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The new device is therefor a socalled "combination" devise that claims to have the same intended uses as several different types of predicate devices

The new device has incorporated features of the above tools into one device, resulting in one instrument that can bring into view and ligate hemorrhoids, all at the same time, by the operating surgeon. No assistant is needed. The tool is a double barreled tube, the internal tube carrying a preloaded latex elastic band slightly protuding from the external tube. An obturator is inserted into the devise and after adequate lubrication, the tool is inserted into the anal canal and rectum. The obturator is then removed. The anatomical site for banding is chosen, by acurate positioning the tool, A long narrow, angled tenaculum, or any other grasping device is inserted into the tube, the chosen tissue is grasped and pulled into the tube. The inner tube is retracted with the operators thumb and the outer barrel pushes the elastic band off the internal barrel and the band lodges around the tissue.

This document is a 510(k) Summary for a medical device called the "Solo Band Ligator," which is intended for hemorrhoid ligation. It claims equivalence to existing predicate devices. However, this document does not contain the information requested regarding acceptance criteria or a formal study proving the device meets specific acceptance criteria.

The provided text is a summary seeking marketing clearance based on substantial equivalence, not a detailed scientific study report with quantifiable performance metrics against pre-defined acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer most of the requested questions because the necessary information is not present in the provided text.

Here's an assessment based on the available information:

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

   • N/A. The document does not specify any quantitative acceptance criteria for device performance (e.g., success rate of ligation, complication rates, ease of use scores). It makes general claims about "doing it more accurately" and "easier" but without metrics.

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: Approximately 100 hemorrhoid ligations.
   • Data Provenance: The study was conducted in "my office" by the submitting surgeon, on an "outpatient basis." This indicates a single-center, retrospective (over the past two years) case series by the inventor/developer. No country of origin is explicitly stated, but common sense suggests it's the country where the submission is being made (likely the US, given the 510(k) context).

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):

   • N/A. Ground truth in this context would likely relate to successful ligation, absence of complications, patient experience, etc. This appears to be a case series where the operating surgeon (the device's inventor/submitter) is the primary assessor. There's no mention of multiple independent experts establishing ground truth for the 100 cases. The submitter is an expert (a surgeon performing ligations for over two years with this device), but not in an independent ground truth setting for a study.

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

   • None. There's no multi-reader or adjudication process described. The "results" are based on the operating surgeon's observations.

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 a mechanical device, not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study related to AI assistance is not applicable.

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

   • N/A. This is a manual surgical device, not an algorithm. Performance is inherently "human-in-the-loop."

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

   • The "ground truth" seems to be based on clinical observation by the operating surgeon (the submitter) regarding successful ligation, ease of procedure, and patient/surgeon satisfaction, with a note that "no significant differences before, during or after the banding procedure, were observed by the surgeon or the patient." This is subjective and anecdotal within the context of a 510(k) summary, rather than formally established ground truth via independent assessment, pathology, or rigorously defined outcome metrics.

8. The sample size for the training set:

   • N/A. This is not a machine learning model; thus, there is no "training set." The 100 cases described are simply the total experience with the device reported.

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

   • N/A. See point 8.

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