(90 days)
The Narrowband UV Phototherapy Light Lamp is intended for use, by or under the direction of a physician for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). It is intended for use on all skin types (I-VI). It can be used in hospitals, clinics and households.
The proposed device, Narrowband UV Phototherapy Light Lamp is a portable medical device that consists of LED lamp, irradiator, control circuit. It is a therapeutic product under the direction of a physician for individuals who require ultraviolet radiation for diagnosed skin disorders. It is for the partial treatment excluding eyes. Irradiation time can be adjusted from 0~299s and the treatment status can be controlled by the button on the device. The light comb equipped on the device is intended for easier treatment of target skin covered by hair, such as the scalp. The device is available in two models: model HB-UPLL-01and model HB-UPLL-02.
The device can be used in hospitals, clinics and households.
Here's an analysis of the provided text regarding acceptance criteria and device performance:
Based on the provided text, the device is a "Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)". The submission is a 510(k) premarket notification, which means the manufacturer is asserting substantial equivalence to existing legally marketed devices, rather than seeking approval for a novel device.
In the context of 510(k) submissions, "acceptance criteria" for performance are typically demonstrated through non-clinical tests (e.g., adherence to recognized standards like IEC 60601-1) and comparisons to predicate devices, rather than through a traditional clinical study with defined performance metrics like sensitivity, specificity, or reader improvement. The goal is to show the new device performs as well as or similarly to the predicate, and does not raise new questions of safety or effectiveness.
Therefore, the information you're asking for, particularly concerning AI/imaging device-specific criteria (sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, training sets, etc.), is not applicable to this specific device submission (a UV phototherapy lamp). This device is hardware that emits UV light for therapeutic purposes, not an AI or imaging diagnostic device.
The study proving the device meets the acceptance criteria is fundamentally a non-clinical engineering and comparison study against established standards and predicate devices.
Here's a breakdown of the information that is available in the provided text, and where the requested information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, the "acceptance criteria" are primarily adherence to safety, performance, and biocompatibility standards, and demonstrating comparable technological characteristics to predicate devices.
| Acceptance Criteria (from Non-Clinical Tests & Comparison) | Reported Device Performance (as stated in the submission) |
|---|---|
| Safety and Performance Standards Compliance: | |
| IEC 60601-1: General requirements for basic safety and essential performance (Electrical safety) | Complies with IEC60601-1 and IEC 60601-2-57 (Reported) |
| IEC 60601-1-2: Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 (Reported) |
| IEC 60601-1-11: Home healthcare environment requirements | Complies with IEC 60601-1-11 (Reported) |
| IEC 60601-2-57: Non-laser light source equipment (specific safety) | Complies with IEC60601-1 and IEC 60601-2-57 (Reported) |
| IEC 62471: Photobiological safety | Complies (Inferred from non-clinical test conclusion, though not explicitly stated "complies with IEC 62471" in the same way as others, it's listed under non-clinical tests performed.) |
| Biocompatibility: | |
| ISO 10993-5: In vitro cytotoxicity | Complies with the requirements (Reported, and implicitly by successful testing) |
| ISO 10993-10: Skin sensitization | Complies with the requirements (Reported, and implicitly by successful testing) |
| ISO 10993-23: Irritation | Complies with the requirements (Reported, and implicitly by successful testing) |
| Functional Equivalence to Predicate Devices: | |
| Product Code | FTC (Same as predicate) |
| Regulation No. | 21 CFR 878.4630 (Same as predicate) |
| Classification | Class II (Same as predicate) |
| Intended Use/Indications for Use | Same: treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I-VI), for use in hospitals, clinics, and households (Same as predicate). |
| Prescriptive use | Yes (Same as predicate) |
| Mode of operation | Handheld (Same as predicate) |
| Shell material | ABS (Same as predicate) |
| Treatment Area | Partial treatment excluding eyes (Same as predicate) |
| Test Frequency | 3~5 times per week (Same as predicate) |
| Working distance | HB-UPLL-01: 3cm; HB-UPLL-02: 2cm (Same as predicate's 3cm reference, note provided) |
| UV spectral output | UVB (Same as reference, predicate allows UVA or UVB) |
| Lamp configuration | 1 or 2 UV tube (Same as predicate) |
| Power Source | DC inlet (Similar to predicate's AC outlet or DC jack) |
| IPX - Rating / water resistance | IP22 (Same as predicate) |
| Application Environment | Hospitals, Clinics and Households (Same as predicate) |
| Sterile | Non-sterile (Same as predicate) |
| Single Use | No (Same as predicate) |
| Differences Acknowledged and Justified: | |
| Treatment Time | Proposed: 0 |
| Treatment Area | Proposed: HB-UPLL-01: 30 cm², HB-UPLL-02: 7 cm²; Predicate: 60cm²/100cm²/104cm²; Reference: 12.8 x 9.0 cm. Justification for differences: Not explicitly provided for this point, but generally implies that functionality remains similar despite size variations. |
| Irradiation Intensity | Proposed: HB-UPLL-01: UVB: 2.0 MW/cm², HB-UPLL-02: UVB: 1.2 MW/cm²; Predicate: UVA: 1 |
| Wavelength range | Proposed: UVB: 280 |
Specific Requested Information (and why it's mostly N/A):
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- N/A: No clinical test set data is provided or required for this type of submission. The "tests" are non-clinical engineering and bench validation against standards. The provenance for these would typically be the manufacturer's lab in China.
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)
- N/A: Not applicable as there is no test set in the clinical/diagnostic sense and no ground truth requiring expert adjudication. Acceptance is based on meeting technical specifications and safety standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- N/A: Not applicable. There is no test set for clinical performance that would require adjudication.
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
- N/A: This is a therapeutic device (UV lamp), not a diagnostic AI device. MRMC studies are completely irrelevant to its function or approval process.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A: Not applicable. This is a hardware device; there is no algorithm or standalone performance in the sense of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A: Not applicable. The "ground truth" for this device's performance is adherence to established technical standards (e.g., wavelength output, intensity, safety checks) and demonstrating that its characteristics are substantially equivalent to legally marketed predicate devices.
8. The sample size for the training set
- N/A: Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- N/A: Not applicable. There is no training set.
In summary: The provided document is a 510(k) summary for a physical medical device (UV lamp). Its "acceptance criteria" revolve around demonstrating safety, adherence to international technical standards, and substantial equivalence to existing predicate devices based on non-clinical (bench) testing and comparative analysis of its specifications. The detailed clinical trial and AI/algorithm-specific metrics you've asked about are specific to a different class and type of medical device (e.g., diagnostic software or imaging AI) and are not presented or required for the approval of this UV phototherapy lamp.
§ 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.