(62 days)
Orthopedic, arthroscopic, spinal, and neurosurgical
For resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist.
Cutting
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, Blepharoplasty.
Blended Cutting and Coagulation
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps.
Hemostasis and Nonablative Coagulation
Control of bleeding, Epilation, Telangiectasia
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 Surgi-Max Electrosurgery Generator is a compact source of high radio-frequency RF energy to be employed for a variety of radiosurgery procedures. This action is actieved by front panel selection of waveforms and power level. All selection is effected through push buttons and lamps, which give the operator feedback of status.
Power level for each mode is indicated by front panel digital displays, which also show the status of self-test and monitoring. The display is interlocked with controls to prevent operation when FAILS is displayed. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are offered.
The power output in the CW (Cut) mode is 120 watts into (500 ohms) a matched load. The output frequency is maintained at 4.0 MHz +/- 400Hz over all service and loading conditions includingshort and open for monopolar mode.
Three output waveforms are provided:
CW CUT -- Continuous wave output with average power equal to the maximum with no deliberate modulation.
CUT / COAG – Deeply modulated envelope with average to peak power ratio approximately 50%. Modulation occurring at 120 or 100 Hz rate.
HEMO - Deeply modulated wave with average to peak ratio approximately 50%. Modulation occurring at 120 or 100 Hz rate of square wave.
The provided text is a 510(k) Summary for the Ellman Surgi-Max electrosurgical generator. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not detail a study proving the device meets specific performance acceptance criteria. Instead, it relies on compliance with general safety standards and comparison to a predicate device.
Here's an analysis based on the information provided, and where information is missing for your specific request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the way one might expect for a new performance study. Instead, it lists the output characteristics of the device and states compliance with general safety standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with Electrosurgical Unit Safety Standards | The Ellman Surgi-Max complies with IEC 60601-1 and IEC 60601-2-2. |
| Output Power (CW CUT mode) | 120 watts into 500 ohms (matched load) |
| Output Frequency (CW CUT mode) | 4.0 MHz +/- 400Hz over all service and loading conditions (including short and open for monopolar mode) |
| Output Power (CUT / COAG mode) | 90W @ 500 Ohms |
| Output Power (HEMO mode) | 60W @ 500 Ohms |
| Output Power (BIPOLAR HEMO mode) | 40W @ 200 Ohms |
| Output Power (BIPOLAR TURBO mode) | 120W @ 200 Ohms |
| Output Waveforms (as described for each mode) | CW CUT: 4.0 MHz CW sinusoid |
| CUT / COAG: 4.0 MHz w/ rectified full wave envelope | |
| HEMO: 4.0 MHz w/ square wave rectified envelope | |
| BIPOLAR HEMO: 1.7 MHz w/ square wave rectified envelope | |
| BIPOLAR TURBO: 1.7 MHz w/ modulated envelope | |
| Safety and Effectiveness Equivalence to Predicate Device | "We believe the differences between the subject device and predicate device are minor and conclude that the subject devices are as safe and effective as the predicate devices." (Implied acceptance criteria are that it performs equivalently to the predicate.) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document refers to compliance with standards (IEC 60601-1 and IEC 60601-2-2) and a comparison to a predicate device (Ellman Surgitron IEC 120 / 4.0 DU K013255). It does not describe a new clinical or laboratory study with a "test set" in the context of AI/software performance. The data provenance (country of origin, retrospective/prospective) is also not applicable/provided for this type of submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided and is not applicable to this type of device submission. This document describes a hardware medical device (electrosurgical generator) and its electrical output characteristics and intended uses, not an AI or software device that would typically involve expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable to this device. The Surgi-Max is an electrosurgical generator, not an AI-assisted diagnostic or treatment planning system that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable to this device. The Surgi-Max is a standalone hardware device; the concept of an "algorithm only" performance study typically applies to software/AI.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is its measured electrical output characteristics (power, frequency, waveform) and its compliance with established international safety standards for electrosurgical units (IEC 60601-1 and IEC 60601-2-2). The ultimate "truth" for its market acceptance is its substantial equivalence to a legally marketed predicate device. This is primarily engineering and compliance data, rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not provided and is not applicable as this isn't an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable as this isn't an AI/machine learning device.
Summary of the Study (as described in the document):
The "study" or justification for market clearance for the Ellman Surgi-Max appears to be based on:
- Compliance with Recognized Standards: The device was tested and found to comply with IEC 60601-1 (general requirements for safety) and IEC 60601-2-2 (particular requirements for the safety of high-frequency surgical equipment). This demonstrates that the device meets established safety and performance benchmarks for its category.
- Performance Specifications: The manufacturer presented the output characteristics (power, frequency, waveforms) for each mode of operation. These specifications are inherently verifiable through engineering testing.
- Substantial Equivalence to a Predicate Device: The core of the 510(k) submission is the claim that the Surgi-Max is "as safe and effective" as the legally marketed predicate device, the Ellman Surgitron IEC 120 / 4.0 DU (K013255), and that any differences are minor. This comparison typically involves comparing technical specifications, materials, intended use, and performance claims to show that the new device does not raise new questions of safety or effectiveness.
The document does not describe a new clinical trial, a comparative performance study against a placebo, or an AI validation study. It is a regulatory submission demonstrating compliance with standards and equivalence to an existing device, a common pathway for many medical devices.
§ 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.