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FAQ™ 302 is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.

FAQ™ 302 is a handheld rechargeable square shaped device designed for improving hair growth with 20 laser diodes (wavelength 650±10m) and 20 RED LED beads (640-660nm) on the inside surface.

By pressing the universal button, the user can power the device on, start treatment and change the intensity by quick-pressing the button again. Once the treatment is complete, the device is turned off by pressing and holding the universal power button for 3 seconds.

The device can also be connected wirelessly via Bluetooth to an FAQ App in order to manage treatment. After the treatment is completed, the device automatically powers off.

The device uses a non-detachable polymer lithium battery for power supply in compliance with IEC 62133-2:2017+A1:2021 standard.

Here's a breakdown of the acceptance criteria and study information for the FAQ™ 302 device, based on the provided FDA 510(k) summary:

This device (FAQ™ 302) is an Infrared Lamp intended to promote hair growth. The 510(k) summary explicitly states that clinical testing was considered not to be needed for this 510(k). Therefore, the provided document does not contain information about a study proving the device meets acceptance criteria related to its clinical effectiveness (i.e., promoting hair growth). Instead, the studies presented are non-clinical tests to demonstrate safety and performance equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Since clinical efficacy was "considered not to be needed," the acceptance criteria are not for clinical effectiveness but rather for safety, electrical performance, software functionality, cybersecurity, and usability. The document focuses on demonstrating that the new device is substantially equivalent to predicate devices based on these non-clinical aspects.

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

• Biocompatibility Testing: The document does not specify the sample size (e.g., number of test specimens or replicates) for the biocompatibility tests.
• Electrical Safety and EMC Testing: The document does not specify the sample size used for these compliance tests, as these are typically conducted on a representative sample of the device itself rather than patient data.
• Software Verification and Validation: The document does not specify the number of test cases or data points for software validation.
• Cybersecurity: This involved an analysis, not a test set with patient data.
• Usability Study:
  • Sample Size: 15 adults
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It is implied to be prospective as it's a "validation testing" that "was conducted."

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

• For all non-clinical tests (biocompatibility, electrical safety, EMC, software, cybersecurity): "Ground truth" in the sense of clinical expert consensus is not applicable. These tests rely on established engineering and scientific standards. The "experts" involved would be the testing engineers and scientists responsible for conducting and interpreting these standard-based tests. Qualifications are not specified, but they would be presumed to be competent in the relevant fields.
• For the Usability Study: The document does not mention experts establishing a "ground truth" for usability. The study assessed whether adult users could follow instructions.

4. Adjudication Method for the Test Set

• Not applicable as no clinical test set requiring expert adjudication was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was considered not to be needed for this 510(k)." The device's substantial equivalence is based on non-clinical performance and a comparison of its technical specifications and indications for use with legally marketed predicate devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device is a hardware device (infrared lamp) with embedded software, not a standalone AI algorithm. The software verification and validation section relates to its internal software functionality, not an AI or standalone diagnostic/treatment algorithm.

7. Type of Ground Truth Used

• Biocompatibility, Electrical Safety, EMC: Ground truth refers to compliance with established international and national standards (e.g., ISO, IEC, AAMI compliance).
• Software: Ground truth refers to predefined software requirements and specifications, and the mitigation of identified software hazards.
• Cybersecurity: Ground truth refers to industry best practices, identified risks and vulnerabilities (including comparison with the National Vulnerability Database), and the effectiveness of mitigation strategies.
• Usability Study: Ground truth for this study was the ability of the users to follow the provided instructions to safely and appropriately use the device.

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the context of learning from data to perform a diagnostic or treatment task. Software validation was performed but does not involve a training set as understood in AI/ML.

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

• Not applicable, as no training set was used for an AI/ML algorithm.

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Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED/NIR light & Microcurrent Massage.

Microcurrent: indicated for facial stimulation RED+NIR: indicated to treat periorbital wrinkles

Luna 4 plus has multiple functions combined in a single device, like RED+NIR LED Treatment for wrinkle reduction. The device emits visible red/IR light (Red: 630nm +/- 10nm.) for elevating tissue temperature in improving appearance of facial wrinkles. Microcurrent to target facial stimulation. Two microcurrent pins at the back for a targeted toning massage, emitting microcurrent electrical therapy to deliver skin stimulation where maximum power delivered to the load is controlled and limited by integral software. Luna 4 plus is a single device powered by a rechargeable battery. A controller is integrated on the back to control the device, such as turn on/off the device, mode buttons. Rechargeable Li-battery contained in the controller with a USB cable accessible to target it. To user should use the controller to operate.

Here's an analysis of the acceptance criteria and supporting study for the Luna 4 plus device, based on the provided FDA 510(k) summary:

The document provided primarily focuses on establishing "substantial equivalence" of the Luna 4 plus to existing predicate devices, rather than defining explicit acceptance criteria and then presenting a study to prove meeting those criteria in the traditional sense of a clinical trial for a novel device. The "acceptance criteria" here are implicitly related to demonstrating that the new device is as safe and effective as the predicate devices through conformance to recognized standards and comparative testing.

The "study" that proves the device meets "acceptance criteria" (i.e., is substantially equivalent to predicates) is a combination of:

• Non-clinical testing: Electrical safety, EMC, and biocompatibility, as per applicable standards.
• Lab bench performance testing: Characterization of electrical stimulation output, including Anti-Shock System performance and overload conditions.
• Usability studies: To demonstrate substantial equivalence given new indications.

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

Since explicit "acceptance criteria" in the format of specific numerical thresholds tied to a single study result are not provided, I will construct a table reflecting the key equivalency demonstrations and comparisons made against the predicate devices. The "reported device performance" will be the "Subject Device" values from the Substantial Equivalence Comparison Table, along with notes on safety and efficacy from the "Conclusion" and "Comparison in details" sections.

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

The document does not specify a distinct "test set" in terms of a clinical or image dataset. The testing primarily involved non-clinical lab-based evaluations:

• Electrical safety, EMC, and biocompatibility: Tested against applicable standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 10993 series). This typically involves a single or small number of device units.
• Lab bench performance testing: Characterization of electrical stimulation, Anti-Shock System, and overload conditions. This would also involve a small number of physical devices.
• Usability studies: These are mentioned, but no specifics on sample size (number of users) or study design (e.g., prospective, retrospective, country of origin) are provided.

Therefore, there isn't a "sample size for the test set" in the context of an AI/algorithm performance study using patient data.

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

This information is not applicable/provided in the document as it does not describe a study involving expert-derived ground truth for a test set of patient data, which is typical for AI/algorithm performance evaluations. The evaluations performed are engineering-based and comparative.

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

This information is not applicable/provided as there is no described test set requiring expert adjudication for ground truth.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The device (Luna 4 plus) is a physical device for topical aesthetic treatment and does not involve "human readers" interpreting medical cases or AI assistance in diagnostic tasks.

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

The device is a physical, user-operated aesthetic device. While it contains integrated software ("integral software" to control microcurrent and the "Anti-Shock system"), this is part of the device's functional control, not a standalone diagnostic or interpretative algorithm. Therefore, a "standalone algorithm-only performance study" as typically understood for AI/ML devices is not applicable/provided.

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

The concept of "ground truth" as typically used for AI/ML models is not directly applicable here. The "truth" for this device's evaluation is primarily based on:

• Reference standards: Adherence to national and international engineering and safety standards (e.g., IEC 60601 series, ISO 10993 series).
• Benchmarking against predicate devices: Demonstrating similar or improved safety and functionality compared to legally marketed devices.
• Physical measurements: E.g., optical power density, electrical output characteristics.

For the usability studies mentioned, the "ground truth" would likely be user feedback or successful completion of tasks, but details are not provided.

8. The sample size for the training set

This information is not applicable/provided as the document does not describe the development of an AI/ML model that would require a "training set." The integral software is likely rule-based or control-loop driven rather than a machine learning algorithm.

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

This information is not applicable/provided for the reasons stated in point 8.

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FAQ™ 102 devices are over-the-counter home use devices intended for facial and neck skin stimulation, and non-invasive treatments of mild to moderate facial wrinkles for adult women with all skin tones.

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I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device named FAQ™ (102), stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory requirements, classifications, and indications for use but does not detail performance studies or acceptance criteria.

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The device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.

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The provided document is an FDA 510(k) clearance letter for the FOREO Inc. BEAR 2 Body device. This letter indicates that the device has been found substantially equivalent to a predicate device and is intended for over-the-counter cosmetic use.

However, the document does not contain any of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies. The FDA clearance letter itself does not typically include such detailed technical study reports.

Therefore, I cannot provide the requested information based on the text provided.

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FAO™ 201 and 202 devices are intended to use LED light for the treatment of wrinkles and mild to moderate acne.

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The provided text is an FDA 510(k) clearance letter for the Faq™ 201 and Faq™ 202 devices. This type of document determines substantial equivalence to a predicate device and includes the Indications for Use. However, it does not include detailed information about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or multi-reader multi-case studies as requested in the prompt.

Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on the specific performance study details that would define and prove acceptance criteria.

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PEACH 2, PEACH 2 Duo and PEACH 2 Go are over-the-counter device intended for the removal of unwanted body hair and/or facial hair.

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Based on the provided text, the document is an FDA 510(k) clearance letter for a medical device called PEACH 2, PEACH 2 Duo, and PEACH 2 Go. This letter does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter explicitly states:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This means the clearance is based on a determination of substantial equivalence to existing devices, not necessarily on a new clinical study demonstrating specific performance metrics against acceptance criteria. For 510(k) submissions, manufacturers often rely on non-clinical performance data (e.g., electrical safety, electromagnetic compatibility, biocompatibility, mechanical testing) and comparison to a predicate device's performance to establish substantial equivalence. Clinical studies are often not required for 510(k) clearances unless the device raises new questions of safety or effectiveness.

Therefore, I cannot provide the requested information for the following reasons:

1. Acceptance Criteria Table: The document does not specify any performance-based acceptance criteria for the device, nor does it report any device performance metrics from a study.
2. Study Details: There is no mention of a study (clinical or otherwise rigorous performance study) described in the provided text that would provide information on:
   • Sample size for a test set or training set.
   • Data provenance.
   • Number or qualifications of experts.
   • Adjudication method.
   • MRMC comparative effectiveness study or effect size.
   • Standalone algorithm performance.
   • Type of ground truth used or how it was established.

The document is a regulatory approval letter, not a study report. To get the information you asked for, you would need to refer to the actual 510(k) submission (if it were publicly available and contained such a study) or the manufacturer's own internal documentation or publications.

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FAQ™ 101 devices are over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-VI.

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The provided documents are FDA 510(k) clearance letters for the device FAQ 101. These letters indicate that the device has received substantial equivalence determination, allowing it to be marketed. However, these documents do not contain any information regarding acceptance criteria, study details, device performance data, sample sizes, expert qualifications, adjudication methods, ground truth establishment, or any comparative effectiveness studies (MRMC) or standalone performance studies.

The letters primarily focus on:

• Notifying the applicant (Foreo, Inc.) of the substantial equivalence determination for the FAQ 101 device.
• Listing the regulation number, regulation name, regulatory class, and product codes.
• Providing administrative updates (like adding a product code).
• Stating the general controls provisions of the Act that apply to the device.
• Listing the Indications for Use for the device: "FAQ™ 101 devices are over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-VI."

Therefore, I cannot provide the requested information based on the given input. To answer your questions, I would need a different type of document, such as a study report, clinical trial summary, or a more detailed section of the 510(k) submission that outlines the performance testing and acceptance criteria.

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The BEAR and BEAR mini devices are intended for facial and neck stimulation and are indicated for over-the-counter cosmetic use.

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I am sorry, but the provided text from the FDA 510(k) clearance letter for the FOREO BEAR and BEAR mini devices does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets those criteria.

This document is primarily a clearance letter stating that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It outlines:

• The device name, regulation number, and product code.
• The date of receipt and clearance.
• General controls and regulations applicable to the device.
• The Indications for Use statement.

It does not include:

• Specific acceptance criteria tables for device performance.
• Details of performance studies (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types).
• Information on training sets (sample size, ground truth establishment).

To find the information you requested, you would typically need to consult the full 510(k) submission, specifically the performance data section, which is often not publicly available in its entirety in the FDA's clearance letter database.

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The ESPADA Acne-Clearing Blue Light Pen is intended for use as an at-home device for the treatment of mild to moderate inflammatory acne.

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This PDF does not contain the detailed study information required to answer your request regarding acceptance criteria and device performance for the Espada Acne-clearing Blue Light Pen. The document is an FDA 510(k) clearance letter, which states that the device is substantially equivalent to a legally marketed predicate device. It does not include specific clinical study results, acceptance criteria, or performance data that would typically be found in a clinical trial report or a more detailed submission.

Therefore, I cannot provide the following information from the given text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not available. This is also for an AI device, and the Espada Pen is a light therapy device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not available. Again, this is for an AI device.
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not available.
9. How the ground truth for the training set was established: Not available.

The document primarily focuses on the regulatory clearance of the device based on substantial equivalence. To find the acceptance criteria and study details, you would typically need to consult the original 510(k) submission summary or a clinical study report if one was conducted and made public.

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