(276 days)
The IPL Treatment Device (Model: MDSQMC-01) is intended for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.
Mild to moderate inflammatory Acne (Acne vulgaris)
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.
The IPL Treatment Device is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 400nm-1200nm, Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin. IPL Systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores. Based on this, the IPL Treatment Device (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in permanent hair removal, and reduction of benign pigmented lesions and benign vascular lesions.
The provided FDA 510(k) clearance letter and summary for the IPL Treatment Device (Model: MDSQMC-01) primarily focus on demonstrating substantial equivalence to a predicate device through technical specifications, safety, and biocompatibility testing. It does not contain information about acceptance criteria and clinical study results that would typically prove a device meets those criteria for performance-based claims.
Specifically, the document states:
- "The following performance data were provided in support of the substantial equivalence determination."
- It then lists Biocompatibility Testing, Electrical Safety and EMC, Eye Safety, Software Verification and Validation, and Usability.
These are non-clinical performance data related to the device's safety and fundamental operation, not its clinical efficacy or diagnostic performance as would be demonstrated in studies with acceptance criteria for patient outcomes or diagnostic accuracy.
Therefore, many of the requested details about acceptance criteria and clinical study types (like MRMC studies, ground truth establishment, expert qualifications, sample sizes for test/training sets, effect sizes) are not present in the provided text.
Based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state performance-based acceptance criteria for its indicated uses (permanent hair removal, reduction of benign pigmented/vascular lesions, mild to moderate inflammatory Acne) nor does it provide clinical study results against such criteria. The "Performance Data" section details safety and engineering tests, not clinical performance outcomes.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document lists non-clinical testing (biocompatibility, electrical safety, etc.) but does not describe any clinical test sets, their sizes, or provenance.
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)
This information is not provided. As no clinical test set is detailed, there's no mention of experts or ground truth establishment relevant to clinical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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 information is not provided. The device is an IPL treatment device, not a diagnostic AI device that would typically participate in MRMC studies to evaluate human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The device is a physical IPL treatment device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided for clinical performance. The "ground truth" for the non-clinical tests would be the established standards (e.g., ISO, IEC norms) that the device successfully met.
8. The sample size for the training set
This information is not provided. As no clinical efficacy study is described, there is no mention of a training set.
9. How the ground truth for the training set was established
This information is not provided.
Summary of available "Performance Data" which are non-clinical:
| Acceptance Criteria (Standard Compliance) | Reported Device Performance (Passed/Compliant) |
|---|---|
| Biocompatibility Testing: | |
| ISO 10993-5 (Cytotoxicity) | No toxicity |
| ISO 10993-10 (Skin Sensitization) | No significant evidence of causing skin sensitization |
| ISO 10993-23 (Skin Irritation) | Applied sample did not induce irritation |
| Electrical Safety and EMC: | |
| IEC 60601-1-2 (EMC) | Compliant |
| IEC 60601-1 (Basic Safety & Essential Performance) | Compliant |
| IEC 60601-2-57 (Non-laser light source) | Compliant |
| Eye Safety: | |
| IEC 62471 (Photobiological safety) | Compliant |
| Software Verification and Validation: | |
| Basic Documentation risk level | All software requirement specifications met, hazards mitigated |
| Usability (FDA Guidance) | Evaluated and Verified |
The study that proves the device meets these acceptance criteria are the laboratory and engineering tests listed under "Performance Data," demonstrating compliance with the referenced international standards (ISO, IEC) for safety and software functionality, and adherence to FDA guidance for usability. These studies were performed by the manufacturer as part of their submission without specific mention of external labs or detailed methodologies beyond the standard references.
§ 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.