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The ACCENTO single laser system is indicated for the following:
755 nm Long pulsed Alexandrite laser
Temporary hair reduction, Stable long-term or permanent reduction through selective targeting of melanin in hair follicles.
Treatment of benign pigmented lesions. Treatment of Winkles. The photocoagulation of dermatological vascular lesions ( such as port of wine stains, hemangiomas, telangiectasias)
Permanent hair reduction is defined as the long term, stable reduction in the number of hairs re-growing when measured at 6, 9,and 12 months after the completion of a treatment regime.

The ACCENTO combined laser system is indicated for the following:
755 nm Long pulsed Alexandrite laser
Temporary hair reduction, Stable long-term or permanent reduction through selective targeting of melanin in hair follicles.
Treatment of benign pigmented lesions. Treatment of Winkles. The photocoagulation of dermatological vascular lesions (such as port of wine stains, hemangiomas, telangiectasias)
1064nm Long pulsed Nd: YAG laser
the removal of un-wanted hair reduction, for stable long term or permanent hair reduction and for treatment of PFB to all skin type Fitzpatrick I-VI including tanned skin. Treatment of Photocoagulation and hemostasis of pigmented and vascular lesions such as port wine stain, hemangiomna, warts, telangiectasia, rosacea, venus lake, legveins and spider veins. Coagulation and hemostasis of soft tissue, Benign pigmented lesions such as lentigos (age spot) Solar lentigos ( sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae skin tags, keratoses, tattoo reduction (dart color) and plaques. Pigmented lesions to reduce lesion size and patients with lesions, reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of scar, Treatment of wrinkle.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, 12, months after the completion of a treatment regime

The ACCENTO Dual device are contained two separate laser heads 755nm long pulsed Alexandrite and 1065nm Nd: YAG laser. The output of each laser head is optically combined on the laser rail to delivery same beams path. This single delivery system can obtain either 755nm or 1064nm wavelengths.
The LED touch screen equipped in Control panel to adjust parameters easily Each laser heads has self contained circulation water system to cool system and laser head fully using distilled water at a controlled temperature. The ACCENTO laser system delivers laser energy with various pulse durations from 0.2ms to 350ms. The output of this laser is delivered to the area of treatment by means of lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end.
A trigger switch( Finger or Foots pedal) is used to control the delivery of laser pulse. The user may choose to deliver a single pulse each time the trigger switch is depressed, or pulses may be deliver repetitively as long as the switch is depressed at repetition rates up to 10 pulses per second depending on the chosen pulse duration Energy from the laser is directed to the target area via optical fiber handpiece.
The Dynamic Cooling system provides a short burst of Cryogen spray prior to firing the laser pulse. The Energy is delivered via optical fiber to handpiece with a spot size 2, 3, 5, 8,10,12,18, 20mm diameter circular beam on the skin. Operator may select parameters as desired fluence and repetition rate, and operated using touch screen and display panel
This device consist of
Power supply and modulator system Optical laser Hand pieces and delivery system Circulator system Software control system, Dynamic cooling system, LED control panel
ACCENTO single device are contained 750nm Alexandrite laser only, and provided it optionally to treat related indication.
This device also equipped with safety interlock systems to protect patients and user

The provided document is a 510(k) premarket notification letter from the FDA to Bison Medical Co Ltd regarding their ACCENTO Dual/single Laser. This document is a regulatory approval and does not contain the results of a study proving the device meets specific acceptance criteria in the way a clinical trial report would.

Here's why and what information can be extracted:

• No Acceptance Criteria or Performance Study: The letter explicitly states: "Clinical and Non-Clinical performance test data was not provided in this submission." (Page 5, Section 6). This means there is no study described within this document showing the device's measured performance against a set of acceptance criteria.
• Basis for Clearance: The device received clearance based on substantial equivalence to a predicate device (K130199 CLARITY LPC Lutronic Corp). Substantial equivalence means the new device is as safe and effective as a legally marketed device. This often relies on design, technological characteristics, and intended use being similar, along with adherence to recognized safety standards.
• Mentioned Standards: The document lists several standards the device was manufactured in accordance with (IEC60601-1, IEC60601-1-2, IEC60601-2-22, IEC60825-1). These are safety and electromagnetic compatibility standards, not performance criteria for therapeutic efficacy.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from this document because that information is not present.

However, I can provide information relevant to your other points by indicating what is not present or by describing the basis for clearance:

1. Table of Acceptance Criteria and Reported Device Performance

• Not provided in this document. The submission explicitly stated that "Clinical and Non-Clinical performance test data was not provided in this submission." The device was cleared based on substantial equivalence to a predicate device, not on direct performance data against specific acceptance criteria presented here.

2. Sample Size Used for the Test Set and Data Provenance

• Not applicable/Not provided: No test set data or sample size information is available in this document as performance data was not submitted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Not applicable/Not provided: No test set was detailed in this filing.

4. Adjudication Method for the Test Set

• Not applicable/Not provided: No test set was detailed in this filing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No: A MRMC study was not described or required for this 510(k) clearance, as clinical performance data was not provided.

6. Standalone (Algorithm Only) Performance Study

• No: This device is a laser surgical instrument, which does not involve an algorithm for standalone performance evaluation in the typical sense (e.g., AI diagnostics). Performance data, generally, was not provided.

7. Type of Ground Truth Used

• Not applicable/Not provided: As performance data was not submitted, no ground truth was established or used in this filing. The clearance hinged on substantial equivalence to a predicate device.

8. Sample Size for the Training Set

• Not applicable/Not provided: This document relates to a physical laser device and its regulatory clearance; it does not involve training sets as would be used for AI/machine learning models.

9. How the Ground Truth for the Training Set Was Established

• Not applicable/Not provided: This document does not describe a training set or its ground truth establishment.

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