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The PL-1064 laser, collimated handpiece will be indicated for ablation, vaporizing, excision, incision, and coagulation of soft tissue encountered in dermatology, plastic surgery, and podiatry including but not limited to plantar warts, periungual warts and telangiectasia. .

The PL-1064 will also be indicated for the temporary increase of clear nail in patients with onychomycosis (e.g., derniatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

The Sheaumann PL-1064 is a medical grade, solid-state, infrared diode laser (AlGaAs). The laser is designed to deliver continuous or pulsed, infrared laser energy with a wavelength at 1064 nm. The touch screen display consists of a user interactive screens that allows selection of continuous, pulsed and the TMP/CLEAR NAIL/ Clear Nail modes of operation, repetition rates, aiming beam on/off, procedural information display keys, a Standby/Ready key, the manual emergency stop button and the master key switch.
THE LASER SYSTEM: The laser system consists of a laser diode optical deck, cooling system, voltage power supply and system control electronics that include the touch screen control panel.
The mail console: Contains major electrical components.
DELIVERY SYSTEM: The reusable 1.0 mm collimated handpiece has been designed to deliver a spot size of 1.0 mm. Safety glasses/goggles and a safety sign are also provided with the PL-1064.

The provided text states, "Non clinical Performance Data: None" and "Clinical Performance Data: None". This indicates that no specific studies were presented to demonstrate that the device meets acceptance criteria related to its performance.

Instead, the device, Sheaumann Laser PL-1064, received 510(k) clearance based on its substantial equivalence to a predicate device, the PathoLase PinPointe Foot Laser (K093547). The submission states, "From a design and clinical perspective, the predicate and candidate laser device, are the same technology and have the same intended use. Based upon the fact that the devices are extremely similar, the PL-1064 should not raise any concerns regarding its overall safety and/or effectiveness."

Therefore, the requested information elements related to performance studies, such as acceptance criteria tables, sample sizes, expert involvement, and ground truth, cannot be extracted from the provided document as they were not part of this specific 510(k) submission.

Summary based on the provided text:

• Acceptance Criteria and Reported Device Performance: Not provided, as clearance was based on substantial equivalence to a predicate device, not new performance data for this specific device.
• Sample Size for Test Set and Data Provenance: Not applicable. No test set data was provided.
• Number of Experts and Qualifications: Not applicable. No expert review of performance data for this device was described.
• Adjudication Method: Not applicable. No test set data to adjudicate.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. No such study was mentioned.
• Standalone Performance Study (algorithm only): No. This is a laser device, not an algorithm. No performance studies were conducted or reported for this device in the submission.
• Type of Ground Truth Used: Not applicable. No ground truth data was used for performance evaluation of this specific device.
• Sample Size for Training Set: Not applicable. No training set data was used or described.
• Ground Truth for Training Set: Not applicable.

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