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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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