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The Endius Suction /Irrigation Device is intended to be used to irrigate/aspirate fluids during Endoscopic and open spinal surgical procedures.

The Endius Endoscopic Irrigation/ Suction Device is intended to be used to irrigate and aspirate fluids during Endoscopic and open spinal Procedures and therefore to assist in the visualization. The device consists of a single -use disposable tubing set/trumpet valve which is intended to be attached to a re-usable suction/irrigation attachment.

The provided documents do not contain information regarding the acceptance criteria, specific studies, or detailed performance data for the Endius Suction/Irrigation Device that would allow for a comprehensive answer to all parts of your request.

The documents are primarily an FDA 510(k) clearance letter and a 510(k) summary, which focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed study results against specific acceptance criteria.

Here's what can be extracted and what cannot:

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

• Cannot be provided. The document does not list specific acceptance criteria for performance, nor does it report detailed performance metrics. The 510(k) summary provides a comparison table of the Endius device with the predicate device (EndoSI™ Suction/Irrigation Device) based on features like intended use, materials, sterilization, product labeling, and packaging. This table highlights similarities and minor differences, but it doesn't quantify performance against acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The documents do not describe any specific testing with a 'test set' in the context of clinical or performance studies with sample sizes. The 510(k) process primarily relies on demonstrating substantial equivalence, often through design and functional comparisons, and sometimes non-clinical (e.g., bench) testing, rather than large-scale clinical trials.

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)

• Cannot be provided. The documents do not mention any studies involving experts establishing ground truth for a test set.

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

• Cannot be provided. No information on adjudication methods for a test set is present.

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

• Cannot be provided. The device is a "Suction/Irrigation Device" used in surgical procedures, not an AI-powered diagnostic or imaging interpretation tool. Therefore, MRMC studies involving human readers and AI assistance are not applicable and are not mentioned.

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

• Cannot be provided. This device is a physical instrument for suction and irrigation during surgery, not an algorithm. Standalone algorithm performance is not relevant.

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

• Cannot be provided. Since no specific performance studies or clinical trials are detailed, there is no mention of ground truth establishment. The substantial equivalence largely relies on comparing design, materials, and intended use with the predicate device, assuming the predicate's effectiveness and safety are established.

8. The sample size for the training set

• Cannot be provided. This device is a physical medical instrument, not an AI model that requires a training set.

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

• Cannot be provided. As above, a training set and its ground truth are not applicable to this type of device.

Summary of what the documents do provide:

• Device Name: Endius Suction/Irrigation Device
• Intended Use: To irrigate and aspirate fluid during Endoscopic and open spinal procedures.
• Predicate Device: EndoSI™ Suction/Irrigation Trumpet Valve and Accessories
• Comparison: The 510(k) summary provides a table comparing the Endius device to the predicate based on intended use (expanded to spinal procedures for Endius), materials (PVC, ABS, Delrin for Endius vs. PVC, ABS for predicate), sterilization (gamma irradiation for both), product labeling (sterility and re-usability difference for the attachment part), and packaging.
• Substantial Equivalence: The FDA determined the Endius device is substantially equivalent to the predicate device. This determination is based on the comparison provided in the 510(k) submission, suggesting that the differences do not raise new questions of safety or effectiveness.

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