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510(k) Data Aggregation
(56 days)
The Codman Electrosurgical Irrigator is indicated to provide flow of irrigation fluid to the tips of bipolar irrigating forceps during electrosurgery.
The Codman Electrosurgical Irrigator is a reusable, non-sterile electrosurgical device, for use in electrosurgery to deliver irrigation fluid to tissue. The irrigator is part of an electrosurgical system consisting of an electrosurgical generator connected via an interconnecting cable, and a pair of bipolar irrigating forceps connected via a cord and tubing set.
This document describes the premarket notification (510(k)) for the Codman Electrosurgical Irrigator. It covers the device's indications for use, comparison to a predicate device, and performance data. However, it does not contain the detailed information requested regarding the acceptance criteria and study proving a device meets those criteria for software or AI-based devices. The device described in this 510(k) is an electrosurgical irrigator, which is a physical medical device, not an AI or software product that would typically involve acceptance criteria related to accuracy, sensitivity, or specificity.
Therefore, many of the requested categories are Not Applicable in this context.
Here's a breakdown based on the provided document:
1. Table of acceptance criteria and the reported device performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Bench Testing | Pass requirements | Pass |
| Design Verification Testing | Pass requirements | Pass |
| Flow Accuracy Testing | Pass requirements | Pass |
| Summative Study | Pass requirements | Pass |
| Nurse Design Validation Study | Pass requirements | Pass |
| Surgeon Design Validation Study | Pass requirements | Pass |
| Software Testing | Pass requirements | Pass |
| Software Unit Verification Testing | Pass requirements | Pass |
| Software Integration and System Verification Testing | Pass requirements | Pass |
| Electrical Safety/EMC Testing | Pass specified standards | Pass |
| IEC 60601-1:2005/A1:2012/C1:2012, Edition 3.1 | Pass the standard | Pass |
| IEC 60601-1-2:2014, Edition 4.0 | Pass the standard | Pass |
| Sterilization | (Not applicable, non-sterile) | (Not applicable) |
| Cleaning Validation | Support cleaning instructions | Performed |
| Shelf-Life Testing | (Not applicable, reusable) | (Not applicable) |
| Biocompatibility Testing | (Not applicable, non-patient contacting) | (Not applicable) |
The document states "All testing was performed on final devices" and provides "Conclusion: Pass" for each listed test, implying that the devices met their respective acceptance criteria. Specific numerical acceptance criteria (e.g., "flow rate within +/- 5%") are not explicitly stated in this summary.
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for the "Design Verification Testing," "Flow Accuracy Testing," "Summative Study," "Nurse Design Validation Study," or "Surgeon Design Validation Study." Given the nature of a 510(k) summary for a physical electrosurgical irrigator, "test set" does not refer to a dataset like in AI/software. The testing involved physical devices. No data provenance in terms of country of origin or retrospective/prospective is relevant for this type of device testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The device is a physical irrigator. Ground truth in the context of expert review for AI/software assessment is not relevant. The "Nurse Design Validation Study" and "Surgeon Design Validation Study" imply involvement of relevant healthcare professionals, but specifics on their number or qualifications for establishing "ground truth" are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device premarket submission. The testing involved performance studies of a physical device.
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 is not an AI/software device and does not involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this physical device, "ground truth" would refer to measured physical properties (e.g., flow rate, electrical safety parameters) rather than clinical interpretations requiring expert consensus or pathology.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI model.
In summary: The provided document is a 510(k) summary for a physical medical device (Codman Electrosurgical Irrigator). The requests for information largely pertain to AI/software performance studies and are therefore not applicable to this submission. The document confirms that the device passed various bench, software (for its control functions), and electrical safety tests, supporting its substantial equivalence to a predicate device.
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