(106 days)
The Umeco OPTIMA 694 system is intended for the use in the removal of blue/black tattoos and benign pigmented lesions in dermatology and plastic surgery.
The Umeco OPTIMA 694 system is based on an optical cavity containing a Ruby laser rod. which is activated by means of the use of flashlamps. After the cavity, a red helium neon aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an articulated arm delivery system to a focusing handpiece. The laser is used in non-contact mode. The System is capable of emitting up to 2.2 Joules of light at 694 nm, with a nomimal pulsewidth of 20 nanoseconds. The laser is intended to be used for intended for the removal of blue/black tattoos and benign pigmented lesions in dermatology and plastic surgery. The Ruby laser system is designed with 3 major sub-systems: a) An articulated arm delivery system terminated in a focusing handpiece. b) An electronic power supply and interface circuitry. c} An optical chamber containing laser rod and laser cavity optics.
This 510(k) summary for the Umeco OPTIMA 694 Ruby Laser System does not contain specific acceptance criteria or an analytical study proving the device meets said criteria in the way typically found for diagnostic algorithms or AI-driven systems.
The document is a submission for a medical device (a laser system), not a diagnostic software or an AI algorithm. Therefore, the information provided focuses on demonstrating substantial equivalence to already marketed predicate devices, rather than meeting specific performance metrics against a defined ground truth through an algorithmic study.
As such, many of the requested fields cannot be directly answered from the provided text. However, I can extract information relevant to the device's characteristics and the regulatory process.
Here's an attempt to address your request based on the provided text, with clear indications where information is not available or not applicable to this type of device submission:
Acceptance Criteria and Study for Umeco OPTIMA 694 Ruby Laser System
The provided 510(k) summary for the Umeco OPTIMA 694 Ruby Laser System focuses on demonstrating substantial equivalence to predicate devices already on the market (Derma-Lase DLR-1 and Spectrum RD 1200 Ruby laser systems). This type of submission does not typically involve the setting of specific, quantitative "acceptance criteria" for diagnostic performance or a "study that proves the device meets the acceptance criteria" in the way one would for an AI algorithm or a diagnostic test. Instead, the "acceptance" is based on demonstrating the new device is as safe and effective as existing legally marketed devices.
The "performance" of the device, in this context, refers to its technical specifications and intended use, aligning with the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criterion (Based on Predicate Equivalence) | Umeco OPTIMA 694 Reported Performance |
|---|---|
| Intended Use | Removal of blue/black tattoos and benign pigmented lesions in dermatology and plastic surgery. |
| Wavelength | 694 nm |
| Pulsed Operation | Yes |
| Nominal Pulsewidth | 20 nanoseconds (nominal) |
| Maximum Energy Output | Up to 2.2 Joules |
| Spotsize Range (Diameter) | 4 - 8 mm |
| Delivery System | Articulated arm delivery system |
| Aiming Beam | Class I (red helium neon) |
| Thermal Control | Internal closed loop water-air heat exchanger circuit |
Note on "Acceptance Criteria": The acceptance criteria for a 510(k) submission are generally met if the device demonstrates it is substantially equivalent to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness data. The table above reflects the shared technical characteristics that support this equivalence, rather than specific performance metrics (e.g., sensitivity/specificity) against a diagnostic ground truth.
2. Sample Size for Test Set and Data Provenance
- Sample Size: Not applicable. This document does not describe a clinical trial or test set for evaluating diagnostic performance. The substantial equivalence argument relies on comparing technical specifications and intended uses with existing devices.
- Data Provenance: Not applicable. No specific data (e.g., images, patient records) are described as being used in a test set.
3. Number of Experts and Qualifications for Ground Truth of Test Set
- Number of Experts: Not applicable. No ground truth establishment by experts for a test set is described.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable. No test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done?: No. This type of study is typically performed for diagnostic devices or AI algorithms that assist human readers. The Umeco OPTIMA 694 is a therapeutic laser system.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Done?: No. The Umeco OPTIMA 694 is a physical laser system, not an algorithm. Its performance is evaluated through its physical characteristics and safety, not through standalone algorithmic testing.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the context of diagnostic "ground truth." For a therapeutic device like this laser, "ground truth" might loosely refer to the expected physiological response or the efficacy of tattoo/lesion removal, but this document does not detail studies establishing such "ground truth" for comparative effectiveness in a quantitative manner. The premise is that Ruby lasers at 694nm with similar pulse parameters are effective for the stated indications.
8. Sample Size for Training Set
- Sample Size: Not applicable. This is not an AI algorithm requiring a training set.
9. How Ground Truth for Training Set was Established
- Ground Truth Establishment: Not applicable. No training set is involved.
§ 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.