Search Results

755mm:

The Elite iQ PRO Laser System is indicated for stable long-term or permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 or 12 months after the completion of a treatment regime. It is used for skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

1064nm:

The Elite iQ PRO Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lakes, leg veins and porkiloderma of Civatte; and treatment of beingn cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigines (age spots), solar lentigines (sunspots), cafe au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

Additionally, the laser is indicated for the treatment of pseudo follicultis barbae (PFB) and for stable long-term or permanent hair reduction. Permanent hair reduction is defined as 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 Skintel Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence.

The Elite iQ™ PRO workstation is a dual wavelength system that delivers laser energy in both the Nd:YAG (1064-nm) and Alexandrite (755-nm) wavelengths. Through various spot sizes, fluences and repetition rates, the system offers hair removal treatment and aesthetic treatments across all skin types. An Alexandrite standalone workstation is also available for purchase. The Elite iQ PRO delivers the laser energy through a lens-coupled optical fiber with a wide range of interchangeable, quick-release laser handpieces with electronic spot recognition. The Elite iQ PRO also includes the Skintel® Melanin Reader for objective measurement of the melanin content of skin.

The locking casters allow this stand-alone laser system to be secured in place, as well as to be conveniently moved or transported. When not in use, handpiece components and other system components can be stowed in the storage area located in the side drawer. All system connections, such as the foot switch and remote interlock connections, are located on the rear of the laser. This includes all applicable device labels. User-selectable controls and functions are located on the front of the laser.

Elite iQ PRO software features include a Windows® operating system, LCD touch screen and a state-of-the-art graphic user interface. The software of the device was changed to update the fluence levels for the handpieces in order to support the new 30mm handpiece. The new 30 mm handpiece is also part of the DEKA AGAIN PRO device (K233090). The new fluence levels are within range of the previously approved ranges in the Elite iQ device (K193426). The software was also updated to reflect the Elite iQ PRO branding.

There are no changes to the principle of use of the device compared to the predicates Elite iQ Laser System (K193426) and DEKA AGAIN PRO (K233090).

The labeling of the device has been updated to reflect the name of the device Elite IQ PRO Laser System.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Elite iQ PRO (M122K1) device.

Key Observation: The provided 510(k) summary primarily focuses on establishing substantial equivalence to predicate devices (Elite iQ Laser System (K193426) and DEKA AGAIN PRO (K233090)) through comparison of technical characteristics and intended uses. It does not contain details about a clinical study with acceptance criteria for device performance in terms of efficacy or diagnostic accuracy (e.g., sensitivity, specificity, accuracy) for its intended indications (hair reduction, vascular lesions, etc.).

Instead, the "acceptance criteria" and "study" described are in the context of verification and validation activities against recognized electrical and laser safety standards, and comparing technical specifications to predicate devices.

1. Table of acceptance criteria and the reported device performance

Based on the provided text, the "acceptance criteria" appear to be compliance with established safety and performance standards for medical electrical and laser equipment, as well as maintaining similar technical characteristics to predicate devices. The "reported device performance" is implicitly that the device meets these standards and maintains comparable technical specifications.

Note: The document explicitly states: "The following verification and validation activities have been performed on the modified device." This indicates that the studies performed were primarily focused on demonstrating compliance with these technical and safety standards, rather than clinical efficacy.

Regarding Device Performance (from comparison tables):

The device's performance is described in terms of its technical specifications, which are compared to predicate devices. The key updates for the Elite iQ PRO are:

• Repetition Rate: Up to 12 Hz (compared to 10 Hz for Elite iQ and 12 Hz for DEKA AGAIN PRO).
• Handpiece (Spot) Size: Addition of a 30mm handpiece, similar to DEKA AGAIN PRO (Elite iQ had up to 24mm).
• Software update to reflect new fluence levels for the 30mm handpiece and Elite iQ PRO branding.

These are considered performance improvements or equivalences rather than demonstrating achievement of specific clinical acceptance criteria through a trial.

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 mention a clinical test set sample size, data provenance, or whether it was retrospective or prospective. The studies appear to be technical verification and validation, not clinical trials on patients.

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 information is not provided in the document. As no clinical efficacy or diagnostic accuracy study is described, there's no mention of experts establishing ground truth for a patient test set.

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

This information is not provided, as the document does not describe a clinical test set requiring adjudication.

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

There is no mention of an MRMC comparative effectiveness study, nor any AI assistance/human-in-the-loop performance data. The device is a laser system and a melanin reader; it does not appear to incorporate AI for interpretation or diagnosis that would necessitate such a study.

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

This is not applicable as the device is a laser system and a melanin reader, not an AI algorithm performing diagnostic tasks.

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

Since the studies described are for technical verification and validation against standards, the "ground truth" would be the specifications and requirements of those engineering and safety standards. For the Skintel Melanin Reader accuracy, the ground truth would be established by reference measurements or calibrated instruments. There is no mention of clinical ground truth (e.g., pathology, outcomes data) for the efficacy of hair removal or lesion treatment.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML device that requires a training set in the conventional sense.

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

This is not applicable for the same reason as above.

Ask a specific question about this device

MyEllevate is indicated for use in soft tissue approximation of sub dermis and underlying muscle

The MyEllevate device consists of a Surgical Suture System consisting of synthetic non-absorbable, braided, polyester surgical suture, and a set of instruments designed to efficiently and accurately place the suture for the purpose of performing soft tissue approximation. MyEllevate contains a Skin Marking Tape, a Lancet, a Tunneling Rod, two stainless steel Suturods, and a Light Handle which contains an LED light source. Each Suturod™ has an internal fiber optic "light pipe" which, when connected to the Ligh Handle, illuminates the distal tip of the Suturod™ and permits visual verification of the location and depth of the Suturod™ as it is passed through the subcutaneous space. All components of MyEllevate are provided sterile and are intended for single use only. While the nonabsorbable suture is a Class II device as describes by 21CFR, §878.5000, the remaining instruments are Class I devices exempt from 510(k) requirements. The Lancet, Clearing Device, and Tunneling Rod are manual surgical devices described by 21 CFR §878.4800. The Skin Marking Pen is described in 21 CFR §878.4660, and the fiber optic "light pipe" and Light Handle to illuminate surgical sites, is described in 21 CFR, §876.4530.

The provided document is a 510(k) summary for the MyEllevate device, which is a surgical suture system. This document is a premarket notification for a medical device and therefore does not contain information about an AI/ML-based device.

The document explicitly states:

• "807.92(b)(2) Clinical tests submitted – N/A – No clinical tests submitted" (Page 6), indicating no human performance or clinical studies were conducted for this submission.
• The device being cleared is a "Nonabsorbable Polyester Suture" and associated manual surgical instruments (Suturods, Lancet, Tunneling Rod, Light Handle, Skin Marking Tape). There is no mention of any AI or machine learning component.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI/ML device meets these criteria because the submitted text is a 510(k) for a physical medical device (suture system), not an AI/ML device.

Ask a specific question about this device

The Small 10mm, 10mm, 15mm, and 20mm handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids.

The Small 10mm, 18mm, 25mm, 30mm, and 60mm handpieces and the FlexSure Applicators provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

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

The following surgical modes are applicable to the generator:

Coagulation/Hemostasis: General surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures where electrosurgical coagulation of tissue is performed.

Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags and blepharoplasty.

Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, fistulas, epithelidma, cosmetic repairs, cysts, abscesses, and development of skin flaps.

Fulguration: basal cell carcinoma, papilloma, cyst destruction, tumors. verrucae, hemostasis.

Bipolar: pinpoint precise coagulation, pinpoint hemostasis in any, field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage.

The Cynosure TempSure™ System is a radiofrequency generator with a variety of applications both aesthetic and surgical procedures. The intended action is achieved through application of radiofrequency energy to the patient which results in minimization of heat dissipation and cellular alteration. Output of energy is controlled via the guided user interface (GUI) and the foot and/or hand-switch.

An additional Small 10mm Smart Handpiece is now included for the purpose of tissue heating for selected medical conditions and the treatment of mild to moderate facial wrinkles and rhytids. The handpiece is capable of operating at maximum energy setting of 30 (28W) in the Smart Handpiece Mode. There have been no additional changes to the previous existing handpieces (10, 15, 18, 20, 25, 30 or 60mm), FlexSure Applicators, or Surgical modes (COAG, Cut, Blend, Bipolar, Fulgurate) of the system. The TempSure system is still used with the same existing electrosurgical accessories.

The TempSure™ System includes:
TempSure™ Generator
Temperature Sensing Handpieces (Small 10, 10, 15, 18, 20, 25, 30, and 60mm)
Massage Heads (25, 30, and 60mm)
FlexSure™ Applicators (Large and Medium)
IEC Power Cord
Footswitch
Disposable/Reusable Neutral Pads
Surgical Fingerswitch/Foot Controlled Handpieces
Monopolar Cables
Disposable/Reusable Electrodes, Forceps

The TempSure System is an electrosurgical cutting and coagulation device. The acceptance criteria and the study that proves the device meets them are summarized below.

1. Table of Acceptance Criteria & Reported Device Performance:

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

The document states that bench testing was conducted for the tissue heating evaluation. However, it does not specify a numerical sample size (e.g., number of handpieces tested, number of simulated treatment areas). The provenance is explicitly a "simulated clinical condition," indicating a laboratory-based, prospective evaluation rather than real-world patient data.

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

Not applicable. The reported studies are non-clinical bench tests. There is no mention of expert involvement for ground truth establishment.

4. Adjudication Method for the Test Set:

Not applicable. The reported studies are non-clinical bench tests, which do not typically involve adjudication methods like those used for expert consensus on clinical data.

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

No. The document explicitly states: "N/A - No clinical tests submitted." Therefore, no MRMC comparative effectiveness study was done.

6. Standalone Performance:

Yes, a standalone (algorithm only without human-in-the-loop performance) was done, but in the context of a medical device rather than an algorithm. The non-clinical tests evaluated the device's technical performance (tissue heating capabilities, electrical safety) directly, without human interpretation of results in a diagnostic or treatment decision-making cycle.

7. Type of Ground Truth Used:

For the tissue heating test, the ground truth was based on the ability of the device to heat and maintain a specific temperature in "simulated clinical conditions." This would likely involve quantitative measurements of temperature. For the electrical safety and electromagnetic compatibility tests, the ground truth was regulatory compliance with established international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2), which are objectively measurable criteria.

8. Sample Size for the Training Set:

Not applicable. The device is a radiofrequency generator with handpieces, not an AI/ML algorithm that requires a training set.

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

Not applicable, as no training set was used for an AI/ML algorithm.

Ask a specific question about this device