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

Polypectomy Snare described in this submission is a sterile, single use devices compatible with the working channel of endoscope. The device is used endoscopically in the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract. The device can remove the specified released Hemoclip. EO sterilization and use for single use only.

The provided text describes a 510(k) summary for the Polypectomy Snare, which is submitted to demonstrate substantial equivalence to a predicate device. This document does not detail acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device. Instead, it focuses on the substantial equivalence of the new Polypectomy Snare to an existing one based on technical characteristics, performance data (bench tests), and compliance with medical device standards.

However, I can extract information related to the device attributes and how its performance was evaluated against a predicate device, which can be adapted to the structure of your request if we interpret "acceptance criteria" as meeting or being equivalent to the predicate device's performance, and "study" as the bench testing conducted.

Based on the provided text, here's an attempt to answer your questions by interpreting "acceptance criteria" as the performance of the predicate device and "study" as the bench testing performed for substantial equivalence:

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

Since this is a substantial equivalence submission for a traditional medical device (Polypectomy Snare, not an AI/ML device), the "acceptance criteria" are implied by the performance of the predicate device (K172729) and compliance with relevant standards. The "reported device performance" refers to the results of bench tests conducted on the proposed Polypectomy Snare to demonstrate it is "as safe and effective as our predicate 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 refers to "bench tests" and "non-clinical performance tests."

• Sample Size: Not specified in the provided text for any of the individual bench tests. The text mentions "All the test results show that the proposed device is as safe and effective as our predicate device," implying sufficient testing was done, but specific sample numbers are absent.
• Data Provenance: The tests were conducted by Hangzhou AGS MedTech Co., Ltd., which is based in Hangzhou, Zhejiang, China. The data is prospective, generated specifically for this submission.

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)

This is not applicable as the submission is for a physical medical device (Polypectomy Snare) and relies on performance bench tests against engineering specifications and predicate device performance, not expert-labeled ground truth like in AI/ML studies.

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

Not applicable. This is not an AI/ML study involving human readers or interpretation of results where adjudication would be necessary. The evaluation is based on objective measurements from bench testing.

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/ML device, and no MRMC comparative effectiveness study was performed. The device is a surgical instrument.

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

This question is not applicable to the Polypectomy Snare, as it is a physical medical instrument requiring human operation, not a standalone algorithm.

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

The "ground truth" for demonstrating substantial equivalence for this device is based on:

• Engineering Specifications: Meeting design specifications for various physical and functional parameters (e.g., snare open width, loop length, usability performance tests like durability, extension/retraction, cutting force).
• Compliance with Standards: Meeting recognized international standards for medical devices (IEC 60601 for electrical safety, ISO 10993 for biocompatibility, ISO 11135 for sterility).
• Predicate Device Performance: Demonstrating performance "as safe and effective as" the legally marketed predicate device (K172729) through comparative bench testing.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. There is no training set for this type of device.

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The CORE-SNARE is used endoscopically in the removal of diminutive polyps, pedunculated polyps and tissue from within the GI tract.

The CORE-SNARE is a disposable device for cuts out and removes the tissues such as polyps after entering a site to be treated during endoscopic procedures. The device consists of Snare-loop connected with catheter tube and Catheter tube pass through operating channel of endoscope and Handle connected with snare through the catheter tube. It is available in various sizes and working lengths. Users can choose an Oval or a Crescent or Diamond type based on their preference and the characteristic of the loop sizes can be chosen in accordance with the size of the lesion and the rotational type helps approaching and grasping the lesion. When connected to an electrosurgical generator and activated, the loop delivers a monopolar electrical current to the surgical site. The proposed product is packed in a sealed pouch following EO Sterilization (SAL 10t%). This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.

The provided document is a 510(k) premarket notification for a medical device called CORE-SNARE. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance acceptance criteria in the context of an AI/ML powered device.

Therefore, the document does not contain the information requested in your prompt regarding:

• A table of acceptance criteria and reported device performance for an AI/ML algorithm.
• Sample sizes, data provenance, expert ground truth establishment, or adjudication methods for an AI/ML test set.
• MRMC studies or standalone AI performance.
• Training set details for an AI/ML algorithm.

The document primarily details the non-clinical performance testing to demonstrate the physical, electrical, and material safety and effectiveness of the CORE-SNARE, which is an electrosurgical snare for polyp removal.

Here's what the document does provide regarding its "acceptance criteria" and "study":

Acceptance Criteria and Reported Device Performance (Non-Clinical/Bench Testing)

The "acceptance criteria" in this context are the limits and standards the physical device must meet during various non-clinical tests to be considered safe and effective and substantially equivalent to the predicate. The "study" refers to the bench testing performed.

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The Disposable Polyp Snare is intended to be used in combination with endoscope for cutting polyps or other redundant tissues in digestive tract. The snare can be used with or without high-frequency current.

The subject device is intended to be used in combination with endoscope for cutting polyps or other redundant tissues in digestive tract.

The subject device consists of a handle section, a tube section and a loop section. The loop section is inserted into the tube section and is extended and retracted by operating the handle section.

The tube section and the loop section are inserted into the gastrointestinal tract through the endoscope. The loop is extended from the tube to resect the target tissue. The resection is performed with or without high-frequency current.

The shape of the loop includes oval, crescent, hexagonal, rhombus, dual-width oval, and polygonal. Users can choose the shape of the snare according to their preference and the characteristic of the lesion.

The provided text is a 510(k) summary for a medical device (Disposable Polyp Snare) and does not contain information about software as a medical device (SaMD) or an AI/ML device. Therefore, it does not describe acceptance criteria, the study that proves a device meets those criteria, or the other specific details requested in the prompt related to AI/ML or SaMD performance.

The document pertains to a physical medical device and its substantial equivalence to a predicate device based on non-clinical performance testing. The "510(k) Summary," specifically section 8 "Summary of non-clinical testing," outlines the tests conducted to support its marketing claims and confirm safety and effectiveness.

Based on the provided text, I cannot provide the requested information for the following reasons:

• Device Type: The device is a "Disposable Polyp Snare," which is a physical endoscopic accessory, not an AI/ML or software device.
• Study Type: The document explicitly states "No clinical tests were performed" (Section 9). The "non-clinical testing" summarized in Section 8 refers to physical performance tests (e.g., strength, maneuverability, cutting ability), sterilization, shelf-life, biocompatibility, and electrical safety, not the performance of an AI algorithm.
• Ground Truth/Experts/Sample Size (for AI): Since this is not an AI/ML device, there is no mention of training sets, test sets for AI performance, expert consensus for ground truth, or adjudication methods for AI performance evaluation.

In summary, the provided document does not contain the type of information needed to answer your detailed questions about acceptance criteria and study data for an AI/ML or SaMD product.

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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 SmartBand® EMR Device is intended for endoscopic mucosal resection in the upper GI tract.

The SmartBand EMR Device is an endoscopic mucosal resection device that is provided as a kit or a pack that is designed for ligation assisted endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract. The SmartBand EMR Kit consists of the SmartBand Ligator Kit, supplied non-sterile and the SmartSnare EMR Hexagonal Snare, supplied sterile. The ligator kit contains a ligation handle, loading device, connector tube and a cylindrical barrel with 5 bands separated by a deployment cord. The SmartBand EMR Pack consists of a cylindrical barrel with 5 bands separated by a deployment cord. The SmartBand EMR Pack can be used when more bands are needed to complete a procedure. The SmartSnare EMR Hexagonal Snare consists of a handle, finger slide and a hexagonal snare loop on the distal end.

This document is a 510(k) summary for the STERIS SmartBand EMR Kit. It is a submission to the FDA regarding a modified device and argues for its substantial equivalence to a legally marketed predicate device. As such, it does not contain a study proving the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy.

Instead, this document focuses on demonstrating that the modified device is as safe and effective as the predicate device by showing that the changes made do not affect the fundamental scientific technology or how it is used. The "acceptance criteria" here refer to the regulatory standard of substantial equivalence, and "performance" refers to non-clinical testing performed to support this claim.

Here's an analysis based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly defined as numerical thresholds for clinical performance but rather are inferred from the requirements for demonstrating substantial equivalence to a predicate device. The "performance" reported is related to non-clinical testing to ensure safety and functionality of the modified components.

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

• Test set sample size: Not applicable in the context of a clinical performance study. The non-clinical testing would have involved specific numbers of devices or components for each test (e.g., specific number of devices for biocompatibility, simulated use, ship testing), but these numbers are not detailed in the summary.
• Data provenance: Not explicitly stated as country of origin, but it's internal testing conducted by STERIS Corporation. The nature of the tests (biocompatibility, simulated use) suggests laboratory or engineering testing. It is retrospective in the sense that the justification is made after the modifications.

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

Not applicable for this type of submission. "Ground truth" in this context would likely refer to established engineering standards, regulatory guidelines (e.g., ISO for biocompatibility), and internal quality control specifications, rather than expert clinical consensus on patient data.

4. Adjudication method for the test set

Not applicable. This is a technical submission, not a clinical study requiring adjudication of diagnoses or outcomes.

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 medical accessory for endoscopic mucosal resection, not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study or AI-related effectiveness was assessed.

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

Not applicable. This device does not involve an algorithm.

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

The "ground truth" for the non-clinical testing would be established engineering specifications, material standards (e.g., for biocompatibility), and performance benchmarks derived from the predicate device's known characteristics. For example, the ground truth for biocompatibility is meeting the requirements of ISO 10993 standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable. See point 8.

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

The Captivator and Captiflex Single-Use Polypectomy Snares consist 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 the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.

This document describes a 510(k) premarket notification for Captivator and Captiflex Single-Use Polypectomy Snares. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through bench testing.

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests but does not explicitly define acceptance criteria as numerical thresholds for all tests. It generally states that the modified snares "met all pre-defined specifications." For cutting force, comparative data is provided, implying that the modified devices should perform comparably to or better than the predicate.

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

• Sample Size for Test Set: The document does not explicitly state the numerical sample size (n) for each test. It mentions "All snare configurations were tested" for loop extension and retraction, and "the largest snare (M00561290) was tested to represent all snares" for actuation force. For maximum cutting force, multiple UPNs for both predicate and modified devices are listed, with mean and standard deviation provided, suggesting multiple measurements were taken for each UPN, but the exact number of units/measurements per UPN is not specified.
• Data Provenance: The data is generated from bench testing conducted by Boston Scientific Corporation. This is a controlled, in-vitro environment, not human or animal data. There is no mention of country of origin of the data beyond Boston Scientific's location being Marlborough, MA. The study is effectively a prospective evaluation of the modified devices against internal specifications and comparative data from existing predicate devices.

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

This type of information is not applicable to this submission. The "ground truth" here is defined by engineering specifications and objective physical measurements (e.g., force, functionality), not subjective expert assessment as would be the case for image interpretation or diagnosis.

4. Adjudication Method for the Test Set

This is not applicable. As the testing involves objective bench measurements against specifications, there is no need for adjudication by experts.

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

This is not applicable. This submission is for physical medical devices (polypectomy snares), not an AI-assisted diagnostic or therapeutic system that would involve human readers or AI.

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

This is not applicable. This is not an algorithm or AI device.

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

The "ground truth" for this device's performance demonstration is based on engineering specifications and objective physical measurements obtained through bench testing. This includes:

• Functionality (extension, retraction)
• Force measurements (actuation force, maximum cutting force)
  These are established through internal design validation processes to ensure the devices meet their intended technical performance.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not a machine learning or AI device. The development process would involve iterative design and testing, but not a formally defined "training set" in the context of AI.

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

This is not applicable for the same reasons as point 8.

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The Lariat snare is an electrosurgical device designed to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures. The device can be used with or without monopolar diathermic energy.

The Lariat snare is an electrosurgical device designed to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures.

This document is a 510(k) K200745 Premarket Notification for the Lariat Hot/Cold Snare, which is an electrosurgical device. It outlines the FDA's decision regarding substantial equivalence. However, this document does NOT contain information about acceptance criteria or a study proving the device meets those criteria.

The 510(k) clearance process primarily demonstrates substantial equivalence to a predicate device, rather than requiring extensive clinical trials with strict performance criteria and ground truth validation as would be the case for novel AI/Software as a Medical Device (SaMD) products.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample sizes used for the test set and data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable/present.
4. Adjudication method for the test set: Not applicable/present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable/present.
6. If a standalone (algorithm only) performance was done: Not applicable/present (this is a physical device, not an algorithm).
7. The type of ground truth used: Not applicable/present.
8. The sample size for the training set: Not applicable/present.
9. How the ground truth for the training set was established: Not applicable/present.

The document is a regulatory clearance letter, not a clinical study report or a technical performance description for an AI/SaMD product. The "Lariat, Hot/Cold Snare" is a physical medical device.

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The SmartBand® EMR Device is intended for endoscopic mucosal resection in the upper G1 tract.

The SmartBand® EMR Device is an endoscopic mucosal resection device that is provided as a Kit or a Pack that is designed for ligation assisted endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract. The SmartBand® EMR Kit consists of the SmartBand Ligator Kit, supplied non-sterile and the SmartSnare™ EMR Hexagonal Snare, supplied sterile. The ligator kit contains a ligation handle, loading device, connector tube, and a cylindrical barrel with 5 bands separated by a deployment cord. The SmartBand® EMR Pack consists of a cylindrical barrel with 5 bands separated by a deployment cord, which can be used when more bands are needed to complete the procedure.

This looks like a 510(k) premarket notification for a medical device called "SmartBand EMR Kit." The document describes the device, its intended use, and performance testing, but it does not appear to be a study about AI/ML device performance or include acceptance criteria directly related to AI/ML device performance metrics like sensitivity, specificity, or AUC.

The document mainly focuses on demonstrating substantial equivalence to a predicate device (Captivator™ EMR Device (K140726)) by comparing their design features, intended use, and functional performance through bench testing and biocompatibility assessments.

Therefore, many of the specific details requested in your prompt (e.g., acceptance criteria for AI models, sample size for test sets with ground truth, expert qualifications for ground truth, MRMC studies, standalone algorithm performance, training set details) are not present in this document because it's not a submission for an AI-powered device.

However, I can extract information related to the device's overall performance testing as described in the document, which serves as the "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission.

Here's a breakdown of the available information based on your prompt:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance values for specific metrics relevant to AI/ML. Instead, it describes general performance testing conducted to ensure safe and effective function.

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

• Sample size: Not explicitly stated as a number of "cases" or "patients" in the context of an observational study. Performance testing was conducted on "representative production units" and "components" of the device. This implies bench testing of physical units rather than a clinical dataset.
• Data provenance: Not applicable in the context of bench testing on physical devices.

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

• Not applicable. This document describes bench testing of a physical medical device, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth from medical images or patient data.

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

• Not applicable. See point 3.

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. An MRMC study was not done because this is not an AI-assisted device.

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

• No. This is not an AI algorithm.

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

• Not applicable in the AI/ML sense. The "ground truth" for the bench testing would be the engineering specifications, relevant ISO standards (e.g., for sterilization, biocompatibility), and the performance of the predicate device for comparative purposes.

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it is not an AI/ML product.

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

• Not applicable. See point 8.

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The AcuSnare Polypectomy Snare - Duckbill (ASDB) device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract.

The AcuSnare Polypectomy Snare - Duckbill (ASDB) is a sterile, single use device compatible with the accessory channel of endoscope. This type endoscopic polypectomy device is designed to connect to an electrosurgical unit via an active cord accessory and the drive cable delivers energy through the snare head to cut and/or cauterize tissue as described in the instructions for use. The device consists of a handle, sheath, drive cable and wire loop snare head. The sheath is comprised of polytetrafluoroethylene (PTFE) and is offered in 7 Fr. (2.3 mm) diameter and 240 cm length models. The snare head is available in the shape of a duckbill configuration and offered in a 15 mm or 25 mm width. The stainless-steel drive cable and snare head pass through the sheath and the three ring (polycarbonate) handle allows the user to extend and retract the snare through the distal tip of the sheath.

The provided text describes a 510(k) premarket notification for a medical device called the AcuSnare Polypectomy Snare - Duckbill (ASDB). This is for a device intended for polypectomy (removal of polyps) during endoscopy. The document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study as described in the provided text:

Key Takeaways from the Document:

• This is a Special 510(k) submission, indicating minor modifications to an already cleared device (AcuSnare Polypectomy Snare - K173673).
• The primary change is the addition of a new duckbill shape configuration and associated cannula components.
• The manufacturer claims this change does not alter the method of operation or intended use of the device.
• Performance Data: The document states that a Risk Analysis (DFMECA) was completed, and Design Verification and/or Validation testing was performed to address the impact of modifications. The conclusion is that these tests provide "reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness and demonstrate that the AcuSnare Polypectomy Snare - Duckbill (ASDB) meets the performance requirements to fulfill the intended use of the device."

Important Note: The provided text does not contain detailed information about specific acceptance criteria, quantitative performance metrics, or a formal clinical study with a test set, ground truth, or expert review. The focus of this 510(k) is on demonstrating substantial equivalence through design validation and verification of the modifications rather than a de novo extensive performance study.

Given the information, here's an attempt to answer your questions, highlighting where specific details are not provided in the document:

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

The modification (duckbill shape) "does not change the method of operation or the intended use of the device." |
| Risk Mitigation: | "The Risk Analysis was completed to access the impact of modifications made to the cleared device using the Design Failure Modes, Effects and Criticality Analysis (DFMECA) method."

"We believe risks associated with the modifications to the subject device have been adequately addressed through our Design Control Processes." |
| Biocompatibility (Inferred): | Not explicitly stated but implied by substantial equivalence and design control. The device components (PTFE sheath, stainless steel drive cable and snare head) are likely the same as the predicate and would have undergone biocompatibility testing in the predicate's clearance. The text mentions "materials" are equivalent. |
| Sterility (Inferred): | Not explicitly stated but common for such devices. The device is described as "sterile, single use." This would have been established with the predicate device and verified for the modified device. |
| Mechanical Performance (e.g., cutting, cauterization efficacy, durability of snare): | Not detailed. The text states "Design verification and/or validation testing was performed." These tests would have covered the physical properties and functional performance of the modified duckbill snare to ensure it effectively cuts and cauterizes polyps as intended, at least equivalently to the predicate. Specific metrics (e.g., force to cut, temperature profile, number of cycles) are not provided. |

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

   • The document does not specify a sample size for a clinical "test set" in the context of human patients or a specific dataset.
   • The "testing" mentioned refers to design verification and validation testing. This typically involves laboratory-based tests on device samples, not patient data.
   • Provenance is not applicable as this describes device design testing, not clinical data analysis.
   • The submission is a regulatory filing, not a peer-reviewed research paper detailing a study's methodology.

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)

   • This information is not applicable and not provided. As explained above, the submission describes design verification and validation testing of the device itself, not a study involving human interpretation of data where expert ground truth would be established.

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

   • This information is not applicable and not provided. Adjudication methods are relevant for studies where multiple human readers or algorithms interpret medical images or data against a consensus ground truth. This submission focuses on engineering and design testing.

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, an MRMC comparative effectiveness study was not done (or at least, not reported in this document).
   • This device is a physical medical instrument (polypectomy snare), not an AI or imaging-based diagnostic tool. Therefore, a study on human reader improvement with AI assistance is entirely irrelevant to this device.

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

   • No, this is not applicable. This is a physical device, not an algorithm.

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

   • For the "design verification and validation testing," the "ground truth" would be established against engineering specifications, industry standards, and the performance characteristics of the predicate device. For instance, a test might verify that the snare loop can open to a specified diameter, or that it can effectively cut a tissue phantom without breaking, matching the performance of the predicate. This is functional and safety performance, not clinical ground truth.

8. The sample size for the training set

   • This information is not applicable and not provided. Training sets are used for machine learning algorithms. This document solely concerns a physical medical device.

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

   • This information is not applicable and not provided.

In summary, the provided document is a regulatory submission for a minor device modification. It details the device, its intended use, and states that design verification and validation testing were conducted to confirm that the modifications do not raise new safety or effectiveness concerns and that the device meets performance requirements equivalent to the predicate. It does not provide details on clinical study methodologies or quantitative performance metrics typically found in clinical trials or AI/diagnostic device studies.

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