Search Results

Micro Arthroscope is intended for insertion into a small incision or puncture (through a cannula) to view the surgical site of small and large joints in conjunction with cameras.

Micro Endoscope is intended for insertion into a small incision or puncture (through a cannula) to view the surgical site of small and large joints of the wrists, ankles, elbows, knees, or shoulders in conjunction with cameras.

Not Found

The provided document is a Summary of Safety and Effectiveness for the Micro Medical Devices, Inc. Micro Endoscope. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific performance metrics and acceptance criteria. Therefore, the information required to populate the acceptance criteria table and answer most of the questions is not available in the given text.

Here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Reported Device Performance

Not provided in the document. The document establishes substantial equivalence based on intended use and technological characteristics (materials, sterilization method) compared to a predicate device, not on specific performance metrics with acceptance criteria.

Study Details

The document does not describe a clinical study or a standalone performance study with quantifiable results against acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device.

Here's how each point aligns with the provided text:

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

   • Not provided. There are no explicit acceptance criteria or reported performance metrics in the document.

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 test set or study data is presented. The submission relies on a comparison to a predicate device.

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 test set requiring expert ground truth is described.

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

   • Not applicable. No test set 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

   • No. This device is an endoscope, not an AI-assisted diagnostic tool.

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

   • Not applicable. This device is an endoscope, not an algorithm.

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

   • Not applicable. No study requiring ground truth is described.

8. The sample size for the training set

   • Not applicable. This document is not about a machine learning device, so there is no training set.

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

   • Not applicable. This document is not about a machine learning device, so there is no training set or ground truth for it.

In summary, the provided text is a 510(k) premarket notification primarily focused on demonstrating substantial equivalence to a predicate device, rather than detailing a clinical trial with specific performance metrics and acceptance criteria.

Ask a specific question about this device