(75 days)
The Multi-modality workstation (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.
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 Multi-modality workstation is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 520mm. 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 Multi-modality workstation (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.
This document is a 510(k) Premarket Notification summary for the "Multi-modality workstation, Model: AAD Dual Light." It demonstrates Substantial Equivalence (SE) to a predicate device, rather than providing a study that meets specific acceptance criteria for a new clinical claim.
Therefore, many of the requested details regarding acceptance criteria and performance studies in the context of clinical claims (e.g., sample size, expert ground truth, MRMC studies) are not applicable (N/A) to this type of submission. This 510(k) primarily relies on non-clinical testing and comparative analysis to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The concept of "acceptance criteria" in this 510(k) is framed around demonstrating substantial equivalence to a predicate device, specifically by meeting certain non-clinical performance and safety standards, and having comparable technological characteristics and intended use. There isn't a table of specific clinical performance acceptance criteria and reported clinical device performance because no clinical study was performed.
Instead, the document presents a comparison table with the predicate device (Table 9-2 Performance Comparison and Table 9-3 Setting Comparison of Specified Indication for Use), where "acceptance" means the proposed device's characteristics are either the same or have differences that are argued to have no negative effect on effectiveness and safety, supported by non-clinical bench tests.
Here's a summary of the comparative performance aspects:
| Aspect | Acceptance Criteria (Demonstrated by Substantial Equivalence Basis) | Reported Device Performance (vs. Predicate) |
|---|---|---|
| Product Code | ONF | ONF (SAME) |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 (SAME) |
| Class | II | II (SAME) |
| Intended Use | Consistent with predicate: Permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions. | SAME as predicate. |
| Light Source | Intense Pulsed Light | Intense pulsed light (SAME) |
| Wavelength | Range closed to predicate, slight differences not negatively affecting safety/efficacy, supported by bench tests. | Different ranges for general (520-650; 800~1200; 540-800; 640-1200 vs. 480-1200; 590-1200; 640-1200) and specific indications, but considered "very closed" and differences analyzed to have no negative effect. |
| Delivery System | Sapphire | Sapphire (SAME) |
| Energy Density | Within range of predicate, slight differences not negatively affecting safety/efficacy, supported by bench tests. | 1-50 J/cm2 (SAME as predicate for general, but specific indication ranges varied slightly, e.g., 5-40 for hair removal vs. 10-44 for predicate. "Analysis 2" states differences do not result in negative safety/efficacy). |
| Pulse Width | Within range of predicate, slight differences not negatively affecting safety/efficacy, supported by bench tests. | 1-25 ms (SAME as predicate for general, but specific indication ranges varied slightly, e.g., 1-25 for hair removal vs. 3-14 for predicate. "Analysis 3" states differences do not result in negative safety/efficacy). |
| Max. Power | Conforms to IEC 60601-1 and IEC 60601-1-2 regarding device safety and electromagnetic compatibility despite differences with predicate. | 3500VA (vs. 2200W for predicate). "Analysis 5" justifies higher power by conformance to safety standards. |
| Spot Size | Differences not considered to produce a negative effect on safety, supported by bench tests. | Small: 40x12mm, Large: 46x16mm, Ex-Large: 60x20mm (vs. 12x30mm for predicate). "Analysis 4" states differences in spot sizes are not considered to produce a negative effect on safety. |
| Electrical Safety | Compliance with IEC 60601-1 | Tested to comply with IEC 60601-1 (SE) |
| EMC | Compliance with IEC 60601-1-2 | Tested to comply with IEC 60601-1-2 (SE) |
| Biocompatibility | No toxicity (ISO 10993-5), No irritation (ISO 10993-10), No sensitization (ISO 10993-10) | |
| Cytotoxicity: No toxicity (SE) | ||
| Irritation: Applied sample did not induce irritation to skin (SE) | ||
| Sensitization: Test article showed no significant evidence of causing skin sensitization in guinea pig (SE) | ||
| Power Supply | Conforms to IEC 60601-1 and IEC 60601-1-2 regarding device safety and electromagnetic compatibility despite differences with predicate. | 110V, 60Hz or 230V, 50Hz (vs. 110V 50Hz for predicate). "Analysis 6" justifies differences by conformance to safety standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: N/A. No clinical test set data was used because no clinical study was included in the submission. The "test set" was comprised of the physical device itself undergoing non-clinical bench testing.
- Data Provenance: N/A. The data for this submission primarily comes from the manufacturer's internal non-clinical bench testing and adherence to international electrical and biocompatibility standards.
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)
- Number of Experts: N/A. Since no clinical study was performed, there was no need for experts to establish ground truth for clinical cases.
- Qualifications of Experts: N/A.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: N/A. No clinical study, thus no adjudication of clinical outcomes. The "adjudication" for non-clinical tests would be the pass/fail criteria of the specified international standards (e.g., IEC, ISO).
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
- MRMC Study: N/A. No clinical study. The device is a light-based system for aesthetic and surgical applications, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: N/A. This device is an intense pulsed light system, not an algorithm. Its performance is inherent in its physical parameters and how it operates, validated by non-clinical bench tests. It requires human operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: For non-clinical testing, the "ground truth" refers to the established requirements and specifications of the referenced international standards (e.g., IEC, ISO). For example, for biocompatibility, "no toxicity" or "no irritation" based on ISO 10993 series are the established ground truths/acceptance criteria for the material. For electrical safety, compliance with IEC 60601-1 is the ground truth. There is no clinical ground truth relevant to this 510(k).
8. The sample size for the training set
- Training Set Sample Size: N/A. No clinical training data was used because this is a physical device submission demonstrating substantial equivalence through non-clinical means, not a machine learning/AI device.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: N/A. See point 8.
§ 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.