(285 days)
The Medical Aesthetic Nd.YAG Laser is intended for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialties of general and plastic surgery and dermatology for: . the removal of unwanted hair in Fitzpatrick skin types I-V.
ALTUS Medical Aesthetic Nd: YAG Laser Kits are comprised of the following main components: . a laser system console (including software and control electronics); . a control and display panel; . a permanently attached fiberoptic-coupled handpiece; . a skin cooling device integrated into the handpiece; . a finger-operated exposure switch (handswitch) integrated into the handpiece . (footswitch option available) . a remote interlock connector (disables laser when treatment room door is opened).
Here's an analysis of the provided text regarding the acceptance criteria and study for the ALTUS Medical Aesthetic Nd:YAG Laser.
Based on the provided document, the acceptance criteria and the study conducted are described in a very high-level manner, primarily focusing on demonstrating substantial equivalence to predicate devices for regulatory approval.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or device performance metrics in a clear, tabulated format typically seen for rigorous clinical studies. Instead, it relies on the concept of "safety and effectiveness" demonstrated through clinical data for hair removal.
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied) | Reported Device Performance (as implied) |
|---|---|---|
| Safety | Safe for indicated use in Fitzpatrick skin types I-V. | Demonstrated to be safe through clinical data. |
| Effectiveness | Effective for removal of unwanted hair in Fitzpatrick skin types I-V. | Demonstrated to be effective through clinical data. |
| Principle of Operation | Operates under principles of selective photothermolysis (for 1064 nm wavelength). | Performance data provided to demonstrate operation under selective photothermolysis. |
| Substantial Equivalence | Shares similar indications for use, design features, and functional features as predicate devices. | Found to be substantially equivalent to predicate devices for hair removal/reduction. |
It's important to note that these are implied criteria and performance statements based on the regulatory summary. The document lacks specific quantitative thresholds for safety (e.g., adverse event rates) or effectiveness (e.g., percentage of hair reduction over a specific period).
2. Sample Size Used for the Test Set and Data Provenance
The document states: "clinical data was provided to demonstrate that the Acme Medical Aesthetic Nd:YAG Laser is safe and effective when indicated for the removal of unwanted hair in Fitzpatrick skin types I-V in the medical specialties of general and plastic surgery and dermatology."
- Sample Size for Test Set: Not specified. The document does not provide any numerical details regarding the number of subjects or treatments included in the clinical data.
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not specified. The wording "clinical data was provided" suggests a study was conducted, which could be prospective, but no details are given to confirm this.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not specified. The document does not mention the involvement of experts in establishing ground truth for the clinical data. For hair removal studies, ground truth is typically assessed by clinical observation and possibly standardized photography, but the process and personnel involved are not detailed here.
4. Adjudication Method for the Test Set
Not specified. Given the lack of information on experts and ground truth establishment, no adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device is a laser system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A (Not Applicable). The device is a physical laser system for treatment, not an algorithm. Therefore, a "standalone algorithm performance" study is not relevant in this context.
7. The Type of Ground Truth Used
Based on the indication "removal of unwanted hair," the ground truth would inherently be clinical assessment of hair reduction/removal. This would likely involve:
- Visual inspection.
- Possibly standardized photography with hair counts in treated areas versus control areas.
However, the specific methods for establishing this ground truth are not detailed in the provided text.
8. The Sample Size for the Training Set
Not applicable/Not specified. This device is a laser system, not an AI/machine learning model that undergoes a "training phase" with a training dataset in the same way. The performance data and clinical data described are for validating the device's efficacy and safety rather than training an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not specified. As there is no described training set for an AI/ML algorithm, the method for establishing its ground truth is not relevant here.
Summary of missing information:
The provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to predicate devices for market clearance. As such, it provides very high-level information about the clinical data. It lacks specific details commonly found in a detailed clinical study report, such as:
- Exact number of subjects and treatments.
- Specific endpoints and quantitative measures of effectiveness (e.g., percentage of hair reduction).
- Follow-up periods.
- Details on adverse event reporting and rates.
- Methodology for clinical assessment or "ground truth" establishment.
- Expert involvement or adjudication processes.
§ 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.