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to allow surgeons to view the interior cavities of the human body under direct vision through the scope for the purpose of performing surgery by general surgeons and thoracic surgeons.

Solos 10mm Operating Laparoscope

According to the provided documents, this is a 510(k) clearance letter for the "Solos 10mm Operating Laparoscope" (K970917) from the FDA dated June 10, 1997. This document grants market clearance based on a finding of substantial equivalence to a legally marketed predicate device.

Key takeaway: A 510(k) clearance is based on substantial equivalence to a predicate device, not on acceptance criteria validated by new studies for the device itself.

Therefore, most of the requested information regarding acceptance criteria and performance studies for this specific device (Solos 10mm Operating Laparoscope) is not available in this document. The FDA letter states: "we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976."

This means that Woodbine Optical Corporation demonstrated that their device performs as safely and effectively as a previously cleared device, rather than providing new clinical study data with acceptance criteria for the Solos 10mm Operating Laparoscope itself.

Therefore, I cannot provide you with a table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details on ground truth for this device based on the provided text.

However, I can still elaborate on the limitations of this document regarding your request:

1. A table of acceptance criteria and the reported device performance: Not provided. The performance is assumed to be equivalent to the predicate device.
2. Sample sized used for the test set and the data provenance: Not provided. No new test set data is discussed in this letter for the Solos device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. No new ground truth establishment is discussed for the Solos device.
4. Adjudication method for the test set: Not provided.
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 laparoscope, not an AI-assisted diagnostic tool for "human readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a manual operating laparoscope, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided for the Solos device. The substantial equivalence is likely based on the predicate device's established performance and the Solos's design, materials, and intended use being comparable.
8. The sample size for the training set: Not provided. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not provided.

The crucial information here is that the FDA's decision is based on substantial equivalence to a predicate device, not on independent, new studies demonstrating specific acceptance criteria for the Solos 10mm Operating Laparoscope.

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