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The SOPRANO™ Hair Removal Diode Laser is intended for hair removal and permanent hair reduction. The SOPRANO™ System is indicated for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

The modified MSq SOPRANO™ Hair Removal Diode Laser System is comprised of the following components:

• Console Unit that includes the main CPU Board, Power Supply Units, . Control Panel, Service Panel, Cooling System, Keyswitch, Emergency Stop, and Isolating Transformer;
• Handpiece (with Connector) that includes Optical Head, Tissue Cooling . system (the cold plate) and Handpiece Trigger;
• Footswitch. .

The provided document is a 510(k) summary for the MSq SOPRANO™ Hair Removal Diode Laser System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with acceptance criteria in the manner typically seen for novel medical diagnostics or AI software.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and the specifics of a study proving the device meets those criteria, such as sample sizes, expert qualifications, adjudication methods, or MRMC studies.

Instead of specific acceptance criteria met by the device itself, the document focuses on demonstrating substantial equivalence to a predicate device.

Here's what can be extracted based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable. The document does not describe specific performance metrics or acceptance criteria for the SOPRANO™ system in terms of clinical outcomes (e.g., success rates, hair reduction percentages) and how they were met by a study.
• The "acceptance criteria" in this context is "substantial equivalence" to the predicate device, MSq MYTHOS™ Hair Removal Diode Laser System (K030805), based on shared indications for use, device operation, and overall technical and functional capabilities. The document asserts that the SOPRANO™ system meets this criterion.

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

• Not provided. The document does not describe a clinical "test set" with a specific sample size. The substantial equivalence argument relies on comparing technical specifications and overall capabilities to the predicate.

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

• Not provided. This type of information is not relevant to a substantial equivalence argument for a laser hair removal system based on technical modifications.

4. Adjudication Method:

• Not provided.

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

• No. This type of study is not mentioned or implied, as the device is not an AI diagnostic software requiring human reader evaluation.

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

• Not applicable. The SOPRANO™ device is a laser system, not an algorithm.

7. The Type of Ground Truth Used:

• Not applicable. This concept does not apply to the 510(k) summary for this device. The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.

8. The Sample Size for the Training Set:

• Not applicable. There is no mention of a "training set" as this is not an AI/ML device.

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

• Not applicable.

In summary: The provided 510(k) summary for the SOPRANO™ Hair Removal Diode Laser System demonstrates substantial equivalence to a predicate device by asserting shared indications for use, device operation, and technical/functional capabilities. It does not contain the detailed clinical study information (acceptance criteria, sample sizes, expert involvement, "ground truth" establishment, etc.) that would be expected for a novel device or AI-based diagnostic tool.

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The modified MSq Family of Lovely Light/Laser System and Delivery Devices and Accessories are indicated for a variety of aesthetic and surgical applications in the medical specialties of general and plastic surgery and dermatology, endoscopic/ laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology.

The Lovely System models (Aria and Harmony) are intended for use in aesthetic, cosmetic, and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery, endoscopic/ laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, oral surgery, ophthalmology (skin around the eyes), orthopedics, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications.

Specific indications for different wavelengths and models are listed for Dermatology and Plastic Surgery, General Surgery, Genitourinary, Gynecology, Oral/Maxillofacial, Otorhinolaryngology/ Head and Neck (ENT), Ophthalmology, and Podiatry.

The modified MSq Family of Lovely Light/Laser System and Delivery Devices and Accessories are comprised of the following main components:

• A system console that includes the control display, software and control electronics, keyswitch, emergency stop, cooling system, optics bench;
• Footswitch;
• Variety of handpieces and attachment accessories.

The provided document is a 510(k) summary for a medical device (Modified MSq Family of Lovely Light/Laser Systems). It describes the device's indications for use and states its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, specific device performance data from a study, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

510(k) summaries primarily focus on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting detailed clinical trial results with predefined acceptance criteria and performance metrics in the same way a PMA (Premarket Approval) application would. The summary argues for substantial equivalence based on identical indications for use, and similar design features, and functional features to predicate devices.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
2. Sample size used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method for the test set: This information is not present.
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 a laser system, not an AI diagnostic device, so an MRMC study in this context would not be relevant and is not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not present, as detailed studies with ground truth are not described.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

The document's "Safety and Effectiveness Information" section simply states: "The review of the indications for use and technical characteristics provided to demonstrate that the modified MSq Family of Lovely Light/Laser System and Delivery Devices and Accessories are substantially equivalent to the predicate devices." This indicates that the safety and effectiveness were primarily demonstrated through comparison to already approved devices and their established safety profiles, rather than through a new, independent performance study with specific acceptance criteria that would be outlined in this type of summary.

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The Lovely System models (Aria and Harmony) are intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of plastic surgery and dermatology as follows:

Lovely I (Aria) & Lovely II (Harmony) Models:
The Advanced Fluorescence Technology (AFT) with 420-950 nm wavelengths is indicated for:

• The treatment of moderate inflammatory acne vulgaris.
• The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles).
• . The treatment of 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, erytherna of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and voenous, malformations.
• The removal of unwanted hair and to effect stable long-term or permanent hair reduction. ●

Lovely II (Harmony) Model:
The Nd: YAG lasers (1064nm) are indicated for:

• The removal of black, blue or green tattoos. .
• Coagulation and hemostasis of vascular lesions and soft tissue, including treatment and clearance of superficial and deep telangiectasias) and reticular veing (0.1-4.0 mm diameter) of the leg.
• The non-ablative treatment of facial wrinkles. .

Lovely II (Harmony) Model:

• The UVB Light source (300-380nm) is indicated for:
• The treatment of leukoderma, including vitiligo (acquired leukoderma). .
• The treatment of psoriasis, atopic dermatitis (eczema), and seborrheic dermatitis.

The Lovely System models are also indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The Lovely is a platform for AFT, UVB and Nd:YAG Laser Technology for various Aesthetic and Cosmetic applications. The Lovely has an option to operate seven different handpieces that emits light at 300nm to 1064nm for the following applications:

• Hair removal 트
• Skin Rejuvenation 트
• I Vascular and Pigmented lesion
• 트 Moderate Acne
• 트 Deep leg veins
• . Tattoo removal
• 트 Psoriasis and vitiligo

The system includes:

• A light/laser system console (including software and control 트 electronics) that controls timing and dosing parameters. The console includes a water-cooling system used to remove heat from the power supply and the optical bench.
• A control and display panel including LCD and soft-keys. 트
• Seven optional handpiece(s) that includes the light source, 트 electronics and pipes of the water cooling system.

This document is a 510(k) summary for the "Lovely System" (Models: Lovely I (Aria) & Lovely II (Harmony)), a laser and light-based system for aesthetic and cosmetic applications. Unfortunately, the provided text does not contain acceptance criteria or a detailed study proving the device meets those criteria.

Instead, the document primarily focuses on establishing substantial equivalence to predicate devices, which is the primary requirement for a 510(k) submission. While it mentions "Safety and performance testing" as evidence of equivalence, it does not describe the specific tests performed, the acceptance criteria for those tests, or the results.

Therefore, I cannot provide the requested information in the format specified because the detailed study information is not present in the provided text.

However, I can extract information related to what would typically be considered for such a study, based on the indications for use and the nature of the device:

Indications for Use (which would drive the types of studies performed):

• Treatment of moderate inflammatory acne vulgaris.
• Treatment of benign pigmented epidermal lesions (dyschromia, hyperpigmentation, melasma, ephelides/freckles).
• Treatment of cutaneous lesions (warts, scars, striae).
• Treatment of benign cutaneous vascular lesions (port wine stains, hemangiomas, facial/truncal/leg telangiectasias, rosacea, erythema of rosacea, angiomas, spider angiomas, poikiloderma of Civatte, leg veins, venous malformations).
• Removal of unwanted hair and stable long-term or permanent hair reduction.
• Removal of black, blue, or green tattoos.
• Coagulation and hemostasis of vascular lesions and soft tissue, including superficial and deep telangiectasias and reticular veins.
• Non-ablative treatment of facial wrinkles.
• Treatment of leukoderma (including vitiligo).
• Treatment of psoriasis, atopic dermatitis, and seborrheic dermatitis.
• Intended for use on all skin types (Fitzpatrick I-VI), including tanned skin.

Information NOT available in the provided text:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results or effect size.
• Standalone (algorithm-only) performance results.
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document only broadly states: "- Safety and performance testing." was conducted without providing any specifics. For a complete answer to your request, the actual study reports would be needed.

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The Dio-Dent 10 Dental Diode Laser System is intended for incision, excision, ablation, vaporization and/or coagulation (hemostasis) of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). In addition, the system is intended for teeth whitening. The Indications for Use of the Dio-Dent 10 Dental Diode Laser System include: Cosmetic Dentistry - Light activation for bleaching materials for teeth whitening, Laser-assisted bleaching/whitening of the teeth; Endodontology - Pulpotomy, Pulpotomy as an adjunct to root canal therapv; Periodontology - Sulcular debridement (removal of diseased or inflamed soft tissue in the periodental pocket); Oral Soft Tissue Surgery - Biopsy, Operculectomy, Gingivectomy, Gingivoplasty, Oral papillectomy, Leukoplakia, Treatment of aphthous ulcers, Fibroma removal, Frenectomy, Frenotomy, Tissue retraction for impressions. Incising and draining of abscesses, Draining fistulas, Exposure of unerupted partially erupted teeth, Lesion (tumor) removal, Implant recovery, Implant uncovering, Gingival troughing, Crown lengthening, Hemostasis of donor site, Coagulation and decontamination of extraction sites, Removal of granulation tissue, Degranulation of infrabony defects, Laser assisted flap surgery, Vestibuloplasty, Removal of hyperplastic tissues, Debridement of diseased epithelial lining

The Dio-Dent 10 Dental Diode Laser is designed to perform several medical procedures in the oral soft tissue and to perform laser assisted aesthetic tooth whitening procedures. A Gallium Aluminum Arsenide (GaAlAs) solid state laser diode provides optical energy to oral soft tissues. A fiber optic held by a handpiece delivers up to 10Watts laser energy. A visible light emitted from the handpiece's distal end targets the area of treatment. The optical power output and pulse may be adjusted to specific use requirements.

The provided text describes a 510(k) premarket notification for the Dio-Dent 10 Dental Diode Laser System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as typically found for novel devices or software.

Therefore, many of the requested categories for a rigorous study proving device performance against acceptance criteria cannot be answered directly from this type of regulatory submission. The information provided primarily pertains to compliance with safety standards and equivalence to existing devices.

Here's an analysis based on the provided text, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria with numerical targets for performance and corresponding results from a dedicated study. Instead, it asserts compliance with general safety and performance standards, and substantial equivalence to predicate devices.

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

The document does not describe a clinical test set with a specific sample size. The "study" here is a demonstration of equivalence, relying on the established safety and effectiveness of predicate devices and compliance with recognized standards. There is no mention of a particular cohort of patients or data collected for this specific device's performance validation in a clinical setting.

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

Not applicable. The submission is not based on a study with a ground truth established by experts for performance evaluation. It relies on regulatory compliance and equivalence to predicate devices which have already undergone such assessments.

4. Adjudication Method for the Test Set:

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

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

No MRMC study is mentioned. The device is a laser system, not an AI or imaging diagnostic tool that would typically undergo such a study.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device is a physical laser system, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this submission is primarily:

• Compliance with international and national performance standards (e.g., 21 CFR 1040.10, 21 CFR 1040.11, IEC standards).
• Established safety and effectiveness of the predicate devices.
• Technical characteristics and output values that fall within the range of already cleared devices.

8. Sample Size for the Training Set:

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

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

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

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The MYTHOS 500™ Hair Removal Diode Laser is intended for hair removal and permanent hair reduction. The MYTHOS 500™ System is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

The MYTHOS 500™ system delivers pulsed infrared laser light with a 810nm±10% wavelength and a selectable fluence of 5-60J/cm2. The system enables two pulse modes: Long pulse and Pulse. The pulsed energy is delivered through a 10x12mm handpiece tip. The complete system consists of console and a handpiece connected to the system by an umbilical cord. The handpiece is pressed against the patient's skin and a pulse of laser is delivered. To initiate energy output the system requires simultaneous activation of the handpiece trigger and the footswitch. The handpiece tip is cooled to provide continuous skin cooling. Laser parameters and other system features are controlled from the Operating Buttons and LCD screen on top of the console, which provide interface with the system computer.

The provided text describes the 510(k) summary for the MYTHOS 500™ Diode Laser System, which is intended for hair removal and permanent hair reduction. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data in the context of diagnostic accuracy (like sensitivity, specificity, or AUC) typically seen for AI/ML devices.

Therefore, many of the requested sections related to acceptance criteria, specific study designs, training/test set details, and expert ground truth establishment are not applicable or not provided in this type of submission. This document primarily addresses regulatory compliance, safety, and equivalence to a previously cleared device.

Here's a breakdown of the information that can be extracted or inferred, and what is not present:

Acceptance Criteria and Device Performance

The submission does not present acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) that would be typical for an AI-enabled diagnostic device. Instead, "acceptance criteria" are implied by adherence to regulatory standards and demonstration of substantial equivalence to a predicate device.

Study Details (as inferable from the document)

This submission is a 510(k) premarket notification for a laser device, not an AI/ML diagnostic or prognostic tool. Therefore, a "study" in the sense of clinical trials to establish diagnostic performance against ground truth is not described or required for this type of submission focused on substantial equivalence. The "study" here refers to the engineering, performance, and safety testing to demonstrate that the device meets its specifications and is comparable to the predicate.

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

   • N/A. This information is not provided. The document states "Safety and performance testing" was conducted, but it does not detail specific clinical test set sizes, patient demographics, or data provenance. This is typical for a laser device submission focused on technical specifications and equivalence.

2. 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):

   • N/A. "Ground truth" in the context of diagnostic accuracy is not relevant here. The "truth" for a laser device is its adherence to technical specifications, safety standards, and its ability to achieve the intended physical effect (hair removal). These aspects are typically verified through engineering tests, not expert consensus on medical images or patient outcomes.

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

   • N/A. Not applicable as there is no mention of a test set requiring adjudication in the context of diagnostic accuracy.

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:

   • N/A. This device is a standalone laser system, not an AI-assisted diagnostic tool. Therefore, no MRMC study, human reader comparison, or AI-assistance effect size is relevant or reported.

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

   • Yes, in concept. The "standalone" performance here refers to the device's technical specifications and functionality, separate from a human operator's skill in applying it. The device itself (the laser, its wavelength, fluence, pulse modes) is tested for its intrinsic performance and safety. There is no "algorithm" in the sense of AI/ML.

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

   • Technical specifications, safety standards, and predicate device parameters. For a laser device, the "ground truth" would be the measured physical output (e.g., wavelength, fluence, pulse duration, temperature of cooling tip) against its stated specifications, and comparison against the known performance characteristics of the predicate device (LightSheer™). Compliance with regulatory and voluntary standards (21 CFR 1040.10, 1040.11, IEC 60601 series) serves as a form of "ground truth" for safety and basic performance. Long-term "outcomes data" to prove permanent hair reduction beyond what was shown for the predicate device would typically not be part of the 510(k) submission for substantial equivalence if the predicate's claims are adopted.

7. The sample size for the training set:

   • N/A. There is no "training set" in the context of machine learning. The device is a hardware product.

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

   • N/A. There is no "training set" or corresponding ground truth establishment process for this type of medical device submission.

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