(28 days)
The SCAR 3 scanner, when used with DEKA CO2 lasers, is indicated for ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery.
The SCAR 3 scanner, when used with DEKA CO2 lasers, is indicated for use in the performance of specific applications in dermatology and plastic surgery as follows:
-The ablation, vaporization, excision, and coagulation of soft tissue in the performance of laser burn debridement
-Laser skin resurfacing (ablation and/or vaporization) for treatment of:
· Wrinkles, rhytids, and furrows (including fine lines and texture irregularities)
-Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- Acne scars
- · Surgical scars
The SCAR 3 scanning unit is an optional scanner that can be connected to DEKA CO2 lasers.
The SCAR 3 is composed of the following components:
-
HiScan SCAR 3 head
-
HiScan SCAR 3 cable
Laser emission parameters are selected through the GUI of the DEKA laser device to whom the scanner is connected.
Shape and size of the scanning area may also be selected by using the three keys on the scanning head.
The modification to the device consists in the extension of the DEKA CO2 laser whom the SCAR 3 scanner can be connected to. The predicate device SCAR 3 (K211362) has been cleared to be used specifically in conjunction with DEKA Smartxide family; the proposed SCAR 3 scanner can be connected to all DEKA CO2 lasers.
The indications for use of the modified device remain the same. Modification only extends the range of CO2 laser the scanner can be used with.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SCAR 3 device:
Based on the provided text, the device in question (SCAR 3 scanner) is not an AI/ML powered device, but rather a laser scanning unit. The document describes a 510(k) submission for a modification to an existing device (SCAR 3, K211362), primarily extending its compatibility with a broader range of DEKA CO2 lasers.
Therefore, many of the typical questions related to AI/ML device studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and safety performance tests for the medical device itself, not an AI algorithm's diagnostic or predictive performance.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Electrical Safety | AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 – Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)] | The text states: "Electrical safety tests according to AAMI/ANSI ES60601-1:2005/ (R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 – Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]" This implies the device passed these tests, meeting the safety requirements. |
| EMC (Electromagnetic Compatibility) | IEC 60601-1-2 Ed. 4.1:2020 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | The text states: "EMC Tests according to IEC 60601-1-2 Ed. 4.1:2020 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests" This implies the device passed these tests, meeting EMC requirements. |
| Laser Safety | IEC 60601-2-22 Edition 3.1 2012-10 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment | The text states: "Laser safety tests according to IEC 60601-2-22 Edition 3.1 2012-10 Medical electrical ● equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment" This implies the device passed these tests, meeting laser safety requirements. |
| Laser Emission Specification Validation | Not explicitly stated (implied to be against internal device specifications) | The text states: "Laser emission specification validation tests" This indicates that the device's laser output parameters were confirmed to meet its design specifications. |
| Functional Equivalence | "The modification on SCAR 3 does not adversely affect safety and effectiveness of the scanner unit; proposed SCAR 3 and cleared SCAR 3 (K211362) share the same indications for use, principle of operation, specifications and performances." | The conclusion states: "Based on the comparison of indications for use and the technological characteristics, we can conclude that SCAR 3 scanner is as safe, as effective, and performs as well as the legally marketed predicate device (K211362)." This is the ultimate "performance" metric for a 510(k) - demonstrating substantial equivalence. |
2. Sample size used for the test set and the data provenance: Not applicable. These are engineering and safety tests performed on the device itself, not on a dataset of patient data for an algorithm.
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 device is not an AI/ML diagnostic or prognostic tool requiring expert-labeled ground truth from medical images or patient records.
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 a laser hardware device, not an AI assistance tool.
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 to an AI context. The "ground truth" for this device's performance is adherence to established international and national safety standards (e.g., IEC 60601 series) and its own design specifications (e.g., laser emission validation).
8. The sample size for the training set: Not applicable (no AI/ML algorithm involved).
9. How the ground truth for the training set was established: Not applicable (no AI/ML algorithm involved).
In Summary:
The provided document describes a Special 510(k) submission for a modification to an existing medical laser scanning unit (SCAR 3). The "study" proving it meets acceptance criteria consists of a series of engineering and safety verification tests demonstrating compliance with relevant international standards and ensuring the modification (expanded compatibility with DEKA CO2 lasers) does not negatively impact the device's safety or effectiveness compared to its predicate. It is not an AI/ML device, and thus the questions related to AI algorithm validation studies are not relevant here.
§ 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.