Guardian 1000 with its delivery accessories is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.

Guardian 1000 with its delivery accessories is indicated for use in surgical applications requiring the ablation. vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology, neurosurgery, general surgery, genitourinary surgery (urology), thoracic surgery, gynecology, ophthalmology, orthopedics, otolaryngology (ENT) and podiatry.

Device Description

Guardian 1000 delivers an invisible laser beam in the infrared spectrum at 980 nm using a gallium aluminum arsenide (GaAlAs) source. The laser light beam is carried to the focusing lens on the handpiece probe by quartz optical fibers.

Guardian 1000 consists of two main sub-systems: a laser console and its delivery accessories, as follows: The laser console includes:

i an external enclosure
। power electronics
touch screen display with control electronics which controls:
- o power electronics
- O user interface
- o laser source temperature
- laser source emission o
. a laser system including:
- O laser source
- cooling system (Peltier cells, dissipator and fans) o
- fiber launching system o
- aiming beam o

Laser radiation is delivered to the patient trough an optical fiber and several handpieces depending on the treatment.

The optical fiber is connected to the laser unit trough a SMA905 connector

AI/ML Overview

The provided document is a 510(k) summary for the Guardian 1000 laser device, seeking substantial equivalence to predicate devices. It describes the device's technical specifications, intended use, and provides a summary of performance data.

However, the document does NOT contain information about acceptance criteria and a study proving the device meets those criteria, as typically understood for AI/ML-based medical devices with performance metrics like sensitivity, specificity, or accuracy. This document pertains to a laser surgical instrument, and its "performance data" focuses on electrical safety, EMC, software verification/validation, and its ability to achieve certain therapeutic temperature ranges.

Therefore, I cannot directly answer your prompt using the provided text in the way you've framed it (e.g., ground truth, MRMC study, expert consensus, training/test set sample sizes, AI-human improvement, etc.), as these concepts are not applicable to the type of device and study described in this 510(k) summary.

The "performance data" section of this document is largely related to engineering and physical performance metrics, not clinical diagnostic or AI-driven performance metrics.

I can, however, extract the closest available information related to "acceptance criteria" and "study" from the provided text, interpreting them within the context of a laser device rather than an AI/ML diagnostic.

Here's the closest interpretation of the requested information based on the provided document:

Acceptance Criteria and Device Performance for Guardian 1000 (Laser Surgical Instrument)

The "acceptance criteria" for a laser surgical instrument are primarily defined by safety standards, electromagnetic compatibility, and the device's ability to perform its stated therapeutic function. The "study" in this context refers to the testing conducted to demonstrate compliance with these standards and functional claims.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion (Implicit/Explicit)	Reported Device Performance
Electrical Safety	Compliance with relevant electrical safety standards for medical devices.	"The system complies with the IEC 60601-1, IEC 60601-2-22 standards for safety."
Electromagnetic Compatibility (EMC)	Compliance with relevant EMC standards for medical devices.	"The system complies with the...IEC 60601-1-2 standard for EMC."
Software Functionality	Software verification and validation testing conducted according to FDA guidance.	"Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'."
Therapeutic Temperature Range (Topical Heating)	Ability to achieve and maintain a therapeutic temperature range for topical heating (for temporary relief of minor muscle/joint pain). Explicitly accepted range: 40-45 degrees Celsius.	"The Guardian 1000 device is capable of achieving therapeutic temperature range of 40 - 45 degrees centigrade as accepted by the FDA.""An increase in topical heating of the tissue level by at least 5 degrees centigrade was reached within one (1) minute as demonstrated in the bench testing.""The therapeutic temperature range was maintained for over 10 minutes testing time."
Minimum Temperature Increase (Topical Heating)	An increase in topical heating of the tissue level by at least 5 degrees Celsius within one minute.	"An increase in topical heating of the tissue level by at least 5 degrees centigrade was reached within one (1) minute as demonstrated in the bench testing."Observed range: pre-exposure 31.8-34.3°C to during exposure 40.8-43.9°C.
Maintenance Duration (Topical Heating)	Ability to maintain the therapeutic temperature range for the recommended treatment time (10 minutes).	"The therapeutic temperature range was maintained for over 10 minutes testing time."

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

Test Set (for Topical Heating): 3 subjects.
Data Provenance: The document does not specify country of origin for the subjects, but the manufacturer is based in Italy. The tests were "bench testing" and "measurements were conducted on 3 subjects," implying a prospective, controlled testing environment, not retrospective patient data.

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

This information is not applicable to the type of testing described. Ground truth in this context is defined by physical measurements (e.g., temperature adherence to a specified range) against established scientific principles and FDA-accepted therapeutic ranges, not expert consensus on diagnostic imaging.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on subjective evaluations (e.g., image interpretation). The "ground truth" for the laser device's performance is objectively measured physical parameters (temperature, time).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study would be relevant for devices that assist human readers in tasks like interpreting medical images (e.g., AI in radiology). The Guardian 1000 is a laser surgical instrument, not an interpretive diagnostic aid. Therefore, no effect size for human reader improvement with AI assistance is mentioned.

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

This concept is not applicable as the device is a physical laser instrument, not an algorithm, and its performance is not "algorithm-only" or "human-in-the-loop" in the artificial intelligence sense. Its performance is the direct output of its physical operation.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the Guardian 1000 laser device is based on objective physical measurements (e.g., temperature readings) compared against established medical and engineering standards (IEC standards for safety/EMC, and FDA-accepted therapeutic temperature ranges for topical heating) and bench testing demonstrations. It's not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic would be.

8. The Sample Size for the Training Set

This information is not applicable. The Guardian 1000 is not described as an AI/Machine Learning device that undergoes a training phase with a "training set." Its functionality is based on known physical principles of laser operation and engineering design.

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

This information is not applicable as there is no "training set" for this device in the context of AI/ML.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem consisting of three stylized human profiles facing to the right, with a design above them that resembles a bird or abstract shape.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Ouanta System SPA Mr. Francesco Dell'Antonio Compliance Manager Via IV Novembre, 116 Solbiate Olona (VA) Italy, 21058

October 27, 2015

Re: K151629 Trade/Device Name: Guardian 1000 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX, ILY, PDZ Dated: September 25, 2015 Received: September 28, 2015

Dear Mr. Dell' Antonio:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and 809]); medical device reporting

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(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S.

For Director

Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151629

Device Name

Guardian 1000

Indications for Use (Describe)

Gastroenterology

Hemostasis of esophageal varices; palliation of malignant dysphagia; palliative ablation of obstructive neoplasms; hemostasis in colonoscopy.

Neurosurgery

Tumors adjacent to the spinal cord; tumors adjacent to the cortex.

General Surgery

Ablation, vaporization, excision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include but are not limited to: Laparoscopic: appendectomy, cholecystection. Open: mastectomy, reduction mammoplasty, breast biopsy, rectal and anal hemorrhoidectomy, bowel resection, colectomy, cholecystectomy, liver resection, condyloma, thyroidectomy, cavernous hemangioma.

Genitourinary (Urology)

Transurethral: transurethral incision of the prostate (TUIP), bladder neck incisions, urethral strictures, exterior sphincterotomy, laparoscopic lymphadenectomy. Open: condyloma, circumcision, benign and malignant lesions of external genitalia.

Thoracic Surgery

Pulmonary resection, coagulation of blebs and bullae, adhesiolysis, pericardiectorny, mediastinal and thoracic lesions and abnormalities, mediastinal lymph node dissection, hemostasis: thoracotomy,

Gynecology (GYN)

Laparoscopic excision/lysis of adhesions, endometrial lesions, including ablation of endometriosis, laparoscopic assisted hysterectomy (LAVH), laser uterosacral nerve ablation (LUNA); myomectomy; ovarian drilling, tubal fimbrioplasty, appendectomy. Open: conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia VIN, VAIN, condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erithroplasia of Queyrat) and Bowenoid papulosa (BP) lesions. Intrauterine: Fibroids/ polyps/adhesions; Resection of septum.

Pulmonology Tracheal bronchial lesions.

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Ophthalmology

Oculoplastics, open DCR, endo-nasal DCR, tumor excision and biopsy, eyelid reconstruction; blepharoplasty.

Orthopedics Dissect and coagulate.

Otolaryngology (ENT)

Nasal/Sinus: turbinectomy and turbinate reduction; polypectomy of nose and nasal passages; ethmoidectomy; meatal antrostomy;

Laryngo-tracheal: removal of vocal cord/ fold nodules, polyps and cysts; arytenoidectomy; tracheal stenosis; Oropharyngeal: uvulopalatoplasty (LAUP, laser UTPP); tonsillar cryptolysis, neoplasma) and tonsil; hemi glossectomy;

Head & Neck: tumor resection on oral, sub facial and neck tissues; parathyroidectomy;

Podiatry

Matrixectomy, Periungual and subungual warts, Plantar warts, Neuromas.

Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and /or yeasts Candida albicans, etc.).

Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510(K) SUMMARY

Introduction:

This document contains the 510(k) Summary for the Guardian 1000 laser device. The content of this summary is based on the requirements of 21 CFR 807.92(c).

Applicant /ManufacturerName and Address:	Quanta System SPAVia IV Novembre, 116Solbiate Olona (VA)Italy, 21058
510(k) Contact Person:	Francesco Dell'AntonioCompliance ManagerQuanta System SPAEmail: francesco.dellantonio@quantasystem.comPhone: +39-0331-376797Fax: +39-0331-367815
Date Prepared:	June 4th 2015
Device Name:	Guardian 1000
Classification:	Class II
Classification Name:	Laser surgical instrument for use in general and plastic surgeryand in dermatology.
Regulation Number:	21 CFR 878.4810
Product Code:	GEX, ILY, PDZ

Predicate Devices:

Guardian 1000 is substantially equivalent to the following legally marketed predicate devices:

K110375 Gold Series - Blueshine srl (Italy)
K101893 Nexus 30- USA Laser Biotech Inc. (USA) .

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Description of the device:

Guardian 1000 consists of two main sub-systems: a laser console and its delivery accessories, as follows: The laser console includes:

i an external enclosure
। power electronics
touch screen display with control electronics which controls:
- o power electronics
- O user interface
- o laser source temperature
- laser source emission o
. a laser system including:
- O laser source
- cooling system (Peltier cells, dissipator and fans) o
- fiber launching system o
- aiming beam o

Laser radiation is delivered to the patient trough an optical fiber and several handpieces depending on the treatment.

The optical fiber is connected to the laser unit trough a SMA905 connector

Intended use

Guardian 1000 with its delivery accessories is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology, neurosurgery, general surgery, genitourinary surgery (urology), thoracic surgery, gynecology, pulmonology, ophthalmology, orthopedics, otolaryngology (ENT) and podiatry.

Gastroenterology

Hemostasis of esophageal varices; palliation of malignant dysphagia; palliative ablation of obstructive neoplasms; hemostasis in colonoscopy.

Neurosurgery

Tumors adjacent to the spinal cord; tumors adjacent to the cortex.

General Surgery

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breast biopsy, rectal and anal hemorrhoidectomy, bowel resection, cholecystectomy, liver resection, condyloma, thyroidectomy, thoracotomy; cavernous hemangioma.

Genitourinary (Urology)

Transurethral: transurethral incision of the prostate (TUIP), bladder tumors, bladder neck incisions, urethral strictures, exterior sphincterotomy, laparoscopic lymphadenectomy. Open: condyloma, circumcision, benign and malignant lesions of external genitalia.

Thoracic Surgery

Pulmonary resection, coagulation of blebs and bullae, adhesiolysis, pericardiectomy, mediastinal and thoracic lesions and abnormalities, mediastinal lymph node dissection, hemostasis; thoracotomy.

Gynecology (GYN)

Laparoscopic excision/lysis of adhesions, endometrial lesions, including ablation of endometriosis, laparoscopic assisted hysterectomy (LAVH), laser uterosacral nerve ablation (LUNA); myomectomy; ovarian cystectomy, ovarian drilling, tubal fimbrioplasty, appendectomy. Open: conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia VIN, VAIN, condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erithroplasia of Queyrat) and Bowenoid papulosa (BP) lesions. Intrauterine: Fibroids/ polyps/adhesions; Resection of septum.

Pulmonology

Tracheal bronchial lesions.

Ophthalmology

Oculoplastics, open DCR, endo-nasal DCR, tumor excision and biopsy, evelid reconstruction; blepharoplasty.

Orthopedics

Dissect and coagulate.

Otolaryngology (ENT)

Nasal/Sinus: turbinectomy and turbinate reduction/ablation; polypectomy of nose and nasal passages; ethmoidectomy; meatal antrostomy;

Laryngo-tracheal: removal of vocal cord/ fold nodules, polyps and cysts; arytenoidectomy; tracheal stenosis;

Oropharyngeal: uvulopalatoplasty (LAUP, laser UTPP); tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil; hemi glossectomy;

Head & Neck: tumor resection on oral, sub facial and neck tissues; parathyroidectomy;

Podiatry

Matrixectomy, Periungual and subungual warts, Plantar warts, Neuromas.

Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and /or yeasts Candida albicans, etc.).

Comparison of Technological Characteristics:

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Guardian 1000 has the same technological characteristics (energy source, control mechanism) and specifications as its predicate devices.

Performance data:

The following performance data are provided in support of the substantial equivalence determination:

Safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Guardian 1000 device and its delivery accessories.

The system complies with the IEC 60601-1, IEC 60601-2-22 standards for safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

The Guardian 1000 device is capable of achieving therapeutic temperature range of 40 - 45 degrees centigrade as accepted by the FDA. An increase in topical heating of the tissue level by at least 5 degrees centigrade was reached within one (1) minute as demonstrated in the bench testing. The therapeutic temperature range was maintained for over 10 minutes testing time. The temperatures versus time measurements were conducted on 3 subjects at 2 physical locations (shoulder and knee areas). The preexposed topical skin temperature ranged from 31.8 to 34.3 centigrade degrees. The topical temperature during exposure following brief stabilization time ranged from 40.8 to 43.9 centigrade degrees. These data demonstrate the System meets the generally accepted topical temperature range for therapeutic heat of 40 - 45 degrees centigrade during the recommended treatment time of 10 minutes.

Comparison of Intended Use:

Guardian 1000 device's Intended Use combines the Intended Uses of its predicate devices.

Substantial Equivalence:

The Guardian 1000 device and its delivery system is as safe and effective as its predicate devices. The Guardian 1000 device and its delivery system has the same intended use, technological characteristics and specifications as its predicate devices.

Thus, Guardian 1000 device and its delivery system is substantially equivalent to its predicate devices.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.