(221 days)
The Alma Hybrid Laser System, Delivery Devices, Applicators and Accessories are intended for use in surgical applications requiring the ablation, vaporization, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery).
HyLight-CO2
The Alma Hybrid CO2 non-fractional applicator, with wavelength of 10600 nm is cleared for use for the particular indications as follows:
Dermatology & Plastic Surgery
The ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
- laser skin resurfacing
- laser derm-abrasion
- laser burn debridement.
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts.
Pixel
The Alma Hybrid Pixel CO2 fractional applicator, with wavelength of 10600 nm is indicated for: The ablation, vaporization, and coagulation of soft tissue in dermatology and plastic surgery in the performance of skin resurfacing.
ProScan
The Alma Hybrid ProScan CO2 fractional applicator, with wavelength of 10600 nm is indicated for:
· Laser skin resurfacing (ablation and/or vaporization) of soft tissue.
The Alma Hybrid ProScan 1570nm fractional applicator, with wavelength of 1570 nm, is indicated for:
· Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue
The Alma Hybrid ProScan CO2 &1570nm fractional applicator, with wavelengths of 10600 nm & indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.
The Alma Hybrid Laser System consists of:
- Laser system console (containing the optical bench assembly and laser, the ● microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel)
- LCD control panel with touch-screen technology: the LCD display provides information . on the status and settings of the The Alma Hybrid Laser System with touch-screen technology provided to input commands into the system.
- Two wavelengths – CO2 and 1570 nm
- . Articulated arm
- Footswitch
- Delivery devices (Pixel applicators, Hylight applicators, Proscan applicator) ●
The provided text is a 510(k) Pre-Market Notification for the Alma Hybrid Laser System. Within this document, the main objective is to demonstrate substantial equivalence to predicate devices, rather than establishing new efficacy or safety criteria for the device itself. Therefore, it does not contain a typical "acceptance criteria" table for device performance against specific metrics, nor does it detail a clinical study designed to prove the device meets such criteria in the way one might expect for a novel device.
However, based on the document, we can infer some "acceptance criteria" through the comparisons made with predicate devices and the performance testing conducted. The study described focuses on histology testing on porcine animals to justify technical differences in some applicators.
Here's an attempt to extract and frame the information requested, with the understanding that the document's purpose is a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit acceptance criteria for efficacy in humans are not provided (as it's a substantial equivalence claim), the "acceptance criteria" are implied by demonstrating similar technical characteristics to the predicate devices and confirming tissue effects in an animal model meet expected physiological responses.
| Acceptance Criteria (Implied) | Reported Device Performance (Alma Hybrid Laser System) |
|---|---|
| Technical Equivalence to Predicate Devices: | |
| - Wavelengths | - HyLight CO2 & Pixel CO2: 10600 nm (Same as predicate) |
| - ProScan 1570nm: 1570 nm (Close to predicate's 1565 nm) | |
| - Output Power/Energy | - HyLight CO2: 30W, 70W (Same as predicate) |
| - Pixel CO2: 5mJ/Pixel - 150 mJ/Pixel (Same as predicate) | |
| - ProScan CO2: Up to 1000 mJ (Predicate) vs 120 (30W model)/240 mJ (70W model) (The document states "Output energy" vs "Up to 1000 mJ" for predicate. It also later clarifies "max energy output is within the range of the predicate device" for Pixel CO2, and for ProScan CO2, differences in spot size, beam density and pulse duration are noted, with histology supporting these differences.) | |
| - ProScan 1570nm: 24mJ-144 mJ/pixel (Predicate: 10 mJ per beam – 70 mJ per beam. Hybrid system has different range, but is considered substantially equivalent.) | |
| - Spot Size, Repetition Rate, Pulse Duration, Fluence, Beam Density | Differences noted for some applicators, but documented as being within acceptable ranges or justified by performance testing (e.g., histology). For HyLight-CO2, spot size, pulse duration, and output energy differ, but fluence is within predicate range. For Pixel CO2, pulse duration differs but max energy output is within predicate range. For ProScan, differences in spot size, beam density, and pulse duration are noted. |
| Safety and Performance Standards Compliance: | - Complied with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 10993-1, ISO 17665-1, IEC 62304, ISO 14971. |
| Expected Histological Tissue Response (for ProScan Applicator): | - Histology results complied with FDA requirements at 0, 3, 7, and 14 days. |
| - Re-epithelialization observed three days after radiation in all specimens. | |
| - No adverse events or unexpected complications in the swines. | |
| Device Functionality: | - Functioned as intended and results observed were as expected. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Histology Study): 3 Domestic female (Mixed Landrace & Large White) crossbred swine.
- Data Provenance: The study was implicitly prospective for the animal testing, conducted by Alma Lasers. The document does not specify the country of origin of the data beyond "Alma also performed histology testing on porcine animals."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for evaluating the histology results. It states, "histology results complied with the FDA requirements." This implies interpretation by qualified individuals, but no details are given.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the animal histology results. It simply states that the "histology results complied with the FDA requirements" and "Re-epithelialization was observed three days after radiation in all specimens." This suggests a direct evaluation against predefined criteria rather than a consensus process among multiple independent reviewers.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no human clinical studies were deemed needed to support this submission." The study described is an animal histology study, not a human reader study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a laser system, not an AI or algorithm-based diagnostic tool. The performance described relates to the physical and biological effects of the laser, not a computational algorithm's performance.
7. The Type of Ground Truth Used
For the animal study, the ground truth was histology from punch biopsies taken from the radiated points at 0, 3, 7, and 14 days, examined for re-epithelialization and other tissue effects.
8. The Sample Size for the Training Set
This question is not applicable in the context of this 510(k) submission. The device is a physical laser system, not an AI or machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as point 8.
§ 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.