(19 days)
General intended use: The Discovery Pico Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgerv as follows.
Indications for use:
1064 & 532 nm (Q-Switched, nanosecond mode): The Discovery Pico Family is intended for treatment of vascular lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:
532 nm (Q-Switched, nanosecond mode): Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos, Treatment of vascular lesions including, but not limited to: port wine birthmarks, telangiectasias, spider angiomaa, Cherry angioma, Spider nevi, Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, Ephalides, solar lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus, Ota Nevus, Treatment of seborrheic keratosis, Treatment of post inflammatory hyperpigmentation, Skin resurfacing procedures for the treatment of acne scars and wrinkles.
1064 nm (Q-Switched, nanosecond mode): Removal of dark ink (black, blue and brown) tattoos, Removal of benign pigmented lesions including; nevus of Ota, Café au lait spot, Ephalides, solar lentigo (lentigines), Becker Nevus, Nevus spilus, Treatment of common nevi, Removal or lightening of unwanted hair, Skin resurfacing procedures for the treatment of acne scars and wrinkles.
1064 nm (non Q-Switched - free running mode): Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Treatment of wrinkles. Treatment of mild to moderate inflammatory acne vulgaris.
532 nm (picosecond mode): Indicated for the removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.
1064 nm (picosecond mode): Indicated for the removal of tattoos for all skin types (Fitzpatrick skin types I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.
694 nm (Q-Switched): Indicated for: Tattoo removal: Suggested for blue, sky blue, black, green and violet ink, Pigmented lesion removal (benign): Cafe au lait spot, Ephalides, solar lentigo lentigines), Becker Nevus, Ota and Ito Nevus, Nevus spilus, Mongolian spot.
694 nm (non q-switch - free running mode): Intended to remove benign dermal and epidermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.
IPL 590-1200nm; 625-1200nm; 650-1200nm: Indicated for permanent hair removal. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
IPL 550-1200nm; 570-1200nm: Indicated for photocoagulation of dermatological vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.
IPL 400-1200nm: Indicated for inflammatory acne (acne vulgaris).
Integrated Skin Cooler: The intended use of the integrated cooling system in the laser hand piece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.
The Discovery Pico Family is a laser family that includes Q-Switched and/or Pulsed laser sources, emitting at one or more of the following wavelengths: 532 nm, 1064 nm, 694 nm (Ruby laser). The Discovery Pico Family systems, through the special universal Twain connector, can be equipped with intense pulsed light handpieces (Twain IPL) emitting at the following wavelengths: 650-1200nm, 625-1200nm, 590-1200nm, 570-1200nm, 550-1200nm, 400-1200nm. The Discovery Pico Family systems, when operating with Pulsed laser sources and IPL, can be used in combination with optional contact, or air, cooling systems. The optical delivery system is an articulated arm with fixed handpieces. The optical delivery system for the IPL system is a handpiece (Twain IPL) with fixed or interchangeable light filters at different wavelengths. All the models belonging to the Discovery Pico Family have the same components and the same control software. The only difference between different models is the optical bench that depends on the sources installed. The Discovery Pico Family is controlled via a touch screen display housed in the front of the device. Emission is triggered by means of a footswitch.
The provided text describes modifications to the "Discovery Pico Family" device and its substantial equivalence to the "EVO Platform (K160368)" predicate device. The information focuses on regulatory compliance and technical specifications rather than a clinical study with detailed performance metrics against acceptance criteria for a specific AI-driven diagnostic task.
Therefore, it's not possible to extract the requested information regarding acceptance criteria, reported device performance for a specific task, sample sizes for test/training sets, expert qualifications, ground truth methods, or MRMC study results because this document describes a laser surgical instrument, not an AI diagnostic device. The performance data mentioned refers to engineering and safety standards, not clinical efficacy or diagnostic accuracy.
The document indicates that:
- No specific acceptance criteria for a diagnostic task are listed. The submission is about changes to performance specifications of a laser device, not about a diagnostic algorithm's accuracy.
- No "reported device performance" in terms of diagnostic metrics (e.g., sensitivity, specificity, AUC) is provided. The performance data relates to compliance with laser safety and electrical equipment standards.
- No sample sizes for test sets or training sets are mentioned. This type of data is relevant for AI/diagnostic algorithms, not for the laser device in question.
- No information on experts for ground truth or adjudication methods is available. Again, this is not relevant for the regulatory aspects described in this document for a laser device.
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or reported.
- No standalone (algorithm only) performance was done or reported.
- No type of ground truth (e.g., pathology, outcomes data) is mentioned as this is not a diagnostic device.
- No sample size for the training set or how ground truth was established for a training set is provided.
Summary of available information related to performance and testing:
- Acceptance Criteria & Reported Device Performance: Not applicable for a diagnostic AI. The device was subjected to performance testing in accordance with IEC 60601-2-22 (Medical Electrical Equipment - Laser Equipment) and IEC 60825-1 (Safety of Laser Products). The modified device passed all required testing and is in compliance with these standards. It also complies with IEC 60601-1 (General Requirements For Basic Safety) and IEC 60601-1-2 (Electromagnetic Compatibility).
- Sample sizes for test set and data provenance: Not applicable. The testing described is for laser safety and electrical performance, not clinical diagnostic data.
- Number of experts and qualifications: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: No such study is mentioned.
- Standalone performance: Not applicable as it's not an algorithm.
- Type of ground truth: Not applicable. Ground truth typically refers to accurate labels for diagnostic tasks; here, device performance relates to meeting engineering standards.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
The document primarily focuses on demonstrating that the modified device maintains the same safety and effectiveness as the predicate device by meeting established international performance standards for medical electrical equipment and laser products. The key statement for equivalence is that "the maximum fluence is not changed."
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.