Search Results

The AROMA GRAND is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

The subject device. AROMA GRAND is a surgical device, which is intended for hair removal, permanent hair reduction on all skin tvpes (Fitzpatrick skin type I-VI).

It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser hand-piece. The emission laser is activated by a footswitch.

The provided text describes information about a 510(k) submission for a medical device called "AROMA GRAND". However, it does not contain any information regarding acceptance criteria or a study that proves the device meets those acceptance criteria in the context of clinical performance or diagnostic accuracy.

The document focuses on demonstrating substantial equivalence to a predicate device (VIKINI DIODE LASER SYSTEM) through non-clinical testing, primarily related to electrical safety, EMC, particular performance testing (likely referring to laser output specifications), and software verification.

Here's a breakdown of why I cannot answer most of your questions based on the provided text:

• No clinical performance acceptance criteria: The document does not define specific clinical performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device; or hair reduction percentage, lesion clearance rate for a therapeutic device) or set acceptance criteria for them.
• No clinical study to prove acceptance criteria: Because no clinical performance acceptance criteria are mentioned, there is no corresponding study described to prove these criteria were met.
• "Not applicable" for Clinical Testing: The document explicitly states "Clinical Testing: Not applicable," which further confirms the absence of a clinical study testing the device's efficacy/performance in human subjects for its intended use.

Therefore, I can only address the questions where relevant information is found in the text, primarily focusing on the non-clinical testing.

Here's an analysis of what information is available:

1. A table of acceptance criteria and the reported device performance

   • Clinical Performance: Not applicable/Not provided. The document does not define specific clinical performance acceptance criteria for its indications (hair removal, permanent hair reduction, treatment of benign vascular and pigmented lesions) nor report clinical performance against such criteria.

   • Non-Clinical Performance (General Safety and Technical Standards): The document reports compliance with several international standards. These standards implicitly contain acceptance criteria for the respective tests.

     Acceptance Criteria (Implied by Standard Compliance)	Reported Device Performance
     Biocompatibility:
     - Cytotoxicity standards (ISO 10993-1)	Conducted and reported
     - Sensitization standards (ISO 10993-1)	Conducted and reported
     Electrical Safety:
     - AAMI/ANSI/ES 60601-1:2005(R) 2012 and A1:2012	Complies with standard
     Electromagnetic Compatibility (EMC):
     - EN 60601-1-2:2015	Complies with standard
     Laser Safety:
     - IEC 60825-1:2014	Complies with standard
     Particular Laser Performance:
     - IEC 60601-2-22:2012	Complies with standard
     Software Verification & Validation:
     - FDA Guidance for Software in Medical Devices	Conducted and provided
     Accuracy Testing (Energy Output & Spot Size):
     - Does not deviate from tolerance/fixed value	Tested and complies

2. Sample size used for the test set and the data provenance

   • For Non-Clinical Testing: The document does not specify sample sizes (e.g., number of devices tested) for the non-clinical tests.
   • For Clinical/Performance Testing: "Clinical Testing: Not applicable." Therefore, no test set, sample size, or data provenance for clinical performance is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

   • For Clinical/Performance Testing: "Clinical Testing: Not applicable." Thus, no experts were used to establish ground truth for a clinical test set.
   • For Non-Clinical Testing: Not specified. Standard compliance is typically verified by testing laboratories.

4. Adjudication method for the test set

   • For Clinical/Performance Testing: "Clinical Testing: Not applicable." No adjudication method described.

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 is not an AI-assisted device. The AROMA GRAND is a laser surgical instrument. Therefore, an MRMC comparative effectiveness study regarding "human readers improving with AI" is not relevant and was not performed/described. "Clinical Testing: Not applicable."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • This device is not an algorithm; it is a physical laser device. Standalone algorithm performance is not applicable. "Clinical Testing: Not applicable."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • For Non-Clinical Testing: The "ground truth" for the non-clinical tests is established by the requirements and specifications of the respective international standards (e.g., specific thresholds for electromagnetic emissions, safety limits for laser output, pass/fail criteria for biocompatibility).
   • For Clinical/Performance Testing: "Clinical Testing: Not applicable." No ground truth for clinical outcomes is discussed.

8. The sample size for the training set

   • For Non-Clinical Testing: Not applicable. Non-clinical tests do not typically involve "training sets" in the machine learning sense.
   • For Clinical/Performance Testing: "Clinical Testing: Not applicable."

9. How the ground truth for the training set was established

   • For Non-Clinical Testing: Not applicable.
   • For Clinical/Performance Testing: "Clinical Testing: Not applicable."

In summary, the provided FDA 510(k) letter and summary describe a device that is cleared based on substantial equivalence to a predicate device, supported by extensive non-clinical testing demonstrating compliance with safety and performance standards, but without any clinical performance studies on human subjects.

Ask a specific question about this device