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The Aaron 1200 is intended to be used for large loop excision of the transformation zone, loop electrosurgical excision procedures and other similar low powered procedures in the area of obstetrics and gynecology. LLETZ is indicated for those patients who have had an abnormal pap smear report with cytologic evidence of CIN, colposcopic examination of the cervix with unsatisfactory findings and who, in the physician's opinion are suitable candidates for the procedure. Indications for the LLETZ procedure include::

• a cytological and colposcopic suspicion of CIN
• a transformation zone which is fully visible and fully confined to the cervix .
• a suspicion (cytological or colposcopic) of glandular abnormalities .
• a recurrent and troublesome cervical infection with persistent atypicality .
• a disparity between the cytological and colposcopic diagnosis .
• . a suspicion supported by evidence (cytological or colposcopic) of microinvasive disease

The Aaron 1200 High Frequency Electrosurgical Generator is a non-sterile, reusable electrosurgical generator which is designed to generate high frequencies (RF) of high voltage and low amperage current.

The provided text describes a 510(k) submission for the Aaron 1200 High Frequency Electrosurgical Generator. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study with acceptance criteria and performance metrics against a defined ground truth in the way a diagnostic AI device would.

Therefore, many of the requested categories are not applicable or cannot be extracted directly from this document. The submission relies on comparisons to existing, legally marketed devices.

Here's the information that can be extracted or deduced, and an explanation of why other requested categories are not applicable:

Acceptance Criteria and Device Performance Study for Aaron 1200 High Frequency Electrosurgical Generator

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: In a 510(k) submission for electrosurgical generators, the "acceptance criteria" are not typically framed as specific performance metrics (e.g., sensitivity, specificity) against a clinical outcome, but rather as demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "performance" is therefore the demonstration of this equivalence through various tests and analyses, as summarized above.

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

• Not applicable for this type of device. Electrosurgical generators are hardware devices; their "performance" is evaluated through engineering tests, safety assessments, and direct comparison of specifications and features to predicate devices. There is no "test set" of patient data in the way a diagnostic algorithm would have. Data provenance for clinical efficacy or diagnostic accuracy is not relevant here.

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

• Not applicable. There is no "ground truth" derived from expert consensus for a test set in the context of an electrosurgical generator's substantial equivalence review. Performance is assessed through engineering and safety standards.

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

• Not applicable. No clinical test set requiring adjudication.

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:

• Not applicable. This is an electrosurgical generator, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a medical device, not an algorithm. Its operation involves human-in-the-loop directly.

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

• Not applicable. The "ground truth" for this device's approval is its conformance to engineering standards and its demonstrated substantial equivalence to predicate devices in terms of safety, performance characteristics (e.g., power output, modes), and intended use.

8. The sample size for the training set:

• Not applicable. Electrosurgical generators do not have "training sets" in the context of machine learning.

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

• Not applicable. No training set exists for this device.

Summary of the Study (as described in the document):

The "study" refers to the testing and analysis performed to demonstrate substantial equivalence to previously cleared devices. This included:

• Comparison of specifications: The Aaron 1200 was compared to the Aaron 1200 High Frequency Electrosurgical Generator (K980366), the Aaron 800 High Frequency Desiccator (K955681), and the ValleyLab SSE4 Electrosurgical Generator (K823924) across various parameters: design, operation, intended use, materials, energy source, components, method of preparation, and performance claims.
• Performance testing: "Testing which has been performed on the Aaron 1200 High Frequency Electrosurgical Generator indicates that the devices are substantially equivalent in their performance and method of operation." Specific test details are not provided in this summary but would have been part of the full 510(k) submission.
• Hazard analysis: "Hazard analysis evaluations were performed on the Aaron 1200 High Frequency Electrosurgical Generator." The results showed no new hazards compared to the predicate devices.

The conclusion was that the Aaron 1200 High Frequency Electrosurgical Generator is substantially equivalent to the predicate devices.

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