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The Spectra Hair Removal Laser System is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.

The Spectra Hair Removal System consists of the Spectra Laser and Spectra Skin Sensor. The Spectra Hair Removal Laser is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm. The Spectra Skin Sensor determines whether users can safely use the Spectra Hair Removal Laser.

The provided text is a 510(k) summary for the Spectra Hair Removal Laser System, which focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than presenting a detailed study with acceptance criteria and performance data in the format requested.

Therefore, many of the requested sections (e.g., specific acceptance criteria, sample sizes for test and training sets, expert qualifications, ground truth establishment methods, MRMC studies) are not available in the provided document.

However, I can extract what is mentioned about performance and the associated study:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The study was conducted in a "simulated home-use environment," suggesting a prospective clinical study.

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

• Not specified. The document does not describe the establishment of a "ground truth" using experts for the purpose of evaluating the device's accuracy in a diagnostic or classification task. The study focused on safety and efficacy for hair removal.

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

• Not specified.

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 study was done. This device is a hair removal laser, not a diagnostic imaging device typically evaluated with MRMC studies comparing human readers with and without AI assistance. The focus is on the device's direct effect on hair, not an interpretation task.

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

• Yes, in the sense that the device itself is the primary intervention. The performance data relates to the device's direct application in a simulated home-use environment. It's a therapeutic/cosmetic device, not an AI algorithm.

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

• For hair removal efficacy, the "ground truth" would implicitly be the reduction in hair growth or hair density observed over time. This would typically be assessed through methods like hair counts, photographic assessment, or patient satisfaction, which fall under outcomes data. However, the specific methodology for establishing this "truth" is not detailed.

8. The sample size for the training set:

• Not applicable. This device is not an AI algorithm that undergoes a training phase with a specific dataset. The "training" for such a device would involve engineering and design iterations, potentially supported by internal testing.

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

• Not applicable. See point 8.

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The Spectra Hair Removal Laser is intended for temporary hair removal.

The Spectra Hair Removal Laser is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm.

The provided text states, "Performance Data: None. The specifications and indications for use of the Spectra Hair Removal Laser are substantially equivalent to those claimed in the clearance for the above-listed predicate devices. Thus performance data were not required."

Therefore, based on the input:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission states "None" for performance data because it claims substantial equivalence to predicate devices.
2. Sample size used for the test set and the data provenance: Not applicable. No performance study was conducted for this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No performance study was conducted.
4. Adjudication method for the test set: Not applicable. No performance study was conducted.
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 is a laser device, not an AI diagnostic tool, and no performance study was conducted.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This is a laser device, not an algorithm.
7. The type of ground truth used: Not applicable. No performance study was conducted.
8. The sample size for the training set: Not applicable. No performance study was conducted.
9. How the ground truth for the training set was established: Not applicable. No performance study was conducted.

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