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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 ARTASTM System implements the manual Follicular Unit Extraction (FUE) approach to harvesting follicular units. The ARTASTM 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 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.

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.

The provided text describes specific details about a 510(k) premarket notification for the ARTAS™ System. However, it does not include a table of acceptance criteria or detailed results of a study designed to prove the device meets specific performance criteria like sensitivity, specificity, or accuracy.

The document focuses on:

• Device Description and Indications for Use: What the ARTAS™ System does (harvesting hair follicles in men with male pattern hair loss and black/brown straight hair, assisting physicians in identification and extraction).
• Technological Characteristics Comparison with Predicate Device: How the updated ARTAS™ System differs from its predecessor (e.g., screen views, parameter entry, mobility, auto hair selection, sterile disposables, punch design).
• Nonclinical Test Summary: General statements about software, electrical safety, biocompatibility, and other bench testing, stating that "All required electrical safety tests... were also performed. Biocompatibility testing was performed... The testing referenced above includes all of the tests that were performed on the predicate device. Since the results were identical for these tests, substantial equivalence has been demonstrated through these nonclinical tests."
• Clinical Test Summary: A statement that "A clinical study was performed on ninety-two (92) patients using the modified ARTASTM System. Primary efficacy (transection rates and non-implantable follicles) as well as safety endpoints were met."

Based on the provided text, I cannot extract the detailed information requested in your prompt regarding acceptance criteria and specific study results (like sensitivity, specificity, sample sizes for test/training sets with data provenance, number/qualifications of experts, ground truth methods, MRMC studies, or standalone performance metrics).

The document broadly states that efficacy and safety endpoints were met, and tests demonstrated substantial equivalence to a predicate device, but it does not specify what those endpoints or acceptance criteria were or what performance metrics were measured for transection rates and non-implantable follicles.

Therefore, I cannot provide the requested table or detailed study information. The provided text is a high-level 510(k) summary, which often summarizes testing without presenting all the granular data.

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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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