Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

Electrosurgical Generator is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.

Bipolar Polypectomy Snare Combination has been designed to be used with endoscope and electrosurgical unit for the removal of sessile polyps, pedunculated polyps, tissue and foreign bodies from within the GI tract using high-frequency current.

Single Use Electrosurgical Knife Combination has been designed to be used with endoscopes and electrosurgical units to cut tissue within the digestive tract using high-frequency current.

The Electrosurgical System comprises:

• ◆ Electrosurgical Generator;
• ◆ Bipolar polypectomy snare combination;
• Single use electrosurgical knife combination.

The Electrosurgical Generator is designed to deliver bipolar high-frequency current for the purpose of cutting and coagulating tissue. It consists of High frequency generator, footswitch, bipolar connecting cable and power cord. The Electrosurgical Generator output is actuated via a two-pedal Footswitch. One pedal activated the bipolar high-frequency current output for cut; the other pedal activates the bipolar high-frequency current output for coagulation. The Electrosurgical Generator incorporates proprietary software developed by AGS for generating and controlling the two energies delivered. The Bipolar connecting cable connects electrosurgical instruments to the Electrosurgical Generator, it transfer electrical energy - without changing the energy - from devices to instruments. The Electrosurgical Generator, Footswitch, Bipolar connecting cable and Power cord are non-sterile and reusable.

Bipolar polypectomy snare combination is an accessory to Electrosurgical Generator. It is a sterile device consists of Polypectomy snare (Bipolar) and Distal attachment. It is for endoscopic use. It is used for removal of polyps within the digestive tract using high-frequency current. EO sterilization and use for single use only.

Single use electrosurgical knife combination is an accessory to Electrosurgical Generator. It is a sterile device consists of Single use electrosurgical knife and Distal attachment. It is for endoscopic use. It is used for cutting tissues within the digestive tract using high-frequency current. EO sterilization and use for single use only.

The provided text is a 510(k) summary for an Electrosurgical System, comprising an Electrosurgical Generator, a Bipolar polypectomy snare combination, and a Single use electrosurgical knife combination. However, the document does not describe a study involving acceptance criteria and associated device performance for an AI/ML-based medical device.

Instead, it focuses on demonstrating substantial equivalence to predicate electrosurgical devices through:

• Comparison of Technology Characteristics: This section details differences in output parameters for the electrosurgical generator (e.g., frequency, voltage, power) and differences in the principles of operation, energy use, and structure for the accessories (bipolar vs. monopolar, materials).
• Performance Testing: This section lists the types of performance testing conducted to address the differences between the proposed device and predicate devices. These tests are primarily focused on electrical safety, thermal effects on tissue, biocompatibility, and bench testing.

Crucially, the document explicitly states "No Clinical test is included in this submission" (Page 12, Section 5.9). This strongly indicates that the device's clearance was based on demonstrating equivalence through non-clinical performance data and comparison to existing predicate devices, rather than a clinical study evaluating its acceptance criteria in human subjects, especially not a study involving human readers or AI assistance.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size for test set with provenance, number/qualifications of experts, adjudication method, MRMC study details, standalone performance, ground truth type for test set, training set details) because the document does not describe an AI/ML device or a clinical study that would have generated such data in the context of human-in-the-loop performance or diagnostic accuracy.

The provided text pertains to a traditional electrosurgical device, not an AI/ML-driven solution that would involve complex data analysis or human reader performance studies.

Ask a specific question about this device

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.

Ask a specific question about this device

This device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract.

The subject device consists of a handle section, a sheath section. The snare head section. The snare head section is inserted into the sheath section and is extended and retracted by operating the three-ring handle section.

The sheath section and the snare head section are inserted in the gastrointestinal tract through an endoscope. The snare head is extended from the sheath to resect target polyps. This resection is performed with high-frequency current.

This document is a 510(k) premarket notification for the AcuSnare Polypectomy Snare. It's not a study report that includes typical acceptance criteria and performance data for AI/ML devices. Instead, it demonstrates substantial equivalence to predicate devices for a conventional medical device. Therefore, I cannot extract the information requested as it is not present in the provided text.

Here is why your specific information requests cannot be fulfilled:

1. A table of acceptance criteria and the reported device performance: This document doesn't define acceptance criteria in terms of a study's statistical endpoints (e.g., sensitivity, specificity, AUC) or report quantitative performance metrics like a standalone AI/ML study would. The acceptance criteria for this device are implicitly tied to demonstrating that it performs as intended and is as safe and effective as the predicate devices through non-clinical testing.
2. Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML model for this type of device. The testing described is non-clinical (e.g., tensile strength, shelf life).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert review is mentioned, as this is not an AI/ML diagnostic or prognostic device.
4. Adjudication method: Not applicable for the reasons above.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. This is not an AI/ML model.
9. How the ground truth for the training set was established: Not applicable.

Instead, the document focuses on comparing the AcuSnare Polypectomy Snare to existing predicate devices based on:

• Intended Use: The device is used endoscopically for the removal and cauterization of sessile and pedunculated polyps from the gastrointestinal tract. This is compared to the predicate devices' stated uses.
• Technological Characteristics: Comparison of physical attributes like configuration, snare material, sheath material, handle material, length, FR size, sterility, sterilization method, reusability, and compatibility with electrosurgical units.
• Non-Clinical Testing: A list of tests performed to demonstrate the device's performance and safety, including:
  • Shelf Life Testing
  • Package Integrity Testing
  • Tensile tests (snare to catheter, catheter to handle, snare head to drive cable joint, snare wire to cannula joint, handle/cannula/drive cable joint, pin to handle joint)
  • IEC 60601-1, IEC 60601-2-2, and IEC 60601-2-18 standards compliance (related to electrical safety for electrosurgical equipment)
  • Biocompatibility testing (ISO 10993-1)

The "study" that proves the device meets acceptance criteria, in this context, refers to the non-clinical testing summarized in {5} and the comparison to predicate devices in {4}. The acceptance criteria are implicitly met if these tests show performance equivalent to or better than the predicate devices, and that the device is safe and effective for its stated intended use. The document concludes that the modifications to the subject device have been adequately addressed through Design Control Processes and do not affect the safety or effectiveness.

Ask a specific question about this device

Polypectomy Snare is used endoscopically in the removal of diminutive polyps, pedunculated polyps and tissue from within the GI tract.

The polypectomy snare consists of handle, sheath, flexible wire and electrode that is used to remove polys utilizing monopolar RF energy under endoscopic visualization. The rotary snares' cable and polypectomy can be rotated using the rotation actuator on the handle. Polypectomy snare is sterile for single use with no delayed hypersensitivity and no intracutaneous reactivity, have no animal or human origin substance. The electrode of polypectomy snare has five shapes to be used in clinical practice: Oval, Polygon, Duck Bill, Hexagonal and Round, and the electrode can extend, retract from the snare's flexible outer sheath.

The provided document is a 510(k) summary for a medical device called "Polypectomy Snare." This type of document is a premarket notification to the FDA to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device.

The information requested pertains to the acceptance criteria and study for an AI/ML powered medical device. Based on the content of this document, the device in question is a Polypectomy Snare, which is a physical medical device and NOT an AI/ML powered device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies as these are specific to the evaluation of AI/ML software.

The document primarily focuses on:

• Biocompatibility Testing: Evaluating the device's interaction with biological systems using ISO standards.
• Performance Testing (Bench Tests): Assessing physical attributes like appearance, size, material, usability, and electric properties.
• Substantial Equivalence: Comparing the proposed device to a predicate device (Captivator II, Single-Use Polypectomy Snares, K133987) to show it meets the same safety and effectiveness standards.

There is no mention of an algorithm, AI, machine learning, or software performance in the document. The statement "No Clinical Study is included in this submission" further reinforces that this submission does not involve clinical performance data that would be relevant to an AI/ML device.

Ask a specific question about this device

The Polypectomy Snares are used endoscopically in the removal of diminutive polyps, and pedunculated polyps within the GI tract.

The proposed device Polypectomy Snare is a sterile, single-use endoscopic device, intended to be used endoscopically in the removal diminutive polyps, sessile polyps, and pedunculated polyps from within the GI tract.

The Polypectomy Snares consists of a flexible wire cable and loop which can be extended and retracted from the snare's flexible outer sheath using a 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. The proposed device has eighteen (18) specifications; the main differences of these specifications are dimension and if the loop can be rotatable with the rotation of the handle.

The document describes the Micro-Tech (Nanjing) Co., Ltd. Polypectomy Snare, which is equivalent to the GIP/MEDI-GLOBE POLYPECTOMY SNARES cleared under K943935.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" but includes a "Comparison of Technology Characteristics" table for substantial equivalence. The "Acceptance Criteria" here are inferred to be "Similar" or "Same" to the predicate device's performance characteristics.

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

The document states: "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."

It does not provide specific sample sizes for the "test set" for each non-clinical test. The data provenance is primarily from non-clinical testing conducted by Micro-Tech (Nanjing) Co., Ltd. in China. The study is retrospective in the sense that it relies on established standards and comparative data with a predicate device.

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

Not applicable. The ground truth for this device's performance is established through adherence to recognized international and national standards for medical devices and electrosurgical equipment (e.g., ASTM, IEC, ANSI/AAMI, ISO, USP). There is no mention of human experts establishing a ground truth for a test set in the traditional sense of a clinical study.

4. Adjudication method for the test set:

Not applicable. As this is a non-clinical study based on engineering compliance and comparison to a predicate, there is no mention of an adjudication method involving experts. The compliance is against predetermined 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 is a non-clinical evaluation of a medical device (polypectomy snare), not an AI-assisted diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with AI was conducted.

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

Not applicable. This device is a surgical instrument and does not involve an algorithm. The performance is the device's physical and electrical characteristics.

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

The "ground truth" for the non-clinical tests is based on established industry standards and regulatory requirements (e.g., ASTM, IEC, ISO, AAMI, USP) for seal integrity, biocompatibility, electrical safety, sterilization, and material properties. The comparative analysis against the predicate device also serves as a benchmark for equivalence.

8. The sample size for the training set:

Not applicable. This is a non-clinical evaluation of a medical device, not a machine learning model. Therefore, there is no training set in the context of AI.

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

Not applicable, as there is no training set mentioned in the document.

Ask a specific question about this device

Instrument for flexible endoscopy for grasping and removing tissue in the gastrointestinal tract.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "Traction Polypectomy Snare." It indicates that the device has been found substantially equivalent to previously marketed devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about device performance metrics, sample sizes, expert qualifications, or ground truth establishment.

The document primarily focuses on regulatory aspects:

• Approval of the 510(k) premarket notification.
• Classification of the device (Class II, Product Code: FDI).
• Applicable regulations (21 CFR 876.4300 for Endoscopic electrosurgical unit and accessories).
• General controls provisions of the Act.
• Contact information for various FDA divisions.
• The "Indications for Use" statement for the device.

Therefore, I cannot provide the requested information based solely on the provided text. The prompt asks for details that are part of a performance study report or clinical trial summary, which are not present in this FDA clearance letter.

Ask a specific question about this device