(10 days)
The InbellaMAX System with the BellaXL 810 Black is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime. The BellaXL 755/810 Black and the BellaXL 810/1064 Black are intended for hair removal.
The InbellaMAX System with the BellaVlaze Black is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.
The InbellaMAX System with the Bella515 and Bella580 Black Applicators are indicated for use for the following treatments:
- The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
- The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, superficial leg veins and venous malformations.
The InbellaMAX System with the BellaPlus and BellaForma Handpieces are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The InbellaMAX System with the BellaM8 BApplicators is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV.
The InbellaMAX system is a computerized, versatile system that generates Laser, IPL, and RF energies for the treatment of several clinical indications. The device utilizes different applicators to achieve its mode of operation in accordance with the selected technology and clinical indication. The device system operates when any of the applicators are connected and enables individual adjustment of treatment parameters. The water-cooling system provides cooling for laser and IPL applicators and thermoelectric coolers (TECs). The cooling system includes a radiator, water pump, fan, water reservoir, deionizer, water filter, tissue contact temperature sensor, and water flow sensor. The system is compatible with the following applicators:
- BellaForma
- BellaPlus
- BellaM8 BApplicator and BellaM8 BDeep Applicators
- Bella515 Black
- Bella580 Black
- BellaVlaze Black
- BellaXL 755/810 Black
- BellaXL 810/1064 Black
- BellaXL 810 Black
Based on the provided FDA 510(k) Clearance Letter for the InbellaMAX System, it's important to understand that this document primarily focuses on Substantial Equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and a test set.
The core essence of this 510(k) submission is that the InbellaMAX System is identical in all aspects to the predicate device (Optimas MAX System, K251632) except for the manufacturer and 510(k) holder. This means that the acceptance criteria and the proof of meeting those criteria would have been established and demonstrated for the predicate device, and the InbellaMAX System is simply asserting equivalence based on its identical design and function.
Therefore, the information typically found in a performance study with explicit acceptance criteria for a new, novel device is largely absent here because it's a "copy" of an already cleared device. The "study" proving it meets acceptance criteria is the demonstration that its design, technology, and intended use are identical to the predicate.
Given this, I will answer your questions as best as possible based on the provided text, highlighting where information is absent due to the nature of a substantial equivalence claim for an identical device.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence Logic)
Since the device is declared "identical in all aspects" to the predicate, the "acceptance criteria" for the InbellaMAX System are implicitly that it performs exactly like the predicate device, meeting all the performance standards the predicate device met. The "reported device performance" is, by definition, the performance of the predicate device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied from Predicate Equivalence) | Reported Device Performance (Implied from Predicate Equivalence) |
|---|---|
| Functional Performance: Functions as a computerized system generating Laser, IPL, and RF energies for intended dermatologic procedures. | Confirmed: The InbellaMAX system is a computerized, versatile system that generates Laser, IPL, and RF energies. It utilizes different applicators to achieve its mode of operation. |
| Applicator Compatibility: Compatible with specified applicators (BellaForma, BellaPlus, BellaM8 BApplicator, BellaM8 BDeep Applicators, Bella515 Black, Bella580 Black, BellaVlaze Black, BellaXL 755/810 Black, BellaXL 810/1064 Black, BellaXL 810 Black). | Confirmed: The system is compatible with the listed applicators (Page 6). |
| Cooling System Functionality: Water-cooling system provides cooling for laser/IPL applicators and TECs, including radiator, water pump, fan, water reservoir, deionizer, water filter, tissue contact temperature sensor, and water flow sensor. | Confirmed: The water-cooling system provides cooling for laser and IPL applicators and thermoelectric coolers (TECs). The cooling system includes all mentioned components (Page 6). |
| Adherence to Voluntary Recognized Standards: Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-2, IEC 60601-2-22, IEC 60601-2-57, IEC 60825. | Confirmed: The InbellaMAX System has been tested and complies with all listed voluntary recognized standards (Page 7). |
| Safety and Effectiveness: Functions as safely and effectively as the predicate device for all stated Indications for Use. | Implied by Substantial Equivalence: "identical in all aspects... The only difference is the manufacturer and 510(k) holder." (Page 5) and "Except for the difference in device name and applicator names, the indications for use of the subject device are identical to those of the predicate device. The technological characteristics of the subject device are identical to those of the predicate device." (Page 6). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable/Not provided. No separate clinical or non-clinical test set data specific to the InbellaMAX system is presented because the submission relies on substantial equivalence. The "test set" for the original predicate device (Optimas MAX System, K251632) would have been used to establish its safety and effectiveness, and the InbellaMAX System is declared identical.
- Data Provenance: Not applicable/Not provided. The document does not refer to any new test data for the InbellaMAX System.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. This information pertains to the rigorous evaluation of a new device's performance, typically involving clinical trials or extensive non-clinical testing. For a substantial equivalence claim based on identical design, such details are not required for the subject device. This would have been part of the predicate device's clearance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. As no new test set is described, no adjudication method is referenced. This would have pertained to the predicate device's evaluation.
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/Not provided. This type of study (MRMC, AI assistance) is not relevant to this device, which is a laser/IPL/RF system for dermatologic procedures, not an AI-assisted diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This term typically applies to AI algorithms. The InbellaMAX System is a hardware-based medical device. Its "performance" is its ability to generate laser/IPL/RF energy and function as intended, rather than producing an "output" like an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable/Not provided. No new "ground truth" was established for the InbellaMAX system, as it's a substantial equivalence claim based on an identical predicate device. The clinical effectiveness and safety of the predicate device would have been established through relevant data, which could have included clinical outcomes, expert observations, and other performance metrics depending on the specific indications.
8. The sample size for the training set
- Not applicable/Not provided. This term typically applies to machine learning models. The InbellaMAX System is a hardware device; it does not have a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As above, this concept refers to machine learning models, which is not applicable to the InbellaMAX System.
§ 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.