The AT2 System utilizes monopolar radiofrequency energy for coagulation and to induce tissue changes in dermatologic and general surgical procedures. It consists of a RF generator, cooling module, handpiece, and sterile disposable single-patient use treatment electrodes. It uses accessories including coupling fluid, return pad, coolant canister, and skin marking paper. The AT2 System applies to specific areas of the body radiofrequency energy while cooling the surface of the tissue in contact with the treatment electrode and uses dielectric as the method of applying radiofrequency via the treatment electrode. This submission adds treatment electrodes that have electrode patient contact surface area of 0.25cm² and 1.50cm².

AI/ML Overview

This document, K120527, is a 510(k) summary for the Alpha Orthopaedics AT2 System. It's a submission for an electrosurgical device and largely focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed clinical study demonstrating new performance criteria for this specific submission.

Therefore, many of the typical elements expected in a clinical study for a diagnostic AI device (like acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details) are not present in this type of regulatory submission.

The submission aims to show that the new variations of the AT2 System (with specific electrode sizes) are as safe and effective as previously cleared versions and other legally marketed predicate devices, primarily through technological characteristic comparisons and non-clinical testing.

Here's a breakdown of the information that can be extracted, and an explanation of why other requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

This section is not applicable in the context of this 510(k) submission as it's not a clinical study to prove new performance criteria. The submission aims to demonstrate substantial equivalence based on technological characteristics and existing performance of the predicate devices.

The "performance" described leans towards the device's operational principles and safety testing, not diagnostic accuracy.

Feature	Acceptance Criteria (Implied by Equivalence)	Reported Device Performance (as described for Substantial Equivalence)
Intended Use	Same as predicate devices: Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.	The AT2 System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis (matches predicate).
Operational Principle	Same as predicate devices: Delivers RF energy while cooling the surface of tissue.	The system delivers RF energy while cooling the surface of the tissue in contact with the treatment electrode (identical to predicate).
Modes	Same as predicate devices: Monopolar/Bipolar.	Monopolar/Bipolar (identical to predicate).
Capacitive/Inductive	Same as predicate devices: Capacitive.	Capacitive (identical to predicate).
Operating Frequency	Same as predicate devices: 6 MHz.	6 MHz (identical to predicate).
Treatment Electrodes	Same properties as predicate devices: Sterile, disposable, single patient use.	Sterile, disposable, single patient use. This submission adds 0.25cm² and 1.50cm² electrodes, implying these new sizes maintain the same safety/effectiveness characteristics as existing ones.
Tuning	Same as predicate devices: Built-in RF Generator tuning, automated, software-controlled.	Tuning function built into RF Generator and automated Process is software controlled (identical to predicate).
Safety	Meets general safety standards and performance of predicate devices.	Biocompatibility, EMC, safety, and bench tests have been completed. (Details of these tests are not provided in the summary).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. This submission doesn't describe a clinical "test set" in the sense of a dataset used to evaluate diagnostic performance. The evaluation is primarily based on technological comparison, bench testing, and biocompatibility.
Data Provenance: Not applicable for a clinical test set. The data presented relates to the device's design, operational principles, and results of non-clinical bench testing. No country of origin for clinical data is mentioned because no clinical data is presented for performance evaluation. The submission refers to the predicate devices (K031046 and K082956) as the basis for established safety and effectiveness. The study's design is "retrospective" in the sense that it relies on previously accepted devices and standards, but it's not a retrospective clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Number of Experts: Not applicable. No clinical test set requiring expert ground truth is described.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No clinical test set is described.

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 device is an electrosurgical tool, not an AI-assisted diagnostic or therapeutic device that would typically involve human readers interpreting images or data. Therefore, an MRMC study is 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 device is a hardware-based electrosurgical system. It doesn't rely on an "algorithm only" performance evaluation in the way an AI diagnostic tool would. Its performance is tied directly to its physical operation and the energy delivery.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: Not applicable in the context of this 510(k). The "truth" being established is that the device, with its new electrode sizes, is substantially equivalent in safety and effectiveness to the predicate devices, based on a comparison of technological characteristics and non-clinical testing (biocompatibility, EMC, safety, bench tests).

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Training Set Ground Truth: Not applicable.

Summary

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alpha orthopaedics

JUN 1 8 2012

510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.

1. General Information

Date Summary Prepared: May 31, 2012

Submitted by:	Alpha Orthopaedics, Inc.7700 Edgewater Drive, Suite #405Oakland, CA 94621Phone: (510) 969-7323Fax: (510) 969-7203
Contact name:	Gina ToVice President, Regulatory/Quality

2. Name of Device

Trade Name:	Alpha Orthopaedics AT2 System
Common Name:	Electrosurgical cutting and coagulation device and accessories
Classification:	Product code GEI, Class II, CFR §878.4400

3. Legally Marketed Predicate Devices for Claimed Equivalence

K031046 Thermage ThermaCool TC System: primary predicate device for . substantial equivalence claim
K082956 Alpha Orthopaedics AT2 System: predicate device for substantial . equivalence claim

4. Device Description

5. Intended Use

The AT2 System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

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Image /page/1/Picture/1 description: The image shows the logo for Alpha Orthopaedics. The logo consists of a stylized letter "a" followed by the words "alpha orthopaedics" in a simple, sans-serif font. The logo is black and white.

6. Technological Characteristics

The technological characteristics of the AT2 System, including treatment electrodes, are identical to the Thermage ThermaCool TC System, as follows:

Operational principle:	The system delivers RF energy while cooling the surface of the tissue in contact with the treatment electrode
Modes:	Monopolar/Bipolar
Capacitive vs. Inductive:	Capacitive
Operating Frequency:	6 MHz
Treatment Electrodes:	Sterile, disposable, single patient use
Tuning	Tuning function built into RF Generator and automated Process is software controlled.

· 7. Substantial Equivalence

The AT2 System with the addition of 0.25cm² and 1.50cm² treatment electrodes has the same intended use and the same technological characteristics as the legally marketed predicate device cleared under K031046 and K082956.

8. Summary of Performance Testing

Biocompatibility, EMC, safety, and bench tests have been completed. The technological characteristics demonstrate that the Alpha Orthopaedics AT2 System is as safe, as effective, and performs as well as the legally marketed predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

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

Alpha Orthopaedics, Incorporated % Ms. Gina To 7700 Edgewater Drive Suite 405 Oakland, California 94621

Re: K120527

Trade/Device Name: Alpha Orthopaedics AT2 System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 31, 2012 Received: June 5, 2012

JUN 1 8 2012

Dear Ms. To:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

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

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Page 2 - Ms. Gina To

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 (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.

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

ely yours,

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

Enclosure

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Indications for Use

510(k) Number (if known): K120527

Device Name: Alpha Orthopaedics AT2 System

Indications for Use:

The AT2 System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

Prescription Use × (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)

Signature of

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

K120527 510(k) Number .

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.