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The Endoscopic Water Pump is a peristaltic pump intended to supply fluid to compatible endoscopes or endotherapy devices for irrigation of the gastric and colonic mucosa during endoscopic or endotherapeutic procedures, allowing to aid in visualisation, diagnosis and treatment.

AGS's Endoscopic Water Pump comprises:

• A host machine (including drive system, peristaltic pump head, housing, etc.); -
• Operating component (Rotatable Knob and Footswitch); -
• -Hanger assembly(optional);
• -An irrigation tube (optional)
  The Endoscopic Water Pump is a motorized pump designed to transfer water from a bottle, via a tube, to an endoscope or EndoTherapy devices, and the pump is operated by a footswitch. It uses a peristaltic pump head to move the water through the tube. The speed of the rotation of the pump head is adjustable by the user, using flow control knob on the front of the pump.

The provided text is a 510(k) summary for the Endoscopic Water Pump. It details the device's characteristics and compares it to a predicate device to demonstrate substantial equivalence. However, it does not contain information about acceptance criteria, a study that proves the device meets acceptance criteria, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or the type of ground truth used.

The document explicitly states:

• "No Clinical test is included in this submission." (CH2.03.9)
• And for Performance Data: "The Endoscopic Water Pump meets all design specifications and medical device standards for electrical safety and EMC (IEC 60601), and the Irrigation tube meet the standard for sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device." (CH2.03.8)

This indicates that the submission relies on adherence to design specifications and recognized standards, along with non-clinical performance (which is not detailed as a specific study with acceptance criteria in the requested format), rather than a clinical study or a study directly comparing algorithm performance against specific acceptance criteria.

Therefore, most of the requested information cannot be extracted from this document.

Here's a summary of what can be inferred or directly stated from the provided text, along with the information that is not present:

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

• Not present in the requested format. The document states the device "meets all design specifications and medical device standards" and "non-clinical performance meets the design specification." It also provides a comparison of technical characteristics and performance with the predicate device (Table CH2.03.6), primarily focusing on maximum output flow for different endoscope types. However, explicit acceptance criteria with corresponding performance metrics are not presented in a table.

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

• Not present. No test set or data provenance is mentioned as a clinical study was not performed. The performance evaluation seems to be based on engineering tests and adherence to standards.

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

• Not applicable / Not present. Since no clinical test or test set requiring ground truth was conducted, this information is not available.

4. Adjudication method for the test set

• Not applicable / Not present. Since no clinical test or test set requiring ground truth was conducted, this information is not available.

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 / Not present. This device is an Endoscopic Water Pump, a hardware device, not an AI or software device that assists human readers. No MRMC study was conducted.

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

• Not applicable / Not present. This is a hardware device; the concept of "standalone algorithm performance" does not apply.

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

• Not applicable / Not present. As no clinical study or test set requiring ground truth was performed, this information is not relevant.

8. The sample size for the training set

• Not applicable / Not present. This is a hardware device, not a machine learning model, so there is no training set in the typical sense.

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

• Not applicable / Not present. This is a hardware device, not a machine learning model, so there is no training set or ground truth for it.

Information provided in the document related to performance:

• Performance Comparison (from Table CH2.03.6, "Performance" row):

  • Proposed device (AGS):
    • Maximum output flow is generally higher than the predicate device.
    • For endoscopes with an auxiliary water channel and using irrigation tube AG-5247-3.2: approx. 240~248ml/min at flow setting 10 (maximum) with a new pump head. Recommended flow settings: 1-10.
    • For instrument channel flushing (GIF-Q260, 2.8mm diameter channel): approx. 240~258ml/min at flow setting 10 (maximum) with a new pump head. Recommended flow settings: 1-10.
  • Predicate device (Olympus OFP-2):
    • Water feed controlled by footswitch. Flow rate variable, controlled from front panel.
    • For endoscopes with an auxiliary water channel and using tube MAJ-1608/MAJ-1651 (CF-Q180AL): approx. 230ml/min at flow setting 9 (maximum) with a new pump head. Recommended flow settings: 1-6.
    • For instrument channel flushing (1) (CF-Q260AL/DL, 3.2mm diameter channel): approx. 785ml/min at flow setting 9 (maximum) with a new pump head. Recommended flow settings: 5-9.
    • For instrument channel flushing (2) (GIF-Q260, 2.8mm diameter channel with 2.5mm ultrasound probe): approx. 100ml/min at flow setting 9 (maximum) with a new pump head. Recommended flow settings: 5-9.
  • Comparison Note: The proposed device's maximum output flow is higher than the predicate. The submission states that "we confirmed that the proposed device can meet the clinical requirements through simulate the clinical use of proposed device," and that "the simulation test in Section 12 demonstrates the substantial equivalence of the Endoscopic Water Pump." (Section 12 is not provided in the excerpt).

• Shelf Life:

  • Proposed device: 5 years for host machine, 3 years for irrigation tubes.
  • Predicate device: Unknown.
  • Comparison Note: "we conducted the shelf life validation in Section 14 which can prove that the difference of shelf life doesn't raise different questions regarding its safety and effectiveness." (Section 14 is not provided in the excerpt).

• Sterility/Single Use:

  • Proposed device irrigation tube: Sterile supplied, Single use.
  • Predicate device irrigation tube: MAJ-1608, MAJ-1651 is single day use item; MAJ-1607, MAJ-1681, MAJ-1682 is single use. MAJ-1651, MAJ-1681 and MAJ-1682 supplied sterile.

• Biocompatibility:

  • Proposed device materials contacting human body: ABS, PVC, PC. Biocompatibility tested to ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021.
  • Predicate device: Biological information unknown.
  • Comparison Note: "biological risks are acceptable, please refer to Section 15." (Section 15 is not provided in the excerpt).

In conclusion, the document emphasizes compliance with standards and non-clinical performance assessments rather than a detailed study with specific acceptance criteria and ground truth in the context of diagnostic accuracy, which would be typical for an AI/CADe 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 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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Polypectomy Snare is used endoscopically in the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.

Polypectomy Snare described in this submission is a sterile, single use devices compatible with the working channel of endoscope. The device is used endoscopically in the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract. The device can remove the specified released Hemoclip. EO sterilization and use for single use only.

The provided text describes a 510(k) summary for the Polypectomy Snare, which is submitted to demonstrate substantial equivalence to a predicate device. This document does not detail acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device. Instead, it focuses on the substantial equivalence of the new Polypectomy Snare to an existing one based on technical characteristics, performance data (bench tests), and compliance with medical device standards.

However, I can extract information related to the device attributes and how its performance was evaluated against a predicate device, which can be adapted to the structure of your request if we interpret "acceptance criteria" as meeting or being equivalent to the predicate device's performance, and "study" as the bench testing conducted.

Based on the provided text, here's an attempt to answer your questions by interpreting "acceptance criteria" as the performance of the predicate device and "study" as the bench testing performed for substantial equivalence:

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

Since this is a substantial equivalence submission for a traditional medical device (Polypectomy Snare, not an AI/ML device), the "acceptance criteria" are implied by the performance of the predicate device (K172729) and compliance with relevant standards. The "reported device performance" refers to the results of bench tests conducted on the proposed Polypectomy Snare to demonstrate it is "as safe and effective as our predicate 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 refers to "bench tests" and "non-clinical performance tests."

• Sample Size: Not specified in the provided text for any of the individual bench tests. The text mentions "All the test results show that the proposed device is as safe and effective as our predicate device," implying sufficient testing was done, but specific sample numbers are absent.
• Data Provenance: The tests were conducted by Hangzhou AGS MedTech Co., Ltd., which is based in Hangzhou, Zhejiang, China. The data is prospective, generated specifically 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)

This is not applicable as the submission is for a physical medical device (Polypectomy Snare) and relies on performance bench tests against engineering specifications and predicate device performance, not expert-labeled ground truth like in AI/ML studies.

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

Not applicable. This is not an AI/ML study involving human readers or interpretation of results where adjudication would be necessary. The evaluation is based on objective measurements from bench testing.

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

No. This is not an AI/ML device, and no MRMC comparative effectiveness study was performed. The device is a surgical instrument.

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

This question is not applicable to the Polypectomy Snare, as it is a physical medical instrument requiring human operation, not a standalone algorithm.

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

The "ground truth" for demonstrating substantial equivalence for this device is based on:

• Engineering Specifications: Meeting design specifications for various physical and functional parameters (e.g., snare open width, loop length, usability performance tests like durability, extension/retraction, cutting force).
• Compliance with Standards: Meeting recognized international standards for medical devices (IEC 60601 for electrical safety, ISO 10993 for biocompatibility, ISO 11135 for sterility).
• Predicate Device Performance: Demonstrating performance "as safe and effective as" the legally marketed predicate device (K172729) through comparative bench testing.

8. The sample size for the training set

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

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

Not applicable. There is no training set for this type of device.

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The Hemoclip is indicated for endoscopic clip placement within the digestive tract for the purpose of:

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

Hemoclip consists of Release part and Clip part. Clip part consists of Clip and Frap Tube. Release part consists of Spring End, Spring hose near clip end, Connect end, Plastic Coated Spring Tube / Spring Tube and Handle part. EO Sterilization and use for single use only. For our proposed Hemoclip, the release part could connect and release the clips repeatedly.

We include 5 series for this submission, 55501series, 55502 series, 55504 series and 55505 series. 55501 series and 55502 series are models consist of release part and clip part, and the release part and clip part are already combined, no additional separate clips include, 55501series and 55502 series are reloadable, the release part could connect and release clips repeatedly. 55503 series are models only consist of separate clip part, and the release part of 55501, 55502, 55503 and 55504 series can connect with the separate clip (55503 series) repeatedly. 55504 and 55505 series are models consist of one preloaded Hemoclip (consist of release part and clip part, and the release part and clip part are already combined) and additional separate clips, 55504 series and 55505 series are reloadable, the release part can connect separate clips and release clips repeatedly.

The provided text describes a 510(k) summary for a medical device called Hemoclip. This document does not pertain to an AI/ML device, therefore, the requested information regarding acceptance criteria and study details for such a device is not applicable. The Hemoclip is a medical device for endoscopic clip placement and its clearance is based on substantial equivalence to a predicate device, not on AI/ML performance metrics.

Specifically, the document states:

• No Clinical test is included in this submission. (Section 5.9)
• The performance data provided relates to non-clinical performance (shelf life validation, packaging validation, biocompatibility, and sterility) to meet design specifications and show substantial equivalence to the predicate device (Section 5.8).

As such, I cannot extract the acceptance criteria, study details, human reader performance, standalone algorithm performance, or ground truth information relevant to an AI/ML device from this document.

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The Balloon Dilatation Catheter is intended to endoscopically dilate strictures of the alimentary tract. The device is supplied sterile and intended for single use only.

The proposed device Balloon Dilatation Catheter is comprised of a pebax balloon mounted at the distal end of a pebax catheter with two ports. The balloon can be inflated to three distinct sizes, 6-7-8mm, 8-9-10mm, 10-11-12mm, 12-13.5-15mm, 15-16.5-18mm, 18-19-20mm diameters; the balloon length can be 30mm, 55mm and 80mm. Radiopaque bands placed at the distal and proximal end of the device provide fluoroscopic visualization of the balloon location. The catheter length is 1800mm, 1950mm, 2100mm and 2400mm with an outer diameter of 1.8mm, 2.0mm or 2.3mm. The two ports correspond to a guide wire port and balloon inflation port. A stopcock is included at the proximal end of the balloon inflation port to control pressure movement into or out of the device. For rapid exchange models, there is a small hole on the catheter which is about 200mm far away from the distal end, it is used to insert the guide wire rapidly. The Balloon Dilatation Catheter is EO sterilization and use for single use only.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document explicitly states "The Balloon Dilatation Catheter meets all design specifications and medical device standards for biocompatibility (ISO 10993) and sterility (ISO 11135)". For the other items listed under "Following tests were conducted in our non-clinical bench test," the document states "The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device." This implies that the acceptance criterion for these tests was to meet their respective design specifications.

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

The document does not explicitly state the sample sizes used for the non-clinical bench tests. It also does not provide information on the provenance of data for these tests (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a Balloon Dilatation Catheter, and the assessment relies on engineering and biological performance standards, not expert interpretation of medical images or clinical outcomes that typically require expert ground truth establishment.

4. Adjudication Method

Not applicable. As noted above, this submission focuses on bench testing against established standards and design specifications, not on subjective clinical assessments requiring adjudication.

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

No. The document explicitly states: "No Clinical test is included in this submission." Therefore, no MRMC study was conducted.

6. Standalone Performance Study

Yes, a standalone performance study in the form of non-clinical bench testing was conducted to evaluate the device against its design specifications and relevant medical device standards. The "Performance Data" section details the various aspects tested (e.g., head tip, connect strength, leakage, balloon fatigue, etc.).

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation was based on:

• Design specifications: The device's performance was compared against its own pre-defined engineering and functional requirements.
• Relevant medical device standards: Specifically, ISO 10993 for biocompatibility and ISO 11135 for sterility. While not explicitly named for other tests, it's implied that recognized engineering and performance standards would be followed.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device and its performance is evaluated through bench testing and conformance to standards, not through machine learning models that require training sets.

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

Not applicable, as there is no machine learning training set for this device.

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The Hemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:

1. Endoscopic marking,
2. Hemostasis for:

• Mucosal/sub-mucosal defects

Hemoclip consists of Release part and Clip part. Clip part consists of Clip and Frap Tube. Release part consists of Spring End, Plastic Coated Spring Tube / Spring Tube and Handle. EO Sterilization and use for single use only.
For 510 family, the grooves on the frap tube allow the released clip could be removed by snare loops. If the clip has been deployed, but its position is not satisfactory, or it affects the field of vision, we can remove it.

The provided text is a 510(k) summary for a medical device called "Hemoclip." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way an AI/ML device submission might.

Therefore, many of the requested elements for an AI/ML device study (like sample size for test/training, number of experts, adjudication methods, MRMC studies, and detailed ground truth establishment) are not applicable or not present in this document. This document describes a traditional medical device clearance, not an AI/ML product.

However, I can extract information related to the acceptance criteria and performance data that is provided for this traditional device.

Here's an attempt to answer your request based on the provided text, while noting where information is not available due to the nature of the submission (traditional medical device vs. AI/ML):

Device: Hemoclip (Endoscope Clipping Device)
Type of Device: Traditional Medical Device (Class II)

1. Table of Acceptance Criteria and the Reported Device Performance

The submission states, "The Hemoclip meets all design specifications and medical device standards for biocompatibility (ISO 10993) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device."

While specific numeric acceptance criteria values are not provided in this summary, the document does list the performance tests conducted, implying these tests were used to demonstrate adherence to design specifications and substantial equivalence.

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

• Sample Size: Not specified in the provided summary. Performance testing was "non-clinical bench test."
• Data Provenance: Bench test data. No country of origin or retrospective/prospective distinction is relevant for these types of bench tests.

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

• Not Applicable. For mechanical and biocompatibility testing of a physical medical device, "experts" in the sense of medical professionals establishing ground truth for diagnostic purposes are not relevant. Testing is primarily objective and based on engineering and material science standards.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication is typically for resolving discrepancies in human expert labeling or diagnosis in AI studies. For physical device performance testing, adjudication methods are not typically used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not Applicable. This is a traditional medical device, not an AI-assisted diagnostic device. No human-in-the-loop study involving medical image readers was conducted or is relevant for this type of device.

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

• Not Applicable. This is a physical medical device (a Hemoclip), not a software algorithm.

7. The Type of Ground Truth Used

• For the performance data, the "ground truth" is defined by the design specifications and international standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterility, and implied engineering specifications for mechanical properties). There is no "true positive/negative" ground truth as would be established for a diagnostic device.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

• Not Applicable. As there is no training set, there's no ground truth to establish for it.

Summary for the Hemoclip K211787 Submission:

This 510(k) submission for the Hemoclip is for a traditional physical medical device used for endoscopic clip placement. The "acceptance criteria" revolve around established engineering design specifications, biocompatibility standards (ISO 10993), and sterility standards (ISO 11135). The "study" proving it meets these criteria consisted of non-clinical bench testing. The data presented demonstrates substantial equivalence to a legally marketed predicate device (K172727) by showing that differences do not raise new questions of safety or effectiveness. The concept of "ground truth" as applied to AI/ML diagnostics (expert consensus, pathology, outcomes) does not apply here; rather, the device's performance is objectively measured against predetermined engineering and material standards.

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

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

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

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

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

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

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

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

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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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This device is an accessory to be used with endoscopic biliary devices to lock the guidewire(s) in place during ERCP procedure. The device is supplied sterile and intended for single use only.

The proposed Locking Device is one-piece integrated system that secures onto the accessary channel of an endoscope. The access port in the center of the cap allows access of wire guides and other biliary accessories. The wire guide lock allows the practitioner to lock the wire guide in place for continued ductal access while proceeding with other ERCP therapies. This device consists of locking device and biopsy cap.

The provided text is a 510(k) summary for a medical device called "Locking device." It describes the device, its intended use, and its comparison to a predicate device for the purpose of demonstrating substantial equivalence to the FDA. However, the document does not contain information about acceptance criteria, specific performance metrics, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI devices.

Instead, it focuses on bench testing and biocompatibility for a physical medical accessory. Therefore, I cannot extract the requested information as it is not present in the provided text.

The information that is available includes:

• Device Name: Locking device
• Intended Use: An accessory to be used with endoscopic biliary devices to lock the guidewire(s) in place during ERCP procedure. Supplied sterile and intended for single use only.
• Predicate Device: Wilson-Cook USW Cap and Wire Lock (K040137)
• Performance Testing Mentioned:
  • Guidewire fixing force performance (for 0.025inch, 0.035inch, 0.038inch diameter guidewires)
  • Biocompatibility tests (In Vitro Cytotoxicity Test: ISO 10993-5:2009; Skin sensitization Test: ISO 10993-10:2010; Intracutaneous Reactivity Test: ISO 10993-10: 2010)
  • Manufacturing process for sterility (ISO 11135)

The document explicitly states: "No Clinical test is included in this submission."

Therefore, I cannot populate the table or answer the specific questions related to AI device performance evaluation as the document describes a purely mechanical medical device accessory.

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The device is used for the endoscopic removal of biliary stones and foreign bodies.

The subject Disposable Stone Extraction Basket is comprised of a stainless steel/nitinol basket at the distal end of a sheath with handle. Basket is advanced out of and retracted into the single lumen polytetrafluoroethylene catheter sheath using the handle component's actuator. The device is not compatible with any mechanical lithotripter. EO Sterilization and use for single use only.

The provided text is a 510(k) summary for the Disposable Stone Extraction Basket. It describes the device, its intended use, and compares it to a predicate device. However, it does not include detailed acceptance criteria or the specifics of a study proving the device meets those criteria, especially not in the context of an AI/ML powered device.

The document discusses performance data broadly in Section 5.8: "The Disposable Stone Extraction Basket meets all device standards for biocompatibility (ISO 1099) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device." This refers to general device safety and functionality standards, not specific performance metrics related to diagnostic accuracy, sensitivity, or specificity that would be typical for an AI/ML powered medical device.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving its performance for an AI/ML powered device based on the given text. The device described is a physical medical device (stone extraction basket), not an AI/ML algorithm.

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