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The Entuit PEG is intended for percutaneous endoscopic gastrostomy placement to provide enteral nutrition and/or medication to patients requiring nutritional support, and gastric decompression. This device is indicated for adult use only.

The Entuit PEGJ is intended for percutaneous endoscopic placement to provide enteral nutrition and/or medication to patients requiring nutritional support, and gastric decompression. This device is indicated for adult use only.

The Entuit PEG (subject device) includes a silicone enteral feeding tube (PEG tube) available in 24 Fr or 20 Fr, with site preparation components, introduction components, adapters, and connectors. The device is supplied sterile and is intended for single use in adults. Entuit PEGJ (subject device) includes a polyurethane enteral feeding tube (PEGJ tube) that is available in 12 Fr or 9 Fr. The Entuit PEGJ tube is for direct access to the jejunum. The 12 Fr PEGJ tube is designed to be inserted through the 24 Fr PEG tube and the 9 Fr PEGJ tube is designed to be inserted through the 20 Fr PEG tube such that the distal end extends into the jejunum and the proximal end extends out of the existing PEG tube.

There are several feeding adapters for use with the PEG and PEGJ tubes. The PEG kit has one feeding adapter that is ENFit compatible and two feeding adapters that are compatible with Christmas tree/slip tip giving sets and syringes (Non-ENFit). The PEGJ tubes are also available with either ENFit compatible or Christmas tree compatible feeding adapters (Non-ENFit).

The Entuit PEG is provided as a kit to facilitate either push or pull techniques of placement. In addition, the Entuit PEG kits are available in standard, safety, and international versions. The Entuit PEGJ is sold as a separate kit and available in standard versions.

I'm sorry, but this document contains a letter from the FDA regarding a 510(k) premarket notification for a medical device. It discusses the device's intended use, comparison to a predicate device, and a summary of non-clinical testing.

However, the document does not contain any information about acceptance criteria, device performance results, sample sizes for test or training sets, data provenance, the number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is not present in the provided text.

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The TeslaTome Bipolar Sphincterotome is intended for cannulation of the ductal system and sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP (endoscopic retrograde cholangiopancreatography). Also indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.

The Tesla Bipolar Active Cord is used to connect the TeslaTome to compatible electrosurgical generators.

The TeslaTome Bipolar Sphincterotome is an endoscopic electrosurgical accessory composed of a single stainless steel drive wire within a triple-lumen polymer catheter. The proximal end of the catheter/wire assembly terminates in a handle, held by the physician or assistant during ERCP procedures and fulfills three (3) functions: connection to an electrosurgical generator, injection of diluted contrast, introduction of an endoscopic wire guide and manipulation of the cutting wire. The distal end contains a stainless steel cutting wire and ink and band markings. Half of the cutting wire is insulated with a non-conductive polymer coating. The device allows for short-wire, distal wire guide exchange through the separation of a weakened wall in the wire guide lumen that separates with manual control. The device is also compatible with traditional long wire guides. The TeslaTome Bipolar Sphincterotome is available in eight model numbers reflecting cutting wire length of 20 or 25 mm, and a .035" Acrobat II wire guide in either 260 cm or 450 cm length, and an optional rotatable handle.

The Tesla Bipolar Active Cord (TESLA-ACU-B) is used to facilitate connection to an Electrosurgical generator (ESU). It uses a magnetic connection at the sphincterotome alignment but facilitates connection with ERBE generators on the distal end with conventional ESU-compatible plugs. The Active cord is non-sterile and reusable.

The provided text describes a 510(k) premarket notification for the TeslaTome Bipolar Sphincterotome and Tesla Bipolar Active Cord. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in a way that would require a table of acceptance criteria and reported device performance.

The document focuses on demonstrating substantial equivalence to predicate devices rather than proving specific numerical performance metrics against predefined acceptance criteria for the new device itself. The "Discussion of Performance Tests and Test Results" section outlines various tests conducted, but these are verification tests to ensure design inputs are met and the device performs as intended, not a comparative study with quantitative performance metrics and acceptance thresholds.

Given the information provided, it's not possible to populate a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9, as they pertain to clinical study design and ground truth establishment, which are not detailed in this 510(k) summary.

Therefore, I must state that the requested information (a table of acceptance criteria and reported device performance, sample size, data provenance, expert details, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and ground truth establishment for the training set) is not present in the provided text.

The document primarily focuses on:

• Device Description: What the device is and how it functions.
• Intended Use: The medical purpose of the device.
• Substantial Equivalence Argument: Comparing the new device to previously cleared predicate devices, highlighting similarities in design, materials, and intended use, and explaining any minor differences.
• Performance Tests: A list of conducted tests (e.g., mechanical, electrical, biocompatibility, simulated use, cleaning validation) to ensure the device meets its design specifications and is safe, but without presenting quantitative acceptance criteria or detailed results of these tests that would fit into the requested table format. These tests are internal verification activities rather than external clinical performance studies with defined acceptance metrics for a specific clinical task.

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This device is used for endoscopic injection into gastrointestinal mucosa. The intended population is adult use only.

The Gastrointestinal Injection Needles (subject devices) are sterile, single use devices that consist of a needle on an inner catheter fitted inside an outer catheter sheath featuring a luer slip/adjustment wheel handle with either a plastic or metal hub used as an injection port at the proximal end of the device. The devices are compatible with endoscopes with a minimum accessory channel of 2.0 mm or 2.8 mm. The Gastrointestinal Injection Needles have catheters which ranges in length from 195 to 315 cm, outer diameters of 5.4 FR and 6.9 FR, and needle gauges of 21, 23 and 25. Some configurations of the Gastrointestinal Injection Needles include ink marks at the distal end of the device to aid endoscopic visualization.

The provided text describes the regulatory clearance for "Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)" and primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. It does not contain information about an AI/ML device or its acceptance criteria and a study proving it.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study or its effect size.
6. Standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document states that "non-clinical bench testing demonstrates that the Gastrointestinal Injection Needles meet the performance requirements to fulfill the intended use of the device" and lists the following tests:

• Functional Testing
• Tensile Strength Testing
• Needle Verification and Validation Testing
• Shelf Life Testing
• Packaging Validation
• Biocompatibility testing (in accordance with ISO 10993-1)

However, it does not provide specific acceptance criteria or detailed results from these tests. It only concludes that the testing "confirmed that the subject device performs as intended" and that modifications "do not raise any new questions of safety or effectiveness."

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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

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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Used for collection of cells in the biliary system.

The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brush (subject devices) represent modifications made to the Wilson-Cook Double Lumen Biliary Cytology Brush and Fusion® Cytology Brush (predicate devices) cleared to market via 510(k) K171573 by Wilson-Cook Medical, Inc.

The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brushes consist of a nylon brush on a stainless-steel drive wire with a stainless-steel tip, a double lumen catheter with ink markings, radiopaque markers, wire guide access via a wire guide hub or an IDE port, a detachable extension line with a leur lock for optional flushing of the wire guide hub and a pinvise handle.

The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brushes are used by passing the device through an endoscope over a prepositioned wire guide to a target location. The cytology brush is located at the distal end (patient contacting) of the device with the pin vise handle located at the proximal end (non-patient contacting). The handle is actuated by pushing the pin vise handle forward to extend the cytology brush and then pulling backward to retract the brush.

This document is a 510(k) summary for a medical device (Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush) and primarily focuses on demonstrating substantial equivalence to a predicate device based on modifications and non-clinical bench testing. It does not present a clinical study or performance data related to AI/algorithm performance, which is what your request is specifically asking for regarding acceptance criteria, training/test sets, ground truth establishment, or human reader improvement with AI assistance.

Therefore, I cannot provide the information requested in your prompt based on the provided text, as the document does not contain any details about:

1. Acceptance criteria and reported device performance (in the context of an AI/algorithm). The "performance data" mentioned here refers to mechanical and material properties, not clinical diagnostic accuracy or AI metrics.
2. Sample sizes used for a test set or data provenance for an AI/algorithm.
3. Number of experts and their qualifications for establishing ground truth for an AI/algorithm.
4. Adjudication method for a test set for an AI/algorithm.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used for an AI/algorithm.
8. Sample size for the training set for an AI/algorithm.
9. How ground truth for the training set was established for an AI/algorithm.

The document states: "Performance testing consisting of non-clinical bench testing that demonstrates the subject devices met the performance requirements to fulfill their intended use. This testing provides reasonable assurance that the subject devices will function as intended. The subject devices do not raise new questions of safety or effectiveness as compared to the predicate devices." This highlights that the evaluation was primarily focused on bench testing for mechanical and material properties, not clinical performance metrics typical for AI-powered diagnostics.

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The Glo-Tip® Spray Catheter is used in conjunction with an endoscope to spray the gastrointestinal mucosa.

The Glo-Tip® Spray Catheter (subject device) is a sterile, single use device compatible with the accessory channel of an endoscope. The device consists of a long, thin polytetrafluoroethylene (PTFE) tube (catheter) with a stylet (metal wire) that together are introduced into the ductal area or elsewhere in the GI tract. Fluid (e.g., water or saline) can be injected through the catheter to spray the tissue that needs cleaning. The Glo-Tip® Spray Catheter can also be used in chromoendoscopy (to apply a dye to the mucosa of the gastrointestinal tract through an endoscope to aid in disease detection).

The provided text describes the Glo-Tip® Spray Catheter and its performance data, but it does not detail a study involving AI or human readers. The document is a 510(k) summary for a medical device submitted to the FDA, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Therefore, many of the requested categories related to AI performance, human reader studies, and ground truth establishment in that context are not applicable.

Here's the information that can be extracted and a note on the unavailable information:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:
   The document refers to "Performance testing consisting of sterilization, shelf life, biocompatibility, and nonclinical bench testing." It does not specify sample sizes for these tests, nor the exact provenance of any data used (e.g., country of origin, retrospective/prospective). These are typically internal lab tests conducted by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. The performance testing described is for a physical medical device (catheter), not an AI/diagnostic device that would require expert-established ground truth.

4. Adjudication method for the test set:
   Not applicable, as this is for a physical medical device and not an AI/diagnostic device involving expert review.

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/diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is not an AI/diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For a physical device like this, "ground truth" would correspond to objective physical, chemical, and biological measurements or observations made during bench, sterilization, biocompatibility, and shelf-life testing, conforming to established standards (e.g., ISO for biocompatibility). There is no "expert consensus" or "pathology" in the diagnostic sense.

8. The sample size for the training set:
   Not applicable. This is not an AI/diagnostic device requiring a training set.

9. How the ground truth for the training set was established:
   Not applicable. This is not an AI/diagnostic device requiring a training set.

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Howell D.A.S.H.® Sphincterotome with Dome Tip® (Cook Reference Part Numbers DASH-21, DASH-21-480, DASH-1, DASH-260, DASH-480, DASH-ACRO-25-450, DASH-35, DASH-ACRO-35-260, DASH-35-480, DASHACRO-35-450): This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.

Tri-Tome pc® Triple Lumen Sphincterotome (Cook Reference Part Numbers TRI-20, TRI-20M, TRI-25, TRI-25M, TRI-25M-P, TRI-25M-SLT, TRI-30, TRI-30M): This device is used for cannulation of the ductal system and for sphincterotomy.

Classic Cotton® CannulaTome® (Cook Reference Part Numbers CCPT-25, CCPT-25-MONO, CCPT-25ME), CannulaTome II® Double Lumen Sphincterotome (Cook Reference Part Numbers CT-20, CT-20M, CT-30, CT-30M), Cotton Cannulatome II PreCurved Double Lumen Sphincterotome (Cook Reference Part Numbers CT-25, CT-25M, CT-25M-P UTS®), and Ultra Taper Sphincterotome (Cook Reference Part Numbers UTS-15, UTS-20, UTS-20M, UTS-25, UTS-25M, UTS-30, UTS-30M): This device is used for cannulation of the ductal system and for sphincterotomy.

Billroth II Sphincterotome (Cook Reference Part Numbers PTG-20-6-BII-NG) and Soehendra® BII Sphincterotome (Cook Reference Part Numbers PT-5.5-BII-SOEHENDRA): This device is used for the cannulation of the ductal system and for sphincterotomy.

Models ACU-1 and ACU-1-VL active cords: This device is used to connect Cook monopolar electrosurgical accessories to compatible electrosurgical generators.

The sphincterotomes described in this submission are a sterile, single use devices compatible with the accessory channel of endoscope. The device consists of a long, thin plastic tube (cannula) with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of the papilla is opened by passing highfrequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation. The active cords are accessories to sphincterotomes so that a sphincterotome can be connected to an electrosurgical unit.

This document is a 510(k) premarket notification for electrosurgical accessories, specifically sphincterotomes and active cords. It does not describe a study that uses acceptance criteria in the manner you've outlined for performance of an AI/ML device.

The document details the device's technical specifications and compares them to a predicate device (Zimmon® Papillotome K901443) to demonstrate substantial equivalence, a regulatory pathway for medical devices. The "Performance Data" section lists various engineering and biocompatibility tests conducted, but these are for the physical device components and their functionalities (e.g., sterilization, material strength, electrical safety standards) rather than for an AI/ML algorithm's diagnostic or predictive performance.

Therefore, I cannot extract the information you requested about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device, as this document pertains to a traditional medical device.

To directly answer your request based on the provided document:

There is no information in this document regarding:

1. A table of acceptance criteria and the reported device performance (for an AI/ML device): Not applicable. The document lists performance tests for traditional device functionality (e.g., sterilization, joint strength), not performance metrics for an AI/ML algorithm.
2. Sample size used for the test set and the data provenance: Not applicable for AI/ML.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for AI/ML.
4. Adjudication method: Not applicable for AI/ML.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for AI/ML.
6. Standalone (algorithm only) performance: Not applicable for AI/ML.
7. Type of ground truth used: Not applicable for AI/ML.
8. Sample size for the training set: Not applicable for AI/ML.
9. How the ground truth for the training set was established: Not applicable for AI/ML.

The "Performance Data" section (Page 6) lists a series of engineering and biocompatibility tests for the electrosurgical accessories (e.g., GLP Cytotoxicity, IEC 60601 standards for electrical safety, joint strength, packaging integrity). These tests are designed to ensure the physical and electrical safety and functionality of the device components, not the analytical performance of an AI/ML algorithm.

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This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.

The Fusion® OMNI Sphincterotome (subject device) is a sterile, single use device compatible with the accessory channel of endoscope. The device consists of a long, thin plastic tube (cannula) with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of the papilla is opened by passing high- frequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation.

The provided text describes a 510(k) premarket notification for a medical device (Fusion® OMNI™ Sphincterotome), not an AI/ML-based medical device. Therefore, the information required to answer the questions regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), and ground truth establishment for AI/ML performance is not present in the provided document.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Identical Intended Use: The Fusion® OMNI™ Sphincterotome has the same intended use as the predicate device (Wilson-Cook OMNI™ Sphincterotome).
• Minor Technological Differences: These differences (e.g., catheter diameters, wire guide port, slightly decreased voltage) are deemed not to raise new questions of safety and effectiveness.
• Performance Data: This section details non-clinical bench testing, sterilization, shelf life, biocompatibility, and electrical safety/EMC testing, all of which are standard for traditional medical devices to ensure they perform as intended and safely.

There is no mention of an algorithm or AI/ML components, nor any studies that would involve human readers, ground truth established by experts for image interpretation, or training/test sets as would be required for such devices.

Therefore, I cannot provide the requested table or answer the specific questions about AI/ML device performance and validation based on the provided text.

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Endoscopic removal of stones in the biliary system and foreign bodies.

The Non-Lithotripsy Extraction Basket is a sterile, single use device compatible with the accessory channel of endoscopes. The device consists of basket, catheter, and handle components. The basket component is constructed of monofilament or multifilament metal wires joined at the distal and proximal ends, and is advanced out of and retracted into the single or double lumen polytetrafluoroethylene catheter sheath using the handle component's actuator. The device is not compatible with any mechanical lithotripter.

This is a 510(k) premarket notification for a medical device called the "Non-Lithotripsy Extraction Basket," which is used for the endoscopic removal of stones and foreign bodies in the biliary system. The document states that performance testing, consisting of sterilization, shelf life, biocompatibility, and nonclinical bench testing, demonstrates that the device meets the performance criteria.

However, the provided text does not include acceptance criteria for device performance or a detailed study proving the device meets specific performance criteria. The performance data section is very high-level and only lists the types of tests conducted:

• Stone and Foreign Body Capture Testing
• Tensile Testing
• Flexibility Testing
• Post-Aging Functional Testing

Therefore, I cannot provide the requested information about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided document.

To answer your request, here's what the document does provide in relation to a study, but falls short of a comprehensive answer to your questions:

1. A table of acceptance criteria and the reported device performance:
Not provided in the document. The document only lists types of tests performed, not the specific criteria or results.

2. Sample sized used for the test set and the data provenance:
Not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as this is a physical device testing, not an AI or diagnostic study requiring expert ground truth for interpretation.

4. Adjudication method for the test set:
Not applicable/not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a physical medical device, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.

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 an algorithm.

7. The type of ground truth used:
For the physical tests listed (Stone and Foreign Body Capture, Tensile, Flexibility, Post-Aging Functional), the "ground truth" would be the measurable physical properties and functional performance of the device against pre-defined engineering specifications. The document does not detail these specifications.

8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established:
Not applicable.

In summary: The provided 510(k) notification states that non-clinical bench testing was performed and that the device meets the performance criteria. However, it does not provide the specific acceptance criteria, quantitative performance results, sample sizes, or detailed methodologies of these tests.

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The Captura® Disposable Hot Biopsy Forceps is used endoscopically in conjunction with monopolar electrosurgical current to obtain gastrointestinal mucosal tissue biopsies and for removal of sessile polyps. This device is indicated for adult use only.

The Captura® Disposable Hot Biopsy Forceps is a sterile, single use device compatible with the accessory channel of endoscopes. The device consists of stainless steel forceps cups joined to a spool handle by a Pebax-coated stainless steel coilspring catheter and stainless steel drive cable. The handle's spool actuates the opening and closing of the forceps cups and its brass electrosurgical pin is intended for connection to an electrosurgical generator.

The provided document is a 510(k) premarket notification for the Captura® Disposable Hot Biopsy Forceps. This type of submission focuses on demonstrating substantial equivalence to an existing legally marketed device, not necessarily extensive clinical trials proving novel performance or the use of AI.

Therefore, the specific information requested, such as acceptance criteria, sample sizes for test and training sets, number and qualifications of experts for ground truth, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, is not available in this document. This document is for a medical device (biopsy forceps), not an AI/software as a medical device (SaMD).

Here's what can be inferred from the document regarding performance and validation:

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

The document broadly states that the device meets performance criteria required for its intended use, but does not provide specific acceptance criteria values or detailed performance metrics in numerical form.

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

This information is not provided. The testing mentioned is primarily non-clinical bench 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):

This information is not applicable and not provided. The device is a physical tool, and its performance is assessed through engineering and bench tests, not expert interpretation of diagnostic data.

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

This information is not provided and not applicable for the type of testing described.

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 not an AI-powered diagnostic tool.

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

Not applicable. This is not an algorithm or SaMD. The performance assessment is for a physical medical device.

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

For physical and electrical performance tests, the "ground truth" would be established by validated test methods, adherence to relevant standards, and engineering specifications. For example, a tensile test would measure a force against a specific standard for material strength. Biocompatibility would be assessed against ISO standards.

8. The sample size for the training set:

Not applicable. There is no AI model or training set described in this document.

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

Not applicable. There is no AI model or training set described in this document.

In summary: The provided document describes the regulatory submission for a physical medical device (biopsy forceps). The assessment of this device's safety and effectiveness relies on non-clinical bench testing, electrical safety, biocompatibility, sterilization, and shelf-life data, demonstrating substantial equivalence to a predicate device. It does not involve AI, clinical efficacy studies with human subjects for diagnostic accuracy, or associated ground truth establishment methods typically found in AI/SaMD submissions.

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