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The AutoBand Multiple Band Ligator is used to band esophageal varices or hemorrhoids in the colon. The device is intended for single use only.

The AutoBand Multiple Band Ligator device consists of the applicator unit (including the band barrel, handle, activation wheel, wheel grip, beaded string, interior stainless steel trigger wire, and fixation arm), a fixation strap, and the ligation bands that are mounted on the barrel.

The device is intended for single use and is supplied non-sterile. The ligation bands are intended for endoscopic placement in the esophagus or colon, with the trigger wire introduced through the biopsy port of the endoscope. Each AutoBand barrel is pre-loaded with seven bands. Models are manufactured for compatibility with either gastroscopes or colonoscopes. AutoBand model designations also are differentiated based on compatibility with different endoscope manufacturers.

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

Acceptance Criteria and Device Performance

Note on Biocompatibility - Cytotoxicity: The document explicitly states the "Ligation Band material is cytotoxic when tested in accordance with ISO 10993-5:1999." This appears to be a deviation from a typical "passed" acceptance criterion for cytotoxicity in the conventional sense of indicating no cytotoxic effect. However, it's presented in the context of demonstrating substantial equivalence to the predicate device, which also stated its material was cytotoxic. This suggests that for this specific application (ligation bands contacting mucosal membranes for prolonged duration), a certain level of cytotoxicity might be considered acceptable or an inherent characteristic of the material, and the goal was to demonstrate that the new material is no worse than the predicate.

Study Details

The provided document describes non-clinical testing rather than a human clinical study. The device is a modification of an already approved device (K083556), and the submission focuses on demonstrating substantial equivalence.

1. Sample sizes used for the test set and the data provenance:
* Test Set Sample Size: Not explicitly stated for each specific bench test. The document mentions "bench testing of performance" and "laboratory biocompatibility testing."
* Data Provenance: The testing was conducted in a laboratory setting ("laboratory biocompatibility testing"). The country of origin of the data is not specified, but it can be inferred to be within the scope of the manufacturer's (EndoChoice, Inc. in Alpharetta, GA, USA) operations or contracted labs. It is retrospective in the sense that it's testing a finished product modification against established standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. This was a non-clinical, laboratory-based study validating material properties and functional performance against technical specifications and international standards (ISO 10993-1, ASTM D6499-07, ASTM D74727-08), not human expert evaluation against a "ground truth" in the clinical imaging sense.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable. This was a non-clinical, laboratory-based study.

4. 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 a medical device (ligation band) and not an AI/imaging diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is a medical device, not an algorithm. However, the non-clinical functional verification testing can be considered "standalone" as it evaluates the device's intrinsic mechanical and material performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* For biocompatibility: International standards (ISO 10993-1, ISO 10993-5:1999) and specific ASTM test methods (ASTM D6499-07, ASTM D74727-08) served as the "ground truth" or reference for evaluating material safety.
* For functional performance: Engineering specifications and expected performance characteristics (e.g., improved band deployment) of the modified components served as the "ground truth."

7. The sample size for the training set:
* Not applicable. This is a non-clinical study for a physical medical device, not an algorithm that requires a training set.

8. How the ground truth for the training set was established:
* Not applicable. There is no training set for this type of device submission.

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The Auto Band Ligator is used to band esophageal varices or hemorrhoids in the colon. For single use only.

The Scandimed Auto-Band Ligator consists of a ligator wheel head mounted on a scope fixation arm and connected by a stainless steel thread to the band barrel.

The only modifications being proposed in this current Special 510(k) Premarket Notification are to change the latex formulation of the rubber ligating bands and to expand the product line to include 6 and 8 band variations.

The Auto-Band Ligator incorporates the following product features:

• Automatic Reverse Movement to START position after each release
• Snap Fixation system ensures stable fixation on the scope
• Adjustable Snap Fixation System facilitates fixation on all brands of scopes
• Precision One-Step Release Mechanism of bands
• Only a single band can be released at a time
• Latex or Latex Free Rubber Bands
• Available in 5, 6, 7, 8 or 10 band configurations

The provided 510(k) summary for the Scandimed International Auto-Band Ligator (K083556) is for a Special 510(k) Premarket Notification to address a material formulation change to the ligation bands and to expand the product line to include 6 and 8 band variations. This type of submission typically focuses on demonstrating that the modifications do not negatively impact the safety and effectiveness established for the predicate device.

Therefore, the study described is primarily performance testing to confirm the continued safety and effectiveness of the modified device.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• This type of information is not applicable to the performance testing described. The summary indicates physical performance tests of the device itself, not clinical studies requiring expert interpretation of data.

4. Adjudication Method for the Test Set

• Not applicable. The summary refers to performance testing of the device, not a clinical study involving human assessment and adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This 510(k) is for a physical device (ligator), not a diagnostic AI algorithm.

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

• No, a standalone (algorithm only) performance study was not done. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• For the described performance testing, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate device. The tests would confirm that the modified device's performance aligns with these objective standards.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance testing involves physical samples of the device.

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

• Not applicable. As above, there is no "training set" for this type of device.

Summary of Device Performance and Study:

The 510(k) summary states that "The Auto-Band Ligator was subjected to relevant performance testing. The results of the performance testing demonstrated the safety and effectiveness of the device." For a Special 510(k) for a material change and product line expansion, "performance testing" would typically involve:

• Functional testing: To ensure the band release mechanism, snap fixation system, and other features work correctly with the new band material and in the new 6/8 band configurations.
• Material properties testing: To ensure the new latex formulation meets required physical properties (e.g., elasticity, strength, durability) and biocompatibility standards.
• Dimensional verification: To confirm the new 6 and 8 band configurations fit and function as intended within the existing device design.

The claim of substantial equivalence relies on demonstrating that these modifications do not alter the fundamental technological characteristics, safety, or effectiveness established by the predicate device (Scandimed International Auto-Band Ligator #K031236 and #K081142). The details of these tests, including sample sizes and specific criteria, are not provided in this public summary.

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The Auto Band Ligator is used to band esophageal varices or hemorrhoids in the colon. For single use only.

The Scandimed Auto-Band Ligator consists of a ligator wheel head mounted on a scope fixation arm and connected by a stainless steel thread to the band barrel. The only change being proposed in this current Special 510(k) Premarket Notification is to convert the original latex rubber ligating bands to latex free rubber ligating bands. The Auto-Band Ligator incorporates the following product features: Automatic Reverse Movement to START position after each release. Snap Fixation system ensures stable fixation on the scope. Adjustable Snap Fixation System facilitates fixation on all brands of scopes. Precision One-Step Release Mechanism of bands. Only a single band can be released at a time. Latex Free Rubber Bands. Available in 5, 7 or 10 band configurations.

This document is a 510(k) Premarket Notification for the Scandimed International Auto-Band Ligator. The purpose of this notification is to introduce a material change from latex ligation bands to latex-free ligation bands.

As such, this document does not contain information related to acceptance criteria, specific device performance data in a quantifiable manner, sample sizes, ground truth establishment, or multi-reader multi-case studies typically associated with AI/ML device evaluations. This submission is for a medical device that has undergone a material change (latex to latex-free bands) and is not an AI/ML powered device.

Therefore, the requested information cannot be extracted from the provided text.

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The InScope Multi-Clip Applier is indicated for use with an endoscope to place clips in the gastrointestinal (GI) tract for the purpose of:

• Endoscopic marking, .
• Hemostasis for: ●
  • o Mucosal and submucosal defects

The InScope™ Mult-Clip Applier is a sterile, single patient use, disposable instrument capable of attaching clips to the mucosal lining of the gastrointestinal (GI) tract. The clips are used to create hemostasis and/or tissue approximation. The distal, flexible portion of the applier is designed to work with a flexible endoscope having a minimum working channel diameter of 3.2 mm. Two opposing jaws grasp tissue via a manually activated lever on a proximal handle. Once the closure lever is latched, a firing mechanism is manually activated, which deploys a titanium clip over the target tissue. The device is supplied preloaded with four (4) titanium clips.

The provided text describes the 510(k) summary for the InScope™ Multi-Clip Applier. This is a medical device submission, and the "study" referred to is the pre-clinical and bench testing conducted to demonstrate substantial equivalence to predicate devices, rather than a clinical trial involving human subjects or AI algorithms. As such, many of the typical questions for AI/algorithm performance studies do not apply.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The "acceptance criteria" for this device are demonstrating substantial equivalence to predicate devices in specific performance aspects. The reported device performance is that it meets these criteria.

Table of Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • The document refers to "bench and preclinical testing" and "preclinical data." It does not specify sample sizes for these tests.
   • Data provenance is preclinical/bench testing. No information on country of origin is provided, but typically, these tests are conducted by the manufacturer (Ethicon Endo-Surgery, Inc. in Cincinnati, OH, USA). The data is retrospective in the sense that it refers to testing done before the 510(k) submission.

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

   • This question is not applicable. The "ground truth" for a medical device like this is based on measurable physical properties and biological responses in preclinical models (e.g., tissue viability, clip retention force, hemostasis effectiveness), not on expert interpretations of medical images or patient outcomes in a clinical setting in the way an AI algorithm would be evaluated. These assessments are typically performed by engineers, biologists, or veterinarians specializing in device testing. The document does not specify the number or qualifications of these individuals.

3. Adjudication Method for the Test Set:

   • This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for human reader studies or to resolve discrepancies in expert labeling, which is not relevant here.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI algorithms that assist human readers in interpreting medical data (e.g., radiology images). The InScope Multi-Clip Applier is a physical surgical tool; its effectiveness is evaluated through direct performance metrics, not by how it influences human interpretation.

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

   • Not applicable. The InScope Multi-Clip Applier is a physical device used by a clinician, not an algorithm. Its performance is inherently "with human-in-the-loop" as it requires manual operation.

6. The Type of Ground Truth Used:

   • For the preclinical testing, the "ground truth" was based on direct measurements and observations of physical performance and biological responses in laboratory and animal models. This includes:
     • Measured hemostatic effectiveness.
     • Measured clip retention force/durability.
     • Histopathological assessment of tissue viability after clip placement.
     • Observation of outcomes for procedures like perforation closure in preclinical models.

7. The Sample Size for the Training Set:

   • Not applicable. This device does not use an AI algorithm that requires a training set. The "design and development" process would involve iterative testing and refinement, but this is distinct from machine learning training.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable. As there is no AI algorithm or training set, this question does not apply.

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The Auto-Band Ligator are used to band esophageal varices or haemorrhoids in the colon. For single use only.

Not Found

The provided 510(k) summary (K031236) for the Scandimed International Auto-Band Ligator is a clearance letter from the FDA. It declares the device substantially equivalent to legally marketed predicate devices.

Crucially, this document is a regulatory clearance letter and does not contain the details of a study proving the device meets specific acceptance criteria. This type of FDA clearance relies on demonstrating substantial equivalence to a predicate device, rather than requiring new clinical trials to establish de novo performance criteria.

Therefore, I cannot provide the information requested in your bullet points because the provided text does not contain a study report or clinical trial data.

To clarify what this document does provide:

• Device Name: Scandimed International Auto-Band Ligator
• Intended Use: Used to band esophageal varices or hemorrhoids in the colon. For single use only.
• Regulatory Classification: Class II, Product Code: 78 MND
• Predicate Device: Not explicitly named in this letter, but implied by the "substantial equivalence" determination.

Without a detailed clinical study report, it's impossible to answer your specific questions regarding acceptance criteria, sample sizes, expert qualifications, ground truth, or comparative effectiveness.

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The Bard® UltraView™ Multiple Band Ligator is used for endoscopic ligation of esophageal varices.

The Bard® UltraView™ Multiple Band Ligator is comprised of a ligating unit that fits over the distal end of an endoscope with seven premounted rubber latex ligating bands. The ligating unit is attached to the handle by the activating sheath. The bands are 1.9 mm thick with a 5.1 mm outer diameter and a 2.0 mm diameter. Four endoscope adapters and a centering sleeve are provided to allow the ligating unit to fit securely on endoscopes ranging from 8.5 mm to 11.5 mm. The small adapter fits 8.5 to 9.3 mm scopes. The medium adapter fits 9.3 to 10.2 mm scopes. The large adapter fits 10.2 to 10.8 mm scopes. The X-large adapter fits 10.8 to 11.5 mm scopes. A scope gauge is included to determine the required adapter for the endoscope. The modified design differs from the predicate device in that the ligating tip has been modified to improve the sealing integrity of the lip seal during aspiration and to improve the smooth actuation of the Band Driver over the Band Carrier by the addition of 12 ribs to the Band Driver. The sheath attaches to the handle assembly, which can be held in the physician's hand or attached to the endoscope sheath outside of the patient. The bands are deployed by depressing the thumb paddle on the handle assembly causing the bands to be pushed/deployed off of the band carrier. The modified device mounts flush with the tip of the endoscope, as does the predicate device, to allow maximum visualization. The modified and current device tips extend beyond the distal tip of the endoscope allowing variceal tissue to be suctioned into the band carrier cylinder for ligation.

The provided text describes modifications to an existing medical device, the Bard® UltraView™ Multiple Band Ligator, and demonstrates its substantial equivalence to the predicate device. This is a 510(k) premarket notification, which typically focuses on demonstrating equivalence rather than establishing new performance criteria for a novel device.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state formal "acceptance criteria" in a quantitative sense as might be seen for a new device's efficacy study. Instead, the performance data focuses on demonstrating that the modified device is substantially equivalent to the predicate device and remains safe and effective for its intended use.

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

The document does not provide details on sample sizes for the functionality, tensile, aspiration, or cytotoxicity tests. These are typically engineering and laboratory tests, not clinical studies with patient populations. The data provenance (country of origin, retrospective/prospective) is not specified, but these would be internal validation tests conducted by the manufacturer.

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

This information is not applicable to the type of testing described. The "tests" mentioned are engineering performance tests (e.g., tensile strength, aspiration efficacy, functionality) and biocompatibility tests (cytotoxicity), not tests requiring expert interpretation of diagnostic outcomes or clinical ground truth.

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

This information is not applicable. Adjudication methods are typically used in clinical studies where multiple human readers or experts assess and come to a consensus on "ground truth" for medical images or clinical outcomes. The tests described are laboratory and engineering performance tests.

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

There was no MRMC comparative effectiveness study and no mention of AI assistance. This document describes a traditional medical device (a ligator) and its modification, not an AI-powered diagnostic or therapeutic tool.

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

This information is not applicable. The device is a physical medical instrument, not a standalone algorithm.

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

The concept of "ground truth" as typically applied in diagnostic or AI studies is not directly relevant here. The "truth" for the performance claims is based on:

• Biocompatibility Standards: For cytotoxicity, adherence to established standards for determining toxicity.
• Engineering Specifications: For functionality, tensile strength, and aspiration, performance is measured against internal engineering specifications and, by extension, the characteristics of the predicate device to demonstrate "substantial equivalence." The "ground truth" is whether the device performs as specified and as comparably to the predicate as required for safety and effectiveness.

8. The sample size for the training set

This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The development process for this type of device involves engineering design, prototyping, and testing to meet functional requirements.

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

This information is not applicable as there is no "training set."

In summary: This 510(k) submission details modifications to an existing physical medical device and relies on engineering and laboratory performance testing (biocompatibility, functionality, tensile, aspiration) to demonstrate substantial equivalence to its predicate device. It does not involve AI, clinical efficacy studies with human subjects, or the establishment of "ground truth" in the diagnostic sense. The "acceptance criteria" are implied by the need to show that the modified device remains safe and effective and performs at least as well as the predicate, which was confirmed through these specific tests.

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The Bard® UltraView™ Multiple Band Ligator is used for endoscopic ligation of esophageal varices.

The Bard® UltraView™ Multiple Band Ligator is comprised of a ligating unit that fits over the distal end of an endoscope with seven premounted natural rubber latex ligating bands. The ligating unit is attached to the handle by the activating cable sheath. The bands are 1.9 mm thick with a 5.1 mm outer diameter and a 2.0 mm inner diameter. Three endoscope adapters and a centering sleeve are provided to allow the ligating unit to fit securely on endoscopes ranging from 8.5 mm to 10.8 mm. The small adapter fits 8.5 to 9.3 mm scopes. The medium adapter fits 9.3 to 10.2 mm scopes. The large adapter fits 10.2 to 10.8 mm scopes. No adapter is required for 10.8 to 11.5 mm scopes. A scope gauge is included to determine the required adapter for the endoscope.

Here's an analysis of the provided text regarding the Bard® UltraView™ Multiple Band Ligator:

This document, K022434, describes a 510(k) premarket notification for a medical device. The 510(k) process is typically used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than to establish strict acceptance criteria based on novel performance metrics. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the way one might expect for a new, groundbreaking technology with quantitative performance targets is not directly applicable here.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices through comparative performance data and other characteristics.

Therefore, many of the requested points below will reflect this aspect of substantial equivalence rather than a new device's performance against predefined quantitative benchmarks.

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

As mentioned, there aren't explicit quantitative "acceptance criteria" presented in the document in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through various tests.

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

The document does not specify sample sizes for any of the testing mentioned (biocompatibility, functionality, tensile, aspiration/retention). It simply states that these tests were completed.

The data provenance (country of origin, retrospective/prospective) is also not specified in this summary. These details would typically be found in more detailed test reports or study protocols, not usually in the 510(k) summary itself. The submitting company is Bard Endoscopic Technologies, C.R. Bard, Inc., based in the USA, but the contact person is from N.V. KEMA in The Netherlands, suggesting potential international collaboration or testing.

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

This type of information is not relevant to this device's submission. The device is a mechanical ligator, not an AI or diagnostic imaging device that requires expert ground truth labeling of images or data. The "ground truth" for this device's performance would be the direct results of the physical and functional tests, compared against the performance of the predicate devices.

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

Not applicable for this type of device and submission. Adjudication methods are typically used in clinical studies or expert review processes for diagnostic accuracy, which is not the primary focus 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. This device is a surgical tool, not an imaging or diagnostic aid, and therefore MRMC studies are not relevant. Its effectiveness is based on its mechanical function and ability to perform ligation, not on improving human reader performance.

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

Not applicable. This is a physical, human-operated medical device. There is no "algorithm only" performance to evaluate.

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

For a device like this, the "ground truth" or standard for comparison is embedded in the predicate devices themselves and the established understanding of their functional performance.

• Functionality: The "ground truth" for functionality is the successful and consistent operation of the predicate devices in performing ligation, aspiration, and band deployment. The new device is tested to perform these actions similarly.
• Tensile Strength: The "ground truth" is the established tensile strength properties of the bands used in the predicate devices, or industry standards for such materials in this application.
• Biocompatibility: The "ground truth" is adherence to established international standards for biocompatibility (e.g., ISO 10993 series) and no adverse biological reactions.
• Aspiration/Retention: The "ground truth" performance of aspiration and retention would be benchmarked against the known performance of the predicate devices on endoscopes.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, and therefore does not have "training sets."

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

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

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The HX-5/6-1 Clip Fixing Devices are intended to be used with an Olympus endoscope for the purpose of:
(1) endoscopic marking,
(2) hemostasis for
(a) mucosal/sub-mucosal defects

Not Found

The provided text is a 510(k) summary for the Olympus HX-5/6-1 Endoscopic Clipping Device. While it describes the device's intended use and provides a comparison to predicate devices, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance studies.

Therefore, I cannot extract the requested information from the given text.

The document discusses:

• Device Name: Rotatable Clip Fixing Devices HX-5/6-1
• Manufacturer: Olympus Optical Co., Ltd.
• Regulation Number: 21 CFR 876.4400 (Hemorrhoidal Ligator, Class II)
• Intended Use: Endoscopic marking, hemostasis (for mucosal/sub-mucosal defects, bleeding ulcers, arteries

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The Modified Superview is indicated for use in treatment of esophageal varicies utilizing combination ligation /injection therapy. The Modified Superview is indicated for band ligation treatment of anorectal hemorrhoids.

The Microvasive Modified Superview is a Multiple Band Ligator composed of two major components.

1. The Ligating Unit: The main component of the ligating unit is a cylinder which fits at the distal end of the endoscope. Elastic bands are stretched around the distal portion of the cylinder.
2. Handle Unit with Trip Wire and Scope Fastener: The main component of the Handle Unit is a plastic spool which turns only in the clockwise direction. A trip wire is attached to the plastic spool. When the plastic spool is rotated, the handle will make a distinct "click" sound, and one band will be fired automatically. The Handle Unit also incorporates a scope fastener to secure the handle onto the endoscope. An irrigation valve is located on the side of the Handle Unit.

The provided text is a 510(k) Summary for the Speedband Superview Multiple Band Ligator and does not contain a study comparing the device's performance against specific acceptance criteria. Instead, it aims to demonstrate substantial equivalence to a predicate device. Therefore, I cannot complete a table of acceptance criteria and reported device performance or information about a study proving the device meets acceptance criteria.

However, I can extract other relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance
Not provided. The document focuses on demonstrating substantial equivalence rather than meeting specific performance acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set data is described. The submission relies on laboratory testing and biocompatibility assessments, not a clinical study with a test set.

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. No ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set and thus no adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical instrument (ligator), not an AI-assisted diagnostic or imaging device, so an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth data is described for this submission. The submission references "Laboratory testing regarding characteristics was performed on the Modified Superview to verify its safety and performance" and "A biocompatibility assessment was performed... with satisfactory results." These are technical verifications, not clinical ground truth.

8. The sample size for the training set
Not applicable. No training set is described as this is not an AI/ML device.

9. How the ground truth for the training set was established
Not applicable. No training set is described.

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