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ClearHemograsper has been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.

ClearHemograsper is a monopolar endoscopic instrument intended to coagulate or to perform hemostasis using high-frequency current within the digestive tract. It can assist in endoscopic surgical procedures such as ESD (Endoscopic Submucosal Dissection). ClearHemograsper consists a Slider for opening or closing the Jaw, a Catheter Tube which is a part passing through the working channel of endoscope, a pair of Jaw for catching the bleeding site and for delivering high-frequency current, a plug for connecting with high frequency transmission equipment, and an irrigation port for removing foreign substances by injecting distilled water or saline solution. It is available in various working lengths.

The provided FDA 510(k) clearance letter for ClearHemograsper is for an endoscopic electrosurgical unit and accessories, which is a physical medical device, not an AI/software as a medical device (SaMD). Therefore, the provided text does not contain information on acceptance criteria, test sets, ground truth establishment, or clinical studies typically associated with the evaluation of AI models.

The information requested in the prompt (acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is specific to the validation of AI/SaMD, particularly for diagnostic or prognostic purposes where ground truth and human reader performance are critical.

Since the ClearHemograsper is a physical device used for cauterizing and coagulation, its performance is evaluated through bench testing (e.g., dimension, rotatable performance, pushability, actuation, tensile strength, output value, hemostatic performance, short circuit, catheter tube temperature tests), biocompatibility studies, sterilization validation, shelf-life studies, and electrical safety/EMC testing. Clinical studies were not considered for this submission (as stated on Page 10, Section 13).

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to AI/SaMD metrics.
• Sample sizes, data provenance, expert numbers, adjudication, MRMC studies, standalone performance, or ground truth establishment methods for an AI test set.

The document describes the device's technical specifications and comparisons to a predicate device, focusing on physical and electrical performance, and safety standards for a mechanical/electrical medical device.

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This instrument has been designed to be used with endoscopes to collect tissue, cauterize, coagulate and perform hemostasis using high-frequency current within the digestive tract.

The subject device Disposable Hot Biopsy Forceps is a sterile, single-use endoscopic device, intended to be used with endoscopes to cut, coagulate and stop bleeding in the digestive tract by using high-frequency current.

The disposable Hot Biopsy Forceps consists of an insertion part and a handle part. The insertion part includes a jaw assembly and a spring tube; the handle part includes a handle, a finger ring, a conductive column, a rotating sleeve, a locking sleeve, and a sheath tube.

The subject device has 7 specifications. The differences among these models are the jaws type, Jaw O.D, and Working Length.

The subject device is EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 ° and placed in a sterility maintenance package to ensure a shelf life of 3 years.

The materials used for construction of Disposable Hot Biopsy Forceps are typical for this type of medical device. Materials of Jaw and spring tube is stainless steel SUS304, the Sheath tube is made of HDPE, the Locking sleeve, Rotating sleeve and handle are made of ABS. The conductive column is made of H62.

Based on the provided text, the device in question is a "Disposable Hot Biopsy Forceps" and it is a Class II medical device. The document describes several non-clinical tests conducted to evaluate its performance and functionality against specific acceptance criteria.

However, it's crucial to note that the provided text explicitly states: "No clinical study is included in this submission." This means that the device's acceptance criteria and proven performance are based solely on non-clinical (bench) testing, not on human-in-the-loop (MRMC) or standalone (algorithm only) clinical performance studies.

Therefore, for the following points, I can only provide information based on the non-clinical test data presented. Information related to clinical studies, human expert involvement, or AI performance will be marked as "Not Applicable" or "Not Provided" as per the document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds for each test item in a clear "acceptance criteria" column. Instead, the "Description" column implies the criteria (e.g., "smooth rotation and without interference" for rotation performance). The reported performance is generally stated as "has been verified" or "fulfilled." For "Conduction resistance," a numerical acceptance criterion and result are provided.

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

The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., how many forceps were tested for pushability). It broadly states "Bench testing was performed."

• Sample Size: Not explicitly stated for individual tests. The phrasing "the subject device has been subjected to compliance testing" implies a sufficient number of units were tested to demonstrate compliance.
• Data Provenance: This is non-clinical bench test data, not patient data. The tests were performed in a lab setting by the manufacturer, Beijing ZKSK Technology Co., Ltd. (China). The document does not specify whether the data is retrospective or prospective, as this distinction typically applies to clinical studies.

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

• Number of Experts: Not applicable. These are non-clinical bench tests; ground truth is established by objective measurements against engineering specifications and industry standards, not by human expert interpretation of medical images or conditions.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As these are non-clinical, objective bench tests, there is no need for expert adjudication. The results are based on direct measurement or observation against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No. The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study comparing human readers with and without AI assistance was performed or reported.
• Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Study: No. The device is a physical medical instrument (forceps), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance evaluation is for the physical device itself.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the non-clinical tests is based on engineering specifications, industry standards (e.g., ISO, IEC), and predefined functional requirements. For example, the criterion for "Conduction resistance" ($\le 30 \Omega$) is an engineering specification. Biocompatibility is assessed against ISO 10993 standards.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI model. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as this is not an AI model requiring a training set. The design and validation of the device rely on established engineering principles and compliance with relevant medical device standards.

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These products are used in combination with an applicable endoscope to perform the endoscopic treatments for the target site in the gastrointestinal tract, such as ablation, incision, cauterization, coagulation and avulsion of tissue and arrest of bleeding, and to inject saline or submucosal injection agent for endoscopic surgery into the submucosal layer in the gastrointestinal tract, which is exposed after dissection, under the management of physicians in medical facilities. Never use this product for any other purpose.

FUJIFILM Diathermic Slitter (FlushKnife) is an electrosurgical instrument that removes tissue and controls bleeding by use of high-frequency ("HF") electrical current. The device is available with either a needle or ball tip slitter and comes in a variety of sizes.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device. It does not contain information about an AI/ML medical device or a clinical study with human subjects, therefore, most of the requested information cannot be extracted from the document. The document describes a Diathermic Slitter (FlushKnife) used for endoscopic treatments in the gastrointestinal tract. This is a physical, electrosurgical instrument, not an AI or software-based device.

Therefore, many of the requested fields related to AI/ML device performance, such as sample size for test sets, ground truth establishment, expert adjudication, MRMC studies, and training set details, are not applicable to this document.

However, I can provide information based on the "Performance Data" section regarding the device's technical validation.

Here's what can be extracted based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device met pre-defined acceptance criteria for all tests. Specific numerical acceptance criteria or performance metrics are not detailed in this summary; rather, it refers to compliance with standards and successful completion of tests.

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

• Sample Size: Not specified for any of the performance tests. The document refers to "bench testing" and evaluations against standards, which typically involve a specified number of samples, but these numbers are not disclosed.
• Data Provenance: The testing appears to be conducted by the manufacturer as part of their submission for regulatory clearance. The document doesn't specify country of origin for data but states the manufacturer is FUJIFILM Corporation, located in Japan. The tests are described as "bench testing," implying a laboratory, likely prospective testing for the purpose of the submission.

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 a traditional electrosurgical device, not an AI/ML device that requires expert-established ground truth for image interpretation or diagnosis. Ground truth, in this context, refers to the physical properties and performance characteristics of the device being measured against engineering specifications and regulatory standards.

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

• Not Applicable. As this is not an AI/ML device relying on human interpretation, an adjudication method for test set ground truth is not relevant.

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 therefore no MRMC study or assessment of human reader improvement with AI assistance was conducted or is relevant.

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

• No. This is not an algorithm or software device. Its performance is evaluated intrinsically as a physical piece of medical equipment.

7. The type of ground truth used

• Technical Specifications and Consensus Standards: The "ground truth" for this device's performance relies on its ability to meet engineering design specifications and comply with recognized consensus standards for electrical safety, biocompatibility, sterility, and device-specific functionalities (e.g., slitter length, conductivity). This is established through laboratory testing and verification against pre-defined performance metrics, rather than expert consensus on diagnostic interpretations or clinical outcomes data in a comparative study.

8. The sample size for the training set

• Not Applicable. This device uses traditional engineering principles, not machine learning, and therefore has no "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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Bipolar Coagulation Forceps have been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.

The Bipolar Coagulation Forceps described in this submission are a sterile, single use devices compatible with the working channel of endoscope. The device is used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.
Bipolar Coagulation Forceps consists of Handle part, plug, sheath and forceps part.

The acceptance criteria and study proving device performance are not present in the provided text. The document is a 510(k) summary for the Bipolar Coagulation Forceps, asserting substantial equivalence to a predicate device (Coagrasper™).

The document mentions that "The Bipolar Coagulation Forceps meets all design specifications and medical device standards for electrosurgical safety (IEC 60601), biocompatibility (ISO 10993) and sterility (ISO 11135)." and "The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device." However, concrete acceptance criteria and detailed performance data, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies are not provided.

Specifically, the following information requested in the prompt is not available in the provided text:

• Acceptance Criteria Table and Reported Performance: No such table is present. The document generally states compliance with standards but provides no specific metrics or thresholds.
• Sample Size for Test Set and Data Provenance: No test set or sample size is mentioned.
• Number of Experts and Qualifications for Ground Truth: No experts or ground truth establishment method for a test set are described.
• Adjudication Method: Not applicable as no human-read test set is described.
• Multi-reader Multi-case (MRMC) Comparative Effectiveness Study: The document explicitly states "No Clinical test is included in this submission," indicating that no human-in-the-loop study was performed.
• Standalone Performance: While "non-clinical performance meets the design specification" is stated, no specific standalone performance metrics or the study details are provided.
• Type of Ground Truth Used: Not applicable as no clinical test or human-read evaluation is detailed.
• Sample Size for Training Set: No training set is mentioned as this is a medical device, not an AI/ML model being trained on data.
• How Ground Truth for Training Set was Established: Not applicable.

The document primarily focuses on demonstrating substantial equivalence through a comparison of technological characteristics with a predicate device and adherence to general medical device standards. It lists biocompatibility tests conducted for the proposed device due to differences in materials compared to the predicate, but these are not for establishing a "ground truth" in the context of an AI/ML or diagnostic device clinical study.

In summary, the provided document does not contain the detailed study information or acceptance criteria requested, as it is a 510(k) summary focused on substantial equivalence rather than a detailed performance study report.

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These instruments have been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.

The proposed Ensure™ Single-Use Coagulation Forceps is a sterile, single-use endoscopic device, intended to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract. The proposed device is only for adult patients. The Coagulation Forceps is a hemostasis device which combines both mechanical property and energy. It consists of a jaw, coated spring sheath, high frequency electrical interface and handle. The Coagulation Forceps can be advanced through an appropriate endoscope channel to reach targets and by pushing and pulling its Finger Ring of the handle, the forceps opens and closes. The bleeding point will be clamped with the Coagulation Forceps. At that point, high-frequency and high-voltage power will be delivered at the precise site of bleeding using an electrosurgical current generator so as to achieve hemostasis. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of 2 years.

This submission is for a medical device called the Ensure™ Single-Use Coagulation Forceps, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies related to AI/ML device performance (such as sample size for test sets, expert qualifications, and effect size of AI assistance) is not applicable.

The provided document describes the substantial equivalence of the subject device to a predicate device based on technological characteristics and performance data from bench tests, biocompatibility testing, sterilization validation, and electrical safety standards.

Here's the relevant information that can be extracted:

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

The document does not explicitly present a table of acceptance criteria with reported performance values. Instead, it lists the types of tests performed and states that the proposed device "meets the requirements" of various ISO standards and that "The tests performed demonstrated that the proposed device and predicate device are substantially equivalent."

Here's a summary of the performance claims based on the provided text:

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 does not specify the sample sizes for the bench tests. The tests were performed by Micro-Tech (Nanjing) Co., Ltd. in China, so the data provenance is likely from their facilities. The tests are bench tests, not clinical studies, so the terms "retrospective or prospective" do not directly apply in the usual clinical context.

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, as this is a medical device and not an AI/ML diagnostic system requiring expert consensus on image interpretation or similar. The "ground truth" for these tests are the established engineering and biological standards.

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

Not applicable, as there is no human interpretation or adjudication described for these engineering and biological performance tests.

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/ML device, and no MRMC study or AI assistance is mentioned.

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 (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is based on the adherence to established international and national standards for medical devices, including:

• ISO 10993-1: Biological Evaluation of Medical Devices
• ISO 11135: Sterilization of Health Care Products
• ISO 10993-7: Ethylene Oxide Sterilization Residuals
• ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
• IEC 60601-1 series: Medical Electrical Equipment - General requirements for basic safety and essential performance, and collateral standards for specific applications (e.g., high frequency surgical equipment).

8. The sample size for the training set

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

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

Not applicable.

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Disposable biopsy forceps are used to obtain mucosal tissue samples for pathology using monopolar energy, including the avulsion technique, during endoscopic procedures in the gastrointestinal tract, for example the esophagus, stomach, small intestine and colon. Tissue samples will be submitted for pathologic review.

This product is intended only for adult populations.

The Avulsion Forceps is used during endoscopic procedures in the gastrointestinal tract. The avulsion technique in Endoscopy involves using both mechanical forces as well as high energy cutting current to tear the tissue away from the gastrointestinal tract.

The Avulsion Forceps consists of a handle on the proximal end that actuates two toothed jaws on the distal end. An Olympus-style active cord connector is included that allows the Avulsion Forceps to be connected to an electrosurgical generator for use with monopolar energy. The device also includes a spring sheath catheter housing the drive cable which transfers the linear motion of the handle slider to open and close the jaws.

The provided text describes the acceptance criteria and the summary of verification activities for the STERIS Avulsion Forceps, a medical device. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the individual sample sizes for each test in the test set. It only states that verification activities were performed. The data provenance is not explicitly mentioned as retrospective or prospective, nor are the countries of origin for the data. This information would typically be detailed in the full study reports, not in this 510(k) summary.

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

The document does not mention the use of experts to establish ground truth for the test set. These are engineering and performance tests, not clinical evaluations that would typically involve expert review of cases.

4. Adjudication method for the test set:

Not applicable, as expert adjudication is not mentioned for these types of engineering and performance tests.

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 document describes a medical device (Avulsion Forceps) for biopsy, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not applicable and was not performed.

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

Not applicable. The device is a physical instrument, not an algorithm.

7. The type of ground truth used:

For the tests described:

• Structural Integrity: Ground truth is based on the structural integrity limits of the predicate device.
• Dimensional: Ground truth is based on dimensional specifications.
• Functional: Ground truth is based on the intended function in tortuous conditions.
• Simulation Testing: Ground truth is the successful retrieval of tissue samples.
• Electrical: Ground truth is compliance with IEC 60601-2-2 (3rd Edition) industry standards.
• Biocompatibility: Ground truth is compliance with ISO-10993-1 for biological safety.
• Shelf-life: Ground truth is maintaining device performance for 1 year.

These are primarily engineering and performance standards, not clinical diagnostic ground truth like pathology or outcome data.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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This device is used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments.

The proposed device Disposable Hot Biopsy Forceps is a sterile, single-use endoscopic device, intended to be used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments. It consists of a flexible wire cable and jaws which can be opened and closed by a handle. When passed through an endoscope the forceps can be activated to deliver a monopolar electrical current for histological sampling or electrocoagulation with the jaws.

The main component of the proposed device is jaws, spring sheath and handle.

The proposed device has four (4) models, HBF55-11023180 and HBF55-11023230, HBF65-11023180 and HBF65-11023230. HBF65-11023180 and HBF65-11023230 are two new models added. The differences between the two new models and the two approved models (predicate device) are the color of Handle and the jaws. The news models are White-blue Handle and Alligator Forceps; the two approved models are Grey-blue Handle and oval forceps.

The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 to the power of -6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.

The provided FDA 510(k) summary (K180018) for the "Disposable Hot Biopsy Forceps" describes the acceptance criteria and the studies performed to demonstrate that the device meets those criteria.

Here's the breakdown of the information requested:

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

The document states that "Non clinical tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment, the non-clinical tests verify that the proposed device met all acceptance criteria." However, it does not provide a specific table detailing each acceptance criterion with a corresponding reported performance outcome. Instead, it lists the standards that the device complies with, implying that meeting these standards constitutes the acceptance criteria.

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 the sample sizes used for each of the non-clinical tests listed. It also does not explicitly state the provenance (country of origin, retrospective/prospective) of the data beyond the fact that Micro-Tech (Nanjing) Co., Ltd. is located in Nanjing, Jiangsu, China. The tests are described as "Non-Clinical Tests," implying laboratory or bench testing rather than human subject data.

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. The studies conducted are non-clinical (bench/laboratory tests) and do not involve human subject interpretation or expert ground truth establishment in the medical sense (e.g., radiologists interpreting images).

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

This information is not applicable as the studies are non-clinical and do not involve human interpretation or adjudication.

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 MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical study is included in this submission."

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

This is not applicable. The device is a physical medical instrument (Disposable Hot Biopsy Forceps), not a software algorithm, so the concept of standalone performance for an algorithm does not apply. The "performance" here refers to the physical and biological properties of the device meeting established standards.

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

For the non-clinical tests, the "ground truth" is established by the specifications and measurement techniques outlined in the referenced international and national standards (e.g., ASTM, ISO, USP). For example, a "sealed" package must pass specific dye penetration or burst strength tests as defined by the ASTM standards, and "sterility" is defined by the absence of microbial growth as per USP criteria.

8. The sample size for the training set

This is not applicable. This device is a physical medical device and does not involve machine learning algorithms that require a "training set."

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

This is not applicable as there is no "training set" for this type of medical device submission.

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Ensizor® Monopolar Endoscopic Scissors are designed to cut and dissect tissue, cut sutures and cut nonmetallic materials during all flexible endoscopic procedures.
Ensizor® Monopolar Endoscopic Scissors are designed to cut and dissect tissue, cauterize tissue, cut sutures and cut non-metallic materials during all flexible endoscopic procedures.

The Ensizor Monopolar Endoscopic Scissors is a single-use ethylene oxide sterile electrosurgical scissors. This device is designed to be used with an electrosurgical monopolar HF generator to cut and dissect tissue, cauterize tissue, cut sutures and cut non-metallic materials during all flexible endoscopic procedures.

The device is compatible with flexible endoscopes with a minimum channel diameter of 2.8 mm. The maximum insertion portion diameter is 2.6 mm, and insertion lengths are 165 cm and 235 cm. The patented Edge Flex™ technology used for the Scissor Blades ("Blades") enhances the cutting performance of this flexible endoscopic scissors. The Ensizor's rotation feature enables accurate-radial positioning, and the nitinol actuator wire allows for tortuous endoscopic paths while minimizing loss of distal control. The Blades are designed with blunt tips to enable the atraumatic dissection of tissue planes and when closed, make a non-sharp rounded cauterizing surface.

The provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria, as requested in the prompt's outlined structure. Instead, the text is a 510(k) summary for the Ensizor Monopolar Endoscopic Scissors, comparing its technological characteristics and performance data to predicate devices to demonstrate substantial equivalence.

Specifically, the document includes:

• Trade/Device Name: Ensizor® Monopolar Endoscopic Scissors
• Indications for Use: Designed to cut and dissect tissue, cut sutures and cut non-metallic materials during all flexible endoscopic procedures, and also cauterize tissue.
• Predicate Devices: Ensizor® Endoscopic Scissors (K150939) and the Apollo Endosurgery Endoscopic Scissors (K090583).
• Performance Data: Nonclinical testing was performed to evaluate substantial equivalence. This involved "Product Attribute Testing," "Product Performance Testing," "Sample Cutting" various materials (rubber, polyethylene, different types of sutures), and an "Insulation Test." In all listed tests, both the Ensizor® Monopolar Endoscopic Scissors and the Apollo Endosurgery Endoscopic Monopolar Scissors "All units passed."
• Conclusion: Based on non-clinical performance data, the device is concluded to be as safe, as effective, and performs as well as or better than the predicate devices.

However, the summary does not provide:

1. A table of specific acceptance criteria (e.g., minimum tensile strength, maximum cutting force) and the reported device performance against those predefined criteria. Instead, it states "All units passed" for broad test categories and material cutting.
2. Sample size used for the test set or data provenance beyond "nonclinical testing."
3. Number of experts used or their qualifications.
4. Adjudication method.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes of human readers with/without AI assistance (this device is a surgical instrument, not an AI diagnostic tool).
6. Standalone performance (while non-clinical testing was done, the "acceptance criteria" against which it was measured are not detailed).
7. The specific type of ground truth used (e.g., pathology, outcomes data), beyond stating "raw chicken for electrocautery functionality test." The "All units passed" suggests qualitative or pass/fail criteria rather than quantitative ground truth.
8. Sample size for the training set (not applicable as this is not an AI/machine learning device).
9. How the ground truth for the training set was established (not applicable).

Therefore, I cannot fulfill the request using the provided input as the necessary information is not present.

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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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This instrument has been designed to be used with an Olympus endoscope to electrosurgically collect tissue, to electrosurgically cauterize or to perform electrosurgical hemostasis within the urinary organs.

The Single Use Hot Biopsy Forceps FD-231 consists of a handle and insertion portion. Fenestrated cups in the distal end of insertion are activated in the open and closed position by maneuvering the slider in the handle.

During operation, insertion will be inserted into endoscopes. Once the tissue is held by the cups, the tissue is subjected to high frequency electric current transmitted from plug which allows for collecting tissue. Once the tissue is touched by closed cups, the tissue is subjected to high frequency electric current transmitted from plug which allows for cauterization and hemostasis.

By means of high frequency electric current passing through the tissues between electrical plate attached on patient`s skin and the cups, heat will be produced from electricity resistance by the tissue and the heat will be utilized for collecting tissue, cauterization and hemostasis.

The provided document describes a medical device, the "Single Use Hot Biopsy Forceps FD-231," and its premarket notification for FDA clearance (K171916). However, the document does not contain information about acceptance criteria and a study proving that the device meets those criteria, specifically in the context of AI/algorithm performance or a multi-reader multi-case study as requested in the prompt.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing of performance specifications, material biocompatibility, electrical safety, and sterilization. It lists various tests performed to ensure the safety and effectiveness of the device as a physical medical instrument, not an AI or software-based diagnostic tool.

Therefore, I cannot provide the requested information for acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details because these are not present in the provided text.

The closest information relating to "acceptance criteria" not directly tied to AI/algorithm performance is mentioned in the "Summary of non-clinical testing" section:

• Risk Analysis: "Finally, risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971 Second edition 2007-03-01. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment."
• Sterilization Residuals: "The EO residual and ECH residual were measured after sterilization of the device to meet the criteria defined in ISO 11135 Second edition 2014 and AAMI/ANSI/ISO 10993-7:2008(R)2012."

These references describe general acceptance criteria for risks and sterilization, which are standard for medical devices but do not relate to the performance metrics of an AI system or clinical study outcomes.

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