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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.

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.

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The Acme Medical Aesthetic Nd: YAG Laser is intended for dermatologic use. The 1064nm wavelength, long pulse duration, and large spot size of the Acme Medical Aesthetic Nd: YAG Laser allows for effective coagulation and hemostasis of vascular lesions. The laser system consists of a laser console and a delivery handpiece. The delivery handpiece is placed in contact with the target via a contact tip that is capable of cooling the epidermis. Clinical use of the device is indicated for clinical practitioners in plastic surgery and dermatology who have been technically trained on the use of the Acme Medical Aesthetic Nd: YAG Laser.
For coagulation and hemostasis of vascular lesions.

The Acme Medical Nd:YAG Aesthetic Laser is a long pulsed, solid-state infrared laser. It is intended to deliver laser energy for use in surgical applications requiring coagulation and hemostasis of vascular lesions. The Aesthetic Nd: YAG Laser produces a beam of infrared light at a wavelength of 1064nm. The system consists of:

• a laser console; .
• internal computer; .
• control and display panel; .
• permanently attached fiber optic delivery system; .
• handswitch with the option of a footswitch; and .
• fiber optic coupled handpiece and tip with cooling capability. .

The provided document is a 510(k) Summary Statement for the Acme Medical Nd:YAG Aesthetic Laser. It indicates that no performance data was submitted in conjunction with this Pre-market Notification submission. The determination of substantial equivalence was based solely on the comparison of technical and functional characteristics between the Acme Medical Aesthetic Nd:YAG Laser and predicate lasers. Therefore, the document explicitly states that performance data was not required.

This means that the document does not contain information about acceptance criteria or a study proving the device meets those criteria.

To specifically address the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document states, "No performance data was submitted in conjunction with this Premarket Notification submission."
2. Sample size used for the test set and the data provenance: No test set was used as no performance data was submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set was used and no performance data was submitted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set was used and no performance data was submitted.
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 device is a laser, not an AI-assisted diagnostic tool, and no performance studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a laser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance data was submitted.
8. The sample size for the training set: Not applicable, as no performance data or algorithm training was relevant for this type of device submission.
9. How the ground truth for the training set was established: Not applicable.

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