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

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.

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.

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.

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

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

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

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.

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