Search Results

A bowel catheter system kit with odor barrier properties for diversion of liquid or semi-liquid stool to facilitate the collection of fecal matter in patients with little or no bowel control.

The InstaFio Bowel Catheter System Kit contains two main parts: the catheter (made with odor barrier film) and the collection bag. The insertion end of the catheter contains a retention cuff and the other end of the catheter has a twist lock fitting to attach the collection bag. The retention cuff leads to a drain tube that allows stool to drain directly from the rectum into the bag. There are two catheter connectors attached to the catheter. The Blue connector is used to inflate and deflate the retention cuff. The Clear connector is used only to irrigate the device when needed.

The provided text describes a 510(k) summary for the InstaFlo Bowel Catheter System Kit, which details performance testing conclusions but does not contain specific acceptance criteria or an in-depth study report with the detailed information requested.

Therefore, I cannot populate the table and answer all questions with the provided information. However, I can extract what is available.

1. Table of Acceptance Criteria and Reported Device Performance

Details not explicitly available in the provided text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified. The document states "non-clinical testing" was performed, which typically refers to bench testing rather than human clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this was non-clinical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as this was non-clinical 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. This is a medical device (catheter system), not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (catheter system), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for non-clinical testing. Ground truth in this context would be adherence to engineering specifications and performance standards.
8. The sample size for the training set: Not applicable, as this is non-clinical device testing, not an AI model.
9. How the ground truth for the training set was established: Not applicable, as this is non-clinical device testing, not an AI model.

Summary of available information regarding the "study" (non-clinical testing):

• Type of Study: Non-clinical testing for functional and structural parameters, biocompatibility, odor barrier capabilities, and connection/joint integrity (bond strength and leakage).
• Purpose: To demonstrate that the modified InstaFlo Bowel Catheter System Kit is as safe and effective and substantially equivalent to its predicate device (K100273).
• Key Findings:
  • Biocompatibility testing met US FDA Office of Device Evaluation General Program Memorandum #G95-1 and ISO 10993 standards.
  • Odor testing verified the odor barrier capabilities compared to the predicate.
  • Connections and joints tested for bond strength and leakage showed acceptable results, demonstrating no impact from the change in tubing.

Ask a specific question about this device

For diversion of liquid or semi-liquid stool to facilitate the collection of fecal matter in patients with little or no bowel control.

The InstaFlo Bowel Catheter System Kit contains two main parts: the catheter and the collection bag. The insertion end of the catheter contains a retention cuff and the other end of the catheter has a twist lock fitting to attach the collection bag. The retention cuff leads to a drain tube that allows stool to drain directly from the rectum into the bag. There are two catheter connectors attached to the catheter. The Blue connector is used to inflate and deflate the retention cuff. The Clear connector is used only to irrigate the device when needed.

This document does not describe a study to prove a device meets acceptance criteria. Instead, it is a 510(k) summary for the InstaFlo Bowel Catheter System Kit, which is a medical device.

The 510(k) process is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device) and does not require premarket approval (PMA). This is typically achieved by demonstrating substantial equivalence to a predicate device, rather than through a clinical study with acceptance criteria in the traditional sense.

Here's how to interpret the document in the context of your request:

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

Since this is a 510(k) submission for a modification to an existing device (ActiFlo Indwelling Bowel Catheter System Kit), the "acceptance criteria" are implied by demonstrating substantial equivalence. The document highlights changes in technological characteristics and intended use compared to the predicate, and asserts that product evaluation supports acceptability.

The "study" that proves the device meets the acceptance criteria (i.e., substantial equivalence):

The document explicitly states: "Biocompatibility testing was performed based on the United States Food and Drug Administration Office of Device Evaluation General program Memorandum #G95-1 and ISO 10993 biocompatibility testing standards. Product evaluation supports acceptability of the device for its intended clinical use."

This indicates that the primary "study" or evaluation performed was biocompatibility testing. The "product evaluation" mentioned likely encompasses a review of the design changes, materials, manufacturing processes, and how they compare to the predicate device to ensure the modified device is as safe and effective.

Detailed answers to your specific questions based on the provided text:

1. A table of acceptance criteria and the reported device performance
See the table above. The "acceptance criteria" are not given as numerical thresholds of performance metrics but rather as demonstration of substantial equivalence through design and material property comparisons, and biocompatibility testing.

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

• The document does not specify sample sizes for biocompatibility testing. Biocompatibility testing often involves in vitro and in vivo tests, which have their own sample size considerations, but these are not detailed here.
• Data provenance: Not specified, but standard ISO 10993 testing is generally conducted by accredited labs. It is not indicated if the data is retrospective or prospective, but typical biocompatibility testing would be considered prospective for the specific material/device being tested.

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 in this context. Biocompatibility testing results are generally evaluated against established biological endpoints and acceptance criteria from ISO 10993 standards, rather than requiring expert consensus for a "ground truth" like in clinical image interpretation studies.

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

• Not applicable. Adjudication methods are typically for subjective assessments (e.g., medical image interpretation), not for objective physical or chemical tests like biocompatibility.

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

• No. This is a medical device (catheter system), not an AI/imaging device. Therefore, MRMC studies are not relevant.

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

• No. This is a physical medical device, not an algorithm.

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

• For biocompatibility testing, the "ground truth" is defined by the established biological endpoints and thresholds of the ISO 10993 standards and FDA guidance (G95-1). This involves assessing for cytotoxicity, sensitization, irritation, acute systemic toxicity, etc., as per the standards.

8. The sample size for the training set

• Not applicable. This is not a machine learning/AI device, so there is no "training set."

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

• Not applicable. There is no training set.

In summary, the information provided is typical of a 510(k) submission for a device modification, focusing on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and performance (in this case, primarily biocompatibility testing), rather than a clinical study with detailed acceptance criteria and performance metrics.

Ask a specific question about this device

The VaPro intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.

The VaPro intermittent catheter is a hydrophilic coated single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. The catheter comes in a protective sleeve and is offered with a protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion. The packaging contains a vapor strip that hydrates the catheter coating which then lubricates the catheter. The outer packaging was designed to facilitate access for those with limited dexterity.

The provided text is a 510(k) Summary for a medical device (VaPro™ Intermittent Catheter), which focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study with detailed metrics typically associated with AI/software devices.

Therefore, many of the requested sections about acceptance criteria, detailed study design, ground truth, and AI performance metrics are not applicable to this type of submission.

Here's a breakdown of what can and cannot be extracted from the provided text based on your request:

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

• Not Applicable in the traditional sense of a performance study with specific metrics. The provided document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than defining and meeting specific quantitative performance acceptance criteria in an AI/Software context.
• The "performance" described is primarily functional and safety-related for a physical catheter, evaluated through biocompatibility and product evaluation to support functionality.

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

• Not Applicable. This is a hardware device (catheter) submission. There is no "test set" of data in the context of an AI/Software algorithm. The testing would involve physical samples of the catheter for biocompatibility and functional evaluation. No details on sample sizes for these physical tests are provided in the summary.

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 is a hardware device. There is no ground truth established by experts in the context of diagnostic interpretation or AI model training/testing.

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

• Not Applicable. No adjudication method for a test set is mentioned as this is not an AI/Software device requiring such a process.

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 a physical medical device (catheter), not an AI/Software system. Therefore, no MRMC study or AI assistance is relevant.

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)

• Not Applicable. For this physical device, "ground truth" would relate to confirmed physical properties, material safety (biocompatibility), and functional performance (e.g., flow rates, lubrication effectiveness) validated against established standards, not diagnostic outcomes.

8. The sample size for the training set

• Not Applicable. This is a physical device, not an AI/Software system that requires a "training set."

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

• Not Applicable. Same as above, no training set for a physical device.

Information that can be extracted or inferred regarding device evaluation:

• Device Performance Reported (for a physical device):

  • Biocompatibility: "Biocompatibility testing was performed based on Performance Testing the United States Food and Drug Administration Office of Conclusions: Device Evaluation General program Memorandum #G95-1 and ISO 10993 biocompatibility testing standards. Results indicate compliance to the standard."
  • Device Functionality: "Product evaluation also supports device functionality."

• Predicate Device Equivalence (which implies the new device also meets foundational criteria present in predicates):

  • Intended Use: Matches or is highly similar to predicates.
  • Condition of Use: Single Use (matches predicates).
  • Prelubricated: Yes - by water vapor hydration (similar mechanism to predicates).
  • Ready to Use: Yes (similar to Speedicath and Incare, different from Lofric).
  • End Design: Funnel (matches predicates).
  • Sterile: Yes (matches predicates).
  • No-touch design: Yes - contains sleeve (similar to Lofric and Incare, different from Speedicath).
  • Lubricant: PVP Based (similar to Lofric and Speedicath, different from Incare).
  • Protective Tip: Yes (similar to Incare, different from Lofric and Speedicath).

Conclusion:

The provided 510(k) summary is for a physical medical device (intermittent catheter). The evaluation criteria and "proof" of performance are based on standard engineering tests for physical properties, materials, and biocompatibility, as well as demonstrating substantial equivalence to other legally marketed devices. It does not contain information related to acceptance criteria, study sizes, ground truth establishment, or performance metrics typically associated with AI/Software medical devices.

Ask a specific question about this device

The ActiFlo Indwelling Bowel Catheter System is intended for diversion of fecal matter to minimize external contact with the patient's skin, to facilitate the collection of fecal matter for patients requiring stool management, to provide access for colonic irrigation and to administer enema/medications.

The ActiFlo Indwelling Bowel Catheter System consists of a rectal catheter and accessories (waste collection bag, irrigation bag, skin barriers, syringe and lubricating jelly). The insertion end of the catheter contains a retention cuff and an intraluminal balloon, each with its own Luer connector used for inflation and deflation. A third connector provides a way to administer medications into the rectum and provides access for colonic irrigation. The ActiFlo Indwelling Bowel Catheter System allows stool to drain directly from the rectum into a closed or drainable collection bag.

The provided text is a 510(k) summary for the ActiFlo™ Indwelling Catheter System Kit, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and validation study results in the manner requested.

Therefore, the requested information regarding acceptance criteria, a study proving device performance against those criteria, sample sizes, expert qualifications, and ground truth establishment is not available in the provided text.

The document primarily compares the technological characteristics and indications for use of the ActiFlo™ system to two predicate devices (K023344 and K012113). It mentions "Accessory Performance Testing Conclusions" stating that "Biocompatibility testing was performed on the additional accessories based on the United States Food and Drug Administration Office of Device Evaluation General program Memorandum #G95-1 and ISO 10993 biocompatibility testing standards. Product evaluation supports acceptability of the added accessories for their intended clinical use." However, this is a general statement about biocompatibility, not a detailed study of the device's primary function against specific performance acceptance criteria.

Key takeaways from the document:

• Device: ActiFlo™ Indwelling Catheter System Kit.
• Purpose: Diversion of fecal matter, collection of fecal matter for stool management, access for colonic irrigation, and administration of enema/medications.
• Regulatory Pathway: 510(k) submission, demonstrating substantial equivalence to predicate devices.
• Predicate Devices: K023344 (Indwelling Fecal Management System- Non-Sterile) and K012113 (Indwelling Fecal Management System (IFMS)).
• Testing Mentioned: Biocompatibility testing for accessories, conforming to G95-1 and ISO 10993 standards. This confirms material safety but not the functional performance of the device in its intended clinical use.

In summary, the provided text does not contain the specific details required to answer your questions about acceptance criteria and a study proving the device meets them because the 510(k) submission primarily relies on substantial equivalence to predicate devices, not on a new clinical performance study with detailed acceptance criteria.

Ask a specific question about this device

The evadri Bladder Control System is intended to provide electrical stimulation or electromyographic or pressure biofeedback for the treatment of urinary and fecal (electromyographic biofeedback) incontinence.

The evadri Bladder Control System is an office based instrument that is intended to be used by physicians, nurse clinicians, and physiotherapists in an office, clinic, or hospital. The evadri office prisitials, maros marse entronyography or pressure biofeedback from pelvic musculature. The device also provides electrical stimulation to the pelvic musculature. The modalities of biofeedback and electrical stimulation are intended for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of incontinence.

I am unable to provide a description of the acceptance criteria and study as the provided text does not contain that information. The document is a 510(k) summary for a medical device (evadri Bladder Control System), which primarily focuses on describing the device, its intended use, and its substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and results.

The document includes:

• Sections 1-6: Details about the sponsor, device name, predicate devices, detailed description of the evadri Bladder Control System (including technological characteristics for stimulation and biofeedback).
• Section 7: A conclusion stating that the device is safe and effective and substantially equivalent to identified predicate devices.
• FDA Letter: A letter from the FDA confirming the 510(k) clearance and the device's substantial equivalence.
• Statement of Intended Use: A reiteration of the device's intended use.

There is no mention of specific acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement in a performance study within the provided text.

Ask a specific question about this device

The restore Wound Cleanser is intended for the removal of foreign material such as dirt and debris from dermal wounds.

The Restore Wound Cleanser is a buffered isotonic water based surfactant solution that is a clear colorless slightly viscous liquid that is intended to remove foreign material such as dirt is a debris from dermal wounds. The device can be used on low, medium or high exudating and wounds. The product is available in an 80z. spray bottle. The Restore Wound Cleanser is applied to the dermal wound area using a trigger spray closure that helps facilitate the removal of foreign material such as dirt and debris.

The provided text is a 510(k) summary for the Restore Wound Cleanser. This type of regulatory submission historically did not typically include detailed performance studies with acceptance criteria in the same way modern AI/ML device submissions do. My analysis will explain why most of the requested information cannot be found in this document, and what limited information can be extracted.

Based on the provided document, the following information can be extracted or deduced:

The Restore Wound Cleanser is a legally marketed device that gained clearance based on substantial equivalence to predicate devices (Carrington Carra Klenz Wound Cleanser K022670, Allclenz Wound Cleanser K965120, Derma Sciences Dermagran Wound Cleanser with Zinc K945802). Substantial equivalence means that the device has the same intended use, and the same technological characteristics as the legally marketed predicate device, or if there are differences in technological characteristics, these differences do not raise different questions of safety and effectiveness.

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

Explanation: This document does not describe specific numerical acceptance criteria or performance metrics for the Restore Wound Cleanser in terms of efficacy or performance compared to a standard. The 510(k) pathway relies on establishing substantial equivalence to a predicate device, not on meeting specific, pre-defined performance thresholds for device functionality in clinical use.

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

Sample Size for Test Set: Not applicable.
Data Provenance: Not applicable.

Explanation: This 510(k) clearance relied on a comparison of technological characteristics and safety data (biocompatibility) with predicate devices, rather than a clinical performance study with a test set of patient data.

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

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

Explanation: As no clinical performance study on a test set (with ground truth) was conducted or presented, there were no experts involved in establishing ground truth for such a test set.

4. Adjudication method for the test set

Adjudication Method: Not applicable.

Explanation: No test set requiring expert adjudication was utilized for this 510(k) submission.

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

MRMC Study: No.
Effect Size: Not applicable.

Explanation: This device is a wound cleanser, not an AI/ML diagnostic or interpretive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.

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

Standalone Performance Study: No.

Explanation: This device is not an algorithm, so a standalone algorithmic performance study is not applicable.

7. The type of ground truth used

Type of Ground Truth: Not applicable.

Explanation: As there was no clinical performance study requiring a "ground truth" for classification or measurement outcomes, this concept is not applicable. The primary "truth" established in a 510(k) is the safety and effectiveness on par with a predicate device, often supported by bench testing and biocompatibility data.

8. The sample size for the training set

Sample Size for Training Set: Not applicable.

Explanation: This device is not an AI/ML algorithm that requires a training set.

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

Ground Truth Establishment for Training Set: Not applicable.

Explanation: No training set was used for this device.

Summary of what the document focuses on regarding "proof":

The "study" or evidence provided to prove the device meets acceptance criteria (specifically, being substantially equivalent to predicates) primarily consists of:

• Comparison of Intended Use: The Restore Wound Cleanser has the same intended use (removal of foreign material like dirt and debris from dermal wounds) as the identified predicate devices.
• Comparison of Technological Characteristics: It is a buffered isotonic water-based surfactant solution, similar to the predicates. All are intended for use on low, medium, or high exudating wounds.
• Biocompatibility Testing: The document states that "Issues of biomaterial safety or biocompatibility have been addressed based upon biomaterial history or in separate in-vitro or in-vivo laboratory evaluations using licensed commercial reference laboratories." This assessment followed principles and guidelines from ISO 10993, FDA G95-1, USP, FHSA, and FDA GLP regulations. This testing demonstrates that the device is "appropriate for its intended use" from a biological safety perspective.

In essence, for this 510(k), the "acceptance criteria" were that the device's intended use and technological characteristics were sufficiently similar to legally marketed predicate devices, and that any differences (including materials) did not raise new questions of safety or effectiveness, supported by biocompatibility testing. No specific performance study in a clinical setting with numerical acceptance criteria, as one might see for an AI/ML diagnostic, was required or performed.

Ask a specific question about this device

The electrical stimulation component of the InCare Pelvic Floor Therapy System provides stimulation capabilities that are intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.

The biofeedback components of the InCare Pelvic Floor Therapy System are intended to provide electromyography or pressure biofeedback from the pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence.

The InCare Pelvic Floor Therapy System is an office based instrument that is intended to be used by physicians, nurses, nurse clinicians, and physiotherapists in a physicians office, clinic, or hospital for the purpose of providing electromyography or pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and the restoration of neuromuscular control for the treatment of urinary incontinence.

The InCare Pelvic Floor Therapy System also provides electrical stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.

The proposed InCare Pelvic Floor Therapy System is comprised of a combination of an instrumentation unit and a personal computer. Other peripheral devices such as monitors and printers can be added for convenience or ease of use. The personal computer and instrumentation unit are physically separate devices "linked" to each other by a communication pathway. Features or functions that are "data manipulation and presentation" activities are properly associated with the personal computer. Features or functions that are" patient therapy" actions are controlled by the instrumentation unit.

The provided text is a 510(k) premarket notification for the Hollister Incorporated InCare Pelvic Floor Therapy System. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, the document does not contain the information requested in the prompt regarding:

• A table of acceptance criteria and reported device performance: This is not a study assessing performance against pre-defined criteria.
• Sample size used for the test set and data provenance: No new clinical study data is presented.
• Number of experts used to establish ground truth and their qualifications: Not applicable, as no new ground truth was established for a test set.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

What the document does provide:

The core of this document is a statement of "substantial equivalence" to predicate devices, which means that the device has the same intended use and similar technological characteristics to devices already legally marketed.

Here's a summary of the relevant details from the provided text:

1. Device Name: InCare Pelvic Floor Therapy System
2. Intended Use:
   • Electrical stimulation component: To provide electrical stimulation for the rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.
   • Biofeedback components: To provide electromyography or pressure biofeedback from pelvic musculature for the rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence.
3. Predicate Devices:
   • InCare Pelvic Floor Therapy Systems (K930530/c, K961872, K974048)
   • Elpha 2000 Conti Device (K964738)
4. Technological Characteristics (briefly described as justification for equivalence): The proposed system is an office-based instrument combining an instrumentation unit and a personal computer, with separate functions for "data manipulation and presentation" (PC) and "patient therapy" (instrumentation unit). The key update in this 510(k) is an "expanded stimulation parameter of 10 Hz and updated clinician application software."
5. Conclusion of the 510(k): "Based upon the information presented within this pre-market notification it is concluded that the proposed InCare Pelvic Floor Therapy System with expanded stimulation parameter of 10 Hz and updated clinician application software is substantially equivalent to the predicate devices."

In essence, this document is a regulatory submission for market clearance based on similarity to existing devices, not a scientific study proving performance against specific acceptance criteria.

Ask a specific question about this device

The InCare Biofeedback Vaginal Pressure Probes and Anal Pressure Probes are intended to provide pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence.

The InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe are designed with a silicone bladder or sack that covers the probe body and tubing that connects the probe to a pressure transducer. Once the probe is inserted into the anus or vagina the bladder is filled with air. The probes measure the strength of the pelvic floor muscles by offering resistance to a patient's voluntary contractions of these muscles.

The provided text describes a 510(k) submission for the Hollister InCare Pressure Biofeedback Vaginal and Anal Pressure Probes, which are accessories to the InCare Pelvic Floor Therapy devices. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K891774).

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a dedicated table format. However, it indicates the overarching acceptance criterion is substantial equivalence to the predicate device (K891774) in terms of intended use, manufacturing processes, labeling, and product performance.

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

The document does not provide any information regarding the sample size used for the performance tests, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). It simply states "product performance test results demonstrate...equivalence."

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

This information is not provided in the document. The nature of the device (pressure probes for biofeedback) suggests that "ground truth" would likely involve instrument calibration against known pressures or direct comparison of measurements between the new and predicate devices, rather than expert consensus on diagnostic images.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the likely nature of the performance tests (instrument physical characteristics or comparison of readings), an adjudication method as described (e.g., 2+1, 3+1) is unlikely to be relevant or applicable to this type of device submission.

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

An MRMC comparative effectiveness study is not applicable and was not done. This device is a biofeedback probe, not an AI-assisted diagnostic tool for which human reader performance would be a primary efficacy endpoint. The submission is for a physical device, an accessory to a therapy system.

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

A standalone algorithm performance study is not applicable and was not done. This device is a physical probe, and there is no mention of a standalone algorithm for its function. Its purpose is to measure pressure and provide biofeedback for human-guided rehabilitation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth used. However, for a device like a pressure probe, the "ground truth" for performance would most likely involve:

• Calibration against known, standardized pressure sources.
• Direct comparative measurements between the new device and the predicate device, or a highly accurate reference standard, under controlled conditions.
• Biocompatibility testing against established regulatory standards (USP, G95-1, ISO 10993-1).

It is highly unlikely that expert consensus, pathology, or outcomes data would be directly used as "ground truth" for the performance of a pressure-measuring probe itself. Such data would be relevant for the overall biofeedback therapy effectiveness, but not for the performance of the probe as an accessory.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. The device is a physical probe, not an AI/machine learning model that requires a training set.

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

This information is not provided and is not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The InCare Pre-lubricated Intermittent Catheter is indicated for use by male, female and pediatric patients for the purpose of bladder drainage. The Catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.

The InCare Advance and Advance Plus Intermittent Catheters are pre-lubricated with gel to promote easy insertion and user convenience. The catheter gel is contained in an integral reservoir, which eliminates gel migration throughout the package. The InCare Advance and Advance Plus catheters are sterile, non-latex, polyvinyl chloride catheters. A unique manufacturing process ensures that the eyes of the intermittent catheters are polished and smooth to help eliminate trauma to the urethra, reducing the possibility of hematuria. The catheter packaging has been designed to facilitate easy opening for those users with limited dexterity. Both catheters incorporate a no-touch design, which enables the user to easily insert the catheter without direct hand contact, thus reducing the possibility of contamination. The InCare Advance Plus Intermittent Catheter has an introducer tip that is intended to reduce reoccurring UTI and a collection bag to contain urine. The InCare Advance Plus is also available in a kit known as InCare Advance Plus Kit. The InCare Advance and Advance Plus pre-lubricated intermittent catheters are available in various sizes and with a straight or coude tip to accommodate a wide range of male, female, and pediatric end users.

The provided text is a 510(k) Summary for the InCare Pre-lubricated Intermittent Catheters. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific performance acceptance criteria through a clinical study. Therefore, much of the requested information (acceptance criteria, study details, sample sizes, expert involvement, ground truth, effect size with AI assistance, etc.) is not typically included or required in a 510(k) Summary for a device like this.

The 510(k) summary focuses primarily on:

• Identifying the device and its intended use.
• Comparing its technological characteristics to legally marketed predicate devices.
• Demonstrating biocompatibility through established guidelines and standards.

Here's an analysis of the provided text in relation to your request:

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

• Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for device performance. The primary "acceptance" relies on demonstrating substantial equivalence to predicate devices, meaning it works similarly (design, materials, intended use) and addresses basic safety (biocompatibility).
• Reported Device Performance: Instead of performance metrics, the document describes features designed for performance and safety:
  • Pre-lubricated with gel for easy insertion and user convenience.
  • Gel contained in an integral reservoir to prevent migration.
  • Sterile, non-latex, PVC material.
  • Polished and smooth eyes to prevent urethral trauma and hematuria.
  • Packaging designed for easy opening for users with limited dexterity.
  • No-touch design to reduce contamination.
  • InCare Advance Plus has an introducer tip to reduce recurring UTIs and a collection bag.

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

• The document does not describe a clinical "test set" or a study involving human subjects to evaluate these performance characteristics. The assessment primarily relies on a biocompatibility assessment based on established principles and guidelines (United States Pharmacopoeia, G95-1, ISO 10993-1). This is a non-clinical evaluation of the materials.

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 as there was no clinical test set or ground truth established by experts in the context of device performance in humans. The "ground truth" for biocompatibility would be the results of standard biocompatibility tests interpreted by toxicologists or materials scientists, but these details are not provided.

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

• Not applicable as there was no clinical test set requiring adjudication.

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 device is an intermittent catheter, not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic imaging systems, often involving AI.

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

• Not applicable. This device is not an algorithm or AI system.

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

• For biocompatibility, the "ground truth" is based on the results of standardized biological safety tests (e.g., cytotoxicity, sensitization, irritation) and their comparison against established thresholds and guidelines mentioned (USP, ISO 10993-1). There is no mention of expert consensus, pathology, or outcomes data in the context of a clinical study for this 510(k).

8. The sample size for the training set

• Not applicable. This device is not an AI model, so there is no "training set."

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

• Not applicable. This device is not an AI model, so there is no "training set" or ground truth established for it.

In summary, the provided document outlines a 510(k) submission focused on demonstrating substantial equivalence and biocompatibility, not comprehensive performance criteria through clinical studies. The "study" mentioned is a "biocompatibility assessment" based on established regulatory guidelines and standards rather than a clinical trial with human subjects and performance metrics.

Ask a specific question about this device

The InCare Intermittent Catheter is indicated for use by male, female and pediatric patients for the purpose of bladder drainage. The Catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.

The InCare Intermittent Catheters are intended to be used as a means of managing urinary incontinence by draining urine from the bladder. The InCare Intermittent Catheters are sterile, non-latex, PVC catheters. A unique manufacturing process ensures that the eyes of the intermittent catheters are polished and smooth to help eliminate trauma to the urethra, reducing the possibility of hematuria. The catheter packaging has been designed to facilitate easy opening for those users with limited dexterity. The InCare Intermittent catheters are available in various sizes to accommodate a wide range of male, female, and pediatric end users.

The provided text is a 510(k) Summary for the InCare Intermittent Catheter. This document does not describe a study to prove the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices. Substantial equivalence relies on comparing the new device's design, materials, and intended use to existing, legally marketed devices, rather than conducting new performance studies against specific acceptance criteria.

Therefore, the requested information elements related to a study (like acceptance criteria table, sample sizes, expert ground truth, adjudication, MRMC, standalone performance, and ground truth for training data) are not available in this document.

Here's what can be extracted based on the nature of the document:

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

• This information is not provided. The document focuses on demonstrating substantial equivalence rather than performance against pre-defined acceptance criteria from a specific study.

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

• This information is not applicable. No specific test set or study data is mentioned for performance evaluation.

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

• This information is not applicable. No test set or ground truth establishment by experts is described for performance evaluation.

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

• This information is not applicable. No test set or adjudication method is described.

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

• No MRMC study was done, as this is not an AI-assisted device.

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

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

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

• Not applicable. The "ground truth" in a 510(k) for substantial equivalence relies on comparing features to existing predicate devices, not on a ground truth for performance.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm device that requires a training set.

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

• Not applicable. This is not an AI/algorithm device that requires a training set or ground truth for it.

Based on the provided text, the key information is related to the substantial equivalence determination:

• Acceptance Criteria for Substantial Equivalence: The criteria implicitly accepted by the FDA for substantial equivalence in this context are:

  • Identical Intended Use: The new device must have the same intended use as the predicate device(s).
  • Same Technological Characteristics: If the technological characteristics are the same, the device is substantially equivalent.
  • Different Technological Characteristics but as Safe and Effective: If the technological characteristics are different, the device must not raise different questions of safety and effectiveness, and information must be provided that demonstrates the device is as safe and effective as the legally marketed device.

• Reported Device Performance (in terms of Substantial Equivalence):

  • Intended Use: The InCare Intermittent Catheter is "indicated for use by male, female and pediatric patients for the purpose of bladder drainage" which is stated as substantially equivalent to the predicate devices.
  • Technological Characteristics: The device is described as "substantially equivalent to the predicate devices in design, materials used, and intended use." Specifically, it is made of "PVC material that is substantially equivalent to the predicate devices."
  • Biocompatibility: A biocompatibility assessment was conducted based on established guidelines (USP, G95-1, ISO 10993-1). The materials are "considered biocompatible and appropriate for their intended use." This addresses a key aspect of safety.

In summary, this 510(k) document is a declaration of substantial equivalence, not a report of a performance study against specific acceptance criteria.

Ask a specific question about this device