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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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