This 510(k) summary (K082956) for the Alpha Orthopaedics AT2 System indicates that the device's substantial equivalence was established based on non-clinical performance testing, rather than a clinical study with specific acceptance criteria related to a diagnostic output or human reader performance.

Therefore, many of the requested points are not applicable to this submission.

Here's a breakdown of the available and non-applicable information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly detailed in the summary, implied acceptable limits for various non-clinical tests.	Biocompatibility, EMC, safety testing, and software tests have been completed, and the results demonstrate the device is "safe and effective and is substantially equivalent to the legally marketed predicate devices."

Explanation: The 510(k) summary states, "Biocompatibility, EMC, safety testing, and software tests have been completed." This implies that the device met pre-defined acceptance criteria for these non-clinical tests, but the specific criteria (e.g., maximum current leakage, minimum insulation resistance, specific software validation metrics) are not itemized in this summary document. The "reported device performance" is a high-level statement of compliance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable for clinical studies. This submission relies on non-clinical performance data and a comparison to a predicate device. The sample sizes would refer to the number of units tested for biocompatibility, EMC, safety, and software, which are not detailed here. The provenance of such testing is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No expert ground truth was established for a diagnostic or clinical performance study. The "ground truth" for non-clinical tests is based on engineering standards and regulatory requirements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication was performed as there was no expert review of clinical cases.

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

No, an MRMC study was not done. This device is an electrosurgical cutting and coagulation system, not an AI-powered diagnostic tool. The concept of human readers improving with AI assistance is not relevant here.

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

Not applicable. This is not an algorithm-only device. Its performance is assessed through its physical and electrical properties, not an AI algorithm.

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

Not applicable for clinical ground truth. The "ground truth" for the non-clinical performance tests would be defined by established engineering standards (e.g., ISO standards for biocompatibility, IEC standards for EMC and safety).

8. The sample size for the training set

Not applicable. This device does not employ machine learning or AI that would require a training set.

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

Not applicable. No training set was used.

In summary: K082956 is a 510(k) submission for an electrosurgical device. The substantial equivalence pathway for this device focused on demonstrating that its technological characteristics and non-clinical performance (biocompatibility, EMC, safety, software) were comparable to a legally marketed predicate device. The information provided in the 510(k) summary does not include details on clinical performance studies, expert adjudication, or AI model evaluation metrics, as these were not required for this type of device and submission.

Summary

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K082956

510(k) Summary

Company Information:	Alpha Orthopaedics, Inc.23575 Cabot Blvd., Ste. 210Hayward, CA 94545	DEC 1 8 2008
Contact Information:	Gina ToVice President, Regulatory/QualityPhone: (510) 783-5888Fax: (510) 783-5889
Date Summary Prepared:	November 5, 2008
Trade Name:	Alpha Orthopaedics AT2 System
Common Name:	Electrosurgical cutting and coagulation device and accessories
Classification:	Product Code GEI, Class II, CFR §878.4400
Predicate Devices (LegallyMarketed Device):	• K013639 Thermage ThermaCool TC System• K043402 Thermage ThermaCool System Treatment Tip

DEVICE DESCRIPTION

The AT2™ System consists of a RF generator and accessories, including disposable treatment electrodes.

INTENDED USE

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

TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the AT2 System are same as the Thermage ThermaCool TC System.

SUBSTANTIAL EQUIVALENCE

The AT2 System that is the subject of this notification is substantially equivalent to the predicate legally marketed devices listed above.

SUMMARY OF PERFORMANCE TESTING

Biocompatibility, EMC, safety testing, and software tests have been completed.

CONCLUSION

The technological characteristics and the results of the performance data demonstrate that the Alpha Orthopaedics AT2 System is safe and effective and is substantially equivalent to the legally marketed predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alpha Orthopaedics, Inc. % TÜV SÜD America, Inc. Ms. Dawn Tibodeau 1775 Old Highway 8 NW / Suite 104 New Brighton, MN 55112-1891

DEC 1 8 2008

Re: K082956

Trade/Device Name: Alpha Orthopaedics AT2 System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories. Regulatory Class: Class II Product Code: GEI Dated: November 26, 2008 Received: December 3, 2008

Dear Ms. Tibodeau:

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 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.

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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 Center for Devices and Radiological Health's (CDRII's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millman

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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Indications for Use

510(k) Number (if known): K082956

Device Name: Alpha Orthopaedics AT2 System

Indications for Use:

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

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. Millhuser

(Division Sign-Ciral, Restorative, Division of G and 510(k) Number

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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.