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The ArgoCap has been designed to be attached to the distal end of the endoscope to facilitate endoscopic therapy.

The ArgoCap is intended for the following:

• Gastrointestinal endoscopic mucosal resection and coagulation
• Keeping the suitable depth of the endoscope's view field

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the ArgoCap (200.52) does not contain any information regarding the acceptance criteria or the study that proves the device meets the acceptance criteria.

This document is a formal notification of substantial equivalence for a medical device, outlining regulatory information such as:

• Device name and product codes
• Regulation numbers and regulatory class
• Indications for Use
• General controls provisions of the Act
• Links to FDA guidance documents
• Requirements for Quality System (QS) regulation, UDI rule, and medical device reporting

It does not include details about:

• Specific performance metrics or acceptance criteria for the device itself
• Clinical or non-clinical study design, results, or statistical analyses
• Sample sizes, data provenance, ground truth establishment, or expert qualifications
• Adjudication methods or MRMC studies

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported performance, nor can I provide information on the various aspects of the study mentioned in your prompt, as none of that data is present in the document.

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The BARS Set is indicated for clip placement within the context of flexible endoscopy in the GI tract for the purpose of:

• Hemostasis for:
  • Mucosal/submucosal defects

The subject device constitutes an over-the-scope clip application device used within the context of flexible endoscopy in the gastrointestinal tract. The over-the-scope clip application capabilities center around a memory-shape alloy clip mounted on a transparent plastic cap. Cap (and clip) are mounted on the distal end of an endoscope. Endoscopic instruments are provided in the BARS Set to facilitate insertion and for mobilization of target tissue into the cap lumen. With the target tissue inside the cap lumen, the memory-shape alloy clip is applied onto the target tissue using a thread mechanism. Contents of the BARS Set are: - BARS (readily assembled unit of memory-shape alloy clip, transparent plastic cap, thread deployment components, working channels, and guide elements)

• Endoscopic instruments (BARS Anchor silver, BARS Anchor black, Insertion Balloon, Space Keeper Balloon, Guide Wire)

The provided text is a 510(k) Premarket Notification from the FDA for a device called the BARS Set. It describes the device, its indications for use, and a summary of non-clinical tests. However, the document explicitly states "Not applicable - no clinical testing submitted for demonstration of substantial equivalence."

Therefore, I cannot provide the detailed information requested regarding acceptance criteria and a study that proves the device meets those criteria from this document alone. The questions posed in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are all related to clinical or performance studies with human data/expert review, which were not submitted for this 510(k).

The document focuses on demonstrating substantial equivalence through bench testing and comparison to predicate and reference devices, rather than a new clinical study.

Here's what I can extract based on the provided text, primarily regarding the non-clinical bench testing:

Non-Clinical Bench Testing Summary (based on the device's substantial equivalence pathway):

• Acceptance Criteria for Non-Clinical Bench Testing & Reported Device Performance: This information is not presented in a table with specific criteria and results. The document states:

  • "Performance bench testing settings investigated key aspects of device safety and effectiveness."
  • "The established precedent from these devices were met as evidenced by application of acceptance criteria and / or comparison to their respective performance bench testing substantial equivalence."
  • The tests mentioned for the subject device are:
    • Functional capability and robustness
    • Endoscope compatibility
    • Clip application ring strength
    • Space keeper balloon capability and robustness
    • Usability
    • MRI suitability
  • However, specific quantitative acceptance criteria (e.g., "Clip application force > X N") and the numerical results the BARS Set achieved are not detailed in this public summary. The document only confirms that the device "met" these criteria or "the established precedent" set by reference devices.

• Sample Size Used for the Test Set and Data Provenance:

  • Not applicable as no clinical test set (i.e., human subject data for performance claims) was submitted. The tests mentioned were bench tests.
  • The provenance of any data used for bench testing (e.g., whether conducted in the US, Germany, etc.) is not specified.

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

  • Not applicable as no clinical test set or expert-adjudicated ground truth was submitted for device performance evaluation. The "ground truth" for the non-clinical tests would be defined by engineering specifications and physical measurements.

• Adjudication Method for the Test Set:

  • Not applicable as no clinical test set requiring expert adjudication was submitted.

• If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

  • No, explicitly stated: "Not applicable - no clinical testing submitted for demonstration of substantial equivalence."

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

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

• The Type of Ground Truth Used:

  • For the non-clinical bench tests, the "ground truth" would be the engineering specifications and physical properties of the device and its components, and comparison to the performance of legally marketed predicate/reference devices. This is not clinical ground truth (e.g., pathology, outcomes data).

• The Sample Size for the Training Set:

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

• How the Ground Truth for the Training Set was Established:

  • Not applicable.

In summary: The provided FDA 510(k) summary focuses on demonstrating "substantial equivalence" of the BARS Set to existing predicate and reference devices through non-clinical bench testing, without the need for new clinical data or human-in-the-loop performance studies like those typically conducted for AI/software devices. The document confirms that the device "met" acceptance criteria related to its physical and functional characteristics based on these bench tests.

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The gel is an injection agent for endoscopic mucosal resection (EMR) and/or endoscopic submucosal dissection (ESD).

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The provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria.

The document is an FDA 510(k) clearance letter for a device called "LiftUp" (a gel for endoscopic mucosal resection and/or endoscopic submucosal dissection). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements for the manufacturer.

To answer your request, I would need a different document that details the performance study and acceptance criteria for the "LiftUp" device.

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Instrument for flexible endoscopy, for full-thickness resection and diagnostic tissue acquisition through removal of suitable lesions in the stomach and duodenum.

The gastroduodenal FTRD is indicated for the resection of lesions

Not Found

The provided text is an FDA 510(k) clearance letter for the gastroduodenal FTRD Set. It does not contain information about acceptance criteria, device performance, study design, expert qualifications, or ground truth establishment.

The document describes the device's indications for use and lists general regulatory compliance requirements. It is a clearance letter, not a clinical study report or a summary of such a report.

Therefore, I cannot provide the requested information based on the input text.

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Instrument for flexible endoscopy for fixation of metal stents in the gastrointestinal tract for use in adults only.

Not Found

This is a 510(k) premarket notification for a medical device (stentfix OTSC System Set), not a study evaluating device performance or AI. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in the provided text.

The document is a clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and general controls, but not a specific performance study against acceptance criteria.

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The remOVE System consists of the DC Impulse and the DC Cutter Set.

The remOVE DC Impulse is a medical electrical device for fragmentation of OTSC® (endoscopic device for effective treatment of hemorrhage and acute or chronic wall defects in the GI tract) and FTRD® (endoscopic device for full-thickness resection of colorectal wall lesions) clips made by Ovesco Endoscopy AG for the digestive tract.

The remOVE DC Cutter Set is a set of instruments for use in flexible endoscopy. It consists of a bipolar DC instrument for the fragmentation of OTSC (endoscopic device for effective treatment of hemorrhage and acute or chronic wall defects in the GI tract) and FTRD (endoscopic device for full-thickness resection of colorectal wall lesion) clips from Ovesco Endoscopy AG, a pair of forceps and a cap for removal of these fragmented clips,

The remOVE System is comprised of the DC Impulse generator and the DC Cutter Set for the fragmentation and removal of OTSC ("over the scope clip" cleared under K101428) and FTRD ("full thickness resection device" cleared under K153550) clips from the digestive tract.

DC Impulse:
The DC Impulse is an electrical generator that produces pulsed, direct current (DC) to cut OTSC and FTRD clips. The DC Impulse generator is equipped with internal energy storage, allowing the device to generate pulsed DC without additional load on the power supply. The internal energy storage is charged before delivering the pulsed DC. DC Impulse is designed specifically for use with the DC Cutter and cannot be used with other instruments. Components required for operating the DC Impulse generator are a foot switch, a DC cord for connection to the DC Cutter instrument, and a power cord. The DC Impulse and accessories are reusable.

DC Cutter Set:
The DC Cutter Set includes three components: DC Cutter instrument, SecureCap retrieval cap, and Grasper. The DC Cutter is a bipolar, direct current instrument for flexible endoscopy and is meant for use only with the DC Impulse generator and flexible endoscopes with a working channel diameter of 2.8 mm. It is connected to the DC Impulse generator via the DC cord. The Grasper is used to retrieve the clip fragments. The dimensions of the Grasper are 2200 mm in length and 2.3 mm in diameter. The set is provided sterile and intended for single use only.

The provided text does not contain information about acceptance criteria and a study that proves the device meets them in the format typically used for AI/ML device evaluations (e.g., performance metrics like sensitivity, specificity, AUC). Instead, it describes regulatory information, device details, non-clinical/bench studies, animal studies, and limited clinical information (compassionate use cases) for a medical device called the "remOVE System," an endoscopic electrosurgical clip cutting system.

The "acceptance criteria" in this context are implicitly the fulfillment of various safety and effectiveness requirements demonstrated through the described studies. The "study that proves the device meets the acceptance criteria" refers to the entire body of evidence presented in the document, which supports the De Novo request.

However, I can extract the relevant information from the provided text and present it in a modified format as best as possible, aligning with the spirit of your request.

Acceptance Criteria and Study for the remOVE System

The provided document describes the regulatory approval process for the remOVE System, an endoscopic electrosurgical clip cutting system, via a De Novo request. The "acceptance criteria" are implicitly defined by the regulatory requirements and "Special Controls" outlined in the document, which focus on safety, effectiveness, biocompatibility, sterility, shelf-life, and usability. The "study that proves the device meets the acceptance criteria" refers to a combination of non-clinical bench testing, animal studies, and limited compassionate use clinical experience.

1. Table of Acceptance Criteria and Reported Device Performance

• Usability (operability, field of view, comprehensibility of labeling)
• Stress (device integrity over lifespan)
• Compatibility (with specified instruments)
• Reliability | Usability: Passed IEC 62366 testing; evaluated functional/operational aspects supporting safe/effective use. Key elements (operability, field of view, labeling comprehensibility) evaluated.
  Stress: DC Impulse generator passed all test cycles (165 A max, 75 ms pulse) over its lifespan; no deterioration.
  Compatibility: DC Cutter designed specifically for DC Impulse, cannot be used with other instruments.
  Reliability: Implied by successful stress testing and animal/clinical outcomes. |
  | Electrical and Thermal Safety (e.g., unintended tissue damage, burns, perforations) | Compliant with IEC 60601-1; thermal safety evaluated via risk management; electrophysiological safety tests showed current/density below adverse effect thresholds. Animal studies evaluated thermal collateral tissue damage. |
  | Electromagnetic Compatibility (EMC) (e.g., interference, electrical shock) | Compliant with IEC 60601-1-2. |
  | Biocompatibility (for patient-contacting components, e.g., adverse tissue reaction) | DC Cutter Set (external communicating, limited contact) tested per ISO 10993-1; all results demonstrated acceptable biocompatibility profile. |
  | Sterility (for components provided sterile, e.g., infection) | Ethylene Oxide (EO) sterilization validated per ISO 11135-1 (SAL of 10-6) for DC Cutter Set. |
  | Shelf Life (continued sterility, package integrity, device functionality) | Labeled for 1 year based on accelerated aging (ASTM F1980-07); post-aging, devices passed integrity (seal strength, visual, dye penetration) and functional bench testing. |
  | Tissue Damage Evaluation (in vivo, including thermal effects, and clip removal effectiveness) | Animal Studies: In vivo/ex vivo testing in esophagus, gastric wall, duodenum, colon. Evaluated safety and effectiveness of clip removal, thermal collateral tissue damage. Grasper and SecureCap functionality tested. "Results support safe and effective use." |
  | Clinical Effectiveness & Safety (successful clip removal, absence of serious complications) | Compassionate Use (Europe): 11 patients: Complete retrieval in 10. One firmly ingrown piece left, no further consequences. All bleeding treatable. No changes in heart rhythm.
  Retrospective Study (74 patients incl. above): Clip removal successful in 72. Two not possible (epithelialized). 9 had fragment remain (deeply incorporated). No serious complications. Two minor bleedings treated. One superficial mucosal tear closed. 63 (of 74) had complete clip removal. "Overall, the information on the 74 cases support the safety and effectiveness."
  Compassionate Use (US): Approved requests, follow-up reports indicated successful procedures with no serious complications. |
  | Labeling (instructions, shelf life, warnings, precautions) | Complies with 21 CFR 801 and special controls. Includes IFU, brochure, package labels. DC Cutter Set labeling includes shelf life. |

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

The text primarily describes non-clinical and animal studies, along with limited human experience.

• Human Data (Clinical Experience):

  • Sample Size: 11 patients (European compassionate use) + 63 additional patients for a total of 74 patients (retrospective study in Europe, including the initial 11). Additionally, unspecified "several compassionate use requests" in the United States.
  • Data Provenance: Europe (initial 11 and the retrospective 74 patients), United States (additional compassionate use cases).
  • Retrospective or Prospective: The 74-patient study is explicitly called a "retrospective study on the compassionate use." The initial 11 patients were part of "compassionate use" experience. US compassionate use cases are also described retrospectively.

• Animal Studies:

  • Sample Size: Not specified (e.g., number of animals or procedures).
  • Data Provenance: Not specified, assumed controlled laboratory setting.
  • Retrospective or Prospective: Not specified, generally considered prospective for controlled studies.

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

This information is not provided in the text. The "clinical information" is from compassionate use cases and a retrospective study, where outcomes were likely assessed by the treating clinicians rather than a panel of independent experts establishing a "ground truth" for a predefined test set in a typical AI/ML validation context.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the clinical data (compassionate use and retrospective review), a formal adjudication method by a panel of experts is highly unlikely to have been employed in the manner typical for AI/ML validation studies.

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

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. The remOVE System is a mechanical/electrical device, not an AI/ML diagnostic or assistive tool for human readers.

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

The concept of "standalone performance" for an algorithm is not applicable here, as the remOVE System is a physical medical device (an electrosurgical clip cutting system) that requires human operation. It is not an AI algorithm. Its "standalone performance" would equate to its bench and animal study performance, which was indeed evaluated without human intervention in the decision-making process.

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

For the human clinical data (compassionate use and retrospective study), the "ground truth" for success/failure of clip removal and complication assessment was based on clinical outcomes data as observed and documented by the treating physicians during and after the procedures. For animal studies, the "ground truth" for safety and effectiveness was based on direct observation of tissue damage, thermal effects, and device functionality. For bench testing, the ground truth was based on pre-defined performance specifications and measurement outcomes.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. The remOVE System is a hardware device; it does not employ an AI/ML algorithm that requires a training set of data. Its design and development would have involved various engineering tests and iterations, but not data-driven "training" in the AI/ML sense.

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

This question is not applicable as there is no AI/ML algorithm or training set for the remOVE System.

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FTRD System: Instrument designed for flexible endoscopy. Instrument is designed for diagnostic tissue acquisition and full-thickness resection through the removal of suitable lesions in the colon and rectum. The FTRD System is indicated for the resection of lesions

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA regarding the FTRD System Set, which is a medical device. It outlines the device's classification, regulatory requirements, and indications for use. It does not include performance data, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the device's performance against specific acceptance criteria.

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DTC Snare:
The DTC Snare is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for haemostasis or for treating lesions of the wall of gastrointestinal organs. Marking of lesions.
The clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of.

• Endoscopic marking
• Hemostasis for:
  • Mucosal/submucosal defects

Not Found

The provided document is a 510(k) summary for a medical device called the "DTC Snare" and related instruments (Marking Probe, Grasper). It is a letter from the FDA determining substantial equivalence to a predicate device. This type of document indicates that the device has met the safety and effectiveness requirements of the predicate device, but it does not contain information about acceptance criteria or specific studies proving the device meets those criteria, nor does it typically include details about sample sizes, ground truth establishment, or expert involvement for a new study demonstrating performance.

Instead, this document confirms the device is substantially equivalent to a legally marketed predicate device based on its indications for use, technological characteristics, and safety and effectiveness information, which often involves comparing to published data or previous submissions for the predicate.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on the regulatory clearance process rather than detailed performance study results of the DTC Snare itself.

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The OTSC Proctology instrument is indicated for compression of tissue in the anal and rectum, for treating wall lesions or for haemostasis other than hemorrhoids in proctology.

The OTSC Proctology clip is indicated for placement within the anal and rectum for the purpose of treating mucosal/submucosal defects

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for the OTSC Proctology device, indicating its substantial equivalence to a legally marketed predicate device.

It primarily covers:

• The FDA's review and determination of substantial equivalence.
• Regulatory class and product code.
• General controls provisions of the Act.
• Contact information for FDA divisions.
• Indications for Use for the OTSC Proctology device.

There is no mention of specific acceptance criteria, device performance results, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or how ground truth was established for any study.

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Instrument for flexible endoscopy for dissection of tissue e.g. in endoscopic submucosal dissection (ESD) and for haemostasis during this procedure.

Not Found

I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the AqaNife electrosurgical cutting and coagulation device, indicating that it has been found substantially equivalent to predicate devices.

The text includes:

• The device name: AqaNife
• Regulation number and name: 21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories
• Regulatory class: II
• Product code: GEI
• Indications for Use: Instrument for flexible endoscopy for dissection of tissue e.g. in endoscopic submucosal dissection (ESD) and for haemostasis during this procedure.

However, there is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, or study type (retrospective/prospective) for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is primarily an administrative letter from the FDA concerning market clearance, not a detailed report of a performance study.

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