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For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications.

The Flexi-Seal® SIGNAL™ Fecal Management System is comprised of a soft catheter tube assembly, a Luer-lock syringe, a collection bag with cap and a cinch clamp to pinch off flow in the catheter when required for medication retention or to stop waste flow. The components are contained in a rigid thermoformed plastic clamshell. The catheter main drain tube is fabricated from collapsible silicone rubber with the addition of an odor adsorber, which is added in order to help contain the fecal odor which often permeates through the wall of the catheter. The drain tube has a low-pressure silicone retention balloon at the distal end and a connector for attaching a collection bag (provided with the device and also available separately) at the proximal end. There is a recess (pocket) under the balloon for the clinician's finger, which allows the device to be positioned digitally. Two ports are attached to the side of the catheter. One port is used to inflate the retention balloon with water or saline after the device has been inserted into the patient's rectum. This port also provides a visual and tactile signal of when the low pressure retention balloon is filled to its optimal volume. The other port is used to flush the device if needed and administer medication if prescribed. An additional sampling port is located on the side of the catheter, which allows access to clinicians for stool sample collection. A syringe (provided with the device) is used to fill and evacuate the retention balloon for insertion and removal. The device, collection bag and syringe are intended for single us, are provided non-sterile and contain no components made with animal products, natural rubber latex or DEHP.

The provided document is a 510(k) premarket notification for a medical device called the Flexi-Seal® Signal™ Fecal Management System. This document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing detailed acceptance criteria and a study to prove they are met in the manner one might find for a novel device or AI/software.

However, I can extract and infer information relevant to your request based on the content available.

Here's an analysis of the acceptance criteria and the study as described in the document, framed around your specific questions:

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

The document does not explicitly present "acceptance criteria" in a quantitative, pass/fail table format with specific thresholds and reported performance against those thresholds like one might see for a diagnostic device's sensitivity/specificity. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to a predicate device (Flexi-Seal® SIGNAL™ Fecal Management System, K112342). The performance is reported as being "substantially equivalent" in various parameters.

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 describes non-clinical bench testing rather than human clinical studies with a test set of patients. Therefore, specific sample sizes for a "test set" in the context of patient data are not applicable. The testing was conducted by ConvaTec Ltd. which is based in the UK. The document does not specify if the testing was done at their UK facility or elsewhere, nor does it refer to "retrospective" or "prospective" as these terms typically apply to clinical studies using patient data.

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 question is not applicable. The device is a physical medical device, not a diagnostic algorithm requiring expert "ground truth" for interpretation. The evaluation involved bench testing of physical properties and biocompatibility.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies when interpreting ambiguous results, often involving multiple readers. This premarket notification describes bench testing for substantial equivalence, not such a clinical study.

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 question is not applicable. The device is a physical fecal management system, not an AI or software device that would involve human readers or AI assistance.

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

This question is not applicable. The device is a physical medical device, not an algorithm.

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

For the physical and functional parameters, the "ground truth" is established by bench testing against engineering specifications and performance standards. For biocompatibility, the "ground truth" is established by adherence to ISO-10993 standards. These are objective, measurable physical properties, not subjective interpretations or clinical outcomes in the typical sense of "ground truth".

8. The sample size for the training set

This question is not applicable. This is a physical device clearance, not an AI/ML submission that would involve a "training set."

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

This question is not applicable, as there is no "training set" for this type of device submission.

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Intermittent catheters are single use devices indicated for routine short term drainage of the bladder. The catheter is inserted through the urethra.

The intermittent urinary catheter is a thin hollow tube, fitted with a connector at one end and an olive tip (ball) at the other, which is inserted intermittently through the urethra and up to the bladder so that urine can drain. Both components are prepared from plastic materials and are bonded by cyclohexanone. The products are designed for transient use only and are available in various diameters; six FR (CH) sizes: FR08, FR10, FR12, FR14, FR16 and FR18. An increasing French size corresponds to a larger external diameter.

The catheter is primary packaged in a paper/film peelpack and is sterilized by Ethylene Oxide.

The catheter tube has a smooth, clear surface with two lateral eyelets and closed angled tip with small ball called an olive. Eyelets are placed on the left and right site of the catheter and the angled portion of the catheter tip is oriented upward.

This document describes the GentleCath Male Coudé Olive Tip Intermittent Urinary Catheter and its substantial equivalence to predicate devices, focusing on performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states "All the parameters are similar or superior for the GentleCath Male Coudé Olive Tip Intermittent Urinary Catheter" compared to the predicate devices. Specific quantitative acceptance criteria are not explicitly listed in this summary but are referenced as being in Section 18 of the submission.

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

The document summarizes performance testing ("Bench Performance Testing") and states that "Details relating to performance testing of the subject device and the 2 predicate devices can be found in section 18 of this submission." This summary does not provide the specific sample sizes used for each test.

The data provenance is not explicitly stated as "country of origin." However, the applicant is ConvaTec Ltd. which has an address in Deeside, Flintshire, UK. The tests are described as "laboratory testing," suggesting they were conducted in a controlled environment, likely by the manufacturer. The study is retrospective in the sense that it compares features of a new device to existing predicate devices.

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

This document describes bench testing of a medical device (catheter) and not a study involving human interpretation of data where "experts" would establish ground truth in the traditional sense. The "ground truth" here is based on quantifiable physical properties and performance metrics of the catheters themselves, as measured by standard laboratory methods. Therefore, this section is not applicable in the context of this submission. Device performance is measured against established engineering and regulatory standards and predicate device characteristics.

4. Adjudication Method for the Test Set:

Not applicable, as this is a bench testing study of a physical device, not an interpretation-based study requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This study is focused on the physical and functional equivalence of a medical device through bench testing, not on the effectiveness of human readers using the device or interpreting associated data.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, this can be considered a standalone study in the sense that the device's physical and functional performance was tested independently of human interaction during the actual measurement process. The tests evaluate the intrinsic properties of the catheter itself (flow rate, strength, tip angle, ball diameter). There is no "algorithm" involved in this type of device.

7. Type of Ground Truth Used:

The ground truth used for this study is based on measurable physical properties and functional performance characteristics of the catheters. These include:

• Catheter flow rate
• Strength of tube and connector attachment
• Angle of Coudé tip
• Diameter of the ball

These are objective, quantitative measurements determined by laboratory testing, often against established standards for medical devices of this type, or established performance of the predicate devices.

8. Sample Size for the Training Set:

This document describes performance testing for substantial equivalence, which primarily relies on comparison to predicate devices and established standards. There is no explicit "training set" mentioned, as this is bench testing of a physical product, not a machine learning model.

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

Not applicable, as there is no "training set" in the context of this physical device testing.

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DuoDERM CGF Control Gel Formula Border Dressing is indicated for use on chronic wounds such as pressure ulcers, leg ulcers, diabetic ulcers and acute wounds such as superficial wounds (e.g. minor abrasions), second degree burns and donor sites. DuoDERM CGF Control Gel Formula Border Dressing provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the dressing without damaging newly formed tissue,

The concept of DuoDERM CGF Control Gel Formula Border Dressing is not significantly different from other commercially available absorbent dressings intended to cover exudating wounds.

The provided text is a 510(k) Premarket Notification for a wound dressing (DuoDERM CGF Control Gel Formula Border Dressing). This document details regulatory classification, indications for use, and substantial equivalence to a predicate device. However, it does not contain the type of performance study data and acceptance criteria typically found for diagnostic or AI-powered devices.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details because the document does not describe such a study for this type of medical device (wound dressing).

Specifically, the document states:

• "Data/information supporting the safety of DuoDERM CGF Control Gel Formula Border Dressing was presented in Premarket Notifications K901155. All testing was performed in accordance with Good Laboratory Practice Regulations." - This refers to safety testing, not a performance study against specific acceptance criteria for diagnostic accuracy or effectiveness in the way an AI algorithm would be evaluated.
• The 510(k) summary emphasizes substantial equivalence to a predicate device (SignaDRESS Hydrocolloid Dressing) based on intended use and dressing characteristics, rather than a quantifiable performance study with acceptance criteria.

Without a detailed performance study described in the provided text, I cannot fill out the requested table or answer the specific questions about sample size, ground truth, expert adjudication, or MRMC studies.

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DuoDERM Hydroactive Dressing is indicated for use on chronic wounds such as pressure ulcers, diabetic ulcers and acute wounds such as surgical wounds (post-operative wounds, donor sites), traumatic wounds (minor abrasions, lacerations), burns (first and second degree), dermatological excisions. DuoDERM Hydroactive Dressing provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the dressing without damaging newly formed tissue.

The concept of DuoDERM Hydroactive Dressing is not significantly different from other commercially available absorbent dressings intended to cover exudating wounds.

The provided text describes a 510(k) Premarket Notification for DuoDERM® Hydroactive® Dressing. It focuses on establishing substantial equivalence to another marketed device and expanding claims for moist wound healing and diabetic ulcers, while removing references to third-degree burns.

However, the document does not contain information about acceptance criteria, a specific study proving device performance against such criteria, or details regarding sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The text primarily outlines:

• Intended Use: For chronic wounds (pressure ulcers, leg ulcers, diabetic ulcers) and acute wounds (surgical, traumatic, first and second-degree burns, dermatological excisions).
• Substantial Equivalence: Claimed to ConvaTec's SignaDRESS Hydrocolloid Dressing, based on equivalent intended use and dressing characteristics.
• Safety Data: References "Data/information supporting the safety of DuoDERM Hydroactive Dressing was presented in Premarket Notifications K821656. All testing was performed in accordance with Good Laboratory Practices Regulations." However, the details of K821656 are not provided in this document.
• Contraindications: Known sensitivity to the dressing or its components.
• FDA Response: The FDA determined the device is substantially equivalent but placed limitations on labeling claims (e.g., no labeling for third-degree burns, no claims of accelerating healing, no claims of long-term/permanent dressings, no claims of treatment/cure for wounds).

Therefore, I cannot provide the requested information in the format of acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or MRMC/standalone study results because this information is not present in the provided text. The document is a regulatory submission for substantial equivalence rather than a detailed report of a clinical performance study with specific acceptance criteria.

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