(87 days)
The Philips BlueControl is intended to emit energy in the blue region of the spectrum, is generally indicated to treat dermatological conditions and specifically indicated to treat mild psoriasis vulgaris.
The Philips BlueControl is a rechargeable battery-operated, wearable device for delivery of blue light to treat mild psoriasis vulgaris. It is a prescription device designed for home use. The Philips BlueControl is sold as a kit, which contains the following items: Components: o BlueControl Device o Fixation Strap (Device Holder and Slings) o Power Supply (USB Cable, Adapter and Charger) Accessory: ● 0 Carrying Case Instructions for Use.
The Philips BlueControl device is intended to treat mild psoriasis vulgaris. The provided text outlines the performance data, including clinical studies, that support the substantial equivalence determination for this device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria for its clinical performance. Instead, it describes clinical studies and their outcomes as evidence of effectiveness. The primary endpoint for effectiveness was a statistically significant improvement in Local Psoriasis Area and Severity Index (LPASI) scores.
| Acceptance Criteria Category | Specific Metric (Inferred) | Acceptance Threshold (Inferred) | Reported Device Performance |
|---|---|---|---|
| Clinical Effectiveness | Change from Baseline (CfB) of the LPASI at week 12 | Statistically significant improvement in treated plaques compared to control plaques. | - The primary endpoint, change from baseline (CfB) of the LPASI at week 12, revealed a significant improvement of the treated compared to the control plaques (△CfB: -0.92 ± 1.10, p = 0.0005, t test; p = 0.0006, Wilcoxon signed-rank test; mean 95% CI –1.38, –0.45). |
- The mean change from baseline to week 12 was -2.38 (-3.02 to -1.73) in the treated plaque and -1.46 (-2.13 to -0.79) in the control plaque. |
| Safety | Incidence of serious adverse events (SAEs) related to treatment | No serious adverse events considered related to any of the studied treatment regimen. | - No serious adverse events were considered related to any of the studied treatment regimen. - All 16 adverse events observed during the study were evaluated. No serious adverse events were reported. None of the adverse events were device-related or treatment-related.
- Hyperpigmentation (tanning) was expected and reported, which reduced within a few days after treatment completion. No other device-related adverse effects were observed. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: N=23 enrolled subjects in the main clinical study, with each subject having treated and control plaques.
- Data Provenance: Prospective, clinical studies conducted in Europe per ISO 14155 (Clinical investigation of medical devices for human subjects -- Good clinical practice).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test set (i.e., evaluate LPASI scores). It mentions that "psoriasis severity was evaluated using the Local Psoriasis Area and Severity Index (LPASI), a modified version of the validated PASI." This typically implies trained clinicians or dermatologists, but specific details are not provided.
4. Adjudication Method for the Test Set:
The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for the LPASI evaluations in the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The study design involved comparing treated plaques to control plaques within the same subjects, rather than comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance:
Not applicable. The Philips BlueControl is a light therapy device, not an AI algorithm, so a standalone algorithm-only performance assessment is not relevant in this context.
7. Type of Ground Truth Used:
The ground truth for effectiveness was based on clinical assessment using the Local Psoriasis Area and Severity Index (LPASI), performed by presumably clinical investigators or dermatologists as part of the clinical studies. For safety, it was adverse event reporting and evaluation.
8. Sample Size for the Training Set:
Not applicable. The Philips BlueControl is a medical device, not an AI/machine learning algorithm, so there is no "training set" in the conventional sense for algorithm development. The device's performance is based on its physical properties and clinical evaluation in humans.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI algorithm. The device's design and parameters are based on scientific understanding of blue light therapy for psoriasis and established medical device development standards, rather than AI model training.
§ 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.