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The AMT Low-Profile Suprapubic Catheter & Drainage Set is indicated for patients 7 years of age and older with lower urinary tract dysfunctions such as neurogenic bladder dysfunction or urethral obstruction or who are severely disabled or requiring constant care. The AMT Low-Profile Suprapubic Catheter & Drainage Set is indicated to be used for temporary suprapubic urinary diversion and drainage for less than or equal to four weeks. The AMT Low- Profile Suprapubic Catheter is intended to be placed directly into the bladder through a secured (initial placement) or formed (replacement) stoma.

The Applied Medical Technology, Inc. (AMT) Low-Profile Suprapubic Catheter & Drainage Set (LPSPC) consists of two primary assemblies. The LPSPC is identical in materials and manufacturing processes to the Low-Profile Balloon Feeding Device cleared in K161413 for a different indication.

The Suprapubic Catheter is used to provide urinary diversion and drainage through the lower abdomen, placed and maintained in a percutaneously prepared cystostomy opening. The Drainage Set is intended to allow a connection between the suprapubic catheter device and a urinary collection bag system. The device is designed for bladder drainage by way of a secured (initial placement) or formed (replacement) cystostomy tract and may be used for irrigation. Patients may include: any user with urethral trauma, those who require long-term catheterization and urethral catheterization is intolerable, or those with a spinal cord injury and an inability to self-catheterize who may find the suprapubic method simpler to manage.

The LPSPC is a urinary drainage device made principally of silicone elastomer. The device consists of an internal retention balloon and a flexible external bolster with a balloon fill-valve, interlocking irrigation port, and safety plug. The catheter is inserted through the stoma and into the urinary bladder and is secured by the internal retention balloon. The device is offered in various sizes to accommodate different stoma diameters and lengths. On the shaft near the end is located a balloon which, when properly inflated, acts as an internal stabilizer preventing outward displacement through the stoma in the abdominal wall. The balloon is inflated through a separate inflation valve located in the external portion of the device.

The external profile of the device acts as a stabilizer to prevent inward migration and affords the user the ability to connect a provided Drainage Set.

The Drainage Set is identical in material and manufacturing process to certain configurations of the Irrigation Set included with the AMT Bowel Management Device previously cleared in K180026. The right-angle connector of the Drainage Set is compatible with the interlock on the LPSPC and is used to direct fluids drained from the bladder, through the catheter, and into a separate urinary collection bag.

The AMT Low-Profile Suprapubic Catheter & Drainage Set may optionally be marketed with a Foley Insertion Tray accessory. If included, the accessory would be a legally marketed Foley Insertion Tray, such as:

• AMSure Foley Insertion Tray (previously cleared Class II, Product Code FCM, K030664)
• Bardia Foley Insertion Tray (registered Class II, Product Code OHR, 510(k) exempt)
• Dynarex Foley insertion Tray without Catheter (registered Class II, Product Code OHR, 510(k) exempt)

The device is sold as sterile and can be initially placed in an outpatient-setting by a health care professional. The device may be replaced in an outpatient-setting or home setting by a health care professional or care giver.

The provided text describes a 510(k) premarket notification for the "AMT Low-Profile Suprapubic Catheter & Drainage Set." This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study with specific acceptance criteria and performance metrics in the format requested.

Therefore, much of the requested information cannot be extracted directly from this document. The document primarily describes the types of testing performed and concludes that the device met acceptance criteria, but generally does not specify these criteria or report quantitative performance results against them.

Here's an attempt to answer the questions based on the available information:

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

The document states that the device "met or exceeded all the acceptance criteria and does not raise new questions of safety or effectiveness when compared to the predicate/reference devices." However, specific numerical acceptance criteria and precise performance data are not detailed in this summary. The performance is generally stated as meeting standards.

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:
  • Bench Testing: Not specified. The document lists the types of tests but not numbers of samples.
  • Clinical Performance (Literature Review): Clinical experience was reported on 34 adults and 188 pediatric patients across 22 published articles.
• Data Provenance: The clinical data is from a systematic literature review (retrospective). The countries of origin are not specified, only that the literature from "independent organizations" was reviewed.

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. This was a systematic literature review, not a study where experts established ground truth for newly collected patient data. The "ground truth" for the clinical performance was derived from the findings reported in the published literature.

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

Not applicable. The clinical evidence was gathered through a systematic literature review. The "reporting of this systematic review was guided by the standards of the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) Statement, as well as the Cochrane Handbook for Systematic Reviews of Interventions. Assessment of the included literature was completed using the critical appraisal tools published by the Joanna Brigges Institute." This describes the methodology for reviewing existing literature, not an adjudication process for a new test set.

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

Not applicable. This device is a suprapubic catheter, not an AI-assisted diagnostic or therapeutic device. The submission does not mention any AI components or MRMC studies.

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 consensus, pathology, outcomes data, etc)

For the clinical performance aspects, the "ground truth" was derived from "clinical experience... reported on 34 adults and 188 pediatric patients" across published literature, guidelines from organizations like the Pediatric Urologists of Canada and the Canadian Urological Association, operative textbooks, and information from the International Continence Society (ICS). This can be broadly categorized as published clinical outcomes data and expert-derived guidelines/clinical experience.

8. The sample size for the training set

Not applicable. This is a physical medical device submission, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for this type of device.

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The AMT Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery and interventional radiology procedures in child, adolescent and adult populations.

The AMT Suture Passer is a sterile, single-case use, hand-held suture grasping device. The device features a hypodermic needle through which a suture can be passed and retrieved through another. The retrieval component may be offered in two configurations: a non-magnetic version, and a magnetically assisted version, using a grasper with a magnetized arm. Using either configuration, the AMT Suture Passer provides more flexibility in stitch geometry and approach than traditional U-stitches. The preferred method to introduce the suture is through a separate introducer needle; the AMT Suture Passer Kit with Magnet Assist instrument set bundles the magnetically assisted configuration of the AMT Suture Passer with an introducer needle and two magnetic sutures to create a non-procedure-specific kit. For the magnetically assisted configuration, the magnetized arm of the grasper works in conjunction with a magnetic suture to reduce the technical difficulty of intracorporeal suture retrieval under laparoscopic, endoscopic, radiologic, or ultrasound guidance. This magnet-assist technology is derived from the ATLAS Suture Delivery System (K193612), also manufactured by Applied Medical Technology, which performs the same clinical function and is used in similar clinical applications. Both configurations of the AMT Suture Passer feature identical components, except for the end-effectors, and make use of Luer-lock compatible hubs that allow a syringe to be attached for the purpose of administering contrast through the device. The contrast enters through the Luer hub and exits from the distal end of the needle, which allows the needle position to be verified prior to passing the suture during interventional radiology procedures.

This document is an FDA 510(k) clearance letter for a medical device called the "AMT Suture Passer." It outlines the regulatory review process and the basis for the FDA's determination of substantial equivalence to previously cleared devices.

The request asks for details on acceptance criteria and a study proving the device meets these criteria. However, the provided document does not describe a study involving an AI/Machine Learning algorithm, human readers, or a test set with ground truth established by experts.

Instead, the document details the performance data for a physical medical device (AMT Suture Passer) through bench testing, biocompatibility testing, sterilization validation, and shelf-life testing. It explicitly states:

• "B. Software: There are no software components related in any way to this device. Therefore, Software Validation is not applicable to this device."
• "E. Animal Study: Animal testing was NOT performed."
• "F. Clinical Study: Clinical testing was NOT performed."

Therefore, I cannot provide the requested information regarding an AI study, test sets, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details from this document. The information requested aligns with studies typically performed for AI/ML-driven medical devices, which the AMT Suture Passer is not.

However, I can extract the acceptance criteria and performance data for the physical device as presented in the document:

Acceptance Criteria and Device Performance (Based on the Provided Document for a Physical Device)

The "AMT Suture Passer" is a physical medical device, not an AI/ML diagnostic tool. Therefore, the acceptance criteria and performance data relate to its physical properties, sterility, biocompatibility, and functionality as a surgical instrument. There is no mention of AI performance metrics like sensitivity, specificity, AUC, or reader improvement.

Here's a summary of the performance data and acceptance criteria as described:

1. Table of Acceptance Criteria and Reported Device Performance

Since the device is a physical instrument without AI components, the following points as requested in the prompt are not applicable or detailed in the provided document:

2. Sample size used for the test set and the data provenance: Not applicable for a physical device's bench/biocompatibility testing in this context. These tests are typically performed on a statistically relevant sample size of manufactured devices/materials, but specific numbers are not provided. Data provenance would be from manufacturing and testing labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is established by direct measurement and compliance with engineering/material standards, not by expert interpretation of data.
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 (no AI component).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (no AI algorithm).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, the "ground truth" for acceptance is determined by adherence to established material specifications, manufacturing tolerances, mechanical performance criteria, and sterility/biocompatibility standards as measured through laboratory testing.
8. The sample size for the training set: Not applicable (no AI component).
9. How the ground truth for the training set was established: Not applicable (no AI component).

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The AMT G-Tube Balloon Gastrostomy Feeding Device is indicated to be used as a percutaneous gastrostomy tube. This device will assist in providing nutrition directly into the stomach through a secured (initial placement) or formed (replacement) stoma in a human patient, 10kg or above, who is unable to consume nutrition by conventional means. The AMT G-Tube Balloon Gastrostomy Feeding Device can also deliver medication and allow for decompression of the stomach.

The Applied Medical Technology, Inc. G-Tube Balloon Gastrostomy Feeding Device (AMT G-Tube) is made of silicone elastomer and is designed for enteral feeding in a gastrostomy tract. The device can be used as a replacement device through a mature stoma tract or for initial placement in a supported stoma tract. The device is offered in several French (FR) sizes ranging from 12 FR to 24 FR. On the shaft near the end is located a balloon which, when properly inflated acts as an internal stabilizer preventing outward displacement through the stoma in the abdominal wall. The external bolster (preassembled on the AMT G-Tube) acts as a stabilizer to prevent inward migration. The device is sold as sterile and can be placed in an outpatient or home setting by a health care professional or care giver.

Here's a breakdown of the acceptance criteria and study information for the AMT G-Tube Balloon Gastrostomy Feeding Device, based on the provided FDA 510(k) summary:

This device is not an AI/ML powered device, therefore, sections 2-6 and 8-9 do not apply.

Acceptance Criteria and Reported Device Performance

Device Name: AMT G-Tube Balloon Gastrostomy Feeding Device

Study Information

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The provided document does not specify the sample sizes for the individual bench tests or the country of origin/provenance for the data. The studies performed were bench testing, meaning they were conducted in a laboratory setting rather than with human subjects, therefore, provenance like "country of origin" is less relevant than for clinical data. The tests are prospective in nature, as they are specifically designed to evaluate the performance of the manufactured device.

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 as the studies described are bench tests (biocompatibility, sterilization, shelf life, and various physical performance tests) and do not involve expert review or establishment of ground truth in the context of diagnostic interpretation. The "ground truth" for these tests is the objective measurement against established engineering, material, and safety standards (e.g., a specific tensile strength, absence of pyrogens, a confirmed SAL).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This section is not applicable. Adjudication methods like 2+1 or 3+1 refer to a consensus process among human readers/experts, typically in diagnostic studies. The studies performed were bench tests against pre-defined engineering and safety standards.

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. The device is a physical medical device (gastrostomy feeding tube), not an AI/ML powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This section is not applicable. The device is a physical medical device and does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the various performance tests (biocompatibility, sterilization, shelf life, and bench tests) is based on established industry standards, design specifications, and objective laboratory measurements. For instance, a confirmed Sterility Assurance Level ($10^{-6}$) is an objective measurement against a standard, not an expert consensus or pathology report. Similarly, meeting specific tensile strength, flow rate, or leak test criteria are objective measurements against defined engineering specifications.

8. The sample size for the training set:
This section is not applicable as the device is a physical medical device and does not involve AI/ML that requires a training set.

9. How the ground truth for the training set was established:
This section is not applicable as the device is a physical medical device and does not involve AI/ML that requires a training set and its associated ground truth establishment.

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The NutriGlide™ Nasal Feeding Tube is indicated for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.

The Nutriglide™ Nasal Feeding Tube is a nasal feeding tube available in both sterile and non-sterile ENFit® and legacy configurations featuring a y-port, widening lumen diameter, dissolvable tube tip, and optional stylet with water activated lubricous coating. The device is identical between the ENFit® and legacy configurations but for the y-port which will feature either ENFit® adapters or the legacy ports. Both configurations feature tubing with a unique taper design where the lumen gradually increases from the proximal end (external) to the distal opening (indwelling). This design creates a tube that is smaller near the external y-port and gradually increases to its largest diameter at the distal tip opening where the nutrition/medication exists into the patient's stomach or small intestine. The lubricious dissolvable tip offers increased comfort during placement on the various configurations of both the ENFit® and legacy devices, and then once dissolved it reveals the entire rounded distal opening of the tube, allowing for maximum flow during feeding.

The provided text is a 510(k) Premarket Notification for the Nutriglide™ Nasal Feeding Tube. It describes the device's characteristics, intended use, and comparison to predicate devices, along with performance data. However, this document does NOT contain information about a study proving the device meets acceptance criteria related to an AI/ML algorithm or a multi-reader, multi-case study.

The performance data section (Section VII) focuses on biocompatibility, sterilization, shelf life, and bench testing for the physical device itself. It explicitly states:

• C. Animal Study: Animal testing was NOT performed.
• D. Clinical Study: Clinical testing was NOT performed.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets these criteria in the context of an AI/ML algorithm, as no such study is described in this document.

The document covers the following for the physical medical device:

1. A table of acceptance criteria and the reported device performance:
The document references that the device met "all the acceptance criteria" for various bench tests. However, it does not provide a specific table detailing these acceptance criteria alongside the quantitative reported performance for each. It mentions conformance to recognized standards and "reliable design and performance under the specified testing parameters according to predetermined criteria."

• Bench Testing Acceptance Criteria (General Statement): The subject device met all the acceptance criteria and does not raise new questions of safety or effectiveness when compared to the predicates.
• Bench Testing Categories Performed (without specific numeric criteria or results):
  • Testing per ASTM F2528 (Enteral Feeding Devices with a Retention Balloon)
  • Testing per EN 1618:1997 (Catheters other than intravascular catheters - Test methods for common properties)
  • Testing per EN1615:2000 (Enteral Feeding catheters and Enteral Giving Sets for Single Use and their Connectors - Design and Testing)
  • Testing per ISO 80369-3 (Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications)
  • Bench testing according to AMT specifications for:
    • Kink Distance
    • Clog Formation
    • Clog Removal
    • Tip Dissolution
    • Lubricious Coating
    • Component Attachment strength
    • Component integrity testing

Regarding the other requested information (which would typically be relevant for an AI/ML device approval but are not present here):

• 2. Sample sized used for the test set and the data provenance: Not applicable, no AI/ML test set described.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no AI/ML ground truth establishment described.
• 4. Adjudication method 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, no MRMC study described.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no AI/ML algorithm described.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable, no training set described.
• 9. How the ground truth for the training set was established: Not applicable.

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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.

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The Micro Transgastric-Jejunal Feeding Device is inchildren and adults who cannot absorb adequate nutrition through the stomach, who have intestinal motility problems, gastric outlet obstruction, severe gastroesophageal reflux, are at risk of aspiration, or in those who have had previous esophagectomy or gastrectomy.

The use of this tube is also clinically indicated when simultaneous gastric decompression and jejunal feeding are needed. This includes patients in whom malnutrition already exists, or may result, secondary to concurrent conditions.

The AMT Micro Transgastric-Jejunal feeding device is a single-use feeding tube that provides for simultaneous gastric decompression / drainage and delivery of enteral nutrition into the distal duodenum or proximal jejunum. It enters the stomach through a gastric stoma. The tube in held in place (within the stoma tract) by means of an inflatable balloon and a low-profile external bolster. The external bolster contains two ports; one labeled "JEJUNAL" (glow green) and one labeled "GASTRIC" (white). Incorporated within each port is a one-way valve which is opened by attaching the appropriate AMT Extension Set. AMT Extension Sets are color coded and connect to the feeding and drainage ports. The JEJUNAL (glow green) port is used for feeding into the small intestine. The GASTRIC (white) port is used to drain the stomach with the use of low intermittent suction or gravity drainage. A third port labeled "BAL" is used to inflate and deflate the balloon.

The Micro Transgastric-Jejunal Feeding Device is provided sterile (Ethylene Oxide) for prescription use only.

The provided text does not contain specific acceptance criteria with numerical targets. Instead, it describes various performance tests conducted on the Micro Transgastric-Jejunal Feeding Device to demonstrate conformance to applicable recognized standards and comparability to the predicate device.

Therefore, I cannot populate a table of acceptance criteria with reported device performance or describe a study that proves the device meets specific numerical acceptance criteria.

However, I can extract information about the types of tests performed and the general conclusion regarding device performance.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

As noted, specific numerical acceptance criteria and reported device performance are not provided in the document. The text broadly states that the device "meets all the acceptance criteria and performed comparable to or better than the primary predicate."

Therefore, the table would look like this, indicating the lack of specific data in the provided document:

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

• Test Set Sample Size: Not specified. The document mentions "various performance tests on the components" and lists types of tests, but does not provide the number of units or samples tested for each.
• Data Provenance: The tests were conducted internally by AMT ("AMT conducted various performance tests") and are bench tests. The document does not specify a country of origin for the data or whether it's retrospective or prospective, though bench testing is inherently prospective for the specific tests performed.

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

• Not applicable for performance bench testing. Ground truth, in the context of expert review, is typically relevant for interpretative tasks (e.g., image analysis, diagnosis) where human experts determine the correct outcome. The tests described are physical performance tests (e.g., strength, flow rate).

4. Adjudication Method for the Test Set:

• Not applicable for performance bench testing. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies among multiple human readers or experts when establishing ground truth. This is not relevant to objective physical performance measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. The document explicitly states: "F. Clinical Study: Clinical testing was NOT performed." MRMC studies involve human readers and clinical cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. The device is a physical medical device (a feeding tube), not an algorithm or software. The document explicitly states: "B. Software: There are no software components related in any way to this device. Therefore, Software Validation is not applicable to this device."

7. The Type of Ground Truth Used:

• For the performance testing, the "ground truth" would be the physical measurement standards and design specifications established by AMT and defined by the listed ISO and ASTM standards. The device's performance was compared against these established technical benchmarks.

8. The Sample Size for the Training Set:

• Not applicable. The device is a physical medical device, not an AI or machine learning model that requires a training set.

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

• Not applicable. As a physical device, there is no "training set" or "ground truth for a training set" in the context of AI/ML.

Summary of Device Performance Study (as described):

The manufacturer, Applied Medical Technology, Inc. (AMT), conducted various bench tests on the components of the Micro Transgastric-Jejunal Feeding Device. These tests aimed to demonstrate conformance to applicable recognized standards and to compare the device's performance to its primary predicate (AMT Low-Profile Transgastric-Jejunal Feeding Tube Kit, K123716).

Tests performed included:

• Testing per AMT Design Specifications:
  • Balloon Assembly Bond Peel/Tear Strength
  • Balloon Burst
  • Fill Valve Blow Out
  • Fill Valve Pullout
  • Flow Rate
  • Leak Test
  • Tensile Test to remove jejunal interlock
  • Tensile Test to remove gastric interlock
  • Tensile Test to tear tubing at jejunal hole
  • Tensile Test to tear tubing at gastric hole
  • Minimum Overmold External Bolster Bond Strength
  • Stoma Pullout
  • Tubing Tensile Test
  • Gastric Strap Tensile Test
  • Jejunal Strap Tensile Test
• Testing per ASTM F2528-06 (Standard for Gastrostomy and Jejunostomy Feeding Tubes):
  • Balloon Integrity in Simulated Gastric Fluid
  • Balloon volume maintenance
  • Balloon size and shaft size
  • Balloon concentricity
  • Balloon integrity
• Testing per ISO 80369-20 (Small-bore connectors for liquids and gases in healthcare applications):
  • Fluid leakage
  • Stress cracking
  • Resistance to separation from axial load
  • Resistance to separation from unscrewing
  • Resistance to overriding
  • Disconnection by unscrewing
• Testing per ASTM F2052 (Magnetic Resonance Safety):
  • Magnetically induced displacement force
• Testing per ASTM F2119 (Magnetic Resonance Safety):
  • MR image artifact
• Testing per ASTM F2182 (Magnetic Resonance Safety):
  • Radio frequency induced heating
• Biocompatibility Testing following ISO 10993 standards (Parts 1, 3, 5, 6, 7, 10, 11, 12, 17) for permanent contact with mucosal membranes and breached/compromised surfaces.

Conclusion of the study: The document states that the Micro Transgastric-Jejunal Feeding Device "meets all the acceptance criteria and performed comparable to or better than the primary predicate." No animal studies or clinical studies were performed. The specific numerical data from these tests that support this conclusion are not included in the provided text.

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The Traditional Length GJ Feeding Device is indicated for use in adult, adolescent, children, and infants over 10kg who cannot absorb adequate nutrition through the stomach, who have intestinal motility problems, gastric outlet obstruction, severe gastroesophageal reflux, are at risk of aspiration, or in those who have had previous esophagectorny or gastrectomy.

The use of this tube is also clinically indicated when simultaneous gastric decompression and jejunal feeding are needed. This includes patients in whom malnutrition already exists, or may result, secondary to concurrent conditions.

The Traditional Length GJ Feeding Device is a single-use feeding tube that provides for simultaneous gastric decompression / drainage and delivery of enteral nutrition into the distal duodenum or proximal jejunum. It enters the stomach through a surgically-created gastric stoma. The multi-lumen tubing is marked with a graduated scale and held in place by means of an inflatable internal retention balloon and a sliding external bolster. The external tri-port is overmolded onto the tubing and contains three ports: one large port for administering nutrition/medication in the jejunum labeled "JEJUNAL," one large port for gastric decompression/drainage labeled "GASTRIC," and one smaller port housing the balloon fill valve labeled "BAL."

The tri-port component of the Traditional Length GJ Feeding Device is offered in two variations: a legacy model and an ENFit® model designed to ISO 80369-3. Both variations of the device are identical except for the design of the tri-port component configurations.

• The tri-port of the legacy model has two large silicone funnel ports, and a small port to fill 1. the retention balloon. The JEJUNAL and the GASTRIC ports have individual attached silicone straps and plugs intended to independently close each funnel when not in use. The BAL port houses a small, MR conditional balloon fill valve.
• 2. The tri-port of the ENFit® model has 2 large ports and one small port akin to the legacy model, but with a twist-lock thermoplastic male ENFit® connector housed in each the JEJUNAL and the GASTRIC funnel ports. The ENFit® connectors are compliant to ISO 80369-3. The JEJUNAL and the GASTRIC ENFit® ports have individual attached tethers and plugs intended to independently close each ENFit® port when not in use. The BAL port houses an MR safe balloon fill valve.

Both the legacy and the ENFit® variations of the Traditional Length GJ Feeding Device are offered in different French sizes. The gastric length of both variations of the Traditional Length GJ Feeding Device is adjustable, depending on where the sliding external bolster is placed along the multi-lumen tubing. Various jejunal lengths are available. The distal portion of only the 16Fr and 18Fr jejunal tubing contains an anti-kink design using a metal spring. At the distal end of every tube, a silicone tip is attached to the device through which a non-absorbable suture is attached. The Traditional Length GJ Feeding Device is provided sterile (Ethylene Oxide) for prescription use only.

The document provided is a 510(k) summary for a medical device called the "Traditional Length GJ Feeding Device". It describes the device, its intended use, comparison to a predicate device, and performance data to support its substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various performance tests conducted on the Traditional Length GJ Feeding Device. For each test, the general acceptance criterion is that the components and materials "met or exceeded design specifications established by AMT." The reported performance is that the device "meets all the acceptance criteria and performed comparable to or better than the primary predicate."

Therefore, a table can be constructed as follows:

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

The document mentions "various performance tests on the components" and bench tests. However, it does not explicitly state the sample sizes used for these tests. The data provenance is implied to be from bench testing conducted by AMT (Applied Medical Technology, Inc.), the manufacturer. No details about country of origin for the data or whether it's retrospective or prospective are relevant here as it's not a clinical study.

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

This information is not applicable as the evaluation involved bench testing and biocompatibility testing, not expert-adjudicated clinical data.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

This information is not applicable as the evaluation involved bench testing and biocompatibility testing, which do not typically require adjudication for ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done. The device is a physical medical device (feeding tube), not an AI-powered diagnostic or interpretive tool.

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

No standalone algorithm performance study was done. The device is a physical medical device and does not involve an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the performance testing cited is the design specifications established by AMT and the requirements of recognized standards (ISO and ASTM standards). For biocompatibility, the ground truth is compliance with the requirements of ISO 10993 series for biological evaluation.

8. The Sample Size for the Training Set:

This information is not applicable as there is no training set for a physical medical device applying for 510(k) clearance based on bench testing.

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

This information is not applicable for the same reason as above (no training set).

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The Bowel Management Device is intended to instill fluids through a stoma into the colon to promote evacuation of the contents of the lower bowel through the anus and is intended to be an aid in the management of fecal incontinence. The catheter is placed and maintained in a percutaneously prepared opening, such as a cecostomy or appendicostomy. The Bowel Management Device is intended to be used in children and adults.
The Bowel Management Irrigation Set is intended to allow connection between a compatible bowel management device and the delivery tubing of an irrigation/enema bag system.

The Bowel Management Device is an indwelling low profile catheter used to promote evacuation of the lower bowel through antegrade colonic flushing. It consists of an internal retention balloon and a flexible external bolster with a balloon fill-valve, interlock irrigation port, and safety plug. The catheter is inserted through the stoma and into the colon and is secured by the internal retention balloon when inflated. The Bowel Management Irrigation Set has a connector on one end that connects to the interlock on the catheter and an adapter on the other end to connect to the irrigation/enema delivery system. Fluids can then be instilled directly into the colon through the catheter.

The provided text describes a 510(k) premarket notification for a medical device called the "Bowel Management Device and Irrigation Set." It includes information about the device's intended use, technological characteristics, and performance testing to demonstrate substantial equivalence to predicate devices.

However, the document does not contain the specific details required to answer your questions about acceptance criteria and a study proving those criteria are met.

Here's why and what information is missing:

Missing Information:

• Specific Acceptance Criteria Table and Reported Device Performance: While the document states, "The Bowel Management Devices meet all the acceptance criteria and performed comparable to or better than the primary predicate," it does not provide a table outlining these acceptance criteria or the specific performance metrics achieved by the device against those criteria. It only lists the types of tests performed (e.g., Strap Tensile Testing, Flow Rate Test, Balloon Integrity).
• Detailed Study Information:
  • Sample size used for the test set and data provenance: The document mentions "bench tests have been carried out," but does not specify sample sizes (e.g., number of devices tested, number of individual measurements) or the origin of any data (e.g., country, retrospective/prospective).
  • Number of experts used to establish ground truth and qualifications: This information is not relevant for the type of bench testing described.
  • Adjudication method: Not relevant for bench testing.
  • Multi-reader multi-case (MRMC) comparative effectiveness study: The document describes bench testing comparing device performance (mechanical and functional aspects) to a predicate, not a clinical study involving human readers or AI. Therefore, no effect size of human readers improving with/without AI is present.
  • Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
  • Type of ground truth used: For the bench tests, the "ground truth" would be established by the design specifications and performance of the predicate device, but this isn't explicitly detailed as a ground truth methodology.
  • Sample size for the training set: Not applicable as this is not an AI/machine learning device requiring a training set.
  • How the ground truth for the training set was established: Not applicable.

What the document does provide regarding performance testing:

• Performance Testing Overview: AMT conducted various performance tests on components.
• Comparison to Predicate: Bench tests were carried out to compare performance to the primary predicate (Cook Chait Cecostomy Catheter, K982500).
• Specific Tests Performed:
  • Strap Tensile Testing
  • Tube Tensile Testing
  • Minimum Overmold Bond Strength
  • Stoma Pullout
  • 2 Minute Leak Test
  • Flow Rate Test
  • Testing per ASTM F2528-06 (Balloon Integrity in Simulated Gastric Fluid, Balloon volume maintenance, Balloon size and shaft size, Balloon concentricity, Balloon integrity)
  • Testing per ISO 80369-3 (Fluid leakage, Stress cracking, Resistance to separation from axial load, Resistance to separation from unscrewing, Resistance to overriding, Disconnection by unscrewing)
• General Performance Conclusion: "The Bowel Management Devices meet all the acceptance criteria and performed comparable to or better than the primary predicate."

In summary, while the document states that the device met acceptance criteria based on performance testing comparable to a predicate, it does not provide the granular detail requested in your prompt regarding specific numeric acceptance criteria, detailed study parameters (like sample size or data provenance), or clinical/reader study information typical for AI or diagnostic devices. This document focuses on the engineering and material performance of a physical device for a 510(k) submission.

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The Low Profile Non-Balloon Feeding Device is indicated for use in patients who require long term feeding, are unable to tolerate oral feeding, who are at low risk for aspiration, require gastric decompression and/or medication delivered directly into the stomach through a secured (initial placement) or formed (replacement) stoma.

The Low Profile Non-Balloon Feeding Device is used to provide nutrition, medication, and decompression access into the stomach through a secured (initial placement) or formed (replacement) stoma. The device may be placed using one of two insertion methods including an 'obturator' insertion method and a 'capsule' insertion method.
Capsule Insertion Method: The internal bolster of the device is encased by water dissolvable capsule. The capsule technology provides a low-profile option that is delivered by lubricating the capsule with lubricant, inserting the device through the stoma site, and pulling on a pull tab that pulls a suture through the capsule and deploys the internal dome. Once the capsule is deployed, the internal dome returns to its uncompressed shape and the device is held in place.
Obturator Insertion Method: A T-Handle and ratcheting obturator rod (Snap Arm Assembly) is used to extend the internal dome, decreasing the outer profile of the dome. When the dome is fully elongated, the internal dome maintains a narrow profile that can easily be inserted into the stoma site with proper lubrication. Once inserted into the stoma site, the ratcheting rod and T-handle are removed and device is held in place by the internal bolster.
Once placed, both devices provide access to nutrition, medication, and decompression into the stomach via a Mini ONE® feeding port. Both devices are identical after placement regardless of the insertion method chosen.
Removal of feeding device can be performed by using a removal tool assembly (Snap Arm and T-handle with removal tool reinforcer). Removal is done by elongating the internal bolster to reduce the outer diameter of the dome, providing for an easier removal process. The Low Profile Non-Balloon Feeding Device will be offered in several different diameters including14 Fr, 18 Fr, 20 Fr, and 24 Fr and will be available in stoma lengths ranging from 1.0 cm to 4.4 cm.
The Low Profile Non-Balloon Feeding Device is provided sterile for single use only. The molded body of the Non-Balloon feeding device is made of medical silicone. The Low Profile Non-Balloon Feeding Device consists of an external bolster, feeding catheter, and internal retention bolster similar to the predicate devices. The external bolster consists of a feeding port for access to the stomach through the tubing of the device and a strap with a plug to close the feeding port while not in use. In addition, an anti-reflux valve is included in the feeding port area to prevent backflow of stomach contents while not in use. The feeding catheter is inserted into the stomach through a stoma and is held in place with the internal retention bolster. There are two different insertion methods for the proposed device, the 'capsule' and the 'obturator' method. The 'capsule' version includes a tapered capsule enclosing the internal bolster at one end that allows ease of insertion and an obturator rod is pre-loaded in to the shaft prior to use. The 'obturator' version uses a T-Handle and snap arm assembly for controlled insertion and elongation through the device shaft. The Low Profile Non-Balloon Feeding Device and the predicate devices are provided in a number of sizes to accommodate different stoma diameters and lengths.

The provided text describes the 510(k) summary for the "Low Profile Non-Balloon Feeding Device." It outlines the device's characteristics, intended use, and substantial equivalence to predicate devices, supported by performance testing. However, the document does not contain the level of detail typically found in a study description for an AI/ML device, especially regarding acceptance criteria directly linked to a specific study with statistical results.

The document discusses performance testing in general terms for a medical device (a feeding tube), but not for an AI/ML component. Therefore, much of the requested information regarding AI/ML study specifics (e.g., sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable or cannot be extracted from this text.

Here's a breakdown of what can and cannot be extracted based on your request and the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text lists various performance tests conducted for the device. It states, "Testing found that all components and materials met or exceeded design specifications established by AMT." However, it does not explicitly state quantitative acceptance criteria for each test, nor does it provide the specific numerical results for each test. Instead, it offers a general statement of compliance.

• Tip Poke-Through Force: Met specifications.
• Snap Arm Body to Rod Attachment Force: Met specifications.
• Snap Arm to T-Handle Snap Engagement Force: Met specifications.
• T-Handle Tooth Shear Strength: Met specifications.
• Interlock Pullout: Met specifications.
• Time to Capsule Rupture: Met specifications.
• Suture Deployment Force: Met specifications.
• Ripcord Tensile Strength: Met specifications.
• Pull Tab-to-Suture Bond Strength: Met specifications.
• Liquid Leakage Test: Met specifications.
• Flow Rate Test (Water and Viscous Fluid): Met specifications.
• Tube Tensile Test: Met specifications.
• Obturator Bond Strength Test: Met specifications.
• Duckbill Flow and Backflow Test: Met specifications.
• Obturator Poke-Through Evaluation: Met specifications.
• Obturator Push-Through Force Test: Met specifications. |

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

• Sample Size: Not specified. The document mentions "samples of the Low Profile Non-Balloon Feeding Device" were used for bench tests, but no specific number of samples is provided for any test.
• Data Provenance: Not applicable in the context of clinical data. These are bench tests conducted on physical device samples. The company conducting the tests is Applied Medical Technology, Inc. (AMT), based in Brecksville, OH, USA. The tests are prospective in the sense that they were conducted for the purpose of this 510(k) submission.

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 the performance testing described is for a physical medical device (feeding tube) through bench testing, not for an AI/ML algorithm requiring expert interpretation of data for ground truth.

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

• Not applicable for physical bench testing. The results would be based on direct measurement or observation against predetermined specifications by test engineers.

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

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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

• For the bench tests, the "ground truth" would be the engineering design specifications and expected physical properties and performance characteristics of each component and the assembled device. These are objective measurements rather than expert consensus on clinical data.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device. While presumably, some prototypes or earlier versions of the device would have been tested during development, the concept of a "training set" for an algorithm does not apply.

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

• Not applicable. This is not an AI/ML device.

In summary, the provided document details the regulatory submission for a physical medical device. It confidently states that the device met its design specifications through various bench tests, but it does not delve into the specifics of AI/ML performance evaluation as requested in the prompts.

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The Low Profile Balloon Feeding Device is indicated for use in patients who require long term feeding, are unable to tolerate oral feeding, who are at low risk for aspiration, require gastric decompression and/or medication delivered directly into the stomach through a secured (initial placement) or formed (replacement) stoma. The Low Profile Balloon Feeding Device is intended for all age groups.

The Low Profile Balloon Feeding Device is used to provide nutrition, medication, and decompression access into the stomach through a secured (initial placement) or formed (replacement) stoma. The Low Profile Balloon Feeding Device consists of an external bolster, feeding catheter, and internal retention balloon, similar to the predicate devices. The feeding catheter is inserted into the stomach through a stoma and is held in place with an internal retention balloon. The device can have an MR Conditional balloon fill-valve or will be MR Safe when assembled with the Invisi-Valve. The devices are provided in a number of sizes to accommodate different stoma diameters and lengths and can have either a blunt or tapered tip balloon. The catheter tubes range in diameter from 10Fr to 24Fr, which is the same as the primary predicate. The stoma lengths are available in a wider range of options, from 0.5cm to 10.0 cm.

The provided text describes a 510(k) submission for a "Low Profile Balloon Feeding Device" and does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.

The document is a traditional medical device submission (K161413) to the FDA, demonstrating substantial equivalence to predicate devices, rather than an AI/ML device requiring performance evaluation against specific metrics like sensitivity, specificity, or AUC.

Therefore, I cannot extract the requested information (points 1-9) which are relevant to AI/ML device studies. The document focuses on:

• Device Description: What the device is and how it works.
• Intended Use: The medical purpose of the device.
• Technological Characteristics: Materials, sizes, and features.
• Biocompatibility Testing: Ensuring the materials are safe for patient contact, detailed with ISO standards used.
• Performance Testing: Bench tests to confirm the physical integrity and function of the device components, such as balloon burst strength, pullout strength, and flow rates.
• Substantial Equivalence: Comparison to existing devices on the market.

None of these sections discuss AI/ML models, algorithms, or their performance metrics.

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