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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.

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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 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, and 16 Fr. The reference device supports the inclusion of 8 Fr models.

The provided text describes the acceptance criteria and the studies performed for the Luja Coude urological catheter. However, it does not contain information relevant to AI/ML device performance, ground truth establishment for a training set, MRMC studies, or standalone algorithm performance. The device is a traditional medical device, not an AI/ML device.

Therefore, many of the requested fields cannot be answered from the provided document.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various non-clinical performance tests and associated standards. The general reported performance is that the "proposed subject devices met the pre-determined acceptance criteria per specified requirements" and "The performance testing demonstrates the subject device is as safe and effective as the predicate device." Specific numerical acceptance criteria and performance results are not provided in this summary.

2. Sample size used for the test set and the data provenance:
Not applicable information for the provided device type. The device is a physical catheter, and the testing involves bench performance and biocompatibility rather than a "test set" of data in the AI/ML context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not an AI/ML device requiring expert-established ground truth for a test set.

4. Adjudication method for the test set:
Not applicable. This is not an AI/ML device requiring adjudication of a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.

7. The type of ground truth used:
Not applicable. The "ground truth" for this device's performance is established through physical and biological testing against established international and ASTM standards, as well as Coloplast's internal test methods.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.

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SpeediCath Soft 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 cather is inserted into the bladder allowing urine to drain.

The product is for adult male patients only.

The SpeediCath Soft is a sterile, single use hydrophilic coated polyurethane catheter for men. The catheter is to be used for intermittent drainage of the bladder through the urethra by adult males with missing or reduced bladder control. The catheter has a grip which serves as protection from the user's touch and aids the user during insertion.

The provided text details the 510(k) submission for the Coloplast SpeediCath Soft urological catheter. Based on this document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document lists a comprehensive set of performance tests conducted for the SpeediCath Soft, implying that for each test, pre-determined acceptance criteria were established. The general statement made is that "All tests met the pre-determined acceptance criteria." While specific numerical acceptance criteria and detailed performance results for each test are not explicitly provided in a table within this document, the following table summarizes the types of tests conducted (which serve as the basis for acceptance) and the general performance statement provided.

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

The document does not specify the sample sizes used for each of the non-clinical tests listed. It states that "Performance testing for SpeediCath Soft was conducted according to applicable sections of non-recognized and recognized voluntary consensus standards." These standards typically define appropriate sample sizes for testing.

The data provenance is for a medical device (urological catheter) and the tests conducted are non-clinical, likely in a laboratory setting by the manufacturer, Coloplast. There is no indication of country of origin of the data beyond the manufacturer being based in Humlebaek, Denmark. The studies are described as "Performance testing," implying they were specifically conducted for this submission, making them prospective in nature for regulatory purposes, although the underlying methods might be well-established.

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

This section is not applicable. The tests conducted are non-clinical engineering and performance tests on the catheter itself (e.g., flow rate, tensile strength, biocompatibility), not tests involving human "readings" or interpretations that would require expert consensus for ground truth. Usability testing, which might involve human subjects, is mentioned, but details on "experts establishing ground truth" are not provided.

4. Adjudication method for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for medical image analysis or clinical trials where multiple human readers interpret data, and a consensus mechanism is needed for the ground truth. The tests performed are objective, quantitative measurements or qualitative assessments 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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any element of AI assistance in this submission. This is a 510(k) for a physical medical device (catheter), not a diagnostic AI system.

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

This is not applicable, as the device is a physical urological catheter, not an algorithm or AI system.

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

For the non-clinical performance tests, the "ground truth" is defined by the acceptance criteria specified in the referenced ASTM and ISO standards. For example, a flow rate test would have a pre-defined minimum or range of acceptable flow rates. Biocompatibility would be assessed against established criteria for cytotoxicity, irritation, etc., as per ISO 10993 standards. These are objective measures against a standard, not expert consensus or pathology in a clinical sense.

8. The sample size for the training set

This is not applicable as the device is a physical product and not an AI or machine learning algorithm that requires a "training set."

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

This is not applicable as the device is a physical product and not an AI or machine learning algorithm that requires a "training set" with established ground truth.

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SpeediCath Flex Coude Pro 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.

The SpeediCath Flex Coude' Pro catheter is a sterile single use hydrophilic coated polyurethane catheter for men. The catheter is to be used for intermittent drainage of the bladder through the urethra by males with missing or reduced bladder control. The catheter has a bended flexible tip that facilitates passage through the urethra to the bladder. The catheter is shielded by a sleeve, which serves as protection form the user's touch during insertion. The SpeediCath Flex Coude' Pro Catheters are offered with a 33cm effective length and range in size from 10Fr to 16Fr. The hydrophilic coating makes this single use catheter ready to use.

This document is an FDA 510(k) summary for the SpeediCath Flex Coudé Pro catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study that "proves the device meets acceptance criteria" in the way one might describe a clinical trial for a diagnostic AI.

Here's an analysis based on your requested information, acknowledging that the nature of this submission (a device modification for a urological catheter) means some of your categories might not be directly applicable in the same way they would be for an AI diagnostic device:

Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on the device meeting performance specifications established by voluntary standards and by testing conducted on a predicate device. The "device performance" is reported as "All tests passed the pre-determined acceptance criteria."

Study Details:

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

   • The document does not specify exact sample sizes for each test. It refers to "Performance testing." For a physical device like a catheter, this would typically involve testing a statistically significant number of production units according to the applicable standards.
   • "Data provenance" is not explicitly stated in terms of country of origin, but it is implied to be internal testing by the manufacturer, Coloplast Corp, based in Minneapolis, MN, USA. The studies are non-clinical (laboratory/bench testing).

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

   • This question is not applicable to this type of device submission. Ground truth, in the context of diagnostic AI, usually refers to definitive diagnoses by experts or pathology. For a physical device, the "ground truth" is typically the physical property being measured (e.g., flow rate, tensile strength) as determined by standardized laboratory methods and equipment, which may be operated by qualified technicians or engineers, but not "experts" in the clinical diagnostic sense.

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

   • Not applicable. This concept relates to resolving discrepancies among multiple human readers for diagnostic tasks, which is not relevant to non-clinical bench testing of a physical medical device like a catheter.

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:

   • Not applicable. This is a physical medical device (catheter), not an AI diagnostic system. Therefore, no MRMC study, human readers, or AI assistance is involved.

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 or AI system.

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 the objective measurements and pass/fail criteria established within the referenced voluntary standards (e.g., ISO, ASTM, EN). For example, a flow rate measurement would be compared against a specified minimum flow rate from the standard.

7. The sample size for the training set:

   • Not applicable. This refers to AI/machine learning models. This submission is for a physical medical device.

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

   • Not applicable. This refers to AI/machine learning models. This submission is for a physical medical device.

Summary of Study (Based on Provided Document):

The study described is a series of non-clinical bench and laboratory performance tests conducted to demonstrate the safety and effectiveness of the SpeediCath Flex Coudé Pro catheter and its substantial equivalence to a predicate device (SpeediCath Flex Coude' Pro: K180070). The new device is a modified version, with changes in pouch material/dimensions, sleeve material/dimensions, wetting agent material/volume, and product variants (line extension).

The studies performed include:

• Accelerated Aged Shelf Life Testing: To assess the stability of the coating and tip bend over time, per ISO F1980-16.
• Biocompatibility Testing: According to ISO 10993-1 and FDA Guidance to ensure the materials are safe for patient contact.
• Coefficient of Friction Testing: Per ASTM D1894: 2014, to evaluate the lubricity of the catheter.
• Transportation Testing: Per ASTM D4169, to assess the device and packaging's integrity after simulated shipping conditions.
• Impact Testing (due to modifications): Includes catheter kink testing, catheter tip integrity, coating inspection, proof of packing seal, and peel force test of new material for ease of opening.
• Performance Specifications (based on predicate device testing): Flow rate (EN1616/EN1618 and ASTM F623-99: 2013), tensile strength (EN1616/EN1618), and connector security (EN1616).

The document states that "All tests passed the pre-determined acceptance criteria," implying that the device performs as expected and meets the necessary safety and performance standards for its intended use, demonstrating substantial equivalence to the predicate device despite the minor modifications.

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