(61 days)
The BIOPHOTAS Celluma CONTOUR is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.
The BIOPHOTAS Celluma CONTOUR is intended to deliver heat in the near infra-red spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis, and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
The BioPhotas Celluma CONTOUR is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full-face wrinkles.
The BioPhotas Celluma CONTOUR is a Light emitting diode (LED) system that applies 640nm light for the purpose of reducing the circumference of the hips, waist, and thighs for aesthetic benefit, 640nm and 880nm light for the purpose of temporarily elevating skin temperature and 640nm and 880nm light for the purpose of treating full face wrinkles.
The BioPhotas Celluma CONTOUR comprises of a flexible, shape-taking frame upon which is mounted an array of LEDs, this allows the device to be contoured to the treatment area. The LEDs are embedded within a biocompatible foam covering that holds a transparent polycarbonate cover recessed within it. The biocompatibility nature of allows the device to be placed in contact with the skin.
The flexible LED panel is permanently connected by a three-foot long cable attached to a control panel that contains the circuitry and software that controls the device. The control panel contains several push buttons beneath a sealed cover. A power button that switches the device ON/OFF, a mode button that allows the user to select from 3 preprogrammed treatment modes "Contour" "wrinkles" and "Aches and Pains", and a Start button that activates the desired treatment mode. The control panel receives its power from a separate cable that connects via an AC adaptor for 110-220 Volts to a standard U.S. electrical power outlet. The control panel contains an automatic shut-off safety feature.
The provided FDA 510(k) summary for the Biophotas Celluma CONTOUR (K232977) does not contain comprehensive details on acceptance criteria and specific study results in a format that would typically be described for a diagnostic AI device. This document is a premarket notification for a Class II medical device (Low Level Laser System For Aesthetic Use), and the information presented focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance metrics through large-scale clinical trials with defined acceptance criteria and statistical proofs.
However, based on the information provided, I can extract and infer some points regarding performance testing and acceptance, particularly concerning safety and usability for an Over-The-Counter (OTC) device.
Here's a breakdown of the available information structured to address your questions, with the understanding that this device is not an AI diagnostic tool and thus many of your questions related to AI-specific metrics (e.g., MRMC, standalone algorithm performance, training set ground truth) are not applicable or explicitly stated for this type of device submission.
Description of Acceptance Criteria and Studies
1. Table of Acceptance Criteria and Reported Device Performance
For this device, "acceptance criteria" are mainly focused on demonstrating compliance with safety standards, usability for OTC use, and equivalence of technological characteristics to predicates. Performance is assessed through compliance with these standards and comparison to predicates.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance (as demonstrated) |
|---|---|---|
| Electrical Safety | IEC 60601-1: ed 3.1 | Successfully passed testing. |
| EMC Testing | IEC 60601-1-2: ed 4 | Successfully passed testing. |
| Software Validation | IEC 62304:2015 | Successfully passed testing; Software safety classification: Class A; FDA level of concern: Minor. |
| Usability/Label Comprehension | IEC 62366:2015 (Medical devices Application of usability engineering to medical devices) | No new use errors, hazardous situations, or hazard-related use scenarios were discovered. Improvement of the user interface design related to safety deemed unnecessary. Device is successfully used by laypersons (inferred from equivalence with OTC predicate and label comprehension study). |
| Biocompatibility | (Not explicitly stated, but implies compliance with relevant standards) | Hardware is identical to previously cleared versions (K122237, K131113, K152280, K171323, K211038) in terms of material, manufacturing, tissue contact type, and duration. No change in biocompatibility. |
| Technological Equivalence | Equivalent properties to predicates (e.g., energy type, wavelengths, intensity, treatment protocol, control, electrical power) | Proposed device is within the bandwidth of predicate wavelengths, has equivalent output intensities, identical treatment times, and equivalent electrical power to predicates. |
2. Sample Size Used for the Test Set and Data Provenance
-
Usability/Label Comprehension Study:
- Sample Size: 24 test subjects.
- Data Provenance: Not explicitly stated, but typically these studies are conducted prospectively with recruited participants in a controlled environment. The country is not specified.
-
For other non-clinical performance tests (electrical safety, EMC, software validation, biocompatibility), these are typically engineering tests performed on the device itself or its components (e.g., materials for biocompatibility) rather than human subjects. Thus, the concept of "sample size" for a test set (like for a diagnostic device) doesn't directly apply in the same way.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is largely not applicable as this device is not an AI diagnostic tool that requires expert ground truth for performance evaluation in the context of disease detection or measurement.
For the usability study, "ground truth" refers to whether lay users can correctly understand and operate the device safely based on labeling. This is assessed through questions and observation, not expert consensus on medical images or patient outcomes. The experts involved would be human factors engineers or usability specialists who design and analyze the study. The document does not specify the number or qualifications of such experts.
4. Adjudication Method for the Test Set
This question is not applicable for the type of studies described in this submission (safety, EMC, software validation, usability). Adjudication implies resolving disagreements among experts for ground truth establishment, which is relevant for diagnostic performance studies.
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 a light-emitting diode (LED) system for aesthetic and pain relief uses. It does not involve AI for diagnostic interpretation or human reader assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This device does not feature a standalone diagnostic algorithm. The software mentioned is for controlling the device's operational modes and safety features, not for standalone diagnostic performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For safety and performance characteristics (electrical, EMC, software): The "ground truth" is adherence to established international and national engineering standards (IEC 60601-1, IEC 60601-1-2, IEC 62304). Third-party testing labs or in-house engineering teams confirm compliance.
- For usability/label comprehension: The "ground truth" is the correct understanding and safe operation of the device by lay users, as measured by their responses to questions and observed interactions, compared against the intended use and safety protocols.
- For biocompatibility: The "ground truth" is the material's previously established biocompatibility or demonstration of compliance with relevant biocompatibility standards (e.g., ISO 10993 series), confirmed by testing (which was not repeated here due to material identity to cleared devices).
8. The Sample Size for the Training Set
Not Applicable. This device is not an AI/ML system that utilizes a training set for model development in the context of diagnostic performance. The software is noted as a Class A medical device software (lowest risk) and its validation focuses on life cycle processes and functional correctness, not machine learning training.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no "training set" in the context of an AI/ML algorithm for this device, this question does not apply.
§ 878.5400 Low level laser system for aesthetic use
(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.