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The Nest VT Vitrification Device is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos and blastocyst stage embryos.

The subject devices, Cook Nest VT Vitrification Devices, are sterile, single-use assisted reproduction storage devices for use in vitrification procedures to contain and maintain oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos. The Cook Nest VT Vitrification Devices are composed of a stick (124.5 mm) and cap (38.5 mm) design with a combined length of 136.5 mm, a 35 mm space for notations, and a 6 mm long loading well. Visible marks are on the distal tip end, on the body of the stick and at the opening of the cap, which are created through laser etching to indicate the location of the tip, the upright orientation of the device and the opening of the cap, respectively. The stick and cap include a taper design that create a seal when assembled. All the subject devices included in this submission are identical except for their color. There are 5 different colors: blue, purple, red, yellow, and green. The subject devices are sterilized using gamma radiation to a sterilization assurance level of 10-9, are one-time use, and have a 2 year shelf-life. During the vitrification procedure, the oocytes or embryos are loaded on the tip of the stick and the stick is capped prior to plunging the device in liquid nitrogen and for subsequent storage.

The provided document is a 510(k) summary for the "Nest VT Vitrification Device". It outlines the device's indications for use, comparison to a predicate device, and a summary of non-clinical performance testing. However, it does not contain information on a study proving the device meets acceptance criteria related to AI/algorithm performance, human reader improvement with AI assistance, or the establishment of ground truth by multiple experts.

The document describes the device as a "cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos and blastocyst stage embryos." The performance testing discussed (sterilization, endotoxin, cooling/warming rates, MEA testing, package integrity, mechanical performance) are related to the physical and biological compatibility of the device itself, not to an AI or diagnostic algorithm's performance.

Therefore, I cannot fulfill your request as the provided text does not describe a study involving an AI or algorithm, nor does it detail acceptance criteria and performance data for such a system. The questions you posed (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are relevant to the evaluation of AI/ML-based medical devices, which this document does not concern.

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The product has been designed for retrieval of implanted Günther Tulip and Cook Celect Vena Cava Filters in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.

The Günther Tulip Vena Cava Filter Retrieval Set is composed of a retrieval loop system with a braided platinum wire loop, a coaxial retrieval sheath system, an entry needle, a wire guide, and a dilator. The outer sheath is provided with a radiopaque band on the distal tip to assist in positioning of the sheath. The Günther Tulip Vena Cava Filter Retrieval Set is intended to retrieve the implanted Günther Tulip and Cook Celect Vena Cava Filters in patients who no longer require a filter.

The Günther Tulip Vena Cava Filter Retrieval Set is a packaged, sterile device intended for single use.

The provided document is a 510(k) premarket notification for a medical device called the "Günther Tulip Vena Cava Filter Retrieval Set." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study for a specific performance claim (e.g., diagnostic accuracy for an AI device).

The document states that modifications were made to the predicate device, specifically a change in the dilator material and a change in the o-ring material. To demonstrate that these changes do not negatively impact safety and effectiveness, the manufacturer performed non-clinical performance tests.

Therefore, the information requested in your prompt regarding acceptance criteria, study design parameters (sample size, experts, ground truth, MRMC study, standalone performance), and training set details are not applicable (N/A) in the context of this specific 510(k) submission for a mechanical medical device. These types of details are typically required for AI/ML-based medical devices or devices making specific claims about diagnostic or predictive performance.

Here's a breakdown of the requested information based on the provided document:

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)

N/A - This document describes non-clinical performance testing (biocompatibility, dimensional, leakage, tensile) of a mechanical device. There is no "test set" in the context of patient data, nor is there data provenance as would be relevant for clinical studies or AI/ML evaluation. These were laboratory-based physical tests.

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)

N/A - No human expert "ground truth" was established as this was non-clinical performance testing of a mechanical device.

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

N/A - Adjudication methods are not applicable to the non-clinical performance testing 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

N/A - This device is a mechanical Vena Cava Filter Retrieval Set, not an AI-based system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

N/A - This is a mechanical device, not an algorithm.

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

N/A - For the non-clinical tests, the "ground truth" would be the engineering specifications and recognized standards (e.g., ISO 10993 for biocompatibility) against which the device's physical performance was measured. There is no biological or outcome-based ground truth mentioned.

8. The sample size for the training set

N/A - No "training set" is relevant for this type of mechanical device submission.

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

N/A - See point 8.

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The Bakri Essential Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

The Bakri Essential Postpartum Balloon is composed of a double lumen silicone balloon catheter and a stopcock. The balloon catheter has a balloon with maximum inflation volume of 500 mL and a 24 Fr silicone shaft with an overall length of 58 cm, which includes the working length of 54 cm and proximal fittings. The shaft has two lumens, one designated for drainage, and the other for balloon inflation. The Bakri Essential is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

The Bakri Essential Postpartum Balloon is packaged in a Tyvek®Polyethylene Peel-Open Pouch with five individually packaged and labeled products per marketing carton, is provided sterile, and is intended for one time use.

This document is a 510(k) premarket notification for the Bakri Essential Postpartum Balloon, a medical device. It does not describe a study involving an AI/ML device, therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific aspects cannot be extracted.

The document discusses the substantial equivalence of the Bakri Essential Postpartum Balloon to a predicate device (Bakri Postpartum Balloon, K170622). It focuses on non-clinical performance testing related to packaging modifications and the removal of a syringe from the product set, not on a study proving a device's performance against specific clinical acceptance criteria in the context of an AI/ML system.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance (in the context of an AI/ML device).
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size with AI assistance.
6. Whether standalone performance was done for an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

The "Summary of Non-clinical Performance Testing" section details tests performed for the physical device's packaging and sterilization integrity, with specific acceptance criteria for those tests:

• Pouch Seal Strength Testing: Minimum seal strength shall meet or exceed 1.2N per 15mm when tested in accordance with ASTM F88-15.
• Bubble Leak Testing: Packaging shows no signs of cracks, pinholes, or imperfect seals indicated by bubbles, per ASTM F2096-11.
• Dye Penetration Testing: No packaging seal may be breached by dye per F1929-15.
• Additional distribution testing followed by functional verification: Device shows no signs of damage after sterilization and simulation distribution.

These criteria and tests relate to the physical integrity and sterility of the packaged device, not a performance study of a diagnostic or therapeutic AI/ML algorithm.

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Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular applications in the arterial system.

Endovascular Dilator and Sets are manufactured from vinyl radiopaque dilator tubing and consist of either one or two dilators that are used percutaneously to dilate puncture sites or catheter tracts, thereby facilitating the placement of other therapeutic or diagnostic devices into an artery for vascular clinical applications that require percutaneous access. The serial dilator components are designed with long, gradual tapers and include hydrophilic coating, and are available in various inner and outer diameter and length combinations.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "Endovascular Dilator and Sets." This type of document is a regulatory submission for medical devices, not a study report or clinical trial. Therefore, it does not contain the detailed information about acceptance criteria, study methodologies, or performance results that would be found in a clinical study publication.

Specifically, the document states:
"There are no device, material, or design changes to any of the devices included in the Endovascular Dilator and Sets. Since there is no design change to the device subject of this submission, the testing that was provided for the predicate device in submission K183036 remains to support this submission. No additional testing or design control activities or risk assessment are required to support substantial equivalence."

This indicates that the FDA clearance for this device (K210734) is based on its substantial equivalence to a previously cleared predicate device (K183036), meaning no new performance studies were conducted for this specific submission to demonstrate the device meets acceptance criteria. The original testing for the predicate device (K183036) would contain such information.

Therefore, I cannot provide the requested information from this document because it is not a study report. The document asserts that no new testing was performed specific to this submission (K210734) as the device itself hasn't changed.

To address your request, one would need access to the 510(k) submission for the predicate device, K183036, as that is where the original performance data and testing details would be described.

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Extra Large Check-Flo introducers and guiding sheaths are intended to introduce therapeutic devices into the vasculature.

Cook Incorporated's Extra Large Check-Flo® Introducer is a single-use, sterile, disposable product that is used to introduce therapeutic or diagnostic devices into the vasculature. The Extra Large Check-Flo® Introducer consists of an introducer sheath, Check-Flo® hemostatic valve assembly, and dilator. The sheath is constructed with a hemostatic valve that accepts a large range of French sizes while preventing blood reflux and air aspiration. The subject device, the Extra Large Check-Flo® Introducer, is manufactured in diameters of 20.0, 22.0 and 24.0 French with sheath lengths of 25, 40, or 65 centimeters. The dilator is manufactured in lengths 16 centimeters longer than the sheath (41, 56, and 81 centimeters, respectively). The diameter of the distal endhole of the dilator measures 0.035 inch. The introducer sheath and dilator are matched as a unit to provide a smooth transition.

Based on the provided text, the document is a 510(k) Premarket Notification for a medical device called the "Extra Large Check-Flo® Introducer." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) application.

Therefore, the information typically requested in your prompt regarding acceptance criteria for AI/ML device performance (e.g., sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not applicable to this document. This document describes the acceptance criteria and study that proves a physical medical device (a catheter introducer) meets performance specifications, not an AI/ML-based diagnostic or therapeutic device.

However, I can extract the acceptance criteria and the performance results for the physical device as described in the provided text.

Here's the relevant information from the document:

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

The document lists various tests performed and states that the "Test results met predetermined criteria" or "The predetermined acceptance criterion was met." Specific numerical acceptance criteria values are generally not provided in this summary, but the success of meeting them is stated.

Regarding the other points of your prompt (2-9), these are not applicable to the information provided in this 510(k) summary for a physical medical device:

• 2. Sample sized used for the test set and the data provenance: Not applicable. This refers to a physical device, not an AI/ML model with test data. The number of physical units tested per criterion is not specified.
• 3. Number of experts used to establish the ground truth... and the qualifications of those experts: Not applicable. Ground truth as typically understood in AI/ML (e.g., expert labels on images) is not relevant here. Device performance is measured by physical tests according to standards.
• 4. Adjudication method: Not applicable. Device performance is determined by adherence to engineering specifications and international standards, not expert adjudication of diagnostic outcomes.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. This is for AI/ML diagnostic or assistive devices, not for a catheter introducer.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm involved.
• 7. The type of ground truth used: Not applicable. Device performance is measured against engineering specifications and test standards (e.g., tensile strength, dimensions, biocompatibility), not clinical "ground truth" derived from patient outcomes or expert consensus in the diagnostic sense.
• 8. The sample size for the training set: Not applicable. This is a physical device, not an AI/ML model that undergoes training.
• 9. How the ground truth for the training set was established: Not applicable. See point 8.

In summary: The provided document is a 510(k) summary for a physical medical device. It demonstrates performance by stating that the device passed a series of engineering and biocompatibility tests in accordance with established industry standards and internal specifications, thus supporting its substantial equivalence to a predicate device. It does not contain information related to AI/ML model performance or associated clinical study designs.

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Cook-Cope Loop Nephrostomy Set: This device is used for percutaneous placement of a loop catheter in the renal pelvis for nephrostomy drainage.

Ultrathane Nephrostomy Set with Mac-Loc: This device is used for percutaneous placement of a loop catheter in the renal pelvis for nephrostomy drainage.

Ultrathane Suprapubic Set with Mac-Loc: The Ultrathane Suprapubic Set with Mac-Loc is used to provide bladder drainage by percutaneous placement of a loop catheter.

The bundled submission includes the Cook-Cope Loop Nephrostomy Set, Ultrathane® Nephrostomy Set with Mac-Loc®, and the Ultrathane® Suprapubic Set with Mac-Loc®

• . Cook-Cope Loop Nephrostomy Set and Catheter: The catheter is placed using standard percutaneous nephrostomy techniques into the kidney. The catheter is then secured in place by pulling the suture taut to create the distal retention loop, wrapping around the catheter shaft and knotting the suture. The latex is then folded over the suture and the excess suture is cut off. The catheter is kept in place within the patient using a retention disc.
• . Ultrathane Nephrostomy Set with Mac-Loc: The catheter is placed using standard percutaneous nephrostomy techniques. The catheter is then secured in place by pulling the suture taut to create the distal retention loop. While maintaining traction on the monofilament, the locking cam lever is pushed down until a distinct "snap" is felt. The catheter's distal loop is now locked into position. The excess suture is trimmed off. The catheter is then kept in place within the patient using a retention disc.
• Ultrathane Suprapubic Set with Mac-Loc: The catheter is placed using standard . suprapubic techniques. The catheter is then secured in place by pulling the suture taut to create the distal retention loop. While maintaining traction on the tether, the locking cam lever is pushed down until a distinct "snap" is felt. The catheter's distal loop is now locked into position. The excess suture is trimmed off. The catheter is then kept in place within the patient using the enclosed StatLock device.

The subject percutaneous drainage catheter sets consist of a flexible tube with an open distal tip and drainage holes. The distal end of the subject devices has either a Mac-Loc locking loop or a cope loop. A Mac-Loc locking loop mechanism secures the distal catheter loop configuration by means of a nylon monofilament. After the catheter is placed in the desired location, the nylon thread is pulled tight to form the distal loop configuration. Then the locking cam lever can be pushed down to snap into position, thereby locking the distal loop in position. The cope loop configuration is formed by pulling back the suture, and then the loop can be locked in place by sliding a latex sleeve over the suture.

Some catheter sets have a radiopaque marker to aid the user in placement. The proximal hub assembly of the devices provides a Luer lock hub to allow the user to connect to a fluid collection device (not subject of this submission). Accessories include introducing catheters, catheter securing devices, needles, cannulas, stylets, dilators, and wire guides.

The provided text is a 510(k) Summary for medical devices and does not contain information about acceptance criteria or a study proving that the device meets such criteria in the context of an AI-powered diagnostic system. Instead, it describes performance testing conducted to demonstrate substantial equivalence to predicate devices for traditional medical devices (catheter sets).

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them, nor can I provide information regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information is not present in the provided document.

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Used to gain precise percutaneous access to the kidney by means of controlled fine wire puncture from within the collecting system for patients aged 12 years and older.

The Lawson Retrograde Nephrostomy Wire Puncture Set is used to gain percutaneous access to the kidney by means of a controlled fine wire puncture from within the collecting system.

The Lawson Retrograde Nephrostomy Wire Puncture Set is composed of the tipdeflecting wire guide, catheter, sheathed puncture wire, coaxial needle assembly (inner and outer needle cannulae) and working wire guide. The tip-deflecting wire guide is used to direct the catheter into the desired calyx in a retrograde manner using standard access techniques, followed by exchange of the deflecting wire with the sheathed puncture wire. To initiate percutaneous nephrostomy access, the puncture wire is unsheathed and advanced from the catheter through the kidney towards the patient's flank and through the skin. The coaxial needle assembly is then advanced over the puncture wire and into the renal collecting system, and then the puncture wire and inner needle cannula are removed to allow a working wire guide to be placed through the outer needle cannula.

• . The tip-deflecting wire guide has a three-ring handle which twist-locks with the catheter. The tip-deflecting wire guide is made from stainless steel and is available in an outer diameter of 0.045 in.
• . The catheter is available in an outer diameter of 7 Fr with a length of 82.5 cm and made of braided nylon tubing. The sheathed puncture wire can interlock with the proximal portion of the catheter.
• The sheath is made of radiopaque TFE tubing which extends 1 cm from the . catheter when locked together. The sheath is available in an outer diameter of 3 Fr with a length of 85 cm.
• . The puncture wire is made of stainless steel with a plastic pin vise handle. The puncture wire has an outer diameter of 0.43 mm with a length of 145 cm.
• . The needle set has a 22 gage inner needle that is 22.5 cm in length with the outer needle being 18 gage and 14 cm in length.
• . The working wire guide is made of stainless steel and is 0.97 mm in diameter and 145 cm in length.

The set will be supplied sterile and is intended for one-time use. The set is packaged in a peel-open pouch with a three-year shelf life.

The provided text describes a medical device, the Lawson Retrograde Nephrostomy Wire Puncture Set, and its 510(k) submission to the FDA. However, the document does not contain information related to acceptance criteria or a study proving the device meets those criteria in the context of AI/ML or diagnostic performance.

The performance data listed refers to engineering and biocompatibility tests for a physical medical device, not a diagnostic algorithm or AI system. Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria, study details, human reader performance, or ground truth for an AI-based device.

The "Performance Data" section lists the following tests:

• Biocompatibility
• Compatibility (likely referring to component compatibility)
• Dimensional
• Tensile Strength (Hub-to-Shaft Bond of Catheter, Sheath, Stylet, Needles; Tip-to-Shaft Bond of Catheter; Distal Tip of Deflecting Wire; Shaft of Puncture Wire)
• Radiopacity
• Shelf Life following Accelerated Aging to Three-year Real-Time Equivalency
• Packaging, Sterility and Stability

These are standard tests for physical medical devices to ensure safety, functionality, and manufacturing quality. The document concludes: "All predetermined acceptance criteria of the testing were met. Therefore, the results of these tests support a conclusion that the Lawson Retrograde Nephrostomy Wire Puncture Set will perform as intended and support a determination of substantial equivalence to the predicate device."

Since the provided text does not describe an AI/ML device or its associated performance study, I cannot fill out the requested table or answer the questions related to AI performance, expert adjudication, or training/test sets for an AI model.

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Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.

Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.

Weinmann-Multi Tracheostomy Exchange Set is intended for adult tracheostomy tube exchange.

The subject devices Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set/Tray and the Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set/Tray are designed for percutaneous dilational tracheostomy for management of the airway. The devices allow for single-stage dilation, which is achieved with a single rhino-horn-shaped dilator using an in-andout motion. Sets and trays include a Blue Rhino G1 Dilator or Blue Rhino G2 Dilator, loading dilators (6.5, 7.0, 7.5, 8.0, 8.5, 9.0, and 10.0 mm) an 8 Fr guiding catheter, a 14 Fr access dilator, and a wire guide. Sets and trays are available in multiple configurations, which include various set and tray components (Table 1) associated with the procedure and/or for gaining percutaneous access.

The subject device Weinmann-Multi Tracheostomy Exchange Set is comprised of a Blue Rhino G1 Dilator, loading dilators (7.0, 7.5, 8.0, 8.5, and 9.0 mm), an 8 Fr Cook Airway Exchange Catheter, and two Rapi-Fit Adapters.

This document is a 510(k) Premarket Notification from the FDA, focusing on the substantial equivalence of medical devices. It primarily compares new devices to previously cleared predicate devices. Therefore, the information typically requested about acceptance criteria and detailed study designs for performance evaluation of AI/ML-based medical devices (like training/test set sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance) is not present for this specific type of device and submission.

The document states that the safety and/or effectiveness of the subject device for modifications (new sizes, OD changes, package/labeling changes) are supported by performance testing and biocompatibility testing. However, it does not provide the detailed acceptance criteria and study results in the format requested for an AI/ML device.

Based on the provided text, here's what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

The document lists several tests performed and states that "The pre-determined acceptance criteria were met" for some mechanical tests. However, it does not provide specific numerical acceptance criteria or the reported performance data.

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

Not provided. The document mentions "performance testing" and "biocompatibility testing" but does not specify sample sizes for these tests, nor the data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typical for detailed clinical or AI/ML performance studies, not for the manufacturing and material changes of a device like this.

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

Not applicable/Not provided. This information is relevant for studies involving human interpretation or clinical outcomes used as ground truth, particularly in AI/ML performance evaluations. For physical medical devices undergoing performance and biocompatibility testing for manufacturing changes, this concept of "ground truth" established by experts in a test set is not directly relevant in the same way.

4. Adjudication method for the test set

Not applicable/Not provided. Similar to point 3, adjudication methods are used in studies where there's variability in interpretation (e.g., expert readers reviewing medical images). This is not applicable to the types of performance and biocompatibility tests described for this device.

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. An MRMC study is not mentioned. This type of study is specific to evaluating AI/ML systems that assist human readers in tasks like image interpretation. This submission is for a physical medical device (tracheostomy introducer/exchange set) and does not involve AI assistance.

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

No. This is not applicable as the submission is for a physical medical device, not an algorithm.

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

Not explicitly provided in specific detail for each test. For the physical performance tests (like security of attachment, compression force, tensile strength, verification of outer diameter), the "ground truth" would be the engineering specifications and established standards (e.g., BS EN ISO 5366:2016 for security of attachment). For biocompatibility, the ground truth is defined by the biological response assays and limits set by ISO standards (ISO 10993-5, -7, -10, -11, -12). The document states compliance with these standards, implying that the results met the requirements dictated by these standards for safety.

8. The sample size for the training set

Not applicable/Not provided. This concept is specific to AI/ML models. The devices here are physical medical devices, not AI algorithms, so there is no training set in this context.

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

Not applicable/Not provided. As there is no training set for an AI/ML model, this question is not applicable.

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"Intended for the intravascular introductional devices into the peripheral, including pulmonary, vasculature."

Lumax® Guiding Catheters are conduits introduced, either singly or as a coaxial pair, into a vein or artery and tracked over a wire guide to the site of a vascular lesion where interventional devices can be delivered through the guiding catheter's internal lumen for treatment. The Lumax® Guiding Catheters may include either a single guiding catheter or a coaxial catheter pair (composed of an outer guiding catheter and an inner coaxial catheter). The single guiding catheters are available in a 7.0 French outer diameter in lengths of 80 or 90 cm. They are manufactured with a multilayered braided nylon shaft, bonded Luer hub, and radiopaque tip. The guiding catheters are designed with a multipurpose (MPA) distal curve configuration. The coaxial catheter pair comprises an outer guiding catheter matched to an inner coaxial catheter. The guiding catheter component is available in an outer diameter of 8.0 French and a length of 80 cm. The inner coaxial catheter is manufactured from radiopaque braided nylon tubing and has an outer diameter of 6.0 French and a length of 100 cm. For lubricity, the distal 40 cm of the inner catheter is treated with hydrophilic coating. The Lumax® Guiding Catheters are supplied as packaged, sterile devices, intended for single-patient use.

The provided text describes the Lumax® Guiding Catheters and their acceptance criteria through various performance tests. However, it does not include a study that proves the device meets acceptance criteria for an AI/CADe device, as this device is a physical medical catheter, not a software or AI-based diagnostic tool.

Therefore, many of the requested categories for AI/CADe studies will not be applicable or present in this document.

Here's the information extracted from the document regarding the acceptance criteria and performance of the Lumax® Guiding Catheters:

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

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

This information is not provided in the document. The document describes laboratory performance testing, not a clinical trial with a "test set" and "data provenance" in the context of an AI/CADe study.

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 and not provided. The testing described is performance testing of a physical device against engineering and safety standards, not an evaluation requiring expert interpretation of results to establish ground truth.

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

This is not applicable and not provided.

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 is not applicable and not provided, as this is a medical device (catheter) and not an AI or CADe system.

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

This is not applicable and not provided, as this is a medical device (catheter) and not an AI or CADe system.

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

The "ground truth" for this device's performance testing is based on established engineering standards (e.g., ISO, BS EN ISO) and pre-determined acceptance criteria for physical and mechanical properties, as well as biocompatibility.

8. The sample size for the training set

This is not applicable and not provided. This document describes the performance testing of a manufactured medical device, not the training of an AI model.

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

This is not applicable and not provided. There is no concept of a "training set" or "ground truth" establishment for training in the context of this device's regulatory submission.

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The McLean-Ring Nasojejunal Feeding Tube Set is intended for enteral feeding and medication in adult and pediatric populations. The device is intended to be used in the treatment of the following pediatric subgroups: children and adolescents.

The McLean-Ring Nasojejunal Feeding Tube Set is composed of a feeding tube and wire guide. The feeding tube is made of a 9.5 French polyurethane tube. The feeding tube is available in 130 centimeters only, measured from the distal tip to the proximal hub. The distal end of the feeding tube features six sideports. The distal tip of the feeding tube is open with a smooth round finish. A 0.650-inch long stainless steel weight is fit outside the distal end of the feeding tube and is completely covered with a shrink tube, forming 0.180-inch outer diameter over the weight. The proximal end of the feeding tube features a hub with a cap that is made of polyurethane. The wire guide is made of stainless steel in a 0.038-inch diameter. The wire guide is 275 centimeters long. In addition, the entire length of the wire guide is coated with PTFE. The distal end of the wire guide is straight but flexible. The subject device, McLean-Ring Nasojejunal Feeding Tube Set, may be introduced directly when there is adequate peristalsis and no gastric outlet obstruction. Alternatively, the feeding tube may be passed over a wire guide. The feeding tube is intended to be indwelling up to 30 days and is for one-time use.

The provided document is a 510(k) Premarket Notification from Cook Incorporated for the McLean-Ring Nasojejunal Feeding Tube Set. It describes the device, its intended use, and its comparison to a predicate device (Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube).

Critically, this document describes a medical device, specifically a feeding tube, not an AI/ML-based medical device. Therefore, the concepts of "acceptance criteria for an AI/ML device," "study proving the device meets acceptance criteria for an AI/ML device," "sample size used for the test set," "data provenance," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "training set," and "how ground truth for training set was established" are not applicable to the information provided.

The document focuses on the substantial equivalence of a physical medical device. The "studies" mentioned are bench testing to assure reliable design and performance (e.g., dimensional, flow rate, kink resistance, MRI compatibility) and biocompatibility testing. Additionally, clinical evidence is provided through a review of published literature on the use of similar feeding tubes in pediatric patients. This literature review is used to support the safety and performance for the device's intended use in children and adolescents, not to prove the performance of an AI algorithm.

Since the request is about an AI/ML device and the provided text describes a physical medical device, I cannot extract the requested information.

If you have a document describing an AI/ML medical device, please provide it, and I will be able to answer your questions accordingly.

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