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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 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.

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.

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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