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The ZIONIC PRO MAX (radiofrequency) equipment when used with the capacitive or resistive handpiece is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite.

The Zionic Pro Max with Radiofrequency is a non-invasive topical heating device that produces RF energy to warm subcutaneous tissue the therapeutic temperature of 40-45°C. The device includes two different type of RF handpieces, resistive and capacitive, which are connected to a console and software-powered user interface. The Zionic Pro Max adds a new capacitive handpiece and user interface to a previously cleared generation of the device.

The provided FDA 510(k) clearance letter for the Zionic Pro Max (Radiofrequency) device primarily concerns the safety and effectiveness of a medical device intended for topical heating and reduction of cellulite. It is not an AI/ML device that deals with image analysis, diagnosis, or prediction, and therefore, many of the typical acceptance criteria and study details associated with AI/ML medical devices (like MRMC studies, ground truth establishment by experts, sample sizes for training/test sets in the context of machine learning, etc.) are not applicable to this document.

The document discusses performance testing in the context of electrical safety, electromagnetic compatibility, and the device's ability to achieve and maintain a specific tissue temperature. It does not involve any AI/ML components requiring complex ground truth adjudication or studies for human-in-the-loop performance improvement.

Therefore, I will extract relevant information that is present in the document pertaining to the device's performance criteria and how it was shown to meet them.

Acceptance Criteria and Reported Device Performance

The core performance criterion for the Zionic Pro Max device, as established through non-clinical testing, is its ability to heat tissue to a specific therapeutic temperature.

Study Details (Based on available information in the 510(k) Summary)

Since this is not an AI/ML device, the standard questions regarding AI/ML study design (such as data provenance, expert ground truth establishment for diagnostic performance, MRMC studies, training set details) are not directly addressed in this type of 510(k) summary. The "study" here refers to non-clinical, benchtop performance testing to ensure the device meets its physical and electrical specifications and performs its intended function (heating tissue) effectively and safely.

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

   • The document mentions "Tissue thermal testing" and "Bench testing" but does not specify the sample size (e.g., number of test repetitions, number of ex-vivo tissue samples, or number of devices tested).
   • Data Provenance: Not specified, but generally, bench testing data would be generated in a lab setting, likely by the manufacturer (TermoSalud S.L.) or a contracted testing facility. No indication of patient data or country of origin for such data.

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

   • Not applicable. The "ground truth" for this device's performance is determined by physical measurements (temperature, power, frequency, voltage) using calibrated equipment, not by expert interpretation of complex visuals or medical conditions. Therefore, no human experts are mentioned for establishing ground truth in this context.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human experts are interpreting complex data (e.g., medical images) and their decisions need to be reconciled. This device's testing involves objective physical measurements.

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 hardware for topical heating and cellulite reduction, not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies are not relevant.

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

   • Not applicable. This device does not have a standalone algorithm in the sense of an AI/ML component performing diagnostic tasks. Its "performance" is based on the physical output and safety of the radiofrequency energy. The "software" mentioned (IEC 62304) relates to the control unit's functionality, not an AI/ML diagnostic algorithm.

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

   • The "ground truth" for the non-clinical testing appears to be measured physical parameters (e.g., temperature attained, electrical output values) against predefined specifications (40-45°C, accurate power/frequency/voltage).

7. The sample size for the training set:

   • Not applicable. There is no indication of a machine learning model being trained with a dataset mentioned in this 510(k) document. The "training" here refers to manufacturing and operational parameters, not data for an AI algorithm.

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

   • Not applicable. As there is no mention of an ML training set, there's no ground truth establishment method for it.

In summary, the provided document details the regulatory clearance for a physical medical device (radiofrequency equipment) based on its direct electrical and thermal performance characteristics, not on the performance of a software algorithm leveraging a dataset of medical cases.

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The VMAP PRO is intended for relief of minor muscle aches and pains, temporary increase in local blood circulation and activation of connective tissue.

The VMAT PRO is a pressure pulse device that creates pneumatically generated pressure pulses caused by compressed air delivering ballistic projectile through a handpiece coming into contact with the skin. VMAT PRO is equipped with one handpieces that includes four transmitters [VAT120 (diameter of 20mm), VAT220 (diameter of 20mm), VAT215 (diameter of 15mm), and VAT 135 (diameter 35mm)] that allow radial treatments, ergonomically designed to allow the user to work in various areas of the body. To facilitate the movement of the transmitter on the skin, and guarantee a correct contact, an ultrasound gel FDA cleared should be used (i.e. Aquasonic 100 Ultrasound Transmission Gel K802146).

The provided text is a 510(k) Summary for the VMAT PRO device, seeking substantial equivalence to a predicate device (D-Actor 200 Vibration Massage System). It focuses on demonstrating that the new device is as safe and effective as the legally marketed predicate. However, this document does not describe a study involving human readers, AI assistance, or the establishment of ground truth by multiple experts for a test set.

The closest information provided is about performance testing to establish that the VMAT PRO control unit performs as intended, and a comparison of its technological characteristics with the predicate device.

Therefore, I cannot fully address all the points in your request as the information is not present in the provided document. I will fill in what can be inferred and explicitly state where information is missing.

Here's an analysis based on the provided document:

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

The document does not explicitly state "acceptance criteria" in the format of a threshold that must be met. Instead, it aims to demonstrate "substantial equivalence" to a predicate device. The performance is assessed by comparing various technical specifications. The acceptance criterion is implicit: the device's performance characteristics must be sufficiently similar to the predicate device, or any differences must not impact safety or efficacy.

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

This document describes technical and performance testing of the device itself (e.g., electrical safety, EMC, acoustic characteristics), not a clinical study or a study involving a "test set" of patient data for AI evaluation. Therefore, this information is not applicable to this 510(k) summary. The testing refers to the device unit's performance, not a dataset.

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. This document does not concern an AI/clinical diagnostic device requiring expert adjudicated ground truth. The "ground truth" for the device's technical specifications is established through engineering and physical measurements according to international standards (IEC).

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

Not Applicable. As no diagnostic test set is used, no adjudication method is relevant.

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. The document explicitly states: "Clinical Evidence – N/A. No clinical studies were conducted as part of this submission." Therefore, no MRMC study was performed.

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

No. This is not an AI algorithm but a physical therapeutic device. The "performance testing" described refers to the device's physical and electrical characteristics as per IEC standards, not an algorithm's output.

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

For the technical characteristics comparison, the "ground truth" is derived from:

• Engineering measurements and specifications of the VMAT PRO device itself, conducted in a laboratory setting (e.g., "measured in a laboratory, using ultrasound" for applicator displacement).
• Published specifications of the predicate device (D-Actor 200) from its own 510(k) submission or technical documentation.
• Adherence to international standards such as IEC 60601-1, IEC 60601-1-2, and IEC 63045:2020 for safety, EMC, and ultrasonic characteristics.
• Biocompatibility testing according to ISO 10993-1:2018.

For the purpose of this 510(k) submission, the "ground truth" is primarily device-centric technical specifications and compliance with recognized standards, not clinical diagnostic outcomes or human expert interpretations of patient data.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not Applicable. As there is no training set.

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Intended Use ENEKA SELECTIF is intended for use in dermatologic and general surgical procedures.

Indications for Use

ENEKA SELECTIF System with 755nm Laser applicator is intended for:

• Hair removal with Dynamic and Fast Dynamic (FDHR) modes 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 regime.
• Treatment and prevention of Pseudofolliculitis barbae (PFB).
• Use on all skin types (Fitzpatrick I-VI).
• Treatment of benign pigmented lesions.

ENEKA SELECTIF System with 810nm Laser applicator is intended for:

• Hair removal with Dynamic and Fast Dynamic (FDHR) modes 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 regime.
• Treatment and prevention of Pseudofolliculitis barbae (PFB).
• Use on all skin types (Fitzpatrick I-VI).
• Treatment of benign pigmented lesions.

ENEKA SELECTIF System with 1060nm Laser applicator is intended for:

• Hair removal with Dynamic and Fast Dynamic (FDHR) modes 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 regime.
• Treatment and prevention of Pseudofolliculitis barbae (PFB).
• Use on all skin types (Fitzpatrick I-VI).
• Treatment of benign vascular lesions.

ENEKA SELECTIF System with 810 - 1060mm Laser applicator is intended for:

-Hair removal with Dynamic and Fast Dynamic (FDHR) modes 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 regime.

• Treatment and prevention of Pseudofolliculitis barbae (PFB).
• Use on all skin types (Fitzpatrick I-VI).

The ENEKA SELECTIF is a non-invasive diode laser system used for hair removal, prevention and treatment of Pseudofolliculitis barbae and treatment of vascular and pigmented lesions.

The system operates at different wavelengths (755, 810 and 1060 nm) separately plus a blended handpiece combining three wavelengths (810, 940 and 1060 nm).

The ENEKA SELECTIF is a diode laser device with 7 handpieces (spot sizes 10x9mm, 20x9mm and 30x12mm) and it allows two modes of treatment, DHR and FDHR. Both of them can be applied with every handpiece. Mode DHR allows the configuration of pulse width, frequency and fluency and mode FDHR allows the configuration of frequency and fluency.

The provided FDA 510(k) summary for the ENEKA SELECTIF device does not contain specific acceptance criteria, reported device performance (in terms of clinical metrics like efficacy percentages for hair reduction or lesion treatment), or detailed information about a study that proves the device meets such criteria.

Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate and reference devices (Primelase Excellence and ENEKA PRO). This means that the device is considered safe and effective because it is sufficiently similar in technological characteristics and intended use to devices already on the market.

However, I can extract the information related to the device's characteristics and the types of testing performed to support its safety and performance based on the provided document.

Here's an attempt to structure the answer based on your request, highlighting what is available and what is not:

Acceptance Criteria and Device Performance Study (as inferred from the 510(k) submission)

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the 510(k) summary does not present a table of specific quantitative acceptance criteria (e.g., "X% hair reduction") or corresponding numerical device performance data from a clinical study. The assessment is based on demonstrating substantial equivalence to pre-existing cleared devices and compliance with recognized standards.

However, the "Performance Testing" section states that: "Verification and validation activities were successfully completed and establish that the ENEKA SELECTIF performs as intended." This implies that the device met its design specifications and functional requirements as confirmed by the listed engineering and safety tests.

Summary of Device Performance (from "Performance Testing" and "Conclusion" sections):

• Intended Performance: Performs as intended for dermatologic and general surgical procedures, specifically for hair removal (permanent reduction in hair regrowth), treatment/prevention of Pseudofolliculitis barbae (PFB), use on all skin types (Fitzpatrick I-VI), and treatment of benign pigmented/vascular lesions.
• Output Power: Verified at each power level with all handpieces.
• Safety & Essential Performance: Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22.
• Biocompatibility: Patient-contacting materials are identical to the previously cleared Eneka Pro, implying acceptable biological safety.
• Software: Verification and validation testing conducted in accordance with FDA guidance.
• Contact Detection System: Includes a contact detection system for increased safety, designed to avoid firing the laser when no contact with skin is established.

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

• Test Set Sample Size: Not applicable (N/A) for clinical data. The submission states "Clinical Evidence - N/A. No clinical studies were conducted as part of this submission."
• Data Provenance: N/A for clinical data. The technical and safety testing data would be from laboratory and engineering tests, likely conducted at the manufacturer's facilities (TermoSalud, Gijón, Spain) or by certified testing bodies.

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

• N/A for clinical data. Since no clinical studies were conducted, there was no "ground truth" derived from expert consensus on patient outcomes for this submission. The ground truth for technical performance and safety would be established through compliance with recognized standards and internal engineering specifications, validated by internal technical experts and external testing laboratories.

4. Adjudication Method for the Test Set

• N/A for clinical data. No clinical adjudication method was used given the absence of clinical trials.

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

• N/A. This device is a laser system, not an AI-powered diagnostic or assistive tool, so an MRMC study is not relevant to its performance assessment as described in this submission.

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

• N/A. This device does not have an "algorithm only" component in the sense of AI or image analysis. Its performance is the direct output of the laser system itself.

7. The Type of Ground Truth Used

• For technical performance and safety: The "ground truth" is established by compliance with international and national standards (e.g., IEC 60601 series, ISO 10993-1) for medical electrical equipment, laser safety, electromagnetic compatibility, and biological compatibility. This is demonstrated through testing that verifies the device meets the requirements of these standards.
• For demonstrating substantial equivalence: The "ground truth" for the device's therapeutic efficacy (hair removal, PFB, lesion treatment) is based on the established safety and effectiveness of the legally marketed predicate devices (Primelase Excellence and Eneka Pro) which have similar technological characteristics and indications for use.

8. The Sample Size for the Training Set

• N/A. This type of device does not involve a "training set" in the context of machine learning.

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

• N/A. As above, no training set in the context of machine learning is applicable.

In summary: The FDA 510(k) for ENEKA SELECTIF demonstrates substantial equivalence through extensive technical characteristic comparison with predicate devices and by ensuring compliance with established safety and performance standards. It explicitly states that "No clinical studies were conducted as part of this submission." Therefore, quantitative clinical acceptance criteria, clinical performance data, expert ground truth establishment for clinical cases, and MRMC/AI-related studies are not present in this document.

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The Zionic Aesthetic is intended to provide topical heating tor the purpose of elevating tissue temperature for treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.

The ZIONIC ASTHETIC is a resistive radiofrequency device which output energy can reach up to 200W. It has two different electrodes with different sizes, to adapt the treatment to the different body areas. The electrodes roll to perform a massage while applying the radiofrequency energy.

This document is an FDA 510(k) summary for the ZIONIC AESTHETIC device. It asserts substantial equivalence to a predicate device, the Nuera Tight RF. The information provided heavily focuses on the technical specifications and safety testing, not on efficacy or clinical performance data typically associated with acceptance criteria and studies demonstrating device performance against those criteria, especially for claims like "temporary reduction in the appearance of cellulite" or "temporary relief of pain."

Therefore, based solely on the provided text, it is not possible to fully answer many of the requested points, particularly those related to clinical performance, a multi-reader multi-case study, or detailed ground truth establishment for a test set demonstrating efficacy. The document explicitly states "Clinical Evidence – N/A. No clinical studies were conducted as part of this submission."

However, I can extract the information that is present regarding the technical performance and the comparative testing against the predicate device.

Here's an attempt to answer based on the provided text, highlighting what is present and what is explicitly stated as not applicable or missing:

Acceptance Criteria and Reported Device Performance

The acceptance criteria described in this document are primarily related to technical performance, electrical safety, and software validation, rather than direct clinical efficacy for the stated indications. The "performance testing" section outlines these.

Detailed Study Information (Based on the provided text):

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:
* Clinical "Test" for Temperature Maintenance: "two patients and three test sites – abdomen, thighs, and arms—". This is a very small sample focused on a biophysical parameter (temperature maintenance), not clinical efficacy.
* Provenance: Not explicitly stated, but the applicant's address is Gijón, Spain, so it's possible this limited testing was conducted there. It is retrospective in the context of this 510(k) submission, as it was performed prior to the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable / Not stated. For the temperature maintenance test, "ground truth" would be the direct temperature measurements. For clinical indications like cellulite reduction or pain relief, no clinical studies were performed, and thus no expert-derived ground truth for efficacy was established for the ZIONIC AESTHETIC. The premise of the 510(k) is substantial equivalence to a predicate, not independent clinical proof of efficacy.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable. Given the nature of the "performance testing" (technical and temperature measurements), there's no mention or need for an adjudication method as would be used in a clinical efficacy study involving subjective assessments.

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, not applicable. The device is a physical aesthetic/therapeutic device, not an AI or imaging diagnostic tool that would typically involve human readers or MRMC studies. The document explicitly states: "Clinical Evidence – N/A. No clinical studies were conducted as part of this submission."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. This isn't an algorithm that would have "standalone" performance in the sense of an AI diagnostic. The device functions independently in applying RF energy and massage. Its performance is measured by its output characteristics and ability to maintain temperature.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* For the technical performance tests (electrical safety, software, output accuracy), the ground truth is based on engineering specifications and adherence to international standards (e.g., IEC standards).
* For the temperature maintenance test, the ground truth was direct temperature measurements from the skin (on 2 patients).
* For the clinical indications (pain relief, cellulite reduction), the document explicitly states "No clinical studies were conducted as part of this submission." Therefore, no ground truth related to clinical outcomes was established for the ZIONIC AESTHETIC in this submission. The claim for these indications relies on substantial equivalence to the predicate device which presumably had a basis for these claims.

8. The sample size for the training set:
* Not applicable. This device is not an AI/machine learning model where a "training set" would be relevant.

9. How the ground truth for the training set was established:
* Not applicable. See point 8.

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The Symmed Elite Aesthetic is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation.

The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.

The Symmed Elite Aesthetic device is a radiofrequency generator that is used for a number of pain related applications such as" to relieve pain, muscle spasms and increase local circulation through electrical and thermal stimulation of the treated tissues". In addition, it contains a massage function that provides temporary improvement in the appearance of cellulite. The Symmed Elite Aesthetic consists of a console plus 2 handpieces, each with 3 different size electrodes. Each handpiece is capable of being fitted with the optional massager. This allows for flexible treatment parameters throughout the working range and handpieces.

The provided document, a 510(k) summary for the Symmed Elite Aesthetic, does not describe an AI medical device. Instead, it details a radiofrequency generator for topical heating and a massage device for cellulite reduction. Therefore, the questions related to AI device acceptance criteria, ground truth, expert adjudication, MRMC studies, and training/test set data are not applicable.

However, I can extract the relevant performance testing information for the described device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Indiba Diathermia RF, K161458) through comparison of specifications and direct performance testing. While explicit "acceptance criteria" for each performance metric are not listed as pass/fail thresholds in a table, the performance testing section describes what was evaluated and the comparison table highlights areas of similarity or difference with the predicate.

Key Performance Testing Conducted (General Acceptance Criteria Implied):

• Electrical Safety & Performance:
  • IEC 60601-1:2005 (Third Edition) + A1:2012 (General requirements for basic safety and essential performance)
  • IEC 60601-1-2:2014 (Electromagnetic compatibility requirements and tests)
  • IEC 60601-2-2:2017 (Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories)
• Biocompatibility:
  • ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (Implies components in contact with the body are safe)
• Software Verification & Validation:
  • IEC 62304:2006/A1:2016 (Implies software functions as intended and is safe)
• Specific Device Functionality:
  • Performance testing to show that frequency, impedance, voltage output, and output power all performed within the accepted range (Implies these electrical parameters were measured and found compliant).
  • Tissue Heating Capability: The device "can maintain a skin surface temperature of 40°C for 10 minutes of treatment." (This is a specific functional acceptance criterion and was met).

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

The document states: "The Symmed Elite Aesthetic device has been validated through an in-house study to demonstrate that the device can maintain a skin surface temperature of 40°C for 10 minutes of treatment."

• Sample Size: Not specified. It's an "in-house study," which typically implies a limited number of test subjects or a bench test setup simulating skin.
• Data Provenance: "In-house study," likely conducted by the manufacturer, Termosalud, in Spain (Ataulfo Friera Tarfe, 8 - 33211 Gijón, Spain). It is a prospective test of the device's performance.

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

N/A for this type of device. There is no "ground truth" established by experts in the context of diagnostic interpretation as there would be for an AI device. The validation is based on physical measurements (temperature, electrical parameters, safety standards).

4. Adjudication Method for the Test Set:

N/A. This is not an interpretive diagnostic study requiring adjudication. Performance is measured against predefined technical specifications or the ability to achieve a physical outcome (e.g., maintaining a specific temperature).

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

No, an MRMC study was not done. This is not an AI device, and its performance is not assessed in terms of human reader improvement.

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

N/A. This is a physical device, not an algorithm. The device's performance is inherently standalone in its function (e.g., it heats by itself).

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on engineering specifications, international consensus standards (IEC, ISO), and direct physical measurements (e.g., temperature, electrical outputs). For the tissue heating study, the ground truth was the measured attainment of 40°C for 10 minutes on the skin surface.

8. The Sample Size for the Training Set:

N/A. This is not an AI/machine learning device that requires a training set.

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

N/A.

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Indications for use for Eneka Pro diode laser hair removal system with 808nm applicators include:

· Hair Removal with Dynamic (DHR) and Fast Dynamic (FDHR) mode 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 regime.

• · Treatment of Pseudofolliculitis barbae (PFB).
• · Use on all skin types (Fitzpatrick I-VI)

The Eneka Pro is a non-invasive diode laser based system used for Hair Removal. The system is based on a single wavelength diode laser with 2 handpieces (spot sizes 20x9mm and 34x14mm) and the ability to control the pulse width, frequency and power. The Hair Removal Laser is intended for use on all skin types (Fitzpatrick skin types I-VI).

The provided text is a 510(k) summary for the Eneka Pro device. It describes the device, its indications for use, and its substantial equivalence to a predicate device (Primelase). However, it explicitly states "No clinical studies were conducted as part of this submission" and does not include performance data or acceptance criteria that would typically be found in a clinical study report.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample size, ground truth, experts, and adjudication methods is not available in the provided document.

Here's the information that can be extracted or derived from the text:

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

   • Not available. The document does not provide a table with specific acceptance criteria or quantitative performance metrics from a study. It only lists general "Performance Testing" which included electrical safety, EMC, laser safety, biocompatibility, and software V&V.

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

   • Not available. Since "No clinical studies were conducted," there is no test set of patients or associated provenance information.

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 available. Without clinical studies, there was no need for experts to establish ground truth for a test set.

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

   • Not available. Not applicable as no clinical studies were 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 available. This device is a laser hair removal system, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

   • Not applicable. This is a hardware device, not an algorithm, so "standalone" performance in the AI context does not apply.

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

   • Not available. No clinical studies, therefore no ground truth was established from patient data. The "Performance Testing" mentioned refers to engineering and safety standards, not clinical outcomes.

8. The sample size for the training set

   • Not applicable / Not available. This is a physical device, not a machine learning model, so there is no concept of a "training set" in the context of an algorithm.

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

   • Not applicable / Not available. As above, no training set for an algorithm was used.

Summary of available information regarding performance:

The document states: "Verification and validation activities were successfully completed and establish that the Eneka Pro performs as intended." These activities included:

• IEC 60601-1:2005 (Third Edition) + A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
• IEC 60601-1-2:2014 Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility Requirements and tests
• IEC 60601-2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
• ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• Software verification and validation testing in accordance with FDA's Guidance for Premarket Submissions for Software Contained in Medical Devices.

The conclusion is based on substantial equivalence to the predicate device (Primelase) and the successful completion of these non-clinical performance and safety tests, rather than clinical efficacy data.

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