(197 days)
Intended Use The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures.
Indications for Use The Alma Diode Tabletop Laser includes three possible diode laser modules depending on the customer order.
Diode Laser Modules:
The indications for use for the 810nm Alma Diode Tabletop Laser include:
- The Alma 810nm diode tabletop laser is indicated for endovenous laser surgery for saphenous incompetent veins.
The indications for use for the 980 nm Alma Diode Tabletop Laser include:
-The Alma 980nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980nm diode tabletop laser is further indicated for laser assisted lipolysis.
The indications for use for the 1470nm Alma Diode Tabletop Laser include:
-The Alma 1470nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470nm diode tabletop laser is further indicated for laser assisted lipolysis.
The Alma Diode Tabletop Laser is comprised of the following major components:
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- The main console unit
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- Footswitch.
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- Accessories
This is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with acceptance criteria in the way a de novo or PMA submission would. Therefore, the document does not contain the detailed performance study information requested for an AI/ML device.
Here's an analysis based on the provided text, highlighting what is and isn't available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance in the context of clinical efficacy or specific accuracy metrics from a study. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to the predicate device by matching technical characteristics and indications for use.
The tables in sections 8-VI (Tables 1, 2, and 3) compare the "Alma Diode Tabletop Laser" (K13) to the "Quanta Diode Laser Family" (K100558) across several technical parameters. The "reported device performance" in this context is the Alma device meeting these technical specifications and having similar indications for use.
| Parameter | Alma Diode Tabletop Laser (K13) (Reported Performance - Matches Predicate) | Predicate Device (K100558) (Implicit Acceptance Criteria) |
|---|---|---|
| Product Code & Regulation No. | GEX, 21 CFR 878.4810 | GEX, 21 CFR 878.4810 |
| Laser Wavelength [nm] (1470nm module) | 1470 | 1470 |
| Max power (1470nm module) | 15W | 15W |
| Light/Laser Source | Diode | Diode |
| Laser Delivery | Optical Fiber | Optical Fiber |
| Operation Mode | Continuous wave, single pulse, pulsed | Continuous wave, single pulse, pulsed |
| Pulse Duration (1470nm module) | 10-990ms | 3ms - 2.5s |
| Bare fiber size | 200, 300, 320, 400, 600, 800, 1000 | 200, 300, 320, 400, 600, 800, 1000 |
| User Interface | LCD touch screen | LCD touch screen |
| Aiming beam (1470nm module) | 635nm | 650nm |
| Electrical Requirements | 100-240 V AC 50-60 Hz, 6.3 A | 100-240 V AC 50-60 Hz, 6.3 A, single phase |
| Indications for Use (1470nm) | Endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux; laser assisted lipolysis. | Endovenous occlusion of the greater saphenous vein in Patients with Superficial Vein Reflux; laser assisted lipolysis. |
Similar tables exist for the 980nm and 810nm modules, with minor differences in wavelength, max power (30W for 980nm/810nm), and aiming beam wavelength (635nm vs 650nm for predicate).
The study that proves the device meets the acceptance criteria:
The "study" cited is the comparison to predicate devices and adherence to recognized electrical and laser safety standards. There are no clinical performance studies, accuracy metrics, or AI/ML specific evaluations described in this 510(k) summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) for a laser device, not an AI/ML diagnostic. There are no test sets of patient data mentioned for performance evaluation. The device was tested to meet specific safety and electrical standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This type of information is not relevant to this 510(k) submission, which focuses on substantial equivalence of a physical laser device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication in this context.
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 device is not an AI/ML product designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this submission is implicitly the established safety and performance profile of the predicate device and adherence to international electrical and laser safety standards.
The device was tested by a certified laboratory according to:
- IEC 60601-1: 1988+A1:1991+A2:1995: Medical Electrical Equipment Part 1: General Requirements for basic safety and essential performance
- IEC 60601-1-2: Medical electrical equipment: Part 1-2: General requirements for safety-Collateral Standard: Electromagnetic compatibility - Requirements and tests (2001 + A1(4))
- IEC 60601-2-22:1995 Medical electrical equipment- Part 2-22: Particular requirements for the safety of diagnostic and therapeutic laser equipment 1995.
- IEC 60825-1:2007 (2nd edition) Safety of Laser Products-Part 1: Equipment Classification and Requirements
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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.