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The Disposable Sphincterotome is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. This device can also be used to cannulate and inject contrast medium.

The subject device Disposable Sphincterotome is a sterile, single-use endoscopic device, intended to be used with flexible endoscopes for intubation of the pancreaticobiliary system and for sphincterotome. The disposable sphincterotome consists of cutting wire, sheath, quide wire connector, injection connector, conductive column, finger ring, handle, and imaging ring. The subject device has 72 specifications. The differences among these models are the Cutting Length, Tip Length, Working Length and Type of guide wire lumen channel. The subject device is EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 3 years. The main materials used for construction of Disposable Sphincterotome include PTFE, ABS, SUS304.

The provided document is a 510(k) Summary for a Disposable Sphincterotome. This type of device is a medical instrument and not an AI/ML powered device. Therefore, the information requested about acceptance criteria and studies that prove the device meets these criteria in the context of AI/ML is not applicable.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Boston Scientific Corporation's Autotome™ RX). The "study" referenced in the document is a series of non-clinical, bench tests, and material conformity assessments rather than a clinical trial or AI/ML performance study.

Here's a breakdown based on the provided text, indicating why AI/ML specific questions are not relevant:

1. AI/ML Device Type: Not an AI/ML powered device. It is a physical medical instrument.

2. Acceptance Criteria and Reported Device Performance (as per the document):

   Acceptance Criteria / Test Performed	Reported Device Performance (Summary)	Relevance to AI/ML
   Sterilization and Shelf Life	Successfully tested per ISO 11135 and ASTM 1980; 3-year shelf life.	Not Applicable
   Biocompatibility	Successfully tested per ISO 10993 (cytotoxicity, sensitization, intracutaneously irritation, acute systemic toxicity, material medicated pyrogenicity); non-toxic and biocompatible.	Not Applicable
   Performance Testing (Bench)	All tests verified (Appearance, Dimension, Operational Performance, Tensile Performance, Hydraulic Leak Resistance, Injection Connector performance, Conduction resistance, Contrast Agent Injection Function, Cutting Line Function, Radiopacity, Compatible endoscopes tests, Thermal effect test).	Not Applicable
   Electromagnetic Compatibility & Electrical Safety	Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-2.	Not Applicable

3. Sample Size for Test Set and Data Provenance:

   • Sample Size: Not specified for individual bench tests, but generally refers to a set of devices tested in a lab setting.
   • Data Provenance: The tests are "bench tests" performed by the manufacturer, Beijing ZKSK Technology Co., Ltd. Origin would be China (where the manufacturer is located). These are not patient data.

4. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications: Not applicable. Ground truth for a physical medical device's performance in bench testing is established by engineering specifications and direct physical measurement/observation, not expert consensus on medical imaging or clinical interpretation.

5. Adjudication Method: Not applicable.

6. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: No. The device is a physical instrument, not an AI assistance tool for human readers.

7. Standalone (Algorithm Only) Performance: Not applicable as it's not an algorithm.

8. Type of Ground Truth Used: Engineering specifications, physical measurements, and conformity to international standards (e.g., ISO, IEC). This is about device function and safety, not diagnostic accuracy.

9. Sample Size for the Training Set: Not applicable. There is no AI model or training set.

10. How the Ground Truth for the Training Set Was Established: Not applicable.

In summary, the provided document describes a traditional medical device (Disposable Sphincterotome) submission to the FDA. The listed "studies" are bench tests and compliance assessments to demonstrate the device's physical and material properties, safety, and functionality, and to establish substantial equivalence to a predicate device. It does not involve any AI/ML components or associated performance testing.

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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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Disposable Hemoclip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of:

1. Endoscopic marking, 2 ) Hemostasis for: Mucosal/sub-mucosal defects

The clip is pre-installed at the front of the chuck releaser, the chuck releaser is delivered by the conveyor duct through the endoscope to the Gastrointestinal (GI) tract system finds the bleeding site, thumb ring releases the chuck, so that the clip clamps the bleeding site to stop the bleeding.

The proposed device is a sterile, single-use endoscopic clipping device. It is consisted of two main components: the delivery system and the HC series. The delivery system is available in three different working length. The clip is deployed from the delivery system during use. The hemoclip jaws can be opened and closed no more than five times prior to deployment, aiding in repositioning of the clip at the lesion site.

There are 30 models of Disposable Hemoclip.The main structure and material of each specification model are completely consistent. The outer tube of the plastic wrap type has one more layer of plastic than that of the ordinary type. The material is PE, but the other is the same.

This document describes the premarket notification for the "Disposable Hemoclip" (K213217) and its substantial equivalence to a predicate device. The information details non-clinical tests conducted to demonstrate the device meets acceptance criteria.

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

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

   • Sample size: The document does not explicitly state the numerical sample size for each performance test. It refers to "a piece of 10cm*10cm isolated pig stomach tissue" for certain tests (e.g., Release the performance, Clamping force, Repositionability, Hemoclip assembly mechanical integrity) and "sample block comparison" for surface roughness. For other tests like reducing substances, extractable metal content, pH, evaporation residue, and UV absorbance, it references using specific volumes of test solutions (e.g., "0.2g sample", "1ml of water", "10mL of the test solution", "25mL of the test solution", "50 mL of the test solution"). The biological tests (cytotoxicity, skin sensitization, acute systemic toxicity, pyrogens, sub-acute systemic toxicity) would have their own sample sizes as per the ISO standards cited, but these are not provided in this summary.
   • Data provenance: The data is based on non-clinical testing conducted by the manufacturer, Beijing ZKSK Technology Co., Ltd., in China. The tissue model used in several tests is "isolated pig stomach tissue," indicating an ex-vivo or in-vitro animal tissue model. All results are from laboratory tests performed on the device itself or its materials, not human clinical trials. Thus, the data provenance is retrospective (tests already performed) and from the manufacturer's facility in China.

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

   • Not applicable. This submission is for a medical device (hemoclip) and relies on objective, quantifiable performance and biocompatibility testing against established standards, not on expert-adjudicated ground truth like in diagnostic imaging with AI. The "ground truth" here is derived directly from the physical properties of the device and its interaction with test materials, measured according to recognized test methodologies and standards.

4. Adjudication method for the test set:

   • Not applicable. As described above, the evaluation is based on objective measurements and adherence to specific numerical or qualitative criteria (e.g., "Meet the requirements", specific values for chemical tests, visual observation of functionality), not on human expert 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:

   • Not applicable. This device is a manual endoscopic tool, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

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

   • Not applicable. This is not an algorithm-only device. It is a physical medical device. The "standalone" performance testing refers to the device's inherent mechanical, material, and functional properties as evaluated in the non-clinical tests.

7. The type of ground truth used:

   • The "ground truth" for the non-clinical tests is established by:
     • Standardized measurement methodologies: Testing performed according to recognized international and national standards (ISO, ASTM, USP).
     • Objective performance criteria: Specific quantitative thresholds (e.g., force values, concentration limits, roughness parameters) and qualitative observations (e.g., smooth rotation, no separation, no cytotoxicity) defined in the acceptance criteria.
     • Material properties and chemical analysis results: Direct measurements of material hardness, chemical residues, extractables, pH, and UV absorbance.
     • Functional demonstrations: Observing the device's ability to open, close, clamp, release, and rotate as intended with a tissue model (isolated pig stomach tissue).

8. The sample size for the training set:

   • Not applicable. This submission concerns a physical medical device, not an AI model requiring a training set.

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

   • Not applicable, as no training set was used.

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Used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.

Multi-band ligator inculding control handle (rotation handle, shaft and joint), loading catheter, irrigation adapter (irrigation pipe and base), barrel, trigger cord (cord and pellets) and loop.The barrel preloaded with 4~9 loops. This device is designed for attachment to the end of an endoscope for ligating esophageal varices or hemorrhoids. Once assembled and attached the endoscope is advanced to the desired banding site and individual bands are deployed via manipulation of the deployment handle and trigger cord. The multi-band feature allows for serial ligations, which reduces the need to remove the endoscope for reloading. This device is supplied non-sterile and is intended for single use only.

The provided document is a 510(k) summary for a medical device called "Multi-Band Ligator." It outlines the device's characteristics, intended use, and a comparison to a predicate device to demonstrate substantial equivalence to legally marketed devices.

Here's an analysis of the acceptance criteria and the study information as requested:

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

The document does not explicitly state "acceptance criteria" in a quantitative format for each test. Instead, it describes the purpose or goal of each test and then generally states that the device "meets the related requirements" or "complied with the Indication for Use."

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 used for any of the bench tests (e.g., how many units were tested for appearance, functional performance, chemical properties, etc.).

The data provenance is from China, as the submitter, Beijing ZKSK Technology Co., Ltd., is located in Beijing, China, and the designated submission correspondent is in Shanghai, China. The testing described is prospective in nature, as it involves testing new units of the device against predefined requirements.

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 section is not applicable as the document describes bench testing for a mechanical device, not an AI/imaging device where expert ground truth establishment for a test set would be relevant. The "ground truth" for these tests comes from engineering specifications and industry standards.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth from multiple expert opinions, which is not the type of testing described here. The testing involves objective measurements and compliance with engineering specifications.

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. This device is a mechanical multi-band ligator and not an AI-assisted diagnostic tool or an imaging device involving human readers.

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

No, a standalone (algorithm-only) performance study was not done. This is a mechanical medical device, not an algorithm or software.

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

The "ground truth" for the bench tests described is based on:

• Engineering specifications and design requirements: For functional and mechanical performance, appearance, and physical properties.
• International standards: Such as ASTM F 1980-16 for shelf life and ISO 10993 for biocompatibility.
• Company's technical requirements: For specific mechanical properties of the loop.

8. The sample size for the training set

This is not applicable. The document describes a medical device, not an AI/machine learning model that requires 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 device.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

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

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

8. The sample size for the training set

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

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

• Not applicable.

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Single use injection needle is to be used in conjunction with an endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.

Endoscopic Injection Needle consists of Handle, Rod, Needle, Needle holder, Sheath, Catheter, Adapter, Sheath holder, Sheath protection pipe, Tube cap.

The Endoscopic Injection Needle is available in three needle sizes (20 gauges 22 gauge and 25 gauge), five needle lengths (4mm,5mm,8mm and 10mm),five working length(1200mm,1600mm, 1950mm,2000mm, 2300mm). There are 5 series (SN18-05 series, SN18-07 series, SN18-09 series, SN19-05 series and SN19-07 series) total ninety (90) specification injection needles.

The Endoscopic Injection Needle is sterile, single-use device. It is expected to be used in conjunction with an endoscope to perform endoscopic injections into tissue in the GI tract during an endoscopic procedure.

The Endoscopic Injection Needle is designed to pass through the endoscope's forceps to mark the lesions of the digestive tract and use it for injection. Compatibility with endoscopes, working lengths are 1600mm, 1950mm,2000mm, 2300mm, and the minimum working clamp channel is φ 2.8 mm.

The provided text describes the Endoscopic Injection Needle (K213239) and its acceptance criteria, along with a summary of the testing performed to demonstrate its safety and effectiveness.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the successful completion of the tests listed. The "Reported Device Performance" column indicates that the device met these criteria through successful testing.

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

• Test Set Sample Size: The document does not explicitly state the sample size used for each specific bench test item. It generally refers to "bench testing" being performed.
• Data Provenance: The data is from "Summary of non-clinical and performance testing- Bench testing" carried out by Beijing ZKSK Technology Co., Ltd. The tests were performed according to recognized consensus standards and the company's technical requirements. This is retrospective testing performed by the manufacturer on its own device prototypes/production samples. The country of origin for the testing is implied to be China, where the manufacturer is located.

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

Not applicable. This device is a physical medical instrument, not an AI/software device that relies on expert interpretation for ground truth in its performance evaluation as described in the context of AI/ML devices. The "ground truth" for the bench tests is based on objective measurements and adherence to engineering and biological standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not an AI/ML device requiring human adjudication for performance evaluation. Adjudication methods are typically relevant for subjective expert assessments or when there are disagreements in interpretations.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an Endoscopic Injection Needle, a physical instrument, and its evaluation focuses on bench testing and mechanical/biocompatibility performance, not on AI-assisted human reading.

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

Not applicable. This is not an algorithm or AI device; it's a physical medical instrument. Therefore, the concept of "standalone performance" for an algorithm doesn't apply.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on objective measurements, adherence to recognized consensus standards (e.g., ISO 7864, ISO 9626, ISO 10993 series, ISO 11607-1, ISO 80369-7), and the manufacturer's internal design requirements and specifications. For biocompatibility, the ground truth is established by the biological responses observed against the criteria in ISO 10993.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The device's safety and effectiveness are established through physical and biological testing as described above.

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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