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The handLITE is intended to emit energy in the red and near infrared region of the light spectrum, is generally indicated to treat dermatological conditions and specifically indicated to treat contact dermatitis of the hand and wrist.

The handLITE device consists of:

1. Flexible silicone glove with integrated controller (contains rechargeable lithium-ion polymer battery)
2. Power supply and country specific adaptors

handLITE is a home use wearable light emitting diode (LED) phototherapy device.

The device consists of a flexible silicone glove that contains red (630nm) and near infrared (830nm) light emitting diodes (LEDs) and an integrated controller. The LEDs generate the light at an intensity of 30mW/cm², delivering 18J/cm² per treatment.

The power supply is used to charge the integrated Lithium battery in the handLITE.

The provided document contains information on the handLITE (TN19S) device, but it does not contain acceptance criteria or a study that specifically proves the device meets predefined acceptance criteria for a new and complex AI/ML device.

The document describes a 510(k) clearance, which largely focuses on demonstrating substantial equivalence to a predicate device. While a clinical study was performed to support safety and effectiveness, it's not structured as a typical AI/ML validation study with pre-defined performance metrics and acceptance thresholds.

Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in what can be inferred or directly stated, and clearly mark what information is not present.

Acceptance Criteria and Device Performance (Not Applicable in the traditional AI/ML sense)

The FDA 510(k) clearance process for this device, a light-emitting device for dermatological conditions, focuses on demonstrating substantial equivalence to predicate devices. There are no explicitly stated numerical "acceptance criteria" for the device's performance in the way one might define them for an AI/ML diagnostic algorithm (e.g., "sensitivity must be >X% AND specificity >Y%").

Instead, the clinical performance testing aims to show the device is safe and effective for its intended use, analogous to how a new drug might demonstrate efficacy and safety in trials. The "performance" is articulated as an improvement in contact dermatitis symptoms.

Table of Performance (Based on Clinical Study Results):

Study Details

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

   • Clinical Study (Effectiveness & Safety):

     • Enrollment: 25 subjects
     • Completed Full Treatment: 23 subjects
     • Data Included in Evaluation: All available data from 25 subjects (including the 2 who did not complete the full course).
     • Data Provenance: Not explicitly stated, but the submission is from a UK company ("iSMART Developments LTD, Birmingham, B73 5LT United Kingdom"). The clinical study likely took place in the UK or a region where the sponsor operates, but this is an inference, not directly stated.
     • Retrospective/Prospective: Prospective (clinical study undertaken to support safety and effectiveness).

   • Usability/Human Factors Study:

     • Sample Size: 19 subjects
     • Data Provenance: Not explicitly stated.
     • Retrospective/Prospective: Prospective (study conducted to assess label comprehension).

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

   • This is not an AI/ML device requiring expert consensus for ground truth on images or other diagnostic data.
   • The "ground truth" for the clinical effectiveness study was objective measurement of dermatitis signs and symptoms using the SCORAD index, likely performed by clinical investigators. The qualifications of these investigators are not detailed in this summary.

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

   • Not applicable as this is not a diagnostic AI/ML device that requires adjudication of interpretations. The SCORAD index is a standardized scoring system.

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 MRMC study was performed. This is not an AI/ML diagnostic or assistive device for human readers. It is a light therapy device.

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

   • Not applicable. This device is a treatment device, not a standalone diagnostic algorithm. Its performance is measured directly by its effect on the patient's condition.

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

   • For the effectiveness study: Clinical Assessment (SCORAD index) of the signs and symptoms of contact dermatitis. This is a standardized, objective scoring system. Patient-reported outcomes were also collected.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set in the conventional sense. Its "training" would be device design and engineering.

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

   • Not applicable as no AI/ML training set is mentioned or implied for this device.

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The Philips BlueControl is intended to emit energy in the blue region of the spectrum, is generally indicated to treat dermatological conditions and specifically indicated to treat mild psoriasis vulgaris.

The Philips BlueControl is a rechargeable battery-operated, wearable device for delivery of blue light to treat mild psoriasis vulgaris. It is a prescription device designed for home use. The Philips BlueControl is sold as a kit, which contains the following items: Components: o BlueControl Device o Fixation Strap (Device Holder and Slings) o Power Supply (USB Cable, Adapter and Charger) Accessory: ● 0 Carrying Case Instructions for Use.

The Philips BlueControl device is intended to treat mild psoriasis vulgaris. The provided text outlines the performance data, including clinical studies, that support the substantial equivalence determination for this device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria for its clinical performance. Instead, it describes clinical studies and their outcomes as evidence of effectiveness. The primary endpoint for effectiveness was a statistically significant improvement in Local Psoriasis Area and Severity Index (LPASI) scores.

• The mean change from baseline to week 12 was -2.38 (-3.02 to -1.73) in the treated plaque and -1.46 (-2.13 to -0.79) in the control plaque. |
  | Safety | Incidence of serious adverse events (SAEs) related to treatment | No serious adverse events considered related to any of the studied treatment regimen. | - No serious adverse events were considered related to any of the studied treatment regimen.
• All 16 adverse events observed during the study were evaluated. No serious adverse events were reported. None of the adverse events were device-related or treatment-related.
• Hyperpigmentation (tanning) was expected and reported, which reduced within a few days after treatment completion. No other device-related adverse effects were observed. |

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

• Sample Size for Test Set: N=23 enrolled subjects in the main clinical study, with each subject having treated and control plaques.
• Data Provenance: Prospective, clinical studies conducted in Europe per ISO 14155 (Clinical investigation of medical devices for human subjects -- Good clinical practice).

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test set (i.e., evaluate LPASI scores). It mentions that "psoriasis severity was evaluated using the Local Psoriasis Area and Severity Index (LPASI), a modified version of the validated PASI." This typically implies trained clinicians or dermatologists, but specific details are not provided.

4. Adjudication Method for the Test Set:

The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for the LPASI evaluations in the test set.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The study design involved comparing treated plaques to control plaques within the same subjects, rather than comparing human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance:

Not applicable. The Philips BlueControl is a light therapy device, not an AI algorithm, so a standalone algorithm-only performance assessment is not relevant in this context.

7. Type of Ground Truth Used:

The ground truth for effectiveness was based on clinical assessment using the Local Psoriasis Area and Severity Index (LPASI), performed by presumably clinical investigators or dermatologists as part of the clinical studies. For safety, it was adverse event reporting and evaluation.

8. Sample Size for the Training Set:

Not applicable. The Philips BlueControl is a medical device, not an AI/machine learning algorithm, so there is no "training set" in the conventional sense for algorithm development. The device's performance is based on its physical properties and clinical evaluation in humans.

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

Not applicable, as there is no training set for an AI algorithm. The device's design and parameters are based on scientific understanding of blue light therapy for psoriasis and established medical device development standards, rather than AI model training.

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The Tända Max System is intended for the treatment of wrinkles, rhytides and fine lines in the periorbital region.

Tända Max is a modular system that offers simplicity in use and convenience. The system can operate while connected directly to an electrical outlet or can be used in cordless mode drawing upon its rechargeable batteries to deliver the treatment. The system components include the control unit, the treatment head, recharging stand, Pre-treatment gel, AC adapter and goggles.

Tända Max utilizes red light at 660 nm. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The surface that comes into contact with the skin has been selected to ensure the light is administered to the skin while providing a smooth surface for cleaning.

The provided text describes the Tända Max System, an LED light system intended for the treatment of wrinkles, rhytides, and fine lines in the periorbital region. However, the document explicitly states that "additional clinical information is not necessary" and therefore no clinical study was performed to demonstrate device effectiveness.

The submission focuses primarily on comparing the Tanda Max System to predicate devices based on technological characteristics and non-clinical testing.

Given this, I cannot provide detailed information for many of your requested points as a clinical study proving the device meets acceptance criteria was not conducted or reported in this document.

Acceptance Criteria and Reported Device Performance:

Since no clinical study was performed, there are no specific clinical acceptance criteria or reported device performance metrics from such a study. The "acceptance criteria" appear to be met by demonstrating substantial equivalence to predicate devices and adherence to non-clinical safety standards.

Study Details (Not Applicable/Information Not Provided):

1. Sample size used for the test set and the data provenance: Not applicable, no clinical test set mentioned.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical test set mentioned.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, no clinical test set mentioned.
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, no clinical study was done, and this device is not an AI-assisted diagnostic tool for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no standalone performance study was done as it's not an algorithm-only device.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, no clinical ground truth established or used.
7. The sample size for the training set: Not applicable, no training set for a clinical study or AI algorithm mentioned.
8. How the ground truth for the training set was established: Not applicable, no training set or ground truth established.

Summary of Determination:

The FDA's review concluded that the Tända Max System is substantially equivalent to legally marketed predicate devices based on its intended use, technological characteristics (output, wavelength, treatment duration, regimen), and adherence to safety and biocompatibility standards. This substantial equivalence determination allowed the device to be marketed without requiring new clinical data, as explicitly stated in section 9: "Based on the above information, additional clinical information is not necessary."

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The PlasmaLuxLS is a medical light source, which is intended for use for the treatment of moderate acne vulgaris with blue light.
The PlasmaLuxLS is a medical laser device, which is intended for the treatment of moderate inflammatory acne vulgaris.

The PlasmaLuxLS is a compact light source that delivers a uniform distribution of light, with spectral output at peak wavelengths of 417 nm (Blue Light) a It is intended for use by or under the direction of a physician for the treatment of moderate acne vulgaris with blue light. The desired dose is selected using the operator interface located on the front panel of the device. The PlasmaLux LS device delivers local area phototherapy, whereby lamps deliver the specified dose of Blue Light.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

This 510(k) summary does not contain any information about acceptance criteria or specific studies to prove device performance.

The document explicitly states under the "Performance Data" section: "No Data Provided."

Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices. This means the manufacturer is asserting that their device is as safe and effective as existing, approved devices because it has a similar design, operates on the same principles, and is intended for the same use.

Therefore, since no performance data was provided, it's impossible to fill out a table of acceptance criteria or describe a study proving the device meets them.

However, I can extract the other requested information based on the premise that a study would exist, though none is present in this 510(k) summary.

Summary of Acceptance Criteria and Device Performance (Not Applicable - No Data Provided)

Since no performance data was provided, the following sections will indicate "Not Applicable" or "No information provided" as the relevant details are missing from the given document.

Detailed Information about the Study (Not Applicable - No Study Data Provided)

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

   • Sample Size (Test Set): No information provided.
   • Data Provenance: No information provided.

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):

   • No information provided.

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

   • No information provided.

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 information provided. (The device is a light therapy device, not an AI-assisted diagnostic tool, so an MRMC study in this context is unlikely).

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

   • No information provided. (The device is a light therapy device, not an algorithm, so this concept does not apply).

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

   • No information provided.

7. The sample size for the training set:

   • No information provided.

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

   • No information provided.

Reasoning for "No Data Provided"

The Daavlin Distributing Company's 510(k) submission for the PlasmaLuxLS relies on demonstrating substantial equivalence to predicate devices rather than providing new performance data from clinical studies for this specific device. They state:

• "The PlasmaLuxLS is constructed in the same design configuration as the predicate devices, utilizing similar energy types and materials of identical composition."
• "The light emitted by the PlasmaLux is of identical spectrum and power as that of the predicate devices."
• "The PlasmaLux can be used with exactly the same treatment regimes as the predicate devices."

This approach is common for devices that are very similar to already approved ones, where the FDA determines that new clinical performance data is not necessary to establish safety and effectiveness. The "Performance Data: No Data Provided" explicitly indicates that the manufacturer did not submit specific studies for this device.

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This is a hand held device intended to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

The Baby Quasar consists of a collection of red and near infrared diodes [LEDs], packaged in a compact handheld device. The device has a head containing the led array, momentary switch, and indicator light.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Baby Quasar Infrared Lamp:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document focuses on demonstrating substantial equivalence to a predicate device rather than setting specific quantitative acceptance criteria or reporting detailed clinical performance metrics like wrinkle reduction percentages or photographic evidence. The "reported device performance" is largely framed by its similarity to the predicate device.

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

The provided document does not mention any clinical test set involving human subjects for evaluating the effectiveness of the Baby Quasar device. The testing described primarily covers functional performance, electrical safety, and EMC of the device itself.

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

As there's no mention of a clinical test set with human subjects, there's no information about experts used to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set using human subjects is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is an infrared lamp for wrinkle reduction, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI-related metrics are relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

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

7. The Type of Ground Truth Used

For the device's functional and safety testing, the ground truth would be based on established engineering and safety standards (e.g., power level specifications, electrical safety criteria, EMC standards).

For the intended effect (wrinkle reduction), the document states an equivalence to predicate devices, which would have historically demonstrated effectiveness. However, no specific clinical ground truth (e.g., expert consensus on wrinkle severity, photographic analysis) is described for the Baby Quasar itself in this submission.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product that utilizes a training set.

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

Not applicable, as there is no training set mentioned.

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The ClearWave Phototherapy System for Acne provides phototherapeutic blue light to treat mild to moderate inflammatory acne.

The Clear Wave® Phototherapy System for Acne is a hand held light device which emits a low intensity of blue light at a wavelength of 414 ± 10 nm in the visible range of the spectrum. The head is programmed with a timed treatment cycle. The light modules are contained in the changeable head of a hand held device. The Clear Wave® Phototherapy System for Acne is small and light weight which allows for easy handling and mobility.

This looks like a 510(k) submission for a phototherapy device for acne, not an AI/ML medical device. The provided text describes the device, its intended use, and substantial equivalence to a predicate device, focusing on electrical safety, biocompatibility, and usability testing. There is no mention of an algorithm or AI.

Therefore, most of the requested information regarding acceptance criteria, study details for AI performance, sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, or MRMC studies is not applicable to this document.

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The Anti-Wrinkle Light, model: AAL, is a handheld device intended for use in the treatment of periorbital wrinkles.
The Anti-Wrinkle Light is a hand held device intended to emit energy in the visible and IR regions of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

The Anti-Wrinkle Light, Model AAL is a hand-held device consisting of low intensity light emitting diodes (LED's) that emit Low and Sub- IR light for direct exposure to the skin. The device components include an LED array of 605nm, 630nm, 660nm, and 855nm wavelengths, a (non-flammable plastic) hand piece housing a printed circuit board upon which the LED's are mounted, single non-timer on/off switch with 5-ohm resistor, receiver jack in the hand piece accommodating a removable power cord and a separate AC to DC ( 9-volt ) power supply. Treatment time is recommended to be 3 minutes and is controlled by the user.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Anti-Wrinkle Light, Model AAL:

It's important to note that the provided 510(k) summary (K092800) for the Anti-Wrinkle Light, Model AAL, is extremely limited in the detail it provides about the clinical study conducted. Many of the requested details are not present in the document.

Acceptance Criteria and Reported Device Performance

The document states, "After an analysis of the safety, indications and intended uses, performance, features, technological properties and methods of operation, LED Intellectual Properties, LLC believes that no significant differences exist between the predicate devices listed in Section 3, above. A clinical study has been submitted."

This implies that the acceptance criterion was likely demonstrating substantial equivalence to predicate devices, particularly in performance for the reduction of periorbital wrinkles and rhytides. However, the specific quantitative acceptance criteria (e.g., a certain percentage reduction in wrinkles, or a specific score improvement) and the corresponding reported device performance (i.e., the numerical results from the clinical study) are NOT provided in this summary.

Therefore, a table of acceptance criteria and reported device performance cannot be fully constructed from the given information as the specific performance metrics and outcomes are absent. The general "performance" stated is that it is believed to be "no significant differences" from predicates.

Study Details:

Here's what can be extracted and what is missing:

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

   • Acceptance Criteria: Implicitly, substantial equivalence to predicate devices for the reduction of periorbital wrinkles and rhytides. No specific quantitative criteria (e.g., target percentage reduction, statistical significance) are stated.
   • Reported Device Performance: Not provided in the summary. The summary only states that "LED Intellectual Properties, LLC believes that no significant differences exist between the predicate devices," implying successful performance relative to the predicates, but no specific outcome data is presented.

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

   • Sample Size: Not specified. The document only mentions "Individual subjects participating in the clinical study."
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

   • This information is not provided in the document.

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

   • This information is not provided in the document.

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 not applicable as the device is a therapeutic light device, not an AI diagnostic/interpretive tool that assists human readers.

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

   • This is not applicable as the device is a therapeutic light device, not an AI algorithm. Its performance is measured directly on the patient's skin condition.

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

   • The "ground truth" for a device intended for wrinkle reduction would typically involve clinical assessment of wrinkle severity before and after treatment, possibly using standardized grading scales (e.g., Fitzpatrick Wrinkle Scale, photonumeric scales) or objective measurements (e.g., 3D imaging). However, the specific method used is not detailed in this summary. It would fall under "outcomes data" or expert assessment of outcomes.

8. The sample size for the training set:

   • This device is not an AI/machine learning algorithm that requires a "training set" in the conventional sense. It's a light therapy device. The clinical study mentioned would be considered the validation or performance study, typically for demonstrating safety and effectiveness on an independent cohort.

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

   • Not applicable for a therapeutic light device.

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