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The LED Light Therapy Mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LED Light Therapy Mask is an over-the-counter device intended to emit energy in the red and Near Infrared spectrum and is intended for the use in the treatment of full-face wrinkles.

The LED Light Therapy Mask is a home use wearable light emitting diode (LED) phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full-face wrinkles and mild to moderate acne vulgaris of the face. The system consists of a Face mask and a controller. The Face mask contains the light emitting diodes (LEDs). The LEDs generate the light. The mask is worn on the face and is held in place by adjustable head strap. The LEDs produce blue, red and near infra-red (NIR) light in the visible spectrum (Blue: 415nm +/- 10nm, Red: 630nm +/- 10nm, NIR 830nm +/-10nm.). The controller allows the user to select one of two treatment modes (acne or wrinkles) and switches the LEDs ON/OFF, controlling power to the mask. The modes can be selected by short pressing the Power/mode button. The controller contains a countdown timer and counts down from 10 minutes. The user may stop the treatment during the 10 minutes by long pressing Power/mode button. The controller contains a rechargeable Lithium-ion polymer battery. The controller uses a Power indicator to show the user the battery power level during working status and the charge status during charging. The Power adapter and power cable are used to charge the Lithium battery. The power cable is also used to connect the controller and face mask during working status. The LED Light Therapy Mask cannot be operated while charging. The LED Light Therapy Mask includes optional heating pads for the lower eyelids, providing localized thermal comfort within a temperature range of 38℃~41℃. The heating function is controlled via the controller and does not interfere with the treatment of acne or wrinkles.

The provided document is an FDA 510(k) clearance letter and summary for the LED Light Therapy Mask (RT01). It does not contain information about a specific study proving the device meets acceptance criteria, but rather a summary of non-clinical tests performed to demonstrate substantial equivalence to a predicate device.

Here's an breakdown of the information requested based only on the provided text, with clear indications where the information is not available:

Acceptance Criteria and Device Performance

The document does not explicitly list "acceptance criteria" in a quantitative format for specific performance metrics of the device itself (e.g., efficacy rates for acne reduction or wrinkle improvement). Instead, the performance is demonstrated through compliance with various safety and electrical standards, and a statement of "substantial equivalence" to a predicate device based on identical technical specifications and indications for use.

Below is a table summarizing the non-clinical tests performed that verify the device meets requirements, inferred as "acceptance criteria" in this context. The "reported device performance" is the statement that the device met these requirements.

Study Details

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence."
   • Therefore, there is no sample size for an clinical "test set" and no data provenance information available for such a test. The performance was established through non-clinical bench testing and comparison to a predicate device.

2. 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/Not provided. As no clinical test data was used, no experts were needed to establish ground truth for a test set.

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

   • Not applicable/Not provided. No clinical test set.

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/Not provided. This device is a light therapy mask, not an AI-assisted diagnostic tool for human readers. No MRMC study was mentioned.

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

   • Not applicable/Not provided. This device is a light therapy mask, not an algorithm. Its performance is inherent to its physical operation, not an output of an algorithm in the context of diagnostic performance. However, "Software verification and validation testing" was conducted, and the software was classified as "moderate concern," to ensure its safe operation, not diagnostic accuracy.

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

   • The "ground truth" for the non-clinical tests was established by compliance with recognized international standards (e.g., IEC for electrical safety, ISO for biocompatibility). For substantial equivalence, the "ground truth" was the technical specifications and performance of the legally marketed predicate device (MZ Skin LightMAX Supercharged LED Mask 2.0, K213184).

7. The sample size for the training set:

   • Not applicable/Not provided. As no clinical test data was used and the device is not an AI/algorithm that requires a training set in this context.

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

   • Not applicable/Not provided. No training set was used for clinical performance evaluation.

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• Mode 1 (Red + Infrared light): treatment of full face wrinkles.
• Mode 2 (Blue light): Treatment of mild to moderate inflammatory acne.
• Mode 3 (Mixed light): Treatment of mild to moderate inflammatory acne.

LED phototherapy masks are over-the-counter light-emitting diode (LED) devices that emit energy and are used in dermatology to treat acne and wrinkles. The device emits red (630nm) and infrared (850nm) light to treat wrinkles and blue (415nm) light to treat mild to moderate acne. All models had to be fitted with an eye mask and strapped to the treatment area, and all had a controller to set the parameters of the device. There are 10 models of the device (model: E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A), all of which are operated through a controller.

The provided text describes an FDA 510(k) premarket notification for an "LED light therapy mask." This document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than clinical performance studies.

Therefore, the information required to answer your request regarding acceptance criteria and performance based on clinical studies is largely not present in the provided text. The document explicitly states:

"8.2 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."

This means there was no multi-reader, multi-case study, no standalone algorithm performance, no detailed ground truth establishment, and no sample sizes for test or training sets from clinical data because a clinical study was not performed or required for this submission.

However, I can extract the information related to the non-clinical tests performed and common regulatory standards:

Summary of Information from the Provided Document:

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

• Clinical Performance: Not applicable/not performed for this 510(k) submission.
• Non-Clinical Performance (Acceptance Criteria are inferred by compliance with standards):

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

• Clinical Test Set: Not applicable, no clinical test set was used/required.
• Non-Clinical/Engineering Tests: Sample sizes for hardware, software, and biocompatibility testing are not specified in this summary, which is typical for 510(k) summaries of this nature (they primarily list the standards complied with). Data provenance for these tests would typically be from the manufacturer's internal testing or third-party accredited labs.

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

• Not applicable, as no clinical test set requiring expert ground truth establishment was used.

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

• Not applicable, as 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, a MRMC study was not done. The device is an LED light therapy mask, not an AI diagnostic assistant for human readers.

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

• Not applicable. This device is a direct treatment device, not an algorithm.

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

• Not applicable for clinical ground truth. For non-clinical tests, "ground truth" would be the specifications and requirements defined by the relevant engineering and safety standards (e.g., specific wavelength output, power intensity, safety thresholds for electrical current, absence of cytotoxic effects, etc.).

8. The sample size for the training set:

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

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

• Not applicable.

In summary, this FDA 510(k) submission for the LED light therapy mask relied on non-clinical performance data and compliance with recognized consensus standards to demonstrate substantial equivalence, rather than new clinical trials or studies involving human "readers" or AI performance evaluation.

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BLU TOTALE is an over the counter phototherapy device for use in dermatology for the treatment of mild to moderate acne.

BLU TOTALE is a battery-operated device that uses low power light spectrum at blue LED, at wavelength of 415 ±15nm emitting optical power in a uniform distribution with no hot spots. It is a hand held light emitting diode (LED) device for the treatment of acne designed for home-use.

The provided text is a 510(k) summary for the BLU TOTALE device (Model: ENEOB852), an over-the-counter phototherapy device for treating mild to moderate acne. This document describes the device, its intended use, and its substantial equivalence to a predicate device (Sapphire, K172555).

However, the document does not contain any information regarding acceptance criteria, performance studies (clinical or otherwise), sample sizes, ground truth establishment, or expert involvement related to demonstrating the device's efficacy for treating acne. The "Non-clinical Testing" section only lists various safety and performance bench tests conducted to conform to international standards (e.g., electrical safety, EMC, biocompatibility, photobiological safety), and does not report on clinical efficacy.

Therefore,Based on the provided text, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them because:

1. No clinical efficacy acceptance criteria or corresponding performance claims are present. The document focuses on demonstrating substantial equivalence to a predicate device through shared specifications and conformance to safety and electrical standards. There are no tables of acceptance criteria for treatment efficacy or reported clinical performance metrics in the provided text.

2. No study proving clinical efficacy is described. The "Non-clinical Testing" section details laboratory bench tests for safety (electrical, EMC, photobiological, biocompatibility) and basic device performance (pyrogen, skin temperature, LED wavelength/power density). It does not describe any study (retrospective, prospective, standalone, or MRMC) that evaluates the device's effectiveness in treating acne on human subjects.

Without information on a clinical study or stated performance criteria related to the device's indicated use for acne treatment, it is impossible to answer the specific questions below.

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The pmd clean acne is intended for over-the-counter use to treat mild to moderate inflammatory acne.

The pmd clean acne adopts light emitting diodes (LED) in the blue (415nm ± 5nm) spectrum to irradiate on the face to realize its therapeutic effect. The pmd clean acne adopts handheld design, LEDs are contained in the blue light treatment window, and on its reverse side, the soft silicone bristols can be used to clean the face before the blue light treatment. The product is provided with internal battery and it can be charged by external adaptor. To prevent irradiation of LED lights to eyes during the treatment, pmd clean acne is equipped with goggles which blocks light energy from LEDs.

The PMD Clean Acne device (K230490) is intended for over-the-counter use to treat mild to moderate inflammatory acne. Its substantial equivalence was determined based on non-clinical studies and testing, demonstrating compliance with various safety and performance standards.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of clinical performance data using human subjects. The device's substantial equivalence determination relies on non-clinical testing against recognized standards. Therefore, there is no mention of a sample size for a test set of human subjects or their data provenance (country of origin, retrospective/prospective).

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

Not applicable as the device's approval is based on non-clinical testing against established engineering and safety standards, not on clinical performance evaluated by experts against a ground truth for a test set of medical conditions.

4. Adjudication method for the test set

Not applicable, as there was no test set involving human subjects and expert adjudication.

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 PMD Clean Acne is a standalone light therapy device, not an AI-assisted diagnostic or interpretive tool for human readers.

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

Yes, the regulatory submission primarily relies on standalone non-clinical testing to demonstrate the device's safety and performance characteristics against established technical standards. This includes electrical safety, EMC, photobiological safety, battery safety, and biocompatibility. There is also specific mention of "Software verification and validation test" which would assess the algorithm/software performance independently.

7. The type of ground truth used

The "ground truth" for the non-clinical studies was the established technical and safety standards (e.g., IEC, ISO, ANSI AAMI standards) that the device was required to comply with. For biocompatibility, the ground truth was the standards for cytotoxicity, sensitization, and irritation. For software, the ground truth was the requirements outlined in FDA's guidance document for software in medical devices.

8. The sample size for the training set

Not applicable. This device does not appear to involve a machine learning or AI model that would require a "training set" of data in the typical sense. The software validation mentioned refers to standard software development and testing practices, not machine learning model training.

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

Not applicable, as no training set for a machine learning model is indicated.

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The LUSTRE 3XPRESS Light Beauty Therapy patches (Model: PR6001, PR5001) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.

The LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001 and PR5001 is an over-the-counter light emitting diode (LED) device that emits energy to treat mild to moderate acne. The device uses two types of LEDs: 415 nm and 630nm.

The LUSTRE 3XPRESS Light Beauty Therapy patches components include the device containing two Light Beauty Therapy Patches, an USB Cable with an integrated controller, 120 Mini Dots, a Goggles, a Travel pouch and a User Manual. Among them, mini dots are used for fixed device, goggles are used to protect eyes, and travel pouch are used to store device.

There is a total of 24 LEDs for each model to provide a power intensity of about 30 mw/cm².

The user pastes the device on the treatment area, and the device will shut down automatically after a 3minute after finishing treatment.

The two models are only different in shape. PR6001 is triangular and PR5001 is crescent.

The provided text is a 510(k) Summary for the LUSTRE 3XPRESS Light Beauty Therapy patches. It describes the device, its intended use, and a comparison to a predicate device, as well as non-clinical testing performed.

However, the document states that "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, I cannot provide information regarding acceptance criteria and the study that proves the device meets them in a clinical context because no clinical study was conducted or presented in this document. The device's approval is based on substantial equivalence to a predicate device and non-clinical performance testing against recognized standards.

Here's a breakdown of what can be extracted or inferred based on the provided text, while explicitly stating what is missing due to the lack of clinical studies:

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

• Clinical Acceptance Criteria and Performance: Not applicable, as no clinical study was performed.
• Non-Clinical Test Standards and Compliance (Acceptance Criteria & Performance):

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, as no clinical test set was used. The non-clinical tests relate to device hardware and software compliance, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable, as no clinical test set with a ground truth established by experts was used.

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

• Not applicable, as no clinical test set was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable, as no clinical comparative effectiveness study, MRMC study, or AI component involving human readers was mentioned. This device is a light therapy patch, not an AI diagnostic tool.

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

• Not applicable, as this is a physical light therapy device, not an algorithm, and no standalone performance study in a clinical context was conducted.

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

• Not applicable, as no clinical ground truth was established for a clinical study. The "ground truth" for the non-clinical tests is their adherence to the specified technical standards and safety requirements.

8. The sample size for the training set

• Not applicable, as it's a physical light therapy device, not a machine learning algorithm requiring a training set.

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

• Not applicable, as there is no training set for this device.

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LED Facial Mask is an over the counter device. The Red light mode is intended for the treatment of periorbital wrinkles. The Red and Infrared light combination mode is intented for the treatment of full-face wrinkles. The blue light is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only.

LED Facial Mask (Model: AST-804, AST-804A, AST-804B, AST-805, AST-805A, AST-805B)

The provided text is an FDA 510(k) clearance letter for an LED Facial Mask. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.

The letter only states that the device is "substantially equivalent" to a legally marketed predicate device for the following indications for use:

• Red light mode: Treatment of periorbital wrinkles.
• Red and Infrared light combination mode: Treatment of full-face wrinkles.
• Blue light: Treatment of mild to moderate inflammatory acne.
• Target population: Adults only.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This information would typically be found in the 510(k) submission itself, not in the clearance letter.

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The Luminance RED Acne Device is intended to enit energy in the spectrum, and is specifically indicated to treat mild to moderate acne.

The Luminance RED Acne Device is a lightweight, handheld device that consists of a body handle and treatment head. The body handle contains 2 LEDs that emit visible blue light (415 nm +/- 10 nm) or visible red light (660 nm +/- 10 nm) through the treatment head to help reduce the appearance of mild to moderate acne. The body consists of a plastic shell which includes a button to turn the device on/off, a button for red visible light, a button for blue visible light, and a digital countdown timer. The Luminance RED Acne Device is powered by a lithium-ion battery.

The provided documents describe the Luminance RED Acne Device, a handheld LED device intended to treat mild to moderate acne. However, the documents do not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The submission is a 510(k) premarket notification, which establishes substantial equivalence to legally marketed predicate devices, rather than proving efficacy through clinical trials with defined acceptance criteria.

The 510(k) summary (Section 5) explicitly states:

• "No clinical testing was conducted as part of this 510(k) submission" (Page 8, Section 5.13).
• The conclusion is based on "nonclinical tests" demonstrating the device is "as safe, as effective, and performs as well as or better than the legally marketed predicate device" (Page 8, Section 5.14).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria because it is not present in the provided text.

The closest information available is the comparison to predicate devices for substantial equivalence, which includes characteristics like:

• Indications for Use: Treat mild to moderate acne (same as predicates).
• Energy Type: LED (same as predicates).
• Wavelength: 415 nm (+/-10 nm) and 660 nm (+/-10 nm) (similar to predicates).
• Dose Rate: 4.5 Joules of each wavelength (red and blue), 50 mW/cm² for each (similar to predicates).
• Treatment Regimen: 90 seconds of blue light, then 90 seconds of red light, 2 times per day (similar to predicates).
• Safety Testing: Adherence to IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 62471).
• Usability Testing: Yes, per guidance and IEC 62366.
• Biocompatibility Testing: Cytotoxicity, Irritation, Sensitization.

These are design and testing parameters to demonstrate substantial equivalence, not performance acceptance criteria from a clinical study.

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Micro-current vibration facial cold and hot service is an over the counter device that is indicated for the treatment of mild to moderate inflammatory acne and facial stimulation for the over the counter aesthetic use.

The Micro-current vibration facial cold and hot service device (Model: TPML-100) is a hand-held, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, and USB cable. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the USB cable. The device is un-usable when charging. The device is only home environment use, which has three metal heads (Dual / Single), and two LED light windows (Red / Blue) to provides following functions: a) EMS (micro current output stimulation) function. The device generates a low-frequency micro-current on the Dual Heads which will applied in the facial skin to do facial stimulation. b) Red and Blue LED irradiation function. The device outputs the red light at the wavelength of 630 ± 10 nm and the blue light at the wavelength of 415 ± 10 nm to apply the light in narrow spectral bandwidth on facial skin to treat mild to moderate acne. c) Vibration function. The device generates different patterns of micro-vibration by a builtin micro motor to relax the facial skin. (This function is classified as class I and not need for 510K.) d) Warming and Cooling function. The device heats Dual Heads up to 44 ± 2 °C or cool the Single Head down to 10 ± 2 °C, to relax the facial skin with a warm or cold sensation. (This function is not for medical purpose.)

This document describes the premarket notification (510(k)) for the Micro-current vibration facial cold and hot service (model: TPML-100) device. The FDA's letter indicates that the device has been determined to be "substantially equivalent" to legally marketed predicate devices.

However, the provided text does not contain information about acceptance criteria for performance metrics or a study proving the device meets these criteria in the context of clinical effectiveness and accuracy, especially concerning the treatment of mild to moderate inflammatory acne and facial stimulation for aesthetic use.

The document details:

• Regulatory information: Device classification, product codes, and regulatory standards.
• Device description: Features, functions (EMS, LED irradiation, vibration, warming/cooling), power supply, and materials.
• Intended Use/Indications for Use: Treatment of mild to moderate inflammatory acne and facial stimulation for aesthetic use.
• Test Summary: Lab bench testing for safety and performance against various IEC and ISO standards (electrical safety, EMC, home healthcare environment, nerve/muscle stimulation, non-laser light source, biocompatibility).
• Comparison to predicate devices: A detailed table outlining similarities and differences in technical characteristics.
• No Clinical Test conducted: Explicitly states "No Clinical Test conducted."
• Usability Testing: Mentions that usability testing was conducted to ensure lay users can self-select, apply treatment safely, and understand labels, indications, contraindications, warnings, and precautions.

Based on the provided text, there is no study described that proves clinical effectiveness for the stated indications, nor are there explicit acceptance criteria for such effectiveness. The "Test Summary" section refers to engineering and biocompatibility tests, not clinical performance or accuracy in treating acne or providing facial stimulation. The substantial equivalence determination is based on the device's technological characteristics, features, specifications, materials, and intended use being similar to (substantially equivalent) predicate devices, and that the differences do not raise new safety or effectiveness issues.

Therefore, I cannot populate the requested table or answer questions related to clinical performance studies, such as sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details, because this document explicitly states "No Clinical Test conducted" (Section 8). The performance demonstration is based on bench testing and comparison to predicate devices, not clinical efficacy trials demonstrating specific outcomes related to acne or facial stimulation.

Summary of missing information based on the prompt's requirements:

• Acceptance Criteria & Reported Performance Table: Not available as clinical performance (efficacy) studies are not detailed.
• Sample size (test set) & data provenance: Not applicable; no clinical test set described.
• Number of experts & qualifications: Not applicable; no clinical ground truth established by experts for performance evaluation.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not conducted.
• Standalone performance study: Not conducted in a clinical efficacy context.
• Type of ground truth used: Not applicable; no clinical ground truth as no clinical study was performed.
• Training set sample size: Not applicable; no AI/ML model for clinical diagnosis or outcome prediction mentioned or trained.
• How ground truth for training set was established: Not applicable.

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The Infrared Red Blue LED Light Heat Beauty Machine is an hand-held over-the-counter phototherapy device, the red and infrared light is intended for the use in treating wrinkles on the face and the blue light is intended for the treatment of the mild to moderate inflammatory acne. This device is indicated for adults only.

The proposed device Infrared Red Blue LED Light Heat Beauty Machine, is a over-the-counter device hat uses low power light spectrum at red blue and infrared LED, at wavelength of 625±5nm, 465mm, 850±5nm emitting optical power in a uniform distribution. The device is composed of a handpiece for delivery of light energy, base unit for charging and storage when not in use, and A.C.charging adapter. It is a hand-held light emitting diode (LED) device for treatment of wrinkles on face and mild to moderate inflammatory acne designed for home use.

The provided text describes a 510(k) premarket notification for the "Infrared Red Blue LED Light Heat Beauty Machine." This document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing and comparison of specifications, rather than detailing a specific clinical study with acceptance criteria and device performance evaluation in the typical sense of a diagnostic or AI-powered medical device.

Therefore, the requested information regarding acceptance criteria, performance from a clinical study, sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies is largely not applicable or not provided in this document, as the submission relies on non-clinical tests and comparisons to existing devices for substantial equivalence.

Here's a breakdown of the information that can be extracted and an explanation of why other requested details are missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists compliance with specific international standards as the "acceptance criteria" for non-clinical aspects. The reported "device performance" in this context refers to its conformity with these standards and a comparison of its specifications to predicate devices. There are no specific performance metrics (e.g., sensitivity, specificity, accuracy) like one would find for a diagnostic device.

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 / Not Provided for clinical data. The document explicitly states: "Clinical data was not including in this submission."
• For the non-clinical tests (electrical safety, biocompatibility, photobiological safety, EMC), sample sizes and data provenance are not detailed, as these are typically conducted in a laboratory setting per standard requirements.

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 / Not Provided. There was no clinical test set requiring expert-established ground truth.

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

• Not Applicable / Not Provided. No clinical test set.

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 an AI-powered device, 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 is not an algorithm-only device.

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

• Not Applicable / Not Provided for clinical data. For the non-clinical tests, ground truth is established by adherence to the specified international standards and measurement methodologies defined within those standards.

8. The sample size for the training set:

• Not Applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in that context.

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

• Not Applicable. No training set.

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