The radiofrequency-energy only delivery components of the Alpha Orthopaedics AT3 System are indicated for use in general surgical procedures for electrocoagulation and hemostasis.

The simultaneous application of radiofrequency energy and skin vibration by the Alpha Orthopaedics AT3 System is indicated for use in:

General surgical procedures for electrocoagulation and hemostasis .
. Relief of minor muscle aches and pain
. Relief of muscle spasms
Temporary improvement of local circulation (i.e., blood circulation) .

Device Description

The AT3™ System delivers RF energy while cooling tissue by conduction. Components and accessories include the handpiece with vibration, return pad, electronic footswitch (optional), cryogen canister, coupling fluid, skin marking paper, and treatment electrodes.

AI/ML Overview

The provided text is a 510(k) Summary for the Alpha Orthopaedics AT3™ System. It focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than describing a specific study with acceptance criteria and detailed performance metrics as one might find for a novel diagnostic or AI-driven device.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not present in this document.

Here's a breakdown of what can be extracted or inferred based on the provided text, and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (Summary Statement)
Safety: Demonstrated through performance, EMC, and safety testing.	"Performance, EMC, safety, and software testing have been completed."
Effectiveness: Demonstrated through performance testing and similar technological characteristics to predicate devices.	"The technological characteristics and the results of the performance data demonstrate that the Alpha Orthopaedics AT3 System is safe and effective..."
Technological Characteristics: Similar to predicate devices.	"The technological characteristics of the AT3 System are same as the Thermage ThermaCool NXT System."
Intended Use: Matches or is substantially similar to predicate devices.	The stated "Intended Use" aligns with general surgical procedures for electrocoagulation and hemostasis, and with the additional uses (minor muscle aches/pain, muscle spasms, local circulation improvement) likely covered by the predicate devices or deemed appropriate for the technology.

Missing: Specific quantitative acceptance criteria (e.g., specific thresholds for rise in temperature, lesion size, power output within a certain tolerance), and detailed performance metrics (e.g., actual values for power output, temperature, tissue impedance, or a success rate for a specific clinical outcome). The document only states that testing was "completed" and that the device is "safe and effective."

2. Sample size used for the test set and the data provenance

Missing: The document does not describe a clinical "test set" in the context of a study evaluating clinical performance or an AI algorithm. The performance testing mentioned likely refers to bench testing, engineering verification, and validation, not necessarily patient data. Therefore, sample size and data provenance are not applicable or provided in this type of submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Missing: This information is not relevant to a 510(k) submission based on substantial equivalence for an electrosurgical device, which primarily relies on engineering and safety testing. No "ground truth" using human expert review, as would be common for diagnostic AI, is mentioned.

4. Adjudication method for the test set

Missing: Not applicable for this type of device and submission.

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

Missing: This information is not applicable. The Alpha Orthopaedics AT3™ System is an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic tool for human readers. There is no mention of AI in the general sense, and specifically no MRMC studies or human reader improvement.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Missing: Not applicable. The device is a physical electrosurgical system, not a standalone algorithm.

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

Missing: No "ground truth" in the clinical sense (like pathology or outcomes data) is described for product performance. The ground truth for this type of device would typically be established by established engineering standards, biophysical principles of RF energy, and comparison to the known performance of predicate devices through bench testing.

8. The sample size for the training set

Missing: Not applicable. The device is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

Missing: Not applicable. The device is not an AI algorithm requiring a training set.

In summary: The provided 510(k) summary is a regulatory document focused on demonstrating "substantial equivalence" of a new electrosurgical device to existing, legally marketed predicate devices. It relies on a comparison of technological characteristics, intended use, and general statements about the completion of performance, EMC, safety, and software testing. It does not contain the kind of detailed study information (specific acceptance criteria, sample sizes, ground truth establishment by experts, MRMC studies, or AI performance metrics) that would be expected for a novel diagnostic device or an AI-driven product.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Alpha Orthopaedics. The logo features a stylized letter "A" followed by the words "alpha orthopaedics" in a simple, sans-serif font. The text is all in lowercase letters. The logo is black and white.

APR - 7 2010

510(k) Summary

Company Information:	Alpha Orthopaedics, Inc.23575 Cabot Blvd., Ste. 210, Hayward, CA 94545
Contact Information:	Gina ToVice President, Regulatory/QualityPhone: (510) 783-5888; Fax: (510) 783-5889
Date Summary Prepared:	April 6, 2010
Trade Name:	Alpha Orthopaedics AT3™ System
Common Name:	Electrosurgical cutting and coagulation device and accessories
Classification:	Product Code GEI, Class II, CFR §878.4400
Predicate Devices (LegallyMarketed Device):	• K090580 Thermage ThermaCool NXT System• K072849 Modification to Thermage ThermaCool System• K052778 Thermage ThermaCool Skin Marking Paper• K051710 Thermage ThermaCool Coupling Fluid

K013639 Thermage ThermaCool TC System .

DEVICE DESCRIPTION

INTENDED USE

The radiofrequency-energy only delivery components of the Alpha Orthopaedics AT3 System are indicated for use in general surgical procedures for electrocoagulation and hemostasis.

The simultaneous application of radiofrequency energy and skin vibration by the Alpha Orthopaedics AT3 System is indicated for use in:

. General surgical procedures for electrocoagulation and hemostasis
. Relief of minor muscle aches and pain
. Relief of muscle spasms
. Temporary improvement of local circulation (i.e., blood circulation)

TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the AT3 System are same as the Thermage ThermaCool NXT System.

SUBSTANTIAL EQUIVALENCE

The AT3 System that is the subject of this notification is substantially equivalent to the predicate legally marketed devices listed above.

SUMMARY OF PERFORMANCE TESTING

Performance, EMC, safety, and software testing have been completed.

CONCLUSION

The technological characteristics and the results of the performance data demonstrate that the Alpha Orthopaedics AT3 System is safe and effective and is substantially equivalent to the legally marketed predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle.

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

APR - 7 2010

Alpha Orthopaedics, Inc. % Ms. Gina To 23575 Cabot Boulevard, Suite 210 Hayward - CA-94545 -----------

· Re: K094041

Trade/Device Name: Alpha Orthopaedics AT3TM System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulation Class: II Product Code: GEI Dated: April 6, 2010 Received: April 7, 2010

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 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

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Page 2- Ms. Gina To

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,

Mark McMillan

Mark N. Melkerson 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): K094041

Device Name: Alpha Orthopaedics AT3™ System

Indications for Use:

The radiofrequency-energy only delivery components of the Alpha Orthopaedics AT3 System are indicated for use in general surgical procedures for electrocoagulation and hemostasis.

The simultaneous application of radiofrequency energy and skin vibration by the Alpha Orthopaedics AT3 System is indicated for use in:

General surgical procedures for electrocoagulation and hemostasis .
. Relief of minor muscle aches and pain
. Relief of muscle spasms
Temporary improvement of local circulation (i.e., blood circulation) .

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)

signature

(Division (Division of Surgical, Orthopedic, Divisionative Devices

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510(k) Number K094041

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.