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The SCAR 3 scanner, when used with DEKA Smartxide family lasers (K180193), is indicated for ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery.

The SCAR 3 scanner, when used with DEKA Smartxide family lasers (K180193), is indicated for use in the performance of specific applications in dermatology and plastic surgery as follows:

-The ablation, vaporization, excision, incision, and coagulation of soft tissue in the performance of laser burn debridement

-Laser skin resurfacing (ablation and/or vaporization) for treatment of:

· Wrinkles, rhytids, and furrows (including fine lines and texture irregularities)

-Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:

• Acne scars
• · Surgical scars

The SCAR 3 scanning unit is an optional scanner that can be connected to the Deka SmartXide family lasers (K180193).

The SCAR 3 is composed of the following components:

• HiScan SCAR 3 head
• HiScan SCAR 3 cable

Laser emission parameters are selected through the GUI of the DEKA laser device to whom the scanner is connected.

Shape and size of the scanning area may also be selected by using the three keys on the scanning head.

This document is a 510(k) summary for the SCAR 3 scanner, a medical laser scanning unit. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria. Therefore, many of the requested fields cannot be directly extracted from the provided text.

Here is the information that can be extracted, acknowledging the limitations of the document's purpose:

1. Table of acceptance criteria and the reported device performance

The document does not present specific quantitative acceptance criteria or detailed device performance metrics in a readily extractable table format for clinical efficacy. Instead, it relies on demonstrating substantial equivalence to a predicate device by comparing indications for use, principle of operation, and technological characteristics.

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 "Clinical Performance Data: None." and discusses "Non-Clinical Performance Data." Therefore, there is no test set in the context of clinical performance data used for this submission. The non-clinical performance data consisted of testing against recognized standards (see point 1 and 8).

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 performance study with a test set requiring expert-established ground truth was conducted.

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

Not applicable, as no clinical performance 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. This device is a laser scanning unit, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

Not applicable. This device is a physical laser scanning unit, not an algorithm. Performance was evaluated through non-clinical testing against standards.

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

For the non-clinical performance testing (compliance with standards), the "ground truth" was compliance with the specified requirements and criteria outlined in the standards (e.g., electrical safety limits, electromagnetic compatibility limits, laser safety classifications). This is determined by engineering measurements and tests.

8. The sample size for the training set

Not applicable, as no clinical performance or machine learning study involving a training set was conducted for this submission. The device is a physical medical instrument.

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

Not applicable, as no training set was used.

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Intended Use:

The PHYSIQ device is intended in EMS mode for:

Prevention or retardation of disuse atrophy Maintaining or increasing range of motion Muscle re-education Relaxation of muscle spasms Increasing local blood circulation Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

and in TENS mode for:

Symptomatic relief and management of chronic, intractable pain Post-surgical acute pain Post-traumatic acute pain

The PHYSIQ is a device provided with 4 handpieces by 2 electrodes each intended to employ EMS (Electrical Muscle Stimulation) and TENS (Transcutaneous Electrical Nerve Stimulation) technologies for various medical applications.

The PhysiQ consists of :

• an AC/DC power supply unit,
• EMS/TENS driving electronic board
• CPU controller; ●
• user interface with LCD touch screen, . ●
• 4 EMS/TENS handpieces with interconnecting cables ●

EMS or TENS treatment is enabled at the same time on all 4 handpieces. The operator can choose how many handpieces to use and leave the unused ones in the proper holder.

Through the handpieces the electrical energy is delivered to the patient, which repeatedly contracts muscles by passing electrical currents through electrodes on the affected body area.

During TENS treatments, PHYSIQ generates electrical pulses and transmits it to the electrodes which are in contact with the patient's skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.

During EMS treatments, PHYSIQ generates electrical pulses and transmits it to the electrodes in contact with the patient skin, causing the muscle to expand and contract. It is used to relax muscle spasms, prevent or retard atrophy, maintain or increase range of motion, increase local blood circulation, re-educate muscle and provide immediate post-surgical stimulation of calf muscle to prevent venous thrombosis.

Handpieces are directly applied on the area to be treated, such as-upper and lower back, abdomen, legs and arms.

The user interface allows to fully control the treatment parameters. The operator can manage Electro Muscle Stimulation (EMS) or Transcutaneous Electrical Nerve Stimulation (TENS) (OFF or ON from 1 to 50, with selection step of 1).

Treatment time can be changed regardless of the suggested one.

The provided text describes a 510(k) premarket notification for the PHYSIQ device, which is a powered muscle stimulator and transcutaneous electrical nerve stimulator. The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This type of submission generally relies on non-clinical performance data rather than extensive clinical studies with acceptance criteria based on patient outcomes.

Therefore, the acceptance criteria and study detailed below will focus on the non-clinical performance benchmarks used to establish substantial equivalence with the predicate device, rather than clinical performance metrics typically found in efficacy trials.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the PHYSIQ device are based on demonstrating similar performance characteristics to its predicate device, The InMode System with Tone Applicator (K192249), and compliance with relevant safety standards. The reported device performance aligns with these criteria.

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VIVID LASER handpiece: Indicated for the treatment of benign vascular lesions, benign pigmented lessions, hair removal and permanent harr reduction. 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. SPARKS LASER handpiece : Indicated for removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of benign pigmented and vascular lesions, such as but not limited to warts, teleangiectasia, leg veins and spider veins, treatment of benign pigmented lesions. PRISMA LASER handpiece: Indicated for removal of dark tattoos and treatment of benign pigmented lesions. RUBER, LILAC Pulsed Light handpieces: Permanent hair reduction, photocoagulation of benign vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions. Different wavelength ranges of Pulsed Light attachment are indicated for the various treatments and skin types. as indicated in the following table: 500-1200nm: Benign Vascular lesions Skin Types I, II; Blood vessels Skin Types I, II. 520-1200nm: Benign Vascular lesions SkinType III; Blood Type III; Benign Pigmented lesions Skin Types I, II. 550-1200nm: Hair reduction Skin Types I, II; Benign Pigmented lesions Skin Type Ill. 600-1200nm: Hair reduction Skin Type Ill. 650-1200nm: Hair reduction Skin Type IV; Benign Pigmented lesions Skin Type IV. LAZUR Pulsed Light handpiece: The handpiece (with and without contact-cooling) 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 and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. - Use on all skin types (Fitzpatrick I-VI). VIRIDIS Pulsed Light handpiece: Photocoagulation of benign dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial andleg veins), and the treatment of benign pigmented lesions.

The DEKA LUXEA is a versatile medical platform that can be equipped with various types of laser and pulsed light handpieces. Thanks to its universal connector it is possible to quickly insert and deactivate the various handpieces to cover a wide spectrum of application. The available handpieces are - VIVID: 808±10 nm Laser - SPARKS: 1064nm Laser - PRISMA: 1064nm O-Switched laser - VIRIDIS: Pulsed Light handpiece 15mmx13mm with integrated 500-1200 nm filter - LILAC: Pulsed Light handpiece 48mmx13mm with interchangeable filters - RUBER: Pulsed Light handpiece 48mmx17mm with integrated 550mm filter - LAZUR: Pulsed Light handpiece 48mmx13mm with integrated 420-950 nm filter Emission activation is either by footswitch or fingerswitch. Electrical specifications are 115-240V~, 50-60Hz, 2300VA max.

The provided text is a 510(k) Pre-Market Notification from the FDA regarding the DEKA LUXEA device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove the device meets specific performance acceptance criteria for a new clinical claim.

Therefore, the document does not contain the information requested in your prompt regarding:

1. A table of acceptance criteria and reported device performance: This document explicitly states "Clinical Performance Data: None." The performance metrics provided (fluence, spot size, pulse duration, repetition rate) are technical specifications for comparison to predicate devices, not performance against clinical acceptance criteria.
2. Sample size used for the test set and the data provenance: No clinical test set data is presented.
3. Number of experts used to establish the ground truth... and their qualifications: No ground truth establishment is described as there's no clinical data.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Explanation of the Document's Purpose:

This 510(k) submission primarily relies on the "substantial equivalence" pathway for regulatory clearance. This means the manufacturer is asserting that their new device is as safe and effective as a legally marketed device (predicate device) that was on the market before May 28, 1976, or has been reclassified.

To establish substantial equivalence, manufacturers typically compare their new device to predicate devices in terms of:

• Indications for Use: The DEKA LUXEA handpieces have indications for use that are very similar to their respective predicate devices.
• Technological Characteristics: The document provides detailed comparisons of technical specifications like laser wavelength, fluence, spot sizes, pulse duration, and pulse repetition rate for each handpiece against its chosen predicate. The core argument is that these characteristics are either identical or sufficiently similar that the device is as safe and effective as the predicate.
• Non-Clinical Performance Data: The document explicitly mentions conformance with safety and electromagnetic compatibility (EMC) standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, IEC 60601-2-57). This demonstrates electrical safety and performance within established engineering norms, not clinical performance for specific outcomes.
• Clinical Performance Data: The document explicitly states "None." This is common for 510(k) submissions where substantial equivalence can be established through non-clinical means and comparison of technological characteristics.

In summary, the provided FDA document is a regulatory submission demonstrating substantial equivalence, not a clinical study proving device performance against specific acceptance criteria for a new clinical claim.

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