(94 days)
Valleylab Coated Electrodes are intended as an alternative to uncoated stainless steel electrodes or "non-stick" coated electrodes for use in conventional monopolar electrosurgical accessories. The Coated Electrodes are intended for use in situations where monopolar electrosurgical cutting and coagulation are normally used.
The Valleylab Coated Electrodes are modifications of Valleylab's line of singleuse electrodes that includes various tip configurations. The coating provides a non-stick surface for easier cleaning of eschar during electrosurgery.
The electrodes are intended for use with monopolar electrosurgical accessories, and will be packaged separately as well as in combination with Valleylab electrosurgical pencils. The Coated Electrodes will also fit in currently marketed electrosurgical pencils offered by other manufacturers.
The provided text describes safety and performance testing for a medical device (Valleylab Coated Electrodes) for regulatory submission (K962044). However, it does not contain the level of detail typically found in a study for evaluating AI/ML-based medical devices or diagnostic tools. Therefore, I will extract and infer information where possible based on the text provided, but many requested fields will be unanswerable or only partially answerable due to the nature of the original document.
Here's an attempt to answer your request based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|
| Biocompatibility: Materials demonstrate appropriate levels of biocompatibility. | Assured through selection of materials. |
| Cleanability: Retain easy-to-clean properties for a longer period of use compared to other electrodes. | Retained easy-to-clean properties for a longer period than other coated electrodes or standard uncoated stainless steel electrodes tested. |
| Durability: Withstand bending without coating cracking. | Bent to a maximum of 90 degrees ten times or until failure of the steel blade, without visible cracking of the coating. |
| Cut Performance: Initiate cutting immediately and cut more readily and consistently than "non-stick" coated blades at various power settings. | Initiates cutting immediately and continues to cut more readily and consistently than "non-stick" coated blades at both lower and higher power settings. |
| Pre-Clinical Performance: Equal or superior surgeon rating compared to other coated blades. | Surgeons rated the performance equal or superior to other coated blades tested. |
2. Sample sizes used for the test set and the data provenance
- Sample Size for performance testing: The text mentions "prototype Valleylab Coated Electrodes (blade configuration)" were tested, which is "representative of the range of electrodes". It does not specify the exact number of prototypes or individual electrodes tested.
- Data Provenance: The preclinical trials were conducted "in swine." The location is not specified. The testing appears to be prospective as it involves new prototypes and pre-clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not explicitly stated for performance or bendability tests. For the pre-clinical trials, it generally refers to "surgeons." The number is not specified.
- Qualifications of experts: Only stated as "surgeons" for the pre-clinical trials. No specific experience or specialization is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication method: Not described. The evaluations seem to be direct observations or qualitative assessments (e.g., "rated the performance").
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
- MRMC Study: No. This document is for a physical medical device (electrocautery electrodes), not an AI-based diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithm or software device. Performance tests were done on the physical electrode.
7. The type of ground truth used
- Ground Truth:
- Biocompatibility: Based on materials selection and likely adherence to established biocompatibility standards.
- Cleanability: Comparative observations and possibly objective measurements of cleaning effort, but not explicitly stated.
- Durability (Bendability): Direct observation of physical failure (cracking) during mechanical stress.
- Cut Performance: Comparative observations of cutting initiation and consistency.
- Pre-Clinical Performance: Expert (surgeon) consensus/rating during in-vivo (swine) procedures.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This document describes testing for a physical device, not an AI/ML model that requires a training set. The prototypes used for testing represent the "product developed."
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for a physical medical device in this context.
§ 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.