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The InMode Hair Removal (HR) device is indicated for use for hair removal.

The InMode Hair Removal (HR) device is designed to deliver optical energy to the skin via a pre-cooled sapphire block. The good optical contact between sapphire block and skin is achieved by using water based gel. The device provides individual adjustment of light fluence and pulse duration to achieve maximum efficiency and safety for each patient. The scanning system embedded into the laser InMode HR hand piece allows efficient treatment with less risk of overlap. The hand piece has integrated skin cooling to enhance safety and comfort of the treatment.

The InMode Hair Removal device consists of an AC/DC power supply unit, a diode driver, water cooling system, controller and user interface including an LCD screen and functional buttons. The diode laser hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises the InMode HR laser with linear scanning system, cooled sapphire output window (8 x 50mm), and electronic shutter.

The sapphire light guide is located on the front tip of the hand piece and delivers the laser beam energy to the treated tissue, while cooling the skin. The pair of thermoelectric coolers (TECs) located on both sides of the sapphire block provide cooling to a temperature of 4°C. The hand piece contains a trigger button which starts the laser scan and radiation. Fluence (light energy density) is delivered within the limits of 10 to 60J/cm2. The hand piece has a cable that is 170cm long and connects to the hand piece to the console via a connector.

The manufacturer, InMode MD Ltd., states that the InMode Hair Removal (HR) device is substantially equivalent to two predicate devices: Lumenis Ltd.'s LightSheer (K001746) and Quantel Derma GmbH's Leda EPI 808 (K090762). Therefore, the acceptance criteria for the InMode Hair Removal (HR) device are based on demonstrating its equivalence to these predicate devices in terms of design, performance, and safety.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test set sample size: Not applicable for a human subject test set. The document describes non-clinical bench testing.
• Data provenance: Not explicitly stated for specific data points, but the testing was conducted by InMode MD Ltd.

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

• Not applicable as this was a non-clinical bench test comparing output parameters, not a clinical study requiring expert ground truth for efficacy.

4. Adjudication method for the test set:

• Not applicable. The "test set" refers to bench testing to compare device parameters, not a clinical trial requiring adjudication of 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:

• No. This device is a hair removal laser, not an AI-assisted diagnostic tool.

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

• The performance assessment focused on the device's technical specifications and safety compliance. "Clinical Performance Data: Not Applicable" is explicitly stated. Therefore, a standalone algorithm performance study (as would be relevant for software/AI) was not performed. The performance evaluation was based on bench testing of the physical device's output parameters.

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

• For the non-clinical performance data, the "ground truth" was established by the specified laser output parameters of the predicate devices (Leda EPI 808) and compliance with various international safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, IEC 60601-1-4).

8. The sample size for the training set:

• Not applicable. This device is a laser system, not a machine learning algorithm that requires a training set.

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

• Not applicable, as there was no training set for a machine learning algorithm.

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The Lumenis One Family of Systems (and the delivery accessories that are used with them to deliver light and/or laser and/or RF energy) is indicated for use in surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology as follows:

Intense Pulsed Light (IPL) Wavelengths (515 - 1200 nm):
The 515-1200 nm intense pulsed light wavelengths are indicated for:

• The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
• The treatment of tattoos;
• 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, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
• The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.

Nd:YAG Laser Wavelength (1064 nm):
The 1064 nm wavelength produced by the Nd: YAG laser is indicated for:

• The coagulation and hemostasis of vascular lesions and soft tissue, including:
• Treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg:
• The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction in skin types I-V through selective targeting of melanin in hair follicies;
• The non-ablative treatment of facial wrinkles.

LightSheer Diode Laser Wavelength (800 mm):
The 800 nm wavelength produced by the LightSheer diode laser is indicated for:

• The removal of unwanted hair, and to effect stable long-term, or permanent', hair reduction through selective targeting of melani, in hair follicles;
• The treatment of vascular lesions, including angiomas, hemangiomas telangiectasia and other benign vascular lesions;
• The treatment of leg veins;
• The treatment of benign pigmented lesion;
• The treatment of pseudofolliculitis barbae;

The LightSheer diode laser is intended for use on all skin types (Fitzpatrick skin types 1 - VI), including tanned skin.

Aluma RF Energy (468 kHz):
The Aluma 468 kHz energy is indicated for:

• The Aluma Skin Renewal System is intended for use in Dermatologic and General Surgical procedures for the non-invasive treatment of wrinkles and thytids.

Lumenis One systems are comprised of the following main components:

• System console;
• Control and Display;
• One or more delivery handpieces, the Treatment Heads (up to three attached out of four handpieces available for each system);
• Skin cooling technology integrated into the handpiece (as applicable);
• Trigger button integrated into the handpiece; an additional safety button integrated into the laser handpieces;
• Remote interlock connector (disables pulse emission when treatment room door is opened).

This 510(k) summary explicitly states that no clinical data was provided for the Lumenis One Family of Systems. The device's substantial equivalence to predicate devices was based on shared indications for use and similar or identical technical specifications, not on new performance studies.

Therefore, the following information cannot be found or accurately described from the provided text:

• A table of acceptance criteria and reported device performance
• Sample sizes used for test sets
• Data provenance for test sets
• Number of experts used to establish ground truth
• Qualifications of experts
• Adjudication methods
• MRMC comparative effectiveness study results
• Standalone performance results
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

The document makes a direct statement that is crucial for understanding why these details are absent:

"Clinical data therefore was not provided." (Section VII, page 2)

The rationale for not providing clinical data is that:
"The Lumenis One Family of Systems share the same indications for use and the same or similar technical specifications as the currently marketed predicate Lumenis Family of Intense Pulsed-Light (IPL) and IPL Nd: Y AG Laser Systems (K020839, K024093, K030342, K030527), the LightSheer Pulsed Diode Array Laser System (K973324, K974346, K982940, K001746, K003614), and the Aluma Skin Renewal System (K051214). The small differences that exist in certain technical specifications are not significant and they do not alter the safety or effectiveness of the Lumenis One Family of Systems." (Section VII, page 2)

In summary, the device's acceptance criteria were implicitly met by demonstrating substantial equivalence to already cleared predicate devices, without the need for new clinical performance studies or establishing new acceptance criteria and demonstrating compliance.

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The Candela Family of Pulse Dye Laser Systems Pigmented Lesion Handpiece Accessory is indicated for the Treatment of Benign Epidermal Pigmented Lesions

The Candela Family of Pulsed Dye Laser Systems are 585, 595nm flash-lamp excited pulse dye medical lasers, indicated for the following uses: The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams or elliptical beams on the skin.. The Pigmented Lesion Handpiece Accessory attaches to the standard handpiece and replaces the standard distance gauge for the treatment of benign epidermal pigmented lesions The Candela Family of Pulsed Dye Laser Systems is equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment. The pigmented lesion handpiece accessory is designed for use with the Candela Pulsed Dye Laser handpiece, for the treatment of Benign Epidermal pigmented Lesions

The provided text is a 510(k) Summary for a medical device (Candela Family of Pulsed Dye Lasers Pigmented Lesion Handpiece Accessory) and does not contain detailed information about specific acceptance criteria or an in-depth study proving the device meets those criteria. The document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of acceptance criteria for a clinical study measuring device performance (e.g., lesion clearance rates, skin reaction scores). Instead, it refers to regulatory compliance and safety standards.

2. Sample Size for Test Set and Data Provenance:

The document does not provide information on a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the clinical performance of the pigmented lesion handpiece accessory. The "Testing" section focuses on regulatory compliance for laser and electrical safety, and biocompatibility, rather than clinical efficacy/safety studies for the accessory's intended use.

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

This information is not provided in the document. As there's no mention of a clinical study with a test set that required ground truth establishment, these details are absent.

4. Adjudication Method for the Test Set:

This information is not provided in the document, as there is no mention of a clinical test set that would require adjudication.

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

An MRMC study was not conducted or reported in this document. The focus is on regulatory clearance through substantial equivalence, not on comparing human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study was not conducted or reported. This device is a laser accessory, not an AI algorithm.

7. Type of Ground Truth Used:

This information is not provided as no specific clinical study data requiring ground truth for efficacy assessment is presented. The "ground truth" for regulatory clearance is based on adherence to established safety and performance standards for laser products and materials, and comparison to predicate devices.

8. Sample Size for the Training Set:

This information is not applicable/not provided. The device is a physical laser accessory, not an AI model that requires a training set of data.

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

This information is not applicable/not provided for the same reason as above.

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The Spectra Hair Removal Laser is intended to effect temporary hair removal.

The Spectra Hair Removal Laser is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm.

Here's an analysis of the provided text regarding the Spectra Hair Removal Laser, focusing on the acceptance criteria and study aspects you requested:

Acceptance Criteria and Study Analysis for Spectra Hair Removal Laser (K032846)

This 510(k) submission explicitly states that no performance data was required or submitted for the Spectra Hair Removal Laser. The basis for clearance was substantial equivalence to legally marketed predicate devices, and the indications for use were a subset of those claimed by the predicates. Therefore, the device did not undergo a specific study to prove it meets acceptance criteria, nor were explicit acceptance criteria defined within this document.

Given this, many of the specific questions about the study design cannot be answered from the provided text.

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

Explanation: The 510(k) states: "None. The specifications and indications for use of the Spectra Hair Removal Laser are a subset of those claimed in one or more of the clearances for the above-listed predicate devices. Thus performance data were not required." This means the device's performance was considered acceptable based on its similarity to already cleared devices, not on specific, pre-defined quantitative criteria.

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

• Sample Size (Test Set): Not applicable, no performance study was conducted.
• Data Provenance: Not applicable, no performance study was conducted.

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)

• Number of Experts: Not applicable, no performance study was conducted.
• Qualifications of Experts: Not applicable, no performance study was conducted.

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

• Adjudication Method: Not applicable, no performance study 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

• MRMC Study: No. This device is a hair removal laser, not a diagnostic AI system with human-in-the-loop interaction for interpretation tasks.
• Effect Size: Not applicable.

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

• Standalone Study: No. This device is a laser for hair removal, not an algorithm.

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

• Type of Ground Truth: Not applicable, no performance study was conducted. The "ground truth" for this submission was the established safety and effectiveness of its predicate devices for temporary hair removal.

8. The sample size for the training set

• Training Set Sample Size: Not applicable, no AI/ML algorithm was involved, and no performance study was conducted for this specific device.

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

• Ground Truth Establishment for Training Set: Not applicable.

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The LC100 diode laser system is indicated for hair removal and permanent hair reduction. Permanent hair reduction is defined as a long-term, stable reduction in the number of re-growing hairs after a treatment regime.

The LC100 is also indicated for photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, hemangioma, spider nevi, and other benign vascular lesions; photothermolysis of blood vessels (treatment of facial and leg veins); removal of benign pigmented lesions, including lentigines, nevi, chloasma, and café-au-lait; incision/excision, ablation and coagulation (homeostasis) of soft tissue.

The LC100 is indicated for use in patients with skin types I-VI, including tanned patients.

The LC100 delivers infrared laser light with a wavelength of 810 nm, a selectable pulse duration of 50 - 1000 ms. The corresponding fluence is delivered through a 12x12 or 12x6 mm handpiece tip. The laser pulses are generated at a maximum pulse repetition frequency of 3.3 Hz.

The complete system consists of a, chiller, a footswitch, and a handpiece containing diode bars connected to the power unit with an umbilical. In standard use, the handpiece is pressed against the patient's skin and a light pulse is delivered when the footswitch is depressed. The handpiece tip is water-Laser cooled to provide active skin cooling. parameters and other system features are controlled from the user interface panel on top of the laser unit, which provides an interface to the system computer.

The provided document is a 510(k) summary for the Palomar LC100 Diode Array Laser System, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission does not typically include the kind of detailed study data (like acceptance criteria tables, sample sizes for test/training sets, ground truth establishment, MRMC studies, or standalone performance) that would be present in a Clinical Study Report or a more extensive Premarket Approval (PMA) application.

The document primarily focuses on establishing substantial equivalence by comparing the LC100 to predicate devices (Palomar SLP 1000 Diode Laser and LightSheer Diode Array Laser) through a description of its system and intended use. It explicitly states: "The differences in the specifications of the LC100 laser and the predicate device do not result in different performance or raise new questions of safety or efficacy. Based on the foregoing, the LC100 Diode Conclusion: Array Laser System is substantially equivalent to the legally-marketed claimed predicate device."

Therefore, based solely on the provided text, I cannot provide the specific details requested in your prompt because they are not present in this 510(k) summary.

Here's what I can extract or infer based on the nature of a 510(k) submission:

• Acceptance Criteria and Reported Device Performance: Not explicitly stated in a quantitative table. The "acceptance criterion" for a 510(k) is typically substantial equivalence to a predicate device, meaning it performs as safely and effectively as the predicate without raising new questions of safety or efficacy. The "reported device performance" is essentially that it is considered substantially equivalent to the predicate devices for its stated indications for use.
• Study Proving Acceptance Criteria: The "study" is the submission itself, which argues for substantial equivalence by comparing the LC100's specifications and intended use to those of the predicate devices. This is generally a comparative analysis rather than a traditional clinical study with detailed performance metrics.
• Sample Size for Test Set and Data Provenance: Not applicable/not provided. This is not a study that involved a test set in the sense of a clinical trial.
• Number of Experts and Qualifications: Not applicable/not provided. Ground truth establishment with experts is not detailed for this type of submission.
• Adjudication Method: Not applicable/not provided.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable/not provided. These are complex studies not typically required or included in a 510(k) for a laser system.
• Standalone Performance: Not applicable/not provided as a distinct study. The comparison is against predicate devices.
• Type of Ground Truth Used: Not applicable/not provided as this is not a diagnostic device requiring external validation of its output against a 'ground truth.'
• Sample Size for Training Set: Not applicable/not provided. This device is not an AI/ML algorithm that would have a training set.
• How Ground Truth for Training Set was Established: Not applicable/not provided.

In summary, the provided document is a regulatory submission for substantial equivalence, not a detailed clinical performance study. The information requested regarding explicit acceptance criteria, detailed study design, sample sizes, and ground truth establishment is not typically found in this type of 510(k) summary.

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