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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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