Search Results

SpeediCath Flex 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 for male patients only.

The SpeediCath Flex Set is a sterile, single use hydrophilic coated polyurethane catheter for men with an integrated collection bag (urine bag) which provides ease of use during collection and emptying of urine. 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 protective sleeve which serves as protection from the user's touch and aids the user during insertion of the catheter into the urethra. The device is intended for use by prescription only. The device comes in FR size 10, 12, 14, and 16; corresponding to model numbers 28931, 28932, 28934, and 28936 respectively.

The provided text describes the regulatory clearance for the SpeediCath Flex Set, a urological catheter. It does not contain information about an AI/ML powered device, therefore no information regarding acceptance criteria or performance of such a device can be extracted.

The document discusses the device's indications for use, technological characteristics, and non-clinical testing performed to demonstrate its safety and effectiveness compared to predicate devices. The listed tests are standard for medical devices like catheters and include standards for urine collection bags, sterile urinary catheters, material properties (coefficient of friction), usability, biocompatibility, packaging performance, and shelf life.

Here's the information that can be extracted, based on the provided text, heavily inferring from the context of a medical device submission:

1. A table of acceptance criteria and the reported device performance
   The document states: "All tests met the pre-determined acceptance criteria." It lists the standards and internal requirements against which the device was tested, but does not provide specific numerical acceptance criteria or reported performance values for each test. For example, it lists "ISO 8669-2:1996 Urine collection bags - Part 2: Requirements and test methods" as a fulfilled requirement, but doesn't detail what those requirements are or the specific results.

   Acceptance Criteria (Inferred from standards and internal requirements)	Reported Device Performance
   Requirements of ISO 8669-2:1996 (Urine collection bags)	Met all requirements
   Requirements of ISO 20696:2018 (Sterile urinary catheters and accessory devices)	Met all requirements
   Requirements of ASTM F623-99:2013 (Foley Catheters - Flow rate only)	Met all requirements
   Requirements of D1894:2014 (Coefficient of friction)	Met all requirements
   Requirements of ISO 62366-1:2015, AAMI HE 75:2009, and FDA Guidance (Usability)	Met all requirements
   Requirements of ISO 10993-1 (2018) and FDA Guidance (Biocompatibility)	Met all requirements
   Requirements of ASTM D4169 (Performance Testing of Shipping Containers)	Met all requirements
   Requirements of ASTM F1980-16 (Real Time and Accelerated Aging shelf life)	Met all requirements
   Internal requirements for break-off tap force	Met all requirements
   Internal requirements for cap/handle opening torque	Met all requirements
   Internal requirements for drip-tight closure of handle and cap	Met all requirements
   Internal requirements for pH and Osmolality of the wetting agent/hydrophilic coating	Met all requirements
   Internal requirements for protective sleeve welding strength	Met all requirements

2. Sample size used for the test set and the data provenance
   The document does not specify the sample sizes used for the non-clinical tests. It states "Performance testing for SpeediCath Flex Set was conducted..." but gives no details on the number of units tested. The data provenance is internal testing by Coloplast A/S. The text does not mention patient data, so neither retrospective nor prospective patient data is referenced.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
   Not applicable, as this is a non-clinical testing report for a physical medical device. Ground truth, in the context of expert review, is not relevant here. The "truth" is established by adherence to specified testing standards and internal requirements.

4. Adjudication method for the test set
   Not applicable for non-clinical device performance 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
   Not applicable. The device is a urological catheter, not an AI/ML-powered diagnostic tool.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
   Not applicable in the sense of clinical "ground truth." The "ground truth" for the non-clinical tests is defined by the requirements outlined in the referenced international standards, ASTM standards, relevant FDA guidances, and Coloplast's internal specifications.

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.

Ask a specific question about this device

SpeediCath Compact and SpeediCath Compact Plus is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The product is indicated for female patients only (adults and children of and above the age of 2 years). Choice of the catheter for the individual patient is made upon recommendation by the local health care professional.

The SpeediCath Compact and SpeediCath Compact Plus are sterile, ready to use intermittent catheters for females. These are single use catheters. The subject catheters have a hollow polyurethane inner tube that facilitates drainage of urine from the bladder through the urethra. SpeediCath Compact is available in size FR/CH 8. FR/CH 12. and FR/CH 12. and FR/CH 14. SpeediCath Compact Plus is 2 cm longer than SpeediCath Compact and is available in FR/CH 10, FR/CH 12, and FR/CH 14. The catheter is hydrophilic coated and placed in a sterile solution (swelling medium) inside the inner tube, which together with a handle and plug make up the primary packaging and the sterile barrier.

After inserting the catheter through the urethra and into the bladder, urine flows through the polished evelets (holes) at the tip of the catheter, the handle, and the plug. The hydrophilic coating on the catheter, as well as the swelling medium, provide a lubricated surface for minimized friction through the urethra.

The provided text describes a 510(k) premarket notification for a urological catheter (SpeediCath Compact and SpeediCath Compact Plus). The document primarily focuses on demonstrating substantial equivalence to a predicate device, as opposed to a new AI/ML device requiring extensive standalone and comparative effectiveness studies.

Therefore, many of the requested details regarding acceptance criteria, study methodologies for AI performance, sample sizes for AI training/test sets, expert adjudication methods, and MRMC studies are not applicable or extractable from this specific document. This document is for a medical device (catheter), not an AI/ML diagnostic tool.

However, I can extract information related to the device's performance testing to meet its acceptance criteria for safety and effectiveness, focusing on what is available in the document.

Acceptance Criteria and Device Performance (as applicable to a physical medical device)

The document details performance testing conducted to ensure the device's safety and effectiveness, particularly in light of a change in its swelling medium compared to the predicate device. The acceptance criteria are implicitly that the device meets the standards of the listed tests.

• Catheter coating - dry out in air
• Catheters, objective friction measurement
• pH of the swelling medium
• Osmolality of the swelling medium |

Study Details (as applicable to a physical medical device's performance testing):

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

   • The document does not specify the exact sample sizes (e.g., number of catheters) used for each performance test.
   • Data provenance is not explicitly stated in terms of country of origin or retrospective/prospective, but these are in vitro and ex vivo laboratory tests on the device materials and performance, not clinical studies with patient data.

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

   • Not applicable. This device is a physical medical device (catheter), and the "ground truth" for its performance is established by adherence to recognized international standards (ISO, ASTM) and internal test protocols for parameters like friction, biocompatibility, and sterility. There isn't a "ground truth" established by human experts in the context of diagnostic interpretation.

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

   • Not applicable. This concept pertains to human review of diagnostic outputs; here, performance is measured against objective engineering and biological standards.

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 not an AI/ML device.

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

   • Not applicable. This is not an AI/ML device. The "standalone" performance here relates to the physical catheter meeting its specifications.

6. The type of ground truth used:

   • The "ground truth" for this device's performance is derived from established scientific and engineering standards and validated test methodologies. For example, biocompatibility is assessed against ISO 10993, friction against ASTM D1894, and sterility against ISO 11137.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense.

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

   • Not applicable.

Ask a specific question about this device

SpeediCath Compact Set is indicated for use by patients with chronic urine retention and patients with a 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. This device is intended for males only.

The SpeediCath Compact Set is a sterile, ready to use intermittent catheter for males. It is a single use catheter with an integrated urine bag. The catheter is a hollow tube consisting of polyurethane and methylmethacrylate-acrylonitrilebutadiene-styrene polymer [MABS]. It facilitates drainage of urine from the bladder through the urethra to the collection bag. It is available in one size FR/CH 12/18. The catheter is hydrophilic coated and placed in a sterile solution (swelling medium) containing polyethylene glycol (PEG) inside a tube. The swelling medium resides between the catheter and the tube and lubricates the catheter.

The provided text describes the 510(k) premarket notification for the "SpeediCath Compact Set" Urological Catheter and Accessories, product number K200820, from Coloplast A/S. This document focuses on demonstrating substantial equivalence to a predicate device (SpeediCath Compact Set, K121458), rather than detailing specific acceptance criteria and a study to prove a device meets those criteria from an AI/algorithm perspective.

The document does not describe an AI/algorithm-based device and therefore does not contain information on:

• Acceptance criteria for an AI algorithm's performance.
• A study proving an AI device meets acceptance criteria.
• Sample size used for an AI test set or its data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods for an AI test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone performance of an AI algorithm.
• Type of ground truth used for AI models.
• Sample size for an AI training set.
• How ground truth for an AI training set was established.

Instead, the document focuses on the substantial equivalence of a physical medical device (a urological catheter) based on non-clinical performance testing.

Here's a summary of the non-clinical performance testing for the SpeediCath Compact Set, as described in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of specific numerical acceptance criteria (e.g., a specific coefficient of friction value) and reported performance against those. Instead, it indicates that testing was conducted per applicable standards and that "the results were acceptable."

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

• Sample Size: Not specified in the provided text for any of the tests.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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 and not provided. The tests described are non-clinical, laboratory-based performance tests, not clinical evaluations requiring expert interpretation of ground truth in the context of an AI device.

4. Adjudication method for the test set:

• This information is not applicable and not provided, as the tests are non-clinical.

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

• Not applicable, as this is not an AI device.

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

• Not applicable, as this is not an AI device.

7. The type of ground truth used:

• Not applicable, as the tests are non-clinical hardware performance evaluations against established physical/chemical standards, not against "ground truth" as it would be defined for an AI diagnostic or predictive model (e.g., pathology, outcomes data, expert consensus). The "ground truth" here is effectively the established engineering and biological standards.

8. The sample size for the training set:

• Not applicable, as this is not an AI device.

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

• Not applicable, as this is not an AI device.

Conclusion from document: The document concludes that "The performance testing demonstrates the subject device is as safe and as effective as the predicate device." This is the basis for the FDA's substantial equivalence determination for this physical medical device.

Ask a specific question about this device

SpeediCath Compact Set is indicated for use by patients with chronic urine retention and patients with a 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. This device is intended for females only.

The SpeediCath Compact Set is a sterile, ready to use intermittent catheter for females. It is a single use catheter with an integrated urine bag. The catheter is a hollow polyurethane tube that facilitates drainage of urine from the bladder through the urethra to the collection bag. It is available in three sizes FR/CH 10, FR/CH 12 and FR/CH 14. The catheter is hydrophilic coated and placed in a sterile solution (swelling medium) inside a tube, which together with a cover and plug make up the primary packaging and the sterile barrier. The subject device is the same as the predicate device, apart from the swelling medium. The swelling medium resides between the catheter and the tube and lubricates the catheter. The swelling medium in the subject device contains polyethylene glycol (PEG), and the predicate contains polyvinylpyrrolidone (PVP).

The provided text is a 510(k) summary for a medical device (SpeediCath Compact Set), and it describes the performance testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not detail the acceptance criteria and device performance in the context of an AI/ML device or a similar complex medical device that would necessitate the extensive requirements outlined in your prompt (e.g., number of experts, adjudication methods, MRMC studies, training set details).

This document is for a urological catheter, where the primary concern is the material (specifically, the swelling medium) and its physical and biological properties. The "performance testing" here refers to standard engineering and biocompatibility tests, not clinical performance in the sense of diagnostic accuracy or effect on human readers.

Therefore, I cannot directly answer your prompt using the provided text. The information requested (e.g., acceptance criteria for AI, sample sizes for AI test/training sets, expert consensus for ground truth in diagnostic accuracy, MRMC studies) is fundamentally different from the nature of the device and testing described in this 510(k) summary.

In summary, the provided document does not contain the information needed to address your prompt about acceptance criteria and study design for an AI/ML medical device.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

Urinary catheter for intermittent use.
The catheter is indicated for use by patients with chronic urine retention and patients with a 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 the urine to drain.

The SpeediCath Standard is a sterile single use hydrophilic coated polyurethane catheter. The catheter is placed in a swelling media, packed and sealed in a foil pouch and sterilized.

The provided text is a 510(k) summary for the SpeediCath Standard urological catheter. It outlines the device's characteristics, indications for use, and a summary of non-clinical testing conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

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

The document does not explicitly state numerical acceptance criteria in a table format for specific performance metrics. Instead, it indicates that "All tests met the pre-determined acceptance criteria." It lists the types of performance tests conducted.

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

The document does not specify the sample size used for any of the tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) as the tests are non-clinical, benchtop, and accelerated aged studies.

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 and not provided in the document. The studies described are non-clinical (biocompatibility, bench testing, shelf life, sterilization dose confirmation), which do not typically involve human expert interpretation for "ground truth" in the way clinical studies or AI algorithm evaluations do.

4. Adjudication method for the test set

This information is not applicable and not provided in the document. As mentioned in point 3, the studies are non-clinical and do not involve human adjudication processes for 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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a urological catheter, and the studies described are non-clinical; thus, an MRMC study related to AI assistance for human readers would not be relevant.

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

This information is not applicable and not provided. The device is a physical medical device (catheter) and does not involve an algorithm or AI.

7. The type of ground truth used

The concept of "ground truth" as typically defined in AI/clinical studies (e.g., expert consensus, pathology, outcomes data) is not directly applicable to physical device performance testing as described. For the non-clinical tests, the "ground truth" would be established by the specifications and validated methodologies of the referenced standards (e.g., ISO, ASTM). For example:

• Biocompatibility: Ground truth is defined by the criteria within ISO 10993-1 and FDA guidance.
• Bench Testing: Ground truth is defined by the specified parameters and ranges within ASTM D1894 and internal test methods.
• Shelf Life: Ground truth is established by the specified degradation limits and stability parameters within ASTM F1980-16.
• Sterilization: Ground truth is defined by the validated sterilization dose (e.g., sterility assurance level) according to ISO 11137-2.

8. The sample size for the training set

This information is not applicable and not provided. As the device is a physical medical product and not an AI/software product, there is no "training set."

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

This information is not applicable and not provided. There is no training set for this type of device submission.

Ask a specific question about this device

The SpeediCath Flex Coudé Pro is indicated for use by patients with urine retention and patients with a 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 the urine to drain. The product is for male patients only.

The SpeediCath Flex Coudé 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 from the user's touch during insertion.

The provided text is a 510(k) premarket notification for a medical device, the SpeediCath Flex Coudé Pro. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through clinical efficacy studies. Therefore, the document does not contain the information requested about acceptance criteria, clinical study details (like sample size, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to AI/diagnostic device performance).

The "performance testing" mentioned in the document refers to non-clinical bench testing to ensure the physical properties and safety of the modified catheter are comparable to its predicate device. This is typical for a 510(k) submission where the device is a minor modification or a line extension of an already cleared device.

Specifically, the document states:

• "Performance testing for SpeediCath Flex Coude Pro was conducted according to applicable sections of voluntary standards in order to document the following properties of the SpeediCath Flex Coudé Pro catheter." It lists tests such as flow rate, coefficient of friction, tensile strength, connector security, and biocompatibility.
• "The proposed changes do not impact the performance testing." This implies the core performance (mechanical, material, biocompatibility) is expected to be the same as the predicate.
• "The following tests were completed to determine the impact of the modification based on assessment of the device risk documentation: Coating inspection at average and extreme temperatures according to internal test methods. Tip bend inspection at extreme temperature according to internal test methods. Biocompatibility assessment per ISO 10993-1: 2009 Accelerated Aged (per ISO F1980-16) shelf life testing per internal test method assessments for coating and tip bend inspections."
• "All tests passed the pre-determined acceptance criteria."

Since this is a catheter and not a diagnostic device or an AI/ML algorithm-based device, the concepts of human reader improvement with AI, standalone algorithm performance, and expert ground truth establishment for diagnostic accuracy are not applicable to this 510(k) submission.

Therefore, I cannot populate the requested table and information as it pertains to a clinical efficacy study or AI/ML performance evaluation. The document focuses on demonstrating physical and material equivalence through non-clinical testing.

Ask a specific question about this device

The catheter is indicated for use by patients with urine retention and patients with a 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 Coudé 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 flexible bendable tip that facilitates passage through the urethra to the bladder. The catheter is shielded by a sleeve, which serves as protection from the user's touch during insertion.

Here is an analysis of the provided FDA document regarding the SpeediCath Flex Coudé device, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criteria / Performance Aspect	Reported Device Performance
   Bench Testing
   Flow rate	Passed (according to EN1616/EN1618 & ASTM F623-99:2013)
   Coefficient of friction	Passed (according to ASTM D1894:2014)
   Tensile strength	Passed (according to EN1616/EN1618)
   Connector security	Passed (according to EN1616)
   Biocompatibility	Passed (according to ISO 10993-1 and applicable parts of FDA Blue Book Memorandum #G95-1)
   Clinical Performance (Cadaver Study)
   Insertion & navigation in difficult male urethral anatomies	Comparable to a standard coudé catheter in terms of insertion and navigation through difficult male anatomies (enlarged prostate and strictures). Implies meeting performance equivalent to established devices for these challenging cases.
   Clinical Performance (Clinical Evaluation of Published Data)	Safety and efficacy profile equivalent to the predicate and reference devices.

   Note: The document states "All tests passed" for the bench performance data, implying that the acceptance criteria for each of these tests were met.

2. Sample Size and Data Provenance

   • Test set (cadaver study): The document mentions "male cadavers with difficult urethral anatomies." It does not specify the exact number of cadavers used.
   • Data Provenance (cadaver study): Not explicitly stated, but implies a laboratory setting for the "pre-clinical study." It is a prospective observational study in a pre-clinical setting.
   • Clinical Evaluation: Based on "available published data," which would be retrospective analysis of existing clinical literature. No specific sample size mentioned for this review beyond the studies themselves.

3. Number of Experts and Qualifications for Ground Truth

   • Cadaver Study: The document does not specify the number of experts or their qualifications involved in establishing "ground truth" or evaluating insertion/navigation in the cadaver study. It only states the device "was comparable to a standard coudé catheter." This comparison would likely have been made by experienced individuals, but their number and specific qualifications are not detailed.
   • Clinical Evaluation: For the "clinical evaluation of available published data," the "experts" would be the authors of the published studies being reviewed. The document does not state how many individuals conducted this literature review or their qualifications.

4. Adjudication Method for the Test Set

   • The document does not describe any formal adjudication method (like 2+1 or 3+1) for the cadaver study or the clinical evaluation. The comparison in the cadaver study ("comparable to a standard coudé catheter") implies a direct observation and assessment, but multi-reader adjudication is not mentioned.

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

   • No MRMC comparative effectiveness study involving human readers with and without AI assistance was performed. This device is a medical device (catheter) for physical use, not an AI diagnostic/interpretive tool.

6. Standalone Performance (Algorithm Only)

   • Not applicable. This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

   • Bench Testing: Engineering measurements and adherence to specified standards (e.g., ASTM, EN, ISO).
   • Cadaver Study: Direct observation and assessment of the device's physical performance (insertion and navigation) in anatomical models (cadavers) with known difficult anatomies (enlarged prostate and strictures). The "ground truth" is the physical reality of successful navigation and the comparative ease with a predicate.
   • Clinical Evaluation: Clinical outcomes and safety profiles reported in existing published literature for predicate and reference devices.

8. Sample Size for the Training Set

   • Not applicable as this is a physical medical device, not a machine learning algorithm. The "development" or "training" would refer to design iterations and engineering evaluations, not a data-driven training set in the AI sense.

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

   • Not applicable for the same reason as point 8. The "ground truth" for the device's design would stem from engineering principles, user needs, and clinical requirements for urinary catheterization.

Ask a specific question about this device

SpeediCath Compact Eve is indicated for use by patients with chronic urine retention and patients with a 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 catheter is for female patients only.

The SpeediCath Compact Eve is a sterile, single use, disposable polyurethane catheter for females. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. In use, the handle is turned to break the packaging, connect a urine bag to the end of the handle, if required, and the catheter is pulled out of the packaging. The catheter is then ready to use allowing easy handling and urine to flow through the catheter and handle.

The provided document is a 510(k) premarket notification letter and summary for the SpeediCath Compact Eve urinary catheter. This document does not contain information related to software or AI/ML device performance, acceptance criteria, or studies involving human readers or ground truth establishment in the context of AI/ML.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document describes a physical medical device (catheter) and its testing for substantial equivalence to a predicate device, focusing on material, design, and regulatory compliance through physical and biological evaluations, not AI/ML performance.

Ask a specific question about this device