(199 days)
The Surginetics AdvantageBlade is intended as an alternative to uncoated stainless steel as well as coated electrodes for use in conventional monopolar electrosurgical accessories. The AdvantageBlade is intended for use in situations where monopolar electrosurgery is used.
The Surginetics AdvantageBlade™ coated electrodes are indicated for use in surgical procedures (general, neurosurgical, laparoscopic, orthopedic, gynecologic, etc.) where monopolar electrosurgical cutting and coagulation are normally used. The coated electrodes are an alternative to conventional monopolar electrosurgical electrodes used for these indications.
The Surginetics AdvantageBlade is a coated blade intended for use as a monopolar electrosurgical accessory. The blade reduces the smoke emitted into the surgical area, uses lower wattages with less tissue damage and the coating provides a surface that facilitates ease of cleaning of tissue residues that may accumulate during use. The coating provides for ease of eschar cleaning.
The blades are intended for use with monopolar electrosurgical accessories and will be packaged separately. The coated blades will also fit in currently marketed electrosurgical pencils offered by other manufacturers.
The provided document describes the performance testing for the Surginetics AdvantageBlade™, an electrosurgical device. Here's a breakdown of the requested information:
1. Acceptance Criteria and Reported Device Performance
The document presents performance data for several metrics, comparing the Surginetics AdvantageBlade™ to predicate devices (Valleylab Uncoated E1551X and Valleylab Coated E1450X EDGE). The acceptance criteria are implicitly defined as outperforming or matching the predicate devices across these metrics, with "lower numbers are better" for Titrated Power Test metrics and "larger numbers are better" for Insulation Penetration Test.
| Acceptance Criteria (Implicit) | Reported Device Performance (Surginetics AdvantageBlade™ Mean) | Predicate Device A (Valleylab E1551X Uncoated) Mean Performance | Predicate Device B (Valleylab E1450X EDGE Coated) Mean Performance |
|---|---|---|---|
| Titrated Power Test | |||
| Lower Power for Cutting | 6.667 WATTS | 15 WATTS | 21.7 WATTS |
| Less Delay/Drag | 8 Score | 27 Score | 107 Score |
| Less Smoke Production | 0 Score | 46 Score | 41 Score |
| Less Eschar Accumulation | 0 Score | 44 Score | 36 Score |
| Less Tissue Damage | 0 Score | 46 Score | 46 Score |
| Insulation Penetration Test | |||
| Greater Insulation Integrity | 200 seconds (test stopped) & 83 grams | Not applicable (uncoated) | 0.1 seconds & 7.33 grams |
2. Sample Size and Data Provenance
- Sample Size (Test Set): For both the Titrated Power Test and the Insulation Penetration Test, 3 blades were tested for each device type (Surginetics AdvantageBlade™, Valleylab Uncoated, and Valleylab Coated).
- Data Provenance: The data appears to be prospective and generated from laboratory testing ("Performance testing was performed on prototype Surginetics AdvantageBlade electrodes"). The document does not specify the country of origin of the data beyond "Surginetics™ 4900 Pearl East Circle Suite 100 Boulder CO 80301". The tissue sample used was fresh beef liver, implying in-vitro testing.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts used or their qualifications to establish ground truth for the test set. Instead, the "scores" (Delay/Drag, Smoke, Eschar, Tissue Damage) appear to be subjective assessments made during the tests, potentially by the testing personnel, but without declared expertise. The comments for each metric (e.g., "produced clouds of smoke," "dark brown cooked tissue appearance," "gliding through the tissue") suggest observational scoring rather than expert consensus using a predefined rubric by multiple qualified professionals.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for the test set. Given the subjective nature of the scoring (e.g., "Smoke Score," "Eschar Score"), it's unclear how consistency was ensured if multiple individuals were involved in scoring.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on device performance metrics (cutting power, smoke, eschar, tissue damage, insulation integrity) rather than human reader accuracy or improvement with AI assistance. The device is an electrosurgical blade, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done. The entire study described focuses on the direct performance of the electrosurgical blades themselves, without any human-in-the-loop interaction in the context of interpretation or decision-making. The measurements (power, scores, time to failure) are direct observations of the device's physical interaction with tissue and its material properties.
7. Type of Ground Truth Used
The ground truth used in this study is based on:
- Observed physical phenomena and measurements:
- Titrated Power Test: Power settings at which effective cutting started, subjective scores for delay/drag, smoke production, eschar accumulation, and tissue damage appearance. These scores are presented as quantitative values, but their underlying generation appears to be observational.
- Insulation Penetration Test: Measured time (seconds) until insulation failure and the final weight (grams) driving the penetrator. This is a direct physical measurement.
- The "ground truth" is established by the test procedures themselves and the subsequent scoring/measurement of the outcomes. There is no mention of external validation against pathology results or clinical outcomes.
8. Sample Size for the Training Set
The document does not mention a training set. This type of study focuses on characterizing the performance of a physical medical device (electrosurgical blade) through engineering and materials testing, not a machine learning algorithm. Therefore, the concept of a "training set" for an algorithm is not applicable here. The "prototype Surginetics AdvantageBlade electrodes" used for testing could be considered part of the development and refinement process, but they are not characterized as a "training set" in the sense of AI/ML.
9. How the Ground Truth for the Training Set was Established
As there is no training set for an algorithm, the question of how ground truth for a training set was established is not applicable.
§ 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.