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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.

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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.

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.

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