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The Stylus is intended to assist in the placement of Low-Profile Gastrostomy Feeding Tube or Gastrostomy Button by providing temporary feeding tube stability during insertion through patient stoma tract.

The Stylus (may also be referred as Stylet, Introducer, Obturator or Stiffener) is an Introducer for the Low-Profile Gastrostomy Feeding Tube or Gastrostomy Button (LPGFT/B - K122030) originally cleared in July 2012 which was developed at Degania Silicone Ltd. The Stylus is made of Polycarbonate (Macrolon®) and has various ranges of lengths, colors and weights. The Stylus is inserted all the way into the Feeding Port of the LPGFT/B port of the cleared gastrostomy device. The use of the Stylus is optional, it provides stiffness to the LPGFT/B shaft to guide the LPGFT/B through the stoma. The Stylus should not exceed the buttons distal tip. The Stylus is being sterilized by Ethylene Oxide (EtO) along with a compatible Low Profile Gastrostomy Feeding Tube/ Gastrostomy Button kit, rather than a standalone device.

The provided text describes the "Stylus" device, which assists in placing gastrostomy feeding tubes. The 510(k) summary (K233591) details its regulatory information and a brief overview of testing. However, it does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and study specifics.

Based on the available text, here's what can be extracted and what remains unknown:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Bench Performance Testing" that included:

• Tensile strength testing
• Stylus stiffness testing
• Dimensional testing
• Gastrostomy compatibility testing

The reported performance conclusion is: "The results show that the device is at least as [effective as] a legally marketed predicate device."

However, the specific numerical acceptance criteria or the quantitative results for these tests are not provided in the given text. A table cannot be generated without these details.

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

The document states, "Bench Performance Testing included tensile strength testing, styls stiffness testing dimensional testing, and gastrostomy corpatibilitytesting." However, no details about the sample size used for these tests or the data provenance (e.g., country of origin, retrospective/prospective) are provided.

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

This information is not mentioned in the provided text. The testing described appears to be bench testing, not involving human interpretation or ground truth established by experts.

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

This information is not mentioned in the provided text. Adjudication methods are typically relevant for studies involving human assessment or interpretation, which is not described for this bench testing.

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

An MRMC study is not mentioned in the provided text. The device described, the Stylus, is a physical introducer for feeding tubes, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable as the Stylus is a physical medical device, not an algorithm or software. The testing mentioned is device performance testing, not algorithm performance testing.

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

For the bench performance tests mentioned (tensile strength, stiffness, dimensions, compatibility), the "ground truth" would be the engineering specifications and established physical measurement standards relevant to the device's function and comparison to the predicate. The document doesn't explicitly state "ground truth" in this context but implies a comparison to predicate device performance.

8. The sample size for the training set

The Stylus is a physical device and not an AI/ML model, so there is no training set in the context of machine learning. The testing described is physical performance testing.

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

As there is no training set for this type of device, this question is not applicable.

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The Aquarius™ Stoma Measuring Device is designed to determine the depth (length) of a well-established gastrostomy stoma tract in order to assist in proper length selection of the Aquarius™ Gastrostomy Button (G-Button). Intended for transient use (less than 60 minutes).

The Aquarius™ Stoma Measuring Device comprises a 12 Fr with graduated scale, a funnel with an inflation valve and a tubular shaft retaining balloon. The Aquarius™ Stoma Measuring Device is made of 100% silicone, EtO sterilized and for single use. Intended to be use in hospital environment.

The provided text describes the Aquarius™ Stoma Measuring Device, its intended use, and the regulatory review process. However, the document does not contain information about acceptance criteria or a study that specifically "proves the device meets the acceptance criteria" in terms of algorithmic performance, as would be common for AI/ML-based medical devices.

This device is a physical medical device and its "acceptance criteria" are related to its physical specifications, material properties, and functionality, as demonstrated through verification testing. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel performance study in the way an AI/ML device would.

Therefore, many of the requested elements (e.g., sample size for AI test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable or not present in this type of document for this type of device.

Here's an attempt to answer the questions based only on the provided text, highlighting what is present versus what is not.

Acceptance Criteria and Device Performance (Based on Provided Text)

The document lists "verification tests" performed on the device. These tests implicitly define the "acceptance criteria" by requiring the device to comply with established standards and internal requirements. The "reported device performance" is a statement that the tests were conducted and the device complied.

Specific Study Details:

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

   • Test set size: Not explicitly stated for each test. For a physical device, this would typically involve a specific number of units manufactured for testing.
   • Data provenance: Not applicable in the context of clinical data for AI. The tests are performed on the manufactured device itself. No country of origin for "data" is relevant here in the AI context. The tests were "conducted on the final sterile device," implying tests performed by the manufacturer, Degania Silicone, Ltd. (Israel).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a physical device, ground truth is established by engineering measurements, adherence to material specifications, and functional testing against predefined standards (e.g., balloon bursting volume). Expert radiologists or similar personnel are not involved in establishing ground truth for these types of tests.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication is relevant for subjective assessments or disagreements in clinical interpretations, which is not the nature of these engineering and material tests.

4. 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 physical measuring tool, not an AI algorithm assisting human readers. No MRMC study was performed or is relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device's verification would be based on:

   • Engineering specifications and drawings: For dimensions, surface finish, markings.
   • Material standards: For tensile strength, biocompatibility.
   • Functional requirements: For balloon concentricity and bursting volume.
   • Regulatory standards: ISO 14971:2012 for risk management.

7. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of AI/ML.

8. How the ground truth for the training set was established: Not applicable. As there's no training set for an AI algorithm, there's no ground truth to establish for it.

In summary: The provided document is for a traditional, physical medical device. It demonstrates substantial equivalence and verification against engineering and material specifications, not algorithmic performance. Therefore, most of the questions pertaining to AI/ML device studies are not applicable. The "study" mentioned is a compilation of non-clinical verification tests confirming compliance with design and safety requirements.

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AQUARIUS™ Gastrostomy Replacement Tube is intended for use in a well-established gastrostomy tract for feeding and/or administration of medications. May be used for gastric decompression.

Aquariusi Gastrostomy Replacement Tube is a silicone feeding tube comprised of a double lumen tube with external proximal specific ENFit safety access port/s, external retention disk, balloon, and distal open flow-through tip. The tube is with external graduations (cm) and radiopaque marker at the distal end. The tube size and balloon capacity are clearly indicated on the shaft and pouch of each device. The tube is made without use of natural latex, BPA, or phthalates plasticizers.

The provided document is a 510(k) premarket notification for a medical device called the AQUARIUS™ Gastrostomy Replacement Tube. It is a submission to the FDA (Food and Drug Administration) for clearance to market the device, demonstrating substantial equivalence to a legally marketed predicate device.

This document does not describe a study related to the performance of an AI/ML (Artificial Intelligence/Machine Learning) device or a study involving human readers. Therefore, I cannot extract information related to acceptance criteria and studies in the context of AI/ML or human performance improvement.

Instead, the document details the non-clinical summary for the AQUARIUS™ Gastrostomy Replacement Tube, which focuses on device functionality and safety. Here's an analysis of the "acceptance criteria" and "study" in that context:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various performance functionality tests conducted on the Gastrostomy Replacement Tube. While specific quantitative acceptance criteria are not explicitly stated in this summary, the completion of these tests implies that the device met pre-defined acceptable limits for each. The "reported device performance" is essentially the successful completion of these tests.

2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical device testing, not a dataset. The "test set" would be the specific physical samples of the device used for each test. The provenance is the manufacturer (Degania Silicone, Ltd. in Israel).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is for physical device testing, not expert-adjudicated data.

4. Adjudication method for the test set: Not applicable. This refers to physical device testing, not expert-adjudicated data.

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 document is for a medical device (gastrostomy tube), not an AI/ML system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is for a medical device (gastrostomy tube), not an AI/ML system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for these non-clinical tests is established by industry standards, international standards (like ISO 14971:2012 for risk management), and internal engineering specifications for the device's physical and functional performance. It's based on objective, measurable parameters and established engineering principles, not expert consensus or clinical outcomes data in the usual sense.

8. The sample size for the training set: Not applicable. This document is for a medical device (gastrostomy tube), not an AI/ML system. There is no concept of a "training set" for physical device testing.

9. How the ground truth for the training set was established: Not applicable. As there's no training set, there's no ground truth to establish for it in this context.

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The Aquarius™ Nasal Feeding Tubes, /Nasogastric & Nasojejunal / provide nutritional support for patients who require liquid feedings as a substitution for solid food. Intended for enteral administration of nutrients. fluids and/or medications into alimentary tract via natural nasoenteric route.

The Aquarius™ Nasogastric Tubes are for the administration of nutrition. fluids and/or medications by the natural naso-enteric route for the patients who are physically unable to ingest enough nutrients through normal mastication and deglutition. Nasogastric feeding tube is designated for patients who require intermittent or continued feeding/and or medication into the stomach.

The Aquarius™ Nasojejunal Feeding Tubes are for the administration of . nutrition, fluids and/or medications by the natural naso-enteric route for the patients who are physically unable to ingest enough nutrients through normal mastication and deglutition. Designated for patients who are critically ill and require early enteral feeding/and or medication into the small intestine; may be with a dual tube allowing simultaneous gastric drainage.

The Aquarius™ Nasal Tube / Nasoqastric Tube (NG-Tube) & Nasojejunal Tube (NJ Tube) / are enteral feeding tubes comprised of flexible tubes and ENFit enteral specific connection access. The tubing part of the devices is constructed with radiopaque polyurethane material and with a hydrophilic coating at the distal end to assist the easy insertion of the tube. The Nasogastric Tube may be with metal stylet and/ or with weighted tip to assist the tube insertion and to maintain the tube in the place. The Nasoieiunal Tube is with stylet and with radiopaque polyurethane antenna tip at the distal end of the tubing to assist to advance the tube into the jejuna. There is an external marking on both NG & NJ-Tubes for measuring of the tube length inserted into the alimentary tract.

This document describes the Aquarius™ Nasal Feeding Tubes (Nasogastric & Nasojejunal) and their substantial equivalence to predicate devices, based on nonclinical testing. It does not contain information about studies proving the device meets acceptance criteria or details regarding human reader performance, AI-assistance, or ground truth establishment for AI/ML-based devices.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests conducted, implying these tests serve as acceptance criteria. However, explicit numerical acceptance criteria and the quantitative reported performance for each are not provided in this document. Instead, it states that the device was "found to be in compliance with the design and performance requirements."

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

This document summarizes nonclinical testing. It does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for the tests conducted. These tests are typically performed on physical samples of the device, not patient data in the context of an AI/ML device.

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

This information is not applicable as the document describes nonclinical, physical device testing, not an AI/ML study requiring expert ground truth for patient data.

4. Adjudication Method for the Test Set:

This information is not applicable as the document describes nonclinical, physical device testing.

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

No, an MRMC comparative effectiveness study was not conducted. This document describes the 510(k) premarket notification for a physical medical device (feeding tubes), not an AI/ML-driven diagnostic or assistive system that would typically undergo such a study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone performance study was not done. This is not an AI/ML device.

7. The Type of Ground Truth Used:

The "ground truth" for the nonclinical tests would be the established engineering specifications and international standards (e.g., ISO 80369-1:2010, EN1615:2000, ISO 10993 series, ISO 14971:2012). The device's physical properties and performance during these tests are compared against these predetermined specifications.

8. The Sample Size for the Training Set:

This information is not applicable as this is not an AI/ML device and therefore does not have a training set in that context.

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

This information is not applicable as this is not an AI/ML device.

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AQUARIUS™ Extension Feeding Set is intended for use as an extension set for AQUARIUS™ G-button/ or other gastric feeding device, incorporating safety connectors which help mitigate the risk of accidental connection of an IV system to the enteral system, or the enteral system to IV system.

The Aquarius™ Extension Feeding Set comprise from the hollow Tube with Connector and Funnel at the ends. The Funnel connects to delivery source of nutrition and the Connector connects to a gastric feeding device. The Aquarius™ Extension Feeding Set is compatible with Aquarius™ Gastrostomy Button (G-Button) and any castric feeding device with Mc-Key™ connection ring. A device is for single patient use only.

This document describes a Special 510(k) submission for the AQUARIUS™ Extension Feeding Set, focusing on its non-clinical summary. The submission asserts that the device is substantially equivalent to a predicate device (K132686).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not provide specific sample sizes for each test mentioned (e.g., number of devices tested for tensile strength, flow rate, leakage, or biocompatibility tests). It also does not specify the country of origin for the data or whether the studies were retrospective or prospective. The non-clinical summary suggests these were laboratory-based tests conducted on the proposed device.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

This study involves non-clinical (laboratory) testing, not assessments that require human expert interpretation of results to establish ground truth in the way medical imaging or diagnostic tests do. Therefore, the concept of "experts used to establish ground truth" with specific qualifications (like radiologists) is not applicable here. The ground truth is established by the objective measurements and observations against pre-defined engineering and safety standards.

4. Adjudication Method for Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation (e.g., when multiple readers assess images and their opinions need reconciliation). As this is a non-clinical, laboratory-based study focusing on device performance and safety, an adjudication method is not applicable. The results are based on direct measurements and adherence to specified standards.

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

No MRMC comparative effectiveness study was conducted. This device is an extension feeding set, and the evaluation is based on its physical properties, biocompatibility, and functional performance, not on diagnostic accuracy requiring human interpretation or comparison with AI assistance.

6. Standalone (Algorithm Only) Performance Study

No standalone (algorithm only) performance study was conducted. This is a medical device (hardware), not an algorithm or AI software. Therefore, this section is not applicable.

7. Type of Ground Truth Used

The ground truth used in these non-clinical studies is based on:

• Standardized Test Methods and Criteria: These are established by international and national standards such as ISO 10993-5, ISO 10993-10, ISO 80369-1 Annex B, and AAMI/ANSI ID54.
• Objective Measurements: Results are derived from quantitative and qualitative measurements (e.g., tensile strength values, flow rates, visual inspection for leakage, assays for cytotoxicity, irritation, sensitization, and physical connection tests for compatibility).
• Compliance with Specifications: The device's performance is compared directly against pre-defined engineering and safety specifications derived from the predicate device and relevant standards.

8. Sample Size for the Training Set

This product is a physical medical device. The concept of a "training set" is typically associated with machine learning algorithms. Therefore, a training set as understood in that context is not applicable. The device's design and manufacturing processes are likely informed by prior engineering knowledge and predicate device characteristics, but there isn't a "training set" in the AI sense.

9. How Ground Truth for the Training Set Was Established

As there is no "training set" in the context of an AI algorithm, the method for establishing its ground truth is not applicable. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, regulatory requirements, and the performance characteristics of the predicate device.

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AQUARIUS™ Enternal Extension Set is intended for use as an extension set for AQUARIUSTM G-button' or other gastric feeding device, incorporating safety connectors which help mitigate the risk of accidental connection of an intravenous therapy system to the enteral system, or the enteral system to intravenous therapy system.

Not Found

This FDA 510(k) clearance document for the AQUARIUS™ Enternal Extension Set is a premarket notification, indicating substantial equivalence to a predicate device. It does not include detailed information on acceptance criteria or the specific studies performed to demonstrate performance.

Therefore, the requested information cannot be fully extracted from the provided text. The document primarily focuses on regulatory approval based on equivalence and administrative details.

Here's what can be stated based on the provided text, and what cannot:

What can be extracted:

• Device Name: AQUARIUS™ Enternal Extension Set
• Regulatory Class: II
• Product Code: KNT
• Indication for Use: "AQUARIUS™ Enternal Extension Set is intended for use as an extension set for AQUARIUSTM G-button' or other gastric feeding device, incorporating safety connectors which help mitigate the risk of accidental connection of an intravenous therapy system to the enteral system, or the enteral system to intravenous therapy system."
• Type of Use: Prescription Use

What cannot be extracted from this document:

• A table of acceptance criteria and the reported device performance: This document is a regulatory approval letter, not a detailed study report. It states that the device is "substantially equivalent" to a legally marketed predicate device, but does not provide specific performance metrics or acceptance criteria for that equivalence.
• Sample sized used for the test set and the data provenance: Not available.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
• Adjudication method: Not available.
• 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 device or an imaging device requiring reader studies.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
• The type of ground truth used: Not available. The clearance is based on substantial equivalence, implying performance similar to a predicate device, but the specific "ground truth" for the current device's testing is not detailed here.
• The sample size for the training set: Not applicable. This is not an AI algorithm.
• How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.

Conclusion:

The provided document is a 510(k) clearance letter from the FDA. It confirms that the AQUARIUS™ Enternal Extension Set is substantially equivalent to a predicate device for its stated indications for use. However, it does not contain the detailed technical or clinical study data, including acceptance criteria, performance metrics, sample sizes, ground truth establishment, or expert qualifications, that would typically be found in a study report. This kind of detailed information is part of the 510(k) submission, but not part of the publicly released clearance letter.

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SILICONE FOLEY CATHETER WITH TS, 6FR, intended for urological use only. TSC indicated for drainage of the urinary bladder and simultaneous monitoring of temperature.

Not Found

This document is a 510(k) premarket notification FDA approval letter for a SILICONE FOLEY CATHETER WITH TS, 6FR, (TSC). It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval letter based on substantial equivalence, not a performance study report.

Therefore, I cannot provide the requested information from the provided text.

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Degania Silicone Gastrostomy Button is a replacement gastrostomy tube indicated for long term use in a well established gastrostomy tract for feeding and/or administration of medication. May be used for gastric decompression.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for the Degania Silicone Gastrostomy Button. It is not a study report and therefore does not contain the information requested in your prompt regarding acceptance criteria and performance data for a device.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device but does not provide any details about performance criteria, study design, or results.

To answer your questions, I would need access to the actual 510(k) submission (K122030) or a separate study report for the Degania Silicone Gastrostomy Button.

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Coude Foley catheter / or Tiemann Foley Catheter/ is all silicone Foley catheter 2-way intended for urological use only. Indicated for routine drainage of the urinary bladder.

Maximum recommended indwelling time is not more than 30 days.

Prescription Use ONLY (Part 21 CFR 801 Subpart D)

Coude Foley catheter / or Tiemann Foley catheter is all silicone Foley catheter 2-way.

This document is a 510(k) summary for a medical device (Coude Foley catheter / or Tiemann Foley catheter). It primarily focuses on the regulatory clearance process, specifically demonstrating substantial equivalence to a predicate device.

Therefore, the provided text does not contain information about acceptance criteria, device performance metrics, study designs (sample sizes, ground truth establishment, expert qualifications, adjudication methods), or any comparative effectiveness studies as requested in the prompt.

The document states the "Indications for Use" for the device, which is "for routine drainage of the urinary bladder" with a "Maximum recommended indwelling time is not more than 30 days." However, these are indications, not performance metrics or acceptance criteria.

To answer your request, I would need a different type of document, such as a clinical study report, a performance testing report, or a detailed technical specification for the device.

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Gastrostomy Replacement Tube of Degania Silicone Ltd is indicated for use in a well established Gastrostomy tract for feeding and/or administration of medication. May be used for gastric decompression.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a Gastrostomy Replacement Tube and does not contain information about acceptance criteria or a study proving the device meets those criteria. The document only confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information.

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