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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.

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

Not Found

This document is a 510(k) summary for the Microvasive® Needle Knife Sphincterotome. It outlines the manufacturer's claim of substantial equivalence to previously marketed devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner requested by the prompt.

Therefore, much of the requested information regarding "acceptance criteria" and "study data" for an AI/device performance evaluation is not applicable here because this document describes a traditional medical device (a sphincterotome) undergoing a 510(k) clearance process, not an AI or software as a medical device (SaMD).

However, I can extract the relevant information from the document that touches upon performance and equivalence.

Here's the breakdown of what can be extracted and what information is not present based on the provided text:

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

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

• Not Applicable. The document describes "laboratory testing" and a "biocompatibility assessment," but it does not specify a "test set" in the context of clinical trial or AI model validation. It's a medical device clearance, not a data-driven performance study in the way the prompt implies.

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. This is not an AI or diagnostic device where expert ground truth for a test set is established.

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

• Not Applicable.

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

• Not Applicable. This is a physical medical device, not an AI-assisted diagnostic tool.

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

• Not Applicable.

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

• Not Applicable. The "ground truth" for this device's clearance would be its compliance with material standards, sterilization protocols, and functional performance in laboratory settings, as well as its similarity to previously cleared predicate devices.

8. The sample size for the training set

• Not Applicable. This is not an AI model requiring a training set.

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

• Not Applicable.

Summary of what the document does provide regarding device performance:

The document focuses on establishing substantial equivalence to existing legally marketed devices (Microvasive® Rapid Exchange Sphincterotome and Ultratome XL™ Triple Lumen Sphincterotome).

Key points from the document regarding performance:

• Laboratory testing: Stated that "Laboratory testing regarding characteristics was performed on the Microvasive® Needle Knife Sphincterotome to verify its safety and performance." However, no specific performance metrics or detailed results from this testing are provided in the summary.
• Biocompatibility: "A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Microvasive® Needle Knife Sphincterotome with satisfactory results."
• Sterilization: The device "will be sterilized using ethylene oxide gas using the AAMI protocol for ethylene oxide sterilization."
• Pyrogenicity: "Pyrogenicity testing will be performed on a periodic basis to monitor bacterial endotoxin levels."
• Conclusion: The manufacturer "believes that Microvasive® Needle Knife Sphincterotome is substantially equivalent... A comparison of the descriptive characteristics of these products demonstrate the Microvasive® Needle Knife Sphincterotome is equivalent in its indications for use, while being very similar in design and materials."

In essence, this 510(k) summary asserts that the new device is safe and effective by demonstrating its similarities to already approved devices and by confirming basic safety aspects through laboratory tests, rather than providing a detailed study with specific performance metrics against a defined acceptance criterion.

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