Search Results

Reinforced Tube: Rusch Reinforced Endotracheal Tubes are designed for nasal intubation and are indicated for airway management. The correct designation (oral, nasal or oral/nasal) is printed on the tube and unit package. Reinforced Endotracheal Tubes may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. The Reinforced Endotrached to be used on all patients requiring ventilation, pediatric and adult.

Safety Clear and Safety Clear Pediatric Tubes: Rusch Endotracheal Tubes, Cuffed and Uncuffed, with or without Murphy Eye are for oral or nasal intubation. They are indicated for airway management. The Rusch Endotracheal Tubes are intended to be used on all patients requiring ventilation, pediatric and adult.

An endotracheal tube is a device that is inserted into the trachea via the nose or the mouth to establish a patent airway to allow ventilation. The proposed Teleflex Medical Rusch Endotracheal Tubes are sterile, single use devices that are made non made with DEHP. The tracheal tubes contain a compatible cuff, inflation line, pilot balloon and one-way valve. A radiopaque line is incorporated into the full length of the Safety Clear tracheal tube, while the Reinforced tube contains an embedded stainless-steel spiral that allows for X-ray visualization. Each tracheal tube is supplied with an appropriately sized 15mm connector.

The provided document is a 510(k) Premarket Notification from Teleflex Incorporated to the FDA regarding their Rusch Endotracheal Tubes. It details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Crucially, this document does NOT describe a study that involves AI or machine learning, human readers, or image-based diagnostics. The "device" in question is an endotracheal tube, a physical medical device, not a software or AI-driven diagnostic tool.

Therefore, many of the requested criteria related to AI/ML model performance, such as sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this submission.

The "acceptance criteria" and "device performance" in this context refer to the physical and biological characteristics of the endotracheal tube, verified through standard bench testing and biocompatibility assessments, rather than diagnostic accuracy or reader improvement.

Here's an attempt to fill in the relevant information based on the provided text, while clearly stating when information is Not Applicable (N/A) due to the nature of the device:

Acceptance Criteria and Device Performance Study for Rusch Endotracheal Tubes

This submission focuses on establishing substantial equivalence for physical medical devices (endotracheal tubes), not software or AI-driven diagnostic tools. Therefore, many standard AI/ML study components are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the successful completion of the described bench testing and biocompatibility assessments, demonstrating that the device performs as intended and is safe for its indicated use. The "reported device performance" is the successful fulfillment of these tests, confirming substantial equivalence to the predicate devices.

| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance (as implied by acceptance) |
|------------------------------|----------------------------------------------------------------+|--------------------------------------------------------|
| Physical Performance | Visual inspection | Acceptable |
| | Dimensional testing | Within specifications |
| | Bonding strength (main tube to side arm, inflation tube, connector) | Acceptable |
| | Tube curvature | Acceptable |
| | Cuff restrained burst | Acceptable |
| | Bevel angle | Acceptable |
| | Cuff inflation | Acceptable |
| | Kink resistance | Acceptable |
| | Cuff herniation | Acceptable |
| | Cuff diameter | Acceptable |
| | Tube collapse | Acceptable |
| | Tracheal seal testing | Acceptable |
| Biocompatibility | Cytotoxicity (ISO 10993) | Pass |
| | Sensitization (ISO 10993) | Pass |
| | Irritation (ISO 10993) | Pass |
| | Acute Systemic Toxicity (ISO 10993) | Pass |
| | Material Mediated Pyrogenicity (ISO 10993) | Pass |
| | Implantation (ISO 10993) | Pass |
| | Subacute Systemic Toxicity (ISO 10993) | Pass |
| | Genotoxicity (ISO 10993) | Pass |
| | Chemical Characterization (Exhaustive & Simulated Use) | Pass (Toxicological Risk Assessment Related to Extractables and Leachables) |
| | Particulates and VOC | Pass (Toxicological Risks Related to Inhalation of VOCs and Particulates) |

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

• Sample Size for Test Set: The document does not specify the exact sample sizes (e.g., number of tubes) used for each bench test or biocompatibility test. It indicates that "testing performed verifies that the performance of the subject device is substantially equivalent." For biocompatibility, it states "Materials have been tested per ISO 10993-1" and lists the tests performed, implying standard sample sizes as per the ISO standard.
• Data Provenance: The data provenance is from internal testing conducted by Teleflex Medical, Inc. (the manufacturer). The type of data is physical testing and chemical/biological analysis of device materials. It is implicitly "prospective" in the sense that the testing was performed on newly manufactured devices for the purpose of this submission. Country of origin not specified, but likely where Teleflex manufactures or tests its products, or where the testing labs are located.

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

• Not Applicable (N/A): For a physical device like an endotracheal tube, "ground truth" is established through standardized engineering specifications, material science, and regulatory standards (e.g., ISO standards). It does not involve expert readers reviewing output in the same way an AI diagnostic tool would. The experts involved would be engineers, material scientists, and toxicologists conducting the testing and interpreting the results against established physical and biological acceptance criteria.

4. Adjudication Method for the Test Set

• Not Applicable (N/A): As there is no human interpretation or subjective assessment of "ground truth" images or data points (as in an AI diagnostic study), there is no adjudication method in the context of multiple expert readers. Compliance is determined by objective measurements against predefined engineering and biological limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No: This is a physical medical device; an MRMC study is not relevant.

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

• Not Applicable (N/A): This submission is for a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

• Engineering Specifications and Standardized Test Results: The "ground truth" for this medical device is based on established engineering specifications for physical characteristics (e.g., dimensions, bond strength, kink resistance, cuff performance) and adherence to recognized international standards for biocompatibility (ISO 10993 series). The device's performance is measured against these objective criteria rather than expert consensus on a diagnostic outcome.

8. The Sample Size for the Training Set

• Not Applicable (N/A): This is a physical 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 (N/A): As there is no training set, this question is not applicable.

Ask a specific question about this device

RUS is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning for patients. RUS accepts DICOM compliant medical images acquired from iodine contrast-enhanced abdomen CT.

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

The software provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, image fusion, surface rendering, measurements, reporting, storing, storing, general image management and administration tools, etc.

It includes a basic image processing workflow and a custom UI to segment anatomical structures, which are visible in the image data (bones, organs, vascular structures, etc.), including interactive segmentation tools, basic image filters, etc.

It also includes detection and labeling tools of organ segments, including path definition through vascular and interactive labeling.

The software is designed to be used by trained professionals (including physicians, surgeons and technicians) and is intended to assist the clinician who is solely responsible for making all final patient management decisions.

RUS uses DICOM (Digital Imaging and Communications in Medicine) standards to analyze CT images. This software provides trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. By observing the medical images standard protocol (DICOM standards), this software can receive transmitted images from medical imaging devices through the h-Server and can be interfaced with PACS (Picture Archiving and Communication System).

RUS allows surgical planning by 3D modeling from patient's CT data. Surgical planning in RUS does not replace actual surgery and can only be used as an auxiliary tool.

CT is taken at the hospital, the patient's CT data is obtained from PACS, and the CT data is transferred from PACS to h-Server. When CT data and patient information are registered in the h-Server, the data is pseudonymized and anonymized and safely moved to the h-Space. If you request hu3D production by registering CT data and patient information through h-Server, hu3D will be provided within 72 hours. Then you may download the hu3D model through RUS Stomach Planning and perform Surgical planning.

RUS is a software suite and includes three software components: h-Server, h-Space, and RUS Stomach Planning.

1. h-Server
   h-Server includes modules dedicated to data management and data gateway. The software is a simple tool either to anonymize or pseudonymize multidimensional digital images acquired from a variety of medical imaging modalities (DICOM images). There is no 3D data volume interpretation in this software.

2. h-Space
   h-Space includes data management (except for DICOM files anonymization/pseudonymization module) and 3D reconstruction. This software offers a flexible solution to help trained medical professionals with image processing knowledge (usually radiologists or radiologist technicians) in (1) the evaluation of patient's anatomy, and (2) in the creation of a 3D model of the patient's anatomy. This software proposes flexible workflow options: visualization of patient's anatomy from medical images; creation a 3D model of the patient's anatomical structures, organ segments and volumetric data; creation of an anatomical atlas (a colored image where each color represents a structure); and exports these medical data to be analyzed or reviewed later.

3. RUS Stomach Planning
   RUS Stomach Planning includes modules dedicated to patient & data management and surgical planning. This software offers a flexible visualization solution to help trained medical professionals (clinicians) in the evaluation of patient's anatomy to plan therapy or surgery.

Here's a breakdown of the acceptance criteria and study details for the RUS device, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

1. Sample Size used for the test set and data provenance:

   • Test Set Sample Size: 60 imaging studies.
   • Data Provenance: Not explicitly stated, but implies diverse patient population and CT system manufacturers from the statement "The data used in the device validation ensured diversity in patient population and CT system manufacturer." The document also states "No dataset contained more than one imaging study from any particular patient," and "independence of training and testing data were enforced at the level of the scanning institution, namely, studies sourced from a specific institution were used for either training or testing but could not be used for both." This suggests a multi-institutional dataset. The data includes patients with and without disease.

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

   • The document implies ground truth was established by "medical professionals" for organ and vessel segmentations, and "3D scan data" for pneumoperitoneum.
   • Expert Number: Not explicitly stated.
   • Expert Qualifications: Not explicitly stated beyond "medical professionals."

3. Adjudication method for the test set: Not explicitly stated. Ground truth was established by comparing machine learning model outputs against segmentations generated by medical professionals and 3D scan data.

4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned in the provided text. The study focuses on the standalone performance of the AI models.

5. Standalone (algorithm-only without human-in-the-loop) performance: Yes, this was done. The reported device performance metrics (DSC, MAE, measurement accuracy) are for the machine learning models directly, not in an assisted reading setting.

6. Type of ground truth used:

   • Organ and Vessel Segmentation: Segmentations generated by medical professionals.
   • Pneumoperitoneum: 3D scan data.
   • Length Measurement: Phantom data and hu3D data.

7. Sample size for the training set: Not explicitly stated. The document mentions that "No imaging study used to verify performance was used for training; independence of training and testing data were enforced at the level of the scanning institution, namely, studies sourced from a specific institution were used for either training or testing but could not be used for both." However, the exact number of studies for training is not provided.

8. How the ground truth for the training set was established: Not explicitly stated, but it can be inferred that it was established similarly to the test set, i.e., likely through segmentations by medical professionals or 3D scan data, as these are the modalities against which performance was verified.

Ask a specific question about this device

2 Way SoftSimplastic Catheters:

Indicated where routine transurethral drainage of the bladder is required either postoperatively or for patients with conditions requiring transurethral urine drainage.

3 Way SoftSimplastic Catheters:

Indicated where routine transurethral drainage of the bladder is required either postoperatively, for patients with conditions requiring transurethral urine drainage and for patients requiring bladder irrigation.

The Rusch SoftSimplastic Foley Catheter is a balloon retention type catheter and is single use, disposable and sterile. The catheters are made of transparent PVC. They have a 2 lumen or 3 lumen shaft with proximal funnel, inflation valve and a distal retaining balloon made of latex. Balloon capacity is in ml and the shaft size in French gauge (Fr.) as indicated on the funnel of each individual catheter.

The provided text describes a 510(k) premarket notification for a medical device, the Rusch SoftSimplastic Foley Catheter, not an AI/ML medical device. Therefore, the information required to answer the prompt regarding acceptance criteria and studies for an AI/ML device (e.g., sample size for test/training sets, expert qualifications, ground truth establishment, MRMC studies) is not present in the document.

The document focuses on demonstrating substantial equivalence to a predicate device (Rusch Simplastic Foley Catheters) based on:

• Intended Use: Similar indications for use for bladder drainage and irrigation.
• Technological Characteristics: Similar balloon retention type, materials (PVC), sizes, lumens, sterilization method, single-use, and radiopacity. The key differences highlighted are a change in PVC plasticizer, extended shelf life, and slightly different size ranges.
• Non-Clinical Performance Testing: This includes:
  • Biocompatibility testing (e.g., cytotoxicity, sensitization, systemic toxicity, implantation) according to ISO 10993 standards.
  • Bench performance testing (e.g., visual inspections, strength, connector security, balloon safety, flow rate, kink stability, tensile force, radiopacity) according to ISO 20696, ASTM F623, and ASTM F640 standards.
  • Sterilization and Packaging validation according to ISO 11135-1, ISO 10993-7, ISO 11607, ASTM D4169, ASTM F1886, ASTM F88, EN 868-5, and ASTM F2096.

The document explicitly states: "Differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness." and "Performance test results demonstrate that the subject device is as safe and effective as the predicate device."

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device based on the provided text. The document pertains to a traditional medical device demonstrating substantial equivalence through non-clinical bench and biocompatibility testing, not an AI/ML algorithm requiring clinical performance studies against defined ground truth with human reader involvement.

Ask a specific question about this device

These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use.

The Intermittent Urethral Catheters consist of a tubular shaft with attached funnel as the connecting device. PVC material used in the catheter. The product sizes range from 10 Ch. to 24 Ch. The device shaft is uncoated.

This document, a 510(k) summary from the FDA for the Rusch Intermittent Urethral Catheter, does not contain the information requested about acceptance criteria and a study proving a device meets them for an AI/ML medical device.

The document is a submission for a traditional medical device (a catheter), not an AI/ML diagnostic or prognostic tool. Therefore, it discusses:

• Substantial Equivalence: The primary focus is on demonstrating that the new device is substantially equivalent to a previously cleared predicate device (K173596).
• Device Description: Details on the physical characteristics and materials of the catheter.
• Indications for Use: What the catheter is intended for (routine drainage of urine).
• Changes: The only change mentioned is to the labeling (adding contraindications to the Instructions for Use).

None of the requested information regarding AI/ML device performance studies, such as:

1. Table of acceptance criteria and reported device performance: This would be relevant for an AI's accuracy, sensitivity, specificity, etc., which is not applicable here.
2. Sample size, data provenance, experts for ground truth, adjudication method: These are specific to evaluating AI model performance on a test dataset.
3. MRMC study, standalone performance, type of ground truth, training set details: These are all methodologies used to validate AI models.

In summary, this document is about a low-risk, non-AI medical device and therefore does not include the details of an AI/ML performance study.

Ask a specific question about this device

The subject device is a tubular device that is inserted through the urethra to pass urine from the bladder.

The Teleflex Rusch®FloCath Quick™ 18 French (Fr.) Coudé Hydrophilic Intermittent Catheter is single use, disposable and sterile. The catheter is made of clear polyvinylchloride (PVC) with vertically cut and softly rounded, polished eyes and has a hydrophilic coating. It is composed of a shaft with a proximal funnel and a tip. The funnel is made of PVC. The shaft size is an 18 French gauge and is identified on the packaging. The funnel is color coded red to facilitate size identification. The catheter is 40 cm in overall length. The FloCath Quick is an integrated package that contains the FloCath catheter with a blue protective catheter sleeve and a packet of sterile 0.9% saline. Before opening, the sterile saline pouch is broken to hydrate the catheter. The protective catheter sleeve allows for touchless insertion. The sleeve can also be pushed back and used as an extension to the catheter. The FloCath Quick packaging has a packaging hole to facilitate opening the catheter. Either the packaging hole or the adhesive patch on the catheter pack can be used to hang up the catheter in an appropriate, convenient location while the catheter is hydrated.

The provided text is a 510(k) summary for a medical device (Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria for performance metrics in a clinical context.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of algorithm performance or clinical outcomes are not applicable or cannot be extracted from this document, as it primarily details bench testing and a comparison to a predicate device for regulatory clearance.

However, I can extract the relevant bench testing performance data which serves as the "study" for this type of submission and interpret the "pass" results as meeting implicit acceptance criteria for substantial equivalence.

Here's the information that can be extracted, with explanations for what is not applicable:

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

For a 510(k) submission, the "acceptance criteria" for bench testing are generally that the device performs comparably to the predicate or meets established standards, and in all reported cases, the device "Passed". Specific numerical acceptance thresholds are not explicitly detailed in this summary for each test, but "Pass" indicates they were met.

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: The document does not specify the sample size for any of the bench tests conducted.
• Data Provenance: The document does not specify the country of origin of the data. The testing described is bench testing, not clinical data, so terms like "retrospective or prospective" do not directly apply.

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 section is Not Applicable (N/A). The "ground truth" concept is usually associated with clinical or image-based studies where expert consensus or diagnostic outcomes are used. This submission focuses on engineering bench tests and material biocompatibility, which do not typically involve experts establishing "ground truth" in this manner. The evaluations are based on compliance with international standards and internal protocols.

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

This section is Not Applicable (N/A). Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, not for objective bench testing of device performance parameters.

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 section is Not Applicable (N/A). This device is a urological catheter, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.

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

This section is Not Applicable (N/A). As stated above, this is a physical medical device, not an algorithm.

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

This section is Not Applicable (N/A) in the traditional sense. For the bench tests, the "ground truth" or reference for assessment is established by the specified international and industry standards (e.g., EN 1616:1997, ASTM F623:2013, ISO 10993 series, ISO 11135-1:2014). Passing these standards serves as verification that the device meets defined engineering and safety specifications.

8. The sample size for the training set

This section is Not Applicable (N/A). This device is not an AI/ML algorithm that requires a training set.

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

This section is Not Applicable (N/A). As this is not an AI/ML device, there is no training set or ground truth in that context.

Ask a specific question about this device

The Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are tubular devices that are inserted through the urethra to pass urine from the bladder.

The Teleflex Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are single use, disposable and sterile. The catheters are made of clear polyvinylchloride (PVC) with vertically cut and softly rounded polished eyes and are coated with a hydrophilic coating. They are composed of a shaft with a proximal funnel and a tip. The funnel is made of PVC. The shaft size ranges from 6-20 French gauge. The funnel is color coded to facilitate size identification. The Rusch® FloCath™ Quick is an "all-in-one catheter" that allows for convenience and the Rusch® MMG H2O™ is a closed system with integrated collection bag that allows for "no touch" catheterization due to an introducer tip that helps bypass the first 1.5" of the urethra.

This document describes the Teleflex Rusch Hydrophilic Intermittent catheters (comprising Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, and Rusch MMG H2O Singles). This submission is for a 510(k) premarket notification, indicating a claim of substantial equivalence to a predicate device, not necessarily a claim of superiority or novel performance requiring extensive clinical studies typically associated with AI/ML devices. Therefore, much of the requested information regarding AI-specific studies (e.g., sample sizes for test sets, expert ground truth, MRMC studies, standalone algorithm performance, training set details) is not applicable to this type of medical device submission.

The submission focuses on establishing substantial equivalence through "bench testing" and biocompatibility studies.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list numerical "acceptance criteria" for each performance characteristic with corresponding reported values in a table format that would be typical for an AI/ML device. Instead, it states that "The bench testing performed verifies that the performance of the subject devices are substantially equivalent in terms of critical performance characteristics to the predicate device." and "The testing performed verifies that the performance of the subject devices are substantially equivalent in terms of critical performance characteristics to the predicate device." It also adds, "Overall, the results are comparable to the predicate and support a determination of substantial equivalence."

Here's a summary of the performance characteristics evaluated and the reported outcome:

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

The document does not specify exact sample sizes for each bench test performed. For physical tests like flow rate and friction, standard engineering practices would involve testing a statistically representative sample from multiple production lots. For biocompatibility, testing is typically performed on material extracts according to ISO standards, which define the sample sizes and controls.

As this is a physical device, not an AI/ML system, concepts like "data provenance" (country of origin of data, retrospective/prospective) are not applicable in the same way. The testing would have been conducted in a laboratory setting.

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

Not applicable. For a physical medical device submission like this, "ground truth" as it relates to expert consensus or labeling of images/data for AI training/testing is not relevant. The performance is assessed against engineering specifications, industry standards (e.g., ASTM F623, ISO 10993), and direct comparison to a predicate device.

4. Adjudication Method for the Test Set:

Not applicable. This concept is typically relevant to AI/ML where human reviewers might adjudicate disagreements in interpretations. For physical device testing, the methods are typically standardized and objective (e.g., measuring flow rate, instrumental assessment of friction).

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. An MRMC study is designed for evaluating diagnostic or interpretive AI systems in a clinical setting by comparing human performance with and without AI assistance. This submission is for a physical urological catheter, not an AI-enabled diagnostic tool.

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

Not applicable. This device is not an algorithm. Performance is assessed on the physical device itself.

7. The Type of Ground Truth Used:

For the physical and biocompatibility testing, the "ground truth" is derived from:

• Engineering Specifications: The design specifications of the device.
• Predicate Device Performance: The known and established performance of the legally marketed predicate device (Rusch® FloCath - K000070). The subject device aims to be "substantially equivalent."
• International Standards: Adherence to standards such as ASTM F623 for physical properties and ISO 10993 series (1, 5, 10) for biocompatibility.

8. The Sample Size for the Training Set:

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

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

Not applicable. This is not an AI/ML device that requires a training set or ground truth in that context.

Ask a specific question about this device

The Intermittent Urethral Catheters are indicated for routine drainage of fluids from the bladder. These catheters are not intended or designed for indwelling use.

The Rusch® Intermittent Urethral Catheters are single use, uncoated, disposable and sterile. The catheter is comprised of a tip, shaft, and funnel. The catheter tube is made of polovviny chiloride (PVC), the tip of a PVC/liquid colored PVC which is cured to the tube and a catheter funnel also made of PVC. The dimensions range from Charrièr (Ch.) Ch. 10 to Ch. 24 which is a range of 3.3 mm to 7.9 mm in Outer Diameter with a length 40 cm. The catheters are produced with two different tips - Tiemann and Nelaton-Robinson. Each catheter size has a color-coded tip.

The Nelaton-Robinson catheters have a size range from 10 Ch. to 24 Ch. and have two drainage holes. The Tiemann catheters have a size range from 12 Ch. and also have two drainage holes. Additionally the Tiemann and Nelaton-Robinson catheters also contain funnel adhesive solution to which the funnel is adhered to the shaft and hot embossing film or tint for printing text on the catheter.

The provided text describes a 510(k) premarket notification for the "Rusch® Intermittent Urethral Catheters". The document primarily focuses on demonstrating substantial equivalence to a predicate device (K033023). It does not contain information about acceptance criteria and a study proving device meeting acceptance criteria in the way these terms are typically used for AI/ML device evaluations (i.e., performance metrics, ground truth, expert adjudication, MRMC studies, etc.).

Instead, it details the non-clinical performance testing performed to demonstrate substantial equivalence to the predicate device. For this type of medical device (a catheter), "acceptance criteria" would typically refer to meeting industry standards and performance benchmarks for physical and functional characteristics, rather than diagnostic accuracy metrics.

Here's a breakdown of the available information from the provided text, framed as closely as possible to your request, but highlighting what is not present:

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

The document does not explicitly present a table of "acceptance criteria" with corresponding "reported device performance" in the format typically seen for AI/ML diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, it lists non-clinical performance tests that were conducted to establish substantial equivalence.

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 document. The document describes non-clinical (bench) testing, not a clinical study involving 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 (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. The evaluation is based on non-clinical engineering and biocompatibility tests, not expert interpretation of diagnostic images or patient cases.

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

This information is not applicable/provided. There is no "test set" in the context of diagnostic interpretation that would require 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

This information is not applicable/provided. The device is an intermittent urethral catheter, not an AI/ML diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant.

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

This information is not applicable/provided. The device is a physical medical device (catheter), not an algorithm.

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

For the non-clinical performance tests, the 'ground truth' is effectively established by standardized laboratory testing procedures and ISO standards (e.g., ISO 10993 for biocompatibility), and comparison to the characteristics of the legally marketed predicate device.

8. The sample size for the training set

This information is not applicable/provided. This is a physical medical device, not an AI/ML algorithm requiring a training set.

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

This information is not applicable/provided.

Ask a specific question about this device

The Rusch Brilliant Balloon Catheter is indicated for routine transurethral drainage of the bladder.

The Rusch Silicone Foley Catheter is a balloon retention type catheter and is single use, disposable and sterile. The retention balloon is attached to the silicone two-lumen shaft. One lumen is used for drainage and the other lumen for inflation of the balloon. Sterile water is used to inflate and deflate the balloon. The distal end has two opposite eye holes which are used for drainage. On the opposing end of the shaft are a connective funnel and a Luer activated valve.

The provided document is a 510(k) Summary for the Rusch Silicone Foley Catheter, which is a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific efficacy or diagnostic performance acceptance criteria through clinical studies. Therefore, much of the information requested about acceptance criteria and detailed study design for diagnostic performance is not present in this document.

However, I can extract information related to the non-clinical performance testing which served to demonstrate substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific numerical acceptance criteria (e.g., a specific peel strength in Newtons) or reported numerical performance data for the subject device. It states what was tested and the conclusion that the subject device is substantially equivalent.

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

• Sample Size: Not specified for any of the individual non-clinical performance tests.
• Data Provenance: The tests are "bench testing" which are conducted in a laboratory setting. No country of origin is specified for these tests, but the applicant is Teleflex Medical, Inc. in the USA. The data is retrospective in the sense that the tests were performed and analyzed to support this 510(k) submission.

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

This type of information is not applicable to the non-clinical performance (bench testing) described. Bench tests do not involve expert interpretation or ground truth establishment in the way a clinical diagnostic study would.

4. Adjudication Method for the Test Set

This is not applicable as there were no expert interpretations requiring adjudication for these bench tests.

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

No MRMC study was done. This document describes a medical device (catheter) for drainage, not an AI or diagnostic imaging device that would typically involve an MRMC study.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study of an algorithm was done. This is a physical medical device.

7. Type of Ground Truth Used

For the bench tests, the "ground truth" would be the engineering specifications and established test methods (e.g., ISO standards, internal company standards) for measuring properties like peel strength, security, and reliability. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense. For biocompatibility, the ground truth is established by the successful completion of tests adhering to ISO 10993.

8. Sample Size for the Training Set

No training set is mentioned or applicable. This is not a machine learning or AI device.

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

Not applicable as there is no training set.

Ask a specific question about this device

These catheters are indicated for routine transurethral drainage of the bladder or for routine post-operative transurethral drainage and irrigation of the bladder.

The Rusch Simplastic Folev Catheter is a balloon retention type catheter and is single use, disposable and sterile. The catheters are made of transparent PVC. They have a 2 lumen or 3 lumen shaft with proximal funnel, inflation valve and a distal retaining balloon made of latex. Balloon capacity is in ml and the shaft size in French gauge (Fr.) as indicated on the funnel of each individual catheter.

This document is a 510(k) summary for the Rusch Simplastic Foley Catheters (K162989). It focuses on establishing substantial equivalence to predicate devices through a comparison of features and non-clinical performance testing. It does not describe a study in the typical sense of evaluating AI performance or human reader improvement.

Therefore, the requested information, which is largely geared towards evaluating an AI/CADe device's performance, cannot be extracted from this document. This document concerns a medical device (foley catheters), not an AI system. The "acceptance criteria" here refers to the device meeting specific engineering and performance standards, not diagnostic accuracy metrics.

However, I can extract the relevant non-clinical performance testing information as an analogy to acceptance criteria and the study that proves it, interpreting "device performance" in the context of a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The document states "bench testing" was performed, but does not detail the sample sizes for each test. Data provenance (country of origin, retrospective/prospective) is also not applicable for physical device bench testing in the same way it would be for clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as this is not a study requiring expert interpretation of results for ground truth establishment (e.g., image interpretation). These are physical device performance tests.

4. Adjudication method for the test set:
This information is not applicable as this is not a study requiring adjudication of expert interpretations.

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 applicable as this document does not describe a study involving human readers or AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as this document does not describe an algorithm or AI system.

7. The type of ground truth used:
For the non-clinical performance tests, the "ground truth" would be established engineering specifications and regulatory standards. For example, a "Balloon Peel Strength" test would have an a priori defined minimum force requirement for the balloon to remain attached. For biocompatibility, the ground truth is compliance with ISO 10993 standards.

8. The sample size for the training set:
This information is not applicable as this document does not describe a machine learning model or training set.

9. How the ground truth for the training set was established:
This information is not applicable as this document does not describe a machine learning model or training set.

Ask a specific question about this device

Rusch tracheal tubes are indicated for airway management by oral or nasal intubation of the trachea.

The proposed Teleflex Medical Rusch Safety Silk Pediatric Tracheal Tube Series tracheal tubes are sterile, single use devices that are made from Polyvinyl chloride (PVC) resin that is formulated without DEHP ("Non-DEHP" =

The document provided describes a 510(k) premarket notification for the Teleflex Medical Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube. It does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML performance, but rather outlines performance testing for a medical device.

Therefore, many of the requested categories related to AI/ML studies are not applicable. However, I can extract the acceptance criteria and a summary of the performance studies mentioned for the medical device itself.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document states, "Performance test results demonstrate that the proposed device meets its intended use." This is a general statement rather than a detailed report of specific study outcomes for each acceptance criterion. The tests conducted were primarily engineering and material characterization tests to ensure the physical and functional aspects of the tracheal tube met specifications, often by comparing them to existing "current data" or "specifications." The overall conclusion drawn is that the device is substantially equivalent to its predicates.

The following information is not present in the provided document, as it pertains to a different type of medical device assessment (AI/ML performance studies) than what is described for this tracheal tube:

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical medical device, not an AI/ML system.
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.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as there is no "ground truth" in the AI/ML sense for a physical tracheal tube's performance tests. The "ground truth" for these tests would be the established engineering specifications and material properties.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device