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.

Device Description

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.

AI/ML Overview

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.

Summary

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Surginetics™

4900 Pearl East Circle Suite 100 Boulder CO 80301 t: 303.339.9970 f:303.339.9969 www.surginetics.com

062350

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FEB 2 6 2007

October 12, 2006

510(k) SUMMARY

Contact Name:

Maneta Lollar, Director of Regulatory Affairs and Quality Assurance

Name of Device:

Surginetics AdvantageBlade™ Proprietary Name:

Classification Name: Electrosurgical Electrodes

Class II, Electrosurgical cutting and coagulation device and Classification: accessories, General and plastic surgery (21 CFR 878.4400)

GEI Product Code:

Intended Use

Product Description

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Statement of Substantial Equivalence

Surginetics AdvantageBlade is substantially equivalent in function and intended use to the following legally marketed devices:

Valleylab Uncoated E1551X 1.
Valleylab Coated E1450X EDGE 2.

For additional information see the information in Tables 1, A3-1, and A3-2.

Safety and Performance

1. Biocompatibility Testing

The biological safety of the Surginetics AdvantageBlade has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. The components of the blades have incidental short term contact with patient tissues at the surgical site.

Performance Testing 2.

Performance testing was performed on prototype Surginetics AdvantageBlade electrodes. The configuration is representative of the range of electrodes that will be available in coated form.

Testing that adjusted the power from an electrosurgical generator (a Valleylab Force FX) until a particular blade cut effectively was used to obtain most of the performance data. This test, which is called a Titrated Power Test because it adjusts the power until effective cutting occurs, was used to determine the power level at which effective cutting occurred, the amount of delay and drag during cutting, the amount of smoke produced, the amount of eschar accumulated, and the amount of tissue damage. The tissue sample used was fresh beef liver (about six hours old). Beef liver is used because its consistency and size enables high quality comparisons.

Another test, the Insulation Penetration Test, carefully placed a sharp penetrator on the insulated surface of a coated blade and then periodically increased the load on the penetrator and measured the time until the penetrator pushed through the insulating coating and contacted the underlying metal blade.

Electrode low power cutting �
The Surginetics AdvantageBlade starts cutting effectively at lower power than the predicate uncoated and coated blades. Refer to Table A3-1 for the test data.

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Initial delay/drag .
The Surginetics AdvantageBlade produced less drag at startup than the predicate uncoated and coated blades. Refer to Table A3-1 for the test data.
Electrode smoke plume production ●
The Surginetics AdvantageBlade produced less smoke than the predicate uncoated and coated blades. Refer to Table A3-1 for the test data.
Electrode eschar accumulation ●
The Surginetics AdvantageBlade produced less eschar than the predicate uncoated and coated blades. Refer to Table A3-1 for the test data.
Tissue damage ●
The Surginetics AdvantageBlade produced less tissue damage than the predicate uncoated and coated blades. Refer to Table A3-1 for the test data.
Coating penetration ●
The Surginetics AdvantageBlade demonstrated better mechanical integrity when subjected to mechanical penetration forces than the predicate coated blades. This characteristic is not germane for uncoated blades. Refer to Table A3-2 for the test data.

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Table A3-1Test Results for Titrated Power Test(Lower numbers are better)
	Power whencuttingstarted(WATTS)	Delay/DragScore	Smoke Score	Eschar Score	TissueDamageScore
ValleylabE1551X(uncoated)
Blade #1	15	60	48	48	46
Blade #2	15	10	45	42	46
Blade #3	15	10	45	42	46
Mean	15	27	46	44	46
ValleylabE1450XEDGE(coated)
Blade #1	25	200	49	52	46
Blade #2	20	50	40	30	46
Blade #3	20	70	35	25	46
Mean	21.7	107	41	36	46
SurgineticsAdvantageBlade
Blade #1	10	5	0	1	0
Blade #2	5	7	0	0	0
Blade #3	5	12	0	0	0
Mean	6.667	8	0	0	0

Some of the differences in the test results are large enough that it may appear that errors exist. That is not the case. Noticeable differences exist in the results. For example, the Delay/Drag score for Valleylab E1450X EDGE Blade #1 is 200 because that blade had more drag during both of the cuts made with it. Similarly, both Valleylab blades

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produced clouds of smoke and caused tissue damage (dark brown cooked tissue appearance) and the AdvantageBlade devices did not produce any smoke and left the tissue looking as if it had been cut with a sharp steel scalpel. Similar differences were noted in the Eschar scores.

The Delay/Drag scores for the AdvantageBlade electrodes are low because the blades gave the distinct impression of gliding through the tissue. The other blades produced delays at the start of cutting or dragged, or both.

Table A3-2Test Results for Insulation Penetration Test(Larger numbers are better)
	Elapsed Time untilInsulation Failed(Seconds)	Final Weight DrivingPenetrator(Grams)	Comments
ValleylabE1450XEDGE(coated)
Blade #1	0.1	7.33	Failed immediately
Blade #2	0.1	7.33	Failed immediately
Blade #3	0.1	7.33	Failed immediately
Mean	0.1	7.33
Std.Dev.	0	0
SurgineticsAdvantageBlade
Blade #1	200-stopped test	83	Never failed
Blade #2	200-stopped test	83	Never failed
Blade #3	200-stopped test	83	Never failed
Mean	200-stopped test	83
Std.Dev.	0	0

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The insulation penetration tests were carried out with meticulous care when the penetrator (an 18 gauge x 1.5 inch Monoject needle) was placed on the surface of the insulation of each blade. For example, the test fixture was configured so that it was never moved after the needle was positioned on the blade. This technique was used to prevent vibrating or otherwise causing motions that would induce the tip of the needle to work its way into the insulation and toward the metal portion of the blade. In spite of this great care, all of the Valleylab E1450X EDGE blades failed as soon as the tests started. The test results show the time being 0.1 seconds. That is the shortest time interval that the apparatus can measure. The weight of the needle and container above it that accumulates weight during the test run is 7.3 grams. Therefore, a time to failure of 0.1 seconds and a weight of 7.3 grams means that the needle's tip with no added weight penetrated the insulation within the few seconds it took to place the penetrator on the blade's surface and start the timer.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Surginetics % Ms. Maneta Lollar Director, Regulatory Affairs and Quality Assurance 4900 Pearl East Circle Suite 100 Boulder, Colorado 80301

FEB 2 6 2007

Re: K062350

Trade/Device Name: Surginetics AdvantageBlade™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 9, 2007 Received: February 12, 2007

Dear Ms. Lollar:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark M. Melkan

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Kob 2350

Indications for Use

510(k) Number (if known): Not assigned at this time.

Device Name: Surginetics AdvantageBlade™

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter-Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milken

(Division Sign-Off) (Division Sign-Off)
Division of General, Restorative,
Division of General, Devices Division of General Devices
and Neurological Devices V ( 510(k) Number_

510(k) Num

Regulation Number and Section

§ 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.