(19 days)
The InBellaBody System with BellaTform Applicator employs RF technology and EMS-TENS technology for the treatment of selected medical conditions.
The BellaTform Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The BellaTform Applicator in EMS mode is intended for:
- Relaxation of muscle spasms
- · Prevention or retardation of disuse atrophy
- · Increasing local blood circulation
- · Muscle re-education
- · Maintaining or increasing range of motion
- · Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
The BellaTform Applicator in TENS mode is intended for:
- · Symptomatic relief and management of chronic, intractable pain
- · Post-surgical acute pain
- · Post-trauma acute pain
Additionally the BellaTform Applicator in sequential RF/EMS mode is intended for:
- · Non-invasive lipolysis (breakdown of fat) of the abdomen.
- · Reduction in circumference of the abdomen
The InBellaBody System with BellaTform Applicator is deliver non-thermal RF energy and electro-muscle and transcutaneous nerve stimulation for the treatment of different body areas for various medical applications. The InBellaBody System software controls and regulate the different applied energies in accordance with the user system preprograming and treatment settings.
The InBellaBody System System includes the following components:
- LCD display touch screen,
- Audio loudspeaker,
- 48V AC/DC power supply,
- . Real time controller, distributor card and 2 RF generators,
- Fans
The System operates while connected to the BellaTform Applicator.
This document is a 510(k) premarket notification decision letter from the FDA. It states that the InbellaBody System with BellaTform Applicator is substantially equivalent to a previously cleared predicate device (Evolve System with Transform Applicator, K231495) and can therefore be marketed.
Crucially, the document explicitly states "Clinical Performance Data: Not Applicable" and "Non-Clinical (Bench) Performance Data: Not Applicable" and "Animal Performance Data / Histology Data: Not Applicable."
Therefore, based solely on the provided text, there is no study described that proves the device meets specific acceptance criteria.
The claim of substantial equivalence is based on the device being identical to a predicate device, with the only difference being the manufacturer and 510(k) holder. This means that the acceptance criteria and performance data for the InbellaBody System would be those established for the predicate device, Evolve System with Transform Applicator (K231495). However, the details of those studies are not present in this document.
Here's a breakdown of the requested information based on the provided text, highlighting where data is unavailable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Predicate Device) | Reported Device Performance (InbellaBody System) |
|---|---|
| Not specified in this document for the predicate. | Substantially Equivalent to Predicate Device |
| (Likely involved meeting safety and effectiveness standards for RF, EMS, and TENS technologies for the stated indications) | "The indications for use and technological characteristics of InBellaBody System with BellaTform Applicator manufactured by Inbella Medical are the same as those of the Evolve System with Transform Applicator manufactured by InMode Ltd. (K231495). The only difference is the manufacturer and 510(k) holder." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The document states "Clinical Performance Data: Not Applicable" for the InbellaBody System. Any clinical data would have been for the predicate device, which is not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No clinical or non-clinical performance data for the InbellaBody System is provided, nor for its substantial equivalence comparison, beyond the devices being identical in design and function.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical or non-clinical performance data for the InbellaBody System is provided.
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 electrosurgical cutting and coagulation device, 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 electrosurgical cutting and coagulation device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No performance studies (clinical or non-clinical) for the InbellaBody System are described in this document. Substantial equivalence is based on technical and intended use identity with a predicate.
8. The sample size for the training set
- Not Applicable. The device is not an AI/machine learning product that would have a "training set."
9. How the ground truth for the training set was established
- Not Applicable. The device is not an AI/machine learning product.
Summary of what the document does state regarding acceptance and study:
The acceptance of the InbellaBody System for marketing is based on its substantial equivalence to a previously cleared predicate device, the Evolve System with Transform Applicator (K231495). The study for this determination was essentially a comparison of the design, technological characteristics, and intended uses of the InbellaBody System against the predicate device. Since the InbellaBody System was found to be identical to the predicate device in all aspects except the manufacturer, no new clinical or non-clinical performance data was required or submitted for this specific 510(k) submission. The regulatory body (FDA) therefore accepted that the InbellaBody System meets the same safety and effectiveness standards that were established for the predicate device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.