(133 days)
The ARTAS™ System from Restoration Robotics is indicated for harvesting hair follicles from the scalp in men diagnosed with androgenic alopecia (male pattern hair loss) who have black or brown straight hair. The ARTAS System from Restoration Robotics is intended to assist physicians in identifying and extracting hair follicular units from the scalp during hair transplantation.
The ARTAS System implements the manual Follicular Unit Extraction (FUE) approach to harvesting follicular units. The ARTAS System is used, under the direction of a physician, to automate the manual FUE technique. The ARTAS System is positioned over the patient's scalp by the physician. Follicular units are then identified, dissected and extracted from the surrounding tissue on the patient's scalp by the ARTAS System. The follicular units are transported using suction to a storage container where they are stored until they are implanted into the patient's scalp by the physician or technician using current manual implantation techniques. The ARTAS System is an interactive, image-guided, computer-assisted system consisting of seven main subsystems: 1. Robotic Arm Subsystem 2. Imaging Subsystem 3. Needle Mechanism 4. Safety Subsystem 5. Computer 6. Accessory Kits (Disposable and Reusable) 7. Patient Chair These main subsystems, with the exception of the Accessory Kits and Patient Chair, are housed on or within a Control Cart.
Here's a summary of the acceptance criteria and the study details for the ARTAS™ System.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the primary effectiveness endpoint as the difference in the number of surviving implanted hair follicles at Month 9 post-implantation between those harvested using the ARTAS System and those harvested manually. The acceptance criteria essentially were to demonstrate substantial equivalence to the manual method.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantially equivalent (in terms of safety and effectiveness) to predicate devices, specifically the manual FUE method for hair follicle harvesting. | The ARTAS System was found to be substantially equivalent to the manual harvest method in terms of the number of surviving implanted hair follicles at nine months (p = 0.023). No new issues of safety or effectiveness were raised. |
| No new safety issues (adverse events, serious adverse events, unanticipated adverse events) compared to the manual procedure. | No adverse events, serious adverse events, or unanticipated adverse events were reported. All complications were "Mild" in intensity. Subjects did not terminate the study early due to safety-related issues. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 36 subjects.
- Data Provenance: Prospective, multi-center clinical study conducted at two U.S. clinical sites.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
The document does not explicitly state the number of experts used to establish the ground truth for the test set or their specific qualifications (e.g., dermatologists, plastic surgeons, specific years of experience). However, it mentions that the study was conducted under the direction of a physician and involved clinical sites. The intended use states the system is "intended to assist physicians," implying physician involvement in the assessment of outcomes.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method like 2+1 or 3+1. Given the nature of the primary endpoint (number of surviving implanted hair follicles), it's likely that a clinical assessment was performed, but the details of who performed this assessment and how disagreements (if any) were resolved are not provided.
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
The study was a multi-center, prospective, blinded clinical study comparing the ARTAS System (AI-assisted) to the manual hair follicle harvesting method. It was a comparative effectiveness study in that it compared the outcomes of two different methods. However, it was not a typical MRMC study evaluating human readers' performance improvement with AI assistance on diagnostic tasks. Instead, it evaluated the clinical outcome (surviving hair follicles) of an AI-assisted surgical procedure versus a manual surgical procedure. Therefore, an "effect size of how much human readers improve with AI vs without AI assistance" in the traditional sense of diagnostic accuracy is not reported or applicable to this study design.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The ARTAS System is described as an "interactive, image-guided, computer-assisted system" that "assists physicians in identifying and extracting hair follicular units." The study directly compares the system's performance (when used under physician direction) against the manual method. While the system automates parts of the FUE technique, it is used "under the direction of a physician." Therefore, the clinical study assessed the system's performance with a human-in-the-loop, not in a standalone (algorithm only) capacity, as it requires physician oversight and manual implantation.
7. The Type of Ground Truth Used
The ground truth for the primary effectiveness endpoint was outcomes data: "the number of surviving implanted hair follicles at Month 9 post-implantation." This is a direct clinical outcome measure.
8. The Sample Size for the Training Set
The document does not provide information on the sample size used for the training set for the ARTAS System's AI components. The clinical study details describe the test set used for regulatory submission.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established.
{0}------------------------------------------------
THE ARTAS™ SYSTEM FROM RESTORATION ROBOTICS 510(k) PREMARKET NOTIFICATION
SECTION 5
510(K) SUMMARY (CONT.)
Pg. 1 of 4
510(k) Notification K103428
GENERAL INFORMATION
Applicant:
Restoration Robotics, Inc. 1383 Shorebird Way Mountain View, CA 94043 U.S.A. Phone: 650-965-3612 FAX: 650-965-3624
Contact Person:
Kit Cariquitan Vice President, Regulatory Affairs Experien Group, LLC 155-A Moffett Park Drive, Suite 210 Sunnyvale, CA 94089 U.S.A. Phone: 408-400-0856 FAX: 408-400-0865
Date Prepared: November 19, 2010
DEVICE INFORMATION
Classification:
21CFR §882.4560, Stereotaxic Instrument
Product Code:
ONA
Trade Name: The ARTAS™ System
Generic/Common Name: Stereotaxic Instrument
PREDICATE DEVICES
The ARTAS System is substantially equivalent to the following predicate devices:
- Medicamat S.A. Calvitron Hair Transplant System, K952737 .
- Integrated Surgical Systems, Inc. DigiMatch ROBODOC Surgical System, . K072629
APR - 4 2011
{1}------------------------------------------------
SECTION 5 510(K) SUMMARY (CONT.)
INTENDED USE
The ARTAS™ System from Restoration Robotics is indicated for harvesting hair follicles from the scalp in men diagnosed with androgenic alopecia (male pattern hair loss) who have black or brown straight hair. The ARTAS System from Restoration Robotics is intended to assist physicians in identifying and extracting hair follicular units from the scalp during hair transplantation.
PRODUCT DESCRIPTION
The ARTAS System implements the manual Follicular Unit Extraction (FUE) approach to harvesting follicular units. The ARTAS System is used, under the direction of a physician, to automate the manual FUE technique. The ARTAS System is positioned over the patient's scalp by the physician. Follicular units are then identified, dissected and extracted from the surrounding tissue on the patient's scalp by the ARTAS System. The follicular units are transported using suction to a storage container where they are stored until they are implanted into the patient's scalp by the physician or technician using current manual implantation techniques.
The ARTAS System is an interactive, image-guided, computer-assisted system consisting of seven main subsystems:
-
- Robotic Arm Subsystem
-
- Imaging Subsystem
-
- Needle Mechanism
-
- Safety Subsystem
-
- Computer
-
- Accessory Kits (Disposable and Reusable)
-
- Patient Chair
These main subsystems, with the exception of the Accessory Kits and Patient Chair, are housed on or within a Control Cart.
SUBSTANTIAL EQUIVALENCE
The proposed indications for use for the ARTAS System is substantially equivalent to the indications for use of the Medicamat S.A. Calvitron Hair Transplant System. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the ARTAS System is substantially equivalent to the predicate devices.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary functional and clinical testing was conducted on the ARTAS System to support a determination of substantial equivalence to the predicate devices.
{2}------------------------------------------------
| SECTION 5 |
|---|
| 510(K) SUMMARY (CONT.) |
Nonclinical Testing Summary:
The nonclinical, bench testing included:
- Electrical Safety and Electromagnetic Compatibility Testing .
- Software Verification and Validation Testing .
- Hardware Design Verification Testing .
- � Cytotoxicity Testing
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the ARTAS System meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the ARTAS System does not raise new questions of safety or effectiveness for follicular unit extraction when compared to the manual procedure.
Clinical Testing Summary:
A multi-center, prospective, blinded, clinical study was performed to compare the safety and effectiveness of the ARTAS System to the manual hair follicle harvesting method following a nine month period of post-procedural evaluation. The clinical study enrolled healthy men, between the ages of 30 and 59, who had brown or black straight hair and a clinical diagnosis of androgenetic alopecia (male pattern hair loss).
A total of 36 subjects were treated in this study at two U.S. clinical sites. The mean age of the participants was 48.6 ± 7.5. Subjects predominantly had black hair and stage V or VI baldness on the Norwood-Hamilton Classification scale. The population at both sites was similar.
There were no adverse events, serious adverse events or unanticipated adverse events reported by any subjects during the course of this study. All complications were "Mild" in intensity. None of the subjects terminated the study early due to any safety-related issues.
The primary effectiveness endpoint was the difference in the number of surviving implanted hair follicles at Month 9 post-implantation between those implanted hair follicles that were harvested using the ARTAS System and those that were harvested using the manual method of hair harvest. In comparing the implant results by hair follicle harvest method, the ARTAS System was found to be substantially equivalent to the manual harvest method at nine months (p = 0.023). The primary effectiveness endpoint of this study was achieved.
Page 384
{3}------------------------------------------------
· THE ARTAS™ SYSTEM FROM RESTORATION ROBOTICS 510(k) PREMARKET NOTIFICATION
SECTION 5 510(K) SUMMARY (CONT.)
Page 4 of 4
CONCLUSION
As demonstrated in this clinical study, no new issues of safety or effectiveness are raised by implementing computer-assisted techniques for follicular unit extraction as compared to the manual procedure. The nonclinical and clinical testing of the ARTAS System has demonstrated the device to be at least as safe and effective as the legally marketed predicate devices.
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HS" are arranged in a semi-circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Restoration Robotics, Inc. % Experien Group, LLC Kit Cariquitan Vice President, Regulatory Affairs 155-A Moffett Park Drive, Suite 210 Sunnyvale, California 94089
APR - 4 2011
Re: K103428
Trade/Device Name: The ARTAS™ System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: ONA Dated: March 21, 2011 Received: March 22, 2011
Dear Kit Cariquitan:
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.
{5}------------------------------------------------
Page 2 - Kit Cariquitan
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); medical device 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 go to http://www.fda.gov/AboutlFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours.
ereby yours,
F-e A.V. Def D.A
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
2103428
SECTION 4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K103428
Device Name: The ARTAS™ System from Restoration Robotics
Indications For Use:
The ARTAS™ System from Restoration Robotics is indicated for harvesting hair follicles from the scalp in men diagnosed with androgenic alopecia (male pattern hair loss) who have black or brown straight hair. The ARTAS System from Restoration Robotics is intended to assist physicians in identifying and extracting hair follicular units from the scalp during hair transplantation.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nihil for maken
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103428
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).