Search Results

Regulation Number

Type

Panel

Reference & Predicate Devices

K050673,K050779

Intended Use

1,064nm:

The Vbeam Prima 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, venus lakes, leg veins, and poikiloderma of civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), cafe au lait manules, sebortheic keratoses, nevi, chloasma, verrucea, skin tags, and keratoses. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

595 nm:

General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.

Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia. rosacea, port wine stains, hemangioma, spider angioma, poikiloderma of civatte, and benign cutaneous lesions, such as warts, scars, striae, psoriasis and the treatment of benign epidermal pigmented lesions. Treatment of inflammatory acne vulgaris.

Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.

Podiatry: Treatment of benign cutaneous lesions, such as warts.

Device Description

The Vbeam Prima Laser system is designed as a transportable device that delivers laser energy at wavelengths of 595 nm (pulse-dye) or 1064 nm (Nd: YAG). The device is comprised of a main console, power supply, controlled electronics, firmware, software, cooling system, and handpieces. There is also an internal calibration port with an internal meter located in the system. The handpiece offers a set of distance gauges available in the following spot ranges: 3-7 mm, 7-11 mm, 11-15 mm, and 3 X 10 mm. The user selects treatment settings, such as fluence, number of pulses, and spot size selection via a color touch screen. The handpiece incorporates a Dynamic Cooling Device (DCD) into its handpiece that is designed to cool the skin surface during treatment, which consists of an electrically controlled spray nozzle, cryogen reservoir canister and an electronic control circuitry. The Vbeam Prima Laser System also offers an optional EverCool Delivery System Handpiece for skin cooling during treatment.

AI/ML Overview

The Vbeam Prima Laser System's acceptance criteria and the study proving it meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Electrical Safety and EMC	Compliance with recognized standards:	The device passed the required testing and is in full compliance with the following standards:
	- IEC 60825-1	- IEC 60825-1: Safety of Laser Products – Part 1: Equipment classification and requirements
	- IEC 60601-1-2	- IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for safety - collateral standard: electromagnetic compatibility (EMC)requirements and test
	- IEC 60601-1	- IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
	- IEC 60601-2-22	- IEC 60601-2-22: Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Biocompatibility	Established based on predicate devices and ISO standards.	Biocompatibility was established based on predicate devices and the results of ISO 10993-5 (in vitro cytotoxicity) and ISO 10993-10 (irritation and skin sensitization) series of testing.
Software Verification & Validation	Acceptable for software release according to FDA guidance.	Software verification and validation testing was conducted, and the results demonstrated that testing results were found acceptable for software release. Software testing was performed per FDA's guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices."
Bench Testing (Cooling Performance)	DCD handpiece and Evercool handpiece produce similar cooling results.	A bench study was conducted to confirm that the DCD handpiece and Evercool handpiece can produce similar cooling results. (The document does not provide specific performance metrics, but states "confirm that the DCD handpiece and Evercool handpiece can produce similar cooling results," implying the criterion was met.)
Clinical Testing	Not needed due to similarity to predicate devices.	Based on the similarities of the device specifications, intended use, and indications for use between the Vbeam Prima Laser System and its predicate devices, no clinical studies were needed to support this 510(k) Premarket Notification. The safety and effectiveness are established by substantial equivalence to previously cleared devices.

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

Since no clinical studies were conducted for the Vbeam Prima Laser System due to its substantial equivalence to predicate devices, there isn't a "test set" in the traditional sense for clinical performance.

Electrical Safety and EMC: Testing was conducted on the device itself (Epic Pro 940, implicitly the Vbeam Prima or a prototype). This involved laboratory testing, not human subjects or patient data.
Biocompatibility: Testing was on materials of the device, according to ISO 10993 standards. This is laboratory testing.
Software Verification & Validation: Testing was on the software of the device. This is internal software testing.
Bench Testing (Cooling Performance): Testing was on the DCD and Evercool handpieces. This is laboratory testing.

Therefore, there is no human subject data provenance (country of origin, retrospective/prospective).

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

Not applicable, as no clinical studies were performed. The "ground truth" for the device's safety and effectiveness was established by its compliance with recognized standards and its technological similarity to legally marketed predicate devices, which had previously demonstrated safety and effectiveness through their own studies and clinical use.

4. Adjudication Method for the Test Set

Not applicable, as no clinical studies were performed.

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

No MRMC comparative effectiveness study was done, as no clinical studies were performed. The Vbeam Prima Laser System is a physical medical device (laser system), not an AI algorithm that assists human readers.

6. Standalone (Algorithm Only) Performance

Not applicable, as the Vbeam Prima Laser System is a physical medical device, not an AI algorithm. Its performance is evaluated through engineering and biocompatibility testing, not AI algorithm standalone performance.

7. Type of Ground Truth Used

The "ground truth" for the Vbeam Prima Laser System's safety and effectiveness relies on:

Compliance with recognized international standards for electrical safety, electromagnetic compatibility, and biocompatibility.
Demonstrated equivalence of technological characteristics and intended use to predicate devices that have an established history of safe and effective use.

8. Sample Size for the Training Set

Not applicable, as this is a physical medical device, not an AI algorithm that requires a training set of data.

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

Not applicable, as this is a physical medical device, not an AI algorithm.

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K Number

K170597

Device Name

Syneron Candela Corporation

Manufacturer

Date Cleared

2017-05-25

(86 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K120510,K140122,K133283,K112715,K033461,K143105,K140719,K133364,K121346,K162454,K160607,K153527,K150326,K142372

Intended Use

The PicoWay laser system is indicated for the following at the specified wavelength:

532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

785nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.

1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.

The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.

The Resolve handpieces are also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.

Device Description

The PicoWay Laser System is a solid state laser capable of delivering energy at wavelengths of 1064 nm, 785 nm, or 532 nm at short durations of 240–750 picoseconds (ps) at repetition rates up to 10 Hz (1064 nm, 532 nm) or 5 Hz (785 nm). The device system is comprised of a system console, an articulated arm, and an attached handpiece. The laser output at each wavelength is generated within the laser chassis and delivered to the skin through an articulated arm delivery system terminated by a handpiece. The light-weight and ergonomic handpieces allow the spot size on the skin to be easily adjusted. A range of spot sizes is available for the PicoWay System (up to 10 mm). The system includes an internal calibration port with an internal meter located on the control panel of the system console, which is used to verify the transmission of the articulated arm. The PicoWay system control panel enables the user to select the desired energy density level and repetition rate. The control panel is also used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.

AI/ML Overview

The provided text describes the FDA 510(k) summary for the PicoWay Laser System, primarily focusing on its expansion of indications for use to include the treatment of wrinkles.

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

Device: PicoWay Laser System
Expanded Indication: Treatment of wrinkles using the Resolve handpieces (532nm or 1064nm wavelengths)

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Primary Endpoint Criterion)	Reported Device Performance
80% of treated areas showing improvement in wrinkles appearance, as assessed by the correct identification of the post-treatment photograph and assessment of at least one Elastosis Score unit.	82% of treated areas showed improvement in wrinkles appearance (exceeding the primary endpoint criterion).
Additional findings:

Investigator assessments: 92% improvement rate at 12-week follow-up.
Mean elastosis score improvement: 1.44 ± 0.83.
Investigator satisfaction rate: 88%.
Subjects' satisfaction rate: 74% at the last visit.
Very positive safety profile with no adverse events (though 2 subjects reporting severe pain were counted as AEs out of caution, but resolved next day without intervention).
Anticipated treatment responses (erythema, edema, tingling, crusting, acne breakout) observed and resolved within days without medical intervention.
Most subjects reported low levels of pain during treatment and discomfort in the week following treatment, indicating good tolerability. |

Study Details:

Sample Size and Data Provenance:
- Test Set Sample Size: A total of 74 subjects were enrolled, and 72 subjects were treated.
- Data Provenance: The study was a "multicenter study conducted at 4 sites in the United States." The data is prospective.
Number and Qualifications of Experts for Ground Truth:
- Number of Experts: Two blinded evaluators.
- Qualifications: Not explicitly stated beyond "blinded evaluators." It's common in dermatology/cosmetic studies for these to be board-certified dermatologists or plastic surgeons, but the document does not specify.
Adjudication Method for the Test Set:
- The assessment was performed by "2 blinded evaluators." The text implicitly suggests consensus or independent agreement was sought for the "correct identification of the post treatment photograph and assessment of at least one Elastosis Score unit." However, a formal adjudication process like 2+1 or 3+1 is not explicitly described. It simply states "as assessed by 2 blinded evaluators," implying their combined assessment formed the ground truth for the primary endpoint.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC study was conducted for human readers with and without AI assistance. This device is a laser system, not an AI diagnostic tool that assists human readers. The clinical study was a direct evaluation of the device's effect on wrinkles.
Standalone Performance (Algorithm Only):
- N/A. This is a hardware device (laser system) used for treatment, not an algorithm for diagnosis or image analysis. The "performance" here refers to the clinical efficacy and safety of the physical device.
Type of Ground Truth Used:
- The ground truth for the primary endpoint was established by expert assessment ("2 blinded evaluators") based on "correct identification of the post treatment photograph and assessment of at least one Elastosis Score unit." This is a subjective, observer-reported outcome measure in a clinical setting.
- Additional ground truth indicators included investigator assessments, subject satisfaction, and adverse event reporting.
Sample Size for the Training Set:
- N/A. This is a medical device (laser system), not a machine learning algorithm that requires a separate training set. The study describes a clinical trial evaluating the device's performance directly on human subjects.
How the Ground Truth for the Training Set Was Established:
- N/A. (See point 7).

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K Number

K162454

Device Name

Manufacturer

Date Cleared

2017-02-01

(153 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K140122,K133283,K112715,K033461,K143105,K140719,K133364,K121346,K160607,K153527,K150326,K142372,K120510

Intended Use

The PicoWay laser system is indicated for the following at the specified wavelength:

532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

785nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.

1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.

The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.

Device Description

The PicoWay Laser System is a solid state laser capable of delivering energy at wavelengths of 1064 nm, 785 nm, or 532 nm at short durations of 240-540 picoseconds (ps) at repetition rates up to 10 Hz (1064 nm, 532 nm) or 5 Hz (785 nm). The device system is comprised of a system console, an articulated arm, and an attached Zoom or Resolve Handpiece. The laser output at each wavelength is generated within the laser chassis and delivered to the skin through an articulated arm delivery system terminated by a Handpiece. The light-weight and ergonomic Zoom Handpieces allow the spot size on the skin to be easily adjusted. A range of spot sizes is available for the PicoWay System when using the Zoom Handpiece (up to 10 mm). The Resolve Handpieces are available with 6 x 6 mm spot size for both wavelengths. The system includes an internal calibration port with an internal meter located on the control panel of the system console, which is used to verify the transmission of the laser beam into the articulated arm. The PicoWay system control panel enables the user to select the desired energy density level and repetition rate. The control panel is also used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study findings for the PicoWay Laser System, based on the provided text:

Acceptance Criteria and Device Performance

Criteria	Reported Device Performance
Improvement in acne scar appearance (Primary Endpoint)	94% of treated areas showed improvement, exceeding the 70% criterion.
Mean improvement level	1.17, exceeding the 1 unit improvement defined in the primary endpoint.
Safety Profile	Very positive safety profile; no adverse events during the study.
Resolution of anticipated treatment responses	Erythema, edema, tingling, pinpoint bleeding, crusting, and acne breakout resolved within days.
Pain and discomfort levels	Low levels of pain during treatment and discomfort in the week following treatment.
Investigator satisfaction rate	89% at the last visit.
Subject satisfaction rate	78% at the last visit.
Performance to specifications	All performance testing demonstrated the device performs according to specifications and functions as intended.
Conformity with electrical safety and EMC standards	Conformed to IEC 60601-1, IEC 60601-1-2, IEC 62366, IEC 60601-1-6, IEC 60601-2-22, and IEC 60825-1.
Biocompatibility	Established per ISO 10993 guidelines, based on the predicate device.
Software Validation	Software verification and validation testing results were acceptable.
Bench Testing (energy measurements)	Verified that energy measurements met specifications.

Study Details

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

Sample Size: 36 subjects.
Data Provenance: Prospective, from 3 sites in the United States.

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

Number of Experts: 3 blinded evaluators.
Qualifications: The document does not specify the exact qualifications (e.g., "radiologist with 10 years of experience"). It only states they were "blinded evaluators" who assessed improvement by "correct identification of the post treatment photograph."

4. Adjudication Method for the Test Set:

A consensus-like method was used: "as assessed (by the correct identification of the post treatment photograph) by at least 2 of 3 blinded evaluators." This implies that agreement from at least two out of three evaluators was sufficient for a positive assessment.

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, a multi-reader multi-case (MRMC) comparative effectiveness study comparing AI assistance to human readers was not done. This study solely evaluated the device's performance based on expert assessment of photographs. This device is a laser system, not an AI diagnostic tool.

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

Not applicable. This is a medical device (laser system), not a standalone algorithm. Its performance is directly tied to its physical operation and the in-human results.

7. The Type of Ground Truth Used:

Expert Consensus: The primary endpoint relied on the consensus of at least 2 out of 3 blinded evaluators assessing photographic improvement.
Investigator Assessments: Investigators also provided assessments of improvement rates.
Patient Reported Outcomes (PROs): Subject satisfaction rates were collected.
Histology Data: Biopsy samples provided histological evidence of treatment effects and healing.

8. The Sample Size for the Training Set:

The document refers to "several prospective studies" that have been conducted previously to evaluate the PicoWay System, suggesting a broader dataset exists. However, for the specific expanded indication (acne scars), no separate "training set" is described for this premarket notification. The 36-subject study appears to be the primary clinical evidence for this specific indication.

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

As no explicit "training set" for the acne scar indication is detailed in this document, the method for establishing its ground truth is not provided. For the test set described, ground truth was established through blinded evaluators' consensus, investigator assessments, and histological data.

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K Number

K161043

Device Name

Profound System

Manufacturer

Date Cleared

2016-09-12

(152 days)

Product Code

PBX,GEI

Regulation Number

878.4400

Type

Panel

K123407,K082391,K080145,K150035

Reference & Predicate Devices

Intended Use

The Profound System is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. Specifically, the 25º Dermal handpiece and cartidge are used for percutaneous treatment of facial wrinkles, and the 75° SubQ handpiece and cartridge are used to improve the appearance of cellulite in patients with Fitzpatrick skin types I-III as supported by long-term clinical data (6 months).

Device Description

The Profound System is comprised of the following components: a re-usable console containing a radiofrequency (RF) generator and graphical user interface; two re-usable treatment applicators; and two disposable, single use, sterile electrode cartridges. Bipolar RF energy is delivered from the RF generator through the electrodes into the dermal layers beneath the surface of the skin. The volume of the treated area is defined by the geometry of the individual micro-electrode needle pairs, which are all electrically isolated from each other and controlled independently by separated RF channels within the console. In addition, temperature sensors provide real-time feedback of tissue temperature. The treatment dose is controlled by the physician.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Primary Endpoint)	Reported Device Performance
Primary: 80% of treated thighs show at least 1 point level of improvement in the appearance of cellulite at 3 months post-treatment relative to baseline photos, as assessed by blinded review (considering improvement in dimples and/or undulation irregularities).	Met: 94% (79/84) of the treated thighs, based on observed data, demonstrated an improvement in cellulite appearance per blinded review at 3 months.
88% (37/42) of the treated subjects showed improvement in both thighs in dimples and/or undulation at 3 months follow-up.
(Specifically: 86% of treated thighs with dimples at baseline showed improvement in dimples; 76% of treated thighs with undulation at baseline showed improvement in undulation irregularities.)
Secondary (Effectiveness): Cellulite appearance improvement by blinded evaluators at 6 months post-treatment visit.	Met: Improvement in cellulite appearance was maintained at 6 months follow-up; 93% (78/84) of the treated thighs (per-subject success of 86%) showed improvement in cellulite appearance at 6 months post-treatment compared to baseline based on blinded review.
Secondary (Effectiveness): Cellulite appearance improvement by study investigators and subject improvement/satisfaction assessments.	Met: Investigator cellulite reduction assessment results demonstrated progressively improved treatment effects for the large majority of thighs at 3 and 6 months. Cellulite improvement per Nurnberger-Muller scale showed increasing levels of improvement throughout the study. Investigator satisfaction increased gradually and was demonstrated for the majority of subjects at 3 and 6 months. Subject improvement results showed moderate to excellent reduction for most thighs at 3 and 6 months. Subject satisfaction was reported by a majority of subjects at 3 and 6 months.
Safety: No device-related serious adverse events. Anticipated treatment responses resolve without medical intervention.	Met: Of 50 subjects, only 3 reported a total of 3 adverse events, none serious, and each resolved during the study. Anticipated treatment-associated responses (e.g., erythema, edema) resolved completely without medical intervention.

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

Sample Size (Test Set): 50 treated subjects (100 thighs).
Data Provenance: The study was conducted across 4 U.S. sites. The study was prospective, single-arm, and self-controlled.

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

The document states "blinded review" but does not specify the number or qualifications of the experts who performed this blinded review for establishing the ground truth.

4. Adjudication Method for the Test Set

The document states "blinded review" for assessing improvement in cellulite. However, it does not specify a formal adjudication method like 2+1 or 3+1. It implies direct assessment by the blinded reviewers against baseline photos.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study was a single-arm, self-controlled study focused on the Profound System's performance rather than comparing it against human readers or other devices in a multi-reader context. Therefore, there is no effect size reported for human readers improving with AI vs without AI assistance, as AI assistance in image interpretation is not the function of this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device (Profound System) is an electrocoagulation and hemostasis device used for percutaneous treatment of facial wrinkles and cellulite. It is a physical medical device that delivers energy, not an AI algorithm for diagnostic interpretation. Therefore, a standalone algorithm-only performance study is not applicable and was not performed. The performance evaluated is that of the device itself on patients, not an AI interpreting data.

7. The Type of Ground Truth Used

The ground truth for the effectiveness endpoints was established through blinded expert review of clinical photographs at various follow-up intervals compared to baseline photos. Additionally, investigator assessments and patient self-assessments contributed to the understanding of effectiveness.

8. The Sample Size for the Training Set

The document describes a single clinical study of the device for its new indication. It does not refer to a "training set" in the context of an AI model. The 50 subjects (100 thighs) are the test set for evaluating the device's clinical efficacy for its intended use. If this device had AI components, its training set would be mentioned separately. As it is a physical device, this concept does not apply in the same way.

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

As explained in point 8, the concept of a "training set" for an AI model is not applicable in this context. The clinical study described served as the primary evidence to demonstrate the device's performance for regulatory clearance.

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K Number

K160607

Device Name

Manufacturer

Date Cleared

2016-07-05

(125 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K153527,K150326,K142372,K120510,K140122,K133283,K112715,K033461,K143105,K140719,K133364,K121346

Intended Use

The PicoWay laser system is indicated for the following at the specified wavelength:

532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

785nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.

1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.

The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-V.

Device Description

The PicoWay Laser System is a solid state laser capable of delivering energy at wavelengths of 1064 nm, 785 nm, or 532 nm at short durations of 240-750 picoseconds (ps) at repetition rates up to 10 Hz (1064 nm, 532 nm) or 5 Hz (785 nm). The device system is comprised of a system console, an articulated arm, and an attached Handpiece. The laser output at each wavelength is generated within the laser chassis and delivered to the skin through an articulated arm delivery system terminated by a Handpiece. The light-weight and ergonomic Handpieces allow the spot size on the skin to be easily adjusted. A range of spot sizes is available for the PicoWay System (up to 10 mm). The system includes an internal calibration port with an internal meter located on the control panel of the system console, which is used to verify the transmission of the laser beam into the articulated arm. The PicoWay system control panel enables the user to select the desired energy density level and repetition rate. The control panel is also used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided text, formatted as requested:

Acceptance Criteria and Device Performance Study for PicoWay Laser System

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for the clinical study. Instead, it reports specific outcomes and compares them to expectations based on predicate devices. I have inferred the implied performance goals based on the reported favorable safety profile and substantial clearance for tattoo removal, aligning with the "perfoRMS as intended" declaration.

Acceptance Criterion (Inferred)	Reported Device Performance
Favorable Safety Profile	No device-related serious adverse events. Mild erythema, edema, and pinpoint bleeding observed (anticipated responses). None to moderate discomfort/pain, consistent with predicate. No adverse events in additional Resolve handpiece studies (114 subjects).
Substantial Clearance of Blue and Green Tattoos (785nm)	100% of tattoos correctly identified as pre/post-treatment by 3 blinded reviewers. 83% of blue/green tattoos demonstrated at least 50% clearance compared to baseline after only 2 treatments. Investigator assessment: 83% (15/18) of blue/green tattoos achieved substantial to complete clearance.
Equivalent Performance to Predicate Devices (Safety & Efficacy)	Study results did not present any new types of safety questions compared to predicate devices. Histological evaluation shows effects on treated area using picosecond laser energy with Resolve handpieces are equivalent between PicoWay and PicoSure devices.
Electrical Safety & EMC Conformance	Conforms to IEC 60601-1, IEC 60601-1-2, IEC 62366, IEC 60601-1-6, IEC 60601-2-22, and IEC 60825-1.
Biocompatibility	Established per ISO 10993 guidelines (based on predicate).
Software Verification & Validation	Testing results found acceptable for software release.
Bench Testing (Energy Measurements)	Met specifications.
Bench Testing (Resolve Handpiece efficacy)*	Clears pigment particles similarly to previously cleared Zoom handpiece. 100 pulses of PicoWay 785nm resulted in greater ink clearance than 200 pulses of another legally marketed device. Achieved ink particle fracturing/de-aggregating pigment particles in a substantially equivalent manner to other systems.

Note: The bench testing on Resolve handpiece efficacy is an important performance indicator, even if not phrased as a "criterion" in the same way as safety or clinical clearance percentages.

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

Sample Size: 15 subjects (22 tattoos).
Data Provenance: The document does not explicitly state the country of origin. It describes the study as a "single arm, self-controlled study," implying it was a prospective clinical trial conducted specifically for this submission.

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

Number of Experts: 3 blinded reviewers.
Qualifications of Experts: Not specified. The document only states "independent review by 3 blinded reviewers."

4. Adjudication Method for the Test Set

Method: Not explicitly described as part of an adjudication process in the traditional sense for determining "ground truth." The reviewers "correctly identified the pre and post treatment for all (100%) of the tattoos," suggesting their role was to evaluate the visibility of change rather than to establish a definitive, gold-standard diagnosis or measurement. The percentage clearance was likely based on a subjective rating scale or objective measurement method applied to the images, with the reviewers' agreement confirming the detectability of this change.

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 MRMC study was done. This study evaluated the performance of the device itself (PicoWay Laser System) and not an AI-assisted diagnostic tool or human reader performance.

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

Not applicable. This device is a laser system, not an algorithm. The clinical study evaluated the device's efficacy and safety on patients, not its performance as a standalone diagnostic tool.

7. The Type of Ground Truth Used

For Tattoo Clearance: The "ground truth" for tattoo clearance appears to be a combination of:
- Blinded Expert Assessment: Independent review by 3 blinded reviewers who confirmed identify pre/post-treatment images.
- Quantitative/Semi-Quantitative Clinical Assessment: "At least 50% clearance compared to baseline" (how this was measured isn't detailed, but implies a scoring system).
- Investigator Assessment: "Substantial to complete clearance" assessed by the clinical investigators.
For Safety: Clinical observation of adverse events and patient discomfort.
For Technological Equivalence: Histological evaluation.

8. The Sample Size for the Training Set

Not applicable. The document describes clinical studies conducted to evaluate the device, not to train a machine learning model.

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

Not applicable. As no training set for an AI/algorithm is discussed, this question is not relevant.

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K Number

K153527

Device Name

Manufacturer

Date Cleared

2016-03-02

(84 days)

Product Code

Regulation Number

Type

Panel