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The Intermittent Urethral Catheters are sterile, single-use, flexible tubular devices that are to be inserted through the urethra and used to pass fluids to or from urinary tracts.

The Intermittent Urethral Catheters will be offered in two rne Incernitions Both styles will be offered with or without Catheter. The Standard Urethral Catheter will be hydrophilic coating. offered in three tip configurations.

The provided text is a 510(k) Summary for Intermittent Urethral Catheters and a letter from the FDA. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document focuses on establishing substantial equivalence to previously marketed devices rather than presenting performance data against defined acceptance criteria. Therefore, most of the requested information cannot be extracted from the given text.

Here is a summary of what can be inferred or is explicitly stated:

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

• This information is not present in the provided document. The 510(k) summary focuses on substantial equivalence of design and materials rather than performance metrics.

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

• This information is not present. The document does not describe a performance study with a test set.

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 present. No such ground truth establishment process is described.

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

• This information is not present. No adjudication method is mentioned as there is no described test set.

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

• This information is not present. The device (Intermittent Urethral Catheters) is a physical medical device, not an AI or imaging diagnostic tool, so an MRMC study is not applicable.

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

• This information is not present. As noted above, this is a physical medical device, not an algorithm.

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

• This information is not present. As no performance study is described, no ground truth is discussed.

8. The sample size for the training set

• This information is not present. No training set is applicable or described.

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

• This information is not present. No training set or ground truth establishment is applicable or described.

Information directly available from the text relevant to the device and its submission:

• Device Name: Intermittent Urethral Catheters
• Intended Use: Sterile, single-use, flexible tubular devices that are to be inserted through the urethra and used to pass fluids to or from urinary tracts.
• Classification Name: Catheter, Urological
• Predicate Devices:
  • Mentor Self-Cath - Preamendment
  • Mentor Self-Cath Plus - K003784
  • Maersk Female, Nelaton and Tiemann Catheters (originally Unoplast A/S) - K896729
  • Rüsch International SympaCath Hydrogel Coated Foley Catheter - K964575
• Basis for Equivalence: Substantially equivalent in design and materials. All predicate catheters are PVC, single-use, and intended for one-time intermittent catheterization. The submitted device also offers hydrophilic coating, similar to one of the predicate devices (Mentor Self-Cath Plus, K003784).
• Submission Type: 510(k) Premarket Notification
• FDA Determination: Substantial Equivalence to legally marketed predicate devices.

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Stenting: Esophaqeal stenoses (strictures), such as stenting refractory beniqn strictures and/or malignant strictures Esophageal-respiratory-fistula Maintaining esophagus lumen patency in esophageal strictures caused by intrinsic or extrinsic tumors

The Rüsch Polyflex Stent for the Esophagus with Introducer System consists of the Polyflex Stent, Introducer Sleeve, Stent Loader, Insertion Tube with Dilator, Soft Positioner, Stopper and Stent Clamp.

This document is a 510(k) Summary for a medical device called the "Rüsch Polyflex Stent for the Esophagus with Introducer/Delivery System." It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not include information about acceptance criteria or a study proving the device meets acceptance criteria as this type of information is typically found in a clinical study report, not a 510(k) summary for a Class II device.

Therefore, I cannot provide the requested information based on the provided text.

Specifically, the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or its data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information about a standalone (algorithm only) performance study.
7. The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The Rüsch Guided Cholangiography Catheter is intended for intraoperative cholangiography during laparoscopic cholecystectomy.

The Rüsch Guided Cholangiography Catheter is a sterile, singleuse device that consists of the following components:

• 10Fr, 30cm, Silicone-Sealed, Curved Polyurethane Guide Catheter . with Guide Handle
• 4Fr, 120cm, Curved, Polyvinylchloride Cystic Duct Catheter with ● Luer-Lock Syringe Connector 5mm OD, 27cm length, Silicone-Sealed Polyurethane Introduction Tub

The Guide Catheter is provided with a curved tip and a guide handle. The tip is directable toward the desired site by turning the guide handle thus facilitating placement. The direction of the tip is always known as it is in direct relation to the direction flange on the quide handle.

The Cystic Duct Catheter provides centimeter markings at the distal tip to aid in placement.

Each Rüsch Guided Cholangiography Catheter will be provided sterile, by either Gamma Irradiation or Ethylene Oxide, in a clear poly pouch with a medical paper seal. Each device will be individually labeled. The device will then be packaged in a labeled outer cardboard carton. The device will be marketed 5 units per box.

The provided text is a 510(k) summary for a medical device called the "Rüsch Guided Cholangiography Catheter." This document is primarily focused on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical study or performance verification test might.

Therefore, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for test/training sets, and training set sample size) cannot be directly extracted from this document because it describes a regulatory submission for clearance, not a performance study report.

The document states:

• The device is "substantially equivalent in design and materials" to existing predicate cholangiography catheters.
• "The following technological characteristics are the same as or equivalent to the predicate devices listed above: Materials: The materials used in the cystic duct catheter, the guide catheter and the introducer tube have all been used in predicate Rüsch devices."

This implies that the acceptance criteria were primarily about demonstrating this substantial equivalence in terms of materials, design, and intended use, aligning with the regulatory requirements for a 510(k) submission. Performance is inferred through equivalence, not explicitly detailed with quantitative metrics in this summary.

Based on the provided text, here's what can be answered:

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

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

• This information is not provided in the 510(k) summary. A 510(k) submission for substantial equivalence generally focuses on engineering design, materials, and comparison to existing devices, rather than a clinical trial-style test set performance evaluation with sample sizes.

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 provided as there is no mention of a formal clinical test set with expert ground truth establishment.

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

• This information is not provided as there is no mention of a formal clinical test set with expert ground truth establishment.

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, a MRMC comparative effectiveness study was not done. This device is a physical medical instrument (catheter), not an AI-powered diagnostic or assistive technology. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

• No, a standalone algorithm performance study was not done. This device is a physical catheter, not a software algorithm.

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

• The "ground truth" for this 510(k) submission is primarily the established safety and effectiveness of the predicate devices and the established safety and biocompatibility of the materials used. No specific clinical ground truth based on expert review or pathology for a new performance claim is mentioned.

8. The sample size for the training set

• This information is not provided as this is a physical device submission, not an AI/machine learning algorithm that requires a training set.

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

• This information is not applicable as this is a physical device submission, not an AI/machine learning algorithm.

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The Rüsch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless are intended for airway management of tracheostomized patients.

The Rüsch Crystal Clear Tracheostomy Sets will be offered in two (2) versions - Cuffed and Cuffless. Descriptions are:

Rüsch Crystal Clear Tracheostomy Set, Cuffed:
The Rüsch Crystal Clear Tracheostomy Set, Cuffed consists of a polyvinylchloride (PVC) tracheostomy tube with high volume/low pressure cuff, pilot balloon and tapered tip to facilitate insertion, a PVC flexible neck plate with a Nylon 15mm swivel connector and a polyethylene obturator with a tapered tip to facilitate insertion. The flange on this device is not adjustable. In addition, a PVC disposable inner cannula will be offered separately as an accessory.
This set will be offered in a range of sizes from 3.5mm - 10.5mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the tracheostomy tube.

Rüsch Crystal Clear Tracheostomy Set, Cuffless:
The Rüsch Crystal Clear Tracheostomy Set, Cuffless consists of a polyvinylchloride (PVC) tracheostomy tube with a tapered tip to facilitate insertion, a PVC flexible flange with a PVC turn lock fastener neck plate with a Nylon 15mm swivel connector and a polyethylene obturator with a tapered tip to facilitate insertion. The flange on this device is not adjustable. In addition, a PVC disposable inner cannula will be offered separately as an accessory.
This set will be offered in a range of sizes from 3.5mm - 10.5mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the tracheostomy tube.

Each Rüsch Crystal Clear Tracheostomy Set, Cuffed and Cuffless will be provided sterile, by either Gamma Irradiation or Ethylene Oxide, inside a protective inner pouch in a blister pack sheet with a Tyvek paper seal to provide a sterility barrier. Each pack will be individually labeled. The device will then be packaged, five units per carton, in a labeled outer cardboard carton. The inner cannulae will be marketed separately as accessories under separate part numbers.

The provided text describes a 510(k) Pre-market Notification for a medical device (Rüsch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless) seeking substantial equivalence to a predicate device. This type of submission** does not typically include a detailed study proving performance against acceptance criteria in the way a clinical trial for a novel device would.**

Instead, the submission focuses on demonstrating that the new device has substantially equivalent technological characteristics and intended use to a previously cleared device. Therefore, many of the requested elements for a detailed acceptance criteria study are not present in this document.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and reported device performance:

This document does not explicitly state quantitative acceptance criteria or provide performance data from a study designed to meet such criteria. The "performance" being demonstrated here is the substantial equivalence to an existing predicate device, not the achievement of specific, novel performance metrics.

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

Not applicable in this document. The assessment is based on a comparison of device characteristics and intended use.

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

Not applicable. The ground truth for a 510(k) submission is typically the established safety and effectiveness of the predicate device, not a new, expert-adjudicated dataset for the new device.

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

Not applicable.

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-enabled device, and no MRMC study is 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" implicitly used for this type of submission is the established safety and effectiveness of the existing predicate device (Rüsch Crystal Tracheostomy Set - K972546). The claim is that the new device shares similar technological characteristics and intended use, and therefore can be presumed to be as safe and effective as the predicate.

8. The sample size for the training set:

Not applicable. This device does not involve machine learning or a training set.

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

Not applicable.

Summary of the "study" that proves the device meets "acceptance criteria" (within the context of a 510(k) submission):

The "study" or justification for equivalence is described in section "6. Summary of Technological Characteristics."

• Acceptance Criteria (implicit for 510(k) Substantial Equivalence): The device must be deemed "substantially equivalent" to a legally marketed predicate device in terms of intended use and technological characteristics, such that it raises no new questions of safety or effectiveness.

• Device Performance / Proof of Equivalence:

  • Basis of claim: The Rüsch Crystal Clear Tracheostomy Sets are claimed to be substantially equivalent in design and materials to the predicate device, Rüsch Crystal Tracheostomy Set (K972546).
  • Technological Characteristics Comparison: "The Rüsch Crystal Clear Tracheostomy Sets are identical in materials and sizes to the 510(k) # K972546, Rüsch Crystal Tracheostomy Set, which was determined to be substantially equivalent on April 14, 1998." (Page 3, Section 6)
  • Materials: Both the new device and the predicate are described as being made of polyvinylchloride (PVC) for the tube, pilot balloon, and flexible neck plate; Nylon for the 15mm swivel connector; and polyethylene for the obturator.
  • Sizes: The new device is offered in a range of sizes from 3.5mm - 10.5mm in 0.5mm increments. The document notes that "The 3.0mm and 11.0mm sizes indicated in K972546 have been removed from the current product line" for the new device, implying a slight modification in available sizes but not a fundamental change in the technology or intended use.
  • Intended Use: Both the new device and the predicate device (by virtue of the claim of equivalence) are intended "for airway management of tracheostomized patients."

Conclusion:

This 510(k) summary demonstrates substantial equivalence by comparing the new device's materials, design, and intended use directly to a previously cleared predicate device. It does not involve a traditional clinical study with defined acceptance criteria and performance metrics for the new device itself, but rather leverages the established safety and effectiveness of the predicate. The FDA's letter (Page 3-4) confirms their review led to a finding of "substantial equivalence" based on this comparison.

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The Rüsch Microlaryngeal Tube is a sterile, single-use, oral/nasal tracheal tube intended to be used for airway management during laryngeal procedures.

The Rüsch Microlaryngeal Tube will be offered in three (3) sizes - 4.0mm, 5.0mm and 6.0mm ID. The devices will have a low-pressure/high volume cuff, inflated via a luer activated valve. A pilot balloon will be provided to give a visual indication of cuff status. The Rüsch Microlaryngeal Tube consists of a clear, implant-tested tracheal tube with a radiopaque stripe. The main tube is graduated with multiple centimeter markings to facilitate determination of intubated length.

The provided document is a 510(k) premarket notification for a medical device, the Rüsch Microlaryngeal Tube. It focuses on demonstrating substantial equivalence to pre-existing devices, rather than presenting a performance study with acceptance criteria in the context of an AI/ML powered device.

Therefore, the requested information regarding acceptance criteria, study data, sample sizes, ground truth establishment, expert involvement, and MRMC studies for an AI/ML device is not available in this document.

This document describes a traditional medical device (a tracheal tube) and uses substantial equivalence as its regulatory pathway, which involves comparing its design, materials, and intended use to legally marketed predicate devices. It does not involve any AI/ML components or associated performance studies.

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The Rüsch Edgar Tube is a sterile, single-use, oral/nasal tracheal tube intended to be used for airway management. The integral instillation system is indicated for drug instillation by the endobronchial route, anesthetic administration and gas monitoring.

The Rüsch Edgar Tube will be offered in the Magill pattern in two (2) versions - cuffed and uncuffed. Cuffed versions will have a low-pressure/high volume cuff, inflated via a luer activated valve. A pilot balloon will be provided to give a visual indication of cuff status.

The Rüsch Edgar Tube consists of a clear endotracheal tube with a radiopaque stripe. The main tube is graduated with multiple centimeter markings to facilitate determination of intubated length. The instillation lumen is connected to a luer lock connector with cap by a tube that is color coded to prevent confusion with the cuff inflation line.

The Rüsch Edgar Tube will be available in a variety of sizes ranging from 2.5mm - 6.0mm uncuffed and 6.5mm - 10.0mm cuffed. Both versions will be available in 0.5mm increments.

The provided text is a 510(k) premarket notification summary for the Rüsch EDGAR Tube. This document establishes substantial equivalence to previously marketed devices, rather than presenting a study proving a device meets specific acceptance criteria for performance.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance), training set details, and ground truth establishment cannot be extracted from this document, as such a study was not conducted or reported for this type of device submission.

The 510(k) process is primarily a regulatory pathway to demonstrate that a new device is as safe and effective as a legally marketed predicate device, often by showing similar technological characteristics and intended use, and not through performance studies with acceptance criteria in the way you've outlined for novel AI/medical device performance.

Here's what can be extracted from the document:

• Device Name: Rüsch EDGAR Tube
• Intended Use: "The Rüsch Edgar Tube is a sterile, single-use, oral/nasal tracheal tube intended to be used for airway management. The integral instillation system is indicated for drug instillation by the endobronchial route, anesthetic administration and gas monitoring."
• Predicate Devices:
  • Rüsch Safety Tracheal Tubes - Preamendment
  • Rüsch AGT PVC Preformed Nasal Tracheal Tubes - K931163/K931166
  • Rüsch Oral/Nasal (Safety Clear Plus™) Tracheal Tube, Cuffed, Magill/Murphy, Sterile - K993786
  • The Hudson RCI Sheridan ETCO2 Uncuffed Tubes K861454
  • The Hudson RCI Sheridan LITA Cuffed Tracheal Tubes - K834463
  • The Mallinckrodt Emergency Medical Tube (EMT) 510(k) # Unknown

Conclusion:

The provided document does not contain the information necessary to fill out your requested table and study details because it describes a 510(k) submission based on substantial equivalence, not a performance study against predefined acceptance criteria for a novel medical device like an AI algorithm.

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The Rusch TracheoFix Set (TFS) is a single patient disposable tracheostomy tube for airway management of tracheostomized patients.

TracheoFix Sets will be offered in two (2) versions - Cuffed and Uncuffed. Descriptions are as follows:

Rüsch TracheoFix Set, Cuffed:
The Rüsch TracheoFix Set, Cuffed consists of a polyvinylchloride (PVC) outer tube with low pressure cuff and pilot balloon, a PVC flexible flange with a PVC turn lock fastener. The flange on this device is not adjustable. In addition, the set will also include a polyethylene cannula with standard taper and a replacement cannula which will be offered separately as an accessory, a polyethylene introducer, a standard nylon connector, a Velcro head band also offered separately as an accessory, an ABS phonation valve, an ABS cough cap and an ABS sealing cap.
This set will be offered in a variety of sizes from 7.0mm, to 11.0mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the outer tube.

Rüsch TracheoFix Set, Uncuffed:
The Rüsch TracheoFix Set, Uncuffed consists of a polyvinylchloride (PVC) outer tube, a PVC flexible flange with a PVC turn lock fastener. The flange on this device is not adjustable. In addition, the set will also include a polyethylene inner tube with standard taper and a replacement inner tube which will be offered separately as an accessory, a polyethylene introducer, a standard nylon connector, a Velcro head band which will also be offered as an accessory, an ABS phonation valve, an ABS cough cap and an ABS sealing cap.
This set will be offered in a variety of sizes from 7.0mm, to 11.0mm in 0.5mm increments. The size determinations are the Inside Diameter (I.D.) of the outer tube.

Each Rüsch TracheoFix Set, Cuffed and Uncuffed will be provided sterile, by either Gamma Irradiation or Ethylene Oxide, in a clear plastic thermoformed tray with a Tyvek barrier/label. Each pack will be individually labeled. The device will then be packaged in a labeled outer cardboard carton. The device will be marketed one unit per box. The Velcro headband and the inner cannula will be marketed separately as accessories under separate part numbers. Both accessories will be marketed sterile, individually packaqed and labeled, ten (10) units per box .

The provided text is a 510(k) Summary for a medical device (Rüsch TracheoFix Set, Cuffed and Uncuffed tracheostomy tube). It focuses on establishing substantial equivalence to existing legally marketed devices, rather than presenting a performance study with acceptance criteria.

Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number and qualifications of experts, or adjudication methods for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance.
• Details on the type of ground truth used.
• Sample size for the training set or how ground truth for the training set was established.

The 510(k) summary explains the device, its intended use, and claims substantial equivalence to predicate devices based on design and materials, effectively stating that its performance is implicitly acceptable because it is similar to already approved devices. It does not describe an independent performance study with defined acceptance criteria and results.

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Aseptic Intermittent Self-Catheterization.

The Rüsch FloNeil (coated, with Water Pack) / Rüsch Flocath IntroGel (uncoated, without Water Pack) - consists of a tubular PVC catheter, a split introducer, a silicone introducer tip. introducer cap, lubrication jelly and a pack of 15ml saline (for FloNeil -coated product) inside a closed urine collection bag.

The provided text is a 510(k) Summary for a medical device (urinary catheters) and the subsequent FDA clearance letter. It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway, not a performance study in the sense of accuracy, sensitivity, or specificity.

Therefore, I cannot fulfill your request for the detailed information because the source document does not provide it.

Here's a breakdown of what the document does include:

• Device Name: Rüsch FloNeil (coated, with Water Pack) and Rüsch FloCath IntroGel (uncoated, without Water Pack)
• Intended Use: Aseptic Intermittent Self-Catheterization
• Predicate Device: Rüsch MMG/O'Neil Catheter Set and the MMG O'Neil Urinary Catheter
• Substantial Equivalence: Claimed equivalence in materials, design, and use to the predicate.
• Classification: Class II medical device, 78 KOD, 21CFR 876.5130

To address your query regarding acceptance criteria and a study, these would typically be found in a performance study report, clinical trial summary, or a specific section of a 510(k) submission dedicated to performance testing (if non-clinical or clinical data were required to demonstrate substantial equivalence beyond material and design comparison). This document is a high-level summary.

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