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The Venus Freeze is a non-invasive device intended for use in Dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.

The Venus Freeze is a noninvasive, non-ablative device consisting of:

• Main Unit (console)
• Touch Screen user interface
• RF Power module
• Controller unit
• Two treatment applicators:
  (1) Octipolar M applicator - for large treatment areas, composed of 8 RF electrodes
  (2) Diamondpolar™ applicator - for small treatment areas, composed of 4 RF electrodes.
  The Touch Screen user interface allows the selection of treatment parameters (time and power) by pressing on the treatment buttons and displays the current treatments settings.
  The Controller Unit provides the operational and safety function of the system.
  Treatment applicators transmit Bi-Polar RF energy in a method that creates an organized Bi-Polar RF energy matrix which produces homogeneous heating in the entire treatment area for maximum safety and efficacy, eliminating the need for pre/post cooling mechanisms.
  The RF power module provides RF energy to the selected applicator, producing a 1MHz signal.

The provided text states that for the Venus Freeze device, "Venus-Concept believes that animal and clinical studies are not required to determine the safety and efficacy of the device" due to previously published scientific research and clinical studies on similar radiofrequency devices. Therefore, a specific study proving the device meets acceptance criteria as typically outlined in an FDA submission with performance data, sample sizes, and ground truth establishment was not conducted for this 510(k) submission.

Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices and adherence to relevant performance standards for safety.

Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is explicitly stated as not required or not applicable:

Acceptance Criteria and Device Performance

Study Details (As per the provided document, studies were not conducted for this specific device's 510(k) submission to establish safety and efficacy directly.)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable. No new test set data from a clinical or animal study was generated for this 510(k) submission. The safety and efficacy relied on existing literature for similar devices.

2. 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. No new ground truth was established for a test set specific to the Venus Freeze device in this submission.

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

   • Not applicable. No new test set requiring adjudication was used.

4. 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 non-AI electrosurgical device for dermatologic procedures; therefore, an MRMC study related to readers and AI assistance is not relevant.

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

   • Not applicable. This is a hardware device, not an AI algorithm. Its performance is inherent in its operation and not separate from human-in-the-loop (operator) performance.

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

   • For the purpose of this 510(k) submission, the "ground truth" for safety and efficacy for the device type (radiofrequency devices for wrinkle treatment) was established through "comprehensive animal and clinical study performed in scientific research and published in the literature" of similar devices, rather than new evidence for the Venus Freeze itself.

7. The sample size for the training set:

   • Not applicable. No training set for an algorithm was used or mentioned. The device's design implicitly relies on established engineering principles and prior research of similar devices.

8. How the ground truth for the training set was established:

   • Not applicable. No training set was used.

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The Aluma Skin Renewal System is intended for use in Dermatologic and The Anama UKIN Keneral Systems of the non-invasive treatment of wrinkles and rhytids.

The Aluma Skin Renewal System is a non-invasive, non-ablative unit consisting of a user interface, a programmable logic controller (PLC), an RF power module, internal electronics, a vacuum pump, and a treatment handpiece with interchangeable tips (small and large). The interface allows the selection of treatment parameters by pressing on the treatment buttons; an LCD screen displays the current treatment settings. The PLC is a specially configured computer that provides the operational and safety function of the system. The RF power module provides RF energy to the handpiece, producing a sinusoidal signal at a 468 kHz frequency

The provided text is a 510(k) summary for the Aluma™ Skin Renewal System. It focuses on establishing substantial equivalence to predicate devices for regulatory clearance, primarily for the non-invasive treatment of wrinkles and rhytids.

Unfortunately, the provided document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Details about sample size, data provenance, or ground truth establishment for any test set.
• Information about expert involvement, adjudication methods, or MRMC studies.
• Discussion of standalone algorithm performance.
• Details on the training set or its ground truth establishment.

The document is a regulatory submission demonstrating substantial equivalence to predicate devices (Thermage, Inc ThermaCool™ TC System and Syneron Medical Ltd., Polaris™) based on similar indications for use and technological characteristics. It does not describe a performance study with specific acceptance criteria as you've outlined.

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The FRIALIT® PLUS Dental Implant System is indicated for use in single tooth restorations, edentulous spans restored with multiple single teeth, freestanding bridges and to retain overdentures. The implants can be used for immediate implant placement, delayed immediate or late implant placement.

The XiVE®S PLUS Dental Implant System is indicated for the following: Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations. In the edentulous mandible, a minimum of four XiVE® dental implants (≥9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.

The XiVE® D3.0 PLUS Dental Implant System is indicated for single tooth restorations and splinted tooth restorations in the region of 7 to 10 and 23 to 26.

The XiVE® TG PLUS Dental Implant System is indicated for single-stage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for maxillary and mandibular splinted crowns, bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two transgingival threaded implants. In the edentulous maxilla, a minimum of four transgingival implants are placed in a trapezoidal distribution and rigidly splinted together. In the edentulous mandible, a minimum of four transgingival implants (≥9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.

The FRIALIT®, XiVE® and XiVE® TG dental implants with the new FRIADENT Surface have been cleared for commercial distribution. The purpose of this application is to change the name of the surface to PLUS and obtain clearance for additional marketing claims associated with the PLUS surface.

This 510(k) summary describes a modification to an existing dental implant system, specifically changing the surface name to "PLUS" and seeking clearance for associated marketing claims. As such, the submission focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing de novo performance criteria against acceptance thresholds.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size for Test Set: Not explicitly stated as a number of implants or subjects. The studies were preclinical and animal studies.
• Data Provenance:
  • Country of Origin: Germany (University of Tubingen, University of Cologne) and Brazil (University of São Paulo).
  • Retrospective or Prospective: Not explicitly stated, but preclinical and animal studies are typically prospective in their design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable in the context of this 510(k) summary. The "ground truth" for these types of studies is derived from objective measurements (physiochemical analysis, biomechanical testing, histological evaluation in animal models) performed by researchers at the respective universities, not through expert consensus on interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert interpretations (e.g., medical imaging). The studies involved laboratory and animal experiments with quantifiable outcomes.

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 submission is for a dental implant system (hardware), not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" was established through:

• Physiochemical surface analyses: Laboratory measurements of surface properties.
• Histological and biomechanical analyses in animal models: Evaluation of osseointegration, bone-implant contact, and removal torque values in vivo. This is akin to "pathology" or objective biological outcomes in an animal setting.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device requiring a training set. The studies described are traditional preclinical and animal investigations.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, this is not an AI/ML device.

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