Search Results

The CoapTech PUMA-G Pediatric System is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube. The PUMA-G Pediatric System is intended to be utilized in pediatric patients that meet criteria for minimum weight (15 kg) and appropriate abdominal wall thickness (between 0.6 cm and 3.0 cm), as stated in the instructions for use.
To Aid in Percutaneous Access to the Stomach During Gastrostomy Tube Placement.

The PUMA-G Pediatric System is a medical device designed to aid in the initial placement of permanent feeding tubes, which are placed via percutaneous gastrostomy. Historically, gastrostomy tubes have been placed using either endoscopy or radiography (e.g., fluoroscopy) for visualization. The PUMA-G Pediatric System provides visualization by ultrasound, allowing the user to assess the future gastrostomy tract prior to placement. The PUMA-G Pediatric System contains three main custom components: a balloon catheter, a guidewire, and an external magnet. An internal magnet within the balloon catheter is placed orogastrically into the stomach, where it is pulled up to the anterior abdominal wall by the external magnet. After filling the balloon with fluid, the user's existing ultrasound is used for visualization of the future gastrostomy tract and for ultrasound-guided needle placement. The guidewire is then inserted and snared by the balloon, and the paired unit (balloon catheter and guidewire) is then pulled out the mouth. A gastrostomy tube is then placed over the guidewire using either the Sachs-Vine PUSH technique or the Ponsky PULL technique.

The provided FDA 510(k) clearance letter and summary for the PUMA-G Pediatric System describe a medical device designed to aid in the initial placement of gastrostomy feeding tubes. The summary outlines some performance testing, including a small safety clinical study. However, the document does not contain the detailed acceptance criteria or the specific study design elements (beyond a "small safety clinical study" and "single-center study") that would typically be reported for an AI/software device that needs to meet performance criteria for metrics like sensitivity, specificity, or accuracy based on a test set.

The PUMA-G Pediatric System appears to be a mechanical device with an ultrasound visualization component, not an AI/software-driven diagnostic or assistive device that would rely on a test set with ground truth established by experts and MRMC studies. The "performance data" mentioned focuses on mechanical, biocompatibility, and sterilization aspects, along with a safety study.

Therefore, many of the requested information points (e.g., sample size for the test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not present in the provided document, as they pertain to the rigorous evaluation of AI/software algorithm performance against established ground truth, which is not the primary focus of this device's clearance.

Based on the provided information, here's an attempt to answer the questions, highlighting where information is absent or non-applicable:

Device Description

The PUMA-G Pediatric System is a medical device designed to aid in the initial percutaneous placement of a gastrostomy feeding tube. It utilizes a balloon catheter with an internal magnet and an external magnet to coapt the stomach to the anterior abdominal wall. Users then employ their existing ultrasound for visualization and guided needle placement. The system also includes a guidewire.

Acceptance Criteria and Performance Study Analysis (Based on Provided Document)

Given the nature of the device as a mechanical aid with ultrasound visualization (rather than an AI/software algorithm for diagnosis or image analysis), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on safety, functional performance, and effectiveness in facilitating the procedure, rather than typical AI performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for performance metrics in the way one would see for an AI algorithm (e.g., sensitivity, specificity thresholds). Instead, the performance is described qualitatively and through the outcomes of a safety study.

Ask a specific question about this device

The CoapTech PUMA-G System (PUMA-G) is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube in adults and adolescents of sufficient size ("Transitional Adolescent B" patients 18 to 21 years of age with no special considerations compared to adults).

The PUMA-G System is a medical device designed to aid in the initial placement of permanent feeding tubes, which are placed via percutaneous gastrostomy. Historically, gastrostomy tubes have been placed using either endoscopy or radiography (e.g., fluoroscopy) for visualization. The PUMA-G System provides visualization by ultrasound, allowing the user to assess the future gastrostomy tract prior to placement. The PUMA-G System contains three main custom components: a balloon catheter, a guidewire, and an external magnet. An internal magnet within the balloon catheter is placed orogastrically into the stomach, where it is pulled up to the anterior abdominal wall by the external magnet. After filling the balloon with fluid, the user's existing ultrasound is used for visualization of the future gastrostomy tract and for ultrasound-guided needle placement. The guidewire is then inserted and snared by the balloon, and the paired unit (balloon catheter and guidewire) is then pulled out the mouth. A gastrostomy tube is then placed using the guidewire and Seldinger technique.

The provided text describes the PUMA-G System, a medical device intended to affix the stomach to the anterior abdominal wall to facilitate the initial percutaneous placement of a gastrostomy feeding tube.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in a formal table or list. However, the "Performance Data" section describes the types of performance data collected and the conclusions drawn regarding effectiveness and safety.

Ask a specific question about this device

The AMT Suture Delivery System is intended for anchoring the wall of a hollow viscus to the abdominal wall prior to the introduction of interventional catheters and stay in place for up to 14 days in child, adolescent, and adult populations.

The Suture Delivery System is a sterile, single use suturing device designed to pass suture percutaneously through tissues in order to anchor the wall of a hollow viscus to the abdominal wall prior to the introduction of interventional catheters. The non-absorbable suture meets requirements established by the United Stated Pharmacopeia (USP) for non-absorbable surgical suture. The suture is provided pre-loaded in a hand-held, manually operated, disposable suture application device. Only the suture and the anti-splay component are intended to remain in place while the wall of the viscous adheres to the abdominal wall; all other components of the delivery system are removed completely and discarded.

The provided text describes a 510(k) submission for the "AMT Suture Delivery System." This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance criteria in a clinical setting.

Therefore, the information you are requesting about acceptance criteria and a study proving those criteria are met, particularly regarding AI performance, human reader improvement with AI, training set details, and ground truth establishment, is not present in this document. This document describes a traditional medical device (suture delivery system) and its regulatory clearance process through the FDA, which does not involve AI or the kind of performance studies typically associated with AI-driven devices.

Here's a breakdown of what is available related to performance, and why the other information is absent:

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes performance testing, but it does not provide a table of acceptance criteria with corresponding device performance metrics in the way you've outlined. Instead, it states that "Testing found that all components and materials met or exceeded design specifications established by AMT" and "The AMT Suture Delivery System met or exceeded all the acceptance criteria and does not raise new questions of safety or effectiveness."

The types of "performance" mentioned are largely for engineering and manufacturing validation, not clinical efficacy in the context of an AI device.

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/software device that uses a "test set" in the context of machine learning. The performance tests mentioned are physical and chemical property tests of the device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is not established in this manner for this type of device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication 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 does not involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI. The "ground truth" for this device's performance is objective measurements against established engineering and material science standards (e.g., tensile strength, sterility assurance level, biocompatibility).

8. The sample size for the training set: Not applicable. This device does not involve a training set.

9. How the ground truth for the training set was established: Not applicable. This device does not involve a training set.

Summary of Device and Performance Information Provided:

The document describes the AMT Suture Delivery System, a sterile, single-use suturing device for anchoring a hollow viscus to the abdominal wall. The regulatory submission emphasizes its substantial equivalence to a predicate device (K182832, Enterostomy Suture Anchor Set from Cook, Inc.) in terms of intended use, indications for use, sterilization, prescription status, and principles of operation, despite minor differences in material of retention and method of deployment.

Key Performance Data (not related to AI):

• Biocompatibility Testing: Demonstrated compliance with multiple ISO 10993 standards and USP Pyrogen Test.
• Sterilization: Validated for Ethylene Oxide sterilization to a Sterility Assurance Level (SAL) of 10⁻⁶, complying with ANSI/AAMI/ISO 11135 and ISO 10993-7, and Bacterial Endotoxin Testing (USP chromogenic method).
• Shelf Life: Packaging tested in accordance with ASTM F1980-16, ISO 11607, and ISTA 3A, indicating compliance.
• Bench Testing: Various tests performed according to AMT specifications (deployment force, tensile testing), ISO 7864 (needle hub bond, needle penetration), USP (suture bond), USP (suture tear strength), and ISO 9626 (resistance to breakage, needle stiffness). All stated to have met or exceeded acceptance criteria.
• No Software, Electromagnetic Compatibility, Electrical Safety, Animal, or Clinical Studies were performed or deemed applicable for this submission.

In conclusion, this document is for a traditional physical medical device and does not contain any information relevant to AI/ML device performance or study design.

Ask a specific question about this device

The Fidmi Low Profile Enteral Feeding Device is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.

Fidmi Low Profile Enteral Feeding Device Measuring kit is indicated for measuring the length of the stoma prior to placement of a low-profile feeding tube.

The Fidmi Low Profile Enteral Feeding Device Replaceable Tube is intended for use only with the Fidmi Low Profile Enteral Feeding Device, for the replacement of an existing tube. It is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.

The Fidmi Low Profile Enteral Feeding Device and its components kits allow for enteral nutrition and / or medication delivery directly into the stomach. The device and components are supplied sterile.

Fidmi Medical's Low-Profile Enteral Feeding Device includes kits for initial placement of the tube, and complete removal of the gastrostomy tubes.

Fidmi Low-Profile Enteral Feeding Device incorporates three major components:

The Stoma Measuring Device – The Fidmi Medical Stoma Measuring Device is a single use, sterile, disposable device designed for use in the selection of an appropriate length of the Feeding Device to be used exclusively with the Fidmi Low-Profile Enteral Feeding Device.

Low Profile Enteral Feeding Device - The Low Profile Enteral Feeding Device consists of a gastric port that on one side (on the skin surface) includes the flexible external bumper that stabilizes the stoma and keeps the site dry and allows ventilation. On the other side (the stomach side), it includes the bumper that is designed to stay in place and to be dismantled apart for removal when enteral feeding is no longer required.

The Replacement Feeding Tube – The replaceable tubing is designed to be easily replaced when needed. The replacement tube is designed as an internal component that may be retracted, disposed and replaced without any manipulation to the device itself, i.e., the gastrostomy tube implant. It is designed to be replaced by personnel at a medical facility or at a home setting. As depicted in the instructions for use document supplied with the device, it is recommended to replace the tube either upon accidental dislodgement, clogging or once a week.

This document is a 510(k) premarket notification for the Fidmi Low Profile Enteral Feeding Device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the way typically found for AI/ML-driven devices. Instead, it demonstrates substantial equivalence to existing predicate devices based on a comprehensive set of bench tests and animal testing.

Here's an analysis based on the provided text, focusing on what's available and what's missing in relation to your specific request:

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" values in a quantitative manner for a comparative study against a benchmark or ground truth.

Instead, it lists the types of performance data (bench tests and animal testing) conducted to demonstrate that the device performs as intended and is substantially equivalent to predicate devices. The implication is that meeting the standards referenced (e.g., BS EN 1618:1997, ASTM F2528-06(2014)) constitutes "acceptance."

The general studies performed are:

• Back Flow and Liquid Leakage
• Dimensional Attributes
• Functional Evaluation
• Replaceable Tube & Extension Tube Detachment Force
• Flow Rate
• Bond Strength
• Feeding Device Pullout Force
• Packaging Integrity and Shelf life Testing
• Animal testing

For biological evaluation, the following ISO standards were cited, implying compliance with their requirements:

• EN ISO 10993-1:2018 (Biological Evaluation)
• EN ISO 10993-3:2014 (Genotoxicity, carcinogenicity, reproductive toxicity)
• EN ISO 10993-5:2009 (in vitro Cytotoxicity)
• EN ISO 10993-6:2016 (Local effects after implantation)
• EN ISO 10993-10: 2010 (Irritation and Skin Sensitization)
• EN ISO 10993-11:2017 (Systemic toxicity)
• EN ISO 10993-12:2012 (Sample preparation and reference materials)
• EN ISO 10993-7:2008:AC 2009 (Ethylene Oxide Sterilization Residuals)

The document concludes that "Bench testing of the Fidmi Low-Profile Enteral Feeding Device and components demonstrates that the device performs as intended and is substantially equivalent." This is the reported device performance in the context of a 510(k).

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

The document mentions "bench testing" and "animal testing." It does not specify the sample sizes for these tests, nor does it provide details on the data provenance (e.g., country of origin, retrospective/prospective nature) as it would for a clinical study involving human subjects and diagnostic outputs. The testing appears to be primarily laboratory-based and pre-market validation.

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 hence not provided in the document. The device is a physical medical device (enteral feeding device), not an AI/ML diagnostic tool requiring expert consensus for ground truth establishment. The "ground truth" for this device would be established by measuring physical properties, mechanical performance, and biological compatibility against established scientific and engineering standards.

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

Not applicable. Adjudication methods like '2+1' or '3+1' are typically used in clinical studies where disagreement among human readers or interpreters needs to be resolved, often for diagnostic image interpretation or similar qualitative assessments. The tests described are primarily quantitative engineering and biological tests.

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 not an AI/ML diagnostic or assistive device that would involve human readers or image interpretation. Therefore, an MRMC study is not relevant to its regulatory submission.

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

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

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

For the bench tests and animal testing, the "ground truth" would be established by:

• Engineering specifications and standards: For physical and mechanical properties (e.g., dimensional attributes, flow rate, bond strength, pullout force, back flow, leakage).
• Biological evaluation standards: For biocompatibility (e.g., cytotoxicity, irritation, systemic toxicity, genotoxicity, local effects after implantation), as defined by the EN ISO 10993 series.
• Animal physiology/pathology: For animal testing, assessing the device's performance and safety in a living system.

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. As noted above, this is not an AI/ML device.

Summary in relation to your request:

The provided document describes a traditional 510(k) submission for a physical medical device. It focuses on demonstrating substantial equivalence to predicate devices through bench testing and animal testing, complying with various engineering and biological standards. It does not involve AI/ML technology, and therefore, many of the requested elements pertaining to acceptance criteria, ground truth, expert involvement, and study types (like MRMC or standalone algorithm performance) are not applicable to this type of device and submission. The "acceptance criteria" are intrinsically tied to meeting the requirements of the referenced standards and demonstrating performance comparable to the predicate device.

Ask a specific question about this device

The Cope Pediatic Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the abdominal wall prior to the introduction of interventional catheters and can stay in place for up to 14 days in infant, child, and adolescent populations.

The Enterostomy Suture Anchor Set is intended for anchoring the wall of a hollow viscus to the abdominal wall prior to the introduction of interventional catheters and stay in place for up to 14 days in child, adolescent, and adult populations.

This bundled submission includes two devices: Cope Pediatric Gastrointestinal Suture Anchor Set and Enterostomy Suture Anchor Set. Both subject devices include two suture anchors that are identical.

The Cope Pediatric Gastrointestinal Suture Anchor Set is available in two set configurations. Both set configurations are supplied with two suture anchors that are identical. The first suture anchor is pre-loaded in the lancet-tip introducer needle. The second suture anchor may come pre-loaded in the blunt-tip backload needle. A wire guide is supplied if the second suture anchor comes pre-loaded in the backload needle. The suture anchor is made of a 0.025-inch stainless steel anchor and a 30-cm suture. The anchor is either 2 cm or 1.3 cm long. The suture is the 5-0 size Tevdek® and one end of the suture is bonded at the center of the anchor. The introducer needle is made of 19-gauge stainless steel cannula in the length of 7 cm. The distal tip of the introducer needle is lancet bevel. Similarly, the backload needle is made of 19-gauge stainless steel cannula and 3 cm long. The distal tip of the backload needle is blunt. The wire guide is made of 0.025-inch stainless steel coil and 80 cm in length. Again, the wire guide is only supplied in the set configuration that the suture anchor is pre-loaded in the introducer needle.

The Enterostomy Suture Anchor Set is supplied with two suture anchors, the lancet-tip introducer needle, the blunt-tip backload needle, the wire guide, and the dilator. The suture anchors are pre-loaded in the backload needle. The suture anchor is made of a 0.025-inch stainless steel anchor and a 30-cm suture. The suture is the 5-0 size Tevdek® and one end of the suture is bonded at the center of the anchor. The introducer needle is made of 18-gauge stainless steel cannula in the length of 7 cm. The distal tip of the introducer needle is lancet bevel. Similarly, the backload needle is made of 18-gauge stainless steel cannula and 5 cm long. The distal tip of the backload needle is blunt. The wire guide is made of 0.035-inch stainless steel coil and 80 cm in length. The wire guide is coated in polytetrafluoroethylene. The dilator is made of 8 French polyethylene tubing and 20 cm in length. The distal end of the dilator is tapered to 0.035 inches in diameter.

This document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) regarding Cook Incorporated's Cope Pediatric Gastrointestinal Suture Anchor Set and Enterostomy Suture Anchor Set. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of an AI/ML device.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test and training sets, expert ground truth establishment, MRMC studies, standalone performance, and ground truth types is not available within this document.

This document describes a medical device, not an AI/ML system. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biocompatibility bench testing, not clinical performance or AI model validation.

Here's an breakdown of what is available and why the requested information for an AI/ML device is not applicable:

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

   • Not applicable for AI/ML performance. The document lists "Bench Testing (including time zero and applicable three year accelerated aged testing)" and "Biocompatibility Testing" as performed. These tests confirm design input requirements and biocompatibility, but no specific quantitative performance metrics (like accuracy, sensitivity, specificity for a diagnostic device) with corresponding acceptance criteria are provided in a table format. The conclusion states the device meets design input requirements, implying successful completion of these physical and biological tests.

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 for AI/ML performance. No "test set" in the context of observational data (e.g., medical images or patient records) is mentioned. The testing described is physical/chemical "Bench Testing" and "Biocompatibility Testing" on the device itself.

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 for AI/ML performance. No ground truth establishment by medical experts is mentioned, as this is a physical medical device, not a diagnostic AI.

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

   • Not applicable for AI/ML performance. No adjudication method for expert review of data is mentioned.

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

   • Not applicable. This is a physical medical device, 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 a physical medical device, not an AI algorithm.

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

   • Not applicable for AI/ML performance. The "ground truth" for this device would be its physical properties (e.g., tensile strength, dimensions) and biological compatibility, verified through laboratory testing against established engineering standards and biocompatibility guidelines (e.g., ISO 10993-1).

8. The sample size for the training set:

   • Not applicable. This device does not involve a training set as it is not an AI/ML product.

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

   • Not applicable. This device does not involve a training set.

In summary, the provided document is a regulatory approval (510(k) clearance) for a physical medical device. It demonstrates substantial equivalence to a predicate device based on similar intended use, technological characteristics, and a battery of engineering and biocompatibility tests. It does not contain information relevant to the performance evaluation of an AI/ML-driven medical device, which would require data sets, ground truth establishment, and statistical performance metrics.

Ask a specific question about this device

The CoapTech PUMA-G System (PUMA-G) is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube in adults only.

The PUMA-G System is a medical device designed to aid in the initial placement of permanent feeding tubes, which are placed via percutaneous gastrostomy. Historically, gastrostomy tubes have been placed using either endoscopy or radiography (e.g., fluoroscopy) for visualization. The PUMA-G System provides visualization by ultrasound, allowing the user to assess the future gastrostomy tract prior to placement. The PUMA-G System contains three main custom components: a balloon catheter, a guidewire, and an external magnet. An internal magnet within the balloon catheter is placed orogastrically into the stomach, where it is pulled up to the anterior abdominal wall by the external magnet. After filling the balloon with fluid, the user's existing ultrasound is used for visualization of the future gastrostomy tract and for ultrasound-guided needle placement. The guidewire is then inserted and snared by the balloon, and the paired unit (balloon catheter and guidewire) is then pulled out the mouth. A gastrostomy tube is then placed over the guidewire using the Sachs-Vine PUSH technique.

The provided text describes the CoapTech PUMA-G System and its substantial equivalence determination, but it does not contain the detailed information requested for acceptance criteria and a study proving the device meets those criteria.

Specifically, the document states that "Bench and animal performance data were collected to support a substantial equivalence determination" and lists the types of testing performed (balloon performance, magnetic force characterization, coupling strength, capture reliability, biocompatibility, and sterilization). However, it does not provide:

• A table of specific acceptance criteria and reported device performance values. It only gives a high-level summary that the "PUMA-G System can effectively bring together the stomach and anterior abdominal wall while maintaining healthy tissue" and "reliably captures and retains the guidewire."
• Sample sizes, data provenance, or details of the test sets.
• Information about experts used for ground truth, adjudication methods, or MRMC studies.
• Details about standalone algorithm performance if it were an AI device (which it is not).
• The type of ground truth used (beyond implying animal and bench testing results).
• Training set information, as this is a medical device, not an AI/ML algorithm that requires a training set in the conventional sense.

Therefore, I cannot fulfill the request with the provided text. The document focuses on demonstrating substantial equivalence to a predicate device based on functional and safety performance, but not on detailed performance metrics against predefined acceptance criteria in the format requested.

Ask a specific question about this device

The Entuit Start Initial Placement Gastrostomy Set is intended to assist the physician with the initial placement of feeding tubes while performing a gastrostomy in adult patients only.

The Entuit™ Start Initial Placement Gastrostomy Set includes a heavy duty stainless steel polytetrafluoroethylene (PTFE) coated Amplatz extra stiff wire guide, dilators, and one or more Peel-Away® Introducers. Depending upon set specifications, two or three dilators may be included. The set also includes an entry access needle, scalpel, syringe, and gauze. The Entuit Start Initial Placement Gastrostomy Set is sterilized by ethylene oxide and intended for one-time use.

This document describes the Cook Incorporated Entuit Start Initial Placement Gastrostomy Set, but it does not contain information about software or AI devices, nor does it conduct a study on device performance against acceptance criteria in the manner you described.

The document is a 510(k) premarket notification for a medical device that assists with the initial placement of feeding tubes. It focuses on demonstrating substantial equivalence to a predicate device through a comparison of physical characteristics and the results of various engineering and biocompatibility tests.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/software device. The document details the following for a physical medical device:

1. Table of acceptance criteria and reported device performance:
The document lists various mechanical and biocompatibility tests performed. It states that "The results of these tests show that the Entuit™ Start Initial Placement Gastrostomy Set met the design input requirements based on the intended use and support the conclusion that this device does not raise new questions of safety or effectiveness and support a determination of substantial equivalence." However, it does not provide specific quantitative acceptance criteria or detailed reported performance values for each test. For example, it lists "Wire Guide Tensile" but does not state the minimum tensile strength required (acceptance criteria) or the measured tensile strength (reported performance).

2. Sample size used for the test set and the data provenance:
This information is not provided. The document generally refers to "applicable testing" but does not detail the methodology, sample sizes, or data provenance for these engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as this is not a study requiring expert-established ground truth. The tests are engineering and biocompatibility tests for a physical device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable.

5. If a multi-reader multicase (MRMC) comparative effectiveness study was done:
No, this type of study was not performed or described. This is a 510(k) submission for a physical device, not an AI or imaging device requiring human reader assessment.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable as this is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for the engineering tests would be the established engineering and safety standards.

8. The sample size for the training set:
Not applicable as there is no training set for an AI/software device.

9. How the ground truth for the training set was established:
Not applicable.

Summary of available information from the document (relevant to a physical device):

The document details the device, its intended use, a comparison to a predicate device, and a list of various physical, mechanical, and biocompatibility tests that were performed. The conclusion states that the device "met the design input requirements."

Specific tests listed:

• Compatibility - (Peel away sheath and Gastrostomy Catheter, Dilator and Wire Guide, Needle and Wire Guide)
• Wire Guide Tensile
• Wire Guide Corrosion
• Wire Guide Flex
• Wire Guide Fracture
• Dilator Shaft Tensile
• Dilator Hub-to-Shaft Tensile
• Peel-Away Introducer Shaft Tensile
• Peel-Away Introducer Knob-to-Shaft Tensile
• Peel Force Testing
• Radiopacity Testing
• Biocompatibility Testing Per ISO 10993-1 and FDA guidance, testing for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, and acute systemic toxicity were performed to ensure the biocompatibility of the subject device set.

Ask a specific question about this device

The AMT T-Fastener Anchor Kit is to be used to affix the gastric wall to the anterior abdominal wall for formation of a new stoma tract and subsequent placement of a percutaneous gastrostomy device. Gastropexy during initial placement of a percutaneous gastrostomy device may be indicated for patients with a functioning gut who require long-term tube feeding. This includes patients in whom malnutrition already exists, or may result, secondary to concurrent conditions.

Not Found

I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and a study proving device performance. The document is a 510(k) clearance letter from the FDA for a medical device (AMT T-Fastener Anchor Kit), which indicates the device is substantially equivalent to legally marketed predicate devices.

While it mentions the device and its intended use, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set details).

This type of information is typically found in the scientific and clinical sections of a 510(k) submission, which are not provided in this document. The letter itself is a regulatory outcome, not the study report.

Ask a specific question about this device

The Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy™ T-Fasteners is intended to affix the stomach to the anterior abdominal wall facilitating primary placement of the Kimberly-Clark MIC and MIC-Key brand Enteral Feeding Tubes. It is recommended that these T-Fasteners be used only with the Kimberly-Clark MIC and MIC-KEY brand Enteral Feeding Tubes.

The Kimberly-Clark Enteral Access Dilation System is intended to facilitate stoma tract dilation prior to placement of the Kimberly-Clark MIC and MIC-Key brand Enteral Feeding Tubes. It is recommended that these dilator be used only with the Kimberly-Clark MIC and MIC-KEY brand Enteral Feeding Tubes

Device 1: Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy* T-Fasteners
Device 2: Kimberly-Clark Enteral Access Dilation System

The Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy™ T-Fasteners consists of an internal retention T-Bar and an external suture-lock retention bolster connected by a length of resorbable suture. The T-Bar end is loaded onto the slot of a safety needle.

The Kimberly-Clark Enteral Access Dilation System is a stoma dilator with a peel-away sheath composed of a series of HDPE (high density polyethylene) telescoping dilator sleeves. It is available in 5 terminal sizes from 16FR up to 24FR (every even size).

This submission, K093312, indicates that no clinical or non-clinical laboratory testing was required to determine substantial equivalence because the subject devices (Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy™ T-Fasteners and Kimberly-Clark Enteral Access Dilation System) are identical to components of the predicate device (Kimberly-Clark Introducer Kits, K080253).

Therefore, the acceptance criteria and study detailed in your request (including reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, and training set information) are not applicable to this 510(k) submission. The FDA granted clearance based on the devices being identical in design, materials, sizes, and intended use as components of an already cleared device, without requiring new performance studies.

Ask a specific question about this device

The Medline Gastrostomy Tube is designed as a percutaneous replacement tube which is inserted in a well-healed, mature gastric stoma. The device delivers liquid enteral formula and medications directly into the stomach.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the Medline Gastrostomy Tube. It addresses the substantial equivalence of the device to legally marketed predicate devices. It does not contain information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is a regulatory approval for a physical medical device, not an AI/ML software device.

Ask a specific question about this device