Search Results

The Gladiator system contains three handpieces, each of which has its own indications for use.

The PiXel8-RF handpiece is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostatis.

The Bodysculp laser lipolysis handpiece intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive a desired a desired aesthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.

The Body Tone handpiece is intended for Relaxation of muscle spasms, Prevention or disuse atrophy, Increasing local blood circulation. Muscle re-education. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or increasing range of motion. Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

The Gladiator is a multi-function system that combines RF Microneedling, Low Level Laser and Electronic Muscle Stimulation (EMS) technologies into a single console. The system is intended for dermatologic and general surgery purpose as well as pain relief. The system is comprised of a single console with three handpieces:

• PiXel8-RF - a bipolar radiofrequency micro needling handpiece with disposable tips
• . BodySculp - a low level laser
• . BodyTone (previously called Futura Pro) – an electronic muscle stimulator

The system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source.

The provided text is a 510(k) premarket notification FDA review letter for the "Gladiator" device. It outlines the device description, indications for use, comparison to predicate devices, and performance testing. However, it does not contain the kind of detailed information about acceptance criteria for an AI/ML diagnostic device, nor does it describe a study specifically proving that the device meets such criteria in terms of algorithm performance against a ground truth.

Specifically:

• There's no mention of an AI/ML component in the Gladiator device. The device is described as a multi-function system combining RF Microneedling, Low Level Laser, and Electronic Muscle Stimulation (EMS) technologies.
• The "Performance Testing" section focuses on electrical safety, EMC, software lifecycle processes, risk management, and thermal testing, which are standard for electrosurgical and laser devices. This is not performance testing for an AI algorithm's diagnostic accuracy.
• There is no ground truth establishment, multi-reader multi-case studies, or standalone algorithm performance data discussed.
• The testing described is primarily engineering and safety-related (e.g., thermal damage profiles in ex vivo tissues), not clinical diagnostic accuracy.

Therefore, I cannot provide the requested information as the input document does not describe a study involving performance assessment of an AI/ML algorithm against acceptance criteria for diagnostic accuracy. The document is for a physical medical device (Gladiator) that does not appear to have an AI/ML component requiring the type of performance evaluation outlined in your request.

Ask a specific question about this device

The Bodysculp laser lipolysis system is intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic assthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.

The BodySculp is a diode laser system. The main components of BodySculp are a console and four applicators that deliver the laser energy to the patient. Electrically efficient semiconductors generate optical radiation (1060 nm) which issued to deliver laser energy to subcutaneous tissue layers.

The provided document is a 510(k) summary for the BodySculp device, which is a low-level laser system for aesthetic use. It details the device, its intended use, and a comparison to a legally marketed predicate device (PowerSculp) to demonstrate substantial equivalence.

However, the document explicitly states that "A human clinical study was not required as the device is identical to the predicate device." This means there isn't a study proving the device meets specific acceptance criteria for performance related to its intended aesthetic effect in the way you're asking, i.e., through a clinical trial with human subjects.

Instead, the acceptance criteria and performance data provided in this 510(k) are related to safety, electrical compatibility, and software validation, demonstrating that the device itself is safe and functions as intended, and is substantially equivalent to a device already cleared for market. The clinical effectiveness for aesthetic outcomes relies on the predicate device's prior clearance.

Therefore, for your specific request regarding acceptance criteria and performance related to the aesthetic claims of the device (disruption of adipocyte cells, aesthetic affect), the information is not available in this document because a clinical study for these outcomes was not performed for BodySculp.

Here's a breakdown of what is available in the document regarding "acceptance criteria" through non-clinical performance data:

Acceptance Criteria and Reported Device Performance (Non-Clinical)

Since a human clinical study for efficacy was not conducted for the BodySculp device, the "acceptance criteria" and "reported device performance" in this context refer to the non-clinical performance data supporting the device's safety and functional equivalence to the predicate.

Study Details (Based on the provided document)

As previously stated, a human clinical study was not required or conducted for the BodySculp device itself, as per the FDA 510(k) summary, because it was deemed substantially equivalent to a predicate device already on the market. Therefore, most of the following points cannot be answered from this document.

1. Sample size used for the test set and the data provenance: Not applicable, as no dedicated clinical test set was required or used for this device's 510(k) clearance for aesthetic efficacy. The "test set" in the document refers to the device itself being tested against electrical safety and software standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no human subject clinical ground truth was established for this device. Ground truth for the non-clinical tests (e.g., electrical safety) is typically established by engineering standards and test procedures, not expert consensus on medical images or outcomes.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no human subject clinical test set requiring adjudication was used.

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: Not applicable. This device is a laser lipolysis system, not an AI-assisted diagnostic or imaging device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm for diagnostic performance. Its "standalone" performance refers to its ability to meet engineering and safety standards.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical performance data, the "ground truth" implicitly used is compliance with established international and FDA-recognized standards for electrical safety, electromagnetic compatibility, laser safety, and software development. For the intended use and technological characteristics, the "ground truth" for substantial equivalence is the predicate device's cleared status and specifications.

7. The sample size for the training set: Not applicable. This device does not use an AI/machine learning model trained on data for its primary function.

8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

LED red light: The UltraLight" is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. The UltraLight" is also indicated for use in dermatology for the treatment of superficial, benign vascular, and pigmented lesions.

LED blue light: The UltraLight" is indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

LED green light: The UltraLight "green Light" is indicated for use as a non-invasive dermatological aestheic treatment for the reduction of circumference of hips, waist, and thighs.

The UltraLight LED System is a low level laser system for aesthetic use. The device can emit three different wavelengths (i.e., red light @ 633 nm, blue light @ 415 nm, and green light @ 532 nm) to achieve its intended purpose. All three wavelengths have different indications for use. The device works by illuminating the skin with a single wavelength of red, blue, or green light. The device utilizes a 28.8cm X 38.0 cm irradiation board to deliver light directly to the desired target. The device is activated and controlled through the LCD control panel.

The provided text is a 510(k) Summary for the UltraLight LED System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone clinical study with detailed performance metrics.

Therefore, the following information cannot be fully provided based solely on the given text:

• A detailed table of acceptance criteria and reported device performance for clinical outcomes. The document explicitly states "A human clinical study was not required for this device since the technical specifications of the device are comparable to the technical specifications of the predicates."
• Sample sizes used for a test set (as no clinical test set was required/described).
• Data provenance for a test set.
• Number of experts and their qualifications for establishing ground truth (as no clinical ground truth was established by experts for a test set).
• Adjudication method for a test set.
• Results of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Detailed performance metrics for a standalone algorithm, as this is a physical device, not an AI/algorithm-driven one in the context of the typical AI/ML device submission questions. The "Performance Data" section refers to non-clinical testing for safety and technical specifications, not clinical effectiveness.
• The type of ground truth used for performance validation (beyond demonstrating technical equivalence to predicates).
• Sample size for the training set (not applicable as this is not an AI/ML algorithm that requires a training set for clinical performance validation).
• How ground truth for the training set was established (not applicable).

However, I can extract information related to the device and its claimed performance based on its substantial equivalence to predicate devices:

1. A table of Acceptance Criteria and the Reported Device Performance

Since a clinical study was not required for effectiveness, there aren't explicit clinical "acceptance criteria" met by the device itself in this submission in the way you might expect for an AI/ML algorithm. Instead, the device's technical specifications are compared to legally marketed predicate devices to establish substantial equivalence, which is the "acceptance" for market clearance in this context. The "performance" data refers to non-clinical testing ensuring safety and technical adherence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. A human clinical study (test set) was not required or performed for this device to prove clinical effectiveness, as its substantial equivalence was based on technical specifications compared to predicate devices. The "Performance Data" section refers to non-clinical bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As no clinical test set was required for this submission, no expert ground truth was established for such a set.

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

Not applicable. No clinical test set requiring adjudication was performed.

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 is a physical LED light therapy device, not an AI-based diagnostic or assistive software, so an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

Not applicable. This is a physical device, not an algorithm. Bench performance data was collected to support technical specifications, as stated in the "Performance Data" section, but this is not "standalone algorithm performance."

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

For clinical effectiveness: No direct clinical ground truth was established for the UltraLight LED System in this submission. The "ground truth" for clearance was the established safety and effectiveness of the predicate devices through their previous clearances. The UltraLight LED System demonstrated substantial equivalence by matching the technical specifications and intended uses of these predicates.
For technical/non-clinical aspects: The ground truth was based on recognized international standards (IEC 60601-1, IEC 60601-1-2) and internal bench testing protocols for physical parameters (wavelength, intensity, etc.).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML algorithm that utilizes a training set in that context.

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

Not applicable. See point 8.

Ask a specific question about this device

The PicoLazer laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

1064 nm
The 1064 nm wavelength of the PicoLazer laser system is indicated for:

• treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI)
• tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI)

532 nm

• The 532 nm wavelength of the PicoLazer laser system is indicated for:
• treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III
• tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III

The Rohrer Aesthetics, LLC PicoLazer™ laser system is a dual-wavelength (532 and 1064 nm) Nd:YAG laser system that offers a 450-picosecond pulse duration that produces a maximum energy of 500mJ at 1064nm and 250mJ at 532nm.

The PicoLazer laser system consists of a system console, an articulated arm, a laser handpiece, a footswitch, and a remote interlock plug. Other components necessary for operation, such as power cables, are also included.

This document is a 510(k) Summary for the PicoLazer Multi-wavelength Laser (K192583). It aims to demonstrate substantial equivalence to legally marketed predicate devices, not primarily to prove clinical performance through a comparative effectiveness study with specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and study details for proving the device meets them, especially in the context of AI/human reader performance, is not applicable to this kind of FDA submission.

Here's a breakdown of the provided information in relation to your request:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: For a 510(k) submission like this, the "acceptance criteria" are typically demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. Specific quantitative clinical performance acceptance criteria (e.g., sensitivity, specificity, or human reader improvement with AI) are not usually part of a substantial equivalence claim for a laser system cleared through the 510(k) pathway, especially when clinical studies are not required.

• Reported Device Performance: Instead of clinical performance metrics, the document reports on several performance tests related to safety and electromagnetic compatibility (EMC), which are the typical "performance data" for non-AI medical devices cleared through substantial equivalence. These are:

  • IEC 60601-1 Test for Medical Electrical equipment (General Requirements for basic safety and essential performance)
  • IEC 60601-1-2 Test for Medical Equipment (General Requirements for basic safety and essential performance: electromagnetic compatibility)
  • IEC 60601-2-22 Medical Electrical Equipment (Requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser Equipment)
  • IEC 60825-1 Safety of laser products - Part 1 (Equipment classification, and requirements)

  The document states these tests were "performed in support of the substantial equivalence determination," implying they met the relevant standards, but it doesn't provide specific numerical results or pass/fail thresholds for these tests.

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

• Not Applicable. This submission is for a laser device, not an AI/Software as a Medical Device (SaMD) that typically uses test sets of diagnostic images. The performance data is based on compliance with electrical and laser safety standards, not a clinical test set of patient data.
• The document explicitly states: "A human clinical study was not required as the device is substantially equivalent to the predicate devices."

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

• Not Applicable. No clinical test set requiring expert-established ground truth was used for this 510(k) submission.

4. Adjudication method for the test set

• Not Applicable. No clinical test set requiring adjudication was used.

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. No MRMC study was done, as this is a laser device that directly performs a treatment, not an AI system assisting human readers in diagnosis or interpretation. The document explicitly states "A human clinical study was not required".

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

• Not Applicable. This is not an AI algorithm; it's a physical laser system.

7. The type of ground truth used

• Not Applicable. For a device like this, "ground truth" typically refers to the device's technical specifications and adherence to safety standards, which are verified through engineering tests rather than clinical outcomes or expert consensus on medical images.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device requiring a training set.

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

• Not Applicable. This is not an AI/machine learning device.

Summary of Relevant Information from the Document:

The provided document demonstrates that the PicoLazer Laser System's clearance is based on substantial equivalence to existing predicate devices (PicoWay Laser System K170597 and PicoCare Family K181272).

• Key points for Substantial Equivalence:
  • Intended Use: The PicoLazer's intended use ("surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery") is compared and found similar to the predicate devices.
  • Indications for Use: Detailed comparisons of the specific indications for the 1064nm and 532nm wavelengths (e.g., treatment of benign pigmented lesions, tattoo removal for various ink colors and Fitzpatrick skin types) are provided and found to be substantially equivalent to the predicate devices.
  • Technological Characteristics: A direct comparison table is provided for technical specifications (Wavelength, Laser Type, Max Energy, Peak Power, Spot Size, Pulse Duration, Pulse Repetition rate) and physical specifications (Console Weight, Console Size, Voltage, Current, Frequency). While not identical, the applicant argues these differences do not raise new questions of safety or effectiveness.
  • Performance Data: Non-clinical performance testing (compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1) was conducted to ensure basic safety and essential performance, electromagnetic compatibility, and laser safety. No detailed numerical results from these tests are provided in this summary document, only that the tests were performed.
  • Clinical Studies: The document explicitly states: "A human clinical study was not required as the device is substantially equivalent to the predicate devices." This means the FDA did not require clinical evidence of efficacy or safety beyond the substantial equivalence argument and non-clinical testing.

Ask a specific question about this device

Intended Use:
The EpiLaze Multi-wavelength Laser is intended for use in dermatologic and general surgical procedures.

Indication for Use for the 1064nm wavelength:

• The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) Modes are intended for
• permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen: and
• treatment of Pseudo folliculitis Barbae (PFB).

Indication for Use for the 810nm wavelength:

• The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) . Modes are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
  Indication for use for the 755nm wavelength:
• The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) ● Modes are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
  The STANDARD mode can be used on all skin types (Fitzpatrick I-VI), including tanned skin. The SFT mode can only be used on Fitzpatrick skin type I-IV. Do not use the SFT mode on tanned skin.

The EpiLaze Multi-wavelength Laser is a microprocessor-controlled, user friendly 755nm, 810nm and 1064nm Diode laser system using a sealed diode pack that produces a maximum energy of 120J/cm². The system incorporates a diode pack within each hand piece, and the energy is delivered from the hand piece directly to the desired target. The EpiLaze Multi-wavelength Laser consists of a console, a touch screen user interface, a footswitch and 2 handpieces

The provided text describes the EpiLaze Multi-wavelength Laser, a device intended for dermatologic and general surgical procedures, specifically for permanent hair reduction and treatment of Pseudo folliculitis Barbae (PFB).

The device did not undergo a clinical study to prove its performance against acceptance criteria. Instead, its substantial equivalence to a predicate device (Modified Alma Lasers Soprano XL Family of Multi-application & Multi-technology Platform, Soprano Yag Hand Piece, K170626, referred to as Soprano Ice) was established through a comparison of technical specifications and regulatory compliance.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since no specific acceptance criteria for a clinical study or device performance metrics like sensitivity/specificity are reported, the table below reflects the comparison against the predicate device, which forms the basis of "performance" in this 510(k) submission.

Conclusion from comparison: The technical specifications for the 1064nm wavelength are identical between the EpiLaze and the predicate. For 810nm and 755nm, the specifications are identical for comparable modes (STANDARD/SFT vs HR/SHR). The EpiLaze does not have the "LB mode" present in the predicate and thus does not include indications for treating benign vascular or pigmented lesions. This difference in indications for use is noted but does not prevent substantial equivalence for the shared indications.

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

• Sample Size: Not applicable. The submission states, "A human clinical study was not required as the device is identical to the predicate device." Therefore, there was no independent test set of patients or data for the EpiLaze device's clinical performance.
• Data Provenance: Not applicable for clinical performance. The data provided focuses on technical specifications and regulatory compliance.

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

Not applicable, as no human clinical study or test set requiring expert ground truth was conducted for this device's 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable, as no human clinical study or test set was conducted for this device's 510(k) submission.

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 a laser system for hair removal/dermatological procedures, not an AI-assisted diagnostic or imaging interpretation device.

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

Not applicable. This device is a laser system, not an algorithm. Bench testing was performed to show the difference between set and delivered energy parameters, and software verification and validation were conducted. These are not "standalone algorithm performance" in the context of an AI device.

7. The Type of Ground Truth Used

• For Technical Specifications: The "ground truth" for the EpiLaze's technical specifications was established through internal testing by the manufacturer (Rohrer Aesthetics, LLC) to ensure the device met its design specifications and could be compared to the predicate device's published specifications.
• For Clinical Efficacy/Safety: The "ground truth" is implied to be established by the predicate device's existing clearance (K170626), which presumably had sufficient clinical data or a strong scientific basis to support its indications for use. The EpiLaze's claim of "substantial equivalence" means it is considered to achieve the same clinical effects for comparable indications without new clinical data.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device requiring a training set.

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

Not applicable, as this is not an AI/ML device requiring a training set or ground truth establishment for a training set.

Ask a specific question about this device

The PINXEL-RF system is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The PINXEL-RF System includes the system main body, a bipolar handpiece with disposable micro-needle type electrodes, a footswitch and an LCD touch screen control panel. The RF energy is delivered to a target tissue using a handpiece and disposable tip (micro needle electrode tip), the tip being placed in light contact with the tissue and the handpiece being held at right angles to the target tissue. As the RF energy passes through the tissue, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the micro needle tip, the PinXel system creates heat within the target tissue via micro- needles inserted from the tip.

The provided document describes the PINXEL-RF System, an electrosurgical cutting and coagulation device. It primarily focuses on demonstrating its substantial equivalence to a legally marketed predicate device, the Secret RF by ILOODA CO LTD. The information concerning acceptance criteria and supporting studies is based on this equivalence premise rather than a standalone performance study with specific acceptance thresholds for diagnostic accuracy.

Here's an analysis of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance in terms of diagnostic accuracy or clinical outcomes. Instead, the acceptance is based on demonstrating substantial equivalence to the predicate device. The performance data provided is primarily related to safety, electrical standards, and sterilization, along with an in-vivo tissue study.

The criteria for "acceptance" in this context are implicitly met by showing that the PINXEL-RF System performs comparably to the predicate device in terms of technical specifications and does not raise new safety or effectiveness concerns.

1. A table of acceptance criteria and the reported device performance

(See table above)

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

• Test Set Sample Size:
  • In-Vivo Testing: Not explicitly stated as a numerical sample size but conducted on "3 types of tissue: Liver Kidney and Muscle." The number of individual tissue samples or animals is not specified.
  • Other Testing (IEC Standards): Not applicable for a traditional "test set" sample size in the context of diagnostic performance. These are engineering and performance verification tests, typically performed on the device itself.
• Data Provenance: Not explicitly stated. The in-vivo testing results were "analyzed in a pathology lab," but the country of origin or whether it was retrospective or prospective is not provided.

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

• In-Vivo Testing: The document states the results were "analyzed in a pathology lab." It does not specify the number of experts or their qualifications (e.g., "pathologist with X years of experience").

4. Adjudication method for the test set

• In-Vivo Testing: Not specified. It's likely a standard pathology review process, but no specific adjudication method (e.g., 2+1, 3+1 consensus) is mentioned.

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

• No MRMC comparative effectiveness study was done. This device is an electrosurgical system, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

• Not applicable. This is a hardware medical device, not a software algorithm. Its performance is inherent in its electrosurgical function.

7. The type of ground truth used

• For In-Vivo Testing: The ground truth was established through pathology analysis of the treated tissue, aiming to assess "unexpected injury."
• For Technical Specifications: The ground truth for comparison was the specifications of the legally marketed predicate device (Secret RF).

8. The sample size for the training set

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

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

• Not applicable. As above, no training set was used.

Ask a specific question about this device