(142 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; creating recipient sites; and implanting harvested hair follicles.
The ARTAS System is used under the control of a physician to assist with the harvesting of follicular units and recipient site creation steps of the hair transplantation process. Follicular units are harvested from the patient's scalp, and then implanted into the patient's scalp in the recipient sites created by the physician or the ARTAS System. Additionally, the modified ARTAS System has the capability to assist the physician with the implantation step of the hair transplantation procedure.
The ARTAS System is an interactive, image-guided, computer assisted system consisting of several main subsystems. These include a robotic arm, imaging, needle mechanism, safety, computer, accessory kits and patient chair. The ARTAS System Cart houses the Robotic Arm, the Needle Mechanism, the Imaging subsystems and the Computer. The Needle Mechanism houses the Accessory Kits required for harvesting, recipient site creation, and implantation. The Needle Mechanism is mounted on the Robotic Arm which is mounted on the System Cart. The robotic arm controller is built into the cart and controls the robot and is connected to the computer for communications and transmission of movement instructions. The Accessory Kits contain components necessary to complete the hair transplantation procedure, including the accessories for harvesting, site-making, and implantation.
The Accessory Kits used with the ARTAS System and Procedures include Disposable and Reusable Accessory Kits. For Implantation, the Implant Accessory Kits are used with the modified ARTAS System. The ARTAS Mechanism holds equivalent commercially available components of the predicate device. The Implantation Needle Assembly is inserted into the ARTAS Needle Mechanism with a pre-loaded 'Linear Cartridge' with hair follicles prior to implantation. Restoration Robotics has also incorporated an 'Index Cam-Obturator Assembly' which facilitates the progression of the Linear Cartridge to the next available hair follicle. The Fiducial Platform provides a location for fiducial markings used to track target locations during the Site Making and Implantation Procedures. All items must be sterilized prior to use.
The provided text describes a 510(k) premarket notification for the ARTAS System, focusing on its modified version for hair follicle implantation. Here's a breakdown of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The device's core functionality is to assist in hair follicle implantation, and the primary acceptance criterion appears to be non-inferiority in hair follicle survival rates compared to the manual implantation method.
| Acceptance Criteria / Performance Aspect | Reported Device Performance |
|---|---|
| Primary Efficacy Endpoint: Non-inferiority of implanted terminal hair follicles survival for ARTAS vs. Manual method at 9 months. | Mean difference between manual implanted arm minus the ARTAS implanted arm at Month 9 was 8.2 ± 17.23 hair follicles, representing 5.9% ± 12.3% of total hairs transplanted. |
| Statistical proof that the survival of hair follicles implanted using the ARTAS system method was non-inferior to the manual implanted method, with a one-sided 95% confidence (non-inferiority margin of 14 hair follicles / 10%). | |
| Safety: Device-related adverse events. | No adverse events reported during the clinical study. Post-operative symptoms were common side effects not attributed to the device and affected both implantation areas equally. |
| Intraprocedural Implantation Success Rate (ARTAS side) | 92% (Not recorded for manual side) |
| Biocompatibility | All test results met acceptance criteria for Implant Disposable and Implant Reusable Accessory Kits (304SS and PEEK materials). |
| Sterilization Process Validation | Acceptance criteria for steam sterilization validation were met. |
| Electromagnetic Compatibility (EMC) and Electrical Safety | All test conditions were performed as outlined by IEC and ANSI/AAMI standards; previous testing remains valid with additional testing on the modified ARTAS Mechanism. |
| Overall System Functionality and Safety | Verification and Validation Testing conducted for Implantation and all safety-related features. All test results met acceptance criteria. Risk Management process identified and mitigated hazards, deeming all potential risks acceptable. |
2. Sample size used for the test set and the data provenance
- Sample Size for Clinical Study (Test Set): 30 subjects (N=30 subjects for the 9-month recipient site hair count change from baseline).
- For each subject, two equal size (2cm x 3cm) implantation target areas were identified.
- 140 hair follicles were implanted with one method (ARTAS or manual) into one target area.
- Another set of 140 hair follicles were implanted with the other method into the second target area.
- Data Provenance: The text does not explicitly state the country of origin. The study was an FDA-approved clinical study under Investigational Device Exemption (IDE) G160117, suggesting it was likely conducted in the US. The study design ("Computer-Assisted Hair Implantation Using ARTAS System vs. Manual Implantation Technique: Hair Restoration Study") indicates it was a prospective comparative study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The ground truth for the clinical study (hair follicle survival and safety assessment) was established by:
- Principal Investigator: Responsible for assessing post-operative symptoms, determining if they were adverse events. The qualifications of this individual are not specified beyond being the "principal investigator."
- Statistical Analysis: The calculation of mean differences and confidence intervals for hair follicle survival was done statistically.
- Adjudication method for the test set: The clinical study directly compared the ARTAS system to manual implantation within the same subject. The primary efficacy endpoint compared the number of surviving hair follicles at 9 months. The comparison was statistical, and it appears the hair count was directly measured. There is no explicit mention of an adjudication panel for discordant readings or assessments.
4. 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 MRMC comparative effectiveness study was not done in the context of human readers improving with AI assistance.
- This study was a direct comparison of a device-assisted procedure (ARTAS) versus a manual procedure performed by physicians. It assessed the outcome (hair survival) of the procedure itself, not the diagnostic performance of human readers assisted by AI. The ARTAS system is a robotic surgical assistance system, not an AI diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm only) performance study was not explicitly done in terms of a purely algorithmic output without human intervention. The ARTAS System is described as an "interactive, image-guided, computer assisted system" that is used "under the control of a physician."
- The clinical study evaluates the system's performance in assisting physicians with implantation, not an autonomous algorithm. The 92% intraprocedural implantation success rate for the ARTAS side indicates the system's ability to successfully implant, which is a facet of its "standalone" functionality within the procedural context.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the primary efficacy endpoint in the clinical study was outcomes data, specifically:
- 9-month recipient site hair count change from baseline: This is a direct measure of the physical outcome (hair survival) after the procedure.
- Safety outcomes: Absence of adverse events and assessment of common side effects.
7. The sample size for the training set
The text does not provide information on the sample size used for training the ARTAS System's algorithms or vision subsystem. It states "The Vision Subsystem has been modified to accommodate the required implantation images necessary for the implantation step of the hair transplantation procedure. There have been no other changes made to the Vision Subsystem as was originally cleared in K103428, and subsequently cleared K123548." This implies development but no specifics on training data.
8. How the ground truth for the training set was established
The text does not provide information on how the ground truth for the training set was established. Given the nature of a robotic surgical assistance system, the "training" might involve calibration, image recognition algorithms for hair follicles and insertion points, and motor control parameters, which would have their own internal validation and calibration processes rather than a "ground truth" derived from expert annotations in the same way an AI diagnostic model would. The continuous development and modification of the system (like the vision subsystem for implantation) would imply internal testing and refinement based on engineering and performance targets.
§ 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).