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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.

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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.

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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.

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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.

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SpeediCath Compact Male 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 catheter is for male patients.

The SpeediCath Compact Male is a sterile, single use, disposable polyurethane catheter for males. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. To prepare the catheter for use, the cover is removed and the catheter is pulled out of the packaging thereby extending and locking it to its full length. The catheter is then ready to use allowing easy drainage.

This document is a 510(k) Summary for the SpeediCath Compact Male urinary catheter. It describes the device, its intended use, and substantial equivalence to a predicate device. It also summarizes the testing performed to demonstrate its safety and effectiveness.

However, the provided text does not contain acceptance criteria or a detailed study description that presents the device's performance against specific acceptance criteria.

The document states:

• "SpeediCath Compact Male has been tested and complies with relevant sections of ASTM F 623-99, ASTM D1894-11, EN 1616, EN 1617 and EN 1618."
• "Performance Testing included: Flow Rate, Coefficient of Friction, Tensile Strength."
• "SpeediCath Compact Male has been tested and complies with relevant sections of ISO 10993, Biological Evaluation of Medical Devices."
• "Biocompatibility Testing included: Cytotoxicity, Irritation, Sensitization, Colorant Leachable Study."

While these statements indicate that testing was performed and the device complied with standards, they do not provide the specific acceptance criteria (e.g., "flow rate must be > X mL/min") or the reported device performance values (e.g., "observed flow rate was Y mL/min"). Therefore, I cannot construct the requested table or answer the specific questions about sample size, ground truth, expert involvement, or MRMC studies for performance metrics.

Based on the provided text, the following information is either not available or cannot be fully extracted:

1. A table of acceptance criteria and the reported device performance: Information about specific acceptance criteria (e.g., numerical thresholds for flow rate, friction, tensile strength) and the actual performance values obtained is not provided. The document only states compliance with standards.
2. Sample sizes used for the test set and the data provenance: This information is not provided in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not relevant for the type of device (urinary catheter) and the performance tests described (physical and biocompatibility). These tests do not involve expert interpretation of images or clinical data for ground truth establishment.
4. Adjudication method for the test set: Not applicable for empirical physical and biocompatibility 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: This is not applicable as this is a medical device (urinary catheter), not an AI/software as a medical device for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical and biological tests, "ground truth" would typically be established by validated test methods and reference standards, not expert consensus or pathology in the context of this device.
8. The sample size for the training set: Not applicable as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a physical medical device (urinary catheter) and focuses on demonstrating substantial equivalence through compliance with recognized standards for physical and biocompatibility properties. It does not contain the detailed performance study results, acceptance criteria, or ground truth establishment relevant for AI-based or diagnostic devices.

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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 nonneurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The device is intended for females only.

The SpeediCath Compact Set (Female) is a sterile, single use, disposable polyurethane catheter for females with a pre-attached urine collection bag. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. In use, the cover is removed, the bag is unfolded and the catheter is pulled out of the packaging. The catheter with attached bag is then ready to use allowing easy drainage and collection of urine.

This document appears to be a 510(k) summary for a medical device called "SpeediCath Compact Set." It describes the device, its intended use, and claims substantial equivalence to a previously cleared device. However, it does not contain the detailed acceptance criteria and study results typically found in an AI/ML device submission.

The "Summary of Testing" section is very brief and only mentions compliance with general standards for medical devices and biological evaluations. It does not provide specific performance metrics, sample sizes, ground truth establishment, or details about comparative effectiveness studies that would be relevant to an AI/ML device.

Therefore, based on the provided text, I cannot extract the information you've requested about acceptance criteria and a study that proves the device meets them, especially in the context of an AI/ML device. The SpeediCath Compact Set appears to be a physical medical device (a urinary catheter), not an AI/ML algorithm.

If you have a document pertaining to an AI/ML medical device, please provide that.

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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.

The device is intended for males only.

The SpeediCath Compact Set (Male) is a sterile, single use, disposable polyurethane catheter for males with a pre-attached urine collection bag. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. In use, the cover is removed, the bag is unfolded and the catheter is pulled out of the packaging thereby extending and locking it to its full length. The catheter with attached bag is then ready to use allowing easy drainage and collection of urine.

This document is a 510(k) summary for a medical device (SpeediCath Compact Set) and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies with specific acceptance criteria and performance metrics typically found in clinical trial reports for novel devices.

Therefore, much of the requested information regarding acceptance criteria, specific device performance against those criteria, sample sizes for test/training sets, expert qualifications, and ground truth establishment cannot be found in the provided text. The document describes a regulatory filing for marketing clearance, not a primary research study.

However, I can extract the information that is present and explain why other information is not available:

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

Explanation: The document states that the device "complies with relevant sections" of several standards. These standards themselves contain specific acceptance criteria for various aspects (e.g., biocompatibility testing, material properties, catheter dimensions, lubricity). However, the specific numerical or qualitative acceptance criteria from these standards and the exact numerical performance results of the SpeediCath Compact Set against those criteria are not detailed here. This is typical for a 510(k) summary, which generally affirms compliance rather than presenting raw data.

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

• Sample Size for Test Set: Not specified. The document refers to "testing" against various standards, which would involve samples, but the specific number of units tested is not provided.
• Data Provenance: This information is not provided. The testing refers to compliance with international standards, but where the testing was conducted or whether it involved human subjects (beyond usability aspects) is not detailed. The primary purpose of this filing is to demonstrate substantial equivalence based on material and design characteristics and adherence to recognized standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a urinary catheter, not an AI or diagnostic imaging device that typically requires expert consensus for ground truth establishment on a "test set" from a clinical perspective. The "ground truth" for this device's performance would be its adherence to engineering and biocompatibility standards, and its functional design for urine drainage, which is verified by laboratory testing and design review, not clinical expert consensus in the way an AI algorithm for diagnosis would be.

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

Not applicable. As above, the nature of this device and its testing doesn't involve expert adjudication for ground truth in a clinical sense. Compliance with standards is typically verified through laboratory testing and quality assurance processes.

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-assisted diagnostic device. Therefore, no MRMC study or AI-related comparative effectiveness study was conducted or mentioned.

6. 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.

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

The "ground truth" for this device's regulatory clearance is its compliance with established international and national engineering, safety, and biocompatibility standards (ASTM 623, ASTM D1894, EN 1616, EN 1617, EN 1618, ISO 8669-2, ISO 10993) and its substantial equivalence to a predicate device. This is determined through laboratory testing, design documentation, and comparison of specifications.

8. The sample size for the training set

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

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

Not applicable. As above, no training set in the AI sense was used. The "ground truth" for the predicate device (SpeediCath, K023254) would have been established through its own regulatory pathway, which would also involve compliance with standards and demonstration of safety and effectiveness for its intended use.

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SpeediCath Compact 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.

SpeediCath Compact is a sterile, single use, disposable polyurethane catheter for females. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. The packaging of SpeediCath Compact is an integrated part of the product functioning partly as an insertion handle. In use, the inner tube is extended and removed from the handle as the catheter is locked in place with the handle. The catheter is then ready to use allowing easy handling and urine to flow through the catheter and handle.

The provided text describes a 510(k) summary for the SpeediCath Compact device, a urinary catheter. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Key takeaway regarding your request: The provided text does not contain information about acceptance criteria or a study proving device performance against such criteria in the manner typically associated with clinical trials for AI/ML medical devices (e.g., performance metrics like sensitivity, specificity, F1-score, AUC).*

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Coloplast's SpeediCath) through:

• Material and functional similarity: Both are ready-to-use intermittent catheters with hydrophilic coatings, made of the same material, immersed in the same saline solution, sterile, and single-use.
• Minor differences in packaging and intended user group: SpeediCath Compact has a modified packaging for ease of use and is specifically for female use, while the predicate is for both males and females.
• Compliance with relevant standards: The device has been tested against ASTM 623, ASTM D1894, EN 1616, EN 1618, and relevant sections of ISO 10993 (Biological Evaluation of Medical Devices). These standards generally relate to physical properties, biocompatibility, and intended use characteristics of catheters, not diagnostic performance of an AI/ML algorithm.

Therefore, I cannot populate the table or answer most of your specific questions related to AI/ML device performance criteria, sample sizes for test/training sets, expert ground truth, or MRMC studies, as this information is not present in the provided 510(k) summary for this device.

Below is a table reflecting the type of "acceptance criteria" (compliance with standards) and "reported performance" (compliance achieved) as derived from the document, but it's crucial to understand this is not the typical performance evaluation for AI/ML.

1. Table of Acceptance Criteria and the Reported Device Performance

Regarding the study that proves the device meets the acceptance criteria:

The study that proves the device meets these "acceptance criteria" is a series of tests demonstrating compliance with the relevant sections of the listed national and international standards (ASTM, EN, ISO). These tests would typically assess physical properties, sterility, biocompatibility, and other performance characteristics specific to urinary catheters. The document states, "SpeediCath Compact has been tested and complies with relevant sections..." which serves as the "proof" within this regulatory submission. The specifics of these tests (e.g., sample sizes, methodology) are not detailed in this summary.

The following information is NOT available in the provided text as it pertains to AI/ML device evaluation, which this document does not cover:

2. Sample sizes used for the test set and the data provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided.
4. Adjudication method for the test set: Not applicable/Not provided.
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/Not provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not provided.
8. The sample size for the training set: Not applicable/Not provided.
9. How the ground truth for the training set was established: Not applicable/Not provided.

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