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The AI.ME System is indicated for fractional skin resurfacing.

The AI.ME system is a micro coring device controlled by a robot that removes skin by using a disposable punch assembly containing six (6), hollow needle punches inserted into the skin with a fixed maximum penetration depth of 3 mm to remove up to 10% of skin in the treatment area to excise and/or resurface skin.

The AI.ME system, which is similar in design and performance as the FDA cleared Venus Concept ARTAS system, consists of a cart, a coring mechanism, single-use vacuum assembly and a sterile single-use disposable punch assembly.

This document describes the FDA's 510(k) clearance for the AI.ME System, a microneedling device for aesthetic use. It details the device's substantial equivalency to predicate devices based on non-clinical performance data.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria with corresponding performance metrics like a typical study report might. Instead, it outlines various performance and safety tests conducted and states that they were successfully passed or demonstrated. The acceptance criteria are implicitly linked to compliance with relevant industry standards and guidance documents.

Here's a table constructed from the information provided, outlining the tested aspects and the stated outcome:

Study Details

This document describes a 510(k) premarket notification for a medical device that does not involve an AI algorithm for diagnostic or prognostic purposes, but rather a robotic system that incorporates an "AI.ME System" name. The AI aspect, as described, appears to relate to the robotic control for precision, rather than a data-driven AI model that makes clinical assessments or diagnoses. Therefore, many of the requested details about AI model studies (like sample size for test/training sets, ground truth establishment methods, expert adjudication, MRMC studies) are not applicable to the type of device and testing described in this 510(k) summary.

The "AI" in "AI.ME System" seems to refer to Artificial Intelligence in the sense of an intelligent, automated system (robotics), rather than a machine learning algorithm for image analysis or clinical decision support that would require extensive data for training and testing as per the typical questions.

However, based on the provided text, here's what can be inferred about the "performance data" that serves as the "study":

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set (Pre-Clinical Study): A "swine model" was used for the pre-clinical study. The exact number of animals is not specified.
   • Data Provenance: The study was "pre-clinical" (animal model), likely conducted in a controlled lab environment by the manufacturer or a contract research organization. The country of origin is not specified. It is a prospective study, as it describes an evaluation over time (7, 14, 28 days post-treatment).
   • Other Performance Data: For non-clinical tests like electrical safety, EMC, software validation, sterility, biocompatibility, etc., these are bench tests and lab validations. No patient data or image data sets were mentioned.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

   • For the swine study, "macroscopical and histopathological analysis" was conducted. This implies expert evaluation (e.g., pathologists).
   • However, the number of experts and their specific qualifications are not specified.
   • Ground truth regarding the performance characteristics (e.g., accuracy of needle penetration depth) would have been established by engineering measurements using instruments like the Keyence Laser System, not clinical experts.

3. Adjudication Method for the Test Set:

   • For the pre-clinical (swine) study, the method of adjudication for macroscopic and histopathological analysis is not specified. It generally implies a consensus or independent review process by qualified personnel, but no details are provided.
   • For other performance tests, adjudication methods are not applicable as they involve objective measurements against standards.

4. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. The AI.ME system is a microneedling device, not a diagnostic imaging AI.

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

   • The document describes device performance characteristics and safety validations. While the "AI.ME System" implies an automated aspect (robotics), the testing detailed is on the physical device's mechanics, safety, and biological interaction. It's not a standalone AI algorithm in the sense of a software-only diagnostic tool being evaluated for its performance. The "performance data" reported is for the system as a whole, including its automated functions, but doesn't isolate an AI algorithm's performance in a way that is typically measured for diagnostic AI.

6. The Type of Ground Truth Used:

   • Pre-Clinical Swine Study: Ground truth was established through "macroscopical and histopathological analysis" of tissue from the treated areas at different time points (7, 14, 28 days). This is pathology-based ground truth indicating tissue response and healing.
   • Other Tests: Ground truth for other aspects (e.g., electrical safety, EMC, sterility, biocompatibility, accuracy of needle depth) was established through objective measurements against recognized industry standards and validated methods.

7. The Sample Size for the Training Set:

   • Not applicable / not specified. The document describes a medical device clearance based on substantial equivalence and non-clinical performance testing validated against standards. It does not describe the development or training of a machine learning model that would require a distinct "training set" of data in the typical AI sense. The "AI" in AI.ME likely refers to robotic automation/control, not a learned model from a dataset.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable. As no AI training dataset is explicitly mentioned, the concept of establishing ground truth for a training set does not apply.

Conclusion Summary from Document:

The document concludes that the AI.ME System is safe and effective as the legally marketed predicate and reference devices, and that the performance testing data supports the stated indications for use. It asserts that the AI.ME System did not raise new questions of safety or effectiveness.

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The Venus BlissMAX device is a diode laser system intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less.

In addition, the Venus BlissMAX device is intended for the treatment of the following medical conditions; using the MP2 applicator for delivery of RF energy combined with massage and magnetic field pulses:

• · Relief of minor muscle aches and pain, relief of muscle spasm
• Temporary improvement of local blood circulation
• · Temporary reduction in the appearance of cellulite

In addition, The Venus BlissMAX device using the FlexMAX applicators is intended for muscle conditioning to stimulate healthy muscles.

The Venus BlissMAX device using the FlexMAX applicators is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.

The Venus BlissMAX device using the FlexMAX applicators is intended to be operated by a trained professional.

The Venus BlissMAX device is a computerized system comprised of a system console (main unit), four (4) Diode Laser applicators, one (1) MP2 (RF+ PEMF+ Vacuum) applicator and four (4) FlexMAX (EMS) applicators. The system delivers laser, bipolar RF and biphasic electrical energies, vacuum pressure, and pulsed electromagnetic fields (PEMF) to the skin and the underlying tissues of the treatment area. The device provides individual adjustment of laser power, EMS intensity level, and RF power, in addition to vacuum levels, for each patient.

The console of the Venus BlissMAX device contains a power supply unit, Laser, RF, and EMS controllers, (power modules, on main board), a suction module (vacuum), a controller unit (on main board), Laser water cooling system (power module, on main board), a touch- screen user interface and display panel.

The applicators are connected to the console via a cable. The RF applicator is comprised of various combinations of RF electrodes, magnetic coils, and vacuum conduits.

The Laser applicators are comprised of a light guide, touch sensors and light-emitting diodes.

The EMS applicator is comprised of two electrodes and a light indicator.

This document is a 510(k) summary for the Venus BlissMAX device, a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. Critically, there is no acceptance criteria table or formal study data presented in the provided text in the manner one might see for an AI/ML medical device where specific performance metrics (e.g., sensitivity, specificity) are tested against predefined thresholds.

Instead, this submission leverages the concept of "substantial equivalence" to predicate devices already cleared by the FDA. The "study" proving the device meets its acceptance criteria is primarily a comparison of its technological characteristics and safety testing to these predicate devices. The acceptance criteria are implicit in demonstrating that the new device is as safe and effective as the predicate devices, and that any differences do not raise new questions of safety or effectiveness.

Here's an analysis based on the provided text, addressing your questions where possible:

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

As mentioned, a formal acceptance criteria table with quantifiable performance metrics (like sensitivity, specificity, accuracy) akin to an AI/ML device is not present in this document. The device's performance is "accepted" if it is determined to be substantially equivalent to the predicate devices. The "reported device performance" is the demonstration through non-clinical testing that the device functions according to specifications and conforms to applicable safety standards, which are shared with the predicates.

Implicit Acceptance Criteria (based on Substantial Equivalence):

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

• Test Set Sample Size: Not applicable in the context of human clinical data for this 510(k). The "test set" primarily refers to individual devices or components undergoing engineering and safety testing.
• Data Provenance: The data provenance for the safety and engineering tests (Electrical, EMC, Biocompatibility) would be internal lab testing or testing conducted by independent third-party laboratories. No specific country of origin for this testing data is provided, but it's typically performed in a controlled, accredited environment. The document states these are "non-clinical performance testing" and "Verification and Validation tests." There is no patient data involved in this submission for the Venus BlissMAX.

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

• This type of expert evaluation for establishing ground truth (e.g., for image interpretation in AI/ML) is not applicable to this device's 510(k) submission. The ground truth for device safety and performance here comes from engineering and quality system standards (e.g., IEC standards, ISO 10993-1).

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic devices where human expert consensus is needed to establish ground truth for patient outcomes or interpretations. This 510(k) relies on non-clinical engineering and safety performance testing against established standards.

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, an MRMC study was NOT done or reported. This device is not an AI-assisted diagnostic tool for which an MRMC study would be relevant. Its clearance is based on substantial equivalence for physical therapeutic/aesthetic functionalities.

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

• Not applicable in the context of an "algorithm only" performance study. The device contains software and firmware (page 9), but these are for controlling the hardware functionality (e.g., power levels, timers, safety shutdowns), not for performing analytical tasks or diagnoses independently. The software testing mentioned is for verification of its control functions.

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

• The "ground truth" for this submission is established by international and national consensus standards for medical device safety and performance (e.g., IEC standards, ISO standards for biocompatibility), as well as internal engineering specifications and functional requirements. For example, the "ground truth" that the device is electrically safe is compliance with IEC 60601-1.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML-based device that undergoes a "training set" for an algorithm. Its functionality is based on established physical principles (laser, RF, EMS, vacuum).

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

• Not applicable. As there is no AI/ML training set, there is no ground truth establishment process for a training set.

Summary of the "Study" Proving Compliance:

The "study" proving the Venus BlissMAX meets its acceptance criteria (i.e., is safe and effective and substantially equivalent) is a comprehensive set of non-clinical tests and comparisons:

1. Direct Comparison to Predicate Devices: The core of the submission is a detailed comparison of the Venus BlissMAX to its primary predicate (Venus BlissMAX K213308) and co-secondary predicates (Cynosure SculpSure K182741, Venus Legacy Pro K191528) across various technical specifications (wavelength, power density, components, indications for use, energy type, etc.). The acceptance criterion here is that the new device's characteristics are either identical, very similar, or that any differences do not introduce new safety or effectiveness concerns compared to the already cleared predicate devices.
2. Safety Testing Conformity: The device underwent rigorous testing to ensure compliance with a multitude of international safety and performance standards relevant to medical electrical equipment, lasers, high-frequency surgical equipment, and muscle stimulators. These include:
   • IEC 60601-1 (General requirements for basic safety and essential performance)
   • IEC 60601-1-2 (EMC – Requirements and Tests)
   • IEC 60601-2-2 (High frequency surgical equipment)
   • EN 60601-2-22 (Laser equipment)
   • IEC 60601-2-10 (Nerve and muscle stimulator)
   • IEC 60825-1 (Safety of laser products)
   • IEC 60601-1-6 (Usability)
   • Software verification testing per FDA guidance.
   • Biocompatibility testing per ISO 10993-1 guidance.

The acceptance of the device is based on the satisfactory results of these non-clinical tests and the successful demonstration of substantial equivalence without raising new safety or effectiveness questions.

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The Venus BlissMAX device is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less.

In addition, the Venus BlissMAX device is intended for the treatment of the following medical conditions; using the MP2 applicator for delivery of RF energy combined with massage and magnetic field pulses:

• Relief of minor muscle aches and pain, relief of muscle spasm
• Temporary improvement of local blood circulation
• Temporary reduction in the appearance of cellulite

In addition, The Venus BlissMAX device using the FlexMAX applicators is intended for muscle conditioning to stimulate healthy muscles.

The Venus BlissMAX device using the FlexMAX applicators is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.

The Venus BlissMAX device using the FlexMAX applicators is intended to be operated by a trained professional.

The Venus BlissMAX device is a computerized system comprised of a system console (main unit), four (4) Diode Laser applicators, one (1) MP2 (RF+ PEMF+ Vacuum) applicator and four (4) FlexMAX (EMS) applicators. The system delivers laser, bipolar RF and biphasic electrical energies, vacuum pressure, and pulsed electromagnetic fields (PEMF) to the skin and the underlying tissues of the treatment area. The device provides individual adjustment of laser power, EMS intensity level, and RF power, in addition to vacuum levels, for each patient.

The console of the Venus BlissMAX device contains a power supply unit, Laser, RF, and EMS controllers, (power modules, on main board), a suction module (vacuum), a controller unit (on main board), Laser water cooling system (power module, on main board), a touch- screen user interface and display panel.

The applicators are connected to the console via a cable. The RF applicator is comprised of various combinations of RF electrodes, magnetic coils, and vacuum conduits. The Laser applicators are comprised of a light guide, touch sensors and light-emitting diodes.

The EMS applicator is comprised of two electrodes and a light indicator.

The provided text is a 510(k) summary for the Venus BlissMAX device, which is an electrosurgical cutting and coagulation device. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and comprehensive study results for efficacy.

However, based on the "Performance Data" subsection, we can infer some aspects of the acceptance criteria and the studies performed to demonstrate compliance.

Here's a breakdown of the requested information:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the device's therapeutic claims (e.g., non-invasive lipolysis, muscle aches/pain, cellulite reduction, muscle conditioning) in a way that suggests a clinical trial with specific endpoints. Instead, it focuses on demonstrating that the device meets safety and performance standards.

The "Performance Bench Testing" implies that the device's outputs were measured against predefined specifications. These specifications would be the acceptance criteria for those particular performance tests.

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

The document does not mention a "test set" in the context of clinical data for efficacy. The performance tests mentioned (bench testing, electrical safety, software validation) are primarily engineering and quality assurance tests. There is no information regarding sample size, country of origin, or whether it was retrospective or prospective for a clinical test set.

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. The document does not describe a clinical test set requiring expert ground truth establishment for diagnostic or therapeutic outcomes. The performance data discussed pertains to device functionality and safety standards, which are typically evaluated by engineers and regulatory compliance experts.

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

Not applicable. As no clinical test set requiring expert adjudication for ground truth is described, there is no mention of an adjudication method.

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. The Venus BlissMAX device is not an AI-assisted diagnostic or therapeutic imaging device, and therefore, an MRMC study is not relevant to its assessment.

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

Not applicable. This device is a physical medical device, not an algorithm. Its operation inherently involves a "trained professional," as stated in the Indications for Use for the FlexMAX applicators.

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

For the performance and safety tests described:

• Performance Bench Testing: The "ground truth" would be the predefined engineering specifications and functional design of the device.
• Electrical Safety and Electromagnetic Compatibility: The "ground truth" is compliance with international standards (e.g., IEC 60601 series).
• Software Testing: The "ground truth" is adherence to software requirements and functionality as per design specifications.

For the claims of efficacy, the document states "The results demonstrated that the differences in the technological characteristics of the subject and predicate devices do not raise new types of safety or effectiveness concerns." This suggests the efficacy is primarily being demonstrated through substantial equivalence to previously cleared predicate devices, rather than new clinical outcomes data.

8. The sample size for the training set

Not applicable. As this device is not an AI/machine learning product requiring a training set in the conventional sense, this information is not provided.

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

Not applicable, as there is no training set for an AI/machine learning model.

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The Venus Freedom device is intended for the treatment of the following medical conditions; using the Pearl, Diamond and Slim applicators for delivery of non-thermal RF combined with massage and magnetic field pulses:
• Relief of minor muscle aches and pain, relief of muscle spasm
• Temporary improvement of local blood circulation
• Temporary reduction in the appearance of cellulite.

The Venus Freedom device, part of the Family of Venus RF devices, is a noninvasive, non-ablative device that delivers Radiofrequency (RF) energy, along with the Pulsed Electro-Magnetic Field (PEMF), into the skin to generate heat through electrical impedance in the epidermis, dermis, subcutaneous layers, and muscular tissue.
The device consists of a console (main unit) and three applicators (Pearl, Diamond and Slim).
The Venus Freedom RF energy, PEMF and tissue manipulation (massage), are utilized to trigger changes in the tissue which result in local blood circulation improvement, muscle spasm relief along with pain relief. Temporary reduction in the appearance of cellulite is similarly achieved by the combination of these three main mechanisms: tissue manipulation (massage), RF delivery and PEMF delivery.

Here's a breakdown of the acceptance criteria and study information for the Venus Freedom device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Venus Heal, K182094), rather than setting specific quantifiable acceptance criteria against a defined clinical endpoint like accuracy (e.g., sensitivity, specificity for a diagnostic device). The performance data presented is focused on verification of technical specifications and safety.

• Max PEMF power density met. |
  | Safety - Temperature Control | - Bench test demonstrated the ability to maintain a safe treatment temperature on the surface of human skin using the same protocol as the predicate device, Venus Heal (K182094). |
  | Electrical Safety and Electromagnetic Compatibility (EMC) | - Complied with IEC 60601-1, IEC 60601-1-6, IEC 60601-2-2, and IEC 60601-1-2. All results were "passing." |
  | Software Functionality | - Software verification and validation testing performed; device functioned as intended, and results were as expected. |
  | Biocompatibility | - Disposable tip materials tested per FDA Guidance and ISO 10993-1, 10993-5, 10993-10. Testing included cytotoxicity, sensitization, and irritation. All testing "passed." |
  | Clinical Effect (Equivalent to Predicate) | The Venus Freedom device is stated to be for the "Relief of minor muscle aches and pain, relief of muscle spasm, Temporary improvement of local blood circulation, Temporary reduction in the appearance of cellulite." The basis for this is substantial equivalence to the Venus Heal, which had these indications. No new clinical study data is presented to prove these effects for the Venus Freedom. |

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The provided document describes a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than conducting new, full-scale clinical trials to prove efficacy from scratch. Therefore, the "study" is primarily a set of verification and validation (V&V) tests designed to show that the new device (Venus Freedom) performs comparably to its predicate (Venus Heal) and meets essential safety and performance standards.

The key studies and tests performed are:

• Verification Tests: To ensure the device adheres to its technical specifications for RF power output and PEMF power density.
• Bench Test (Temperature Maintenance): This test specifically aimed to demonstrate the device's ability to maintain a safe treatment temperature on human skin. This was done using a protocol identical to that used for the predicate device, K182094 (Venus Heal).
• Electrical Safety and EMC Testing: Conformance to recognized international standards (IEC 60601 series).
• Software Verification and Validation: To ensure software functions as intended.
• Biocompatibility Testing: On new disposable tip materials, following ISO 10993 standards.

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

• Sample Size: The document does not specify a "sample size" in the context of human subjects or cases for a clinical test set. The performance data described are primarily bench tests and engineering verification tests. For the bench test on temperature, it's a simulation rather than a human subject study.
• Data Provenance: The data originates from internal testing conducted by Venus Concept (the manufacturer) as part of their device development and regulatory submission process. There is no mention of country of origin for data generation specifically, but the company is Venus Concept USA Inc. The tests are prospective in the sense that they were conducted specifically for the Venus Freedom device to support the 510(k) submission.

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

• This information is not applicable to the type of studies presented. The "ground truth" here is adherence to technical specifications, safety standards, and functional performance, which are assessed through engineering and bench testing, not expert consensus on clinical findings.

4. Adjudication Method for the Test Set:

• This is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies involving multiple readers for diagnostic or prognostic tasks to resolve disagreements. The reported studies are technical verification and validation, not clinical efficacy studies requiring expert adjudication.

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:

• No, an MRMC comparative effectiveness study was not done. This device is a therapeutic electrosurgical device, not a diagnostic AI-assisted imaging device. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

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

• This is not applicable as the device is not an AI algorithm but a physical electrosurgical system. Its performance is inherent in its operation and effect on tissue, rather than an "algorithm-only" output.

7. The Type of Ground Truth Used:

• The "ground truth" used for the reported performance tests are:
  • Technical specifications: For RF power, PEMF power density.
  • Safety standards: For temperature maintenance and electrical/EMC performance (e.g., safe temperature limits, IEC standard compliance).
  • Biocompatibility standards: For material safety (ISO 10993 series).
  • Functional requirements: For software performance.

8. The Sample Size for the Training Set:

• This information is not applicable. The Venus Freedom device is not described as an AI/ML-driven device that requires a "training set" in the context of machine learning model development. The design and operation are based on established RF and PEMF physics and engineering principles.

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

• This is not applicable for the same reason as above (no AI/ML training involved).

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The Venus Viva MD™ is a non-invasive device intended to be used by aesthetic-related physicians or dermatologists.

• When used with the Viva MD applicator, the Venus Viva MD™ device is intended for use in dermatological procedures requiring ablation and resurfacing of the skin.
• When used with the Diamondpolar applicator, the Venus Viva MD™ device is intended for use in dermatological and surgical procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin type I-IV.

The Venus Viva MD™ device consists of a console (main unit) and two applicators: Viva MD applicator and Diamondpolar applicator. The console contains a power supply unit, RF generator (power module, on main board), PMF generator, a controller unit (on main board), a touchscreen user interface and display panel.

The Venus Viva MD™ device is a combination of the previously cleared Venus Viva SR (K150161), the primary predicate, and the Diamondpolar applicator that was previously cleared for the secondary predicate Venus Legacy BX (K142910).

Both, the Viva MD and Diamondpolar applicators can now be connected simultaneously to a single console, the Venus Viva MD™ console.

Additionally, the Viva MD applicator is supplied with single use detachable tips with 80- or 160-electrode pins. The 160-pin tip was previously cleared within Venus Viva SR (K150161).

This document is a 510(k) Summary for the Venus Viva MD™ device, indicating it is a submission to the FDA to demonstrate substantial equivalence to previously cleared predicate devices. The information provided heavily focuses on comparing technological characteristics and safety standards rather than detailed acceptance criteria and a specific study proving those criteria are met in the traditional sense of a clinical trial for diagnostic performance.

However, I can extract the relevant information regarding performance testing and how substantial equivalence was established, which acts as the "proof" for regulatory clearance.

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

Based on the document, the "acceptance criteria" are not explicitly stated with numerical targets in a table format as one might find for a diagnostic algorithm's sensitivity/specificity. Instead, the acceptance criteria are implicitly that the Venus Viva MD™ device must perform similarly to its predicate devices and meet relevant safety and electrical standards. The reported device performance is that these similarities were confirmed.

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

• Bench Testing: No specific "sample size" is mentioned for RF and PMF output parameter testing. This typically involves instrument calibration and performance checks, not patient data.
• Animal Testing: The study involved "porcine skin." The number of animals or specific treatment sites is not specified. The provenance would be the location where the animal study was conducted, which is not stated (likely a research lab). It's a prospective study in an animal model.
• Electrical Safety, EMC, Usability, Software Testing: These are engineering and software validation tests, not clinical studies with patient data. No "sample size" in the context of patients is relevant.

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)

• Animal Testing (Histology): For the animal study, the ground truth was established histologically. This implies a pathologist reviewed the tissue samples. The number of experts and their qualifications are not specified in this document.

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

• Animal Testing: No information is provided regarding an adjudication method. Histological review is generally performed by a single pathologist or might be peer-reviewed, but methods are not detailed here.

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

• This device is an electrosurgical cutting and coagulation device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not applicable and was not conducted.

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

• This is a physical medical device (console and applicators), not a standalone algorithm. Performance is based on its physical and electrical outputs and biological effects, as demonstrated in bench and animal testing.

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

• Animal Testing: Pathology (histological evaluation of ablated skin and healing).
• Bench/Engineering/Software Testing: Ground truth is defined by engineering specifications, validated test protocols, and international standards (e.g., IEC 60601 series).

8. The sample size for the training set

• Not applicable. This is a medical device clearance submission, not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for the device's design would come from engineering principles and prior predicate device designs.

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

• Not applicable as it's not an AI/ML algorithm requiring a training set.

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The Venus Epileve is intended for all Fitzpatrick skin types, including tanned skin, for use in dermatology, general and plastic surgery applications for:

• · Hair removal:
• Permanent hair reduction (defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen); and
• · Treatment of pseudofolliculitis barbae.

The Venus Epileve device consists of a tabletop console (main unit) and one detachable diode laser applicator. The system console is the main enclosure that holds and contains all external and internal system components: a power supply unit, laser diode driver, controller unit, and touch screen with LCD display. The console incorporates a water cooling system with a pump in order to constantly keep the tip of the applicator, light guide, chilled. The detachable diode laser applicator is connected to the system via a cable passed through the applicator connectors located in the designated compartment on the system's rear side. When not in use, the applicator can be secured within the applicator cradle on the top panel of the console. The applicator delivers the laser energy to a patient's skin through the applicator's tip made of a sapphire light guide framed in aluminum anodized shells. The applicator is supplied with only one spot size light guide. The device also comes with a footswitch, goggles, patient eye protectors, and water filling kit.

The provided text describes the Venus Epileve device, a laser surgical instrument for hair removal and permanent hair reduction. It outlines its technical specifications, intended use, and the performance tests conducted to demonstrate its safety and effectiveness compared to a predicate device.

However, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria, particularly within the context of an AI/human-in-the-loop system or the detailed methodology of clinical studies for performance metrics like accuracy, sensitivity, or specificity. The "Performance Data" section primarily details engineering and electrical safety tests, and a comparison to a predicate device based on technical specifications.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance (for metrics like accuracy, sensitivity, specificity, etc., common in AI/diagnostic device studies). The document only mentions "performance tests" that demonstrated the device meets system requirements and specifications, without defining quantifiable acceptance criteria for clinical efficacy or outlining the results in a table format.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study details and effect size.
• Standalone algorithm performance details.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Venus Velocity Diode Laser System) based on similar intended use, indications for use, and technological characteristics, supported by engineering performance tests (e.g., electrical safety, software validation, laser safety). It does not describe a clinical study with detailed performance metrics and ground truth establishment, which would be necessary to derive the information you've requested.

The "Performance Data" section summarizes:

• Performance Bench Testing: Evaluated the system's outputs against specifications and compared them to the predicate device. Stated that "differences... do not raise new types of safety or effectiveness concerns."
• Electrical Safety and Electromagnetic Compatibility: Tested per IEC standards (60601-1, 60601-1-2, 60601-1-6, 60825-1, 60601-2-22). All results were "passing."
• Software Testing: Verification and validation showed the system "performed as intended and that the energy outputs... meet specifications."

These are typical pre-market notification (510(k)) submissions for devices demonstrating substantial equivalence to a predicate, rather than novel devices requiring extensive new clinical efficacy studies with the types of performance metrics and ground truth setup you've outlined.

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The Venus Viva™ Device is a non-invasive device intended to be used by aesthetic physicians or dermatologists.

When used with the Diamondpolar applicator, the Venus Viva™ Device is intended for use in dermatological and surgical procedures for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin type I-IV.

When used with the Viva applicator, the Venus Viva™ Device is intended for use in dermatological procedures requiring ablation and resurfacing of the skin.

The Venus Viva™ device consists of a console (main unit) and two applicators – Viva and Diamondpolar. The console contains a power supply unit, an RF generator (power module, on main board), a controller unit (on main board) and a touchscreen user interface and display panel.

The Venus Viva™ device is a combination of the previously cleared Venus Viva™ SR (K150161), the primary predicate, and the Diamondpolar applicator that was previously cleared for the secondary predicate Venus Legacy BX (K142910). Both the Viva and Diamondpolar applicators can now be connected simultaneously to a single console, the Venus Viva™ console.

The Venus Viva™ Device is a non-invasive device intended for use by aesthetic physicians or dermatologists. It is designed for dermatological and surgical procedures, specifically for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV (when used with the Diamondpolar applicator) and for ablation and resurfacing of the skin (when used with the Viva applicator).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" in a typical quantitative clinical performance metric sense (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, it focuses on demonstrating substantial equivalence to predicate devices by meeting performance standards, electrical safety, biocompatibility, and software validation. The key acceptance criteria are implicitly that the new device performs at least as well as, and has similar safety and effectiveness profiles as, the predicate devices.

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

The provided document describes engineering and laboratory performance testing, not a clinical study involving human subjects or patient data. Therefore, there is no "test set" in the context of patient data; instead, the "test set" refers to the device itself and its components undergoing various engineering evaluations.

The data provenance is laboratory testing conducted by Venus Concept USA Inc. or its designated testing facilities, likely in the country of manufacture or where the company is headquartered (USA or elsewhere as a global company). The data is generated from prospective testing of the new Venus Viva™ device against established standards and comparisons to predicate device specifications.

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

This type of information is not applicable to the submission described. The "ground truth" here is objective engineering specifications, regulatory standards (e.g., IEC standards for electrical safety), and verified characteristics of the predicate devices. These are established through established scientific and engineering principles, not through expert human interpretation of results like in a diagnostic study.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable. Adjudication methods like 2+1 (two readers agree, third adjudicates if they disagree) are relevant for clinical studies where human readers interpret data (e.g., medical images) to establish ground truth or assess performance. The tests described are objective engineering measurements and compliance evaluations.

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

There was no MRMC comparative effectiveness study and the device is not an AI/CAD (Computer-Aided Detection/Diagnosis) device. It is an electrosurgical cutting and coagulation device. Therefore, this section is not applicable.

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

This is not an algorithm-only device. It is a physical medical device (an electrosurgical unit with applicators) designed for physician use. There is no "standalone" algorithm performance to evaluate in this context. Therefore, this section is not applicable.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the device's performance relies on several objective measures:

• Engineering Specifications: Pre-defined specifications for RF and PMF output, frequency, power, and other physical parameters.
• International Standards: Compliance with established IEC standards for electrical safety, EMC, and software lifecycle processes (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-1-6, IEC 62304).
• Biocompatibility Standards: Compliance with ISO 10993-1.
• Predicate Device Data: The established performance, safety, and effectiveness of the legally marketed predicate devices (Venus Viva™ SR K150161 and Venus Legacy BX K142910).

8. The Sample Size for the Training Set

There is no "training set" in the context of patient data or machine learning for this device. The device itself is "trained" during its manufacturing and calibration processes to meet the specified engineering parameters and operate reliably. This is not a machine learning or AI device that undergoes training with data.

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

As there is no "training set" in the context of patient data for machine learning, this question is not applicable. The "ground truth" for the device's operational parameters is established through its design specifications, calibration procedures, and testing against known physical and safety standards during its development and manufacturing.

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When used with the Octipolar (LB1) or Diamondpolar (LF1) applicators, the Venus Legacy Pro device is intended for use in dermatologic and general surgical procedures for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV.

When used with the 4D Body (LB2) or 4D Face (LF2) applicators, the Venus Legacy Pro device is intended for the delivery of non-thermal RF combined with Massage and magnetic field pulses for the treatment of the following medical conditions:

• Relief of minor muscles aches and pain, relief of muscle spasm
• Temporary improvement of local blood circulation
• Temporary reduction in the appearance of cellulite

The Venus Legacy Pro device consists of a console (main unit) and four applicators - Octipolar (LB1), Diamondpolar (LF1), 4D Body (LB2) and 4D Face (LF2). The console contains a power supply unit, an RF generator (power module, on main board), a suction module (vacuum), a controller unit (on main board) and a touchscreen user interface and display panel.

The Venus Legacy Pro device combines two previously cleared devices (Legacy BX, K142910 and Legacy CX. K143554) into one device. The two applicators that were cleared for the Legacy BX Device - Octipolar (LB1) and Diamondpolar (LF1) and the two applicators that were cleared for the Legacy CX device - 4D Body (LB2) and 4D Face (LF2) can now be connected simultaneously to a single console, the Legacy Pro device's console.

The provided text describes the Venus Legacy Pro device, its intended uses, and its substantial equivalence to previously cleared predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in terms of clinical performance metrics like sensitivity, specificity, accuracy, or effect size of human improvement with AI assistance.

Instead, the performance data presented focuses on engineering and regulatory compliance, not clinical outcomes.

Here's an analysis based on the information available in the text:

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

The document does not explicitly present a table of acceptance criteria for clinical performance (e.g., reduction in wrinkles by a certain percentage, pain relief score, cellulite reduction percentage). The "Performance Data" section primarily addresses engineering and regulatory compliance.

However, based on the bench tests mentioned, we can infer some performance targets for temperature control:

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

No information is provided regarding sample sizes for clinical test sets as the document focuses on technical performance and regulatory equivalence rather than clinical efficacy studies for this 510(k) submission. The "bench tests" mentioned are likely laboratory tests, not clinical studies with patients.

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. The document discusses device safety, performance verification, and substantial equivalence to predicates, not the establishment of ground truth for a clinical test set.

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

Not applicable. This information is relevant for clinical studies involving human assessment, which are not detailed in this document.

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 not an AI-assisted diagnostic or interpretation tool for human readers. It is a physical medical device for treatment.

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

Not applicable. This device is not an algorithm for standalone performance assessment.

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

For the bench tests, the "ground truth" would be the device's design specifications for temperature output, electrical safety, and electromagnetic compatibility. For clinical efficacy (e.g., wrinkle reduction, pain relief), the document does not describe studies that would establish such ground truth for the Venus Legacy Pro device. It relies on the indications for use of its predicate devices.

8. The sample size for the training set:

Not applicable. The document does not describe a machine learning algorithm that requires a training set.

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

Not applicable.

Summary of what the document focuses on:

The entire document pertains to a 510(k) premarket notification for the Venus Legacy Pro Device. This type of submission primarily demonstrates substantial equivalence to a previously cleared predicate device, rather than performing de novo clinical efficacy trials to establish new acceptance criteria.

The "Performance Data" section discusses:

• Bench Testing: To ensure the device's outputs meet specifications (e.g., temperature ranges for applicators) and are comparable to predicate devices.
• Electrical Safety and Electromagnetic Compatibility: Compliance with international standards (IEC 60601 series).
• Software Testing: Verification and validation to confirm the software performs as intended.

The acceptance criteria are therefore implicitly tied to meeting these engineering and regulatory standards, and demonstrating that any differences from the predicate devices do not raise new safety or effectiveness concerns. The study described is a series of engineering and regulatory compliance tests, not a clinical trial with human subjects to prove clinical efficacy against specific, measurable outcomes that would typically be described with metrics like sensitivity, specificity, or reader improvement.

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The Venus Bliss device is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less.

In addition, the Venus Bliss device is intended for the treatment of the following medical conditions; using the MPapplicator for delivery of RF energy combined with massage and magnetic field pulses:

• Relief of minor muscle aches and pain, relief of muscle spasm
• Temporary improvement of local blood circulation
• Temporary reduction in the appearance of cellulite

The Venus Bliss device consists of a console (main unit), one RF applicator and four Diode Laser applicators. The system delivers laser (Diode Laser Applicators) and bipolar RF energies, vacuum pressure, and pulsed magnetic fields (PMF) to the skin (MP2 applicator) and the underlying tissues of the treatment area.

The console of the Venus Bliss device contains a power supply unit, Laser and RF controllers, (power modules, on main board), a suction module (vacuum), a controller unit (on main board), Laser water cooling system (power module, on main board), a touch- screen user interface and display panel.

The provided text (K190743 FDA 510(k) clearance document for the Venus Bliss device) does not contain information about the acceptance criteria or a study that proves the device meets specific performance acceptance criteria for an AI/ML powered device.

The document primarily focuses on demonstrating substantial equivalence to predicate devices (Venus Legacy CX and Cynosure's SculpSure) based on intended use, technological characteristics, and principles of operation for regulatory clearance. It describes general performance testing conducted, such as:

• Performance Bench Testing: To evaluate device outputs per specifications and compare to predicate device specifications.
• Electrical Safety and Electromagnetic Compatibility: Testing against applicable IEC standards.
• Software Testing: Verification and validation testing.

However, these tests are for the physical device's fundamental operation and safety standards, not for the performance of an AI/ML algorithm that predicts or diagnoses based on analyzed data.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device's performance, because this document describes a physical medical device (diode laser system and RF applicator), not an AI/ML driven one.

If you have a document describing an AI/ML device that has undergone clinical validation and performance testing, please provide that document, and I would be happy to extract the information.

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The Venus Heal device is intended for the treatment of the following medical conditions; using the Large and Small applicators for delivery of non-thermal RF combined with massage and magnetic field pulses:

• . Relief of minor muscle aches and pain, relief of muscle spasm.
• Temporary improvement of local blood circulation .
• Temporary reduction in the appearance of cellulite ●

The subject device Venus Heal system is a modification of the legally marketed Venus Legacy CX system cleared under K143554. The proposed system is a smaller and lightweight version of the previously cleared Venus Legacy CX system. The Venus Heal system consists of a console (main unit) and two applicators (Large and Small). The console design change is driven to enhance the ergonomic capabilities of the product family.

The additional changes are summarized below:
a) Ergonomics of the user interface: bigger Liquid Crystal Display (LCD) color touch screen.
c) Tissue manipulation includes manual massage only.
d) Increase of Maximal RF output power.
e) Updated software to reflect hardware changes.

The Venus Heal RF energy, pulsed magnetic fields (PMF) and tissue manipulation are utilized to trigger changes in the tissue which result in muscle spasm relief and pain relief, along with local blood circulation improvement.

Temporary reduction in the appearance of cellulite is similarly achieved by combination of these three main mechanisms: RF and Pulse Magnetic Field (PMF) delivery as well as tissue manipulation,

Consistent with the previous clearance, the system is intended to be used in professional healthcare facilities (prescription use) just as the predicate, and its major components are still the main console unit, and individual modules/hand pieces.

The Venus Heal device is intended for the treatment of minor muscle aches and pain, muscle spasm relief, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite. The device uses non-thermal RF, massage, and magnetic field pulses.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

• IEC 60601-1 (General Requirements For Basic Safety And Essential Performance)
• IEC 60601-1-6 (General Requirements for basic safety and essential performance)
• IEC 60601-2-2 (Particular Requirements For The Basic Safety and Essential Performance Of High Frequency Surgery Equipment and High Frequency Surgical Accessories)
• IEC 60601-1-2 (Electromagnetic Compatibility Requirements and Tests). |
  | Software verification and validation. | Performed. |
  | Biocompatibility. | Confirmed using the same product material as in the predicate device. |

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

• Sample Size: Not explicitly stated for the benchmark test beyond "skin surface," but implies multiple measurements.
• Data Provenance: The study was a bench test, implying it was conducted in a laboratory setting by the manufacturer (Venus Concept USA Inc.). Country of origin is not specified, but the submission is to the U.S. FDA. It is a prospective test to verify performance.

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

• Experts: Not applicable. The ground truth for the bench test was established through direct physical measurements of temperature and functional assessment against specified engineering and regulatory standards.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The performance was assessed against objective physical and engineering standards, not through expert consensus on subjective outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The submission explicitly states: "Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no clinical studies were deemed needed to support this submission."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: Yes, the described performance testing (bench tests, software verification) appears to be a standalone (algorithm/device only) performance evaluation. It assesses the device's inherent capability to meet technical specifications and safety standards independent of user interaction beyond basic operation. There is no AI component mentioned in the device description.

7. Type of Ground Truth Used

• Ground Truth Type: For the bench test, the ground truth was based on objective physical measurements (e.g., temperature readings) and engineering standards (e.g., compliance with IEC standards) as defined by the device's technical specifications and regulatory requirements.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not appear to involve a machine learning algorithm that would require a "training set." The testing performed was for device performance verification and validation against established standards.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI algorithm.

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