(98 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 is also indicated for creating recipient sites for subsequent manual implantation of the harvested follicles.
The ARTAS™ System implements the manual Follicular Unit Extraction (FUE) approach to harvesting follicular units and has the potential to solve the technical challenges inherent in the manual FUE technique. The ARTAS™ System is used, under the direction of a physician, to automate the manual FUE technique. The ARTASTM System is positioned over the patient's scalp by the physician and follicular units are identified. Follicular units are then harvested from the patient's scalp. The follicular units are stored until they are implanted into the patient's scalp by the physician or technician using current manual implantation techniques. Following harvesting, the ARTAS system is positioned over the patient's scalp by the physician and implantation sites are made in the designated area of the scalp. The ARTASTM 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 is an analysis of the ARTAS™ System's acceptance criteria and testing, based on the provided 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for the ARTAS™ System does not explicitly state quantitative acceptance criteria or detailed reported device performance metrics in a readily extractable table format. Instead, it describes general safety and effectiveness.
However, based on the summary, the implicit acceptance criteria are that the device should:
- Perform consistently during its intended use.
- Not raise new questions of safety or effectiveness compared to predicate devices.
- Function to its specifications and perform as intended.
The reported performance is that the device meets these criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The summary mentions a "multi-center, prospective, blinded, clinical study" that 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)." However, the exact number of participants (sample size) in this clinical study is not specified in the provided text.
- Data Provenance: The study was a "multi-center, prospective, blinded, clinical study." The country of origin is not explicitly stated, but the applicant (Restoration Robotics) is based in San Jose, California, USA, suggesting it was likely conducted in the USA or North America.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- The summary does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. It mentions the study compared the ARTAS System to the "manual hair follicle harvesting method," implying physicians or trained personnel performed both methods.
4. Adjudication Method for the Test Set
- The summary does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating outcomes in the clinical study. It states the study was "blinded," but the specifics of how blinding was achieved and how outcomes were assessed are not detailed beyond "post-procedural evaluation."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was described. The clinical study was designed to compare the "safety and effectiveness of the ARTAS System to the manual hair follicle harvesting method." This implies a comparison of the device's performance against a standard manual procedure, but not specifically an "AI vs. Human with AI assistance" type study. The ARTAS System is the robotic assistance for the physician. Therefore, the study, in essence, compares the robotic-assisted method to the manual method.
- Effect Size: Since an MRMC comparative effectiveness study of "human readers improve with AI vs. without AI assistance" was not described in this context, no effect size can be provided. The ARTAS system is the automated tool assisting physicians; it's not an AI model providing interpretations to human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No standalone (algorithm only) performance study was described. The ARTAS™ System is explicitly stated to assist physicians and operates "under the direction of a physician." Therefore, its intended use and evaluation intrinsically include a human-in-the-loop, where the physician operates and guides the automated system, validating its performance under this paradigm.
7. Type of Ground Truth Used
- The ground truth in the clinical study was based on clinical evaluation and post-procedural assessment over a nine-month period. This would likely involve visual inspection, assessment of hair growth, and identification of any adverse events, conducted by medical professionals within a clinical setting.
8. Sample Size for the Training Set
- The 510(k) summary does not provide information on the sample size used for the training set for the ARTAS System's software or algorithms. The device uses an "interactive, image-guided, computer-assisted system," implying underlying algorithms for image analysis and robotic control. However, the details of their development data are not discussed.
9. How the Ground Truth for the Training Set Was Established
- The 510(k) summary does not describe how the ground truth for any training set was established. Since the ARTAS System involves "identifying and extracting hair follicular units" and "avoiding existing hairs," it's highly probable that ground truth for training would involve manual annotation of follicular units and scalp features by experts on images or directly on patients. However, this is not explicitly stated in the provided text.
§ 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).