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The CO2RE is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee).

The CO-RE is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.

The Standard Handpiece of the CO2RE System is indicated for the following:

Dermatology & Plastic Surgery
The ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:

laser skin resurfacing
laser dermabrasion
laser burn debridement.

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

wrinkles, rhytids, and furrows (including fines lines and texture irregularities)
Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen.

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

keratoses, including actinic and sebortheic keratosis, sebortheic wart, and verruca sebortheica;
vermillionectomy of the lip;
cutaneous horns;
solar/actinic elastosis;
chelitis, including actinic chelitis;
lentigines, including lentigo maligna or Hutchinson's malignant freckle
uneven pigmentation/ dyschromia;
acne scars;
surgical scars:
keloids including acne keloidalis nuchae;
hemangiomas (including Buccal, port wine and pyogenic granuloma pyogenicum/granuloma telagiectaticum):
tattoos;
telangiectasia:
removal of small skin tumors, including periungual (Koenen) and subungual fibromas;
superficial pigmented lesions;
adenosebaceous hypertrophy or sebaceous hyperplasia;
rhinophyma reduction;
cutaneous papilloma (skin tags);
milia;
debridement of eczematous or infected skin;
basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions;
nevi, including spider, epidermal and protruding;
neurofibromas:
laser de-epithelialization;
tricoepitheliomas;
xanthelasma palpebrarum;
syringoma

Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy. Vaporization of:

benign/malignant vascular/avascular skin lesions;
Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual warts.

Podiatry
Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of:

verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts;
fungal nail treatment;
porokeratoma ablation;
ingrown nail treatment;
neuromas/fibromas, including Morton's neuroma;
debridement of ulcers;
other soft tissue lesions.

Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.

Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:

leukoplakia, including oral, larynx, uvula, palatal, upper latera pharyngeal tissue;
nasal obstruction;
adult and juvenile papillomatosis polyps;
polypectomy of nose and nasal passages; lymphangioma removal;
removal of recurrent papillomas in the oral cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords;
superficial lesions of the ear, including chondrodermatitis nodularis chronica helices/Winkler's disease;
rhinophyma;
verrucae vulgares (warts);

Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:

conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN);
condyloma acuminate, including cervical, vulvar, perineal, and Bowen's disease, (Erythroplasia of Quevrat) and Bowenoid papulosa (BP) lesions;
leukoplakia (vulvar dystrophies);
herpes vaporization;
urethral caruncle vaporization;
cervical dysplasia:
benign and malignant tumors;

Dental/Oral Surgery
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:

treatment of ulcerous lesions, including aphthous ulcers;
excision and ablation of benign and malignant lesions;
leukoplakia:

Genitourinary
Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:

benign and malignant lesions of external genitalia;
condyloma;
erythroplasia

The Fractional Handpiece of the CO2RE System is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.

The Surgical Handpiece of the CO2RE System is indicated for the following:

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

vermillionectomy of the lip;
cutaneous horns;
removal of small skin tumors, including periungual (Koenen) and subungual fibromas;
rhinophyma reduction;
basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions;
neurofibromas;
Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy. Vaporization/coagulation of:
benign/malignant vascular/avascular skin lesions;
Moh's Surgery;
Lipectomy;
Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual warts.

Laser incision and /or excision of soft tissue for the performance of upper and lower evelid blepharoplasty.

Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation.

Podiatry
Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of:

verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts;
Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.

Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:

choanal atresia,
nasal obstruction:
adult and juvenile papillomatosis polypectomy of nose and nasal passages; lymphangioma removal;
removal of vocal cord/fold nodules, polyps and cysts;
removal of recurrent papillomas in the oral cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords;
laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue;
Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-assisted esophagodivertuculostomy (ELAED)];
stenosis, including subglottic stenosis;
tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy;
pulmonary bronchial and tracheal lesion removal;
benign and malignant nodules, tumors and fibromas (larynx, trachea, tracheobronchial/endobronchial);
benign and malignant lesions and fibromas (nose and nasal passages);
benign and malignant tumors and fibromas (oral);
stapedotomy/stapedectomy; acoustic neuroma in the ear;
superficial lesions of the ear, including chondrodermatitis nodularis chronica helices/Winkler's disease:
telangiectasia/hemangioma of larynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue);
cordectomy, cordotomy (for the treatment of vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea;
myringotomy/tympanostomy (tympanic membrane fenestration);
uvulopalatoplasty (LAUP, laser UPPP);
turbinectomy and turbinate reduction; septal spur ablation/reduction and septoplasty; partial glossectomy;
tumor resection on oral, subfacial and neck tissues;
rhinophyma;
verrucae vulgares (warts):
gingivoplasty/gingivoctomy.

Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:

conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN);
condyloma acuminate, including cervical, genital, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions;
incision and drainage (1&D) of Bartholin's and nubuthian cysts;
benign and malignant tumors;
hemangiomas.

GYN Laparoscopy
Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic surgery, including GYN laparoscopy, for treatment of:

endometrial lesions, including ablation of endometriosis;
excision/lysis of adhesions;
salpingostomy
oophorectomy/ovariectomy; fimbrioplasty;
metroplasty:
microsurgery (tubal);
uterine myomas and fibroids;
ovarian fibromas and follicle cysts;
uterosacral ligament ablation;
hysterectomy.

Neurosurgery
Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of: Cranial

posterior fossa tumors;
peripheral neurectomy;
benign and malignant tumors and cysts (e.g. gliomas (including basal tumors), acoustic neuromas, lipomas and large tumors);
arteriovenous malformation;
pituitary gland tumors (transphenoidal approach).

Spinal Cord

incision/excision and vaporization of benign and malignant tumors and cysts;
intra- and extradural lesions;
laminectomy/ laminotomy/ microdiscectomy.

Orthopedics
Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include: Arthroscopy

menisectomy;
chondromalacia:
chondroplasty;
ligament release (lateral and other);
excision of plica;
partial synovectomy.

General

debridement of traumatic wounds;
debridement of decubitus and diabetic ulcers;
microsurgery:
artificial joint revision;
PMMA removal.

General/Thoracic Surgery
Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include:

debridement of decubitus ulcers, stasis, diabetic and other ulcers;
mastectomy;
debridement of bums;
rectal and anal hemorrhoidectomy;
breast biopsy;
reduction mammoplasty;
cytoreduction for metastatic disease;
laparotomy and laparoscopic applications;
mediastinal and thoracic lesions and abnormalities;
skin tag vaporization;
atheroma;
cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips;
pilonidal cyst removal and repair;
abscesses:
other soft tissue applications.

Dental/Oral Surgery

Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:
gingivectomy- removal of hyperplasias;
gingivoplasty:
incisional and excisional biopsy;
incision of infection when used with antibiotic therapy;
frenectomy (frenum release);
excision and ablation of benign and malignant lesions;
homeostasis;
operculectomy;
crown lengthening;
removal of soft tissue, cysts and tumors;
oral cavity tumors and hemangiomas;
abscesses;
extraction site hemostasis;
salivary gland pathologies;
preprosthetic gum preparation;
partial glossectomy;
periodontal gum resection.

Genitourinary
Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:

benign and malignant lesions of external genitalia;
condyloma;
Phimosis;
Erythroplasia.

Device Description

The CO₂RE System is a computer controlled radio-frequency (RF) excited carbon dioxide (CO2) laser system that delivers CO2 energy to the target treatment area at 10,600 nm. The CO2RE Laser System is comprised of multiple components, including the control unit and six handpieces. Laser is transmitted to the tissue via a series of lenses integrated into the articulated arm. The CO2 laser energy is absorbed by water in tissue to achieve its intended treatment effects.

AI/ML Overview

Here's an analysis of the provided FDA 510(k) summary relating to the CO2RE Laser System, focusing on the requested acceptance criteria and study details.

Important Disclaimer: The provided document is a 510(k) Summary, not a full 510(k) submission. A 510(k) Summary focuses on demonstrating substantial equivalence to a predicate device, and often relies on existing knowledge of the technology rather than extensive novel clinical studies. Therefore, many of the requested details about acceptance criteria, human reader studies, and detailed ground truth establishment might not be explicitly present or required for a 510(k) submission for this type of device. The information provided below is extracted directly from the given text.

Acceptance Criteria and Device Performance for CO2RE Laser System (K181523)

1. Table of Acceptance Criteria and Reported Device Performance

Criterion / Aspect	Acceptance Criteria (Implicit for 510(k) based on predicate)	Reported Device Performance (Summary of Study Findings)
Intended Use	Same as predicate device (CO₂RE Laser System K151655) for surgical applications requiring ablation, vaporization, excision, incision, and coagulation of soft tissue.	"The CO₂RE System has the same intended use... as its predicate devices."
Technological Characteristics	Similar to predicate device (CO₂RE Laser System K151655) including wavelength, pulse duration, maximum laser power, and maximum energy.	"The CO₂RE System technological characteristics are very similar to those of the predicate devices. The CO₂RE System and its predicate devices are all RF excited CO₂ laser systems that operate at the same or similar parameters... The systems are comprised of the same or similar components for the same intended use."
Performance (General)	Performs as intended for a CO2 laser surgical instrument.	"The CO₂RE System performs as intended based on the performance data provided in the submission."
Software Verification & Validation	Software is appropriate for release.	"Verification and validation testing of the software confirm that the software version is appropriate for release."
Electrical Safety & Electromagnetic Compatibility (EMC)	Meets applicable recognized consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22).	"The CO₂RE System has been tested for electromagnetic compatibility and electrical safety per the applicable recognized consensus standards... Results were passing."
Biocompatibility	Established per FDA's guidelines for patient-contacting components.	"Biocompatibility of the patient contacting components of the device has been established per FDA's guidelines."
Sterilization	Sterilization parameters are validated.	"Sterilization parameters have been validated."
Safety and Effectiveness Questions	Technological differences do not raise new safety or effectiveness questions compared to predicate.	"The technological differences between the CO₂RE System and its predicate devices do not raise any new types of safety or effectiveness questions given that the key treatment parameters remain similar..."
Overall Conclusion	Substantially equivalent to predicate.	"The CO₂RE System is substantially equivalent to its predicate."

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

The document does not describe a "test set" in the context of typical AI/software performance validation involving patient data. For this laser device, the "testing" refers to engineering and quality assurance tests on the device itself.

Sample Size: Not applicable in the traditional sense of a clinical test set for diagnostic accuracy. Testing was conducted on the device's components and system.
Data Provenance: Not applicable. The "data" here refers to measurements from electrical safety, EMC, software, biocompatibility, and sterilization tests. These are internal lab tests, not patient data.

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

Number of Experts: Not applicable. Ground truth, in the context of a medical laser device for surgical and dermatological procedures, typically relies on established medical knowledge, clinical outcomes, and the device's physical/electrical parameters meeting specified standards. It doesn't involve "experts" labeling a test set of images or patient data for an algorithm.
Qualifications of Experts: Not applicable for the type of testing described.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The device's performance is demonstrated through adherence to engineering standards and technical specifications, not through a diagnostic assessment requiring expert adjudication of results.

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

MRMC Study: No. This is a laser surgical instrument, not an AI-assisted diagnostic tool where human readers compare performance with and without AI. The submission focuses on demonstrating the device's technical specifications and safety/effectiveness equivalence to a predicate, not improving human reader performance.
Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done

Standalone Performance: Not applicable. This device is a directly operated laser system, not an artificial intelligence algorithm that operates independently or provides diagnostic output. It does not have an "algorithm only" mode in the sense of AI performance evaluation. The "software" mentioned refers to the operating software of the physical device.

7. The Type of Ground Truth Used

Type of Ground Truth: For this type of device, "ground truth" is established by:
- Engineering Specifications and Benchmarks: The device's output (e.g., laser power, wavelength, pulse duration) must meet design specifications.
- Industry Consensus Standards: Compliance with recognized standards like IEC 60601-1 for electrical safety and electromagnetic compatibility.
- Predicate Device Performance: The primary ground truth for a 510(k) is the demonstration of substantial equivalence to a legally marketed predicate device, implying that if the predicate is safe and effective, the new device with similar characteristics and performance also is.
- Biocompatibility Data: Established guidelines for material safety.
- Sterilization Validation: Demonstrated ability to be safely sterilized.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device does not use machine learning with a "training set" of data in the typical sense. Its functionality is based on established physical principles of laser operation.

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

Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" for an AI algorithm.

Summary of 510(k) Specifics for CO2RE Laser System:

This 510(k) submission for the CO2RE Laser System (K181523) is an example of a substantial equivalence determination for a medical device that is not an AI/ML-driven diagnostic or therapeutic tool. Its 'acceptance criteria' and 'study' are primarily centered around:

Predicate Equivalence: Demonstrating that the new device has the same intended use and similar technological characteristics, indications, and principles of operation as a previously cleared device (K151655).
Performance Testing: Laboratory and engineering tests to ensure the device meets declared technical specifications, electrical safety, EMC, biocompatibility, and sterilization requirements.
Software Validation: Ensuring the embedded software controls the device appropriately and safely.

The framework for evaluating AI/ML devices with detailed criteria like MRMC studies, expert adjudication, and distinct training/test sets is not applicable to a device like the CO2RE Laser System.

Ask a Question

Ask a specific question about this device

K Number

K151655

Device Name

CO2RE System

Manufacturer

SYNERON MEDICAL LTD.

Date Cleared

2015-09-15

(89 days)

Product Code

GEX

Regulation Number

878.4810

Type

Traditional

Panel

General and Plastic Surgery (SU)

Reference & Predicate Devices

K103501,K101321

Intended Use

The CO2RE is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including; aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee),

The CO-RE is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.

The Standard Handpiece of the COJRE System is indicated for the following:

Dermatology & Plastic Surgery
The ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:

laser skin resurfacing .
laser dermabrasion
. laser burn debridement.

Laser skin resurfacing (ablation and/or vaporization) for the treatment of:
wrinkles, rhytids, and furrows (including fines and texture irregularities) . Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen.

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

keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, . seborrheic wart, and verruca seborrheica;
. vermillionectomy of the lip;
cutaneous horns;
solar/actinic elastosis; ●
chelitis, including actinic chelitis; ●
lentigines, including lentigo maligna or Hutchinson's malignant freckle
uneven pigmentation/ dyschromia;
acne scars;
surgical scars: ●
keloids including acne keloidalis nuchae;
. hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telagiectaticum);
. tattoos;
telangiectasia;
removal of small skin tumors, including periungual (Koenen) and subungual fibromas; ●
superficial pigmented lesions: .
adenosebaceous hypertrophy or sebaceous hyperplasia; .
. rhinophyma reduction;
cutaneous papilloma (skin tags):
milia:
. debridement of eczematous or infected skin;
basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions;
nevi, including spider, epidermal and protruding;
neurofibromas:
laser de-epithelialization: .
tricoepitheliomas;
xanthelasma palpebrarum; ●
. svringoma

Laser ablation, vaporization and for excision for complete or partial nail matrixectomy. Vaporization/coagulation of:

benign/malignant vascular/avascular skin lesions; .
Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual warts.

Podiatry
Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of:
. verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts;

. fungal nail treatment;
porokeratoma ablation:
● ingrown nail treatment;
neuromas/fibromas, including Morton's neuroma: ●
debridement of ulcers;
other soft tissue lesions. .

Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.

Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:
● leukoplakia, including oral, larynx, uvula, palatal, upper latera pharyngeal tissue;

nasal obstruction: ●
adult and juvenile papillomatosis polyps;
polypectomy of nose and nasal passages; ●
lymphangioma removal; ●
. removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tonque and vocal cords;
● superficial lesions of the ear, including chondrodermatitis nodularis chronica helices/Winkler's disease;
rhinophvma:
verrucae vulgares (warts);

Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:
. conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN);
condyloma acuminate, including cervical, genital, vulvar, perineal, and ● Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions;

. leukoplakia (vulvar dystrophies);
herpes vaporization; ●
urethral caruncle vaporization; ●
. cervical dysplasia:
benign and malignant tumors; ●

Dental/Oral Surgery
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:

treatment of ulcerous lesions, including aphthous ulcers; ●
excision and ablation of benign and malignant lesions; ●
leukoplakia;

Genitourinary
Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:

benign and malignant lesions of external genitalia; ●
condyloma:
erythroplasia ●

The Fractional Handpiece of the CO2RE System is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.

The Surgical Handpiece of the CO2RE System is indicated for the following:

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

. vermillionectomy of the lip;
cutaneous horns:
removal of small skin tumors, including periungual (Koenen) and subungual fibromas; ●
. rhinophyma reduction;
basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease . (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions:
. neurofibromas:

Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy. Vaporization/coagulation of:

benign/malignant vascular/avascular skin lesions; .
. Moh's Surgery;
Lipectomy; .
Verrucae and seborrhoecae vulgares, including paronychial, periungal, and ● subunqual warts.
Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.
Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation.

Podiatry
Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of:

. verrucae vulgares/plantar (warts), including paronychial, periungal, and subunqual warts:
Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.

Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:

choanal atresia,
nasal obstruction:
adult and juvenile papillomatosis polyps;
polypectomy of nose and nasal passages;
lymphangioma removal; ●
removal of vocal cord/fold nodules, polyps and cysts;
. removal of recurrent papillomas in the oral cavity, nasal cavity, larynx,
pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords;
. laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue;
Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-● assisted esophaqodivertuculostomy (ELAED)];
stenosis, including subglottic stenosis;
● tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy;
pulmonary bronchial and tracheal lesion removal;
benign and malignant nodules, tumors and fibromas (larynx, pharynx, ● trachea, tracheobronchial/endobronchial);
benign and malignant lesions and fibromas (nose and nasal passages);
benign and malignant tumors and fibromas (oral);
stapedotomy/stapedectomy:
acoustic neuroma in the ear;
. superficial lesions of the ear, including chondrodermatitis nodularis chronica helices/Winkler's disease;
telangiectasia/hemangioma of larynx, pharynx and trachea (includes ● uvula, palatal or upper lateral pharyngeal tissue);
cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal ● fold motion impairment), and cordal lesions of larynx, pharynx and trachea;
myringotomy/tympanostomy (tympanic membrane fenestration);
uvulopalatoplasty (LAUP, laser UPPP);
turbinectomy and turbinate reduction/ablation;
septal spur ablation/reduction and septoplasty; ●
partial glossectomy;
tumor resection on oral, subfacial and neck tissues;
rhinophyma:
verrucae vulgares (warts); ●
gingivoplasty/gingivoctomy.

Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:
conization of the cervix, including cervical intraepithelial neoplasia (CIN), ● vulvar and vaginal intraepithelial neoplasia (VIN, VAIN);
condyloma acuminate, including cervical, genital, vulvar, perineal, and ● Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions;

. incision and drainage (I&D) of Bartholin's and nubuthian cysts;
benign and malignant tumors;
hemangiomas.

GYN Laparoscopy
Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of:

endometrial lesions, including ablation of endometriosis; ●
excision/lysis of adhesions; ●
salpingostomy
oophorectomy/ovariectomy: ●
fimbrioplasty;
metroplasty;
microsurgery (tubal);
uterine myomas and fibroids;
ovarian fibromas and follicle cysts: ●
uterosacral ligament ablation;
hysterectomy.

Neurosurgery
Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of:
Cranial

posterior fossa tumors;
peripheral neurectomy; ●
benign and malignant tumors and cysts (e.g. gliomas, menigiomas (including ● basal tumors), acoustic neuromas, lipomas and large tumors);
arteriovenous malformation;
pituitary gland tumors (transphenoidal approach). .

Spinal Cord
incision/excision and vaporization of benign and malignant tumors and ● cysts:

intra- and extradural lesions;
laminectomy/ laminotomy/ microdiscectomy. ●

Orthopedics
Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include:
Arthroscopy .

menisectomy;
chondromalacia;
. chondroplasty:
ligament release (lateral and other);
excision of plica; ●
partial synovectomy.

General

debridement of traumatic wounds; ●
debridement of decubitus and diabetic ulcers; ●
microsurgery;
artificial joint revision; ●
PMMA removal.

General/Thoracic Surgery
Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include:

debridement of decubitus ulcers, stasis, diabetic and other ulcers; ●
mastectomy;
debridement of bums;
rectal and anal hemorrhoidectomy;
breast biopsy;
reduction mammoplasty;
cytoreduction for metastatic disease;
. laparotomy and laparoscopic applications;
mediastinal and thoracic lesions and abnormalities: ●
skin tag vaporization;
atheroma:
cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips;
pilonidal cyst removal and repair;
abscesses;
other soft tissue applications.

Dental/Oral Surgery
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:

gingivectomy- removal of hyperplasias;
. qinqivoplasty:
incisional and excisional biopsy;
incision of infection when used with antibiotic therapy; ●
frenectomy (frenum release);
excision and ablation of benign and malignant lesions: ●
homeostasis;
operculectomy;
crown lengthening:
removal of soft tissue, cysts and tumors;
. oral cavity tumors and hemangiomas:
abscesses:
extraction site hemostasis;
salivary gland pathologies;
preprosthetic gum preparation; ●
. partial glossectomy;
periodontal gum resection.

Genitourinary
Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:

benign and malignant lesions of external genitalia; ●
condyloma; ●
Phimosis:
Erythroplasia.

Device Description

The Syneron CO2RE is a computer controlled radio-frequency (RF) excited carbon dioxide (CO2) laser system that delivers CO2 energy to the target treatment area at 10,600 nm. The Syneron CO>RE is comprised of multiple components, including the control unit and three handpieces (standard, fractional and surgical). Laser is transmitted to the tissue via a series of lenses integrated into the articulated arm. The CO2 laser energy is absorbed by water in tissue to achieve its intended treatment effects.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for the Syneron CO2RE Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a study with performance metrics in the typical sense of a diagnostic or AI-driven device.

Therefore, many of the requested elements (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or cannot be extracted from this type of regulatory submission. This document describes the device's intended uses, technological characteristics, and results of various safety and performance tests, but not a study of its clinical diagnostic performance against specific acceptance criteria with quantifiable metrics.

Here's an attempt to answer the questions based only on the information available in the provided text:

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

This document does not provide a table of acceptance criteria with corresponding performance metrics in a quantifiable sense (e.g., sensitivity, specificity, accuracy) as would be expected for a diagnostic or AI device. Instead, it states that the device "performs as intended" based on various tests.

Acceptance Criteria Category	Reported Device Performance
Software Verification & Validation	Software version is appropriate for release.
Electrical Safety & Electromagnetic Compatibility	Passed applicable recognized consensus standards (IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-22).
Biocompatibility	Biocompatibility of patient-contacting components established per FDA guidelines.
Sterilization	Sterilization parameters validated.
Performance Data	Histological analysis performed to evaluate device effects across a range of treatment parameters. Device performs as intended.
Substantial Equivalence	Has the same intended use and similar indications, technological characteristics, and principles of operation as predicate devices. Technological differences do not raise new safety/effectiveness questions, and performance testing showed the device performs as intended.

2. Sample size 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 document refers to "histological analysis" but does not specify the sample size, data provenance, or whether it was a test set in the context of a statistical study to meet performance criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document describes a laser system intended for surgical and dermatological applications, not a diagnostic device requiring expert interpretation for ground truth.

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

This information is not provided in the document and is not applicable to the type of device and testing 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

This information is not provided in the document and is not applicable. The device is a surgical laser system, 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 provided in the document and is not applicable. The device is a physical laser system, not an algorithm.

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

For the performance data, the document mentions "Histological analysis has been performed to evaluate the device effects across a range of treatment parameters." Histological analysis generally refers to the examination of tissue samples under a microscope, which would serve as a form of pathological ground truth for evaluating the effects of the laser on tissue. No other type of ground truth is explicitly mentioned for clinical effectiveness.

8. The sample size for the training set

This information is not provided in the document. The device is a physical laser system, not an AI algorithm that typically requires a training set.

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

This information is not provided in the document, as it's not relevant for this type of device.

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