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The Medi Lift Mask is intended for facial stimulation and indicated for over-the-counter cosmetic use.

The Medi Lift Mask is composed of a mask made of silicone rubber which is worn on the lower part of the user's face, and covers the user's cheeks and nose. The mask contains two controllers with electrodes, which are attached to the mask. These controllers and electrodes deliver electrical pulses to stimulate facial muscles. The controllers are operated independently by pressing buttons on each controller. The controllers attached to the mask contain two charging pins which allows for the built-in Lithium-ion battery that powers the device to be charged using a USB charging cable and an adapter that is provided as part of the device is not operated during charging.

This document is a 510(k) Summary for the Medi Lift Mask, a medical device. The information provided heavily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance data for a new AI/software-driven device.

Therefore, many of the requested categories for a study proving device performance against acceptance criteria for an AI-driven device cannot be extracted from this document, as the device is not an AI/software device and the clearance is based on substantial equivalence and minor material change, not a performance study of AI.

However, I will extract what is available and note what is not applicable or not provided.

Here's the breakdown based on the provided text:

Device Type: Transcutaneous Electrical Nerve Stimulator For Pain Relief (Aesthetic Purposes) – This is a hardware device, not an AI/software device.

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

The document does not present acceptance criteria for a performance study in the way an AI/software device submission would. Instead, it demonstrates equivalence to a predicate device. The "performance" described is in the context of safety and effectiveness, shown by:

• Risk Analysis: Per ISO 14971:2019 (determined no new risks compared to predicate).
• Biocompatibility Evaluation: Per ISO 10993-1:2018, with testing for Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2021), and Intracutaneous reactivity (ISO 10993-23:2021).
• Prior Tests (Applicable to predicate, deemed still applicable to new device due to no relevant changes): Tensile strength, polycyclic aromatic hydrocarbons, software verification and validation, electrical stimulation outputs, electrical safety, and electromagnetic compatibility.

• Cytotoxicity per ISO 10993-5:2009
• Sensitization per ISO 10993-10:2021
• Intracutaneous reactivity per ISO 10993-23:2021 |
  | Effectiveness (Equivalence) | "The Medi Lift Mask has the same intended use and indications for use as the predicate device... Thus, the Medi Lift Mask is substantially equivalent." |
  | Material Change Impact | The new UV varnish on the controller housing "does not raise different types of safety and effectiveness questions." |

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

• Sample Size for Test Set: Not applicable in the context of a clinical performance study for an AI algorithm. The testing described is primarily material and electrical safety/biocompatibility testing, which typically uses defined sample sizes for specific component tests as per standards, but a "test set" of patient data is not relevant here.
• Data Provenance: Not applicable for patient data. The provenance of the testing conducted would be controlled laboratory conditions in Japan (where YA-MAN Ltd. is located).

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

• Not applicable. This is not an AI diagnostic/prognostic device requiring expert-established ground truth from medical images or patient data.

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

• Not applicable. No clinical test set requiring adjudication 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

• No. This is not an AI-assisted diagnostic device.

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

• No. This is not an AI device.

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

• Not applicable. The "ground truth" for this device revolves around established safety standards (ISO for biocompatibility, electrical safety) and the functional equivalence to the cleared predicate device.

8. The sample size for the training set

• Not applicable. This device does not use a training set for machine learning.

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

• Not applicable. This device does not use a training set for machine learning.

Summary of the K244048 Submission:

The provided text is an FDA 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (Medi Lift Mask). The submission seeks clearance based on substantial equivalence to a previously cleared predicate device (Medi Lift PLUS, K220198). The primary "change" is a different UV varnish material on the controller housing.

The testing performed and documented focuses on confirming that this minor material change does not introduce new safety or effectiveness concerns. This is demonstrated through:

• Risk analysis (confirming no new risks).
• Biocompatibility testing of the new material.
• Reliance on prior testing of the predicate for aspects not affected by the material change (electrical safety, software, etc.).

Therefore, the document does not contain the information typically found in an FDA submission for an AI/software device that requires extensive clinical performance studies with defined acceptance criteria for AI model performance (e.g., sensitivity, specificity, accuracy against human readers or pathology).

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The Medi Lift PLUS is intended for facial stimulation and indicated for over-the-counter cosmetic use.

The Medi Lift PLUS is composed of a mask made of silcone rubber which is worn on the lower part of the user's face, and covers the user's cheeks and nose. The mask contains two controllers with electrodes, which are attached to the mask. These controllers and electrodes deliver electrical pulses to stimulate facial muscles. The controllers are operated independently by pressing buttons on each controllers attached to the mask contain two charging pins which allows for the built-in Lithium-ion battery that powers the device to be charged using a USB charging cable and an adapter that is provided as part of the device. The device is not operated during charging.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of diagnostic or screening performance (e.g., sensitivity, specificity, accuracy). Instead, it's a 510(k) summary for a medical device (Medi Lift PLUS) and focuses on establishing substantial equivalence to a predicate device.

The "Performance Data" section lists several compliance standards (e.g., IEC, ISO) and tests (e.g., chemical characterization, tensile strength, electrical output, software verification). These are typically related to safety, electrical performance, biocompatibility, and manufacturing quality, rather than clinical efficacy or diagnostic accuracy.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth used, training set sample size, ground truth for training set) are not applicable or cannot be extracted from this document, as they pertain to clinical performance studies, which are not detailed here.

However, I can provide information based on the available text regarding the characteristics of the device and its safety/performance testing in a regulatory context.

Here's an attempt to answer the questions based only on the provided text, noting its limitations:

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

The document does not explicitly state quantitative "acceptance criteria" for clinical performance (e.g., a specific improvement percentage in facial stimulation) or directly report "device performance" in that context. Instead, it lists standards the device was assessed against, which imply that compliance with these standards is the "acceptance criterion" for regulatory approval of 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)

This information is not provided in the document. The listed performance data relates to engineering and biocompatibility testing, not human clinical trials with a test set of patients or subjects.

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)

This information is not provided. "Ground truth" in the context of facial stimulation for cosmetic use is not typically established by experts in the same way it would be for a diagnostic medical device (e.g., diagnosis of disease). The document focuses on safety and technical specifications.

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

Not applicable, as no clinical test set requiring adjudication of "ground truth" 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 Medi Lift PLUS is a transcutaneous electrical nerve stimulator for cosmetic facial stimulation, not an AI-assisted diagnostic or screening device involving human "readers."

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

Not applicable. This device is not an algorithm, but a physical electrical stimulator.

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

Not applicable for clinical efficacy in the sense of comparing against a definitive medical diagnosis. The "ground truth" in this context would be compliance with the performance specifications of the device itself and safety standards.

8. The sample size for the training set

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

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

Not applicable.

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The L-SER-KO IR Lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.

The L-SER-KO IR Lamp is intended for use as an infrared heat lamp. The L-SER-KO IR Lamp is a non-invasive device that emits light energy to the skin surface of the human body for the purpose of causing the therapeutic elevation of tissue temperature. The L-SER-KO IR Lamp delivers an invisible laser beam in the infrared spectrum at wavelengths of 810 nm using a gallium aluminum arsenide (GaAlAs) source. The laser beam is generated by an IR diode. The tissue to be treated is illuminated by non-therapeutic red LED guide lights. The L-SER-KO IR Lamp consists of only one hardware component, a handpiece containing the controller, user interface display and the treatment aperture. The handpiece is made of standard medical PVC material.

The document provided is a 510(k) Premarket Notification for the L-SER-KO IR Lamp. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than proving independent efficacy through clinical trials with acceptance criteria. Therefore, several of the requested sections (acceptance criteria, specific study design details like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth descriptions for training/test sets) are not applicable or explicitly stated in this type of regulatory submission.

Here's the information that can be extracted from the provided text, and where gaps exist due to the nature of a 510(k) submission:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" in the context of device performance, as typically understood for a clinical study proving efficacy, is not directly present in this 510(k) summary. Instead, the "acceptance" is based on demonstrating substantial equivalence to a legally marketed predicate device. The performance is assessed against the predicate devices' characteristics and through compliance with recognized standards.

Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets the "acceptance criteria" (defined here as substantial equivalence and compliance with standards) is primarily the 510(k) Premarket Notification submission itself and the testing outlined in Section VI.

The regulatory pathway for this device is based on substantial equivalence to predicate devices already on the market (USA Laser Biotech Inc. LUMINA 1600 Infrared Lamp Therapy System K052814 and Avicenna ALT Laser Model VTR 75 K031612). The "study" therefore consists of:

1. Comparison to Predicate Devices: Section IV and V provide a detailed comparison of the L-SER-KO IR Lamp's characteristics (power supply, heat source, wavelength, average power output, treatment mode, treatment times, delivery system) to the identified predicate devices, demonstrating they are fundamentally similar.
2. Functional Performance Testing: Section VI states that "functional performance testing" was conducted. This testing would verify that the device operates according to its specifications (e.g., emits at the specified wavelength, power output). Specific results are not detailed in this summary, but the conclusion (Section VII) states it "performs as intended."
3. Electrical Safety Testing: Section VI also states "electrical safety testing" was performed to ensure compliance with a list of international standards (21 CFR 1010, 21 CFR 1040, EN 60601-1, EN 60601-1-2, ISO 14971).

Additional Information as Requested:

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not applicable. This is a submission demonstrating substantial equivalence to a predicate device, not a statistically powered clinical trial with a "test set" of patients/data. The "test set" refers to the device itself being tested for functional performance and electrical safety.
   • Data Provenance: The device characteristics are reported by the manufacturer, YA-MAN LTD (Japan). The testing would have been conducted by or for YA-MAN LTD.

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

   • Not applicable. There is no "ground truth" derived from expert consensus on a test set of clinical cases in this 510(k) submission. The "ground truth" for the device's technical specifications is established by the manufacturer and verified through testing against engineering standards.

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

   • Not applicable for a 510(k) device specific to hardware performance and safety based on substantial equivalence.

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 an infrared lamp, not an AI-powered diagnostic tool. There are no "human readers" or AI assistance involved.

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

   • Not applicable. This is a physical therapy device, not an algorithm. However, the device itself is "standalone" in its operation for emitting infrared light.

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

   • The "ground truth" here is the technical specifications and performance characteristics of the device, verified through engineering testing and compliance with recognized standards. For the purpose of substantial equivalence, the "ground truth" also effectively includes the established safety and efficacy profiles of the predicate devices. There is no clinical "ground truth" from pathology or outcomes data presented in this document.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not applicable.

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The Ya-Man, Ltd. Laser 21 diode laser system is indicated for the removal of unwanted hair in Fitzpatrick skin types I-IV.

Not Found

I am sorry, but based on the provided text, there is no information available regarding acceptance criteria, device performance studies, or details about the training and test sets and their ground truth establishment.

The document is an FDA 510(k) clearance letter for the "Laser 21" device, indicating that it has been deemed "substantially equivalent" to legally marketed predicate devices for the removal of unwanted hair in Fitzpatrick skin types I-IV.

The letter focuses on regulatory approval and compliance, and does not contain the specifics of any performance studies or validation data that would typically be found in a study report. Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, or other study details.

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Ask a specific question about this device