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The Beautiful Image Model 900 Facial Toning Device uses microcurrent electrical energy to stimulate facial tissues for aestheric purposes.
Biosonic Technologies Model 900 Facial Toning Device is intended for facial stimulation and is indicated for prescription cosmetic use. The anatomical site for application of the Model 900 is the face.

Beautiful Image Model 900 Facial Toning Device is intended for facial stimulation and is indicated for prescription cosmetic use. The anatomical site for application of the Model 900 is the face.
To enhance safety, the device is operated only from battery voltage and will not operate while connected to line power. A proper recharge should be performed prior to using the machine.
The Model 900 is microprocessor controlled and housed in a white plastic case.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Beautiful Image Model 900 Facial Toning Device:

The provided document describes a 510(k) premarket notification for a medical device. In this type of submission, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving efficacy through a de novo clinical study with specific acceptance criteria in the traditional sense. Therefore, the information you're asking for, particularly the detailed breakdown of acceptance criteria and a study proving the device meets those criteria in the way a clinical trial would, is largely not present in this type of regulatory document.

Instead, the submission focuses on comparing the subject device's technical specifications and safety features to a predicate device and conducting non-clinical tests to ensure safety and effectiveness.

Here's an attempt to answer your questions based on the provided text, highlighting what's available and what's not:

1. A table of acceptance criteria and the reported device performance

As mentioned, this is a 510(k) submission, not a de novo clinical trial report. Therefore, there isn't a table of explicit "acceptance criteria" for a primary efficacy endpoint and corresponding "reported device performance" in terms of clinical outcomes.

The comparison is made against the predicate device's specifications and safety profile to demonstrate substantial equivalence. The "acceptance criteria" here are implicitly that the subject device's characteristics do not raise new questions of safety or effectiveness compared to the predicate.

Here's a table summarizing the comparison of parameters between the subject device and the predicate, which serves as the basis for demonstrating substantial equivalence:

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. This is a non-clinical submission. The "test set" in this context refers to the device itself and its components undergoing engineering and electrical safety tests, not a set of subjects for clinical evaluation.
• Data Provenance: Not applicable for clinical data. The non-clinical test data would be generated in a lab setting by the manufacturer or contracted testing facilities (e.g., for IEC/ISO standards).

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)

• Number of Experts: Not applicable. This is not a study requiring expert-established ground truth for a test set in a clinical context.
• Qualifications of Experts: The testing would be conducted by engineers and technicians qualified in electrical safety, electromagnetic compatibility, and biocompatibility testing according to the relevant international standards (IEC, ISO).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable. This refers to consensus among human readers/experts, which is not relevant for the non-clinical testing performed.

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

• MRMC Study: No. This is not a clinical study, and the device is not an AI-driven diagnostic tool. It's a physical device for facial stimulation.
• Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. This is a physical device, not an algorithm. The device's performance is inherently "standalone" in its operation as a facial toning device, but not in the context of an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: For this 510(k) submission, the "ground truth" for the device's acceptable performance is its compliance with specific engineering and safety standards (IEC 60601-1, IEC 60601-1-2, ISO 10993, 21 CFR 898) and its electrical output specifications meeting predefined ranges that are deemed safe and effective based on the predicate device. In essence, the benchmark is regulatory compliance and substantial equivalence to a device already deemed safe and effective.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the machine learning sense.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable.

Summary of the study conducted (as described in the 510(k) submission):

The "study" in this context refers to non-clinical testing to demonstrate the safety and effectiveness of the Beautiful Image Model 900 Facial Toning Device and its substantial equivalence to the NūFace Facial Toning Device (predicate).

• Tests Performed:
  • Product Safety testing conforming to IEC 60601-1.
  • Electromagnetic compatibility (EMC) testing conforming to IEC 60601-1-2.
  • Biocompatibility testing conforming to ISO 10993.
  • Comparison of electrical and physical parameters against the predicate device.
• Purpose: To confirm that the Model 900 is safe, effective, and substantially equivalent to the predicate device, and that the differences between the two do not adversely affect safety and effectiveness.
• Conclusion: The tests confirmed that the Model 900 meets the safety standards and its performance characteristics (including electrical outputs and maximum current/power density, while having different physical attributes and added safety features) did not raise new issues of safety or effectiveness compared to the predicate. The differences were justified as either enhancing safety (e.g., microprocessor control, automatic trips, indicators) or being a result of user design inputs (e.g., larger size, desktop operation by licensed practitioners) without compromising safety or effectiveness. The increased current and power density were explained by a more precise surface contact area, remaining within safe limits.

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