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Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare is used endoscopically in the removal of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract. Disposable Polypectomy Snare shall be used with monopolar diathermic energy. Disposable Polypectomy Hybrid Snare shall be used with or without monopolar diathermic energy.

The Disposable Polypectomy Snare is available in two different types with rotating snare and non-rotating snare. The cutting wire diameter of the snares is 0.4mm. The catheter diameters are 1.8mm and 2.4mm the depending on the version. The snares are available in different forms, lengths and openings depending on the type.

• Non-rotating snares: available in six different loop shape: Oval, Hexagon, Lune, Combination, Multiple and Composite. Opening widths 10mm, 15mm, 20mm, 25mm,30mm, 35mm. Working lengths 1800mm and 2300mm.
• Rotatable snares: available in six different loop shape: Oval, Hexagon, Lune, Combination, Multiple and Composite. Opening widths 10mm, 15mm, 20mm.25mm. 30mm. 35mm. Working lengths 1800mm and 2300mm.

The Disposable Polypectomy Hybrid Snare is available in two different types with rotating snare and non-rotating snare. Only one available loop shape is Hybrid. The cutting wire diameter of the snares is 0.4mm. The catheter diameters is 2.4mm. The snares are available in different forms, lengths and openings depending on the type.

• Non-rotating snares: available in the opening widths 10mm, 15mm. Working lengths 1800mm and 2300mm.
• Rotatable snares: available 10mm, 15mm. Working lengths 1800mm and 2300mm.

The provided text is a 510(k) summary for a Disposable Polypectomy Snare and Hybrid Snare. This document primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and non-clinical performance data, rather than presenting a study to prove a device meets specific clinical acceptance criteria for a new AI or diagnostic device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not applicable or not provided in this type of submission.

Here's an explanation based on the provided text:

• No clinical study was conducted or included in this submission. The device is being cleared based on substantial equivalence to a legally marketed predicate device, primarily through bench testing and comparison of technical specifications.
• The summary explicitly states: "No Clinical Study is included in this submission." (Section 5.8)

However, I can extract the "Non-clinical Performance Data" which serves as the basis for demonstrating safety and effectiveness for this type of medical device submission.

1. Table of Acceptance Criteria and Reported Device Performance (Non-clinical)

Based on the "Non-clinical Performance Data" section (5.7), the acceptance criteria are generally adherence to recognized international standards and satisfactory results from specific bench tests.

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

• Sample Size: Not specified for the bench tests. Typically, regulatory submissions for physical devices include testing on a representative number of units to ensure consistency and performance across the product line.
• Data Provenance: The tests were performed on the Disposable Polypectomy Snare and Disposable Polypectomy Hybrid Snare (the proposed device). The provenance of the raw data (e.g., country of origin, retrospective/prospective) is not detailed in this summary. These are typically controlled laboratory tests.

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

• Not applicable. This submission relies on objective physical and chemical testing standards (ISO standards, bench tests) rather than expert-derived ground truth.

4. Adjudication method for the test set

• Not applicable. This submission relies on objective physical and chemical testing standards.

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 a physical medical instrument (polypectomy snare), not an AI or diagnostic device that involves human readers.

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

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

7. The type of ground truth used

• For biocompatibility and sterilization, the "ground truth" is defined by adherence to internationally recognized ISO standards.
• For physical properties, the "ground truth" is adherence to pre-defined specifications and satisfactory performance in bench tests.

8. The sample size for the training set

• Not applicable. No machine learning or AI component, thus no training set.

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

• Not applicable. No machine learning or AI component, thus no training set or its associated ground truth establishment.

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The Disposable Polypectomy Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.

The Disposable Polypectomy Snare consists of an insertion part and a handle part. The insertion part includes cutting loop(a flexible wire cable), traction wire, and sheath; the handle part includes sheath sleeve, locking sleeve, rotating sleeve, electrode connector, slider and a handle. The cutting loop can be extended and retracted from the Snare's flexible outer sheath using a three ring handle. The cutting loop can also be rotated 360° using the rotating actuator on the handle. The inner diameter of the sheath is PTFE to provide minimal friction during extension, rotation, and retraction of the loop from the sheath. When passed through an endoscope and activated, the Snare delivers a monopolar electrical current to cut and cauterize tissue with the loop.

The Disposable Polypectomy Snare is sterile for single use with no delayed hypersensitivity and no intracutaneous reactivity, have no animal or human origin substance.

The cutting loop of disposable polypectomy snare has four shapes to be used in clinical practice:

Ellipse type (E type), Hexagonal type (H type), Crescent type (C type), Round type (R type), and the loop can extend, retract from the snare's flexible outer sheath.

The materials used for construction of Disposable Polypectomy Snare are typical for this type of medical device. Materials of Cutting Loop is stainless steel 06Cr19Ni10, the Sheath is made of PTEF, the Electrode Connector is made of stainless steel SUS304. The Handle, Slider, Rotating Sleeve and Locking Sleeve are made of ABS, the Sheath Sleeve is made of HDPE.

The provided text is a 510(k) summary for a Disposable Polypectomy Snare, a medical device used for removing and cauterizing polyps in the gastrointestinal tract.

Based on the information provided, this document does not describe a study involving an AI/Machine Learning device or a study that establishes ground truth based on expert consensus, pathology, or outcomes data.

Instead, it focuses on the substantial equivalence of a new medical device (the Disposable Polypectomy Snare) to a previously cleared predicate device. The performance validation relies primarily on bench testing and adherence to consensus standards, rather than clinical studies or evaluations of diagnostic accuracy typically associated with AI/ML systems.

Therefore, I cannot populate the table or answer most of your questions as they pertain to AI/ML device acceptance criteria and studies proving their performance. The information related to sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to the evaluation described in this document.

Here's what I can extract from the provided text, but it's important to understand this is for a non-AI/ML medical device:

1. A table of acceptance criteria and the reported device performance

The document details performance bench testing rather than diagnostic performance against a specific condition. The "acceptance criteria" are implied by meeting the compliance testing standards and internal requirements.

Regarding the other questions, they are largely not applicable to this 510(k) submission for a non-AI/ML device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document describes bench testing, not a clinical test set with patient data. No specific "sample size" of specimens is explicitly mentioned for each bench test, but implies sufficient testing to meet standards.
• Data provenance: Bench testing conducted by the manufacturer (Beijing ZKSK Technology Co., Ltd. in China). The statement "Results from testing performed confirms that the design requirement specification and user needs have been met" suggests internal testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Ground truth as typically defined for diagnostic AI/ML models (e.g., expert consensus on images, pathological confirmation) was not established or used. The ground truth for bench testing is adherence to physical/chemical specifications and standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable, as no human reader adjudication process is described for this device's performance validation.

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 is not an AI-assisted device, and no MRMC study was performed.

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

• Not applicable, as this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this device's performance is adherence to established engineering specifications, material standards (e.g., ISO, IEC), and functional requirements determined through bench testing.

8. The sample size for the training set

• Not applicable. This is not a machine learning device and therefore does not have a training set.

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

• Not applicable.

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The intended use of the subject device is to electrosurgically remove GI tract polyps through the channel of an endoscope

The device consists of a handle, cable, snare loop and cable. The loop is attached to the handle assembly by means of the cable. The sheath is also connected to the handle assembly and collapses the loop upon its retraction into the sheath.

The provided text describes a 510(k) premarket notification for a medical device called the "Mill-Rose Disposable Polypectomy Snare." This is a regulatory submission to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

Based on the provided documents, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner you've outlined for AI/software devices.

Here's why and what can be extracted based on your questions:

• Type of Device: The Mill-Rose Disposable Polypectomy Snare is a physical medical instrument used for electrosurgical removal of GI tract polyps. It is not an AI/software device, imaging device, or diagnostic tool that would typically have performance metrics like sensitivity, specificity, or reader improvement studies.
• Regulatory Pathway: The 510(k) pathway focuses on demonstrating "substantial equivalence" to a predicate device already on the market. This typically involves comparing material, design, technological characteristics, and intended use to the predicate device, not necessarily conducting performance studies in the way an AI/diagnostic device would. The goal is to show it performs as safely and effectively as the predicate, not necessarily to quantify its performance against a set of statistical cutoffs like an AI model.

Therefore, the requested information categories (e.g., sample size for test sets, ground truth establishment, MRMC studies, standalone performance) are not applicable or not provided in this type of regulatory submission for this type of device.

Here's what can be answered from the provided text, largely by stating "Not Applicable" or "Not Provided" due to the nature of the device and submission:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not Applicable / Not Provided. This type of performance testing with a "test set" and ground truth is not described for this physical device in a 510(k) submission.
• Data Provenance: Not Applicable / Not Provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not Applicable / Not Provided.
• Qualifications of Experts: Not Applicable / Not Provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: 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

• MRMC Study: No, Not Applicable. This is a physical device, not an AI system.
• Effect Size of Human Readers with AI: Not Applicable.

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

• Standalone Performance: No, Not Applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Type of Ground Truth: Not Applicable / Not Provided. Performance is based on substantial equivalence to predicate devices, not on a ground truth established for diagnostic accuracy.

8. The sample size for the training set

• Sample Size for Training Set: Not Applicable / Not Provided. This is a physical device, not an AI/machine learning model that requires a training set.

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

• Ground Truth Establishment for Training Set: Not Applicable / Not Provided.

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