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The HIGHERDOSE BODY SCULPTOR (Model: GS-03) is an over-the-counter device that is intended to improve the appearance of wrinkles.

The HIGHERDOSE Body Sculptor (Model: GS-03) is a home-use light-emitting diode phototherapy device with two proven wavelengths of light 650nm Red light and 850nm Near infrared red light, both of these lights are known to reducing the wrinkle.

The main device is made of black plastic (ABS+PC) and silicone button cup, and contain light emitting diode (LED) which will emit red light and infrared light. The device is a handheld device.

The device contains a rechargeable Lithium battery, which can be charged by charging disk. The HIGHERDOSE Body Sculptor cannot be operated while charging.

Press and hold the power button to turn the product on/off. Press the power button briefly to turn the LED light therapy on/off.

The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.

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The device are indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

The Aduro Hair Growth (Model: M-130) is a device designed to be used with a baseball cap that emits led light with the intention to promote hair growth. The device provides distributed led to the scalp at 660nm±10nm. The device is designed as a head-mounted product, and it consists of the main unit, a controller and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device has only one key for switching on and off the device and it will automatically shut down after a 10-minute treatment is completed.

The Trudermal Halo Hair growth system (Model: M-180A) is a device designed to be used with a baseball cap that emits led light with the intention to promote hair growth. The device provides distributed led to the scalp at 660nm±10nm. The device is designed as a head-mounted product, and it consists of the main unit, a controller and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device has only one key for switching on and off the device and it will automatically shut down after a 10-minute treatment is completed.

The Aduro Hair Growth (Model: M-300) is a device designed to be used with a baseball cap that emits led light and Laser with the intention to promote hair growth. The device provides distributed led and laser to the scalp at 650nm (±10nm). The device is designed as a head-mounted product, and it consists of the main unit, a controller and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device has only one key for switching on and off the device and it will automatically shut down after a 25-minute treatment is completed.

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The Q-Renew LLLT Hair Growth Helmet is indicated for the promotion of hair growth in males who have Norwood-Hamilton classifications of IIa-V, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, and in both, Fitzpatrick Classification of Skin Phototypes I to IV.

The Q-Renew LLLT Hair Growth Helmet is a non-invasive, at-home low-level laser/light therapy (LLLT) device designed to promote hair growth in both men and women. It uses a dual light system that combines laser diodes (wavelength 655nm) with LEDs (wavelengths 630nm, 660nm, and 680nm) to deliver optimal light absorption by the scalp.

The device consists of a Q-Renew LLLT helmet, a charging base and a USB-C charging cable.

The helmet features an adjustable fit, controlled by a rear adjustment wheel, and an intuitive LCD screen for operation. Users can:

• Start or pause treatments
• Select treatment zones
• Check battery status
• View remaining session time

The helmet has a power button for turning the device on/off. The device also includes smart sensors—removing the helmet automatically pauses the session, while repositioning it resumes treatment. Each session lasts 12 minutes, after which the device stop the treatment automatically.

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The ORA Method LED Gua Sha (Model: GS-04) is an Over-the-Counter (OTC) device indicated to emit energy in red and infrared region of the spectrum for treatment of full-face and decolletage wrinkles.

The ORA Method LED Gua Sha (Model: GS-04) is a hand-held, battery-powered device used for the treatment of full-face and decolletage wrinkles by emitting LED red(630nm) and infrared(830nm) light. The device is powered by a Lithium-Ion rechargeable battery, and it has a charging cable,charging base, Goggles,storage bag and instruction manual.

The device have two functions:

A) Red and infrared irradiation function:The device emits energy in red and infrared region of the spectrum to reduce wrinkles on the face and decolletage;

B) Vibration and Gua Sha function. The device generates micro-vibration at a frequency of 200 Hz via its built-in micro motor. When used in conjunction with Gua Sha operation, it provides a soothing massage to the skin intended for relaxing the skin.

The recommended treatment time is 10 minutes per area. If you need to continue treatment, simply turn on the device again.

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KALA MINI 2.0 (Model: KALA-04) (Mode 1) is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

KALA MINI 2.0 (Model: KALA-04) (Mode 2) is an over-the counter device intended for the treatment of full-face wrinkles.

The KALA MINI 2.0 (Model: KALA-04) is a home use light-emitting diode phototherapy device with four proven wavelengths of red light: 630nm, 660nm, and near infrared red light: 830nm, 850nm, the red light (630nm, 660nm) are known to treat the wrinkles and the NIR light (830nm, 850nm) to provide topical heating to elevate tissue temperature for the temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain or muscle spasms and to provide a temporary increase in local blood circulation.

The equipment is a panel that contains LEDs. There are two buttons, one LED display screen on this panel: the button used to control the treatment time and the irradiance of the device; the LED display screen will show the remaining treatment time. Beside the buttons, there are power indicator which will indicate the remaining battery power.

There are fixed straps on the back of the panel, which you can use to hold the panel in your hand. The surfaces patients will contact with hand are constructed of silicone.

The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and be connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The KALA MINI 2.0 (Model: KALA-04) cannot be operated while charging. The cable for connecting with the controller is detachable.

The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.

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TRUDERMAL Pro (Model: ZLD-390) is an over-the-counter(OTC) device that delivering targeted phototherapy using three wavelengths(blue:415nm, red:630nm, Infrared(IR):850nm):

Red light: Reduces full-face wrinkles.
Blue light: Treats mild to moderate inflammatory acne.
IR light: Provides topical heating for the purpose of elevating tissue temperature, temporarily relieving minor muscle and joint pain, arthritis and muscle spasms; relieving stiffness; promoting relaxation of muscle tissues and temporarily increasing local blood circulation.

Mixed lights:
Red+IR light: Reduces full-face wrinkles.
Blue+Red light:Treats mild to moderate inflammatory acne.

The TRUDERMAL Pro is an over-the-counter LED light therapy medical device. The device emits specific wavelengths of low level, narrow band light for the treatment of certain dermatological and musculoskeletal indications. The wavelengths used in the TRUDERMAL Pro system are Blue 415nm, Red 630nm and Near Infrared 850nm.

The device consists of a TRUDERMAL Pro (with LED flexible silicone panel, Controller and AC/DC adapter), power cable, and 2 base seats, a pair of eye protectors. The TRUDERMAL Pro enables treatment of the face and the body via a LED flexible silicone panel.The system is operated by a controller and treatments can be performed by selecting different wavelengths. The light is generated by Light Emitting Diodes(LED's) that are contained within the LED flexible silicone panel. The LED panel can be placed into the Base, holding in the appropriate position to administer a facial treatment. For use on the body,the LED panel is removed from the Base unit and placed over the appropriate body part.

The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.

I apologize, but I cannot fulfill your request to create a table of acceptance criteria and reported device performance, nor can I describe a study that proves the device meets specific acceptance criteria based solely on the provided FDA 510(k) Clearance Letter for TRUDERMAL Pro (ZLD-390).

Here's why:

• No Performance Data or Acceptance Criteria in the Document: The provided 510(k) clearance letter and its associated summary (510(k) Summary) do not contain any information about specific performance acceptance criteria or the results of clinical performance studies that demonstrate the device meets such criteria.
  • The document states, "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively." This explicitly indicates that no clinical performance data (which would typically include performance against acceptance criteria) was provided or evaluated for this 510(k) submission.
  • The non-clinical tests mentioned (electrical safety, EMC, biocompatibility, software V&V) are regulatory compliance tests, not performance studies assessing the therapeutic efficacy against specific clinical endpoints or acceptance criteria.

Therefore, I cannot extract or infer the following information from the provided text:

1. Table of acceptance criteria and reported device performance: This data is not present. The document explicitly states clinical testing was not needed.
2. Sample size used for the test set and data provenance: Since no clinical performance study was conducted or reported, there is no test set, sample size, or data provenance information.
3. Number of experts used to establish ground truth & qualifications: Not applicable, as no clinical performance study data relying on expert ground truth is provided.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study: Not conducted or reported. The device is a phototherapy device, not an AI-powered diagnostic tool, so an MRMC study is generally not relevant.
6. Standalone (algorithm only) performance study: Not applicable. This is a physical phototherapy device, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable, as this is a phototherapy device, not an AI model that would have a "training set" in the traditional sense.
9. How ground truth for the training set was established: Not applicable.

What the document does provide regarding "performance" is:

• Comparison to Predicate Devices: The submission argues for substantial equivalence by comparing the TRUDERMAL Pro's technical characteristics (wavelengths, irradiance, treatment time) to legally marketed predicate devices. The claim is that "The subject device's wavelengths, treatment time, irradiance and radiation dose are similar and close to those of the predicate devices," and this, combined with non-clinical tests, "supports that the subject device is safe and as effective as the predicate devices for its intended use."
• Non-Clinical Test Summary: This section lists the electrical safety, electromagnetic compatibility, biocompatibility, and software verification/validation tests performed, demonstrating compliance with relevant industry standards (IEC, ISO). These tests ensure the device is safe and functions as designed electrically and mechanically, but they do not prove clinical efficacy against specific performance metrics related to wrinkle reduction, acne treatment, or pain relief.

In summary, the provided FDA document is a clearance letter and 510(k) summary that emphasizes substantial equivalence to existing predicate devices based on design, intended use, and non-clinical safety testing, rather than presenting a performance study with defined acceptance criteria and clinical results.

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The KALA Therapy Wand (Model: KALA-03) is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne.

The KALA Therapy Wand (Model: KALA-03) is indicated for over-the-counter aesthetic use. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne. The device is vibrating in red light model. The device is powered by a Lithium-Ion rechargeable battery, and it has a charging cable, USB charging stand, protective goggles, storage case and instruction manual.

The wand can be rotated 135 degrees in either direction.

There are two switches of the device: one function is red light to wrinkle removal and vibration for relax, the other function is blue light to treat mild to inflammatory acne.

The device will automatically shut down after 12 minutes of operation. The recommended treatment time is 3 minutes per area. After every three minutes of treatment, the device will vibrate to indicate the time. If you need to continue treatment, simply turn on the device again.

The provided FDA 510(k) clearance letter and summary for the KALA Therapy Wand (Model: KALA-03) indicate that no clinical performance study was conducted to prove the device meets acceptance criteria. The summary explicitly states:

"7.2 Summary of Clinical Performance: Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."

Therefore, the following information cannot be extracted from the provided document as it pertains to clinical performance which was not performed or deemed necessary for this 510(k) clearance.

1. A table of acceptance criteria and the reported device performance (for clinical performance)
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
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 (This is typically for AI/imaging devices, not a light therapy wand)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done (Not applicable for this device type)
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

However, based on the non-clinical tests performed, we can infer the acceptance criteria for those tests and their reported performance:

Non-Clinical Acceptance Criteria and Reported Device Performance

Additional Information Not Applicable/Provided:

• Sample size used for the test set and the data provenance: Not applicable as no clinical study was performed. For non-clinical tests, these metrics are not typically reported in this format.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study was performed.
• Adjudication method: Not applicable as no clinical study was performed.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is typically for AI/imaging devices.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is typically for AI/software devices.
• The type of ground truth used: Not applicable as no clinical study was performed.
• The sample size for the training set: Not applicable as no clinical study was performed.
• How the ground truth for the training set was established: Not applicable as no clinical study was performed.

In summary, the KALA Therapy Wand (Model: KALA-03) received 510(k) clearance based on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and compliance with relevant safety and performance standards, without the need for a separate clinical effectiveness study.

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The CurrentBody Skin™ LED Light Therapy Mask Series 2 (Model: MK-90H) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.

The CurrentBody Skin™ LED Light Therapy Mask Series 2 (Model: MK-90H) is a home use wearable LED phototherapy device whose purpose is to produce an even, cool, narrow band of light for aesthetic indication for treating facial wrinkles. It emits light energy in the red and near infrared (NIR) region of the light spectrum.

The device consists of a flexible silicone mask that contains light emitting diodes (LEDs) and a controller, multi-straps, a USB-C charging cord, a pair of eye inserts and a storage bag. The LEDs generate the light. The mask is worn on the face and is held in place by the adjustable strap. The controller contains a rechargeable Lithium ion polymer battery and controls power to the mask. The controller has only one key to switch the LEDs ON/OFF and it will automatically shut down after a 10-minute treatment is completed.

The provided FDA 510(k) clearance letter for the CurrentBody Skin™ LED Light Therapy Mask Series 2 (K250966) does not contain the detailed study information typically associated with acceptance criteria and clinical performance for an AI/ML device in the context of diagnostic performance (e.g., detecting a disease).

This device is an LED light therapy mask intended for treatment of full-face wrinkles, falling under the regulation 21 CFR 878.4810 (Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology). The primary focus of the regulatory review for such a device is safety and effectiveness based on its physical properties and intended use for cosmetic purposes, rather than diagnostic accuracy or AI-driven image analysis.

Therefore, many of the requested elements are not applicable to the information provided in this document. The document explicitly states:

• "Clinical testing is not needed for this 510(k)."
• "The non-clinical performance testing described above is sufficient to demonstrate that the device can be used safely and effectively."

This indicates that the device's clearance was based on demonstrating substantial equivalence to a predicate device through non-clinical tests (electrical safety, EMC, photobiological safety, battery safety, biocompatibility, and software verification/validation) and not on clinical performance metrics like sensitivity, specificity, or reader studies for diagnostic accuracy.

Addressing the Request Based on the Provided Document:

Given the nature of the device and the clearance documentation, I will answer the applicable points and explain why others are not present.

Acceptance Criteria and Device Performance for CurrentBody Skin™ LED Light Therapy Mask Series 2 (K250966)

The CurrentBody Skin™ LED Light Therapy Mask Series 2 is an LED phototherapy device for the treatment of full-face wrinkles. The acceptance criteria and performance evaluation for this device, as detailed in the 510(k) summary, are primarily focused on safety, electrical performance, material compatibility, and functional equivalence to a predicate device, rather than diagnostic performance metrics (e.g., accuracy in identifying wrinkles).

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for this device is primarily based on compliance with specific international safety and performance standards, and demonstrating substantial equivalence to a predicate device for its intended use. "Device performance" is therefore reported in terms of compliance with these standards and matching key operational parameters with the predicate.

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

Not applicable for performance evaluation in the context of typical AI/ML diagnostic devices. The clearance is based on non-clinical engineering and safety testing, component material equivalence, and functional equivalence to a predicate device. There is no "test set" of patient data or images in the conventional sense for evaluating diagnostic accuracy or clinical outcomes directly in this 510(k) submission.

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

Not applicable. No ground truth established by experts for a test set of clinical data, as no clinical performance study was conducted or required for this 510(k). Approval is based on safety, hardware specifications, and substantial equivalence.

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

Not applicable. This is not a diagnostic AI device. No MRMC study was conducted or is relevant for this product's intended use (treatment of wrinkles).

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

Not applicable. This device is a hardware LED light therapy mask. While it has software for control (e.g., timer), it is not a standalone diagnostic algorithm.

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

The "ground truth" for this device's clearance is not related to clinical data or diagnostic accuracy. Instead, the "truth" is established by:

• Compliance with recognized international standards for electrical safety, electromagnetic compatibility, photobiological safety, battery safety, and biocompatibility.
• Demonstration of substantial equivalence (same intended use, similar technological characteristics, and no new questions of safety or effectiveness) to a legally marketed predicate device (K221946).

For the purpose of treatment effectiveness validation in general, the underlying scientific basis for LED light therapy's effect on wrinkles (which is outside the scope of this specific 510k submission's clearance process details) would typically stem from clinical trials and dermatological research. However, this 510(k) relies on the predicate's established performance without new clinical studies.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set of data for learning or inference.

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

Not applicable. As above, no training set for an AI/ML algorithm.

In summary, the provided 510(k) clearance letter details an approval based on substantial equivalence and compliance with safety and performance standards for a hardware medical device, not on the clinical performance or diagnostic accuracy of an AI/ML driven system. Therefore, many of the requested details regarding AI/ML study methodologies are not present in this document.

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The CurrentBody Skin Dual Light Hair Growth Helmet is indicated to promote hair growth in males with who have Norwood-Hamilton classifications of IIa-V or females with who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.

The CurrentBody Skin Dual Light Hair Growth Helmet (model:MZ-07A) is an over-the-counter device designed to promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V patterns of hair loss and to promote hair growth in females who have Ludwig-Savin Classifications of I-II; both with Fitzpatrick Skin Types I-IV.

The device consists of 100 laser diodes with wavelength at 655±5nm, and 200 red light diodes with wavelength at 660±5nm.

The CurrentBody Skin Dual Light Hair Growth Helmet includes a hair-growing cap, a device base and a USB power cord. There are LEDs and lasers diodes inside the cap to emit visible red light, the device base acts as a support when the device is not used. There is a power button on cap to turn on/off the device, a digital display to show the remaining treatment time, an power indicator to show charging status and a USB port for charging.

The treatment parameter is pre-set by manufacturer, the device will auto off after treatment.

The provided FDA 510(k) clearance letter and summary for the CurrentBody Skin Dual Light Hair Growth Helmet (K251017) indicate that clinical performance testing was explicitly stated as "not needed" for this 510(k) submission. Therefore, the document does not contain information regarding acceptance criteria or a study that proves the device meets those criteria based on clinical performance data.

The submission relies on non-clinical performance testing to demonstrate substantial equivalence and safety/effectiveness. This non-clinical testing focuses on electrical safety, EMC, photobiological safety, battery safety, biocompatibility, and software validation.

Here's a breakdown of why the requested information about acceptance criteria and a clinical study proving performance cannot be extracted from this document, along with information that is available:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)

Since no clinical performance study was provided, there are no specific performance acceptance criteria for hair growth or efficacy reported in the document. The acceptance criteria for this submission are related to meeting established safety and performance standards through non-clinical testing.

Table of Acceptance Criteria (Non-Clinical) and Reported Device Performance:

Regarding a Clinical Study (Not Applicable for this Submission)

As stated in Section 7.2 of the 510(k) Summary:
"Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."

Therefore, the following information, which would typically be included for a clinical study proving efficacy/performance, is not available in this document:

1. Sample sizes used for the test set and the data provenance: Not applicable.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method for the test set: Not applicable.
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 is generally for diagnostic AI devices, not a therapeutic device like this).
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: Not applicable.
7. The sample size for the training set: Not applicable (referring to clinical training data for performance, not engineering/software validation training).
8. How the ground truth for the training set was established: Not applicable.

Summary of Device Performance Claim Basis for Hair Growth:

The claim about promoting hair growth is based on:

• Substantial Equivalence: The primary strategy for clearance is demonstrating that the CurrentBody Skin Dual Light Hair Growth Helmet is substantially equivalent to legally marketed predicate devices (K231153: Neuhat Hair Growth System; K240456: Bosley Booster Laser Caps). The predicate devices were previously cleared for the same indication (promote hair growth in specific Norwood-Hamilton and Ludwig-Savin classifications with Fitzpatrick Skin Phototypes I-IV).
• Similarity in Design and Parameters: The submission highlights similarities in the intended use, indications for use, type of light (low-level laser and LED), wavelength (very close to predicates), number of diodes, energy per laser diode, and treatment time/irradiance (very close to predicates). The argument is that these similarities mean the subject device will have a similar therapeutic effect to the already-cleared predicate devices.
• Non-Clinical Data: As detailed in the table above, the non-clinical testing ensures the device meets safety standards (electrical, EMC, photobiological, battery, biocompatibility, software) which indirectly supports its safe use for its intended purpose without raising new questions of safety or effectiveness compared to the predicates.

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The Solawave 2-in-1 Skincare Mini (Model: 61043) is an over-the-counter device that emits energy in the red and infrared spectrum for treating wrinkles on the face and decolletage.

The Solawave 2-in-1 Skincare Mini (Model: 61043) is a hand-held, battery-powered device that reduce wrinkles by emitting LED red light (630nm) and infrared light (830nm). The device is powered by a Lithium-Ion rechargeable battery, and it comes with a charging cable, storage bag, and instruction manual.

The Solawave 2-in-1 Skincare Mini is a revolutionary device that offers two simultaneous approaches for your skin routine in one handheld device:

1. Red and Near-Infrared Light Therapy
2. Warming function (This function is not for medical purpose)

The provided FDA 510(k) clearance letter for the Solawave 2-in-1 Skincare Mini (K250532) indicates that no clinical performance studies were conducted or deemed necessary for its clearance.

Therefore, it is not possible to describe acceptance criteria and associated study results for device performance based on the provided document, as no such studies were submitted or reviewed by the FDA for this particular clearance.

The document states:

• "Clinical testing was not needed for this 510(k)." (Page 10, Section 7.2)
• The clearance is based on the device being "substantially equivalent" to legally marketed predicate devices. This means the FDA determined the device has the same intended use and technological characteristics as a predicate device, or if there are differences, those differences do not raise different questions of safety and effectiveness.

Breakdown of the requested information based on the provided document:

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

   • Not applicable. No clinical performance studies were conducted or provided in this 510(k) submission to establish acceptance criteria for device performance or report device performance against such criteria. The "performance" assessment was primarily through comparison to predicate devices and non-clinical testing.

2. 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 clinical test set was used for performance evaluation in this 510(k).

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. No clinical test set requiring expert ground truth was used for performance evaluation in this 510(k).

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

   • Not applicable. No clinical test set requiring adjudication was used for performance evaluation 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 light-based therapy device, not an AI-powered diagnostic or assistive tool, and 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 light-based therapy device, not an algorithm, and no standalone performance study was conducted.

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

   • Not applicable. No clinical ground truth was established as no clinical studies were performed. The "ground truth" for substantial equivalence was based on existing predicate device characteristics and regulatory standards.

8. The sample size for the training set:

   • Not applicable. This device is a physical light-based therapy device, not a machine learning model, and therefore does not have a "training set" in the context of AI/ML.

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

   • Not applicable. As above, no training set for an AI/ML model was used.

Summary of what was reported instead:

The 510(k) submission relied on:

• Non-Clinical Tests:
  • Electrical safety (e.g., IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-1-2)
  • Photobiological safety (IEC 62471)
  • Battery safety (IEC 62133-2)
  • Biocompatibility (ISO 10993-5, ISO 10993-10, ISO 10993-23)
  • Software verification and validation (classified as "moderate" concern)
• Comparison to Predicate Devices: The document extensively compares the Solawave 2-in-1 Skincare Mini with several predicate and reference devices regarding features like intended use, regulation class, product code, power source, irradiance source, wavelengths, irradiances, and treatment time to establish substantial equivalence. The argument for equivalent "treatment effect (wrinkle treatment)" is made based on similar wavelengths, and irradiances/treatment times being "very close to those of reference devices 1 and 2."

In conclusion, for this specific 510(k), the acceptance criteria and proof of device performance were primarily established through substantial equivalence to existing legally marketed devices and successful completion of non-clinical safety testing, rather than through new clinical performance studies.

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