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Orthopedic, arthroscopic, spinal, and neurological

For resection, ablation, and coagulation of soft tissues and hemostasis 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 turbinage, 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, sub-mucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.

The elliquence Surgi-Max® Ultra (IEC6-SP170, IEC6-SU170, & IEC6-SV170) is a modification to the existing Surgi-Max® / Surgi-Max® Plus (K100390) line of radiofrequency (RF) electrosurgical generators. It is a compact source of high-frequency RF energy employed for cutting and coagulation of soft tissue in a variety of surgical procedures. It is designed to enable the performance of monopolar and bipolar functions in conjunction with separatelymarketed electrosurgical accessories and ancillary equipment which have been developed by elliquence for mutually-exclusive use with the Surgi-Max® line of generators.

The Surgi-Max® Ultra (IEC6-SP170, IEC6-SU170, & IEC6-SV170) is the result of an update to internal electrical components of the Surgi-Max® / Surgi-Max® Plus. As a result of this equipment update, device design as it relates to internal electrical system framework was simplified in many respects and overall efficiency was greatly improved upon. This increase in efficiency enabled an increase in the maximum power output of the device from 120W to 170W. Aside from this increase in maximum power output, all other operational aspects of the device were conserved. The only other modifications made to the device were aesthetic in nature.

The modifications enacted do not affect the device's intended use or alter its fundamental scientific technology.

The provided document is a 510(k) summary for the Elliquence Surgi-Max® Ultra, an electrosurgical cutting and coagulation device. The purpose of this submission is to demonstrate substantial equivalence to existing predicate devices, not to present a study proving the device meets specific acceptance criteria in the way a clinical trial for a new drug or a diagnostic AI would.

Therefore, many of the requested criteria for reporting on an AI/diagnostic device study (like sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment) are not applicable to this type of regulatory submission. This submission focuses on engineering testing and comparison to predicate devices to ensure safety and effectiveness.

However, I can extract information related to the acceptance criteria (in terms of performance characteristics and compliance) and the "study" (non-clinical testing) that supports these criteria.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the substantial equivalence comparison to the predicate devices and compliance with relevant electrical safety and usability standards. The "reported device performance" is primarily demonstrated through non-clinical testing ensuring it meets these standards and functions similarly to its predicates, with documented improvements/changes.

Specific Indications for Use:

• Orthopedic, arthroscopic, spinal, and neurological procedures for resection, ablation, coagulation of soft tissues, and hemostasis.
• 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, 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, 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, sub-mucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage. |
  | Technological Characteristics Equivalence (General) | The device is a compact source of high-frequency RF energy for cutting and coagulation of soft tissue, enabling monopolar and bipolar functions, consistent with predicates. |
  | Specific Performance/Technical Parameters Equivalence/Safety | Output Frequency: 4 MHz (monopolar), 1.7 MHz (bipolar) - Identical to primary predicate (K100390).
  Maximum Power Output: 170W - Increased from primary predicate's 120W (K100390), but within safe operating parameters and efficiency improvements documented.
  Voltage (peak-to-peak): 1,200V - Lower than primary predicate's 1,600V (K100390), indicating potential safety benefit or efficiency change.
  Duty Cycle: 10 sec On / 30 sec OFF - Identical to predicates.
  Supply Input Power: 100 V AC – 240 V AC, 50/60 Hz - Identical to predicates.
  Power Activation Control: Footswitch and/or fingerswitch - Identical to predicates.
  Electrical Safety & EMC Compliance: AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-2 - Compliance demonstrated through testing.
  Applied Part Type: CF - Different from primary predicate's BF, but within acceptable safety standards for medical devices.
  Modes of Operation: Cut, Blend, Hemo, Bipolar, Bipolar Turbo - Identical to primary predicate. |
  | Safety and Effectiveness | Demonstrated through compliance with design control requirements (21 CFR 820.30) and verification/validation testing including electrical safety, EMC, usability, software, energy output verification, and thermal effect comparison. |

Study Details (Non-Clinical Testing for Substantial Equivalence)

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

   • Test Set Sample Size: Not applicable in the context of patient data samples. The "test set" here refers to physical testing performed on the device and ex-vivo tissue samples.
   • Data Provenance: Non-clinical (bench) testing. The document explicitly states "ex-vivo bovine tissue" for thermal effect comparison. No geographical or patient-specific provenance is relevant for this type of testing.

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

   • Not applicable. The "ground truth" for electrosurgical device performance is established by engineering specifications, international safety standards (e.g., IEC 60601 series), and documented functional capabilities of the predicate devices. Testing against these standards and comparing to predicate performance does not typically involve expert clinical consensus for "ground truth" in this specific regulatory context.

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

   • Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation). This submission relies on objective engineering measurements and comparisons to established standards and predicate device specifications.

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 is an electrosurgical generator, not an AI or diagnostic device that involves human readers interpreting cases.

5. 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, and is intended for use by a human surgeon. Its performance is inherent in its electrical output and tissue interaction, which was assessed via non-clinical testing.

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

   • The "ground truth" for this submission is based on established engineering specifications, international electrical safety and usability standards (e.g., IEC 60601 series, IEC 62366, IEC 62304), and the documented performance characteristics of legally marketed predicate devices. The non-clinical testing verified that the modified device met these engineering and safety benchmarks, and its performance characteristics were comparable or improved (e.g., increased power output) relative to the predicates in a safe manner.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not applicable, as there is no training set for this type of device.

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