(402 days)
Tricoglam Home Use is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa - V and for both, Fitzpatrick Classification of Skin Phototypes of I - IV.
Tricoglam Home Use is a white and grey plastic helmet and inside is housed an electronic board with all the electrical components and a series of LED diodes on a wavelength, protected by a transparent plastic. The energy is distributed homogeneously. This Helmet is composed by 105 red LEDs arranged uniformly inside the helmet with a wavelength of 650 nm +/- 10 nm. The program consists of the lighting of all the red diodes for a duration of 20 min in continuous (every day). To start the treatment the user should press the button on the back and activate the program. All LEDs light up and, after the pre-set 20 minutes, all LEDs turn off.
The provided text is a 510(k) summary for the Tricoglam Home Use device, which is an infrared lamp for promoting hair growth. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information cannot be extracted directly from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly present a table of acceptance criteria for clinical performance and corresponding reported device performance for the Tricoglam Home Use. Instead, it relies on demonstrating substantial equivalence to predicate devices which have already proven their safety and effectiveness.
The comparison table on page 5-6 primarily focuses on technical and operational characteristics between the new device and predicate devices, to show similarity for substantial equivalence. It does not list specific clinical acceptance criteria or performance metrics related to hair growth.
The closest to "acceptance criteria" for this device, based on the document, would be its intended use and indications, as well as compliance with safety standards.
| Criteria Type | Criteria (Implicitly from Indications for Use and Safety Standards) | Reported Device Performance (from "Substantial Equivalence" and "Performance Data" sections) |
|---|---|---|
| Clinical Performance | Promote hair growth in defined populations: |
- Females with androgenetic alopecia (Ludwig-Savin Classifications I - II)
- Males with androgenetic alopecia (Norwood Hamilton Classifications IIa - V)
- Both with Fitzpatrick Classification of Skin Phototypes I - IV.
- Minimum duration of use: 16 weeks to achieve desired effect (inferred from predicate comparison) | No clinical trial data for the Tricoglam Home Use was submitted for this 510(k).
The safety and effectiveness for its intended use are demonstrated via substantial equivalence to legally marketed predicate devices, which have similar indications and characteristics. The document states: "In addition all clinical data and all performance tests that have been performed in accordance with the Standards for the Software Evaluation and for the Electrical and Electromagnetic Safety test, in addition to the requirements for the laser products demonstrate that Tricoglam Home Use devices have safety and effectiveness for its intended use."
Similarity to Predicate Devices: - Wearable Mounting: Helmet (same as most predicates).
- Wavelength: 105 Red LEDs, 650 nm +/- 10nm (similar to predicates 620-660 nm or 650 nm).
- Fluence: 1.2 J / cm² (similar to predicate 1 J/cm²).
- Power output: 525 mW (similar range to predicates 400mW - 1.360mW).
- Treatment Time: 20 minutes in continuous every day (similar to predicates, e.g., "Every other day 20-35 mins", "Every day 10 mins").
- Minimum duration of use: 16 weeks (same as some predicates, similar to 17 weeks for others). |
| Safety | Electrical Safety: Compliance with IEC 60601-1.
Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2.
General Safety Standards: Compliance with IEC 60601-1-11, IEC 60601-2-57, and IEC 62471 (for optical radiation safety, by inference from context).
Biocompatibility: Materials (e.g., helmet plastic) compliant with ISO 10993-5 and ISO 10993-10.
Human Factors: Evaluation following IEC 62366-1. | Non-clinical performance testing performed: - Evaluation to IEC 60601-1-2 (electrical safety and electromagnetic compatibility).
- Conformance with IEC 60601-1-11, IEC 60601-2-57, and IEC 62471.
- Material of the helmet are biocompatible according to ISO 10993-5 and ISO 10993-10.
- Human factors evaluation of Tricoglam Home Use was considered following IEC 62366-1.
- "Verification and validation data show that the device meets all product specifications."
- "Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical trial data for the Tricoglam Home Use was submitted for this 510(k)." Therefore, there is no "test set" in the context of a clinical performance study for this specific device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical trial data or associated "test set" was submitted for the Tricoglam Home Use device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical trial data or associated "test set" was submitted for the Tricoglam Home Use device.
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 device is an infrared lamp for hair growth, not an AI-assisted diagnostic tool involving "human readers."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an infrared lamp, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as "No clinical trial data for the Tricoglam Home Use was submitted for this 510(k)." The clearance is based on substantial equivalence to predicate devices that presumably demonstrated their efficacy through clinical data or known mechanisms of action.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/machine learning algorithm requiring a "training set."
Conclusion from document:
The FDA clearance (K193008) for the Tricoglam Home Use device is based on demonstrating substantial equivalence to several legally marketed predicate devices (Capillus 82, DermaScalp Laser Caps, Revian Red, Illumiflow Laser Cap), rather than new clinical trial data for the Tricoglam Home Use itself. The manufacturer submitted non-clinical performance data to confirm the device's electrical safety, electromagnetic compatibility, biocompatibility, and human factors compliance.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.