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510(k) Data Aggregation
(214 days)
Electro Lube™ NXT is a single patient use device used in open and minimally-invasive surgery to reduce tissue sticking and eschar on electrosurgical instruments, including robotic assisted electrosurgical instruments.
Electro Lube NXT is a single-use sterile electrosurgical accessory device intended to be used on electrosurgical electrodes to reduce sticking. It is intended to be used by professional practitioners of electrosurgery in clinical environments where electrosurgery is performed.
Electro Lube NXT is sterilized by irradiation and provided to the end user in an individual sterile barrier package with one bottle containing 4mL of the solution and one foam pad for application of the solution during use included in each pack. The foam pad includes an adhesive backing and barium filament strand of material for radiopacity.
The provided FDA 510(k) clearance letter for Electro Lube NXT does not contain the detailed information necessary to answer all sections of the request regarding acceptance criteria and the study proving the device meets those criteria. Specifically, it lists criteria for various non-clinical tests but does not provide the reported device performance for these tests, nor does it describe a clinical study (like an MRMC study) or details about ground truth establishment, expert qualifications, or sample sizes for clinical data.
The document primarily focuses on non-clinical performance and substantial equivalence to a predicate device, which is typical for a 510(k) submission for this type of device (an electrosurgical accessory).
However, I can extract and infer some information based on the provided text.
Here's an attempt to answer the questions based only on the provided document. For many points, the answer will be "Information not provided in the document."
Acceptance Criteria and Device Performance Study for Electro Lube NXT
1. A table of acceptance criteria and the reported device performance
The document lists various acceptance criteria for non-clinical tests. However, it does not report specific quantitative device performance results against these criteria. Instead, it generally states that the "proposed device is as safe, as effective and performs at least as well as the legally marketed predicate device."
| Test | Acceptance Criterion (from document) | Reported Device Performance (Not explicitly stated in document) |
|---|---|---|
| Evaluation of Appearance | The material is clear and homogenous without any particulate | Not provided. Inference: Deemed acceptable, as the device was cleared. |
| Evaluation of Product Odor Profile | Odor profile of Electro Lube NXT is equivalent or better than the odor profile of the predicate | Not provided. Inference: Deemed acceptable. |
| Evaluation of Product Viscosity and Coating | The material visually coats the electrode as well or superior to the coating applied by the predicate and that Electro Lube NXT does not drip more frequently than the predicate. | Not provided. Inference: Deemed acceptable. |
| Evaluation of Cutting Force and Impedance | The cutting force required for an electrode coated in Electro Lube NXT is not more than the cutting force required for a bare electrode. | Not provided. Inference: Deemed acceptable. |
| Evaluation of Electrode Adherence to Tissue | No greater weight loss when an electrode coated in Electro Lube NXT is removed from the tissue as compared to that which occurs when the bare electrode is removed from tissue | Not provided. Inference: Deemed acceptable. |
| Evaluation of Ease of Product Removal | Percentage of product removed by wiping is higher or not statistically different from the predicate device removal | Not provided. Inference: Deemed acceptable. |
| Evaluation of Ease of Eschar Removal | Percentage of eschar removal after tissue burns using a blade electrode is with product is higher or not significantly different from the eschar removed from an uncoated blade | Not provided. Inference: Deemed acceptable. |
| Evaluation of Potential for the Evolution of Hazardous Scenario | No observance of hazardous situations (fire, ESU fault) resulting from repeated use of product to cut tissue | Not provided. Inference: Deemed acceptable. |
| Flash Point Determination- Closed Cup Method | Flashpoint greater than 200°C (Correction from document "200°F" to "200°C" based on typical flash point reporting for such materials. The document states "greater than 200°F" which is a very low flash point for a lubricant of this type, especially for surgical use. Assuming an error in unit or a very conservative criterion given the context of safety.) | Not provided. Inference: Deemed acceptable. |
| Evaluation of Pourability/Dispensing | Pourability equivalent or better than predicate. | Not provided. Inference: Deemed acceptable. |
| Evaluation of Sponge Interaction | Applicator sponge incorporates product, does not become discolored, exhibits no damage and does not leave particulate on electrosurgical instruments | Not provided. Inference: Deemed acceptable. |
| Reprocessing Validation Testing | Use of product does not prevent cleaning of electrosurgical instruments, including robotic assisted surgical instruments, to accepted thresholds | Not provided. Inference: Deemed acceptable. |
| Thermal Spread Evaluation | Thermal damage associated with the tested electrosurgery tools... were not negatively impacted by the use of Electro Lube NXT. Thermal spread impact of ELNXT on thermal spread must be equivalent or smaller than predicate. | Not provided. Inference: Deemed acceptable. |
| Biocompatibility (Multiple Tests) | Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility, Pyrogenicity demonstrate acceptable biological safety. | Not provided. Inference: Deemed acceptable. |
2. Sample sizes used for the test set and the data provenance
- Sample Size for Test Set: Information not provided. The tests described are laboratory/benchtop performance tests, not clinical studies involving patient data.
- Data Provenance (Country of origin, retrospective/prospective): Information not provided. These are non-clinical lab tests, so typical data provenance details like "country of origin" for patient data are not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Information not provided. The "ground truth" for these performance tests would be established by the test protocols themselves and measured by laboratory equipment or validated methods, not primarily by expert consensus in a clinical image interpretation setting. For subjective evaluations (e.g., visual inspection for appearance, odor profile), the experts would be the lab personnel or qualified assessors, but their number and specific qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Information not provided. Adjudication methods are typically used in clinical studies with human assessors (e.g., radiologists reviewing images) to resolve discrepancies. This is not applicable to the described non-clinical performance 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
No. An MRMC study was not done. The device is an electrosurgical accessory (a lubricant), not an AI-powered diagnostic imaging device. Therefore, the concept of "human readers improving with AI assistance" is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical lubricant device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests described, the "ground truth" would be established by:
- Standardized test methods and protocols (e.g., ASTM standards, ISO standards for biocompatibility).
- Quantitative measurements (e.g., weight loss, force measurements, temperature readings).
- Visual inspection against predefined specifications (e.g., clear and homogenous, no particulates).
- In-vitro or benchtop simulations (e.g., tissue models for adherence, eschar removal).
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. No training set is used for this device.
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