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The Shaser V-MINI RX Hair Removal System is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. It is also intended for removal of unwanted hair by using a selective photothermal treatment. The Shaser V-MINI RX Hair Removal System is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - VI. The Shaser V-MINI RX Hair Removal System is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Shaser V-MINI RX is an IPL device with a wavelength range of 400- 1200 nm. The proposed device removes hair by way of Selective Photothermolysis; the preferential thermal treatment of target tissue without collateral effect of surrounding tissue. The pulsed light heats the hair bulb which disables hair growth. The proposed device is intended for males and females to remove unwanted hair from body sites (legs, arms, chest, underarms, stomach, and bikini line) and from facial sites (chin, cheek, chin, neck, side burns, and above the lips). The V-MINI RX is a battery powered, portable device. Electrical requirement (battery charger) is 115 VAC, 15A, 50-60 Hz, single phase.

Here's an analysis of the provided text regarding the Shaser V-MINI RX device's acceptance criteria and supporting studies:

1. Table of acceptance criteria and reported device performance:

   The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or reported device performance metrics in a table format. The "Intended Use" section describes the device's purpose, including "permanent reduction in unwanted hair," defined as "long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen." However, there are no numerical thresholds (e.g., "at least 50% reduction") provided as acceptance criteria, nor are there any corresponding performance results from a study presented to demonstrate that these criteria were met.

   Instead, the submission relies on the concept of "substantial equivalence" to predicate devices (Shaser V-MINI, Radiancy SpaTouch, Radiance SkinStation) rather than presenting new performance data against specific, pre-defined acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   The document explicitly states: "Clinical Performance Data: None" and "Nonclinical Performance Data: None". This indicates that no new test set data was generated or analyzed for this submission. The basis for approval is solely substantial equivalence to predicate devices.

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):

   As no new clinical or nonclinical performance data was presented for the Shaser V-MINI RX, there were no experts involved in establishing ground truth for a test set within this specific 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   Since no new test set data was presented, no adjudication method was used.

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:

   No MRMC comparative effectiveness study was done. The device is a light-based hair removal instrument, not an AI diagnostic or assistance tool for human readers.

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

   Not applicable. The device is a physical light-based hair removal instrument, not an algorithm. Therefore, no standalone algorithm performance study was conducted.

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

   No new ground truth was established for the Shaser V-MINI RX as no new clinical or nonclinical studies were performed for this submission. The approval relies on the ground truth (safety and efficacy) established for the predicate devices.

8. The sample size for the training set:

   Not applicable. The device is not an AI algorithm that requires a training set.

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

   Not applicable, as there is no training set for this device.

Summary of the Acceptance Criteria and Study:

The 510(k) submission for the Shaser V-MINI RX does not present new acceptance criteria or new studies proving the device meets them. Instead, the basis for clearance is Substantial Equivalence to legally marketed predicate devices (Shaser V-MINI, Radiancy SpaTouch, Radiance SkinStation).

The argument made is that the Shaser V-MINI RX has the "same intended use, the same principle of operation and method of action, similar pulse energy range, and very similar wavelength range" as the predicates. The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None," indicating that no new studies were conducted to generate data for this specific device. The differences cited for the V-MINI RX (larger spot size, higher maximum energy level, wider wavelength range) are asserted not to raise "new issues of safety and efficacy."

Therefore, the "acceptance criteria" were met by demonstrating that the device is sufficiently similar to previously approved devices, implying it shares their established safety and efficacy profile, rather than by showing performance against specific, pre-defined metrics in a new study.

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