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The Speedband™ Superview Super7 is indicated for use in endoscopic ligation of esophageal varices and anorectal hemorrhoids.

The Injection Speedband™ Superview Super 7 is indicated for endoscopic treatment of esophageal varices utilizing combination ligation therapy. The Injection Speedband™ Superview Super7 is also indicated for band ligation treatment of anorectal hemorrhoids.

The Speedband Superview Super7 and Injection Speedband Superview Super7 consist of two main components; a ligating unit and a handle assembly. The ligating unit consists of a cylindrical housing with a flexible silicone endoscope adapter, and seven elastic ligating bands. Suture is threaded around each band and passes through suture slots around the perimeter of the housing. The suture enters the endoscope through the working channel of an endoscope and is secured the tripwire on the handle assembly durning set-up.

The handle assembly consists of a handle knob and plastic spool mounted on a bracket with a stem. A tripwire is attached to the spool and passes through the septum and into the stem. The stem fits into the working channel of the endoscope. The septum seals the channel so suction can be maintained. On the Injection models, the septum has a port for insertion of an injection therapy needle.

The provided text is a 510(k) Summary for a medical device (Speedband™ Superview Super7 and Injection Speedband™ Superview Super7) and an FDA clearance letter. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria, detailed study protocols, or performance data in the format requested.

Here's a breakdown based on the information available in the provided text, and where it falls short for your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the document. The document focuses on demonstrating "substantial equivalence" to predicate devices.
• Reported Device Performance: The document only states "Bench testing was conducted to aid with the establishment of substantial equivalence of the proposed devices to the predicate device." No specific performance metrics (e.g., success rate, band deployment force, durability) or their results are provided.

Therefore, a table cannot be constructed from the provided text.

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

• Sample Size: Not specified. "Bench testing" is mentioned, but the number of units tested is not provided.
• Data Provenance: Not specified. Bench testing generally implies laboratory conditions, but the country of origin of the data or whether it was retrospective/prospective is not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• This information is not applicable and not present in the document. Bench testing for a device like a ligator likely involves engineering or quality control personnel assessing mechanical properties, not clinical experts establishing ground truth in a diagnostic context.

4. Adjudication Method for the Test Set:

• Not applicable/Not mentioned. Adjudication methods are typically relevant for clinical studies or studies involving human assessment of data (e.g., image interpretation), which is not described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC study was not done. This type of study focuses on improving human reader performance with AI assistance, which is outside the scope of this device (a mechanical ligator) and the type of performance testing described.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This device is a manual medical instrument, not an AI algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used:

• The document implies that the "ground truth" for "substantial equivalence" was established by comparing the proposed devices' characteristics (intended use, materials, number of bands, handle design) and bench testing results against those of the predicate devices. The specific metrics used for "bench testing" are not detailed. It's essentially a comparison against established performance/design of the predicate.

8. The Sample Size for the Training Set:

• Not applicable. This device is a mechanical instrument, not an AI/ML algorithm that requires a "training set."

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

• Not applicable for the same reason as above.

In summary, the provided document describes a 510(k) submission for a medical device focusing on "substantial equivalence" through bench testing. It does not provide the detailed performance study information, acceptance criteria, or ground truth establishment methods typically associated with AI/ML device evaluations as requested in your prompt.

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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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The Modified Speedband is indicated for use in endoscopic ligation of esophageal varices and anorectal hemorrhoids.

The Microvasive Modified Speedband 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 components 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 endoscope. An irrigation valve is located on the side of the Handle Unit.

The provided document is a 510(k) Pre-market Notification for a medical device called the "Speedband Superview Multiple Band Ligator" (later referred to as "Modified Speedband"). It focuses on demonstrating substantial equivalence to a predicate device already on the market (the "currently-marketed Speedband") and does not describe a study with acceptance criteria and a detailed analysis of device performance as typically understood in a medical device clinical trial or performance study against specific metrics.

Instead, this submission addresses the regulatory requirements for showing the new device is as safe and effective as a legally marketed predicate device. The "performance characteristics" section refers to laboratory testing and biocompatibility assessments, which are not detailed in a way that allows for the creation of an acceptance criteria table with reported performance metrics.

Therefore, many of the requested items (sample size, experts, adjudication, MRMC study, standalone performance, ground truth establishment, training set size) are not applicable or cannot be extracted from this type of regulatory document.

However, based on the information provided, here's what can be stated:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria or detailed reported device performance in the format of a clinical study. The performance evaluation mentioned is against the predicate device to demonstrate substantial equivalence, primarily through:

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

• Sample Size: Not applicable. This document describes laboratory testing and biocompatibility assessment, not a clinical test set with human subjects for performance evaluation.
• Data Provenance: Not specified beyond "Laboratory testing regarding characteristics was performed." No country of origin or retrospective/prospective nature is mentioned for this testing.

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

Not applicable. The document does not describe a test set requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. The document does not describe a test set requiring adjudication.

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

No, a MRMC comparative effectiveness study was not done or reported in this document. This device is a mechanical ligator, not an imaging analysis algorithm that would typically involve human readers.

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

Not applicable. This device is a medical instrument (ligator), not an algorithm. Therefore, "standalone" performance in this context refers to its intended mechanical function, as evaluated through laboratory testing.

7. Type of Ground Truth Used

Not applicable in the conventional sense of clinical trials. The "ground truth" for the declared substantial equivalence relies on:

• The known safety and effectiveness profile of the predicate device.
• Laboratory testing results (e.g., mechanical function, material properties).
• Biocompatibility assessment.

8. Sample Size for the Training Set

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

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

Not applicable.

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The Speedband Multiple Band Ligator is indicated for endoscopic ligation of anorectal hemorrhoids and esophageal varicies.

The major components of the Modified Speedband™ are the ligating handle and the ligating unit.

This 510(k) summary describes a medical device rather than an AI/ML algorithm or a diagnostic tool that would typically have acceptance criteria and performance metrics like sensitivity, specificity, or AUC. Therefore, much of the requested information is not applicable to this document.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it's not applicable:

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

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. The document mentions "laboratory testing," but does not provide details on the number of devices or units tested.
• Data Provenance: Not specified.

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

• Not Applicable. This document describes a physical medical device (ligator) and its mechanical/biocompatibility performance, not a diagnostic test requiring expert interpretation for ground truth.

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

• Not Applicable. Adjudication methods are typically for evaluating human interpretations in diagnostic studies. The testing described here is for physical device performance.

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

• Not Applicable. This is a physical medical device, not an AI or diagnostic tool. No human reader study was conducted.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable (in the traditional sense for diagnostic tools). The "ground truth" for this device's performance would be established by engineering standards, material specifications, and regulatory requirements demonstrating its ability to safely and effectively ligate tissue. This would be verified through specific laboratory tests (e.g., tensile strength, biocompatibility assays).

8. The sample size for the training set

• Not Applicable. There is no "training set" for this type of medical device's performance testing. The principles of AI/ML training do not apply here.

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

• Not Applicable. As there's no training set, this question is not relevant.

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