists of the Supris implantable midurethral support sling and disposable introducers for placement using a "top-down" or "bottom-up" retropubic surgical approach. The Supris sling and introducers are indicated for the surgical treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Coloplast Altis Single Incision Sling (SIS) System includes one implantable single incision midurethral sling and two Altis introducer needles. The Altis Single Incision Sling System is provided sterile (ethylene oxide sterilization) and is for single use only.

The Altis Single Incision Sling is an implantable, synthetic, knitted, low-elasticity, monofilament polypropylene, single incision midurethral sling. The mesh sling body measures approximately 7.75 cm long by 1.1cm wide. The Altis sling assembly is connected on each end to an anchor. One end of the sling assembly is connected to a short length of USP size 1 polypropylene monofilament suture connected to a static (non-tensioning) polypropylene anchor. The other end of the sling connects to a longer length of suture with a dynamic (tensioning) polypropylene/polyurethane anchor. The dynamic anchor is intended to allow intraoperative adjustment and tensioning of the sling, resulting in urethral support during instances of increased abdominal pressure, thereby preventing urine leakage. The Altis sling is non-absorbable and is intended to be permanent.

The Altis introducers are helical-type instruments (one right), used to assist in the surgical placement of the Altis Single Incision Sling a transobturator technique, via a single incision vaginal approach. The introducers are manufactured from polycarbonate (handles) and medical grade stainless steel (needles). These introducers are only to be used with the Altis Single Incision Sling System in accordance with the Instructions for Use.

The Coloplast Aris Transobturator Sling System includes an implantable midurethral sling and disposable introducer needles. The Aris sling and Aris introducers are provided sterile (ethylene oxide sterilization) and are for single use only.

The Aris sling is a synthetic, knitted, low-elasticity, midurethral sling made from monofilament polypropylene. The Aris sling is non-absorbable and intended to be permanently implanted.

Aris introducers (helical pair and flat curve) are instruments used to assist in the correct surgical placement of the Aris sling via the transobturator approach. The introducers are manufactured from polycarbonate (handles) and medical grade stainless steel (needles). These introducers are only to be used with the Aris sling.

The Coloplast Supris Retropubic Sling System includes an implantable midurethral sling and disposable introducer needles. The Supris sling and Supris introducers are provided sterile (ethylene oxide sterilization) and are for single use only.

The Supris sling is a synthetic, knitted, low-elasticity, midurethral sling made from monofilament polypropylene. The Supris sling is non-absorbable and intended to be permanently implanted.

The Supris introducers are instruments used to assist in the correct surgical placement of the Supris sling via a retropubic approach. The introducers are manufactured from polycarbonate (handles) and medical grade stainless steel (needles). These introducers are only to be used with the Supris sling.

No information regarding acceptance criteria or a study proving the device meets acceptance criteria for an AI/ML powered medical device, as described in the prompt's requested information points (1-9), is available in the provided text.

The document discusses the substantial equivalence (510(k) clearance) of a physical medical device: the Altis Single Incision Sling System, Aris Transobturator Sling System, and Supris Retropubic Sling System, which are surgical meshes for treating stress urinary incontinence.

The "Performance Data" section (VII) lists various bench testing conducted to support the substantial equivalence determination for changes to the mesh material, including:

• Biocompatibility Testing (ISO 10993-1)
• Performance Testing (Mesh Density, Thickness, Pore Size, Sling Length, Width, Tensile Strength, Elongation at Break, Elasticity, Stiffness, Suture Pull-Out Strength, Mesh Tear Resistance, Suture/Mesh Weld Strength, Shelf-life testing)
• Sterilization (Ethylene Oxide)
• Packaging and Distribution

The document explicitly states: "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices." This confirms that there was no human reader study, no standalone algorithm performance, or any of the other AI/ML specific criteria mentioned in the prompt.

Ask a specific question about this device

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.

Ask a specific question about this device

The product is indicated for use on moderate to highly exuding acute and chronic wounds such as:

• · Diabetic ulcers
• · Leg ulcers (arterial ulcers, venous ulcers and leg ulcers of mixed etiology)
• · Pressure injuries (stage 2-4)
• Traumatic wounds
• · Partial thickness (second degree) burns
• · Donor sites
• · Post-operative surgical wounds
• · Exudate absorption in oncology wounds, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma

Biatain Fiber Ag is a soft, sterile, primary wound dressing made mainly from non-woven gelling carboxymethyl cellulose (CMC) fibers. In addition, non-gelling bicomponent (BiCo) fibers are incorporated to obtain strength and integrity of the products both in dry and gelled condition. Ionic silver (Ag+) is added for antimicrobial efficacy within the dressing, and ethyl lauroyl arginate (LAE) is added as combined surfactant and chelator within the dressing.

The provided text is a 510(k) summary for the Biatain Fiber Ag wound dressing. This document describes the device, its indications for use, comparison with a predicate device, and performance data to support its substantial equivalence. However, it does not contain information about an AI/ML-enabled medical device study, nor does it describe acceptance criteria and performance in the context of AI/ML algorithms.

Therefore, I cannot provide details on the following, as they are not present in the document:

• A table of acceptance criteria and reported device performance related to AI/ML.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used for AI/ML.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document details the performance data for a traditional wound dressing:

1. Performance Data Provided (Related to a traditional wound dressing):

Summary of Device and Study Type:

The document describes performance data for the Biatain Fiber Ag, which is a wound dressing, not an AI/ML device. The studies listed are standard performance tests for such a product to demonstrate its safety and effectiveness in its intended use, particularly for absorbency, wet strength, and antimicrobial properties.

Ask a specific question about this device

Luja Coude is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The product is for adult male patients only.

Luja Coude is a single-use, sterile catheter for intermittent urinary catheterization. The catheter has a flexible tip which contains several small holes (micro holes) by the tip creating a drainage zone which allows the urine to flow from the bladder through the catheter. The drainage end of the device has an outlet to which a urine bag with a suitable connector can be connected. The catheter also contains a hydrophilic-coating and is sterilized by irradiation. The primary packaging provides the sterile barrier and contains a proof of seal for identification of opened products. Luja Coude is available in one length (33cm) with a flexible tip and diameters of 8 Fr, 10 Fr, 12 Fr, 14 Fr, 16 Fr, and 18 Fr. Luja Coudé CH/FR 18 differs from the predicate device in the catheter size variants. Luja Coudé (predicate) includes French size 8 (CH8) through French size 16 (CH16) variants compared to the subject device which is a line extension to the Luja Coudé. The reference device supports the inclusion of the 18 Fr size variant.

The provided text describes the non-clinical performance testing for the Luja Coude (20108 Male CH18 - large packaging) device. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance values for each test. Instead, it lists the types of tests conducted and generally states that the "properties meet the acceptance criteria" or "proposed subject devices met the pre-determined acceptance criteria."

Here's an inferred table based on the information provided:

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

• Sample Size for Test Set: The document does not specify the exact sample size for each test conducted. It generally states that "the 18 fr size was included in analysis for all worst-case scenarios and included in testing." This implies that a sufficient number of 18 Fr devices were tested to represent the product.
• Data Provenance: The data is from non-clinical in vitro and bench testing conducted by Coloplast A/S (Denmark), with the contact person based in Minneapolis, MN, USA. The studies are retrospective in the sense that they are internal corporate testing used for regulatory submission.

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

This information is not applicable as the studies described are non-clinical bench and lab tests for a medical device (urological catheter). There are no human subjects, images, or diagnostic outputs that would require expert consensus or ground truth establishment by medical professionals like radiologists. The "ground truth" for these tests comes from established engineering and regulatory standards (e.g., ISO, ASTM, Coloplast internal methods).

4. Adjudication Method for the Test Set

This information is not applicable for non-clinical bench testing. Adjudication methods are typically used in clinical studies or studies involving human interpretation (e.g., by multiple readers).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The submission describes non-clinical performance testing for a urological catheter, not an AI or imaging diagnostic device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

This information is not applicable. The device is a physical urological catheter, not an algorithm or software.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the non-clinical tests described is based on:

• Established international and national standards (e.g., ISO, ASTM).
• Internal Coloplast test methods and specifications, which are themselves derived from engineering principles and regulatory requirements for safe and effective medical devices.
• The physical and chemical properties of the device materials and design.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not an AI algorithm that requires a training set. The "training" for the device's design and manufacturing comes from engineering and material science principles.

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

This information is not applicable as the device is not an AI algorithm and therefore does not have a "training set" in that context.

Ask a specific question about this device

Silicone double loop ureteral stents:

The Silicone double loop ureteral stents are intended for adult and pediatric (children and adolescents) patients for drainage of the upper urinary tract over fistulas or ureteral obstacles and/or for healing of the ureter. These stents may remain implanted for up to 12 months.

Pyelostent and Stenostent Silicone double loop ureteral stents: Drainage of the upper urinary tract and/or ureter healing during management of ureteral stenosis:

For Pyelostent® Silicone double loop ureteral stents: Partial enlargement of the stent diameter, for localized stenosis of the ureteropelvic junction in adult and pediatric (adolescents) patients.

For Stenostent® Silicone double loop ureteral stents: Total enlargement of the stent diameter, for ureteral stenosis in adult and pediatric (children and adolescents) patients.

The Pyelostent® and Stenostent® Silicone double loop ureteral stents may remain implanted for up to 12 months.

The ImaJin Silicone double loop ureteral stent kit product family was originally cleared as Porges™ Silicone Double Loop Ureteral Stents in 510(k) K013921. The ImaJin Silicone double loop ureteral stent family consists of three single use, autostatic stents intended to drain the upper urinary tract and allow healing in case of ureteral obstacles or damage to the ureter. The Pyelostent and Stenostent Silicone double loop ureteral stents have partial and complete reinforcement along the straight catheter section respectively to add crush resistance. The devices are provided with a pusher and in some cases a guidewire. The Silicone double loop ureteral stents are ethylene oxide sterilized, single use, implantable devices.

The current submission is to update the indication for use statement, revise the Instructions for Use, add information on MRI compatibility, modify drainage hole size in some models, modify packaging, and modify the device performance specifications.

This document is an FDA 510(k) clearance letter for a medical device (ureteral stents). It does not contain information about the performance of an AI/ML device, nor does it provide the type of detailed study data requested for acceptance criteria and study proving device performance.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, ground truth, or MRMC studies from the provided text.

The document primarily focuses on:

• Confirming the substantial equivalence of the Coloplast stents to a previously cleared predicate device.
• Listing the indications for use.
• Detailing the types of non-clinical (mechanical/performance) testing performed, such as dimensional testing, flow rate, tensile strength, radiopacity, MRI safety, and sterilization validation. It explicitly states: "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices."

This document is about traditional medical device clearance, not an AI/ML-driven diagnostic or assistive device.

Ask a specific question about this device