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The Nd:YAG 1064 Laser is intended for:
• Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of Pseudofolliculitis Barbae (PFB). Permanent hair reduction is 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 regime. The lasers are indicated on all skin types, such as Fitzpatrick I-VI, including tanned skin.
· Photocoagulation and hemostasis of benign pigmented and vascular lesions such as but not limited to port-wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins.
· Coagulation and hemostasis of soft tissue.
· Treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sunspots cafe au lait macules, sebortheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis), tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for benign pigmented lessons to reduce lesion size, for patients with benign that would potentially benefit from aggressive treatment, and for patients with benign lesions that have not responded to other laser treatments.
· Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
· Treatment of wrinkles.
· Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and for yeast Candida Albicans, etc.).

The Alexandrite 755 laser is intended for:
· Temporary hair reduction.
· Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is 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 regime. On all skin types, such as Fitzpatrick I - V1, including tanned skin.
· Treatment of benign pigmented lesions.
· Treatment of wrinkles.
· Photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas).

The Alex+Nd:YAG (755 + 1064 lasers) is intended for:
· Stable long-term or permanent hair reduction targeting of melanin in hair follicles. Permanent hair reduction is 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 regime.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a laser device (Splendor X). It confirms the device's substantial equivalence to previously marketed devices and outlines regulatory requirements. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device submission.

The document is purely a regulatory clearance notice for a physical laser device and does not discuss AI/ML performance or validation studies. Therefore, I cannot extract the requested information from this text.

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The Nd:YAG 1064 Laser is intended for:

• Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of Pseudofolliculitis barbae (PFB). Permanent hair reduction is 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 regime. The lasers are indicated on all skin types, such as Fitzpatrick I-VI, including tanned skin.
• Photocoagulation and hemostasis of benign pigmented and vascular lesions such as, but not limited to, port-wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins.
• Coagulation and hemostasis of soft tissue.
• Treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sunspots), café au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for benign pigmented lesion size, for patients with benign lesions that would potentially benefit from aggressive treatment, and for patients with benign lesions that have not responded to other laser treatments.
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
• Treatment of wrinkles.
• Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and for yeast Candida Albicans, etc.).

The Alexandrite 755 laser is intended for:

• Temporary hair reduction.
• Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is 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 regime. On all skin types, such as Fitzpatrick I - VI, including tanned skin.
• Treatment of benign pigmented lesions.
• Treatment of wrinkles.
• Photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

The Splendor X (Alex, Alex , Nd:YAG, Alex + Nd: YAG), hereinafter referred to as "Splendor X", is a laser equipped with one or two solid-state laser sources.
The 4 configurations differ for the internal crystals of the sources, that can be Alexandrite and/or Nd:YAG. The emitted laser radiation has a wavelength of 755nm, respectively, and 1064nm:

• Alex configuration has only one source and one wavelength available (755 nm).
• . Alex configuration has two sources of the same wavelength (755 nm), in order to increase the maximum power available.
• Nd:YAG configuration has only one source and one wavelength available (1064 nm).
• . In the Alex+Nd:YAG configuration has both the two wavelengths available (755 nm and 1064 nm). In this configuration the two wavelengths can act only individually, simultaneous operations are not allowed. This configuration works with three different modes: only with Alex source, only with Nd:YAG source or in the BlendX mode. With the BlendX mode, an initial pulse with Alexandrite source is followed automatically, without overlapping in time, by another pulse of the Nd:YAG source.
  This device is intended for medical use only.

The provided text is a 510(k) premarket notification for a medical device called Splendor X. This document asserts substantial equivalence to a predicate device and does not describe a study that establishes new acceptance criteria or proves the device meets them with clinical performance data. Instead, it relies on demonstrating that the new device is as safe and effective as a legally marketed device (the predicate).

Therefore, specific information regarding acceptance criteria, device performance, sample sizes for test sets, data provenance, expert-established ground truth, adjudication methods, MRMC studies, standalone performance, training set size, and training set ground truth establishment is not available in this document because it is largely focused on demonstrating substantial equivalence through technical comparisons and compliance with recognized standards, rather than new clinical trials with performance endpoints.

The document states: "Animal and clinical studies were not necessary to demonstrate that the performances are equivalent to the predicate devices." This confirms that a novel study to prove the device meets acceptance criteria as typically understood for new performance claims was not conducted or presented in this submission.

However, I can extract the comparison data provided for substantial equivalence, which serves as an "acceptance" of comparable features and performance to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here implicitly refer to the substantial equivalence to the predicate device, "Family of Square Epil (Alex, Alex2, Nd:YAG, Alex+Nd:YAG), K161632," and reference device "GentleMax Pro Plus, K201111." The "reported device performance" is a comparison of technical specifications and indications for use.

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

• Test set sample size: Not applicable. The submission states, "Animal and clinical studies were not necessary to demonstrate that the performances are equivalent to the predicate devices." The substantial equivalence is based on technical comparisons and compliance with relevant standards.
• Data provenance: Not applicable for a clinical test set. The data provenance discussed relates to technical documentation and regulatory standards.

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. No clinical test set with expert-established ground truth was used for this submission.

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

• Not applicable. No clinical test set.

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/CADe device. It is a laser surgical instrument.

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

• Not applicable. This device is not an AI/CADe device.

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

• Not applicable. No clinical test set with ground truth was used. The submission relies on technical specifications and regulatory compliance.

8. The sample size for the training set:

• Not applicable. No software requiring a training set for clinical performance claims was described.

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

• Not applicable. No training set was described for clinical performance claims.

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The NuEra Tight RF Model OptiStream is intended:

• to provide topical heating to treat selected medical conditions such as for temporary relief of pain or muscle spasms and to increase local circulation on body and face.
• to provide, with a massage device, a temporary reduction in the appearance of cellulite.

NuEra Tight RF Family is a family of devices designed to develop localized heat to warm the subcutaneous tissue by means of radio frequency energy, delivered through electrodes in contact with the patient.

Specifically, there are two devices in the family:

• NuEra Tight RF radiofrequency generator with single RF electrode connector -
• NuEra Tight RF Plus radiofrequency generator with single RF electrode connector. In addition, the NuEra Tight RF Plus has a larger size to accommodate an additional electronic part that has previously been cleared (K201239) and classified under procode NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 21 CFR § 890.5850); hence, this model provides the functions classified under both procodes PBX and NGX.

The treatment performed by the NuEra Tight RF Family consists of increasing the temperature of the treated tissues up to maximum of 45°C. Therefore, depending on the treatment and intended use, different parts of the body can be treated.

The models use RF monopolar and bipolar capacitive electrodes. Monopolar capacitive RF electrodes have different sizes and plug into an RF handpiece that provides connection to the RF generator. Handpieces of different shapes are available to facilitate use by the operator on different body parts. Capacitive electrodes work in combination with a return plate that must be in contact with the patient's body during the treatment in order to close the circuit with the RF generator. Return plates are available as single use, with specific connectors on the panel below the front tray of the main control unit.

One bipolar capacitive electrode is provided fixed to a dedicated handpiece intended for the treatment of small body areas. Being bipolar, the electrode is not meant to work with a return plate.

One massage handpiece is provided to be used to add a mechanical treatment to the heat emission.

All the handpieces are used with a small amount (approximately 1 mm layer) of cream, that is Parker Redux cream K782055. The cream purpose is to provide a lubricious coating to allow the user to glide the electrode over the treated area and to ensure conduction with the return element on the bipolar electrode.

A footswitch is provided as an optional user interface that allows to start and stop the medical treatment. It can be used as an alternative to the GUI start and stop button. The Pause Handpiece can be used to pause the treatment without using the GUI.

The labeling changes proposed in this submission are to clarify that the use of the device to provide topical heating to increase local circulation is not limited to the body but can also include the face with the exception being within the orbital rim and on the neck.

The provided text is a 510(k) summary for a medical device (NuEra Tight RF Model OptiStream), which focuses on establishing substantial equivalence to a predicate device. It does not describe a study involving an AI algorithm or a device that meets acceptance criteria through AI performance metrics. Therefore, I cannot generate the requested information about acceptance criteria and study proving AI device performance.

The document discusses:

• Device Name: NuEra Tight RF Model OptiStream
• Intended Use: Topical heating for pain relief, muscle spasms, increased local circulation (body and face), and temporary reduction of cellulite.
• Comparison to Predicate: The submission is primarily to update the indication statement to include use on the face and to introduce an additional 10mm electrode.
• Performance Data: Refers to literature, bench testing, and clinical testing on the face to support the proposed labeling changes, and testing of the 10mm electrode. It states that the device is able to "induce and maintain such a temperature on the face" (referring to 42°C for face, as opposed to 45°C for body).

There is no mention of:

• Acceptance criteria for an AI algorithm
• Performance metrics like sensitivity, specificity, accuracy, or AUC
• Sample sizes for a test set or training set for AI
• Expert annotation or ground truth adjudication for AI
• MRMC studies or standalone AI performance

Therefore, I am unable to fulfill your request as it pertains to AI device performance.

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The NuEra Tight RF and NuEra Tight RF Plus are intended:

• to provide topical heating for the purpose of elevating tissue temperature for the treatment of conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

• to provide, with a massage device, a temporary reduction in the appearance of cellulite.

• to provide, via heat-induced lipolysis at 1 and 2 MHz, abdominal circumference reduction with adjunctive improvement in the appearance of skin laxity.

NuEra Tight RF and NuEra Tight RF Plus are designed to develop localized heat to warm the subcutaneous tissue by means of radio frequency energy, delivered through electrodes in contact with the patient. Specifically,

• NuEra Tight RF radiofrequency generator with single RF electrode connector. -
• NuEra Tight RF Plus radiofrequency generator with single RF electrode connector. In addition, the NuEra Tight RF Plus has a larger size to accommodate an additional electronic part that has previously been cleared (K201239) and classified under procode NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 21 CFR § 890.5850); hence, this model provides the functions classified under both procodes PBX and NGX.
  The treatment performed by the NuEra Tight RF models consists of increasing the temperature of the treated tissues up to maximum of 45°C. Therefore, depending on the treatment and intended use, different parts of the body can be treated.

The models use RF monopolar and bipolar capacitive electrodes. Monopolar capacitive RF electrodes have different sizes and plug into an RF handpiece that provides connection to the RF generator. Handpieces of different shapes are available to facilitate use by the operator on different body parts. Capacitive electrodes work in combination with a return plate that must be in contact with the patient's body during the treatment in order to close the circuit with the RF generator. Return plates are available as reusable or single use, with specific connectors on the panel below the front tray of the main control unit.

One bipolar capacitive electrode is provided fixed to a dedicated handpiece intended for the treatment of small body areas. Being bipolar, the electrode is not meant to work with a return plate.

One massage handpiece is provided to be used to add a mechanical treatment to the heat emission.

All the handpieces are intended to be used with a small amount (approximately 1 mm layer) of an RF conductive cream (Parker Redux cream, cleared under K782055, or similar cream available in the US). The purpose of the cream is to provide aid to transfer the heat.

A footswitch is provided as an optional user interface that allows to start and stop the medical treatment. It can be used as an alternative to the GUI start and stop button.

The pause handpiece is an optional accessory can be used to pause the treatment without using the GUI.

The provided document describes a 510(k) premarket notification for the "NuEra Tight RF and NuEra Tight RF Plus" devices, focusing on the addition of an abdominal circumference reduction indication. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Enrollment: 82 subjects were enrolled and randomized.
  • Effectiveness Analysis (Primary Endpoint): n=23 for the 1 MHz group and n=18 for the 2 MHz group. This reflects subjects who completed at least 3 of 4 treatment sessions.
• Data Provenance: The study was a "multi-center" study, implying data from multiple locations, likely within one or more countries. The document does not explicitly state the country of origin. It was a prospective, randomized study.

3. Number of Experts and Qualifications for Ground Truth

• For Skin Laxity and Aesthetic Appearance: "Blinded assessors" and "blinded reviewers" were used to evaluate before/after pictures and identify improvements.
• Qualifications: The document does not specify the exact number or qualifications of these assessors/reviewers (e.g., radiologist with 10 years of experience). It just indicates they were "blinded."

4. Adjudication Method for the Test Set

• The document describes "blinded assessors" and "blinded reviewers" for evaluating photographic evidence for skin laxity and aesthetic appearance. It does not mention a specific adjudication method like 2+1 or 3+1 for resolving discrepancies, implying a consensus or majority opinion approach might have been used, or that the "majority" finding was sufficient. For quantitative measurements like circumference, direct measurement itself serves as the ground truth.

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

• No, a Human-in-the-loop (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. The device in question is a medical aesthetic device (radiofrequency energy for tissue heating, circumference reduction, cellulite, and skin laxity), not an AI-based diagnostic or interpretative tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance

• Not applicable. This device is a physical RF energy delivery system, not an algorithm or software designed to operate without human intervention in a diagnostic or analytical capacity. Therefore, a standalone performance evaluation in the context of an algorithm would not be relevant. The "standalone" performance here relates to the device's ability to achieve the intended physiological effects.

7. Type of Ground Truth Used

• Primary Effectiveness (Circumference Reduction): Objective measurements of waist circumference.
• Secondary Effectiveness (Skin Laxity & Aesthetic Appearance): Expert assessment (blinded assessors/reviewers) of photographic evidence and subjective reports from investigators and subjects (GAIS score).
• Safety: Directly observed adverse events and patient-reported discomfort/pain levels (VAS score).

8. Sample Size for the Training Set

• The document does not explicitly mention a "training set" or a separate training phase for the device itself. The clinical study described is the primary efficacy and safety study. As this is not an AI/ML device in the traditional sense, a specific "training set" for an algorithm is not applicable. The device's operational parameters are based on established RF technology and prior predicate devices.

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

• Not applicable, as a discrete "training set" for an algorithm, separate from the clinical validation study, is not described or relevant for this type of device. The "ground truth" for the device's design and operational parameters would have been established through engineering principles, pre-clinical testing, and knowledge gained from predicate devices.

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The NuEra Tight RF Model APMD145.M70-US is intended for:

• 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.
• to provide, with a massage device, a temporary reduction in the appearance of cellulite.

NuEra Tight RF Family is a family of devices designed to develop localized heat to warm the subcutaneous tissue by means of radio frequency energy, delivered through electrodes in contact with the patient.
Specifically, there are two devices in the family:

• NuEra Tight RF radiofrequency generator with single RF electrode connector -
• -NuEra Tight RF Plus - radiofrequency generator with single RF electrode connector. In addition, the NuEra Tight RF Plus has a larger size to accommodate an additional electronic part that has previously been cleared (K201239) and classified under procode NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 21 CFR § 890.5850); hence, this model provides the functions classified under both procodes PBX and NGX.
  The treatment performed by the NuEra Tight RF Family consists of increasing the temperature of the treated tissues up to maximum of 45°C. Therefore, depending on the treatment and intended use, different parts of the body can be treated.
  The models use RF monopolar and bipolar capacitive electrodes. Monopolar capacitive RF electrodes have different sizes and plug into an RF handpiece that provides connection to the RF generator. Handpieces of different shapes are available to facilitate use by the operator on different body parts.
  Capacitive electrodes work in combination with a return plate that must be in contact with the patient's body during the treatment in order to close the circuit with the RF generator. Return plates are available as reusable or single use, with specific connectors on the panel below the front tray of the main control unit.
  One bipolar capacitive electrode is provided fixed to a dedicated handpiece intended for the treatment of small body areas. Being bipolar, the electrode is not meant to work with a return plate.
  One massage handpiece is provided to be used to add a mechanical treatment to the heat emission.
  All the handpieces are used with a small amount (approximately 1 mm layer) of cream, that is Parker Redux cream K782055. The cream purpose is to provide a lubricious coating to allow the user to glide the electrode over the treated area and to ensure conduction with the return element on the bipolar electrode.
  A footswitch is provided as an optional user interface that allows to start and stop the medical treatment. It can be used as an alternative to the GUI start and stop button.
  The pause handpiece can be used to pause the treatment without using the GUI.
  A new accessory, proposed in this submission, is the Handsfree Accessory. The Handsfree will enable the same treatment without requiring the operator to manually move the handpiece and connected electrode over the entire treatment area. This is because the Handsfree electrodes (up to 8) can be connected together in a row with a belt, and also used with a double-sided adhesive tape, to better attach to the entire treatment area.

The provided text is a 510(k) Summary for the NuEra Tight RF Model APMD145.M70-US. It describes a medical device, which is an electrosurgical cutting and coagulation device. However, the document does not contain information about acceptance criteria and a study proving the device meets those criteria, especially in the context of device performance metrics like sensitivity, specificity, accuracy, or any clinical trial results typically associated with establishing device effectiveness against specific endpoints.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K210867) by introducing a "Handsfree Accessory." The "Performance Data and Bench Test" section briefly mentions verification and validation were performed on the Handsfree accessory using methods established by the predecessor device and in accordance with several standards (EN 60601-1, EN 60601-1-2, IEC 62304, ISO 14971). It concludes that "Testing confirms that the Handsfree operates in accordance with the same principles as the cleared electrodes in the predicate, which is to maintain the selected temperature at the treated site."

This level of detail is insufficient to answer the questions posed, as it does not present:

1. A table of acceptance criteria and reported device performance: No specific performance metrics (e.g., in terms of temperature accuracy, duration of elevated temperature, or reduction in cellulite appearance quantified with specific measurements) are provided, nor are numerical acceptance criteria discussed.
2. Sample size and data provenance: No information is given about sample sizes for any tests, nor the provenance of any data (e.g., country of origin, retrospective/prospective).
3. Number and qualifications of experts for ground truth: No experts are mentioned in relation to establishing ground truth, as there are no clinical performance measures reported.
4. Adjudication method: Not applicable as no ground truth establishment is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this device treats patients directly and does not involve human readers interpreting AI output.
6. Standalone performance: While the device acts in a standalone manner, the document doesn't provide detailed performance data typically associated with a standalone study. The "performance data" mentioned refers to bench testing for safety and functional equivalence.
7. Type of ground truth: No specific ground truth (pathology, outcomes data, expert consensus) is discussed regarding device performance, as the primary focus is on safety and functional equivalence to the predicate, specifically for the new accessory. The statement "maintain the selected temperature at the treated site" implies a functional goal, but not how "ground truth" for this was established beyond physical measurement.
8. Sample size for training set: Not applicable, as this is a physical medical device, not an AI/ML algorithm that requires a training set in the conventional sense.
9. How ground truth for training set was established: Not applicable.

In summary, the provided document is a regulatory submission focused on substantial equivalence for a physical medical device and its new accessory, emphasizing safety and functional similarity to a predicate. It does not contain the kind of detailed performance criteria, study data, or ground truth establishment typically found in studies for diagnostic or AI-powered devices measuring specific efficacy or accuracy outcomes.

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The NuEra Tight RF Family is intended for:

• 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.
• to provide, with a massage device, a temporary reduction in the appearance of cellulite.

NuEra Tight RF Family is a family of devices designed to:

• develop localized heat to warm the subcutaneous tissue by means of radio frequency energy, delivered through electrodes in contact with the patient.
  Specifically, there are two devices in the family:
• -NuEra Tight RF - radiofrequency generator with single RF electrode connector
• -NuEra Tight RF Plus - radiofrequency generator with single RF electrode connector. The device has a different design, in particular for larger size, than the NuEra Tight RF, for the presence of an additional electronic part that is cleared under K201239.
  The purpose of the treatment based on the radiofrequency system (NuEra Tight) is to raise the temperature inside the tissues up to maximum of 45℃. Therefore, depending on the treatment and intended use, different parts of the body can be treated.
  The devices use RF electrodes of the capacitive (or monopolar) and resistive (or bipolar) types. Capacitive RF electrodes have different sizes and plug into an RF handpiece that provides connection to the RF generator (through the electrode connectors). Handpieces of different shapes are available to facilitate use by the operator on different body parts.
  The small area handpiece tip is provided sterile and disposable. The tip is Eto sterilized, the sterilization process was verified and validated using FDA-recognized standards UNI EN ISO 11138-1, UNI EN ISO 11138-2 and UNI EN ISO 11138-7. Also, the package integrity and shelf-life for this change have been evaluated through accelerated aging using American Society for Testing and Materials (ASTM) F1980.
  Capacitive electrodes work in combination with a return plate that must be in contact with the patient's body during the treatment in order to close the circuit with the RF generator. Return plates can be reusable or disposable, with specific connectors on the front tray. One resistive electrode is provided fixed to a dedicated handpiece intended for the treatment of small body areas. The resistive electrode, being bipolar, is not meant to work with the return plate. One massage handpiece is provided to be used to add a mechanical treatment to the heat emission. All the handpieces are used with a small amount (approximately 1 mm layer) of cream, that is Parker Redux cream K782055. The cream purpose is to provide aid to transfer the heat.
  A footswitch is provided as an optional user interface that allows to start and stop the medical treatment. It can be used as an alternative to the GUI start and stop button.
  The pause handpiece can be used to pause the treatment without using the GUI.

The provided text describes a 510(k) premarket notification for a medical device called the "NuEra Tight RF Family." This submission seeks to demonstrate substantial equivalence to a legally marketed predicate device (K200359), with the only significant change being the introduction of a sterile, disposable tip for the small area handpiece.

Therefore, the acceptance criteria and study described here are focused on demonstrating that this change does not negatively impact the device's safety or effectiveness, and that the sterilization process itself is valid.

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

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

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 explicitly state the specific numerical sample size for the functional testing of the small area handpiece tips. It indicates "Tips, after sterilization process, have been tested." It also mentions that "Ethylene Oxide sterilization and Shelf-life validation activities for the new disposable configuration of the small area handpiece tip were conducted by external laboratories," implying these tests followed established protocols which would involve specific sample sizes, though they are not detailed in this summary.

The data provenance is not specified (e.g., country of origin, retrospective/prospective). The applicant is listed as "Bios s.r.l." from Italy.

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)

This section is not applicable to the provided document. The studies described are for functional performance and sterilization validation of the device components, not for diagnostic or interpretive tasks where expert ground truth would be required (e.g., image analysis, clinical diagnosis). The "ground truth" here is objective measurement (e.g., temperature, sterility, package integrity) against established standards.

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

This is not applicable as the studies are technical performance and sterilization validations, not involving human interpretation or adjudication for clinical outcomes.

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 is not applicable. The device is an RF energy delivery system for therapeutic purposes (topical heating, cellulite reduction), not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant to this submission.

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

This is not applicable. The device is a physical RF energy system, not a standalone algorithm. Its performance is evaluated through functional testing and adherence to physical standards.

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

For the functional testing, the "ground truth" is based on objective physical measurements against predefined parameters (e.g., maintaining skin temperature within a specific range, over a specific duration, at specified RF frequencies).
For sterilization and shelf-life validation, the "ground truth" is defined by compliance with recognized international standards (ISO 11607, ISO 11135-1, ISO 10993-7, ASTM F1980).

8. The sample size for the training set

This is not applicable. The device is not based on a machine learning model that requires a "training set." The testing performed is for validating physical and sterilization performance.

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

This is not applicable as there is no training set for this type of device.

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The NuEra Tight Family, EMS Model, is intended for:

• improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen;
• strengthening, toning and firming of buttocks, thighs and calves;
• improvement of muscle tone and firmness, for strengthening muscles in arms.

NuEra Tight Family, EMS Model, is a family of devices designed to:

• produce an electromagnetic field that induces electrical current in the muscles. By muscle stimulation, the system helps to strengthen, tone and firm the abdomen, buttocks, thighs and calves.
  The device belonging to the NuEra Tight Family, EMS Model, generates an intense magnetic field which is used to stimulate muscles trough two EMS handpieces, one small and one large, which can treat body parts of different sizes.

This document is a 510(k) summary for the NuEra Tight Family, EMS Model, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria based on clinical outcomes.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, especially in terms of clinical performance, cannot be fully extracted as such a study is not part of this 510(k) submission. This document primarily addresses safety, electrical compatibility, and functional equivalence to a predicate device already on the market.

However, I can extract information related to the performance data presented within the context of demonstrating substantial equivalence.

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

The document does not detail specific acceptance criteria for clinical efficacy or the reported performance of the device against such criteria. Instead, it focuses on demonstrating compliance with safety and technical standards and functional equivalence to a predicate device.

The performance data provided relates to:

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

This 510(k) summary does not describe any clinical study with a "test set" of patients or data provenance in the context of clinical performance. The testing mentioned (electrical safety, software, functional) is laboratory or engineering-based.

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 information pertains to clinical performance evaluations, which are not detailed in this 510(k) submission.

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

Not applicable, as no clinical test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a powered muscle stimulator, not an AI-assisted diagnostic or therapeutic tool with human readers.

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 for muscle stimulation.

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

The document does not describe clinical ground truth establishment. For the technical performance aspects:

• Electrical Safety & EMC: Compliance with international standards (IEC 60601 series).
• Software V&V: Compliance with FDA regulations, standards, and guidance.
• Functional Testing: Device technical specifications served as the "ground truth" for these tests.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-driven device.

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

Not applicable. This is not a machine learning or AI-driven device.

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The NuEra Tight RF Family is intended for:

• to provide topical heating for the purpose of elevaing tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
• to provide, with a massage device, a temporary reduction in the appearance of cellulite.

NuEra Tight RF Family is a family of devices designed to:

• develop localized heat to warm the subcutaneous tissue by means of radio frequency energy, delivered through electrodes in contact with the patient.
  Specifically, there are two devices in the family:
• -NuEra Tight RF - radiofrequency generator with single RF electrode connector
• -NuEra Tight RF Plus -radiofrequency generator with single RF electrode connector. The device has a different design, in particular for larger size, than the NuEra Tight RF, for the presence of a disabled electronic part that is the object of a different 510(k) submission. The detachable components to be used with the part not available are not provided with the Nuera Tight RF Plus.
  The purpose of the treatment based on the radiofrequency system (NuEra Tight) is to raise the temperature inside the tissues up to maximum of 45°C. Therefore, depending on the treatment and intended use, different parts of the body can be treated.

The provided text is a 510(k) summary for the NuEra Tight RF Family device, which is an electrosurgical cutting and coagulation device and accessories that uses radiofrequency energy for topical heating and temporary reduction of cellulite. While it includes information about the device's technical specifications, indications for use, and comparison to predicate devices, it does not contain the specific details required to describe acceptance criteria and a study that proves the device meets those criteria, especially in the context of an AI/ML-based device evaluation.

The document discusses compliance with electrical safety, EMC, usability, and software verification/validation standards (e.g., IEC 60601-1, IEC 62304, ISO 14971), and functional testing to confirm alignment with technical specifications. It also mentions "a test" performed to demonstrate the device can maintain a set skin temperature within a certain interval.

Here's a breakdown of why the requested information for an AI/ML device is not present in this document:

• No AI/ML Component: The NuEra Tight RF Family device, as described, is a physical medical device (radiofrequency generator) for therapeutic applications. It does not appear to incorporate any artificial intelligence or machine learning components. Therefore, the concepts of "test set," "training set," "ground truth establishment," "expert adjudication," "MRMC studies," or "standalone algorithm performance" as typically applied to AI/ML device evaluations are not applicable to this submission.
• Focus on Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device. This is achieved by comparing indications for use, technological characteristics, safety, and effectiveness. The performance data presented generally focuses on meeting recognized standards for electrical safety, EMC, and functional performance, rather than clinical efficacy studies with specific acceptance criteria in the vein of AI/ML performance metrics.
• Limited Clinical Data Details: While it mentions a "test" to maintain skin temperature across different body parts and patients, the level of detail provided (e.g., sample size for this specific test, the exact acceptance criteria for temperature maintenance, specific results, or how "safety and effectiveness" were conclusively proven beyond general statements) is far less than what would be expected for a detailed clinical study demonstrating AI/ML performance.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study proving device meets acceptance criteria as if it were an AI/ML device, based on the provided text.

The document states:
"In addition, a test was performed and resulted demonstrated that the device can maintain the set skin temperature at 2 set point (minimum: 40°C and maximum: 42°C or 45°C depending on the electrode size) and it can maintain the skin temperature inside that interval of + 2°C for 15 minutes. The test is executed for all electrodes in different parts of the patient (3 different body parts) and it is verified for all RF frequencies (470 kHz, 1 Mhz, 4 Mhz, 6 Mhz). In addition, the subset of tests is executed on different patients (2 additional patients) to demonstrate the independency of the results on a specific patient."

However, this is a functional performance test, not a clinical study to assess diagnostic or therapeutic performance in the way AI/ML devices typically undergo evaluation.

To directly answer your request based only on the provided text, acknowledging the limitations for an AI/ML context:

No information regarding acceptance criteria and a study proving an AI/ML device meets those criteria is available in the provided 510(k) summary. The device described is a physical medical device (radiofrequency generator) that does not appear to incorporate AI/ML technology. The "test" mentioned pertains to the device's ability to maintain skin temperature within a specified range, which is a functional performance test, not an AI/ML performance study.

Therefore, the requested table and answers to questions 2-9 cannot be derived from this document, as they are specific to AI/ML device evaluations.

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The Nd: Yag 1064 Laser is intended for:

• Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment hair reduction is 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 regime.
  The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin.
• Photocoagulation and hemostasis of benign pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins.
• Coagulation and hemostasis of soft tissue.
• Treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, sebortheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
  The laser is indicated for benign pigmented lesions to reduce lesion size, for patients with benign lesions that would potentially benefit from aggressive treatment, and for patients with benign lesions that have not responded to other laser treatments.
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
• Treatment of wrinkles.
  The Nd:Yag 1064 Laser is intended for:
• Temporary increase of clear nail in patients with onychomycosis (e.g., derniatophyton rubrum and T. mentagrophytes, and for yeast Candida Albicans, etc.)
  The Alexandrite 755 laser is intended for:
• Temporary hair reduction.
• Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles.
  Permanent hair reduction is 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 regime. On all skin types (Fitzpatrick I - VI) including tanned skin.
• Treatment of benign pigmented lesions.
• Treatment of wrinkles.
• Photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

The FAMILY OF SQUARE EPIL LASER , is a laser equipped with one or two solid-state laser sources:
As shown in the previous table, the 4 configurations of the Family differ for the internal crystals of the sources, that can be Alexandrite and/or Nd:YAG. The emitted laser radiation has a wavelength of 755nm, respectively, and 1064nm:
-Alex configuration has only one source and one wavelength available (755 nm).
-Alex configuration has two sources of the same wavelength (755 nm), in order to increase the maximum power available.
-Nd:Yag configuration has only one source and one wavelength available (1064 nm).
-In the Alex+Nd: Yag configuration has both the two wavelengths available (755 nm and 1064 nm) but can act only individually, simultaneous operations are not allowed.
This device is intended for medical use only.

This document, K161632, is a 510(k) premarket notification for a medical laser system called "FAMILY OF SQUARE EPIL." The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to establish new performance criteria through effectiveness studies. Therefore, much of the requested information regarding acceptance criteria, specific study designs, and quantitative performance metrics beyond safety and basic functionality is not available in this document.

Here's an attempt to answer your questions based on the provided text, with explicit notes where the information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of precise acceptance criteria for specific performance metrics (e.g., hair reduction percentages, lesion clearance rates) nor does it report quantitative device performance against such criteria. The device's performance is asserted through comparison to predicate devices and compliance with safety and electrical standards.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not applicable or not specified. This document relates to a 510(k) submission for substantial equivalence based on technological characteristics and safety standards, rather than a clinical trial with a defined test set for efficacy.
• Data Provenance: Not applicable. The "tests" mentioned are primarily engineering and safety compliance tests, not clinical performance data from a specific patient cohort.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. Ground truth, in the sense of clinical diagnostic accuracy or outcome evaluation, is not established as part of this submission for the new device.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not described or performed according to this document. The submission focuses on substantial equivalence based on technical specifications and safety.
• Effect Size of Human Readers: Not applicable.

6. Standalone Performance Study (Algorithm Only)

• Standalone Performance Study: No, a standalone performance study in the sense of an algorithm's diagnostic or predictive accuracy was not performed. This device is a laser system, not an AI or algorithmic diagnostic tool.

7. Type of Ground Truth Used

• Type of Ground Truth: For safety and performance evaluations mentioned (biocompatibility, electrical safety, software, usability, pre-series tests), the "ground truth" is compliance with established engineering standards, regulatory requirements, and internal design control procedures. For the "clinical performance" related to its intended uses, the ground truth is implicitly defined by the well-established clinical outcomes associated with the predicate devices, which the new device is claimed to be substantially equivalent to. No new clinical outcome data or pathology reports are generated or evaluated for the purpose of this submission to establish novel ground truth.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. As this is not an AI/machine learning device, there is no "training set" in that context. If referring to pre-series tests or design validation, the sample size or number of units tested is not specified but would be part of internal design validation.

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

• How Ground Truth for Training Set Was Established: Not applicable for the reasons stated above.

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The Nd: Yag 1064 Laser Handpiece (Long Pulsed) is intended for:
-treatment of benign vascular lesions such as but not limited to port wine stains, hemangiomas, telangiectasias, rosacea. venus lake, facial and leg veins;
-treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques;
-tattoos (significant reduction in the intensity of black and/or blue-black tattoos);
verrucae, skin tags, seborrheic keratosis;

• reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar;
• coagulation and hemostasis of soft tissue;
  -the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction. Permanent reduction in hair regrowth is 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 regime.

The Nd: Yag 1064 Laser Handpiece (Short Pulsed) is intended for:
Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions
Laser skin treatment procedures for the treatment of: Acne scars, Wrinkles

The Nd:YAG Q-Switched Handpieces (1064 nm) are indicated for treatment of:

• Benign vascular lesions such as, but not limited to treatment of:
  Port wine stains; Hemangiomas; Warts; Superficial and deep telangiectasias; Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas
  -Benign cutaneous lesions, such as, but not limited to:
  Warts; Scars; Striae; Psoriasis
  -Benign pigmented lesions such as, but not limited to:
  Lentigos (age spots); Solar lentigos (sun spots); Cafe-au-lait macules; Seborrheic keratoses; Nevi and nevus of Ota; Chloasma; Verrucae; Skin tags; Keratoses; The removal of black, blue or green tattoos (significant reduction in the intensity of black and /or blue/black tattoos); Plaques
• Pigmented benign lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
• The non-ablative treatment of facial wrinkles, such as, but not limited to:
  Periocular wrinkles; Perioral wrinkles;
  -Laser skin resurfacing procedures for the treatment of:
  Acne scars; Wrinkles
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
• Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The Nd:YAG Q-Switched Handpieces (532 nm) are indicated for treatment of:

• Incision, excision, ablation, vaporization of soft tissue.
• Tattoo removal: Light blue; Yellow; Red; Green
• Vascular lesions: Hemangiomas (Port wine stains/birthmarks, cavernous, cherry, spider, hemangiomas); Angiomas (cherry, spider); Telangiectasia; Spider nevi
  -Benign pigmented lesions: Cafe-au-lait (macules); Lentigines (senile and solar); Freckles (ephelides); Chloasma; Nevi; Nevus spillus; Nevus of Ota ;Becker's Nevi
  -Other benign pigmented cutaneous lesions: Verrucae; Skin tags; Keratoses; Plaques

The 2940 nm Er:YAG Laser Module handpiece is indicated for:
Coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes). Laser skin resurfacing procedures for the treatment of:
A. Acne scars

• Acne scars . . Wrinkles

The 2940 nm Er: Yag Fractional tips are indicated for:
Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars).

The 1540 Fractional Non-ablative Laser Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.

IPL 400-1200 run handpiece is indicated for:
· The treatment of moderate inflammatory acne vulgaris.
· The treatment of benign pigmented epidermal lesions including dyschromia,
hyperpigmentation, melasma, and ephelides (freckles).
· The treatment of benign cutaneous lesions including warts, scars and striae.
· The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations.
·Use on all skin types (Fitzpatrick I-VI).

IPL500-1200 nm handpiece is indicated for:
· The treatment of moderate inflammatory acne (acne vulgaris).
· The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars, striae,
dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, and cafe..au-lait macules. · The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations.
· The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is 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 regime.
•Use on Fitzpatrick skin types I-V.

IPL 550-1200 nm handpiece is indicated for:
· The treatment of moderate inflammatory acne Vulgans.
· The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles).

• · The treatment of face and body vascular and pigmented lesions.
  · The treatment of cutaneous lesions, including scars and striae.
  · The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
  · The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair regrowth is 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 regime.
  · Use on all skin types (Fitzpatrick I-VI).

IPL 580-1200 run handpiece is indicated for:
· The treatment of moderate inflammatory acne vulgaris.
· The treatment of benign pigmented esions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles).
· The treatment of face and body vascular and pigmented lesions.
· The treatment of cutaneous lesions, including scars and striae.
· The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
· The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair regrowth is 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 regime.
· Use on all skin types (Fitzpatrick I-VI).

IPL 620-1200 nm handpiece is iodicated for:
· The treatment of tattoos.
· The treatment of moderate inflammatory acne vulgaris.
· The treatment of benign pigmented epidermal lesions includiog dyschromia, hyperpiementation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and ca!e-au-lait.
· The treatment of cutaneous lesions including warts, scars and striae.
· The treatment of benign cutaneous vascular lesions includiog port wine stains, hemangiomas, facial. truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
: The removal of unwanted hair and to effect stable long-term or permanent reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction io the number of hairs regrowiog when measured at 6. 9, and 12 months after the completion of a treatment regime.
· Use on all skin types (Fitzpatrick I-VI), iocludiog tanned skin.

IPL 755-1200 nm handpiece is indicated for:
• The treatment of tattoos.
· The treatment of moderate ioflammatory acne vulgaris.
· The treatment of benign pigmented epidermal lesions includiog dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
· The treatment of cutaneous lesions iocluding warts, scars and striae.
· The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
· The treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis.
· The treatment of pseudofolliculitis barbae (PFB).
· The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair regrowth is 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 regime.
·Use on all skin types (Fitzpatrick I-VI), including tanned skin.

The portable device SUPERBIUM, is a multilaser and pulsed light system, designated to act on some common conditions of face and body (as specified in detail in Section 4). The equipment is designed as an expandable system for dermatologic and general surgery procedures, composed of a modular platform, which contains the entire electronics of the system and the cooling circuit, and a series of interchangeable handpieces to be connected on the platform, intended to treat specific groups of imperfections. A quick connection enables the quick and easy replacement of the various hand pieces that can be mounted on the modular platform.

This document is a 510(k) summary for the "SUPERBIUM" medical laser system. It compares the device to several predicate devices to demonstrate substantial equivalence, rather than providing a performance study with specific acceptance criteria against a defined ground truth.

Therefore, many of the requested sections about acceptance criteria and study details cannot be fully answered from this document. However, I can extract the relevant information regarding the device's technical characteristics and the comparison to predicate devices, which serves the purpose of demonstrating equivalence.

Here's a summary of the available information based on the provided text:

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

Since this is a 510(k) submission showing substantial equivalence to predicate devices, there isn't a table of explicit acceptance criteria for the study's outcome in the traditional sense of a clinical trial. Instead, the "acceptance criteria" are implied by demonstrating that the SUPERBIUM device's technological characteristics and intended uses are "substantially equivalent" to the listed predicate devices. The "reported device performance" is essentially a comparison of these characteristics.

The tables within the document (e.g., "B) Nd:Yag Handpiece Long Pulse", "C) Nd:Yag Handpiece - Short Pulse", etc.) serve as the core of this comparison. For each handpiece, the SUPERBIUM's specifications (Wavelength, Output power, Max energy per pulse, Beam diameter, Fluence, Pulse duration, Emission frequency, and Intended Use) are presented alongside those of the predicate devices.

Example of "Acceptance Criteria" (Implicit for Substantial Equivalence) and "Reported Device Performance" (Comparison to Predicates):

Note: The document states "Any differences are considered minor and do not raise new issues of the safety and effectiveness of the SUPERBIUM device when compared to the predicate devices." This is the ultimate "acceptance" for a 510(k).

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 explicitly states: "Animal and clinical studies were not necessary to demonstrate that the permormances are comparable to the predicate devices." Instead, the submission relies on direct comparison of technological characteristics. Therefore, there is no test set sample size or clinical data provenance to report. The data provenance for the comparison itself is simply from the regulatory submissions of the predicate devices.

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

Not applicable, as no clinical study with a test set requiring expert ground truth was conducted for this 510(k) submission.

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

Not applicable, as no clinical study with a test set requiring adjudication was conducted.

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, as this is a medical laser system for various dermatological and surgical applications, not an AI-powered diagnostic device, and no MRMC study was performed.

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

Not applicable, as this is a medical laser system, not an algorithm.

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

Not applicable, as no clinical study requiring a specific ground truth was conducted. The ground for the submission is the regulatory information and technical specifications of the predicate devices.

8. The sample size for the training set

Not applicable, as this is a physical medical device and not a machine learning model.

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

Not applicable, as this is a physical medical device and not a machine learning model.

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