Search Results

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.

Ask a specific question about this device