(157 days)
Reprocessed electrosurgical electrodes are intended for precision cutting, dissecting and cauterizing soft tissue. These devices are most commonly used in surgical procedures for which minimal tissue necrosis, bleeding, and surgical field smoke is desired.
SterilMed's reprocessed electrosurgical electrodes are a monopolar electrosurgical instruments consisting of a tungsten tip, stainless steel housing, and several layers of insulation.
The provided text is a 510(k) summary for SterilMed's Reprocessed Electrosurgical Electrodes. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study with specific acceptance criteria and performance metrics for a novel AI/software device.
Therefore, many of the requested items (e.g., AI performance metrics, sample sizes for training/test sets, expert adjudication methods, MRMC studies) are not applicable to this submission.
Here's an analysis of the available information:
Device: SterilMed Reprocessed Electrosurgical Electrodes
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" in this context refers to demonstrating that the reprocessed device performs comparably to new, equivalent devices and meets safety standards for reuse. The submission emphasizes substantial equivalence rather than numerical performance against specific criteria.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence (e.g., cutting, cauterizing ability) | "Representative samples of reprocessed electrosurgical electrodes underwent bench testing to demonstrate appropriate functional characteristics." |
| "The subject device is identical to their predicate device in terms of functional design... and principles of operation." | |
| Cleaning and Sterilization Effectiveness (Safety) | "Process validation testing was done to validate the cleaning and sterilization procedures..." |
| Packaging Integrity (Safety) | "...as well as the device's packaging." |
| Visual and Functional Inspection (Quality Control) | "In addition, the manufacturing process includes visual and functional testing of all products produced." |
| Substantial Equivalence to Predicate Devices | The FDA concurred with the finding of substantial equivalence to: |
| • The Colorado Micro-Dissection Needle manufactured by Stryker Leibinger / Colorado Biomedical Inc (K000348) | |
| • Similar devices from other manufacturers | |
| This equivalence is based on "functional design, materials, indications for use, and principles of operation." |
2. Sample size used for the test set and the data provenance
The document indicates "representative samples" were used for bench testing. It does not specify a numerical sample size for these tests. Data provenance (country of origin, retrospective/prospective) is not mentioned, as this is a reprocessed medical device submission, not a clinical study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission doesn't involve establishing ground truth from expert interpretations of medical images or data. The "ground truth" here is the functional performance and safety of the reprocessed device, assessed through bench testing and process validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a study assessing interpretations of medical data. The evaluation is based on engineering and quality control tests.
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 an electrosurgical electrode, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance and safety is established through:
- Bench testing: Verifying functional characteristics (e.g., cutting ability).
- Process validation: Confirming the efficacy of cleaning, sterilization, and packaging procedures.
- Comparison to predicate devices: Demonstrating consistency in design, materials, and intended use.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for this type of device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.