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The Wrinkle Treatment Device is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.

The Wrinkle Treatment Device is an Over-the-Counter (OTC), home-use, wearable light based device, and intended for the use in treating full-face wrinkles. Light radiates from the inner surface of the device onto the face. This light is generated by VCSEL (Vertical-cavity surface-emitting laser) with two different spectrum wavelengths: red (660nm) and infrared (850nm).

Model JM1 is controlled directly by the button on the main mask body, which can realize device's power on/off and mode switch. The device will automatically shut down when the treatment time is over or when the pure water is run out.

Model JM2B is controlled by a controller that is connect to the main unit and the device's power-on/off, mode switch and treatment time adjustment can be operated by the controller. The device will automatically shut down when the treatment time is over. Both models are powered by rechargeable Li-battery.

The provided FDA 510(k) clearance letter and summary for the Wrinkle Treatment Device (JM1, JM2B) lack detailed information regarding specific acceptance criteria and the comprehensive study results (particularly clinical performance) that would typically prove a device meets those criteria. The submission focuses heavily on non-clinical performance data and substantial equivalence to a predicate device based on similar technological characteristics.

Therefore, many of the requested details about acceptance criteria, clinical study design (sample size, data provenance, expert adudication, MRMC studies, ground truth establishment), and specific performance metrics are not available in the provided text.

However, I can extract and infer some information based on the typical requirements for a 510(k) submission, especially for a device claiming substantial equivalence to a previously cleared device.

Here's an attempt to describe the acceptance criteria and the study that proves the device meets them, based on the provided document and general FDA 510(k) principles:

Acceptance Criteria and Device Performance (Inferred/General)

Since this is an OTC device intended for treating full-face wrinkles, the acceptance criteria would primarily relate to its safety and efficacy for that stated indication. As per the document, the device (JM1, JM2B) is deemed substantially equivalent to its predicate (JM2), implying that its performance is comparable and acceptable.

Given the nature of the device (light-based for wrinkle treatment), typical acceptance criteria in a clinical study would involve demonstrating a statistically significant reduction in wrinkles or improvement in skin appearance as assessed by objective measures (e.g., standardized photography, wrinkle grading scales) and/or subjective measures (e.g., patient satisfaction, expert assessment). Safety criteria would include the absence of serious adverse events and a low incidence of expected, mild side effects.

Table of Acceptance Criteria and Reported Device Performance

Self-correction: The provided document does not contain a table of explicit acceptance criteria or a detailed report of clinical performance metrics against such criteria. The "Performance Data" section lists non-clinical tests.

However, inferring from the "Substantial Equivalence" claim, the underlying acceptance criteria are that the device is "as safe and as effective as the legally marketed predicate device [K240360 (JM2)] for its intended use".

Study Details (Based on the provided document, many details are not explicit and would typically be found in the full 510(k) submission, not just the summary letter):

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not explicitly stated for any clinical performance testing. The document focuses on non-clinical bench and software testing. For the biocompatibility testing, it mentions "the JM1" (implying the device itself), not a sample size of human subjects.
   • Data Provenance: Not specified. If a clinical study was performed for the predicate device, it's highly likely to have been prospective, but the location is not given. For this 510(k) relying on substantial equivalence, the "performance data" listed are primarily non-clinical.

2. Number of Experts Used to Establish Ground Truth and Qualifications:

   • Not applicable as no direct clinical study results requiring such expert assessment are detailed in this summary. If the predicate device had clinical studies assessed by experts (e.g., dermatologists or plastic surgeons grading wrinkles), that information is not present here.

3. Adjudication Method for the Test Set:

   • Not applicable as no direct clinical study results requiring adjudication are detailed in this summary.

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:

   • No evidence of MRMC study: The device described is a light-based wrinkle treatment device, not an AI diagnostic imaging device that typically uses MRMC studies. Therefore, this type of study is not relevant to this device.

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

   • Not applicable. This is a physical treatment device, not a software algorithm for diagnosis that would have a "standalone" performance. Its "performance" refers to its ability to treat wrinkles when used by a human.

6. The Type of Ground Truth Used:

   • For non-clinical performance (safety): The ground truth for biocompatibility was established by recognized international standards (ISO 10993 series). Electrical and laser safety ground truth was established by compliance with IEC standards. Thermal performance ground truth was established through bench testing and ex vivo tissue evaluation against engineering safety limits.
   • For efficacy: The ground truth for efficacy is implicitly established by the predicate device's prior clearance for wrinkle treatment. The applicant argues that their new device is "as safe and as effective" as this predicate. No specific new clinical ground truth data for efficacy is presented in this summary document beyond the claim of substantial equivalence.

7. The Sample Size for the Training Set:

   • Not applicable. This device is not an AI/machine learning algorithm that would typically have a "training set" in the context of data. It's a hardware device.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable (as above).

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The wrinkle treatment device (model: JM2) is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.

The Wrinkle Treatment Device is an Over-the-Counter (OTC), home-use, wearable light based device, and intended for the use in treating full-face wrinkles. Light radiates from the inner surface of the face. This light is generated by LED with two different spectrum wavelengths: red (660nm) and infrared (850nm).

The device is powered by rechargeable Li-battery and controller that is connect to the main unit. The device's power-on/ off, mode switch and treatment time adjustment can be operated by the controller. The device will automatically shut down when the treatment time is over.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Wrinkle Treatment Device (JM2), structured to address your specific points.

The provided document is a 510(k) Premarket Notification summary for a medical device. It primarily focuses on demonstrating "substantial equivalence" of the new device (Wrinkle Treatment Device JM2) to previously cleared predicate devices, rather than providing detailed clinical efficacy trial results. Therefore, many of your requested points, especially those pertaining to clinical study design (sample size, expert ground truth, adjudication, MRMC studies, effect size, standalone performance, training set details), are not present in this type of submission summary.

This document emphasizes non-clinical testing and comparison to predicates for safety and effectiveness, assuming that the predicate devices have already established their clinical efficacy.

Acceptance Criteria and Study Details for Wrinkle Treatment Device (JM2)

Based on the provided 510(k) Summary, the acceptance criteria are implicitly related to demonstrating compliance with relevant electrical and photobiological safety standards, biocompatibility, and software validation. The study primarily consists of non-clinical testing to meet these standards and to show substantial equivalence to predicate devices, especially regarding technology and intended use.

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 in the context of this 510(k) summary. The "test set" here refers to the actual device samples subjected to non-clinical engineering and biocompatibility testing, not a clinical trial cohort. The document does not specify the number of units tested.
• Data Provenance: The report is from Shenzhen Qianyu Technology Co., Ltd. in China. The testing itself would have been conducted in a lab setting, likely by the manufacturer or a contracted testing facility. The data is retrospective in the sense that it's reported after the tests were completed to support the submission. No patient data or clinical trial data provenance (e.g., country of origin, retrospective/prospective clinical study) is mentioned as no clinical study was conducted.

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

• Not applicable. As no clinical study was conducted, there was no "ground truth" to be established by experts in the context of clinical outcomes or diagnostic accuracy. The "ground truth" for the non-clinical tests would be the measured parameters against the specified standards (e.g., electrical leakage within limits, specific wavelengths emitted, no cytotoxicity).

4. Adjudication Method for the Test Set

• Not applicable. There was no human-read test set requiring adjudication in this non-clinical submission.

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. An MRMC comparative effectiveness study was not performed. The device is a direct-to-consumer light therapy device, not an AI-assisted diagnostic or imagıng device.

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

• Not applicable. This is not an AI algorithm. Its performance is based on its physical properties and light emission, not computational algorithms analyzing external data.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on engineering and biocompatibility testing standards and specifications. For instance:
  • Electrical safety: Measured electrical parameters (e.g., leakage current, insulation resistance) compared to IEC 60601-1 limits.
  • Photobiological safety: Measured light output parameters (e.g., irradiance, spectral distribution) compared to IEC 62471 limits.
  • Biocompatibility: In vitro cellular response (cytotoxicity), skin sensitization, and irritation tests results compared to ISO 10993 criteria.
  • Software: Verification and validation against design specifications and FDA guidance.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve a "training set" in the machine learning sense, as it is not an AI/algorithm-based device.

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

• Not applicable. As there is no training set.

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IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.

IPL Hair Removal Device is a personal, light-based, home-use hair reduction device intended to be sold over-the-counter. The device provides hair reduction by using Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.

The device is only powered by the external power adapter (100-240V, 50/60Hz) and its IPL emission activation is by finger switch. It contains a skin sensor to detect appropriate skin contact, if the light outlet of the device is not in full contact with the skin, the device cannot emit the treatment light pulses.

The device includes JP1, JR3, JR9 four models. There is difference in product appearance, physical product dimension, indicator display, spot size and output energy, but their intended use, performance, structure design and operation are basically identical.

This FDA 510(k) summary describes the substantial equivalence of the "IPL Hair Removal Device" to predicate devices, focusing on the safety and efficacy for its intended use. It does not contain information about acceptance criteria and performances of an AI/ML powered device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI/ML, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI component.

The document primarily addresses:

• Device Description: An over-the-counter IPL device for hair removal.
• Comparison to Predicate Devices: Demonstrates similar intended use, technology, and operational characteristics to previously cleared devices.
• Performance Data (Non-Clinical):
  • Biocompatibility Testing: Conducted in accordance with ISO 10993 standards (ISO 10993-5, ISO 10993-10, ISO 10993-23) to assess cytotoxicity, irritation, and skin sensitization. All tests were passed.
  • Electrical Safety and EMC: Tested against IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-83 standards. All tests were passed.
  • Eye Safety: Tested against IEC 62471.
  • Software Verification and Validation: Submitted documentation consistent with a moderate level of concern, demonstrating that all software requirements are met and hazards mitigated.
  • Usability: Evaluated and verified according to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices."

The conclusion states that based on this non-clinical data, the device is as safe and effective as the legally marketed predicate devices.

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Hand-held IPL device (JOVS Hair Removal Device) is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Hand-held IPL device (JOVS Hair Removal Device) is a personal, light-based, hair reduction device. The device contains a Xenon lamp and provides hair reduction by Intense Pulsed Light (IPL) technology and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device is for single-person use only. Hand-held IPL device (JOVS Hair Removal Device) includes JR5C-E, JR5C-W, JR5C-OG, JR5-E, JR5-W, JR5-OG. Their intended use, performance, structure design and operation are basically identical, with the different color appearance.

The provided text is a 510(k) Summary for a medical device (Hand-held IPL device), which is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study for novel device performance claims.

Therefore, the document does not contain the information requested regarding specific acceptance criteria, a study proving the device meets those criteria, or details about test set sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details typical for an AI/ML device submission for which these questions would be highly relevant.

The performance data section (Section 7) briefly mentions:

• Electrical Safety and Eye Safety: Stating that testing was performed to and passed various IEC standards (IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-83). This implies that meeting these standards' requirements for safety would be the acceptance criteria for these aspects. No specific numerical performance figures are given beyond "passed."
• Software Verification and Validation: Mentions that software documentation consistent with a moderate level of concern was submitted, and "System validation testing... demonstrated that all software requirement specifications have been met and all software hazards have been mitigated to acceptable risk levels." This is a high-level statement and does not provide specific performance metrics or studies.
• Usability: States that usability testing was performed to and passed IEC 60601-1-6.

In summary, the document addresses safety and basic performance by stating compliance with recognized electrical safety, eye safety, and usability standards, and that software requirements were met and hazards mitigated. However, it does not provide the specific type of detailed performance study data (e.g., sensitivity, specificity, accuracy, or comparative clinical effectiveness metrics) that would typically be described with the types of questions posed in your prompt, particularly related to AI/ML device performance.

This 510(k) submission primarily relies on demonstrating substantial equivalence through comparison of technological characteristics and confirmation of compliance with established safety standards for similar devices, rather than a novel clinical validation study with the metrics you've requested.

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The Hand-held IPL device (JOVS Graphene Hair Removal Device) is an over-the-counter device intended for removal of unwanted body and/or facial hair.

The Hand-held IPL device (JOVS Graphene Hair Removal Device) is a personal, light-based, hair reduction device. The device contains a Xenon lamp and provides hair reduction by Intense Pulsed Light (IPL) technology and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device is for single-person use only. The Hand-held IPL device (JOVS Graphene Hair Removal Device) includes JOC-910-Yellow and JOC-910-Emerald. Their intended use, performance, structure design and operation are basically identical, with the different color appearance.

The provided text describes the regulatory clearance of a Hand-held IPL device (JOVS Graphene Hair Removal Device) by the FDA, based on its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria related to an AI/ML-driven medical device, nor does it detail a comparative effectiveness study involving human readers or standalone AI performance.

The "Performance Data" section (Page 7 & 8) refers to various standard tests conducted for medical devices, such as:

• Biocompatibility Testing: ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (irritation and skin sensitization).
• Electrical Safety and Eye Safety: IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-83.
• Software Verification and Validation: Stated as consistent with a moderate level of concern, with system validation testing demonstrating met requirements and mitigated hazards.
• Usability: IEC 60601-1-6.

These are standard engineering and safety tests for the device itself, not performance metrics for an AI algorithm's diagnostic capabilities or improvement of human reader performance. The document explicitly states: "Performance data supports that the device is safe and as effective as the predicate device for its intended use." This "performance data" refers to the types of tests listed above, which demonstrate the device's adherence to safety standards and its functional characteristics (e.g., energy density, wavelength) being comparable to legally marketed predicates.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device's performance or its impact on human readers, as the provided document is for a physical IPL device and describes a substantial equivalence determination based on standard device safety and performance characteristics, not an AI algorithm.

The document does not contain the following information, which would be relevant for an AI/ML study focused on diagnostic performance:

• A table of acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC).
• Reported device performance against those criteria.
• Sample sizes for test sets used for AI model evaluation.
• Data provenance for AI evaluation (e.g., retrospective/prospective, country of origin).
• Number/qualifications of experts for AI ground truth.
• Adjudication methods for AI ground truth.
• MRMC comparative effectiveness study details (effect size of AI assistance).
• Standalone AI performance metrics.
• Type of ground truth used for AI (e.g., pathology, outcomes data).
• Sample size and ground truth establishment for AI training sets.

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