(89 days)
The Hair Boom 69 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopeda who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classifications of Skin Phototypes I - IV.
The Hair Boom 69 diode laser is configured within an outer helmet and protective inner liner. The use of diode lasers provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern.
The provided document is a 510(k) premarket notification for a medical device called "Hair Boom 69". It aims to demonstrate substantial equivalence to a previously cleared predicate device, also named "Hair Boom 69" (K182562), for Over-the-Counter (OTC) use.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
Key Takeaway: The submission argues for substantial equivalence primarily based on the identity of the device itself (the new Hair Boom 69 is physically identical to the previously cleared prescription-use Hair Boom 69) and specific testing for OTC use, rather than a clinical performance study demonstrating efficacy.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in the sense of predefined performance metrics (like sensitivity, specificity, or improvement in a clinical outcome) for this specific submission. Instead, the "acceptance criteria" for this 510(k) revolve around establishing substantial equivalence, particularly for an Over-the-Counter (OTC) indication.
The performance data presented is focused on demonstrating safety and usability for OTC use, given the device's technical identity with its predicate.
| Criterion Type | Specific Criterion (Implied) | Reported Device Performance |
|---|---|---|
| Technical Equivalence | Identity in optical, electronic, and mechanical function to predicate device. | "The Hair Boom 69 is an identical device in optical, electronic and mechanical function as well as recommended clinical treatment regime, to the predicate device, the Hair Boom 69." (Page 4) |
| Safety and Effectiveness | As safe and effective as the predicate device. | "It is as safe and effective as the predicate device. Both systems, which use red light diode lasers which are classified as class IIIa/3R laser systems by the IEC standard for allowable emission levels, which is a recognized standard by the FDA as well, and the adverse event profile is the same." (Page 5) |
| Note: No new clinical efficacy data for hair growth was collected for this submission; the efficacy is reliant on the predicate's prior clearance. | ||
| OTC Usability/Safety | Users can self-select appropriately, use the device safely, and understand hazards/precautions. | "Over-the-Counter Testing was performed for this proposed submission. 30 female and male subjects were tested for Self-Selection, Usability and Hazards & Precautions. The results of these tests are contained in Section 10, Substantial Equivalence. The results demonstrate that 86.66% of subjects satisfactorily passed the testing." (Page 4) |
| Compliance to Standards | Adherence to relevant international and national standards. | The device was tested to standards including IEC 60825-1 (Laser Safety), IEC 60601-1 (Basic Safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (Home Use), IEC 62304 (Software), ISO 14971 (Risk Management), and ISO 10993-1/-10 (Biocompatibility). (Page 4) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: 30 female and male subjects were used for Over-the-Counter (OTC) Testing.
- Data Provenance: The document does not specify the country of origin for the OTC testing data. It is a prospective test, as it was "performed for this proposed submission."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information (number and qualifications of experts for ground truth) is typically relevant for studies assessing diagnostic accuracy, especially for image-based AI. For this submission, the "ground truth" for the OTC testing was established by observing and evaluating the subjects' performance in tasks related to "Self-Selection, Usability and Hazards & Precautions." No expert readers of medical images were involved.
4. Adjudication Method for the Test Set
The document does not describe an "adjudication method" in the context of expert review for medical decision-making. For the OTC testing, the results likely involved pass/fail criteria assessed by the researchers or observers conducting the usability study, rather than expert adjudication of conflicting interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical performance data was produced for this submission because the Hair Boom 69 is an identical device in optical, electronic and mechanical function as well as recommended clinical treatment regime, to the predicate device, the Hair Boom 69." (Page 4).
This means there was no study comparing human readers' (e.g., clinicians') performance with and without AI assistance, as "Hair Boom 69" is a physical device (an infrared lamp) and not an AI algorithm assisting human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. "Hair Boom 69" is a physical device, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.
7. The Type of Ground Truth Used
For the OTC testing, the "ground truth" was established based on the performance and understanding of the subjects themselves in relation to the device's instructions for use, self-selection criteria, and safety precautions. It's direct observation and evaluation of user interaction, not clinical outcomes or expert consensus on a medical diagnosis.
For the efficacy claim (hair growth), the ground truth is implicitly tied to the previous clinical data submitted for the predicate device (K182562) for its prescription use. This current submission leverages the substantial equivalence argument to inherit the efficacy claim from the predicate.
8. The Sample Size for the Training Set
The document does not mention a "training set" for an algorithm. There is no AI component described in this device submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm.
§ 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.