(183 days)
The US 500 Intense Pulsed Light Equipment is indicated for use in surgical and aesthetic applications in permanent hair removal. Permanent hair removal 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.
The USS00 Intense Pulsed Light Equipment is a device that emits intense pulsed light in order to achieve hair reduction. The light source is a Xenon lamp that emits light which is filtered to include suitable wavelengths for hair reduction. The device is electrically powered, and main components include the console which includes electrical components and a touchscreen user interface, the IPL handpiece and cable, and a footswitch. The light pulses are emitted from the handpiece which is water cooled. The device is for prescription use only.
The provided text does not include acceptance criteria for standalone device performance, nor details of a study that proves the device meets such criteria. In fact, point 7 of the document explicitly states: "A clinical study was not considered to be needed for this 510(k)." This indicates that no clinical performance study was conducted to demonstrate the device's effectiveness through a direct comparison against predefined acceptance criteria for clinical outcomes.
The document focuses on non-clinical testing and a substantial equivalence comparison to a predicate device (K161286) based on technical characteristics and indications for use.
Therefore, the requested information cannot be extracted from the provided text.
Here's an explanation of why each requested point cannot be answered:
- A table of acceptance criteria and the reported device performance: Not provided. The document lists non-clinical tests (electrical safety, EMC, photobiological safety, biocompatibility) but does not state performance metrics or acceptance criteria for hair reduction effectiveness.
- Sample size used for the test set and the data provenance: Not applicable, as no clinical study was performed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study was performed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical study was performed.
- 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 an Intense Pulsed Light (IPL) equipment, not an AI-powered diagnostic tool, and no clinical effectiveness study was conducted.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No standalone clinical performance study was done to assess its effectiveness in hair reduction against specific clinical metrics.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical study was performed.
- The sample size for the training set: Not applicable, as no clinical study (and therefore no training set for a clinical algorithm) was performed.
- How the ground truth for the training set was established: Not applicable, as no clinical study (and therefore no training set for a clinical algorithm) was performed.
The document focuses on demonstrating substantial equivalence to an existing legally marketed device (K161286), primarily through:
- Non-clinical safety testing (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 62471, ISO 10993-5, ISO 10993-10).
- Comparison of technical specifications and indications for use.
The rationale for not needing a clinical study is implied by the concept of substantial equivalence, where the new device is sufficiently similar to a predicate device that has already demonstrated safety and effectiveness for similar indications.
§ 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.