(29 days)
755mm: Temporary hair reduction. Stable long-term or permanent reduction targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 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. On all skin types (Fitzpatrick I- VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas).
1064nm: Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment 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. The lasers are indicated on 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, hemangioma, warts, telangiectasia, rosacea, venus and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for pigmented lesion size. for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles. Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)
The GentleMax Pro Plus contains two separate laser heads (Alexandrite and Nd:YAG), which produce laser light outputs of 755 nm and 1064 nm, respectively. The output of each laser head is optically combined on the laser rail, so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either 755 nm or 1064 nm wavelengths. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat. The Dynamic Cooling Device (DCD) protects the upper layers of the skin with a cooling burst of cryogen.
This document is a 510(k) premarket notification for the Candela GentleMax Pro Plus laser system, which is a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies. As such, the information you're asking for, particularly regarding acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/algorithm-driven medical device, is not directly applicable to this submission.
This document pertains to a laser surgical instrument, not an AI or algorithm-based diagnostic/therapeutic device. Therefore, the concepts of "test set," "ground truth," "expert consensus," "MRMC studies," and "standalone performance" as they relate to AI model validation are not present here.
However, I can extract the relevant information about how this device's performance and safety were evaluated to demonstrate substantial equivalence.
Here's an analysis based on the provided text, addressing your points where applicable and explaining why others are not relevant:
Device Type: Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology (Product Code GEX). This is NOT an AI/algorithm-driven device requiring traditional AI model performance evaluation.
Acceptance Criteria and Reported Device Performance (as relevant for a laser system):
The "acceptance criteria" for this device are primarily based on demonstrating substantial equivalence to a predicate device (Candela GentleMAX Family of Lasers System, K140122) in terms of design, technological characteristics, intended use, and indications for use. The performance data provided are therefore related to safety and functional equivalency.
| Acceptance Criterion (for Substantial Equivalence to Predicate) | Reported Device Performance (GentleMax Pro Plus) |
|---|---|
| Technological Characteristics Similarity | Same as Predicate (K140122) for many key features: |
- Wavelengths (755 nm & 1064 nm)
- Laser Medium (Flashlamp-excited, Solid state Alexandrite and Nd:YAG laser)
- Aiming Beam (Green diode laser)
- Maximum Fluence (400 J/cm2 (ALEX), 520 J/cm2 (YAG))
- Accuracy of Output (± 20%)
- Operating Modes (Pulse)
- Energy Delivery (Footswitch & finger switch)
- Beam Delivery (Lens-coupled optical fiber)
- Skin Cooling (Cryogen DCD)
- System Cooling (Ambient Air)
- Software/GUI/Touch Screen (Yes)
- Dimensions & Weight
- Power Supply
Minor Differences (not raising new safety/effectiveness questions):
- Maximum Energy (J): Modified: 68 J ALEX; 90 J Nd:YAG (Predicate: 53 J ALEX; 80 J Nd:YAG). This indicates increased power.
- Spot Size (mm): Modified: 1.5, 3, 3x10, 5, 6, 8, 10, 12, 15, 18, 20, 22, 24, 26 (Predicate: 1.5, 3, 3x10, 5, 6, 8, 10, 12, 15, 18). New, larger spot sizes added.
- Repetition Rate (Hz): Modified: 1-10 Hz (Predicate: 1-10 Hz). Text notes "faster repetition rate" but table shows same range. This likely refers to increased maximum repetition rate within the 1-10Hz range for specific parameters, not a change in the overall range.
- Pulse Duration (ms): Modified: 0.25 - 100 ms (new 2ms) (Predicate: 0.25 - 100 ms). This indicates the addition of a specific 2ms pulse setting option. |
| Same Intended Use & Indications for Use | The Intended Use/Indications for Use Statement is unchanged from the predicate device (K140122). |
| Compliance with Electrical Safety and EMC Standards | Complies with IEC 60825-1, IEC 60601-1-2, IEC 60601-1, IEC 60601-2-22. |
| Biocompatibility | Established based on predicate devices and results of ISO 10993-5 and ISO 10993-10 series of testing (acceptable). |
| Software Verification & Validation | Testing conducted and results were found acceptable for software release, performed per FDA's guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices". |
Since this is not an AI/algorithm-driven device, the following points are not applicable and are not discussed in the provided 510(k) summary:
- 2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" in the context of an AI model. Performance evaluation for this laser is primarily functional and safety testing.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No image-based "ground truth" or expert review process as would be needed for an AI diagnostic algorithm.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable. There's no AI model involved that requires a "training set."
- 9. How the ground truth for the training set was established: Not applicable.
Summary of Device Evaluation for Substantial Equivalence:
The manufacturer asserted that the GentleMax Pro Plus is substantially equivalent to its predicate (Candela GentleMAX Family of Lasers System, K140122) because:
- It has the same intended use and indications for use.
- It shares similar design and technological characteristics. While some specifications like maximum energy, pulse duration (new 2ms option), and spot sizes (new larger ones) have changed, the manufacturer states these "minor differences do not raise any new types of safety or effectiveness questions because the GentleMax Pro Plus parameters are similar to the predicates."
- It meets all relevant electrical safety and electromagnetic compatibility standards (IEC 60825-1, IEC 60601-1-2, IEC 60601-1, IEC 60601-2-22).
- Its biocompatibility was established using existing predicate data and ISO 10993 testing.
- Its software underwent verification and validation testing in accordance with FDA guidance, with acceptable results.
- No clinical studies were needed to support this 510(k) due to the strong similarities in device specifications, intended use, and indications for use with the predicate device.
In essence, the "study that proves the device meets the acceptance criteria" for this 510(k) submission is the demonstration, through comparison to a predicate and adherence to relevant safety standards, that the new device is as safe and effective as a device already on the market. This is a common pathway for medical device clearances that are not introducing fundamentally new technologies or indications.
§ 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.