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Facial & Body Beauty Device is a hand-held device for over-the-counter aesthetic purposes.
The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation.

Facial & Body Beauty Device is portable, non-sterile and reusable device, which is designed to achieve the aesthetic effect. The device mainly consists of a main unit and charging cable, and it is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the provided charging cable, but the device can not be used when charging. To use the device, user should place the electrode head on the face and body. The device will automatically shut down after treatment time is over.

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The Facial Toning device is intended to stimulate the face. The device is intended for cosmetic use.

The Facial Toning devices, which come in two models (UIC-189, UIC-589), are intended for facial stimulation and are indicated for prescription cosmetic use. The anatomical site for application of the devices are the face.
UIC-189 is battery powered, has 4 output channels and has 4 operation programs.
UIC-589 is AC powered, has 10 output channels and has 4 operation programs.
The device is equipped with accessories of self-adhesive pads (cleared under K160081), electrode probes, electrode cables and adapters. All accessories, including self-adhesive pads, electrode probes, electrode cables and adapters can only be changed or replaced by a qualified person.

This FDA 510(k) summary does not contain information about the performance of an AI/ML device. Instead, it describes a "Facial Toning device" which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, specifically for cosmetic use involving facial stimulation.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size used for the test set and data provenance (e.g., country of origin of the data, retrospective or prospective) for an AI/ML device.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI versus without AI assistance.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
• The sample size for the training set of an AI/ML device.
• How the ground truth for the training set was established for an AI/ML device.

The document primarily focuses on demonstrating substantial equivalence to predicate devices (K181062 and K130065) through a comparison of technical specifications and compliance with electrical safety and biocompatibility standards for the TENS device.

Information available regarding the Facial Toning Device:

Acceptance Criteria and Reported Device Performance (Summary from Non-clinical Testing section):

The device "met all requirements" based on bench tests. The compliance standards serve as the acceptance criteria for various aspects of the device's safety and performance:

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a "Non-clinical Testing Summary" which involved bench tests.

The document indicates these bench tests verified that the proposed device met all requirements as outlined by the listed international standards. No details on sample size for these bench tests, data provenance (beyond the fact they were "bench tests"), or expert involvement are provided. There is no mention of an AI component or associated studies like MRMC or standalone performance evaluations for an algorithm.

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These devices are implantable bone plates and bone screws for facial procedures including: 1. Fractures - 2. Osteotomies - 3. Reconstructive procedures - 4. Revision procedures where other treatments or devices have failed

The Biomet Microfixation Facial PreBent Plates with Virtual Surgical Planning is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation for Facial reconstruction procedures. The plates include variations of straight, angle, curved, L-shape, Tshape, double T-shape, Z-shape, Y-shape, double Y-shape, H-shape, triangle, square, rectangle, matrix, orbital floor, LeFort, and chin options with various lengths and thickness. Plates are offered flat or pre-bent plates are contoured by Biomet Microfixation per surgeon specifications or patient specific anatomical model and include patient specific guides and instruments, of the VSP System (K120956, cleared December 12, 2012). The VSP System is used by Medical Modeling to create the guides, instrumentation and a patient specific anatomical model from CT scans provided by a surgeon. Medical Modeling uses the surgeon information to create the anatomical patient specific model. The anatomical patient specific model is then used to aide in proper alignment and bending of the plates previously cleared under K121589 (cleared 9/21/12). This bending process is conducted at Biomet Microfixation based on our process specification and inspection criteria previously cleared with K121589.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Biomet Microfixation Facial PreBent Plates with Virtual Surgical Planning:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. No clinical or non-clinical testing was performed as the device was deemed substantially equivalent based on its identical characteristics to a previously cleared predicate device, with an additional pre-bending service.
• Data Provenance: Not applicable. No test set data was generated for this submission. The rationale for substantial equivalence relied on the predicate device's existing clearance and the verification process for the pre-bending.

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

• Not applicable. No test set was used, and therefore no ground truth was established by experts for a test set. The pre-bent plate's congruence to the anatomical model is verified through an internal inspection process by Biomet Microfixation, which aligns with their process specification and inspection criteria.

4. Adjudication Method for the Test Set

• Not applicable. No test set was used.

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 a physical bone plate and not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

• Not applicable. This device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

• For the verification of the pre-bent plates, the "ground truth" is the patient-specific anatomical model created by Medical Modeling from CT scans. The plates are 100% verified against this model. This is essentially a form of design verification/conformance to a patient-specific digital template/model.
• For the overall device clearance, the ground truth is implicitly tied to the established safety and effectiveness of the predicate device (K121589).

8. The Sample Size for the Training Set

• Not applicable. This document describes a medical device (bone plates) submission, not an AI algorithm that requires a training set. The "VSP System" mentioned generates patient-specific anatomical models and guides, but the submission does not detail its development as an AI system requiring a 'training set'.

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

• Not applicable, as no training set for an algorithm is described.

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The Facial Spa is intended for the stimulation of healthy facial skin.
The Facial Spa is indicated for facial stimulation for over-the-counter cosmetic use.

The Facial Spa is a hand-held, battery-powered device used with conductive treatment gel to stimulate the face with microcurrents.

Here's a breakdown of the acceptance criteria and study information for the Nu Skin Facial Spa, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission is for substantial equivalence, meaning the device does not have explicit "acceptance criteria" for performance in the typical sense of a novel device. Instead, the "acceptance criteria" are compliance with relevant standards and demonstrating equivalence to a predicate device. The "reported device performance" is a direct comparison of its technical specifications to the predicate.

Note on "Meets Criteria?": For 510(k)s, "meeting criteria" often means being acceptably similar or having differences that don't raise new questions of safety or effectiveness. The FDA conclusion states that the technological differences do not raise new questions of safety or effectiveness, thus deeming it substantially equivalent.

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in the context of clinical performance or algorithm evaluation with a specific sample size. This is a 510(k) submission based on substantial equivalence to a predicate device, primarily through engineering and technical comparisons and compliance with recognized standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The submission focuses on technical specifications and adherence to safety standards, not on evaluating diagnostic accuracy requiring expert consensus on a test set.

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

Not applicable. There is no mention of a test set requiring adjudication in this 510(k).

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 a transcutaneous electrical nerve stimulator for cosmetic facial stimulation, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a hardware device, not an algorithm, and its performance is evaluated based on its physical properties and adherence to electrical safety and biocompatibility standards.

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

For this submission, the "ground truth" implicitly refers to:

• Recognized Standards: The published requirements of standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-4, ISO 10993-10, ISO 10993-12, and 21 C.F.R. § 898.
• Predicate Device Specifications: The established design and performance parameters of the legally marketed predicate device, NuFace® Plus (K103472), which serves as the benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. The device is not an AI/ML algorithm that requires a training set.

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

Not applicable. No training set is involved.

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The Facial Reconstructive Mesh is intended for use in plastic and reconstructive surgery of the face and head to provide soft tissue repair or reinforcement.

The FRM is a non-absorbable, inert, sterile, porous, surgical mesh composed of reinforcing woven polyester fabric, silicone elastomer and expanded polytetrafluoroethylene (ePTFE). This polymeric mesh is available in a range of lengths and widths to accommodate the surgical application.

The provided document is a 510(k) summary for a medical device called "Facial Reconstructive Mesh" (FRM). It details the device's description, intended use, indications for use, and a comparison to predicate devices, ultimately concluding that the FRM is substantially equivalent to existing devices.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies. The 510(k) summary focuses on demonstrating substantial equivalence based on the device's characteristics and its similarity to predicate devices, rather than on new performance data from a dedicated clinical study with acceptance criteria.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document implicitly claims that the device meets safety and effectiveness criteria because it is substantially equivalent to predicate devices that are already deemed safe and effective.

Here's why the specific information requested is missing from this type of document:

• 510(k) Premarket Notification: This is a submission pathway for medical devices that are "substantially equivalent" to an already legally marketed device (predicate device). The primary goal is to show similarity, not necessarily to conduct a new clinical study from scratch with fresh acceptance criteria and extensive performance data.
• Safety and Effectiveness: For 510(k)s, safety and effectiveness are often demonstrated by showing that the new device has the same technological characteristics and intended use as predicate devices, and that any minor differences do not raise new questions of safety or effectiveness. This can involve bench testing (biocompatibility, biomechanical performance), but typically not large-scale clinical trials measuring performance against defined acceptance criteria in the way a PMA (Premarket Approval) submission would.

Information I can extract from the provided text, related to the request:

1. Acceptance Criteria and Reported Device Performance: Not explicitly stated in terms of numerical thresholds or metrics. The "performance" is implicitly tied to biocompatibility and biomechanical performance data which, according to the document, was provided in the 510(k) submission and demonstrated substantial equivalence to predicate devices. The conclusion states: "The results of these evaluations... support the conclusion that it is safe and effective for its intended use and that it is substantially equivalent to the cited predicate device(s) with regards to its safety and effectiveness." This means the "acceptance criterion" was effectively "substantially equivalent to predicate devices based on safety and effectiveness evaluations."

   Acceptance Criteria

   Reported Device Performance

   Device is safe and effective for its intended use, and substantially equivalent to predicate devices (K851086, K013625, K952898, K971745).

   "The safety and effectiveness evaluations based on biocompatibility and biomechanical performance data provided in this 510(k) demonstrate that the FRM is substantially equivalent to the cited predicate devices.""The results of these evaluations of the FRM support the conclusion that it is safe and effective for its intended use and that it is substantially equivalent to the cited predicate device(s) with regards to its safety and effectiveness."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided. This type of detail would be expected from a clinical study, which is not described. The evaluations were based on biocompatibility and biomechanical performance data, which usually involves laboratory testing rather than human subject test sets.

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, as no human-expert-validated test set is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no human-expert-validated test set is described.

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. The device is a physical surgical mesh, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical surgical mesh.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for substantial equivalence was established by comparing the FRM's characteristics and performance (biocompatibility, biomechanical properties) to those of the predicate devices already on the market and considered safe and effective. This isn't a "ground truth" in the clinical data sense, but rather a regulatory benchmark.

8. The sample size for the training set: Not applicable, as no AI model or training set is mentioned.

9. How the ground truth for the training set was established: Not applicable, as no AI model or training set is mentioned.

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