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• O Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV
  The device is also indicated for:
• O Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, lumors, cosmetic repairs, development of skin flaps, skin tags and blepharoplasty.
• O Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids, verrucae, basal cell carcinoma, nevi, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, and development of skin flaps.
• O Hemostasis: control of bleeding, epilation, telangiectasia.
• O Fulguration: basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, hemostasis.
• O Bipolar: pinpoint precise coagulation, pinpoint hemostasis in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage.

The Ellman Surgitron is a compact source of high power RF energy to be employed for a variety of radiosurgical procedures. This action is achieved by front panel selection of waveforms and power levels. All selections are activated by push buttons with lights that give the operator feedback of operative status. The power level for each mode is indicated by the front panel digital display, which also identifies the status of self-test and monitoring. This display is interlocked with the controls to prevent operation when fail is displayed. The final output power control is made through foot and/or hand switches. Both monopolar and bipolar electrodes are provided.

The Ellman Surgitron is an electrosurgical unit and accessories device that was evaluated for an expanded indication for use: "non-ablative technique" for the treatment of mild to moderate facial wrinkles and rhytids.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantifiable acceptance criteria (e.g., a specific percentage reduction in wrinkles, a particular safety threshold, or a statistical non-inferiority margin). Instead, it relies on a substantial equivalence argument to a predicate device for its performance.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on the sample size used for any specific test set, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective) for the "studies" mentioned. It merely states that "Studies comparing the subject device to the predicate device" were conducted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide any information regarding the number of experts used, their qualifications, or how ground truth was established for any test set.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. There is no information about human readers, AI assistance, or effect sizes.

6. Standalone (Algorithm Only) Performance Study

The device described is an electrosurgical unit, a physical medical device, not an algorithm. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable in this context.

7. Type of Ground Truth Used

Given that the device is an electrosurgical unit for treating wrinkles, the "ground truth" for its effectiveness would typically involve clinical assessments, such as improvement in wrinkle severity scores (e.g., using standard scales like the Glogau or Fitzpatrick wrinkle scale), photographic evidence of changes, and patient satisfaction. However, the document does not explicitly state the type of ground truth used in the supporting studies. It only broadly claims "safe and effective."

8. Sample Size for the Training Set

The document does not mention a training set sample size. As it is a physical device and not an AI/machine learning model, the concept of a "training set" in that context is not applicable. The device's performance relies on its physical and electrical characteristics.

9. How the Ground Truth for the Training Set Was Established

As explained above, the concept of a "training set" with established ground truth is not applicable to this device's submission type (electrosurgical unit, not an AI/ML model). The "studies" likely refer to pre-clinical testing, engineering verification, and potentially clinical trials that demonstrated equivalence to existing predicate devices.

Summary of Study Information:

The provided 510(k) summary relies heavily on demonstrating substantial equivalence to existing predicate devices rather than presenting detailed performance data from a de novo study against specific acceptance criteria.

• Primary Argument: The subject device (Surgitron) is identical in materials and technology to a previously cleared Surgitron (K013255). The only difference is the addition of the "non-ablative technique" for wrinkles, which is similar to the indications for use of another predicate device, Thermage ThermaCool (K040135).
• Performance Data Statement: "Studies comparing the subject device to the predicate device demonstrate that the subject device is safe and effective for use in non-ablative procedures such as the treatment of mild to moderate facial wrinkles and rhytids."
• Lack of Detail: The document is remarkably sparse on specific details regarding these "studies," including methodologies, sample sizes, patient demographics, endpoints, statistical analyses, or the specific "acceptance criteria" met beyond the general claim of "safe and effective" based on substantial equivalence. This level of detail is common in 510(k) summaries where the primary argument is substantial equivalence to a well-understood predicate.

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