Search Results

Date Cleared

2017-08-09

(215 days)

Product Code

GEX,ONF,ONG

Regulation Number

Type

Special

Panel

RESURFX 1565NM LASER MODULE

Reference & Predicate Devices

K020839,K142860,K130028

Predicate For

K183307,K192350,K193500,K200616,K203441

Intended Use

The subject Lumenis M22 System has connection capability with the following available treatment handpieces, for multiapplication treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:
The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200nm (with 10 different filters) is indicated for:

Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos
Cutaneous lesions, including warts, scars and striae
Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations
Removal of unwanted hair from all skin types, and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
Mild to moderate inflammatory Acne (Acne vulgaris)
The Nd:YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd:YAG) is indicated for:
The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias) and reticular veins (0.1 - 4.0 mm. diameter) of the leg
The removal of unwanted hair from all skin types, and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
The non-ablative treatment of facial wrinkles
ResurFX module and handpiece. with wavelength of 1565 nm. is indicated for:
Use in dermatological procedures requiring fractional skin resurfacing and coaqulation of soft tissue
The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064nm is indicated for:
Removal of dark tattoos
Treatment of pigmented lesions
*Note 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 ResurFX System with wavelength of 1565 nm. is indicated for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.

Device Description

The subject Lumenis M22 System is a multi-application, multi-technology platform with four (4) available treatment handpieces:

Universal Intense Pulsed Light (IPL) handpiece:
Multi-Spot Nd:YAG laser handpiece;
ResurFX non-ablative laser handpiece;
Q-Switched Nd:YAG laser handpiece.
The following accessories are provided with and/or may be purchased independently for each of the four (4) available treatment handpieces of the M22 System:
The Universal IPL handpiece has ten (10) different filters available: Cut-off filters of 515, 560, 590,615, 640, 695 and 755 nm, Notch Filters of 400-600 & 800-1200 nm and 530-650 & 900-1200 nm, and a Narrow band filter of 525-585 nm. Further, the IPL handpiece has three (3) sapphire cool light guides available with sizes of: 15mm x 35mm, 8mm x 15 mm, 6mm diameter.
The Multi-Spot Nd:YAG handpiece has four (4) different light guides/tips available in sizes of: 2mm x 4mm, 6 mm, 9 mm and 1.5 mm.
The ResurFX handpiece has two (2) different treatment tips available: SapphireCool and Precision tips.
The Q-Switched Nd: YAG handpiece has both disposable and gold plated metal treatment tips available. The disposable treatment tips are available in four (4) different sizes of: 2, 2.5, 3.5, and 5 mm. The metal treatment tips are available in seven (7) different sizes of: 2, 2.5, 3.5, 4, 5, 6 and 8 mm.

The ResurFX System is an advanced computer-controlled laser emission system operating at a wavelength of 1565 nm, and is intended for Fractional Non-Ablative Skin Resurfacing application when using a dedicated handpiece.
The following accessories are provided with and/or may be purchased independently for the ResurFX System:

Two (2) different treatment tips: SapphireCool and Precision tips.
Footswitch.

AI/ML Overview

The provided document is a 510(k) summary for the Lumenis M22 and ResurFX Systems, which are laser surgical instruments. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria through studies involving human-in-the-loop or standalone algorithm performance.

Therefore, many of the requested details about acceptance criteria, study types, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory document. This document details engineering and performance bench testing to ensure the modified device functions as intended and safely, similar to its predicate.

Here's an analysis of the information that can be extracted from the document:

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

The document doesn't present a table of specific clinical acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy for a diagnostic or AI-driven device. Instead, the "acceptance criteria" are implied by the performance bench testing ensuring the device meets safety and operational standards and functions as intended, similar to the predicate devices. The "reported device performance" is essentially that it passed these engineering and safety tests.

Device Feature/Aspect	Acceptance Criteria (Implied)	Reported Device Performance
IPL Handpiece
Wavelength	Same as predicate (400-1200 nm)	Same (400-1200 nm)
Pulse Duration (msec)	Same as predicate	Same
Operational Wavelengths (Filters)	Addition of new filters (Vascular Filter, KTP filter) without compromising safety/efficacy	Integrated new filters, functioning as intended
Spot sizes (cm²)	Addition of new 6mm round size without compromising safety/efficacy	Integrated new 6mm round size, functioning as intended
Max Fluence	Up to 35 J/cm², or 56 J/cm² supported by K020839 for tip size	Up to 35 or 56 J/cm², upon tip size; expected fluence with new filters/guides showed lower fluence than previously cleared devices.
Pulse Rate [Hz]	Same as predicate (Up to 1 Hz)	Same
Multiple Sequential Pulsing	Addition of AOPT mode with varying fluence per pulse, without compromising safety/efficacy	AOPT mode integrated, functioning as intended
Multi-Spot Nd:YAG Handpiece
Operational Wavelengths	Same as predicate (1064 nm)	Same
Spot sizes (mm)	Same as predicate	Same
Max Fluence	Same as predicate (Up to 600 J/cm²)	Same
Pulse Rate [Hz]	Same as predicate (Up to 1 Hz)	Same
Multiple Sequential Pulsing	Same as predicate	Same
ResurFX Handpiece (M22 System & Standalone)
Operational Wavelengths	Same as predicate (1565nm)	Same
Max Energy	Up to 70mJ per micro-beam; or up to 40mJ supported for new tip	Up to 40 or 70mJ per micro-beam, upon tip; expected fluence with new scan shapes/Precision tip showed same or lower fluence than previously cleared devices.
Type of laser	Same as predicate (Er:Glass Fiber-laser with scanner)	Same
Tip treatment width	Addition of 18mm Precision Tip	Integrated new 18mm Precision Tip, functioning as intended
Scanning shapes	Addition of "vertical line" and "vertical rectangle" without compromising safety/efficacy	Integrated new scanning shapes, functioning as intended
Scanner	Same as predicate (Dual axis scanner)	Same
Q-Switched Nd:YAG Handpiece
Operational Wavelengths	Same as predicate (1064 nm)	Same
Spot sizes (mm, diameter)	Addition of 4mm and 8mm sizes without compromising safety/efficacy	Integrated new 4mm and 8mm sizes, functioning as intended; expected fluence with new tips showed lower fluence than previously cleared device.
Max Fluence	Same as predicate (Up to 14 J/cm²)	Same
Pulse Duration(nsec)	Same as predicate (6-8)	Same
Pulse Rate [Hz]	Same as predicate (0.5-5.0)	Same
General
Risk Analysis	Compliance with ISO 14971	Performed
Electrical Safety & EMC	Conformance with IEC 60601-1, IEC 60601-1-2	Passed
IPL Compatibility	Conformance with IEC 60601-2-57	Passed
Software Changes	Validated to work as intended	Validated
Handpiece Accessories/Features	Validated to work as intended	Validated
ResurFX Environmental Testing	Ability to withstand variant operation, storage, and transportation conditions	Passed

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

Not applicable. This is a 510(k) for a device modification, focusing on engineering verification and validation (V&V) and safety testing. There is no "test set" in the context of clinical data for an AI algorithm. The V&V activities involve testing the physical device and its components.

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. No "ground truth" was established by clinical experts for a test set, as this is not a study of an AI or diagnostic device's clinical performance.

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

Not applicable. No clinical test set requiring adjudication was used.

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 not about an AI-assisted diagnostic device, but rather a laser surgical instrument. Therefore, no MRMC study was conducted or reported.

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

Not applicable. This device does not have a standalone algorithm in the sense of a diagnostic or image interpretation AI. Its "standalone" characteristic refers to the ResurFX system being made available as a separate unit rather than just a module of the M22. This is a hardware device for treatment, not an algorithm for analysis.

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

Not applicable. The ground truth for this device's performance is its physical and electrical specifications, and its ability to function safely and effectively within those parameters as demonstrated by engineering bench testing and compliance with recognized standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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K Number

K130028

Device Name

Manufacturer

Date Cleared

2013-09-03

(243 days)

Product Code

ONG

Regulation Number

Type

Panel

K083733,K091420,K090195,K110907

Reference & Predicate Devices

Predicate For

K142860,K161162,K170060,K202884

Intended Use

The 1565nm ResurFX laser module is indicated for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue

Device Description

The ResurFX module is a 1565nm non ablative laser module that is an add-on to FDA cleared mainframes like the M22 (LUM 2, cleared under K083733).

The ResurFX module is constructed of: 1565nm fiber laser Scanner and scanner controller Power Supply Cooling unit Treatment handpiece The system may be activated by either handpiece or footswitch trigger.

AI/ML Overview

The provided document describes the Lumenis ResurFX laser module, its intended use, and its substantial equivalence to predicate devices. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in the way typically expected for an AI/ML device approval (e.g., sensitivity, specificity, or reader study results).

Instead, the submission focuses on:

Bench performance tests: To ensure the device performs its intended use safely and efficiently.
Histological analysis: To align delivered energy with coagulation impact at the skin tissue level.
Substantial Equivalence Argument: The core of the approval is based on the device being substantially equivalent to existing predicate devices (Fraxel, Palomar Lux1540, Palomar Icon Aesthetic System). This means comparing design, materials, technological characteristics, energy envelopes, and indications for use.

Therefore, many of the specific questions about acceptance criteria for an AI/ML algorithm and related study details cannot be answered from this document.

Here's a breakdown of what can be extracted and what cannot:

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

Acceptance Criteria: Not explicitly stated as quantifiable performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/ML algorithm. The acceptance criteria for this device appear to be compliance with safety standards and functional performance as demonstrated through bench testing and histological analysis, and crucially, substantial equivalence to predicate devices.
Reported Device Performance:
- Safety and Efficacy: Established by a series of performance tests, lab performance tests, design validation, and software verification and validation.
- Histological Analysis: Performed to align delivered energy with coagulation impact at the skin tissue level.
- Compliance with Standards:
  - IEC 60601-1 (Medical Electrical Equipment-Part 1: General Requirements for Safety-1. Collateral Standard: Safety Requirements for Medical Electrical Systems).
  - IEC 60601-1-2 (Electromagnetic compatibility (EMC)).
  - IEC 60601-2-22 ed3.0:2007 (Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment).
  - IEC 60825-1:2007 (Safety of Laser Products - Part 1: Equipment Classification, Requirements and User's Guide).
- Substantial Equivalence: The device has the same intended use and indications as its predicate devices. The technology and the envelope of power and frequency are covered by the predicate devices. Minor differences in human interface and accessories do not raise new safety/effectiveness issues.

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

Not applicable/Not provided: This document does not describe a clinical study with a test set of patient data to evaluate an algorithm's performance. The "performance data" refers to engineering and bench tests, and histological analysis, not a clinical trial with a patient sample size.

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 provided: No test set involving human expert ground truth for an algorithm is described.

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

Not applicable/Not provided: No test set involving human expert adjudication is described.

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 was not performed, as this is not an AI-assisted diagnostic device.

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

Not applicable: This device is a laser module for dermatological procedures, not a standalone algorithm.

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

The closest concept to "ground truth" here is the histological analysis performed to evaluate the coagulation impact at the skin tissue level, correlating delivered energy with physical tissue effect. This serves as a "ground truth" for the device's functional effect. However, it's not "ground truth" in the context of an AI study.

8. The sample size for the training set

Not applicable/Not provided: This is not an AI/ML device, so there is no training set mentioned.

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

Not applicable/Not provided: This is not an AI/ML device, so there is no training set or associated ground truth establishment process described.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the document):

The "study" presented here is not a clinical trial or an AI performance study, but rather a submission demonstrating:

Bench Performance Tests: These tests confirmed the Lumenis ResurFX performs its intended use safely and efficiently.
Design Validation and Software Verification/Validation: These processes ensured the device meets its specifications.
Histological Analysis: This analysis was crucial for correlating the laser's delivered energy with the expected coagulation impact on skin tissue.
Compliance with International and Medical Device Standards: The device was tested and found to comply with relevant IEC standards for medical electrical equipment and laser safety (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22 ed3.0:2007, IEC 60825-1:2007).
Substantial Equivalence to Predicate Devices: The primary argument for approval is that Lumenis ResurFX is substantially equivalent to previously cleared devices (Fraxel, Palomar Lux1540, Palomar Icon Aesthetic System) in terms of intended use, indications, technology, and power/frequency envelopes. This implies that since the predicate devices are already deemed safe and effective, and the new device is functionally similar within accepted parameters, it also meets safety and efficacy criteria without needing new clinical studies. The document explicitly states: "Based on the equivalence with predicates, and on the histological analysis performed, Lumenis believes that clinical studies are not necessary to determine the safety and efficacy of the device."

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K Number

K100384

Device Name

FIBERLASE C02 LASER WAVEGUIDE

Manufacturer

Date Cleared

2010-04-12

(55 days)

Product Code

Regulation Number

Type

Special

Panel

LUME 2 SYSTEM, MODEL GA0005000

Reference & Predicate Devices

K921671

Predicate For

K112166,K130164,K203799

Intended Use

The FiberLase CO2 Laser WaveGuide is intended for use in surgical procedures requiring ablation, vaporization, excision, incision and coagulation of soft tissue. The FiberLase CO2 Laser WaveGuide is indicated for use in open surgical procedures such as ENT surgery and laparoscopy and endoscopic procedures. The device is limited to carbon dioxide lasers having a SMA-905 connector.

Device Description

The CO2 Laser WaveGuide is a laser delivery system for use in surgical procedures requiring ablation, vaporization, excision, incision and coagulation of soft tissue. The CO2 Laser WaveGuide device is indicated for use in open surgical procedures such as ENT surgery and laparoscopy and endoscopic procedures. The CO2 Laser WaveGuide is a hollow, semi-rigid, light-conducting tube designed to operate at wavelengths of 10.6 um and 0.6328 um. These wavelengths correspond to the output of the CO2 laser device and the helium-neon laser aiming beam, thereby allowing both laser radiations to be simultaneously and efficiently transmitted through the same channel. Laser energy entering the waveguide travels down the tube by multiple bounces off the inner reflective surface, and is delivered to the tissue at the distal end.

The CO2 Laser WaveGuide is compatible for use with any laser system that has a 905 SMA connector. The WaveGuide is supplied in several configurations with the dimensions specified in the following table:

Core diameter [µm]	Outer diameters [µm]	Lengths [cm]
300	700, 800	60, 100, 150
500	900, 1040	60, 100, 150, 200
750	1200, 1400	100, 150, 200

Table 1 - CO2 Laser WaveGuide Dimensions

The CO2 Laser WaveGuide is supplied with a set of eight hand pieces through which the WaveGuide may be inserted for easy handling in surgical procedures. The hand pieces are available with various features at the distal end to provide angled beam deflection with a highly polished metal surface. The WaveGuide is also provided with cleaving and cutting tools. The WaveGuide accessories are all provided as reusable tools. The CO2 Laser WaveGuide may be used with a gas purge system providing a flow of air of 2 liters per minute and a regulator pressure of 4.5 psi. The gas purge system keeps the inner channel of the waveguide free of debris. The gas purge system is not supplied with the waveguide.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a CO2 Laser WaveGuide and discusses performance testing. However, it does not contain the specific details required to complete all sections of your request.

Here's an analysis of the provided information:

Key Takeaways from the Document:

Device: CO2 Laser WaveGuide (FiberLase)
Intended Use: Ablation, vaporization, excision, incision, and coagulation of soft tissue in open, laparoscopic, and endoscopic surgical procedures.
Predicate Device: CO2 Laser WaveGuide from Surgilase Inc. (K921671).
Performance Testing: Bench testing was performed to establish "percent transmission" using the longest length fiber optic waveguide as the worst-case scenario.
Substantial Equivalence: The modified device is deemed substantially equivalent to the predicate device in terms of overall design, mechanism of action, mode of operation, performance characteristics, and intended use.

Missing Information:

The document lacks critical details for many of your requested points, especially concerning specific acceptance criteria values, a detailed study report, sample sizes for test and training sets, ground truth establishment methods, and expert qualifications.

Detailed Response based on the provided text:

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

Acceptance Criteria (Missing from document)	Reported Device Performance
Specific quantitative criteria not stated	"Established percent transmission"

Note: The document only states that performance testing was conducted to "establish percent transmission." It does not provide the specific acceptance criteria (e.g., "percent transmission must be > X%") nor the actual measured value of the percent transmission. Therefore, a complete comparison cannot be made from this text.

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 for Test Set: Not specified. The document mentions "the longest length fiber optic waveguide as the worse case test scenario," implying at least one (but likely more) waveguide was tested.
Data Provenance: The study was "bench tested," implying it was conducted in a laboratory setting. Data provenance (country of origin) and whether it was retrospective or prospective clinical data are not applicable/provided, as this was not a clinical study.

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 applicable as the description refers to bench testing of a physical device's performance (percent transmission), not a medical imaging or diagnostic device requiring expert interpretation for ground truth establishment.

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

This information is not applicable for the reasons stated above. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments.

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

This information is not applicable. The device is a physical CO2 Laser WaveGuide, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned or implied.

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

This information is not applicable. The device is a physical medical instrument, not an algorithm.

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

The "ground truth" for this bench test was the actual physical measurement of percent transmission of the laser energy through the waveguide. This is a direct measurement of a physical characteristic of the device.

8. The sample size for the training set

This information is not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the reasons stated above.

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K Number

K083733

Device Name

Manufacturer

Date Cleared

2009-05-04

(139 days)

Product Code

Regulation Number

Type

Panel

Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES

Reference & Predicate Devices

K060448

Predicate For

K142860

Intended Use

The Lume 2, with Intense Pulsed Light ( IPL) wavelengths 515-1200 nm, is indicated for the treatment of:

Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos.

Cutaneous lesions, including warts, scars and striae.

Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations, and

For the removal of unwanted hair from all skin types, an to effect stable long term, or permanent' hair reduction in skin types I-V through selective targeting of melanin in hair follicles.

with Nd:YAG laser at wavelength 1064 nm, is indicated for:

The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg

The removal of unwanted hair from all skin types, an to effect stable long term, or permanent' hair reduction in skin types I-V through selective targeting of melanin in hair follicles.

The non-ablative treatment of facial wrinkles.

1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.

Device Description

The Lume 2 system is a multi-functional platform, computer controlled system which incorporates two technologies and two treatment heads: Intense Pulsed Light (IPL), and Nd:YAG Laser.

The Lume 2 console has a single treatment head connection port that accommodates either the Universal IPL or the Multi-Spot Nd: YAG treatment head.

The treatment heads are attached to the head connector via a flexible cable (umbilical). During operation, deionized water circulates from the system console through the umbilical cable to the treatment heads to cool the flashlamp assembly and/ or the laser head, and the umbilical cable also houses the power cable to provide energy to the light/laser emission and the electrical wiring to power the thermoelectric (TE) cooler. The energy is delivered in pulse sequences, to allow better control.

The principles of operation and fundamental scientific technology are the same for the subject devices and predicate device.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or a detailed performance table. The "Performance Data Summary" section (2) only broadly mentions that "appropriate testing including safety, performance and functional testing to determine substantial equivalence of the Lume 2 system has been conducted."

The primary goal of this 510(k) submission is to demonstrate substantial equivalence to a predicate device (Lumenis One Family of Systems, K060448). This means the device is considered safe and effective if it performs as well as or similarly to the predicate device for its intended uses.

The reported "performance" can be inferred from the stated intended uses, which are the same as the predicate device. These include:

Intense Pulsed Light (IPL) (515-1200 nm):
- Treatment of benign epidermal lesions (dyschromia, hyperpigmentation, melasma, freckles, tattoos).
- Treatment of cutaneous lesions (warts, scars, striae).
- Treatment of benign cutaneous vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea, angiomas, spider angiomas, poikiloderma of Civatte, leg veins, venous malformations).
- Unwanted hair removal and stable long-term/permanent hair reduction in skin types I-V.
Nd:YAG Laser (1064 nm):
- Coagulation and hemostasis of vascular lesions and soft tissue, including treatment and clearance of superficial and deep telangiectasias and reticular veins (0.1-4.0 mm diameter) of the leg.
- Unwanted hair removal and stable long-term/permanent hair reduction in skin types I-V.
- Non-ablative treatment of facial wrinkles.

2. Sample Size and Data Provenance:

The document does not provide any details regarding sample sizes used for testing, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective). The submission relies on demonstrating substantial equivalence to a predicate device, rather than providing new clinical study data with specific test sets.

3. Number of Experts and Qualifications:

The document does not mention the use of experts to establish ground truth for a test set. This is consistent with a 510(k) submission based on substantial equivalence, which primarily relies on engineering and safety testing, and comparison to existing data for the predicate device.

4. Adjudication Method:

Given the lack of information on experts and test sets, there is no mention of an adjudication method.

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

The document does not indicate that an MRMC comparative effectiveness study was performed. The submission is focused on device safety and performance compared to a predicate, not on human-in-the-loop performance or improvement with AI assistance. The device in question is a laser/IPL system, not an AI-driven diagnostic tool.

6. Standalone Performance Study:

The document does not describe a standalone algorithm-only performance study. As stated, "appropriate testing including safety, performance and functional testing to determine substantial equivalence of the Lume 2 system has been conducted." This likely refers to engineering tests and a comparison of technical specifications and performance characteristics against the predicate device, not a standalone clinical performance study of a diagnostic algorithm.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used for any performance evaluation. In the context of demonstrating substantial equivalence for a medical device like this, ground truth would typically be established through:

Clinical observation and assessment by qualified medical professionals for the predicate device's established efficacy.
Histopathological confirmation (for certain skin lesions or hair follicle effects, if new clinical data were presented, which they are not in this summary).
Objective measurements of treatment outcomes (e.g., hair count reduction, lesion disappearance, wrinkle depth reduction).

However, the provided summary focuses on the inherent nature of the device and its operational parameters being similar to the predicate.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set sample size. This type of device does not typically involve machine learning or AI models that require a "training set" in the conventional sense. The "training" for this device refers to the clinical experience and data accumulated for the predicate device, which informs the understanding of the technology's effectiveness.

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

As there is no mention of a "training set" in the context of machine learning, there is no information on how ground truth for such a set was established. Instead, the "ground truth" for the device's efficacy is based on the established clinical effectiveness and safety profile of the predicate device, which has a long history of use and documented outcomes.

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K Number

K043173

Device Name

Manufacturer

Date Cleared

2005-01-31

(76 days)

Product Code

Regulation Number

Type

Panel

LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES

Reference & Predicate Devices

K020839,K030527,K024093,K030342,K011677,K033259,K003460,K023967

Predicate For

K142860

Intended Use

The Q-switched Nd: YAG Laser Treatment Head for the Quantum series is intended for use in the medical specialties of plastic surgery and dermatology for applications requiring selective photothermolysis and photo-acoustic effects in target chromophores.

The Q-switched Nd: YAG Laser Treatment Head for the Quantum series is indicated for:

Removal of dark tattoos
Treatment of pigmented lesions

Device Description

The Lumenis Quantum series of IPL/Nd: YAG systems are intense pulsed-light (IPL) and Nd: Y AG laser devices. Each Quantum system is comprised of three main components:

A system console (including software and control electronics, key-operated power control switch, power-on indicator, emergency shut-off knob and a remote interlock connector);
A control and display panel;
One or more delivery handpiece(s), the Treatment Heads.

The Q-switched Nd: Y AG Treatment Head for the Quantum series is a pulsed laser operating at a wavelength of 1064 nanometers. It is an upgrade that can be installed on any Quantum system.

The Q-switched Nd: YAG Laser Treatment Head is a hand held device comprised of the laser head and optics, trigger circuit, safety components and cooling circuit. The Qswitched Nd: YAG Laser Treatment Head is connected to the Quantum console via an umbilical cable and connector.

AI/ML Overview

The provided text describes the Q-switched Nd:YAG Laser Treatment Head for the Lumenis Quantum series. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the device "shares the same indications for use, same principle of operation, same wavelength, same or similar fluence range and spot sizes as the predicate devices." It also notes that a "Clinical Evaluation Report demonstrated the safety and effectiveness of the Q-switched Nd: YAG laser for the claimed indications for use." However, specific quantitative acceptance criteria (e.g., a certain percentage of tattoo removal, reduction in lesion size) and their corresponding performance metrics are not explicitly stated in the provided document. The document relies on substantial equivalence to predicate devices rather than establishing new, specific performance criteria.

Acceptance Criteria	Reported Device Performance
Implicit Acceptance Criteria: Safety and effectiveness for: - Removal of dark tattoos - Treatment of pigmented lesions	Reported Performance: "A Clinical Evaluation Report demonstrated the safety and effectiveness of the Q-switched Nd: YAG laser for the claimed indications for use." (No specific numerical performance metrics were provided in this document as the basis for substantial equivalence).
Technical specifications (wavelength, fluence range, spot sizes) comparable to predicate devices	"The technical specifications of the Q-switched Nd: YAG Laser Treatment Head for the Quantum series are similar or identical to those of the predicate MedLite C3 Q-switched Nd: YAG laser system (K011677), the Q-Clear laser system (K033259) and the Q-YAG 5 / Clear Light (K003460)."

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

The document mentions "A Clinical Evaluation Report" but does not provide details about the sample size used for the test set, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective nature).

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

This information is not provided in the given text.

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

This information is not provided in the given text.

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

A multi-reader multi-case (MRMC) study is not mentioned in the document. The device is a laser treatment head, not an AI-assisted diagnostic or interpretative tool, so an MRMC study related to human reader improvement with AI would not be applicable here.

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

The device is a laser treatment head, which is a physical instrument used for medical procedures, not a standalone software algorithm. Therefore, a "standalone algorithm-only" performance study is not applicable. The "standalone" performance would be its inherent treatment efficacy, which the clinical evaluation report broadly addressed.

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

The document refers to a "Clinical Evaluation Report" which demonstrated "safety and effectiveness." This implies that clinical outcomes data (e.g., visual assessment of tattoo removal, reduction in lesion pigmentation, adverse event rates) would have been used as the ground truth. However, the exact methods for defining and measuring this ground truth are not detailed.

8. The sample size for the training set

The document does not mention a training set. This is consistent with a medical device submission focused on substantial equivalence to existing predicate devices, where extensive de novo training data for an algorithm might not be required or relevant in the same way it would be for an AI-powered diagnostic tool. The "Clinical Evaluation Report" would likely involve a test or validation set of patients, not a separate training set as understood in machine learning.

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

As no training set is mentioned or implied, this information is not applicable.

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K Number

K030033

Device Name

Manufacturer

Date Cleared

2003-07-21

(199 days)

Product Code

Regulation Number

Type

Panel

LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS

Reference & Predicate Devices

K022060,K894211,K010041,K980156,K882212,K872254,K872253,K973618,K021364

Predicate For

N/A

Intended Use

The Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers is indicated for use in surgical applications requiring ablation, vaporization, excision, incision, and coagulation of soft tissue using laser-generated thermal energy in medical including aesthetic (dermatology and plastic surgery), podiatry, specialties, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery, for the indications for use that the compatible laser system to which attached has been cleared.

Device Description

Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers is comprised of the following main components:

Laser waveguide
Specially-shaped tip
Coupler connector

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers. This document concludes that the device is substantially equivalent to existing predicate devices.

However, the provided text does not contain specific details regarding acceptance criteria and a study that definitively proves the device meets those criteria in the way typically required for AI/ML-based diagnostic devices. The submission focuses on substantial equivalence to predicate devices, which is a different regulatory pathway.

Here's an analysis of the information that is and isn't available in the document, structured according to your request:

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

The document states: "Performance data were provided to demonstrate that the Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers operates in accordance with product specifications."

However, neither the specific acceptance criteria (e.g., minimum laser power output, tip temperature range, durability metrics) nor the quantitative reported device performance are explicitly detailed within the provided text. The submission focuses on substantial equivalence to predicate devices rather than proving a novel performance metric against a set of new acceptance criteria.

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

This information is not provided in the document. The submission does not detail specific clinical or performance studies with test sets in the context of typical AI/ML device evaluations. The performance data mentioned would likely refer to internal engineering tests or bench testing to ensure the device functions as intended, rather than a clinical trial or large-scale data analysis.

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 applicable and not provided. As this is a physical medical device (disposable contact tip for CO2 lasers), not an AI/ML diagnostic system, the concept of "experts establishing ground truth for a test set" in the context of diagnostic interpretation doesn't apply. The device's function is mechanical and thermal, not interpretative.

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

This information is not applicable and not provided for the same reasons as point 3.

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

This information is not applicable and not provided. This is a physical surgical accessory, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided. This is a physical device, and the concept of "standalone algorithm performance" does not apply.

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

As this is a physical device, the "ground truth" would likely relate to objective physical and functional parameters, such as:

Mechanical integrity: Does the tip remain intact during use?
Thermal performance: Does it deliver the expected thermal energy at the tip?
Material compatibility: Are the materials safe and biocompatible?
Sterility: Is the device sterile as provided?

The document states "Performance data were provided to demonstrate that the Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers operates in accordance with product specifications." This implies that the ground truth for performance was defined by these product specifications, which would cover the physical and functional aspects listed above. Specific details of these specifications are not provided in the document.

8. The sample size for the training set

This information is not applicable and not provided. As a physical device, there is no "training set" in the context of machine learning. The device's design and manufacturing processes are validated, not "trained."

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

This information is not applicable and not provided for the reasons stated in point 8.

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K Number

K030342

Device Name

Manufacturer

Date Cleared

2003-07-17

(164 days)

Product Code

Regulation Number

Type

Panel

MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS

Reference & Predicate Devices

K020839

Predicate For

K033946,K040156,K043032,K052688,K060448,K072564

Intended Use

The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/ Nd: YAG laser systems (and the delivery accessories that are used with them to deliver light and/ or laser energy) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows:

Intense Pulsed Light Energy/Wavelengths (515 - 1200 nm) are indicated for:

The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars and striae;
The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melsma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.

Nd:YAG Laser Wavelength (1064 nm) is indicated for the coagulation and hemostasis of vascular lesions and soft tissue, including:

Treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg.
The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.

The Real Time Chiller is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:

Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
Reduce discomfort during and/or associated with light or laser treatment;
Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper and/or hypopigmentation;
Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and
Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

Device Description

Lumenis Family of Intense Pulsed-Light (IPL) and IPL/ Nd:YAG laser systems are comprised of the following main components:

A light/laser system console (including software and control electronics);
A control and display panel;
One or two attached hand-piece(s), which may have integrated skin cooling components.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Laser Systems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies with specific acceptance criteria and performance metrics for a novel device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically:

No acceptance criteria table or reported device performance: The document does not define specific performance metrics or thresholds for the device's efficacy or safety. It focuses on functional and design equivalence to a predicate device.
No sample size for test set or data provenance: There is no mention of a test set, its sample size, or the country of origin/retrospective/prospective nature of data.
No number or qualifications of experts for ground truth: Since there's no defined 'ground truth' or test set evaluation in this type of submission, expert involvement in this context is not applicable or stated.
No adjudication method: Adjudication methods are not discussed as they relate to validating a test set against a ground truth, which is absent here.
No multi-reader multi-case (MRMC) comparative effectiveness study: The document does not describe such a study or any effect sizes of human reader improvement with AI assistance, as the device is not an AI-assisted diagnostic tool.
No standalone (algorithm-only) performance data: The device is a physical laser system, not an algorithm. Standalone performance as an algorithm is not relevant.
No type of ground truth used: As there's no defined test set for performance evaluation, there's no mention of a ground truth type (e.g., pathology, outcomes data).
No sample size for the training set: The document doesn't discuss a "training set" in the context of machine learning, as this device is not an AI/ML product.
No information on how ground truth for the training set was established: This is not applicable for the reasons mentioned above.

The document states the following regarding "Safety and Effectiveness Information":

"Clinical data was provided to demonstrate that the Lumenis Family of IPL and IPL/Nd:YAG laser (1064 nm) systems are safe and effective, when indicated in specific applications in the medical specialties of general and plastic surgery, and dermatology."

However, the details of this "clinical data," including acceptance criteria, study design, sample sizes, and specific performance outcomes, are not provided in this summary. The primary basis for clearance is demonstrating "substantial equivalence" to a predicate device (K020839), rather than presenting a de novo study proving novel performance against predefined criteria.

In summary, the provided text describes a 510(k) submission for substantial equivalence of a physical medical device (laser system) and does not contain the detailed study information (acceptance criteria, sample sizes, ground truth establishment, etc.) typically associated with performance studies for novel or AI/ML-based devices.

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K Number

K024093

Device Name

Manufacturer

Date Cleared

2003-06-19

(190 days)

Product Code

Regulation Number

Type

Panel

LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS

Reference & Predicate Devices

K020839,K020021,K022951

Predicate For

K033946,K043255,K060448,K072564,K113018

Intended Use

The Lumenis Family of Intense Pulsed-Light (IPL) systems and combination IPL/Nd:YAG laser systems (and the delivery accessories that are used with them to deliver light and/or laser energy) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows:

Intense Pulsed Light Energy / Wavelengths (515 - 1200 nm):

The treatment of tattoos and benign pigmented epidermal and cutaneous lesions * including warts, scars and striae;
- The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
- The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent1, hair reduction in skin types I-VI through selective targeting of melanin in hair follicles;

Nd:YAG Laser Wavelength (1064 nm):

- The coagulation and hemostasis of vascular lesions and soft tissue, including:
  - - Treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg;
- The non-ablative treatment of facial wrinkles.

The Real Time Chiller is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:

- Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
Reduce discomfort during and/or associated with light or laser treatment; *
- Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyperand/or hypopigmentation;
- Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and
- Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

Device Description

Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems are comprised of the following main components:

- A light/laser system console (including software and control electronics);
A control and display panel; and *
- One or more attached hand-piece(s), which may have integrated skin cooling components.

AI/ML Overview

This is a pre-market notification for a laser system, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies (such as MRMC, standalone performance, ground truth, and sample sizes) is largely not applicable in the context of AI/ML device evaluation.

Here's a breakdown of why this information isn't present in the provided text for an AI/ML context:

Device Type: The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems are medical devices that physically interact with tissue for surgical, aesthetic, and cosmetic applications. They are not software-based AI/ML devices that provide diagnostic or prognostic insights.
Approval Process: The document is a 510(k) submission, indicating a substantial equivalence pathway. This pathway compares the new device to existing legally marketed predicate devices to demonstrate that it is as safe and effective. It does not typically involve the rigorous performance metric evaluations (like sensitivity, specificity, AUC) associated with AI/ML devices.
"Acceptance Criteria" in this context: For this type of device, "acceptance criteria" primarily refer to demonstrating that the device's technical specifications and performance (e.g., fluence, pulse rate, spot size) are comparable to predicate devices and that clinical data supports its safety and effectiveness for its intended use. There are no "reported device performance" metrics in the sense of AI/ML model output.

However, I can provide the available information relevant to the device's evaluation, reinterpreting "acceptance criteria" and "study" for this non-AI/ML context:

1. Table of Acceptance Criteria and Reported Device Performance (Reinterpreted for a Laser System)

Since this is a 510(k) for a laser system, the "acceptance criteria" are implied by its comparison to predicate devices across various technical and functional specifications, and the "reported device performance" is its demonstrated capability to meet those same specifications and achieve the intended clinical effects.

Category	Acceptance Criteria (Implied by Predicate Comparison)	Reported Device Performance (Lumenis Family IPL/Nd:YAG)
Intended Use	Substantially equivalent or within the scope of predicate devices' intended use (Photocoagulation, photothermolysis, and hemostasis in surgical, aesthetic, cosmetic applications; specific indications like hair reduction, vascular lesions, pigmented lesions, facial wrinkles, and pain/discomfort reduction with chilling).	Matches or Expands Upon Predicates: Photocoagulation, photothermolysis, and hemostasis of soft tissue in general and plastic surgery, and dermatology. Specific indications (some expanded from predicates): treatment of tattoos, benign pigmented lesions, warts, scars, striae, benign cutaneous vascular lesions, unwanted hair removal (stable long-term/permanent reduction), coagulation/hemostasis of vascular lesions/soft tissue (telangiectasias, reticular veins), non-ablative treatment of facial wrinkles.
Device Description	IPL and/or Nd:YAG laser combination or components.	IPL and IPL/Nd:YAG combination.
Output Energy Type	Coherent and non-coherent light.	Coherent and non-coherent light.
Energy Configuration	Wavelengths typically 515-1200 nm for IPL, 1064 nm for Nd:YAG.	515-1200 nm (IPL), 1064 nm (Nd:YAG).
Fluence	Fluence levels comparable to or within ranges of predicate devices.	Up to 150 J/cm² (comparable to or within range of predicates, e.g., IPL Quantum/VascuLight same, Lyra™ up to 250 J/cm², GentleYAG 10-70 J/cm²).
Pulse Duration	Pulse durations comparable to or within ranges of predicate devices.	2 to 16 ms (to 48 ms triple pulsed) (comparable to or within range of predicates, e.g., IPL Quantum/VascuLight same, Lyra™ 10-50 ms, GentleYAG 3 ms).
Pulse Rate	Pulse rates comparable to or within ranges of predicate devices.	0.33 Hz (same as IPL Quantum/VascuLight).
Spot Size	Spot sizes comparable to or within ranges of predicate devices.	6 mm (same as IPL Quantum/VascuLight, different from Lyra™ and GentleYAG).
Beam Delivery	Cooling Hand-piece (or similar mechanisms as predicates like fiber with cooling).	Cooling Hand-piece (same as IPL Quantum/VascuLight, similar to Lyra™ fiber w/cooling and GentleYAG lens-coupled fiber with hand-piece).
Clinical Efficacy & Safety	Demonstrated safety and effectiveness for stated indications, often through clinical data or literature reviews supporting the chosen parameters.	Clinical data provided: "Clinical data was provided to demonstrate that the Lumenis Family of IPL and IPL/Nd:YAG laser (1064 nm) systems are safe and effective, when indicated in specific applications in the medical specialties of general and plastic surgery, and dermatology." This data presumably supports the device's ability to achieve the stated selective photothermolysis, photocoagulation, and hemostasis for the given indications.

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 states: "Clinical data was provided to demonstrate that the Lumenis Family of IPL and IPL/Nd:YAG laser (1064 nm) systems are safe and effective..."
No specific sample size, data provenance, or retrospective/prospective nature of the clinical data is provided in this summary. This level of detail is typically found in the full study reports, not necessarily in the high-level 510(k) summary.

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

Not Applicable. For a laser system, "ground truth" isn't established by experts interpreting outputs in the way it is for AI/ML diagnostic tools. The "truth" would be the observed clinical outcome (e.g., hair reduction, lesion clearance, wrinkle reduction) directly from the treatment.

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

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling expert disagreements in AI/ML performance evaluation, which is not relevant here.

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 is a laser treatment device, not an AI diagnostic/assistant tool. MRMC studies are for evaluating scenarios where humans are interpreting outputs (e.g., medical images) with or without AI assistance, which is not the function of this device.

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

Not Applicable. Again, this is a physical laser device, not an algorithm. Its performance is always "standalone" in the sense that it performs its function without an AI element, but it requires a human operator for application.

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

For a medical treatment device like this laser system, the "ground truth" for demonstrating safety and effectiveness would primarily be clinical outcomes data. This includes:
- Observed clinical efficacy: e.g., photographic evidence of lesion clearance, hair reduction, wrinkle improvement.
- Patient feedback: on pain reduction, discomfort.
- Adverse event reporting: to assess safety.
- These outcomes would be assessed by clinicians.

8. The sample size for the training set

Not Applicable. This device does not use a "training set" in the AI/ML sense. Its operational parameters are designed and validated through engineering principles and clinical studies, not by training an algorithm on a dataset.

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

Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established in this context.

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K Number

K030147

Device Name

Manufacturer

Date Cleared

2003-04-15

(90 days)

Product Code

Regulation Number

Type

Panel