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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 device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. Also indicated for sphincterotome-aided, wire-quided selective cannulation of the biliary ducts.

Tesla BiCord Active Cord:

This device is used to connect the Teslatome Bipolar Sphincterotome to compatible electrosurgical generators.

ln a sphincterotomy, access to the biliary tract is gained by passing a sphincterotome through a duodenoscope and positioning the distal tip adjacent to the major papilla is cannulated using the tip of the sphincterotome. The papilla is then incised using an electrosurgical current applied to the cutting wire by an electrosurgical generator that is connected to the sphincterotome by an active cord.

The Teslatome consists of a three-ring handle, tri-lumen catheter, and cutting wire with a connection to an electrosurgical generator via the Tesla BiCord active cord. The connection delivers a current to the cutting wire that is exposed at the device. A multilumen catheter allows for the injection of contrast and/or the passage over a prepositioned wire guide using the proximal end of the device.

The provided text is a 510(k) summary for the Teslatome Bipolar Sphincterotome and Tesla BiCord Active Cord. It details the device, its intended use, and a comparison to a predicate device. However, it does not contain information about specific acceptance criteria, a detailed study proving the device meets these criteria, or any clinical study details.

The document explicitly states: "The non-clinical tests for seal strength, functional testing after simulated distribution, current carrying capacity, device burnout, neutral electrode thermal performance, and force of device pushability demonstrate adherence to the quality design and risk management systems of the manufacturer. The Teslatome and BiCord active cord are substantially equivalent to the currently cleared predicate devices."

This indicates that while non-clinical tests were performed, the 510(k) relies on the substantial equivalence to a predicate device (K192339) rather than a de novo clinical study with specific acceptance criteria. Therefore, most of the requested information cannot be extracted from this document.

Here's what can be gathered, along with the reasons why other information cannot be provided based on the input:

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

• Cannot be provided. The document broadly mentions "non-clinical tests for seal strength, functional testing after simulated distribution, current carrying capacity, device burnout, neutral electrode thermal performance, and force of device pushability." However, it does not list specific quantitative acceptance criteria for these tests or the reported performance values against those criteria. It only states that the tests "demonstrate adherence to the quality design and risk management systems of the manufacturer" and that the devices are "substantially equivalent."

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

• Cannot be provided. The document does not detail sample sizes for the non-clinical tests. It also does not discuss any test set in the context of clinical data or data provenance (country of origin, retrospective/prospective), as it relies on non-clinical testing and substantial equivalence.

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

• Cannot be provided. This information is relevant for studies involving human interpretation or clinical data with ground truth establishment. The provided text only discusses non-clinical device testing for substantial equivalence, not studies requiring expert ground truth.

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

• Cannot be provided. This is relevant for clinical studies involving multiple readers and ground truth adjudication. Not applicable to the non-clinical testing mentioned.

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

• Cannot be provided. The device described (Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord) is an endoscopic electrosurgical unit and accessories, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study or AI-related effectiveness is not applicable and not mentioned.

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

• Cannot be provided. As noted above, this is not an AI algorithm. The device is a physical medical instrument.

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

• Cannot be provided. For the non-clinical tests mentioned, the "ground truth" would be established engineering specifications, performance standards, or comparison to the predicate device's known characteristics, not clinical ground truths like pathology or expert consensus. Specific details are not included.

8. The sample size for the training set

• Cannot be provided. This information is related to machine learning models. The device discussed is a physical medical instrument, not an AI model requiring a training set.

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

• Cannot be provided. This information is related to machine learning models. Not applicable for this device.

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The Disposable Sphincterotome is indicated for use in the cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device is supplied sterile and intended for single use only.

The Disposable Sphincterotome described in this submission are a sterile, single use devices compatible with the working channel of endoscope. The device consists of a long plastic tube 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 models with injection can inject contrast medium into the biliary ducts. The main materials of the proposed device include PTFE, ABS, SUS304. Type A, Type B and Type C are included in this submission. The proposed devices are 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.

This looks like a 510(k) premarket notification for a medical device. These submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data for novel acceptance criteria.

Based on the provided text, the "acceptance criteria" for the Disposable Sphincterotome are primarily established by its similarity to the predicate device (Hangzhou AGS MedTech Co., Ltd.'s Sphincterotome, K201121) and compliance with relevant consensus standards.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in the way one might see for a novel AI algorithm or a device with new performance claims. Instead, the performance is demonstrated by showing the proposed device is substantially equivalent to the predicate device and meets established safety and performance standards.

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

• Sample Size for Test Set: The document describes bench testing for physical properties ("Appearance, Physical properties") and compliance with standards (e.g., sterilization, biocompatibility). It does not specify the exact number of units tested for these bench tests.
• Data Provenance: The tests are non-clinical (bench tests) conducted by the manufacturer, Zhejiang Soudon Medical Technology Co.,Ltd. The country of origin of the device is China. The data is prospective in the sense that the manufacturer performed these tests specifically for this submission.

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

• This information is not provided as this submission relies on engineering and manufacturing standards verification as opposed to clinical expert assessment of a diagnostic outcome. For bench testing, ground truth is typically defined by engineering specifications and standard test methods.

4. Adjudication method for the test set:

• This is not applicable as the document describes bench testing against predefined engineering specifications and compliance with international standards, rather than expert-adjudicated clinical outcomes.

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

• No, an MRMC study was not done. This device is a Disposable Sphincterotome, which is an electrosurgical accessory used by a clinician, not an AI-assisted diagnostic tool for "human readers." Therefore, this type of study is irrelevant for this device.

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

• No, this is an electrosurgical medical device, not an algorithm or software requiring standalone performance testing in that context.

7. The type of ground truth used:

• For the non-clinical performance data, the ground truth is based on:
  • Engineering specifications and design requirements for "Appearance" and "Physical properties."
  • International Consensus Standards such as ISO 10993-1 (Biocompatibility), ISO 11135-1 (EO Sterilization), and ISO 10993-7 (Ethylene Oxide Sterilization Residuals).
  • Substantial Equivalence to the legally marketed predicate device (K201121) in terms of indications for use, technological characteristics, and safety/performance profiles.

8. The sample size for the training set:

• This is not applicable. This submission is for a physical medical device, not an AI algorithm, and therefore there is no "training set" in the context of machine learning.

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

• Not applicable for the same reason as point 8.

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The Autotome Pro RX Sphincterotome is indicated for use in the selective cannulation of the Common Bile Ducts (CBD) and the transendoscopic sphincterotomy of the Papilla of Vater and/or Sphincter of Oddi. The Sphincterotome can also be used to inject contrast medium.

The Autotome Pro RX Sphincterotome is used for cannulation of the bile duct when performing diagnostic and/or therapeutic endoscopic biliary procedures. The sphincterotome can deliver contrast medium to the distal tip yia an iniection channel to aid in fluoroscopic visualization. The sphincterotome consists of a cutting wire on the distal end to cut and cauterize the Papilla of Vater and/or Sphincter of Oddi when connected to a monopolar electrosurgical generator. The sphincterotome is designed for use with endoscopes that have a working channel of 2.8mm or larger.

The Autotome Pro RX Sphincterotome is a 200cm, triple lumen sphincterotome available in 2 sizes: 3.9Fr and 4.4Fr. The Autotome Pro RX 39 Sphincterotome is capable of accepting a 0.025" (0.64mm) guidewire and the Autotome Pro RX 44 Sphincterotome is capable of accepting a 0.035" (0.89mm) or 0.025" (0.64mm) guidewire. The Autotome Pro RX Sphincterotome includes insulation on the proximal end of the cut wire. The Autotome Pro RX Sphincterotome is also available with a pre-loaded guidewire.

The provided text is a 510(k) summary for the Boston Scientific Autotome Pro RX Sphincterotome. It details the device description, indications for use, and performance data from non-clinical bench testing, simulated use testing, and biocompatibility testing.

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to AI/ML or human reader performance. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing, which are standard for medical devices like sphincterotomes. There is no mention of:

• Acceptance criteria for AI/ML performance (e.g., sensitivity, specificity, AUC).
• A test set size or its provenance.
• The number or qualifications of experts for ground truth.
• Adjudication methods for ground truth establishment.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Training set size or ground truth establishment for a training set.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information about studies involving AI/ML components or human reader performance, as this kind of data is not present in the provided document. The device in question is a physical medical instrument (sphincterotome), not a software or AI-driven diagnostic tool.

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The Sphincterotome is indicated for use in the cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Spincter of Oddi. The device is supplied sterile and intended for single use only.

The Sphincterotome described in this submission is a sterile, single use device compatible with the working channel of endoscope. The device consists of a long plastic tube with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of papilla is opened by passing high-frequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation.

For non-exchangeable models, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 2.8mm, and the recommended guide wire OD is 0.63mm (0.025inch) or 0.89mm (0.035inch);

For normal exchangeable models, there is a small hole on the sheath which is about 200mm far away from the distal end, it is used to insert the guide wire rapidly, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 3.7mm, and the recommended guide wire OD is 0.63mm (0.025inch) or 0.89mm (0.035inch);

For C-type exchangeable models, there is an open channel on the sheath to rapid exchange the guide wire, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 3.7mm, and the recommended guide wire OD is 0.63mm (0.025inch) or 0.89mm (0.035inch);

For 50910, 50913, 50916 and 50917 series, there's preloaded guide wire, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 3.7mm, and the OD of preloaded guide wire is detailed in the device's label.

The provided text describes a 510(k) premarket notification for a medical device called "Sphincterotome." This submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data and does not include a study with explicit acceptance criteria and device performance results in the format requested.

Here's an analysis of what is available and what is missing, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific, quantifiable acceptance criteria and corresponding reported device performance values. Instead, it states broadly that "The Sphincterotome meets all design specifications and medical device standards for electrosurgical safety (IEC 60601), biocompatibility (ISO 10993) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device."

The comparison tables (Table 5.6-1 and Table 5.6-2) highlight similarities and differences between the proposed device and predicate devices for various characteristics but do not present acceptance criteria or quantitative performance data. For example, under "Performance," it lists several performance aspects like "Injection performance, Compatibility with traction guide wire, Compatibility with endoscope, Ray detectability, Visibility under endoscopy, Electric performance, Operation flexibility, Connected firmly, Rotation performance, Force to Bow, Orientation of Cutting Wire and Visualization of Cutting Wire, Ink Validation; Cutting rate; Energy dose analyses;" and states "Unknown" for predicate device K013153 and provides a similar list for predicate K201121. For the proposed device, it states that "Bench test has been conducted to demonstrate substantial equivalence," but the specific results of these tests against predefined acceptance criteria are not presented in the provided text.

2. Sample Size for Test Set and Data Provenance

Not applicable. The document explicitly states: "No Clinical test is included in this submission." The performance data mentioned are non-clinical bench tests. The sample size for these bench tests is not provided, and the data provenance, beyond being "non-clinical," is not specified (e.g., country of origin, retrospective/prospective).

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device submission relies on non-clinical bench testing to demonstrate substantial equivalence, not on human expert assessments of medical images or diagnoses. Therefore, there is no mention of experts establishing ground truth.

4. Adjudication Method for Test Set

Not applicable. As no clinical test involving human readers and ground truth establishment was conducted, no adjudication method is mentioned.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not applicable. The document states "No Clinical test is included in this submission." An MRMC study would be a type of clinical study involving human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device (Sphincterotome), not an AI algorithm. Its performance is assessed through bench testing, not an algorithm-only study.

7. Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence for this device would be established through engineering specifications, recognized medical device standards (e.g., IEC 60601, ISO 10993, ISO 11135), and results from non-clinical bench tests. These tests confirm that the device performs as intended and is comparable to predicate devices in terms of mechanical, electrical, and biological safety and performance. No pathology, outcomes data, or expert consensus (in the typical sense of diagnostic accuracy studies) were used as ground truth for this submission.

8. Sample Size for Training Set

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

9. How Ground Truth for Training Set was Established

Not applicable. As above, this is a physical medical device, not an AI model.

Summary of what is missing/not applicable based on the provided text:

• Specific, quantifiable acceptance criteria and device performance results in a table.
• Sample sizes for the "test set" (as this was non-clinical bench testing, not a clinical test set).
• Data provenance for any performance testing.
• Information on experts for ground truth or adjudication methods.
• Any multi-reader multi-case or standalone AI performance studies.
• Information on training sets or how their ground truth was established.

The document is a 510(k) summary focused on demonstrating substantial equivalence to previously cleared devices through comparison of technical characteristics and compliance with recognized standards via non-clinical testing. It explicitly states that no clinical tests were included.

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The Sphincterotome is intended to be used in the selective cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device can also be used to inject contrast medium.

The proposed device has two types: Sphincterotome / short-wire compatible and Sterile Sphincterotome. Sterile commonly traditional Endoscopic Retrograde Sphincterotome used in Cholangiopancreatography (Hereinafter referred to ERCP) surgery need to be used with a long guidewire, while Sphincterotome / short-wire compatible with short-wire techniques to compatible with a short guidewire to achieve rapid exchange between ERCP devices.

The proposed device consists of Cutting Wire, Outer Tube and Handle Assembly. It is used with the High Frequency Generator (Hereinafter referred to HF Generator) and the endoscopic procedures. The HF Generator supplies high frequency energy through the Cutting Wire of the proposed device to cut the tissue at the appropriate power and voltage. The models with injection can inject contrast medium into the biliary ducts. The main materials of the proposed device include PTFE, ABS, SUS304.

The proposed device has 52 specifications, which mainly differ in cutting wire type, cutting wire length, preloaded guidewire length and with insulation tube or not.

The proposed device Sphincterotome 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 1 year.

This document describes the premarket notification (510(k)) for the Micro-Tech (Nanjing) Co., Ltd. Sphincterotome. The submission focuses on demonstrating substantial equivalence to a predicate device through performance testing rather than clinical studies or specific device performance acceptance criteria against which a study directly proves the device meets. Therefore, some of the requested information, particularly regarding specific acceptance criteria metrics, will not be directly available.

Here's an analysis based on the provided text:

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

The document does not explicitly present a table of quantitative acceptance criteria and corresponding reported device performance values for clinical metrics. Instead, it lists various performance tests conducted to demonstrate essential performance and confirm that the proposed device works as intended and is substantially equivalent to the predicate device. The conclusion states that "the test results meet the requirement," implying that the device passed the internal acceptance criteria for each test.

Key Performance Tests Conducted (without specific numerical acceptance criteria or reported values in this document):

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

The document does not specify the sample sizes (number of devices) used for each of the performance tests listed. Since this is a submission based on physical and functional performance testing of the device itself rather than patient data, there is no information on data provenance in terms of country of origin or retrospective/prospective nature.

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

This information is not applicable. The performance tests described are laboratory-based and do not involve human interpretation against a "ground truth" established by medical experts.

4. Adjudication method for the test set

This information is not applicable as the tests are objective performance measurements, not subjective evaluations requiring 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

There was no MRMC comparative effectiveness study, as this device is not an AI-powered diagnostic or assistive tool. It is a medical instrument (sphincterotome).

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

This information is not applicable as the device is a medical instrument, not an algorithm.

7. The type of ground truth used

This information is not applicable in the context of device performance testing for a physical instrument. The "ground truth" in this context would be engineering specifications and validated test methods for physical, electrical, and functional performance.

8. The sample size for the training set

This information is not applicable as this is not an AI/algorithm device that requires a training set.

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

This information is not applicable as this is not an AI/algorithm device.

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The Sphincterotome is indicated for use in the cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Spincter of Oddi. The device is supplied sterile and intended for single use only.

The sphincterotome described in this submission are a sterile, single use devices compatible with the working channel of endoscope. The device consists of a long plastic tube 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. For 50910 series, there's preloaded guide wire.

The provided document is a 510(k) summary for a medical device called "Sphincterotome" by Hangzhou AGS MedTech Co., Ltd. This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone clinical study. As such, information regarding acceptance criteria, sample sizes for test sets, expert involvement, adjudication methods, multi-reader multi-case studies, and detailed ground truth establishment is not explicitly present in the format typically seen for a de novo or PMA submission.

However, based on the provided text, the acceptance criteria are implicitly derived from the comparison of the proposed device's performance against its predicate devices, as well as adherence to relevant international standards.

Here's a breakdown of the requested information based on the provided text:

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

Since this is a 510(k) submission, the "acceptance criteria" are generally considered to be demonstrating substantial equivalence to the predicate devices through similar technological characteristics and comparable performance. The document states that the proposed device "meets all design specifications and medical device standards" and its "non-clinical performance meets the design specification and shows substantial equivalence to the predicated device."

Specific performance aspects evaluated are implicitly the "acceptance criteria" based on comparison to the predicate.

The document states: "We conducted all the performance testing on our proposed device in comparison with our chosen predicate. All the test results show that the proposed device is substantial equivalence with the predicate." It also notes improved safety in some aspects (e.g., "proposed device is safer than our predicate device" for "Connected firmly" and "as safe and effective as our predicate device" for "Force to Bow," "Orientation of Cutting Wire," "Ink Validation," and "Fluoroscopic Visibility"). Predicate device performance: "No information" on detailed performance specifications is provided for the predicate regarding these bench tests, but the comparison indicates equivalence was demonstrated. |
| Biocompatibility | The proposed device uses different materials (Plastic PTFE, Stainless Steel 304) than the listed predicate materials (Plastic PTFE, Stainless Steel 304, PET; Silicone oil, PTFE, Polyurethane, Medical grade hydrophilic coating).

Biocompatibility tests (In Vitro Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity) were performed according to ISO 10993 standards: ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017. The conclusion is "Biological risks are acceptable." |
| Adherence to Standards | The device meets IEC 60601 (electrosurgical safety), ISO 10993 (biocompatibility), and ISO 11135 (sterility). |

Study that proves the device meets the acceptance criteria:

The primary study mentioned to demonstrate that the device meets the acceptance criteria is a series of non-clinical performance bench tests comparing the proposed device to its predicate devices, as well as adherence to international standards.

• Non-clinical Performance Tests: The submission explicitly states: "We conducted all the performance testing on our proposed device in comparison with our chosen predicate. All the test results show that the proposed device is substantial equivalence with the predicate." Specific tests mentioned include:
  • Injection performance
  • Compatibility with traction guide wire
  • Compatibility with Endoscope
  • X-ray detectability
  • Visibility under endoscopy
  • Electric performance
  • Operation flexibility
  • Rotation performance
  • Connected firmly
  • Force to Bow
  • Orientation of Cutting Wire and Visualization of Cutting Wire testing
  • Ink Validation testing
  • Fluoroscopic Visibility testing
• Biocompatibility Tests: A separate set of tests were conducted due to differences in materials. These include In Vitro Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, and Pyrogenicity, all performed according to ISO 10993 standards.
• Adherence to Standards: The device's compliance with IEC 60601, ISO 10993, and ISO 11135 is cited.

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

• Sample Size: Not specified in the provided text for any of the individual bench tests. The term "bench tests" typically implies a limited number of samples to demonstrate adherence to specifications.
• Data Provenance: The tests were conducted by Hangzhou AGS MedTech Co., Ltd. in China. The nature of these tests (bench tests) is prospective in the sense that they were designed and performed for this submission.

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

Not applicable. For a 510(k) submission based on non-clinical bench testing, expert consensus for ground truth is generally not required in the way it would be for a diagnostic AI device. The "ground truth" for these tests is adherence to engineering and performance specifications, and comparison to the predicate device's characteristics.

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

Not applicable. This concept is relevant for studies involving human interpretation and clinical outcomes, not for the type of non-clinical bench testing described here.

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. The device is a physical medical instrument (Sphincterotome), not an AI software/device that assists human readers.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" for the non-clinical tests is adherence to established technical specifications, engineering measurements, and comparison to the characteristics and performance of the legally marketed predicate devices. For biocompatibility, it's compliance with ISO 10993 standards.

8. The sample size for the training set

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

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

Not applicable. This device is not a machine learning model.

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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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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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