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The Rusch Emergency Mask is designed to assist in providing immediate life support to health emergency victims requiring oxygen support(inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The device is intended for mouth to mask ventilation by trained individuals trained in the use of the device and qualified to use the device. The device is intended to be used on adult,child and infant population.

The Rusch Emergency Mask is one-piece, single use, full-sized light weight PVC mask system which includes a universal breathing tube, one way filtered valve, head straps and oxygen port. The design of the ER mask permits it to fold into a convenient pocket sized case for portability yet deploy instantly for use as a CPR Mask when removed from its package. The mask can be supplied with or without examination gloves. The soft PVC cushion promotes a seal to the face allowing ventilation through both the mouth and nose simultaneously. The transparent structure permits visual identification. The mouth piece and the one way valve with 3M Filtrate TM filter provide the rescuer protection when using "mouth-tomouth" rescue techniques. The proximal end of the breathing tube can be attached to a universal resuscitation bag port while the integral oxygen tube allows for connection to an emergency oxygen system.

The provided document for the Rusch Emergency Mask (K993528) does not contain information regarding
acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a
predicate device (Laerdal Pocket Mask™ K933048). It describes the device's intended use and
technological characteristics, but does not present any performance study data, clinical trials, or
metrics that would allow for the construction of a table of acceptance criteria and reported device
performance.

Therefore, I cannot provide the requested information. The document merely confirms that the FDA
reviewed the 510(k) notification and determined the device to be substantially equivalent to a
legally marketed predicate device, allowing it to proceed to market. This determination is based on
the device's design, intended use, and technological characteristics being comparable to the
predicate, rather than on specific performance acceptance criteria met through a dedicated study.

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The manual resuscitator is intended for use on patients requiring total or intermittent airway support. Provides positive pressure ventilation and allows spontaneous breathing either with a 22mm inner diameter face mask port or through an artificial airway having a 15mm outer diameter connection.
The Rusch Manual Resuscitator is intended for manual ventilation of patients with air or air enriched oxygen The resuscitator is manufactured as either an adult, pediatric, or infant model, intended to treat an adult child, or infant respectively

The product consists of a face mask, bag, valve, reservoir bag, and tubing with connector for introduction of oxygen enriched air. The valve is made from K-Resin and the other main components mentioned above are made from PVC. The cushion mask is clear to permit easy patient monitoring and is mounted on a 360° swivel for convenience. The bag is textured to give a positive grip.

This document is a 510(k) summary for a medical device (Rusch Manual Resuscitator Bag), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and expert reviews.

Therefore, many of the requested elements regarding acceptance criteria, study details, expert involvement, and ground truth cannot be extracted from the provided text. The document is essentially a regulatory submission, not a scientific study report.

Here's an analysis based on the information provided in the extract:

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

No explicit acceptance criteria or reported device performance metrics are provided in the document. The submission aims to prove substantial equivalence based on design, construction, and intended use, rather than quantitative performance against specific criteria.

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

No performance study or test set data is described. The submission focuses on device description and comparison to a predicate.

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)

No experts were used to establish ground truth for a test set, as no such test set is mentioned.

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

No adjudication method is mentioned as there is no described test set or expert review 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

No MRMC study was done, nor is there any mention of AI assistance. This device is a manual resuscitator bag.

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)

No ground truth data (in the context of a performance study) is mentioned. The ground for substantial equivalence is based on comparison to a legally marketed predicate device.

8. The sample size for the training set

No training set is mentioned.

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

Not applicable, as no training set is mentioned.

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The Rusch Silicone Foley is used to drain fluids to and from the urinary tract.
The Rusch Silicone Foley Balloon Catheter is used to drain fluids to and from the urinary tract.

The Rusch Silicone catheter is of the retention type, commonly called a Foley catheter. The device is a single use, disposable, sterile with retention balloon, which is attached to the silicone shaft. One lumen is for draining fluids to and from the urinary tract. The second lumen is to inflate and deflate the balloon with sterile water. On models with a third lumen, it is used in conjunction with the first lumen for flushing the urinary tract. Sterile water is used for inflation and deflation of the balloon. The distal end has two opposite eye holes, which are used for drainage. On the Tiemann tip there is one hole. Cylindrical, Coude and Tiemann tips are available versions of this product. On the opposing end of the shaft, are a connecting funnel and a Luer activated valve. Pediatric sizes are available with the same configurations as the adult with the additional feature of a stylet that is inserted prior to the catheter placement. This product is available in sizes 8 Fr to 26 Fr, smooth and profile shafts. Both shafts are available in coated form. Profile shafts provide drainage channels along the shaft length.

This document is a 510(k) summary for a medical device (Rüsch Silicone Foley Catheter) which primarily discusses its substantial equivalence to predicate devices based on technological characteristics and intended use. It does not contain information about acceptance criteria or a study proving device performance against such criteria.

The 510(k) notification process focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate device, or, if it has different technological characteristics, the differences do not raise different questions of safety and effectiveness and the device is as safe and effective as the predicate device. This typically involves comparison to existing devices, rather than detailed performance studies with acceptance criteria in the way a clinical trial or performance study for a novel device would.

Therefore, for your request, the following information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe specific performance metrics or acceptance criteria for the Rüsch Silicone Foley Catheter beyond its intended use and technological equivalence.
2. Sample size used for the test set and the data provenance: No test set or performance study data is included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment is described.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document primarily states that the "Rusch Silicone catheter with silicone balloon, ported distal tip, and silicone funnel with and without coating, is equivalent to predicate devices" based on its technological characteristics. The performance is essentially inferred to be equivalent to the predicate devices (Bard, Bardex®, and Mentor, 4 Sure®).

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The Device is intended for placement of the Foley catheter in the bladder for drainage when there is difficulty in negotiating the urethra

The Rusch Inc. Simplastic Councill Tip Catheter may be supplied as a stand alone device or may be accompanied with accessories including a filiform and follower. The Simplastic Councill Tip Catheter consists of a 2-way PVC Foley catheter with a 5 ml balloon and an open tip to fit over a guide. The catheter can be supplied with a lubricious coating to facilitate insertion. The guide will be a flexible PVC shaft with standard threaded male Philips connector for attachment of a detachable filiform. The filiform also consists of a PVC shaft with a standard threaded female Philips connector. The catheter and accessories are supplied sterile. Sterility is by Ethylene Oxide Sterilization.

This document does not contain the information needed to answer your request. It is a 510(k) summary for a medical device (a catheter) and primarily focuses on establishing substantial equivalence to a predicate device. It defines the device, its intended use, and confirms FDA clearance.

Specifically, the document does not include:

• Acceptance criteria for device performance.
• Results from any studies proving the device meets acceptance criteria.
• Information about sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, types of ground truth, or details about training sets.

The information provided in this document is purely regulatory clearance related, not performance study related.

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The Device is intended for introduction into the Naris (Nostril) and is is used in the introduction of various commercial or compounded enteral diets to appropriate sites along the Ailimentary tract of the patient.

The subject devices are weighted or unweighted, thermoplastic or elastomer tubes. The distal outlet of the tube may be closed in a spherical tip or opened and polished to facilitate passage through the mucosal tissues of the nose or esophagus. A series of side outlets may be perforated through the side wall of the tubing to allow for dispersion of the enteral diet around the distal end of the tube. A stainless steel stylet may or may not be included with the product for aid in placement

This is a 510(k) summary for a medical device submitted to the FDA, not a study report. Therefore, it does not contain the detailed information about acceptance criteria and a study proving those criteria are met in the way a structured clinical trial or performance study would.

Instead, this document focuses on establishing substantial equivalence to a predicate legally marketed device. The "acceptance criteria" here are implicitly related to demonstrating that the new device is as safe and effective as the predicate device.

Here's an attempt to answer your questions based on the provided text, recognizing the limitations of this type of submission:

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

This document does not present explicit "acceptance criteria" in a quantitative, measurable format like a performance study might (e.g., "device must achieve sensitivity of X%"). Instead, the primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device.

The "reported device performance" is essentially that the device is "equivalent in design and construction" to the predicate.

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 applicable. This document does not describe a performance or clinical study with a "test set" of patient data. It is a submission for regulatory clearance based on substantial equivalence.
• Data provenance: Not applicable.

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. No ground truth establishment for a test set is described.

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

• Not applicable. No 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

• Not applicable. This device is an enteral feeding tube, not an AI-assisted diagnostic device, and no MRMC study or AI component is mentioned.

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

• Not applicable. This device is an enteral feeding tube, not an algorithm.

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

• Not applicable. No patient data or ground truth determination is described in this 510(k) summary. The "ground truth" for this type of submission is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

• Not applicable. No training set is mentioned as this is not a machine learning or AI device submission.

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

• Not applicable.

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The kit is used for percutaneous bladder drainage and to drain fluids to and from the urinary tract.

The kit consists of two major components: silicone catheter and plastic introducer assembly, along with attachment tape to fix the catheter to the skin, if required, and an optional scalpel. The kit is used for percutaneous bladder drainage. There are two types of silicone catheters. The first comes equip with one pair of drainage eyes. The second type of silicone catheter comes with six drainage eves arranged in a pigtail shape.

This document is a 510(k) Summary for a medical device (Rusch Suprapubic Tray). It describes the device, its intended use, and claims substantial equivalence to legally marketed predicate devices.

This document does not contain information regarding acceptance criteria, device performance, study details (like sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study-related details based on the provided text. The document focuses on regulatory submission for substantial equivalence rather than a detailed performance study.

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The Rusch Simplastic Foley Catheter is intended to be used to pass fluids to and from the urinary tract. A pack of lubricating jelly is intended to assist insertion of the catheter through the urethra.

The Rusch Simplastic Foley Catheterization Set contains a pack of lubricating jelly and a Rüsch Simplastic Foley Catheter. The Rusch Simplastic Foley Catheters used in the kit will be available: in 2 way and 3 way formats in various sizes from 12 - 26 F.G. in two hardnesses with various sizes of balloon with various tip and eye configurations. Common features of all the catheters are: a clear polyvinyl chloride tube, a radiopaque stripe of BaSO loaded PVC is fully encapsulated in the tube wall, a latex balloon attached by adhesive bonding, a funnel connected to the main lumen and a luer activated valve for filling and emptying the balloon.

This document is a 510(k) summary for a medical device (Rüsch Simplastic Foley Catheterization Set). It does not describe an AI/ML powered medical device, nor does it present a study proving the device meets acceptance criteria in the manner typically associated with such devices (e.g., performance metrics like sensitivity, specificity, AUC). Instead, it focuses on demonstrating substantial equivalence to predicate devices and adherence to regulatory guidance through laboratory bench testing.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth, expert adjudication, MRMC studies, and separate standalone performance is not applicable to this document.

However, I can extract the relevant information about the "Summary of Performance Data" as presented:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Laboratory bench testing has been completed," implying successful adherence to the standards outlined in the FDA "Draft Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters." Specific numerical acceptance values are not provided in this summary, but are implicitly met by the completion of testing as per guidance.

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

• Sample Size: Not specified. The document refers to "Laboratory bench testing" which typically involves a specific number of units, but this number is not disclosed in the summary.
• Data Provenance: This is bench test data generated in a laboratory setting, not patient-derived data from any specific country. The study is a prospective laboratory evaluation of manufactured devices.

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

• Not applicable. This is not a study involving human interpretation or expert consensus for ground truth. Performance is assessed against physical and material engineering specifications and regulatory guidance.

4. Adjudication Method for the Test Set

• Not applicable. Performance is assessed through objective laboratory measurements against defined standards, not through expert adjudication.

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

• No. This is not an MRMC study. It is laboratory bench testing of a physical medical device.

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

• Yes, in a sense that the device's technical specifications and physical performance were evaluated independently without human intervention or interpretation of results beyond standard laboratory procedure. However, this terminology is typically used for AI algorithms. For a physical device, this refers to its intrinsic performance as measured.

7. Type of Ground Truth Used

• The "ground truth" for this type of device evaluation is based on pre-defined engineering specifications, material properties, and performance standards outlined in regulatory guidance (e.g., FDA "Draft Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters") and biocompatibility standards (ISO 10993 and FDA "Blue Book Memo" #G95/1).

8. Sample Size for the Training Set

• Not applicable. This document describes the testing of a medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. No training set for an AI/ML algorithm is mentioned.

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The Rusch Ultra Tracheoflex Tracheostomy Set-Cuffed is a tracheostomy tube with accessories, intended for intubation through a surgical incision into the trachea, for the purpose of providing a patent airway.

The Ultra Tracheoflex Tracheostomy Set-Cuffed is a sterile, disposable, single use cuffed tracheostomy tube with a fixed flange. The set includes a radiopaque tube, a tube obturator, a cough cap, a 15 mm airway connector, exchangeable inner cannulas, and a neck band. The inner cannula will be also available as a separate item.

The provided text describes a medical device submission (510(k) summary) for the Rüsch Ultra Tracheoflex® Tracheostomy Set - Cuffed. It does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of a performance study involving AI or human readers, as implied by the detailed questions.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and adherence to voluntary standards.

Therefore, I cannot provide answers to most of your questions, as the information is not present in the input text.

Here's what I can extract based on the provided document:

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

• The document doesn't provide specific quantitative acceptance criteria or detailed performance results from a study. It states that the device meets "applicable portions of the following voluntary standards." These standards likely contain implicit acceptance criteria, but they are not explicitly presented as such in the context of a performance study within this document.
  • Voluntary Standards Met:
    • ASTM F1242-89, Standard Specification for Cuffed and Uncuffed Tracheal Tubes.
    • ISO 5366-1, Tracheostomy Tubes, Part 1, Connectors for Tubes for Adults
    • ISO 5366.2, Basic requirements for Tracheostomy Tubes for Adults.
    • ISO 5356: Anesthesia and Respiration Equipment, Conical Connectors, Cones and Sockets.
    • ISO 5361, Tracheal Tubes, Part 5: Requirements and Tests for Cuffs and Tubes.

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. The document explicitly states: "No clinical testing was completed."

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. No clinical testing was performed, so no ground truth establishment by experts is mentioned.

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

• Not applicable. No clinical testing was performed.

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. No clinical testing was performed, and this device is not an AI-assisted diagnostic tool.

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

• Not applicable. This is not an algorithm-based device.

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

• Not applicable. No clinical testing was performed.

8. The sample size for the training set

• Not applicable. This document is not describing an AI/machine learning model, so there is no training set mentioned.

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

• Not applicable. This document is not describing an AI/machine learning model.

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The device is a single use, sterile, cuffed tracheal intubation and indicated for airway management.

consists of a clear, implant tested, P.V.C. tube with an encapsulated stainless steel reinforcing spiral. The tube is graduated with multiple centimeter markings to allow easy determination of the intubated length, and is terminated with a fully inserted connector. The tube is fitted with a low pressure, high volume cuff, which is inflated through a lueractivated valve, pilot baloon, inflation tube and lumen in the wall of the main tube.

The provided document is a 510(k) Substantial Equivalence Summary for the Rusch Reinforced Tracheal Tube - Cuffed, sterile. This document is for a medical device regulatory submission and does not contain any information about clinical studies, acceptance criteria, or performance data of the kind requested.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to pre-existing devices based on design, materials, and intended use, rather than presenting results from a performance study against specific acceptance criteria.

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