(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 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;
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- Robotic Arm Subsystem
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- Imaging Subsystem
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- Needle Mechanism
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- Safety Subsystem
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- Computer
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- Accessory Kits (Disposable and Reusable)
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- 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.
§ 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).