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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

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.

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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

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.

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The Inbella RF System is indicated for use in dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed.

The Inbella RF System is a computerized system generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation/contraction of soft tissue and hemostasis. The Inbella RF System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating. The Inbella RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF handpiece is connected to the console via a cable and a foot switch activates the energy delivery to the handpieces are available, all comprised of a disposable, single use plastic handle with active internal electrodes. A subset of handpieces have both internal (active) and external (return) electrodes.

This device, the Inbella RF System, is an electrosurgical cutting and coagulation device. The provided text, a 510(k) summary, explicitly states that no clinical performance data, non-clinical (bench) performance data, or animal performance data were submitted to support this submission.

The basis for this 510(k) clearance is that the Inbella RF System is identical in all aspects to the predicate device, the InMode RF System (K240780), with the only difference being the manufacturer and 510(k) holder. Therefore, the acceptance criteria and the study proving the device meets those criteria would refer to the predicate device (InMode RF System, K240780), not the Inbella RF System itself.

Since the provided document is for the Inbella RF System and explicitly states no new performance data was submitted, I cannot extract the detailed information requested regarding the acceptance criteria and study data for this specific device.

To provide the requested information, you would need to access the 510(k) summary for the predicate device, InMode RF System (K240780). Without that information, I cannot complete the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details for the Inbella RF System.

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