Search Results

The Polypectomy Snares and Rotatable Snares are used endoscopically in the removal and /or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.

Both the rotatable and non-rotatable snares consists of a flexible wire cable and loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop. For the rotatable snares, the snare can be rotated by using the rotation actuator.

The provided text describes Boston Scientific Corporation's Polypectomy Snares and Rotatable Snares, which are medical devices used endoscopically for the removal and cauterization of polyps and tissue within the GI tract. The 510(k) submission (K131700) is for a change to the device indication only, and the devices are stated to be identical in design, materials, and manufacturing processes to previously cleared predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation does not explicitly state quantitative acceptance criteria or detailed results for each performance metric. It generally states that the devices met required specifications.

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

• Sample Size: The document does not specify the exact sample size for the comparative or in-vitro testing. It refers to "all components, subassemblies, and/or full devices" and "Comparative testing."
• Data Provenance: The testing was "In-vitro testing" and "Comparative testing" performed by Boston Scientific Corporation. The country of origin is not explicitly stated but implied to be the US given the submission to the FDA. The testing is assumed to be prospective for the purpose of this 510(k) submission.

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

There is no mention of experts or human assessment in establishing ground truth for the performance testing. The study focuses on physical and mechanical specifications of the device itself.

4. Adjudication Method for the Test Set

Not applicable. The testing described is primarily in-vitro and comparative, not involving human judgment or adjudication of results in the clinical sense.

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. This document describes a medical device (polypectomy snares) and its physical characteristics and indications for use, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or applicable here.

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

Not applicable. This device is a physical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance study was based on predetermined engineering specifications and measurements (e.g., length, OD, loop width and shape, loop plane deflection, tensile strength), and comparison to predicate devices. There is no biological or clinical ground truth described, as the study is focused on device attributes.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for a physical device.

Ask a specific question about this device