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.

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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.

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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, 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, epithelioma, 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.
There have been no changes to the TempSure Device or handpieces (Small 10, 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 provided document (K223292) is a 510(k) premarket notification for the Cynosure TempSure System. This type of submission asserts substantial equivalence to a legally marketed predicate device, rather than providing new clinical data to establish safety and effectiveness from scratch. As such, the document explicitly states:

• "807.92(b)(1) Non-clinical tests submitted– N/A – No non-clinical tests submitted"
• "807.92(b)(2) Clinical tests submitted – N/A – No clinical tests submitted"
• "807.92(b)(3) Conclusions drawn from clinical and non-clinical tests submitted– N/A"

Therefore, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, because no new non-clinical or clinical studies were submitted for this 510(k) notification.

The submission establishes substantial equivalence by demonstrating that the device has the same intended use and similar technological characteristics as its predicate device (Cynosure TempSure System, K212891), with no changes to the device or handpieces, only an update to labeling with an additional contraindication.

Because no studies were submitted, the following requested information cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance (algorithm only) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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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.

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755mm:
The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal including but not limited to: Nevus of Ota, Hori macules (nevus of Hori), and Melasma. The PicoSure Workstation with the 2mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I – IV.

532nm:
The PicoSure 532-nm delivery system is indicated for tattoo removal and benign pigmented lesions removal in Skin Types I-III.

1064nm:
The PicoSure 1064-nm delivery system is indicated for tattoo and benign pigmented lesions removal.

The PicoSure Workstation is a high-powered, Alexandrite system that delivers laser energy in the 755-nm nominal wavelength. The system offers treatment through a variety of spot sizes, fluences and repetition rates. Laser activation is by footswitch. In addition to the 755nm handpiece, optional 532nm Laser Delivery System and/or 1064nm Laser Delivery System can replace the 755nm handpiece at the distal end of the articulated arm. These Delivery Systems convert the 755nm laser energy into a 532nm wavelength or a 1064 nm wavelength and are available in multiple spot sizes.

The provided document is a 510(k) summary for the PicoSure Workstation, a laser surgical instrument. It details the device's indications for use and compares it to predicate devices. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance directly in the format you requested, especially regarding quantitative performance metrics, sample sizes for test sets, and details about expert involvement in establishing ground truth.

The document indicates that to support the expanded indications for use (Nevus of Ota, Hori macules, and Melasma), a literature search was conducted. This means the clinical evidence is based on existing published studies rather than a new, dedicated clinical trial performed for this 510(k) submission.

Here's an attempt to answer your questions based on the provided text, with clear indications where information is not available from this document:

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

The document does not specify quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or specific improvement percentages) directly associated with this 510(k) submission. Instead, it relies on demonstrating substantial equivalence to a predicate device and supporting new indications through literature review. The reported "performance" is qualitative, focusing on whether the existing literature showed "acceptable clinical effectiveness and safety" for the new indications.

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: Not explicitly stated as a single test set size. The document mentions "at least ten individuals" in each of the six identified articles. Thus, the total number of individuals across all six studies is at least 60. Individual study sizes are not detailed.
• Data provenance: The document states "peer reviewed, published articles." No specific countries of origin are mentioned.
• Retrospective or prospective: The articles were identified as "prospective studies."

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 / Not Available. Since the evidence is based on published clinical studies, the "ground truth" and its establishment would be inherent to the methodologies of those individual studies. The 510(k) summary does not provide details on how ground truth was established within these external studies or the qualifications of any experts involved in those studies.

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

• Not Applicable / Not Available. This information would pertain to the specific methodologies of the clinical studies identified in the literature search. The 510(k) summary does not provide these details.

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 document is for a laser workstation, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance effect size is relevant or mentioned.

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

• Not Applicable. This is a hardware device (laser workstation), not an algorithm or AI system.

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

• Not Applicable / Not Available. The "ground truth" would relate to the diagnosis of the benign pigmented lesions (Nevus of Ota, Hori macules, Melasma) and the success of their removal or clinical improvement. The specific method used to establish these in the surveyed literature is not detailed in this 510(k) summary. It likely involved clinical diagnosis by dermatologists and visual assessment of treatment outcomes.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this device. The device's operation is based on its physical properties and established laser physics, not on a machine learning model trained on data. The clinical literature reviewed supported the indications for use, not a training process for the device itself.

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

• Not Applicable. As there is no training set, this question is not relevant.

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

The 18mm, 25mm, 30mm, 60mm Smart Handpieces and 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: 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.

The FlexSure TM Applicators are now included for the purpose of tissue heating for selected medical conditions. The applicator comes in 2 sizes (large and medium) and has the same maximum output power of 300W in the Smart Handpiece Mode. The FlexSure applicator utilizes the larger disposable neutral pad. There have been no changes to the Smart Handpiece (10, 15, 18, 20, 25, 30 or 60mm) 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 (10, 15, 18, 20, 25, 30, and 60mm)
Temperature Sensing single use applicator (FlexSure)
Massage Heads (25, 30, and 60mm)
IEC Power Cord
Footswitch
Disposable/Reusable Neutral Pads
Surgical Fingerswitch/Foot Controlled Handpieces
Monopolar Cables
Disposable/Reusable Electrodes, Forceps

New Additions to the Tempsure System include:
• FlexSure™ Large Applicator
• FlexSure™ Medium Applicator

The provided text describes a 510(k) premarket notification for the Cynosure TempSure™ System. This submission focuses on establishing substantial equivalence to a legally marketed predicate device (Cynosure TempSure™ K190678), with new additions being the FlexSure™ Applicators. The "study" proving the device meets acceptance criteria primarily relies on non-clinical bench testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria in the way one might expect for a clinical study with specific performance metrics (e.g., sensitivity, specificity for an AI diagnostic device). Instead, the "acceptance criteria" here are implicitly tied to demonstrating substantial equivalence to the predicate device, especially regarding safety and effectiveness.

The key performance aspect tested for the new addition (FlexSure™ Applicator) is its ability to heat and maintain temperature of the treatment area for 10 minutes in a simulated clinical condition.

Table of "Acceptance Criteria" and Reported Device Performance (as inferred from the document for the newly added feature):

Study Details:

This submission is a 510(k) Premarket Notification, which primarily relies on demonstrating substantial equivalence to a predicate device, rather than novel clinical efficacy data. The "study" in this context refers to the non-clinical testing performed to support this equivalence for the new components.

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

   • Sample Size: Not explicitly stated as a number of "samples" in the traditional sense of patient data. For the Tissue Heating with FlexSure™ Applicator bench test, it involved testing the applicator with a "large neutral pad" in a "simulated clinical condition." The specifics of how many times this was tested or over how many "simulated" areas are not provided.
   • Data Provenance: The data originates from bench testing conducted by Cynosure, LLC. The location of the testing is not specified, but the applicant (Cynosure) is based in Westford, Massachusetts, USA. The data is retrospective in the sense that it's reported from completed tests, not ongoing prospective patient studies.

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

   • This question is not applicable in the context of this 510(k) submission. The ground truth for the performance of this electrosurgical device is established through engineering and physics principles, measured physical characteristics (temperature, electrical safety parameters), and compliance with international standards (IEC). There are no human experts establishing a "ground truth" for the device's diagnostic performance, as it is a treatment and surgical device, not a diagnostic AI system.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or studies where human readers (e.g., radiologists) interpret medical images or data, and their interpretations need to be reconciled to form a ground truth. This is a non-clinical bench test of an electrosurgical device.

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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI diagnostic aids where human interpretation is involved. This device is an electrosurgical system. The document explicitly states: "No clinical tests submitted."

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

   • N/A (not applicable in the AI sense). This device is a physical electrosurgical system. Its "standalone" performance means its inherent operational characteristics (e.g., temperature output, electrical safety) independent of a human operator's actions beyond basic control. The bench tests evaluated the device itself. It does not refer to an AI algorithm functioning in isolation.

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

   • The ground truth for the non-clinical tests was based on physical measurements and engineering standards.
     • For Tissue Heating: The "ground truth" was the measured temperature achieved and maintained over time in the simulated tissue, compared against the design specification of "at least 10 minutes."
     • For Electrical Safety and EMC: The "ground truth" was compliance with specified international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).

7. The sample size for the training set:

   • Not applicable. This submission is for a physical medical device, not an AI/Machine Learning algorithm that requires a "training set."

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

   • Not applicable. As there is no training set for an AI algorithm, this question is irrelevant to this device submission.

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755mm:
The Elite iQ Laser System is indicated 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 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 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 poikiloderma of Civatte; and treatment of benign 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 folliculitis 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™ 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 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 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 software features include a Windows® operating system, LCD touch screen and a state-of-the-art graphic user interface.

The provided FDA 510(k) summary for the Cynosure Elite iQ laser system primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and safety testing. It does not involve an AI/ML-driven device, clinical studies to evaluate diagnostic performance (like those for AI-driven image analysis), or human-in-the-loop performance studies. Therefore, many of the requested categories (e.g., sample size for test/training sets, expert ground truth adjudication for AI, MRMC studies) are not applicable to this submission.

The "Performance Testing - Bench" section describes a validation study related to the "Hair Removal Treatment Guidance Mode" (which provides starting settings based on user input, not an AI algorithm) for safety. This is the closest aspect to "acceptance criteria and study that proves the device meets acceptance criteria" within the provided text, but it's not an AI/ML context.

Here's a breakdown based on the provided document, acknowledging the non-AI/ML context:

Device: Cynosure Elite iQ Laser System

Purpose of Submission (K193426): To demonstrate substantial equivalence to legally marketed predicate devices for indications related to hair reduction, vascular lesions, pigmented lesions, and wrinkle treatment, and for the Skintel Reader which measures skin melanin content.

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

The document states that "Performance testing showed no complications from using the recommended settings, thus confirming the treatment parameters set forth in the Hair Removal Treatment Guidance Mode are a safe starting point for practitioners performing test spots." It also mentions "Results showed no undesirable or unexpected AEs from test spots."

While explicit numerical acceptance criteria (e.g., "no more than X% of patients experience AE") are not presented in this summary section, the implicit acceptance criterion for the "Hair Removal Treatment Guidance Mode" validation was that the recommended settings would lead to no undesirable or unexpected adverse events (AEs) when applied as test spots.

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

• Test Set Sample Size: Not explicitly stated as a number of subjects. The document refers to "The subjects chosen were at the high end of the recommended skin type range."
• Data Provenance: The validation study was performed by E. Victor Ross MD, affiliated with Scripps Green Hospital in San Diego, CA (USA). It appears to be a prospective validation study, as it describes patients being "evaluated 48-72 hours post treatment."

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

• Number of Experts: One expert is explicitly mentioned: E. Victor Ross MD.
• Qualifications of Experts: Affiliated with Scripps Green Hospital in San Diego, CA. (Specific domain experience like "dermatologist with X years experience" is not detailed in this summary).

4. Adjudication method for the test set:

Not applicable in the context of this safety validation. The expert (E. Victor Ross MD) performed the study and evaluated the outcomes. There's no mention of multiple reviewers or an adjudication process for what would typically be an AI ground truth dataset in an AI/ML context.

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 system and a skin melanin reader; it does not involve AI assistance for human readers or interpretation of medical images.

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

Not applicable in the context of AI/ML. The "Hair Removal Treatment Guidance Mode" provides recommendations, but those are based on pre-programmed settings and user inputs, not an AI algorithm performing alone.

7. The type of ground truth used:

For the "Hair Removal Treatment Guidance Mode" validation, the "ground truth" was the observed absence of undesirable or unexpected adverse events (AEs) on patients following treatment with the system's recommended settings. This is akin to outcomes data related to safety.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. The "Hair Removal Treatment Guidance Mode" settings were "created based on previous user experience with the Elite+ Laser System," rather than being derived from a formal training dataset for an AI model.

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

Not applicable, as there was no formal "training set" in the context of an AI/ML algorithm. The settings were derived from "previous user experience" with an earlier product (Elite+ Laser System), suggesting historical clinical observations and expert consensus from practical application over time.

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