FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The indications for use for the 810 nm Alma Diode Tabletop Laser include: - The Alma 810 nm 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 980 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980 nm diode tabletop laser is further indicated for laser assisted lipolysis.

The indications for use for the 1470 nm Alma Diode Tabletop Laser include: -The Alma 1470 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470 nm diode tabletop laser is further indicated for

Device Description

The Alma Diode Tabletop Laser is comprised of the following major components:

The main console unit 1.
1. Pull-back
1. Footswitch
Accessories 4.

AI/ML Overview

The provided text is a 510(k) summary for the Alma Diode Tabletop Laser. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, the acceptance criteria and study data provided in this document pertain to the device's substantial equivalence to predicate devices based on technical characteristics and safety standards, NOT to the performance of an AI/ML algorithm or its clinical effectiveness.

Therefore, I cannot provide information on acceptance criteria for an AI/ML device, nor studies proving its performance, nor details about ground truth, expert adjudication, or MRMC studies for an AI/ML algorithm, as none of that information is present or relevant to this 510(k) submission.

The document discusses "Design Verification Testing" for the hardware component (pullback accessory) and software validation for the control software, but this is not equivalent to clinical performance studies for an AI/ML diagnostic or therapeutic algorithm.

Here's what can be extracted from the document regarding the device's (a laser system and its pullback accessory) "acceptance criteria" and "proof" of meeting them, within the context of substantial equivalence:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present "acceptance criteria" in the typical sense of quantitative performance metrics for a clinical task (like sensitivity/specificity for a diagnostic AI). Instead, it relies on demonstrating substantial equivalence to predicate devices by comparing technical characteristics and meeting safety standards.

The closest to "criteria" and "performance" described are:

Technical Characteristics Comparison (Table 1 - Salient Characteristics of the 1470nm module and the Predicate Devices): This table implicitly serves as the "acceptance criteria" by showing that the proposed device's characteristics (e.g., laser wavelength, max power, operation mode, fiber size, user interface) are comparable or identical to the predicate devices. The "reported device performance" is essentially the listed characteristic itself, demonstrating it falls within the range/type of the predicates.

Parameter (Implicit Acceptance Criteria)	New Device (Alma Diode Tabletop Laser - 1470nm)	Predicate Device (K13 Alma diode tabletop laser)	Predicate Device (K100558 Quanta Diode Laser Family)
Laser Wavelength [nm]	1470	1470	1470
Max power	15W	15W	15W
Light/Laser Source	Diode	Diode	Diode
Laser Delivery	Optical Fiber	Optical Fiber	Optical Fiber
Operation Mode	Continuous wave, single pulse, pulsed	Continuous wave, single pulse, pulsed	Continuous wave, single pulse, pulsed
Pulse Duration	10-990ms	3ms - 2.5s (Predicate used is K100558, not K13)	3ms - 2.5s
Bare fiber size	200, 300, 320, 400, 600, 800, 1000	200, 300, 320, 400, 600, 800, 1000	200, 300, 320, 400, 600, 800, 1000
User Interface	LCD touch screen	LCD touch screen	LCD touch screen
Aiming beam	635nm	650nm (Predicate used is K100558, not K13)	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	100-240, V AC 50-60 Hz, 6.3 A, single phase
Indications for Use	Matching predicate (listed)	Listed	Listed

Design Verification Testing (Section VIII):
- Criterion: Actual pullback speeds match requested speeds.
- Reported Performance: "Performing mechanical tests to verify the actual pull back speeds matched the requested speeds." (No specific numerical results provided, only an assertion of matching).
- Criterion: Software fully verified and validated according to IEC 62304 and FDA guidance.
- Reported Performance: "the software controlling the Alma 1470nm diode tabletop laser with the pull-back accessory was fully verified and validated in accordance with IEC 62304 and the FDA guidance document entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"." (Again, an assertion of compliance rather than explicit test results).
Electrical Safety and EMC Testing (Section VII):
- Criterion: Compliance with IEC 60601-1 and IEC 60601-1-2.
- Reported Performance: "Additional product electrical safety testing and EMC testing was successfully completed in accordance with the following standards: IEC 60601-1... IEC 60601-1-2..." (Assertion of successful completion).

2. Sample size used for the test set and the data provenance:

Not applicable for a clinical test set in the context of an AI/ML device. The "testing" mentioned is for hardware performance and software validation of the device's control system, not for an AI algorithm's performance on clinical data.
The document implies lab-based mechanical and electrical tests. There is no information on sample size of patients or data, nor data provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This pertains to clinical ground truth for diagnostic AI. The "ground truth" for this device's testing would be precise measurements of speed, electrical parameters, and successful software operation, established by engineers and test equipment, not clinical experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This pertains to expert review of clinical data, not mechanical or software validation.

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:

No, not done. This is a laser surgical instrument, not a diagnostic AI system intended to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable in the context of AI. The device itself is a standalone instrument. Its software controls its functions, but it's not a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the pullback accessory: The "ground truth" for pullback speed verification would be precise mechanical measurements from calibrated instruments.
For electrical safety and EMC: The "ground truth" would be standardized test procedures and measured electrical parameters against defined thresholds in the IEC standards.
For software: The "ground truth" for software validation would be software requirements specifications and its ability to consistently execute defined functions without errors.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As above, no AI/ML training set is involved.

In summary: The provided document is a 510(k) submission for a traditional medical device (a laser and its accessory). It focuses on demonstrating substantial equivalence to existing devices through comparison of technical specifications and adherence to engineering safety and performance standards, rather than proving the clinical performance or validation of an AI/ML algorithm. Therefore, many of the questions related to AI/ML device performance studies are not applicable to this document.

Summary

Regulation Number and Section

§ 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.