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The Surgitron 4.0 Dual RF S5 - IEC is intended to deliver electrosurgical output to perform cutting, coagulation, and hemostasis of soft tissues and to heat tissue in the non-ablative treatment of mild to moderate facial wrinkles and rhytids. The device is used with compatible Ellman International electrodes and handpieces which are used for these various applications in physician offices and surgical centers.

The Surgitron 4.0 Dual RF S5 - IEC indications are the same as those cleared in K082835:

• Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin . . phototypes I-IV
• . Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags and blepharoplasty.
• . Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, fistulas, epithelidma, cosmetic repairs, cysts, abscesses, and 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 Surgitron 4.0 Dual RF S5 - IEC is a radiofrequency energy generator employed for a variety of electrosurgical procedures. The action is achieved by selection of the desired waveform and power level on the front panel. Selections are activated by push buttons and indicated on the digital display giving the operator feedback on device setting status. Device output is controlled via foot and/or hand switch. Monopolar and bipolar electrodes may be used with the device. The generator includes the following accessories:

• IEC Power Cord ●
• Dual Footswitch & Cable .
• IEC Foot controlled Handpiece ●
• . Bipolar Cable
• . Monopolar cables
• Disposable Neutral Plate .
• Multi-Button Finger switch Handpiece .

Acceptance Criteria and Study Details for Surgitron 4.0 Dual RF S5 - IEC

The provided submission, K123366, for the Surgitron 4.0 Dual RF S5 - IEC, focuses on demonstrating substantial equivalence to a predicate device (Surgitron 4.0 Dual RF – IEC) through compliance with recognized electrical safety and performance standards. It does not involve a study of clinical performance or diagnostic accuracy as would be typical for AI-powered devices. Therefore, many of the requested categories are not applicable to this type of device submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

This device clearance did not involve a "test set" in the context of clinical data or algorithm performance. The testing was physical and electrical conformance testing of the electrosurgical unit itself.

• Sample Size: Not applicable (referring to patient data or images). The "sample" would be the manufactured device(s) subjected to the tests.
• Data Provenance: Not applicable. The testing pertains to the device's adherence to international safety and performance standards.

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

Not applicable. "Ground truth" in this context typically refers to clinical diagnosis or pathology, which is not relevant for an electrosurgical unit's electrical safety and performance testing. The "ground truth" here is the established requirements of the IEC standards themselves.

4. Adjudication Method for the Test Set

Not applicable. This was conformance testing to standards, not a clinical study requiring expert adjudication of patient cases.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for this type of device submission, which focuses on the safety and performance of an electrosurgical generator against established standards, not its comparative effectiveness in a diagnostic or clinical interpretation task involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is an electrosurgical generator, not an AI algorithm. Its performance is always predicated on human operation.

7. The Type of Ground Truth Used

The "ground truth" in this submission is the requirements outlined in the IEC 60601-1 and IEC 60601-2-2 standards. The device's performance was measured against these predefined safety and performance specifications.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm requiring a training set.

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

Not applicable. There is no training set for this device.

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Cutting: Skin and Mucosal Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, Skin Tags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures; Blended Cutting and Coagulation: Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures, ENT procedures; Hemostasis: Control of Bleeding, Epilation, Telangicctasia; Bipolar: Pinpoint, Precise Cutting and Coagulation, Pinpoint Hemostasis in any field (Wet or Dry)

The @llman Surgitron Radiolase II is a high frequency, medium power output electrosurgical medical device. The design is similar to currently marketed electrosurgical generators and provides the essential operational modes that are most often used in medium power electrosurgical applications. The unit consists of both a nominal 50 Watt maximum output power in monopolar mode and a nominal 55 Watt maximum output power in bipolar mode, providing the capability of precision cutting, coagulation, and hemostasis in a four megacycle frequency electrical current. The unit is designed to comply with the international safety standards.

Here's a breakdown of the acceptance criteria and study information for the ellman Surgitron Radiolase II device, based on the provided 510(k) summary:

This document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It typically does not contain detailed primary study results, acceptance criteria, or comprehensive performance data as would be found in a full clinical study report. Instead, it focuses on demonstrating equivalence to existing devices.

Therefore, the information provided below will be based on what can be inferred from the 510(k) submission, particularly the comparison to predicate devices, rather than explicit statements of acceptance criteria and a detailed study proving performance against them.

Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary does not explicitly state "acceptance criteria" in the typical sense of quantitative performance targets. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate devices in terms of intended use, technological characteristics, and safety standards. The reported device performance is described by its technical specifications and capabilities, which are compared directly to the predicate devices.

Study Information (Based on 510(k) Submission)

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

• Test Set: Not applicable for this type of submission. A 510(k) premarket notification primarily relies on a comparison of technological characteristics and intended use to predicate devices, rather than a new clinical study with a "test set" in the sense of clinical data. The submission indicates that the "indications for use is identical to the Surgitron as a preamendment device".
• Data Provenance: The document does not describe specific clinical data or a test set. The provenance of the comparison data is the existing specifications and regulatory clearances of the predicate devices: ellman Surgitron Radiolase (K992382) and ellman Surgitron 4.0 Dual RF/120 IEC (K013225).

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

• Not applicable. There is no mention of a test set with human-established ground truth in this 510(k) submission. Ground truth would be derived from the established safety and effectiveness of the predicate devices.

3. Adjudication method for the test set:

• Not applicable, as no human expert adjudication of a test set is described.

4. 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. This device is an electrosurgical unit, not an imaging or diagnostic device that would typically involve human readers or AI assistance in interpretation. Therefore, an MRMC study is not relevant here.

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

• No. This device is a physical electrosurgical unit. It does not contain an algorithm or AI component.

6. The type of ground truth used:

• For a 510(k) submission, the "ground truth" for demonstrating substantial equivalence is the established safety and effectiveness of legally marketed predicate devices, as determined by the FDA's original clearance of those devices. This includes adherence to recognized performance standards (e.g., IEC 60601-1, 60601-2-2).

7. The sample size for the training set:

• Not applicable. The device does not contain software or AI that would require a "training set."

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

• Not applicable, as no training set exists for this device.

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• 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.

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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.

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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.

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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.

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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.

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