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This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of

• 1. Endoscopic marking,
• 2. Hemostasis for
  • · Mucosal/submucosal defects less than 3 cm
  • · Bleeding ulcers,
  • · Arteries less than 2 mm,
  • · Polyps less than 1.5 cm in diameter,
  • · Diverticula in the colon, and
  • · Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection,
• 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel,

4. As a supplementary method for closure of GI tract luminal perforations less than 20mm that can be treated conservatively
5. Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus in patients with fistulas, leaks, perforations, or disunion.

The Instinct Plus Endoscopic Clipping Device is a sterile, single use metallic clip used for tissue approximation and hemostasis in the gastrointestinal tract. The metallic clip is 14.4 mm long and has an opening span of 16 mm. The clip is preloaded on a 230 cm long introducer comprised of a coated coil spring, drive wire and deployment handle. The clip may be deployed to the site of interest using a straight viewing flexible endoscope with a minimum accessory channel of 2.8 mm, or side viewing flexible endoscope with a minimum accessory channel of 4.2 mm. The clip can be rotated for positioning by rotating the handle of the introducer and may be reopened and closed up to five times prior to deployment.

The Instinct Plus Endoscopic Clipping Device is supplied sterilized by ethylene oxide gas in a peel-open package and intended for one-time use. The product is packaged with one-year shelf life.

This is a 510(k) premarket notification for the Instinct Plus Endoscopic Clipping Device. The document claims substantial equivalence to two predicate devices: the K151802 Resolution™ 360 Clip and the K132809 Instinct Endoscopic Hemoclip.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists "design input requirements" that performance testing was conducted to meet. These essentially serve as acceptance criteria. However, explicit numerical or categorical acceptance values for each criterion are not provided in the summary. Instead, it generally states that the device "met the design input requirements."

Table: Acceptance Criteria and Reported Device Performance

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

The document is a 510(k) summary and does not provide specific details on the sample sizes used for each performance test. It mentions "performance testing was conducted," but no numbers of devices tested, number of simulated cases, or specific patient data are given. As this filing is for a mechanical device and discusses performance data but does not explicitly mention clinical studies using patient data, it is highly likely that the testing involved lab-based, benchtop, or simulated use testing of the device's physical and functional characteristics. Therefore, there is no mention of retrospective or prospective data or country of origin for a clinical test set.

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

Since the testing described is primarily focused on mechanical and functional performance (e.g., strength, deployment, retention), the concept of "ground truth" established by human experts for diagnostic accuracy studies (like radiologists) is not applicable here. The "ground truth" for these performance tests would be defined by engineering specifications, material properties, and functional benchmarks derived from predicate devices or established standards.

4. Adjudication Method for the Test Set:

Not applicable, as this is primarily a performance and mechanical testing summary, not a study involving human interpretation or diagnostic accuracy where adjudication would be necessary.

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

No, an MRMC study was not done. The document describes performance testing of the device itself, not a comparative effectiveness study involving human readers with and without AI assistance (which is typical for AI/CAD devices).

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

Not applicable. This is not an AI/CAD device.

7. The Type of Ground Truth Used:

For the performance data, the "ground truth" would be established by:

• Engineering Specifications: Pre-defined design limits and tolerances for force, dimensions, durability, etc.
• Material Standards: Compliance with known material properties.
• Predicate Device Performance: Benchmarking against the known performance characteristics of the legally marketed predicate devices.
• Established Test Methods: Adherence to validated laboratory testing protocols.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device.

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Used to dilate strictures of the gastrointestinal tract, including strictures of the esophagus, pylorus, duodenum and colon.

The modified Hercules 3 Stage Wire Guided Balloon consists of coaxial catheter with a dilation balloon mounted on the distal tip. The balloon is inflatable with fluid to three distinct and progressively larger size diameters to exert pressure on strictures and affect dilation of the stricture. It is offered in a variety of balloon diameters. Supplied sterile and Intended for Single Use. Inflation device sold separately.

The provided text is a 510(k) summary for the Cook Endoscopy Hercules 3 Stage Wire Guided Balloon, dated January 23, 2009. This document is a regulatory submission to the FDA, not a study report detailing performance data and acceptance criteria for a device that uses an algorithm or AI.

Therefore, the requested information cannot be extracted from the provided text as it does not contain:

1. A table of acceptance criteria and reported device performance: The document states, "We believe risks associated with the modifications to the subject device to be adequately addressed through our Design Control Process," but provides no specific performance data or acceptance criteria.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, or standalone algorithm performance: These concepts are relevant to studies involving algorithms or AI, which are not mentioned in this 510(k) summary for a medical device.
3. Type of ground truth used: Not applicable as no study involving ground truth assessment is described.
4. Sample size for the training set and how ground truth for the training set was established: These relate to AI/ML model development, which is not discussed.

The document is a declaration of substantial equivalence to a predicate device (Quantum T.T.C Balloon Dilation Catheter, K935094) based on similar intended use, fundamental design, operational principle, and scientific technology. It briefly describes the device, its intended use (to dilate strictures of the gastrointestinal tract), and its comparison to a legally marketed device. It does not include performance data in the format of a clinical study with acceptance criteria.

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This device is intended to be used with an ultrasound endoscope for delivery of injectable materials into tissues during endoscopic procedures and fine needle aspirations (FNA) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the GI tract.

The Endoscopic Ultrasound Needle is offered in various needle gauges for injection or aspiration. This device is used in conjunction with an ultrasound endoscope to gain access to the target site. The needle which is dimpled for ultrasonic visualization is advanced into the target site for injection of therapeutic materials or aspiration. The device allows for adjustment of the length of the sheath and needle to enable the user to adjust for the working length of the endoscope and to control needle insertion depth. It is preloaded with a stylet to aid in inserting the needle which is removed for injection and aspiration. The device is supplied sterile and intended for single use only.

The provided document describes a 510(k) Summary for the Cook Endoscopy EchoTip Ultra Ultrasound Needle, submitted to the FDA in 2009. This document is a premarket notification for a medical device seeking to demonstrate substantial equivalence to previously cleared predicate devices. It largely focuses on the device's technical specifications, intended use, and its equivalence to other legally marketed devices, rather than a clinical study evaluating its performance against specific acceptance criteria.

Therefore, much of the requested information regarding detailed acceptance criteria, specific device performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from this document as it is not a clinical study report.

However, I can extract the following based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states:

• "Performance testing performed under simulated use conditions demonstrates that the Endoscopic Ultrasound Needle met the performance requirements of the expanded indications for use."

This indicates that internal performance requirements were established and met under simulated conditions for the expanded indications. However, the specific acceptance criteria (e.g., minimum tensile strength, maximum deflection, aspiration efficiency, injection rate) and the numerical results for these criteria are not provided in this summary. The "reported device performance" is a general statement of compliance.

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

• Sample Size for Test Set: Not specified. The document mentions "performance testing," but does not provide details on the number of devices or simulated scenarios tested.
• Data Provenance: The testing was "performed under simulated use conditions," implying laboratory or bench testing rather than clinical data. No country of origin is specified for the simulated use data, nor is it explicitly stated as retrospective or prospective (though simulated testing is inherently prospective in its design).

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

• Not applicable. This document describes simulated performance testing, not a clinical study where ground truth would be established by experts.

4. Adjudication Method for the Test Set:

• Not applicable. As this was simulated performance testing, not a study involving human interpretation of data, an adjudication method for a test set is not relevant here.

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

• No. The document does not describe an MRMC study. Its focus is on demonstrating substantial equivalence through technical and simulated performance, not on comparative effectiveness with human readers.

6. If a Standalone (Algorithm Only) Performance Was Done:

• Not applicable. This device is a physical medical instrument (an ultrasound needle), not an algorithm or AI. Therefore, standalone algorithm performance is not relevant. The performance mentioned refers to the physical device's characteristics.

7. The Type of Ground Truth Used:

• Not applicable / N/A. For simulated use performance testing of a physical device, "ground truth" in the sense of expert consensus or pathology is typically not established. The ground truth refers to the expected physical performance standards the device is designed to meet, validated through engineering specifications and experimental measurements.

8. The Sample Size for the Training Set:

• Not applicable. As this is a physical medical device, there is no "training set" in the context of machine learning or algorithms.

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

• Not applicable. There is no training set for this type of device.

Summary Limitations:

It is crucial to understand that 510(k) summaries are for demonstrating substantial equivalence to existing devices, not necessarily for proving novel clinical efficacy or diagnostic accuracy through extensive clinical trials. The "clinical evidence" mentioned generally refers to information supporting the safety and effectiveness of the device type for the proposed indications, often referencing scientific literature or previous uses of similar devices, rather than a specific, new clinical trial conducted for this particular submission. The document explicitly states: "The Clinical Evidence supports the substantial equivalence of this device for the new indications for use." This supports the claim that the expanded indications do not pose new safety or effectiveness concerns beyond what is understood for the predicate devices.

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Cook Endoscopy's Esophageal Dilation Balloon is intended to endoscopically dilate strictures of the esophagus. The Esophageal Balloon Dilator is used to endoscopically dilate strictures of the esophagus.

The proposed Cook Endoscopy Dilation Balloon is a single lumen catheter with a balloon mounted on the distal tip. The balloon is inflatable with water to three distinct and progressively larger size diameters to exert force on esophageal strictures resulting in stricture dilation. It is offered in a variety of diameters to accommodate a range of esophageal strictures This device is supplied sterile and intended for single use. This balloon is not sold with inflation device.

The provided text describes a 510(k) premarket notification for the Cook Endoscopy Esophageal Dilation Balloon. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the format requested. The document primarily focuses on establishing substantial equivalence to predicate devices based on intended use, indications for use, performance characteristics, available diameters/lengths, and biocompatibility.

Here's an analysis based on the information provided, highlighting what is present and what is missing in relation to your request:

1. Table of acceptance criteria and reported device performance:

The document mentions "Non-Clinical Testing was performed on characteristics of the balloon with respect to The FDA Guidance for Urological Balloons and additional tests as needed to verify safety and performance." However, it does not provide a specific table of acceptance criteria (e.g., burst pressure, inflation/deflation times, material integrity) nor the detailed reported performance results against those criteria.

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

This information is not present in the provided text. The document refers to "Non-Clinical Testing," which implies laboratory or bench testing rather than a clinical study with a test set of patient data.

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

This information is not present. As the testing appears to be non-clinical, the concept of "ground truth" established by experts in a clinical context (e.g., for diagnostic accuracy) does not apply here.

4. Adjudication method for the test set:

This information is not present. This is typically relevant for studies involving human interpretation or clinical outcomes, which are not described here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size:

This information is not present. An MRMC study compares human readers' performance with and without AI assistance, which is not applicable to a non-clinical device like an esophageal dilation balloon.

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

This information is not present. This applies to AI algorithms, not to a physical medical device like a balloon dilator.

7. The type of ground truth used:

Given that "Non-Clinical Testing" was performed, the "ground truth" would likely refer to engineering specifications and performance standards established by FDA guidance (e.g., "FDA Guidance for Urological Balloons") and internal Cook Endoscopy requirements. However, the exact type of ground truth (e.g., specific measurement tolerances, physical properties verified by calibrated instruments) is not explicitly detailed.

8. The sample size for the training set:

This information is not present. This concept applies to machine learning models, which are not relevant to the described device.

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

This information is not present, for the same reason as point 8.

Summary of what's available and what's missing:

The provided text from K061937 describes the Cook Endoscopy Esophageal Dilation Balloon and its 510(k) submission for substantial equivalence.

• Acceptance Criteria & Performance: The document states that "Non-Clinical Testing was performed on characteristics of the balloon with respect to The FDA Guidance for Urological Balloons and additional tests as needed to verify safety and performance." However, specific quantitative acceptance criteria or detailed performance results (e.g., burst pressure values, diameter consistency, material strength) are not provided.
• Study Design: The study mentioned is "Non-Clinical Testing," indicating laboratory or bench testing rather than a clinical trial with human subjects.
• Missing Information: Crucially, the document does not contain information regarding:
  • Specific quantitative acceptance criteria.
  • Detailed reported performance data.
  • Sample sizes for test or training sets.
  • Data provenance.
  • Number or qualifications of experts.
  • Adjudication methods.
  • MRMC comparative effectiveness studies.
  • Standalone algorithm performance.
  • Type or establishment method of ground truth in a clinical or AI context.

The 510(k) summary focuses on demonstrating equivalence to predicate devices (Wilson-Cook Quantum T.T.C. Dilation Balloon and Microvasive RX Biliary Balloon Dilation Catheter) based on intended use, indications, and general performance characteristics, rather than detailing a specific study with defined acceptance criteria for a novel AI or diagnostic device.

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