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The Sonnet™ Polypectomy Snare consists of a 240cm catheter attached to a handle at the proximal end and incorporates a braided stainless steel wire in a loop configuration that is attached to a stainless steel drive-wire and is extendable and retractable with respect to the catheter distal tip. The handle provides an active cord connection. The catheter has a single lumen.

AI/ML Overview

The provided document is a 510(k) summary for the Sonnet™ Polypectomy Snare. It is a premarket notification to the FDA for a medical device, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving novel clinical safety and effectiveness through extensive studies.

Therefore, the document does not contain the detailed information required to fill out all the items in your request, such as a table of acceptance criteria and reported device performance through a clinical study, specific sample sizes for test and training sets, details on expert ground truth establishment, or multi-reader multi-case study results.

Here's a breakdown of what can be extracted and what is missing:

Description of the Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:

The provided document describes the device and its intended use, and then states that "Test Data: Tests include electrical testing." It concludes by asserting "The subject device is safe and effective and is substantially equivalent to the predicate devices."

This K050294 submission is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to already legally marketed predicate devices, rather than performing de novo clinical studies with predefined acceptance criteria for novel safety and effectiveness. Therefore, the "acceptance criteria" for this submission would primarily revolve around demonstrating that the device performs similarly to its predicates through non-clinical testing (like electrical testing mentioned) and design comparisons. There isn't a "study" in the sense of a clinical trial designed to prove specific performance metrics against clinical acceptance criteria.

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from 510(k) process)	Reported Device Performance (as per document)
Functional/Safety Equivalence	Electrical Safety and Performance	"Tests include electrical testing." The document asserts the device is "safe and effective."
Intended Use Equivalence	Monopolar electrosurgical device for endoscopic polypectomy, similar to predicates.	"The Sonnet™ Polypectomy Snare is a monopolar electrosurgical device used with an electrical unit for endoscopic polypectomy." (Matches predicate's intended use).
Design Equivalence	Similar design features (catheter, handle, braided wire, active cord connection) to predicates.	"consists of a 240cm catheter attached to a handle... incorporates a braided stainless steel wire... The handle provides an active cord connection." (Implicitly deemed equivalent to predicates based on clearance).
Material Equivalence	Use of biocompatible and functional materials.	Device made of "braided stainless steel wire" (Implicitly deemed equivalent/safe based on clearance).
Performance Equivalence	Overall performance similar to predicate devices to ensure substantial equivalence.	"The subject device is similar with respect to intended use and/or design features to the predicate devices in terms of section 510(k) substantial equivalence. The subject device is safe and effective and is substantially equivalent to the predicate devices."

No specific quantitative acceptance criteria or detailed performance results (e.g., in terms of efficiency, precision, or specific clinical outcomes) are provided in this 510(k) summary. The "reported device performance" is a general statement of safety, effectiveness, and substantial equivalence, backed by electrical testing, but without detailed results.

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

Sample Size for Test Set: Not applicable / Not provided. The document refers to "electrical testing" but does not specify the sample size of devices tested or any patient/clinical data.
Data Provenance: Not applicable for clinical data. The "test data" mentioned is likely from internal laboratory/engineering testing of the device itself, not patient data.

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

Not applicable / Not provided. This 510(k) summary does not involve a clinical study with expert-established ground truth.

4. Adjudication method for the test set

Not applicable / Not provided.

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

Not applicable. This device is an electrosurgical snare, not an AI-powered diagnostic tool.

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

Not applicable. This device is an electrosurgical snare, not an algorithm.

7. The type of ground truth used

Not applicable. Given this is a physical medical device, not a diagnostic algorithm based on imaging or other data, the concept of "ground truth" in the manner typically applied to AI/diagnostic studies does not apply here. The "truth" would be the device's functional and safety performance as validated through engineering tests and comparison to predicates.

8. The sample size for the training set

Not applicable / Not provided. This document refers to a physical device, not an AI algorithm requiring a training set.

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

Not applicable / Not provided.

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