The PEAK PlasmaBlade® 3.0S Tissue Dissection Device is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.

Device Description

The PEAK PlasmaBlade® 3.0S consists of a single insulated bendable blade. telescoping shaft that can be configured in both standard and extended length and a handle with integrated controls and cable. The finger grip also incorporates a suction lumen for the evacuation of smoke and fluids. The PlasmaBlade 3.0S is an addition to the PEAK PlasmaBlade Family of Tissue Dissection devices which include the PlasmaBlade 4.0, PlasmaBlade Needle, and PlasmaBlade EXT.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (PEAK PlasmaBlade® 3.0S) and largely focuses on regulatory approval based on substantial equivalence to a predicate device. It explicitly states that "Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria."

However, the document does not contain the detailed information required to fill out your request, which pertains to a specific study demonstrating the device meets acceptance criteria. This type of information is usually found in a detailed study report, not a 510(k) summary.

Here's a breakdown of what can be inferred or directly stated from the text, and what is missing:

Acceptance Criteria/Reported Performance: The document states "Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications." However, no specific acceptance criteria or quantitative performance metrics are provided. The core argument for approval is substantial equivalence to the predicate device (PEAK PlasmaBlade® 4.0), implying that if the predicate met its criteria, this device would also.
Study Details: The document mentions "Laboratory and performance tests," but does not describe a specific study with the required details like sample size, data provenance, ground truth establishment, or expert involvement.

Therefore, most of the requested table and information cannot be directly extracted from the provided text.

In summary, based only on the provided text, here's what can be answered and what cannot:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Not specified	"functioned as intended and met design specifications" (details not provided)
"substantially equivalent to the predicate device"	"Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria."

Detailed Study Information:

Sample size used for the test set and the data provenance:
- Information Not Provided. The document only generally refers to "Laboratory and performance tests."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Information Not Provided. The document does not describe the establishment of ground truth for any tests, nor the involvement of experts beyond the company's internal testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Information Not Provided.
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, and this device is not an AI/imaging device. The device is an electrosurgical cutting and coagulation device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical instrument, not an algorithm. Performance tests would be standalone in the sense they evaluate the instrument itself, but not in the context of an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Information Not Provided directly. Given the nature of the device (electrosurgical instrument), "ground truth" would likely be defined by engineering specifications, material properties, and functional performance benchmarks (e.g., cutting depth, coagulation effectiveness on tissue proxies, safety parameters like temperature increase). However, the specific methodology is not described.
The sample size for the training set:
- Not applicable/Information Not Provided. As this is not an AI/machine learning device, there isn't a "training set" in the conventional sense. Any internal developmental testing data would precede the performance tests mentioned.
How the ground truth for the training set was established:
- Not applicable/Information Not Provided. (See point 7)

Summary

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1093695-

510(k) Summary for PEAK PlasmaBlade® 3.0S

1. Submitter Name and Address:

APR 1 8 2010

PEAK Surgical, Inc. 2464 Embarcadero Way Palo Alto, CA 94303 Phone: 650-331-3020 Fax: 650-331-3293

Contact: Lois Nakayama

January 18, 2010 Date prepared:

2. Device Name:

Trade Name:	PEAK PlasmaBlade® 3.0S
Common Name:	Electrosurgical Device and Accessories
Classification Name:	Electrosurgical Cutting and Coagulation Device andAccessories
Regulation Number:	21 CFR § 878.4400
Product Code:	GEI
Regulatory Class:	Class II

3. Predicate Devices:

PEAK PlasmaBlade® 4.0 (K082786)

4. Device Description:

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The PlasmaBlade 3.0S is an addition to the PEAK PlasmaBlade Family of Tissue Dissection devices which include the PlasmaBlade 4.0, PlasmaBlade Needle, and PlasmaBlade EXT.

ડ. Intended Use:

The PEAK PlasmaBlade® 3.0S is indicated for cutting and coagulation of soft tissue during General, Plastic and reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.

Technological Characteristics 6.

The PEAK PlasmaBlade® 3.0S is similar to the predicate device in output energy, delivery system and materials. They are both electrosurgical instruments used to cut and coagulate soft tissue, utilizing RF powered distal ends. The modifications to the electrode, shaft and finger grip do not significantly affect the safety or effectiveness of the device.

7. Performance Data:

Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria.

8. Sterilization

...

The PEAK PlasmaBlade® 3.0 is provided sterile. The device is not intended for reuse or resterilization.

9. Conclusion:

By virtue of design, technology, principle of operation and intended use, the PEAK PlasmaBlade® 3.0S is substantially equivalent to the predicate device. In establishing substantial equivalence to the predicate device, PEAK Surgical evaluated the indications for use, materials incorporated, product specification and energy requirements of the device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 25 2010

PEAK Surgical, Inc. % Ms. Lois Nakayama 2464 Embarcadero Way Palo Alto, California 94303

Re: K093695

Trade/Device Name: PEAK PlasmaBlade® 3.0S Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 26, 2010 Received: March 29, 2010

Dear Ms. Nakayama:

This letter corrects our substantially equivalent letter of April 13, 2010.

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 (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 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.

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Page 2 - Ms. Lois Nakayama

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Aluh A. Millan

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

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Indications for Use

510(k) Number (if known):

K093695

Device Name: PEAK PlasmaBlade® 3.0S

Indications for Use:

ivision Sigh Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093695

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)

PEAK Surgical, Inc. Special 510(k): Device Modification-PlasmaBlade 3.0S November 27, 2009

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.