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Gold Probe Bipolar Electrohemostasis Catheter is indicated for use in transendoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract.

Injection Gold Probe Bipolar Electrohemostasis Catheter is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. The Injection Gold Probe Catheter also has irrigation capability. Any other use is not recommended.

The Gold Probe is a bipolar electrohemostasis catheter with irrigation capabilities. When passed through an endoscope and activated, it will deliver a bipolar current to cauterize tissue. The Gold Probe is available in 7 Fr and 10 Fr with a working length of 300cm (7 and 10 Fr) and 350cm (7 Fr), compatible with a minimum of 2.8 mm and 3.7 mm scope channels, respectively. The catheter shaft provides firmness for perpendicular and tangential use, while the HemoGlide Coating on the catheter promotes minimal friction during endoscope passage.

The Injection Gold Probe is an injection therapy and bipolar electrohemostasis catheter with irrigation capabilities. The Injection Gold Probe is available in a working length of 210 cm with outer diameters of 7F (2.3 mm) and 10F (3.3 mm), compatible with a minimum of 2.8 mm and 3.7 mm scope channels, respectively. The catheter shaft provides firmness for perpendicular and tangential use, while the HemoGlide Coating on the catheter promotes minimal friction during endoscope passage.

This document is a 510(k) premarket notification for a medical device, specifically the Gold Probe Bipolar Electrohemostasis Catheter and the Injection Gold Probe Bipolar Electrohemostasis Catheter.

Based on the provided text, there is no information about a study proving the device meets acceptance criteria related to AI/algorithm performance, human-in-the-loop studies, or detailed ground truth establishment. The document explicitly states:

"The proposed Gold Probe Bipolar Electrohemostasis Catheter and Injection Gold Probe Bipolar Electrohemostasis Cathter technological characteristics remain unchanged from predicate Gold Probe Bipolar Electrohemostasis Catheter (K970278) and Injection Gold Probe Bipolar Electrohemostasis Catheter (K133933) respectively; therefore, no further performance testing was required."

This statement indicates that the submission is based on substantial equivalence to previously cleared predicate devices, claiming that the technological characteristics are unchanged, and thus, no new performance testing was deemed necessary by the manufacturer for this 510(k) submission.

Therefore, I cannot populate the requested table and details because the provided document does not contain information about:

1. A table of acceptance criteria and reported device performance (in the context of an AI/algorithm study).
2. Sample sizes for a test set or data provenance for such a study.
3. Number and qualifications of experts for multi-reader studies or ground truth establishment in this context.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

This 510(k) summary focuses on demonstrating substantial equivalence to existing devices based on technological characteristics and indications for use, rather than presenting a performance study against specific acceptance criteria for a new or AI-enabled device.

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The Injection Gold ProbeTM Bipolar Electronemostasis Catheter is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites include the following:

• Peptic Ulcers
• Dieulafoy Lesions
• Mallory-Weiss Tears
• Bleeding Polyp Stalks
• Arteriovenous Malformations (AVMs)
• Angiomata

The Injection Gold Probe Bipolar Electrohemostasis Catheter also has irrigation capability. Any other use is not recommended.

The Injection Gold Probe Catheter is an injection therapy and bipolar electrohemostasis catheter with irrigation capabilities. The Injection Gold Probe Catheter is available in a working length of 210 cm with outer diameters of 7F (2.3 mm) and 10F (3.3 mm), compatible with a minimum of 2.8 mm and 3.7 mm scope channels, respectively. The catheter shaft provides firmness for persendicular and tangential use, while the Mediglide coating on the catheter promotes minimal friction during endoscope passage.

I. Injection Therapy
Each Injection Gold Probe Catheter contains a 25 gauge injection needle for injection therapy. The catheter handle contains the injection needle hub. Injection is performed by attaching a luerlock syringe to the "Injection" hub and advancing the needle.

II. Bipolar Electrohemostasis
The gold-spiral electrode on the probe tip provides bipolar electrohemostasis. The Injection Gold Probe Catheter connects directly to the Endostat™ family of Bipolar Electrosurgical Generators. Or utilize the Bipolar Cable Adapter supplied by Boston Scientific for other bipolar electrosurgical generators.

III. Irrigation
Irrigation with saline or sterile water is performed by connecting the irrigation hub to the irrigation port of the bipolar generator or to a 30 cm3 (30 cc) or 60 cm3 (60 cc) luer-lock syringe or mechanical irrigation system for generators without irrigation capability.

This document describes a Special 510(k) Premarket Notification for the Injection Gold Probe™ Bipolar Electrohemostasis Catheter. The submission focuses on demonstrating substantial equivalence to a predicate device (K110887) by addressing material changes made to the proposed device.

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

Acceptance Criteria and Reported Device Performance

Study Information

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

   • The document does not specify sample sizes for the individual bench tests. It only states that tests were performed.
   • The data provenance is not explicitly mentioned (e.g., country of origin). However, as this is a 510(k) submission to the FDA (USA), the testing would typically be conducted under US or internationally recognized standards. The studies appear to be prospective in nature, designed to evaluate the modified device against predetermined specifications.

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

   • This document describes engineering bench testing and biocompatibility testing, not clinical studies involving expert assessment of images or patient outcomes. Therefore, no "experts" in the context of clinical ground truth establishment were utilized or mentioned. The "ground truth" for these tests would be the established engineering specifications and biocompatibility standards.

3. Adjudication method for the test set:

   • Not applicable as this is not a study requiring adjudication of expert opinions (e.g., image interpretation). Bench tests and biocompatibility tests are evaluated against predefined, objective pass/fail criteria.

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:

   • No, an MRMC comparative effectiveness study was not done. This is a submission for a medical device (a catheter) and not an AI/software device that assists human readers.

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:

   • For biocompatibility: Adherence to established biocompatibility standards (e.g., ISO 10993 series).
   • For bench testing: Established engineering design specifications and performance requirements for the device's functions (e.g., flow rates, tensile strength, extension/retraction mechanisms).

7. The sample size for the training set:

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

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

   • Not applicable for the same reason as above.

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The Injection Gold Probe™ Bipolar Electrohemostasis Catheter is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites include the following: Peptic Ulcers, Dieulafoy Lesions, Mallory-Weiss Tears, Bleeding Polyp Stalks, Arteriovenous Malformations (AVMs), Angiomata. The Injection Gold Probe Bipolar Electrohemostasis Catheter also has irrigation capability. Any other use is not recommended.

The Injection Gold Probe Catheter is an injection therapy and bipolar electrohemostasis catheter with irrigation capabilities. The Injection Gold Probe Catheter is available with two different style electrical connectors (plugs), Standard and Banana. The Injection Gold Probe Catheter is available in a working length of 210cm with outer diameter of 7Fr (2.3mm) and 10Fr (3.3mm) compatible with a minimum working channel of 2.8mm and 3.7mm.

I. Injection Therapy
Each Injection Gold Probe Catheter contains a 25gauge injection needle for injection therapy. The catheter handle contains the injection needle hub. Injection is performed by attaching a luerlock syringe to the "Injection" hub and advancing the needle.

II. Bipolar Electrohemostasis
The gold spiral electrode on the probe tip provides bipolar electrohemostasis. The Injection Gold Probe Catheter has a standard plug which adapts to Symmetry Endostat, Endostat II and Bicap bipolar electrosurgical generators or Banana plugs which are recommended for use with Valleylab bipolar electrosurgical generator containing female Banana plug receptacles. The Valleylab generators should be used with the appropriate Valleylab accessories, reference the operating manuals for specifications.

III. Irrigation
Irrigation with saline or sterile water is performed by connecting the irrigation hub to the irrigation port of the bipolar generator for the Standard plug or to a 30ml (30cc) or 60ml (60cc) luer-lock syringe for the Banana plug.

The provided document is a 510(k) summary for the Boston Scientific Injection Gold Probe™ Bipolar Electrohemostasis Catheter. This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device, rather than a novel device requiring extensive clinical trials for effectiveness.

Therefore, the document describes bench testing and biocompatibility testing to demonstrate that material and design changes to the proposed device do not negatively impact its safety and effectiveness compared to the predicate. It explicitly states it is not a study to prove device performance against clinical acceptance criteria often seen with AI/algorithm-based devices.

Here's an analysis based on the provided text, addressing your questions where applicable, and noting when the information is not present as it pertains more to an AI/software device evaluation:

Acceptance Criteria and Device Performance Study Analysis

The document describes a 510(k) submission for a physical medical device (catheter) with material and design modifications. The "acceptance criteria" and "device performance" in this context refer to engineering specifications and safety requirements, not clinical diagnostic accuracy or effectiveness metrics typically associated with AI studies.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified in the document. For bench and biocompatibility testing of a physical device, sample sizes are typically determined by statistical methods for engineering testing (e.g., AQL, confidence interval for reliability), but not explicitly detailed in a 510(k) summary in the same way clinical study sample sizes are.
• Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective). The data comes from in vitro (bench) and in vivo (biocompatibility, likely animal or standardized material tests) testing.

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

• Not applicable as this is not an AI/algorithm device requiring expert-established ground truth for performance. The "ground truth" for the bench tests would be the established engineering specifications and performance benchmarks the device is designed to meet. Biocompatibility "ground truth" would be the standard material safety profiles and test protocols.

4. Adjudication Method for the Test Set

• Not applicable for the type of testing described (bench and biocompatibility tests). Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert assessments for clinical ground truth, which is not relevant here.

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

• No MRMC study was done. This type of study is specific to evaluating the impact of an AI system on human reader performance, which is not relevant for this physical medical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No standalone study (in the context of an algorithm's performance) was done. The "standalone" performance here would refer to the device's functional performance during bench testing, which was conducted to ensure it meets design specifications.

7. Type of Ground Truth Used

• For Biocompatibility: Standards-based toxicological and biological response profiles (e.g., ISO 10993 series).
• For Bench Testing: Engineering design specifications, functional requirements, and established performance parameters of the predicate device and relevant industry standards for electrosurgical and injection catheters. This is effectively "engineering ground truth."

8. Sample Size for the Training Set

• Not applicable. This submission describes a physical medical device, not an AI/machine learning algorithm, so there is no "training set."

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

• Not applicable. As there is no training set for an algorithm, there's no ground truth to establish for it in this context.

In summary: The provided document details a 510(k) submission for a modified physical medical device. The "study" described focuses on demonstrating biocompatibility and meeting design specifications through bench testing to establish substantial equivalence to a predicate device. It does not involve clinical studies or evaluations pertinent to AI performance, expert ground truth, or human-in-the-loop performance improvements typical of AI/CDSS submissions.

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