(133 days)
308nm Excimer Phototherapy Device is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
Ultraviolet phototherapy originated in the 1920s. Due to the development of science and technology, the technology of artificial light source has developed rapidly. UVB therapy, as a representative, has become one of the effective methods to treat various skin diseases in developed countries such as Europe and America.
The provided text is a 510(k) summary for the Xuzhou Kernel Medical Equipment Co., Ltd.'s 308nm Excimer Phototherapy Device. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific performance acceptance criteria for a novel AI or diagnostic algorithm.
Therefore, many of the requested data points (sample size of test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for test and training sets, training set size, how training ground truth was established) are not available in this document because they are typically associated with performance evaluations of AI/diagnostic software devices, which this phototherapy device is not.
The document discusses non-clinical tests to establish the device's safety and performance equivalence to a predicate device.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" in the format of specific sensitivity, specificity, or similar performance metrics for a diagnostic device. Instead, it demonstrates equivalence through adherence to international standards and direct comparison of technical specifications with a legally marketed predicate device.
The "acceptance criteria" here are implied by compliance with the listed standards and demonstrating that the device's technical specifications and intended use are "substantially equivalent" to the predicate device.
| Aspect of Performance/Criteria | Predicate Device (K200971) | Proposed Device Performance | Comparison/Rationale for Equivalence |
|---|---|---|---|
| Indications for Use | Treatment of psoriasis and vitiligo on intact skin. | Treatment of psoriasis and vitiligo on intact skin. | Same |
| Product Code | FTC | FTC | Same |
| Wavelength | 308 nm ±2nm | 308 nm ±2nm | Same |
| Irradiation mode | Handheld irradiation | Handheld irradiation | Same |
| Cooling of light source | Air cooling | Air cooling | Same |
| Treatment Time | 0~120s | 0~120s | Same |
| Maximum dose | 5 J/cm² (5000mJ/cm²) | 5000mJ/cm² | Same |
| MED Dose Determination | Manual MED test | Manual MED test (KN-5000H not applicable) | Same |
| Display | 8 inches touch LCD screen | Touch LCD screen | Same |
| Operating Environment | Temperature: 5 | Temperature: 5 | Same |
| Transportation/Storage Environment | Temperature: -40 ~ 55 °C, Humidity: ≤90%, Pressure: 500 ~ 1060hpa | Temperature: -40 ~ 55 °C, Humidity: ≤90%, Pressure: 500 ~ 1060hpa | Same |
| Sterile | N/A | N/A | Same |
| Single Use | No | No | Same |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
| Biocompatibility | Cytotoxicity (ISO10993-5:2009), Irritation (ISO 10993-10:2010), Sensitization (ISO10993-10:2010) | Cytotoxicity (ISO10993-5:2009), Irritation (ISO 10993-23:2021), Sensitization (ISO10993-10:2021) | Similar standards cited for Irritation and Sensitization, but deemed "Same" in conclusion for SE. |
| Electrical Safety/Performance | Comply with IEC60601-1 and IEC60601-2-57 | Comply with IEC60601-1, 60601-1-11, IEC 60601-2-83 | Similar, passed safety testing. |
| Security Type | Class I, Type B | Class II, Type BF | Similar, complies with IEC 60601-1. |
| Patient Leakage Current | Complied with IEC 60601-1 and IEC 60601-2-57 | Complied with IEC 60601-1, IEC 60601-1-11, IEC 60601-2-83 | Similar, passed safety testing. |
| Treatment Area | 20cm²±10% | Varies by model (e.g., CN-308E: 30cm²±10%; KN-4003B3, KN-4003B4: 8cm²±10%) | Similar, passed safety testing; differences do not affect safety/effectiveness. |
| Max. UV Irradiation Intensity | 50 mW/cm² | 10-70 mW/cm² | Similar, does not affect safety/effectiveness. |
| Power supply | AC100-240V, 50/60Hz, various Input Power | AC 100-240V 50/60Hz, various Input Power | Similar, complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-83. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a phototherapy device, not a diagnostic or AI software device evaluated with a patient test set. The document refers to "non-clinical tests" and "equipment performance testing."
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)
Not applicable. No ground truth was established by experts for a test set in the context of this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's performance involved adherence to technical standards and verifying physical properties (e.g., wavelength, UV intensity, temperature) and safety against established international benchmarks.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 878.4630 Ultraviolet lamp for dermatologic disorders.
(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.