(84 days)
The LaseAway Long Pulse and Q-Switched Ruby Laser System is intended to remove blue/black tattoos and benign dermal and epidermal piqmented lesions, and, to effect hair removal of patients with skin types 1:4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.
Using a wavelength of 694 nm., the LaseAway Long Pulse and Q-Switched Ruby Laser System consists of a Long Pulse and Q-Switched ruby laser together with an articulated delivery arm and focusing optics. The laser parameters are managed by an analog control unit which is coupled to the main system and calibration is facilitated by an energy detector in the front panel. The pulse operation is initiated by a footswitch and a visible helium neon laser to provide guidance for accurate beam delivery.
The provided text is a 510(k) summary for the Polytec PI, Inc. LaseAway Long Pulse and Q-Switched Ruby Laser System. It focuses on demonstrating substantial equivalence to predicate devices for the treatment of tattoos, pigmented lesions, and hair removal.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., a specific percentage of tattoo clearance or hair reduction). Instead, it relies on demonstrating equivalence to predicate devices and the safety and effectiveness shown in a clinical study.
The primary "reported device performance" for clinical claims is the conclusion of substantial equivalence to predicate devices based on a clinical study for hirsutism. For non-clinical tests, the performance indicates compliance with safety standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Clinical - Hirsutism Treatment: Substantial equivalence to legally marketed devices in safety and effectiveness for hair removal. | A clinical study was conducted, and the data was summarized to demonstrate the equivalence of the LaseAway system to legally marketed devices. The IRB considered the protocol a non-significant risk device. |
| Clinical - Tattoo/Pigmented Lesions: Substantial equivalence to predicate devices for removal of blue/black tattoos and benign dermal/epidermal pigmented lesions. | Demonstrated substantial equivalence in intended use, method of operations, material, and design (as compared to predicate devices for these indications) and supported by clinical data (though specific details are not provided for these indications explicitly beyond the hirsutism study). |
| Non-Clinical - Electrical Safety: Compliance with IEC-601-1. | Testing conducted per IEC-601-1 (electrical isolation). No violations found. |
| Non-Clinical - EMC Testing: Compliance with IEC 601-1-2. | Testing conducted per IEC 601-1-2 (EMC testing). No violations found. |
| Non-Clinical - General Safety/Effectiveness: Compliance with FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions" DCRND (Electrical, Mechanical and Environmental Performance Requirements). | Testing demonstrated no design characteristics that violated requirements or resulted in safety hazards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The sample size for the clinical study is not provided in the document.
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: The study was conducted with "written consent from patients" and under an IRB protocol, indicating it was a prospective clinical study.
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)
The document does not provide details on the number or qualifications of experts used to establish the ground truth for the clinical study. It only mentions that the data was analyzed to demonstrate equivalence. For laser aesthetic devices, ground truth often involves photographic documentation and physician assessment of treatment outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method used for the clinical study data.
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
This device (a laser system) is not an AI-powered diagnostic or assistive technology for human "readers," so an MRMC comparative effectiveness study would not be applicable in this context. The study performed was a clinical trial to assess the safety and effectiveness of the laser itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a medical laser system, not an algorithm. Its performance inherently involves human operation and direct interaction with the patient.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the clinical study related to hirsutism, the ground truth would typically be outcomes data, assessed through methods such as:
- Physical examination by a clinician (e.g., hair count, visual assessment of reduction).
- Patient self-assessment.
- Standardized photography.
The document does not explicitly detail the specific metrics used for "outcomes data."
8. The sample size for the training set
This question is not applicable. This device is a physical laser system, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above; there is no "training set" for a physical medical device like this laser system.
§ 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.