(73 days)
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 surgery. Specific indications include treatment of benign vascular lesions, benign pigmented lesions, hair removal, tattoo removal, skin resurfacing for acne scars and wrinkles, photocoagulation and hemostasis of benign pigmented and benign vascular lesions, coagulation and hemostasis of soft tissue, treatment of wrinkles, and treatment of mild to moderate inflammatory acne vulgaris.
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 systems 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 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 or a handpiece (Twain IPL) with fixed or interchangeable light filters. All models have the same components and control software, differing only in the installed optical bench. The device is controlled via a touch screen display and emission is triggered by a footswitch.
The provided FDA 510(k) summary for the Discovery Pico Family laser system focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for clinical efficacy through a standalone study.
Therefore, many of the requested details about acceptance criteria, clinical study specifics, and ground truth establishment are not present in this document. The document primarily relies on engineering performance standards and a comparative analysis with predicate devices.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of explicit acceptance criteria for clinical performance (e.g., specific percentages of tattoo clearance or lesion removal). Instead, it states compliance with recognized engineering performance standards and "thermal-histology performance data for fractional handpieces." It also asserts that "the device performs as intended" and is "substantially equivalent to the predicate devices."
| Acceptance Criteria (Explicit Clinical Performance) | Reported Device Performance |
|---|---|
| Not explicitly defined in terms of clinical outcomes (e.g., % tattoo clearance, % lesion reduction). The document focuses on engineering and safety standards. | "The Discovery Pico Family is substantially equivalent to the predicate devices." |
| Engineering Performance Standards: | Compliance with: |
| - IEC 60601-2-22 (Surgical Laser Equipment) | Met |
| - IEC 60825-1 (Safety of Laser Products) | Met |
| - IEC 60601-1 (General Electrical Safety) | Met |
| - IEC 60601-1-2 (Electromagnetic Compatibility) | Met |
| Thermal-histology performance data for fractional handpieces: | Data exists (details not provided in this summary). |
| Software Verification and Validation: | Conducted and documented per FDA guidance. |
| Biocompatibility: | Established based on predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable/Not provided. The document does not describe a clinical test set with human subjects for efficacy evaluation beyond what might be implied by "thermal-histology performance data."
- Data Provenance: Not applicable/Not provided for clinical efficacy. The engineering standards compliance refers to internal company testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. There is no mention of a ground truth established by experts for clinical performance, as the submission focuses on substantial equivalence based on technical characteristics and predicate devices, rather than a clinical trial with a defined ground truth.
4. Adjudication Method
- Not applicable. No clinical study with a read-out or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study was not done, as this is a laser device and not an imaging AI diagnostic tool that would typically involve multiple readers. The document implicitly compares the new device's capabilities to predicate devices, but not in a formal MRMC study format.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This is a physical laser device, not an algorithm, so the concept of "standalone performance" in the context of AI algorithms doesn't directly apply. The device's standalone performance is assessed through its compliance with engineering standards.
7. The Type of Ground Truth Used
- The ground truth used for relevant aspects where data is mentioned would be:
- Engineering Standards: Compliance with established safety and performance requirements set by IEC standards.
- Thermal-histology data: This would typically involve histological analysis of treated tissue in an experimental setting (e.g., animal or ex vivo human tissue) to assess the thermal impact, which serves as a form of ground truth for tissue response. Details are not provided.
- Biocompatibility: Established by reference to predicate device characteristics.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set in the typical sense.
9. How the Ground Truth for the Training Set was Established
- Not applicable. No training set is used for this type of medical device submission.
§ 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.