Search Results

• 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, SkinTags, 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 CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps,
• Hemostasis
  Control of Bleeding, Epilation, Telangiectasia
• Fulguration
  Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Verrucae, Hemostasis.
• 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 @Wman Surgitron 120 IEC enhanced capability Electrosurgery Generator described herein is a compact source of high power RF energy to be employed for a variety of radiosurgery procedures. This action is achieved 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. 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. It is designed to comply with international safety standards.

This document is a 510(k) Premarket Notification for the Ellman Surgitron 120 IEC electrosurgical generator. It describes the device, its intended uses, and compares it to predicate devices to establish substantial equivalence. It does not contain information about a study proving the device meets specific acceptance criteria in the manner an AI/ML device study would.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies in the context you've outlined (e.g., test sets, ground truth, expert adjudication, MRMC studies, standalone performance, training sets). This type of data is not present in the provided document, as it pertains to a different class of medical device and regulatory submission.

The document focuses on demonstrating substantial equivalence to existing devices, primarily through comparison of:

• Indications For Use: The new device shares the same indications as the predicate devices (Surgitron IEC II and ERBOTOM ICC 200). These include various cutting, blended cutting and coagulation, hemostasis, fulguration, and bipolar functions for general and plastic surgery use, specifically mentioning procedures like snoring treatment, palatal shrinkage, myringotomy, and a range of dermatological and other surgical applications.
• Technological Characteristics: The document compares features such as design specifications, output energy (120 Watt for the new device vs. 100W/200W for predicates), output waveforms (4.0 MHz Sin-wave CW, Fully Rectified, Partially Rectified, and 1.7 MHz for Fulgurating Spark-Gap for the new device vs. similar or different frequencies for predicates), standards met (UL2601 and IEC 601-1 601-2-2, BS15724:2.2), delivery system (Monopolar and Bipolar), biocompatibility, and sterilization methods. The document states that many of these are "Same As New Device" or "Electrodes identical to predicate device," indicating equivalence.

The regulatory process for this type of device (electrosurgical generator) primarily involves demonstrating safety and effectiveness based on established performance standards and comparison to legally marketed predicate devices, rather than a clinical study evaluating diagnostic accuracy or algorithmic performance with elaborate test sets and ground truth as would be seen for AI/ML devices.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Cutting: Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeeurotic Repair, Levator Resection, Arthroscopic Procedures.
Blended Cutting and Coagulation: Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures.
Hemostasis: Control of Bleeding, Epilation, Telangiectasia

Surgitron Radiolase is a high frequency, medium power output electrosurgical device. The design is unique, simple, energy efficiency, safe, and user friendly. Furthermore, it equips the essential operational modes that are most often used in electrosurgical application. The unit has a maximum 50 watt output power and provides the capability of precision cutting, coagulating, and hemostasis in four megacycle frequency electrical current. It is designed to comply with international safety standards.

This document describes the Surgitron Radiolase, an electrosurgical device, and its substantial equivalence to predicate devices, not acceptance criteria for a study proving device performance in the context of AI/medical imaging or diagnostics.

Therefore, many of the requested elements (like "device performance," "sample size for test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "ground truth type," "training set size," and "ground truth for training set") are not applicable to this 510(k) summary. This document is focused on demonstrating that the new device is as safe and effective as previously cleared devices.

Here's a breakdown of what can be extracted or inferred from the provided text, aligning with the intent of the request as much as possible given the nature of the document:

Acceptance Criteria and Study for Surgitron Radiolase

The "acceptance criteria" in the context of this 510(k) summary are primarily based on demonstrating substantial equivalence to existing predicate devices in terms of intended use, technological characteristics, and safety standards. There isn't a "study" reported in the traditional sense of a clinical trial proving a specific performance metric against a numerical acceptance criterion. Instead, the "study" is the comparison made by Ellman International to show that the Surgitron Radiolase is similar enough to its predicates.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. This is not a clinical study involving a test set of patients or data. The evidence for "performance" is based on technical comparison to predicate devices, compliance with standards, and the known safety/efficacy of the underlying technology (radiofrequency electrosurgery).
• Data Provenance: Not applicable. The data provided is a technical comparison of device specifications.

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" established by experts in this context. The determination of substantial equivalence is made by the FDA based on the manufacturer's submission and comparison to predicate devices. The manufacturer's team (e.g., Frank Lin, Ph.D. Director of R&D Engineering) performs the comparative analysis.

4. Adjudication method for the test set

• Not applicable. There is no test set or adjudication process as typically understood in a clinical study. The FDA reviews the submitted technical data and makes a determination of substantial equivalence.

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 device is an electrosurgical unit, not an AI-powered diagnostic or imaging tool.

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

• Not applicable. This device is an electrosurgical unit, not an algorithm. The document explicitly states: "There is no software component in this new device."

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

• Not applicable in the traditional sense of a clinical study. The "ground truth" for demonstrating substantial equivalence relies on:
  • Pre-amendment device history / Established Clinical Practice: The safety and effectiveness of the technology (radiofrequency electrosurgery) and its indications for use are well-established through years of medical practice and prior FDA clearances. The predicate device "Surgitron IEC" is referenced as a pre-amendment device.
  • Regulatory Standards: Compliance with recognized international safety and performance standards (IEC, UL, BSI).
  • Technical Specifications: Direct comparison of physical and electrical characteristics with legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. There is no training set for an algorithm.

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

• Not applicable. There is no training set for an algorithm.

Ask a specific question about this device

is idendical to the Surgitron as a preammendment device such as:

• • 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, SkinTags, 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 CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps,
• • Hemostasis Control of Bleeding, Epilation, Telangiectasia
• • Fulguration Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Verrucae, Hemostasis.
• • 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

Not Found

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) clearance letter from the FDA for the Surgitron IEC device, indicating that it has been deemed substantially equivalent to a pre-amendment predicate device for the listed indications for use.

This means the FDA did not require a new clinical study to demonstrate performance against specific quantitative criteria. Instead, the clearance is based on the device being similar enough to an existing, legally marketed device that it does not raise new questions of safety and effectiveness.

Therefore, I cannot populate the requested table and information, as the provided text does not contain the necessary details regarding acceptance criteria, device performance, study design, sample sizes, expert qualifications, or ground truth establishment.

Ask a specific question about this device

is idendical to the Surgitron as a preammendment device such as:

• Cutting Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures.

• Blended Cutting and Coagulation Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures.

• • Hemostasis Control of Bleeding, Epilation, Telangiectasia
• • Fulguration Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Verrucae, Hemostasis.
• • Bipolar Pinpoint, Precise Coagulation, Pinpoint Hemostasis in any field (Wet or Dry).

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for the "Surgitron Model: IEC" device, indicating that it has been found substantially equivalent to a pre-amendment device.

Specifically, the text includes:

• FDA 510(k) clearance letter: This letter confirms that the device can be marketed in the US.
• Indications for Use: A list of medical procedures for which the Surgitron device is intended, such as various cutting, blended cutting and coagulation, hemostasis, fulguration, and bipolar procedures.

There is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details about test sets.
• The number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• The type of ground truth used.
• Training set sample sizes or how ground truth for the training set was established.

Therefore, I cannot fulfill your request for these specific details based on the provided document.

Ask a specific question about this device

is idendical to the Surgitron as a preammendment device such as:

• Cutting Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures.

• Blended Cutting and Coagulation Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures.

• • Hemostasis Control of Bleeding, Epilation, Telangiectasia
• • Fulguration Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Verrucae, Hemostasis.
• • Bipolar Pinpoint, Precise Coagulation, Pinpoint Hemostasis in any field (Wet or Dry).

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to Ellman International, Inc. regarding their device, Surgitron.

The letter confirms that the FDA has reviewed the notification and determined that the Surgitron device is substantially equivalent to legally marketed predicate devices for the indicated uses. It outlines the regulatory class, product code, and general controls provisions of the Act that apply to the device. The "Indication For Use" section lists various surgical procedures for which the Surgitron is intended, but these are indications for use, not acceptance criteria for a study.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

Ask a specific question about this device

Indication For Use is idendical to the Surgitron as a preammendment device such as:

• Culling
  Skin Incisions. Biopsy. Cysts. Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps. SkinTags, Envi, Keratusis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection.

• Blended Curring and Coagulation Skin Tags, Papilloma Kelvido, Keratosis, Verrucac, Dasal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmenc Repairs, Cysts, Absecsses, Development of Skin Flaps, Oculoplastic Procedures

• Ilemostasıs Control of Blocding, Epilation, Telangectasia

• Fulguration Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Vernicae, Hemostasis.

• Bipolar Pinpoint, Precise Coagulation, Pinpoint Hemostasis in any field (Wet or Dry).

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Surgitron Model: FFPF-EMC". This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter primarily:

• Acknowledges receipt and review of the 510(k) notification.
• States that the device is substantially equivalent to legally marketed predicate devices.
• Grants permission to market the device subject to general controls and FDA regulations.
• Lists the intended uses for the device, which are all surgical procedures (cutting, blended cutting and coagulation, hemostasis, fulguration, and bipolar coagulation).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

Ask a specific question about this device