(90 days)
The ProLite Pulsed Light System is indicated the treatment of benign pigmented lesions and the removal of tattoos.
The ProLite Pulsed Light System delivers pulsed light at a wavelength of 550 nanometers. The device consists of three interconnected sections: The cabinet which houses the power supply, the cooling system and the microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide.
The provided text is a 510(k) summary for the ProLite Pulsed Light System, and it primarily focuses on establishing substantial equivalence to a predicate device rather than presenting detailed data from a specific study designed to meet pre-defined acceptance criteria for the new device.
Therefore, much of the requested information regarding acceptance criteria, specific study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in the provided document.
Here's what can be extracted based on the input:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or provide detailed performance data from a specific study. Instead, it makes a general statement of substantial equivalence to an existing predicate device.
2. Sample size used for the test set and the data provenance
The document does not provide information on a specific test set sample size or data provenance. Since it establishes substantial equivalence, it likely refers to the performance of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on experts used to establish ground truth.
4. Adjudication method for the test set
The document does not provide information on any adjudication method.
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
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a pulsed light system, not an AI-driven diagnostic tool, so such a study would likely not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe a standalone algorithm performance study. This device is a medical instrument used by practitioners.
7. The type of ground truth used
The document does not explicitly state the type of ground truth used as it doesn't describe a specific performance study. Given the intended use (treatment of benign pigmented lesions and tattoo removal), ground truth in relevant studies for such devices typically involves clinical assessment of treatment efficacy and safety, potentially supported by photographic evidence or patient reported outcomes.
8. The sample size for the training set
The document does not provide information on a training set sample size.
9. How the ground truth for the training set was established
The document does not provide information on how ground truth for a training set was established.
Summary of what is available from the document regarding "acceptance" and "proof":
The document's central claim is:
- Conclusion: "The ProLite Pulsed Light System is substantially equivalent to other existing pulsed light systems in commercial distribution for treatment of benign pigmented lesions and the removal of tattoos in Dermatology and Plastic Surgery."
The "proof" for this "acceptance" of substantial equivalence is based on:
- Predicate Device Comparison: The ProLite Pulsed Light System is compared to the Photoderm PL System (K60772).
- Device Description: Both devices deliver pulsed light. The ProLite system delivers pulsed light at a wavelength of 550 nanometers. The document implies that the operating principles and intended use are similar enough to the predicate device to establish equivalence, rather than presenting de novo performance data.
- Intended Use: "The ProLite Pulsed Light System is indicated the treatment of benign pigmented lesions and the removal of tattoos." This matches the general scope of use for similar pulsed light systems according to the 510(k) process for substantial equivalence.
In essence, the "acceptance criteria" here implicitly refer to the FDA's criteria for substantial equivalence, and the "study that proves the device meets the acceptance criteria" is the 510(k) submission process itself, where the manufacturer demonstrates that the new device is as safe and effective as a legally marketed predicate device. The document provided is the FDA's response confirming this substantial equivalence, not a detailed clinical study report comparing performance against specific metrics.
§ 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.