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The Silk'n Toothwave is a powered radiofrequency toothbrush intended to promote good oral hygiene, including reduction of plaque, and the prevention and treatment of gingivitis.

The Silk'n Toothwave is intended for over-the-counter use.

The Silk'n Toothwave device (a.k.a Silk'n H7001 Powered Toothbrush) is a handheld, rechargeable, powered, radiofrequency toothbrush, an over-thecounter device, intended to promote good oral hygiene, including reduction of plaque and the prevention and treatment of gingivitis. The Silk'n Toothwave Device is comprised of the handheld, brush head and recharging units. The device utilizes radio frequency (RF) energy and vibration.

The Silk'n Toothwave is comprised of the handle, the brush head, and recharging unit. The brush head is designed with radiofrequency electrodes and bristles. The handheld unit contains the software, programming, and hardware necessary for the device to function. The device is operated by a push button for activation of the radiofrequency and vibration.

The Silk'n Toothwave device is operated by a single mode push-button located on the handle/hand piece user interface board and a set of light indicators informing the lay user of the device operation.

The Silk'n Toothwave device is designed as a rechargeable handheld electrical toothbrush comprised of the charging base unit and a rechargeable power handheld unit. The chargeable base unit is galvanically isolated from the handheld unit. The Silk'n ToothWave Device is electrically safe in accordance with medical device electrical safety standards (IEC 60601-1, IEC 60601-2-2 and IEC 60601-1-11).

The Silk'n ToothWave Device utilizes vibration and low power RF energy technologies. The action of the brush head has a vibration frequency up to 400Hz. The RF generator generates conductive RF energy at 3 MHz, with a maximal output power of 3W.

The handle or hand piece brush head is designed as a medium oval brush head and features an arrangement of bristles surrounding two low profile hidden RF electrodes and a silicon barrier located in-between the two electrodes. The handle or hand piece is equipped with an ON/OFF switch and indicator panel that indicates the device status (RF activation, vibration level, charging, or error).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Silk'n Toothwave device, structured according to your request.

Please note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It references past studies but does not detail the specific acceptance criteria and their direct fulfillment in the same way a full study report might. Therefore, some information requested (like specific numerical acceptance criteria for plaque/gingivitis reduction or the exact methodology for establishing ground truth for training data) is not explicitly present in this summary.

Acceptance Criteria and Reported Device Performance

The document describes the intended use of the Silk'n Toothwave device as promoting good oral hygiene, including reduction of plaque, and the prevention and treatment of gingivitis. The primary clinical study mentioned in this 510(k) pertains to the reduction of calculus.

Study Details

The provided 510(k) references several studies, primarily performed for a previous DeNovo application (DEN190039). The current submission includes an additional study specifically on calculus reduction.

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

• Calculus Reduction Study (additional study in this 510(k)):

  • Test Set Sample Size: 90 subjects (randomly assigned to either ToothWave or control brush).
    • ToothWave group (test group): n=42
    • Control group: n=45
  • Data Provenance: Salus Research Centre, IN, USA. Prospective.

• Previous Studies (submitted in DEN190039 for plaque/gingivitis):

  • Sample Size: Not specified in this document.
  • Data Provenance: Not specified in this document, but implied to be prospective based on the description of "single-blinded, double arm randomized prospective study" and "additional self-selection study."

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

• Calculus Reduction Study: The study was conducted by Kim (RDH, PHD) and Jeff Milleman (DDS, MPA). These are likely the experts who established the ground truth (e.g., conducted the Volpe-Manhold Index (V-MI) examinations). The exact number of examiners used for each subject is not specified (e.g., if both examined each subject or if one was primary).
  • Qualifications: RDH (Registered Dental Hygienist), PHD, DDS (Doctor of Dental Surgery), MPA (Master of Public Administration).
• Previous Studies: Not specified in this document.

4. Adjudication method for the test set

• Calculus Reduction Study: The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It describes the V-MI examinations performed by the named experts.
• Previous Studies: Not specified in this 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

• No, an MRMC comparative effectiveness study was not done. This device is a powered toothbrush, not an AI diagnostic or assistance system for human readers. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

• Not applicable. This device is a physical product (a toothbrush) that relies on direct human-in-the-loop operation. It is not an algorithm evaluated for standalone performance.

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

• Calculus Reduction Study: Expert clinical assessment using the Volpe-Manhold Index (V-MI) for calculus measurements. This is a recognized clinical index.
• Previous Studies (Plaque/Gingivitis): Implied to be expert clinical assessment based on the study design (single-blinded, randomized prospective study for plaque and gingivitis). Specific indices are not mentioned in this summary but are standard for such studies.

8. The sample size for the training set

• Not applicable. This device is a physical product, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" in this context would refer to the device development leading to its final design, which is not quantified in terms of a sample size.

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

• Not applicable. As above, there is no "training set" in the context of an AI/ML algorithm to establish ground truth for. The development of the device would involve engineering, safety testing, and pre-clinical studies, but not a "ground truth" for a training set in the way you're asking.

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ToothWave™ is indicated as follows:

ToothWave™ is a powered radiofrequency toothbrush intended to promote good oral hygiene, including reduction of plaque and the prevention and treatment of gingivitis. ToothWave™ is intended for over-the-counter use.

The ToothWave™ is a handheld rechargeable electric toothbrush intended to promote oral hygiene, including reduction in plaque and prevention and treatment of gingivitis. The device is for over-the-counter (OTC) use. The device is comprised of the handle, the brush head, and recharging unit. The device utilizes radiofrequency (RF) energy and tactile vibration. The device is operated by a single-mode push button located on the handle/user interface board and includes a set of light indicators informing the user of the device operation (RF activation, vibration level, charging, or error).

The request concerns the ToothWave™ device, a radiofrequency toothbrush. The provided text outlines the device's technical specifications, non-clinical/bench studies, and clinical studies to demonstrate its safety and efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the "Special Controls" section, which outlines requirements for performance testing, label comprehension, usability, biocompatibility, electrical/thermal/safety testing, software validation, and labeling content. The "SUMMARY OF NONCLINICAL/BENCH STUDIES" and "SUMMARY OF CLINICAL INFORMATION" detail how the device's performance meets these criteria.

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

The primary clinical efficacy and safety study ("Safety and Efficacy of the ToothWave™ Toothbrush...") had a test set (randomized subjects, ITT Analysis Set) of 86 subjects: 45 in the treatment group (ToothWave™) and 41 in the control group.

The usability study component used the 45 subjects from the treatment group of the efficacy study.

The self-selection study involved 10 subjects (5 potential end users and 5 contraindicated subjects).

Data Provenance: The text does not explicitly state the country of origin for the clinical study data, but the sponsor information is Home Skinovations Ltd. in Yoqneam Illit, ISRAEL. The study type was a prospective, single-blinded, double-arm randomized study.

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

For the clinical efficacy study, "Efficacy was evaluated by examiners trained in the assessment of gingivitis, dental plaque and calculus." The exact number of examiners is not specified, nor are their specific qualifications (e.g., "radiologist with 10 years of experience"). However, the statement implies qualified personnel performed the assessments to establish ground truth for plaque, calculus, and gingivitis indices.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for disagreements among experts (e.g., 2+1, 3+1). The efficacy assessments were performed by "examiners," implying a standard protocol, but no specific adjudication process is mentioned.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The primary clinical study compared the device (ToothWave™) to a control power toothbrush, not human readers with and without AI assistance. The study focused on the effectiveness of the device itself in reducing plaque, calculus, and gingivitis.

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

No, a standalone (algorithm only) performance study was not conducted. The ToothWave™ is a medical device (a toothbrush) that is used by a human. Its efficacy is directly tied to human use (brushing twice daily). The clinical study evaluated the device's performance in human subjects using it.

7. Type of Ground Truth Used

For the clinical efficacy study, the ground truth was established by expert assessment using validated clinical indices:

• Plaque: Navy Plaque Index (RMNPI)
• Calculus: Volpe-Manhold Index (V-MI)
• Gingivitis: Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI)

These are objective clinical measures assessed by trained examiners.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI algorithms for establishing device performance. The non-clinical and clinical studies are focused on validating the device's physical and functional capabilities and its effectiveness in human use. If "training set" refers to data used to develop the device or its software, that information is not provided. The software section mentions "software verification & validation," which relates to quality assurance for the finished software, not a training phase for a learning algorithm.

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

As noted in point 8, there is no mention of a "training set" in the context of an AI/ML algorithm within the provided text. The device's performance and safety were evaluated through bench testing and clinical trials, not through an AI model that requires a labeled training set for its development.

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The Silk'n Model H5003 is indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs and buttocks areas.

Contraindicated use on injured or otherwise impaired muscles.

Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

The Silk'n MODEL H5003 device is an over-the-counter home use EMS device intended for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. The Silk'n Model H5003 system is comprised of a treatment unit - "applicator", a belt for placing and holding the applicator and a cradle unit for charging of the applicator's battery. The device generates an electrical signal. which is required for muscle stimulation and is transferred to the muscles via the device electrodes.

The Silk'n MODEL H5003 device is easily operated by a single mode push-button, two operational buttons for selection of EMS level, and a set of light indicators informing the lay-user on the device current operation mode (i.e., EMS level treatment, standby or error), all are located on the applicator user interface board.

The Silk'n MODEL H5003 device is equipped with a safety proximity sensor, which initiates the signal only upon full contact between the electrodes and the skin, and disconnects the power in case of no contact during the device operation.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Silk'n MODEL H5003 device, structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter and 510(k) summary for the Silk'n MODEL H5003 device primarily rely on demonstrating substantial equivalence to a predicate device, rather than defining novel clinical performance acceptance criteria with specific thresholds for a new clinical indication.

Instead, the "acceptance criteria" are implied by compliance with recognized standards and the demonstration that the device's technical specifications and intended use are similar to a legally marketed predicate device, without raising new questions of safety or effectiveness.

Summary of the Study Proving Acceptance Criteria:

The provided document describes a Non-Clinical (Bench) Performance Data study to demonstrate that the device performs as expected and meets design requirements. It is not a clinical study to establish new clinical efficacy or safety, but rather to show that the device performs technically as intended and is safe when used according to its design specifications. The primary study presented is for Substantial Equivalence to a predicate device.

Details of the Study:

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

• Non-Clinical (Bench) Performance Data: The document does not specify a "sample size" in terms of patients or human subjects, as it was a bench test. It implies multiple units of the Silk'n MODEL H5003 device were tested.
• Data Provenance: The tests were conducted internally ("A set of performance tests were conducted... to demonstrate that the Silk'n MODEL H5003 device performs as expected..."). No country of origin for the data is explicitly stated for the bench tests, but the applicant and contact persons are based in Israel. The study is retrospective in the sense that the testing was performed on the completed device design.

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

• Not applicable (N/A): This type of information (experts, ground truth, qualifications) is relevant for studies involving human interpretation or subjective assessments, often in clinical or diagnostic contexts. For bench testing of an electrical device against technical specifications and safety standards, the "ground truth" is established by the specifications themselves and the relevant international standards (e.g., IEC 60601 series). Compliance is measured by instrumentation, not expert consensus.

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

• N/A: Adjudication methods are used in clinical trials or studies where there is subjective assessment or disagreement among multiple evaluators. For bench testing against objective technical standards, adjudication is not typically employed. The results are based on objective measurements by testing equipment.

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: No MRMC or clinical comparative effectiveness study involving human readers or AI assistance was performed or reported. The device is a "Powered Muscle Stimulator" and the evaluation focuses on its technical safety and performance compared to a predicate device, not on AI-assisted interpretation or diagnostic accuracy.

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

• No: The device is a physical electromedical device; it does not feature an algorithm for diagnostic or interpretative purposes in the way an AI medical device would. Its performance is related to its electrical output and safety mechanisms, which were tested in a standalone (algorithm-only) sense, meaning the device itself was tested without human interaction during the measurement process, but this is not analogous to an AI algorithm's standalone performance.

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

• For the non-clinical performance data, the "ground truth" was based on predefined technical specifications and international safety/performance standards (e.g., output voltage, current, pulse rate, pulse width measurements, and compliance with IEC 60601 series). These are objective, measurable parameters.

8. The sample size for the training set:

• N/A: The provided document does not mention a "training set." This term is typically used in the development of machine learning or AI models. The Silk'n MODEL H5003 device is an electrical stimulator, not an AI/ML device.

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

• N/A: As there's no mention of a training set, the establishment of ground truth for such a set is not applicable.

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The Silk'n Infinity is an over the counter device intended for the removal of unwanted hair. The Infinity device is also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The Silk'n Infinity electric output is indicated for facial stimulation for over-the-counter aesthetic use.

The Silk'n Infinity device is designed as a hand held, home use device, which utilizes Intense Pulsed Light (IPL) for hair removal and galvanic microcurrents for skin stimulation. The device comprises a power adaptor and device applicator. The applicator consists of a single lamp producing the light energy that is emitted via the flash window, and a chrome-coting stripe (touch electrode) located around the flash window, through which the micro-current pulses are discharged. The applicator spot size is 2.7cm2 The user interface located on the applicator contains ON/OFF button, pulsed trigger button and six green LED indicators which provide information on the energy level, system status & errors. The Silk'n Infinity device contains a skin sensor, providing the user with an additional safety measure to detect appropriate skin tones and a proximity sensor that identifies full contact with the skin before pulse activation. The light output power range is from 3 to 5 J/cm 2, the optical filter cut off wavelength is 475-1200nm.

This document is a 510(k) summary for the Silk'n Infinity device, which is an over-the-counter device intended for hair removal and facial stimulation. The focus of this document is to demonstrate "substantial equivalence" to predicate devices, rather than to prove performance against specific acceptance criteria for a novel device through a formal study.

Therefore, many of the typical elements of an AI/ML device study described in the prompt (e.g., test set sample size, number of experts, MRMC studies, standalone performance, ground truth establishment) are not applicable or not present in this document.

The document primarily focuses on:

• Bench testing: Verifying output parameters and safety in simulated home-use settings.
• Compliance with recognized standards: Showing the device meets established electrical, mechanical, and safety standards for medical electrical equipment.
• Substantial Equivalence Argument: Comparing the Silk'n Infinity to legally marketed predicate devices (Silk'n Glide for IPL hair removal and Facial Spa for microcurrent facial stimulation) based on similar technology, intended use, and safety features.

Here's an attempt to answer the questions based only on the provided text, acknowledging that many questions relate to performance studies that were not conducted or detailed in this 510(k) summary:

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

The document does not present a formal table of acceptance criteria for a device's performance against clinical endpoints like hair reduction efficacy or skin stimulation effectiveness, nor does it provide reported device performance data in that format. Instead, the acceptance is based on:

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

• Test Set Sample Size: For the "simulated home use settings" safety test, the sample size was eight human volunteers.
• Data Provenance: The document does not explicitly state the country of origin for the volunteers. The study was a "bench test" described as evaluating device safety in a simulated home use setting, implying a prospective test conducted for this submission.

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

This information is not provided in the document. The "simulated home use settings" test was a safety test, not a performance study requiring human "ground truth" for disease detection or similar tasks.

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

This information is not applicable/provided. The described tests are bench and safety performance tests, not clinical efficacy studies requiring adjudication of outcomes or diagnoses.

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 MRMC comparative effectiveness study was done or reported in this document. This device is not an AI/ML diagnostic or assistive tool for human readers.

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

This information is not applicable/provided. This device is a direct-use medical device (IPL hair removal and microcurrent stimulation), not an algorithm. Bench tests were performed on the device itself to verify output and safety parameters.

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

For the safety test on human volunteers, the "ground truth" would be the direct observation of adverse events or lack thereof, relative to device parameters. For the technical specifications, the ground truth is established by engineering measurements against predetermined design requirements and compliance with recognized standards.

8. The sample size for the training set:

Not applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. As above, this is not an AI/ML algorithm.

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The Silk'n HST is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV.

The Silk'n HST device is designed as a hand held device, which utilizes both RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (red and IR wavelengths, respectively) and a temperature stabilizer. The Silk'n HST device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The treatment surface is located at the applicator tip and comes in direct contact with the skin. The applicator is equipped with an ON/OFF switch that also selects the energy level as manifested using indicators panel. The adaptor connects the applicator to the electrical outlet using its plug and the applicator socket.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device Name: Silk'n HST
Intended Use: Over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV.

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for effectiveness appears to be a statistically significant reduction of at least 1.0 score in the average score of the Fitzpatrick Wrinkle Severity Scale, according to at least 2 out of 3 blinded dermatologists, measured 3 months post-treatment end compared to baseline.

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

• Sample Size for Effectiveness Study (Test Set): 30 eligible adults (N=30, completer case analysis).
• Sample Size for Usability/Self-Selection Study (Test Set):
  • Self-selection: 25 subjects.
  • Usability/Labeling Comprehension: 20 subjects (from the 25, implying 5 were excluded due to contraindications).
• Data Provenance: The clinical study was conducted at a certified clinic in the US. The text does not explicitly state whether it was retrospective or prospective, but the description of the study design ("included 21 treatment sessions every other day, over a period of 6 weeks, and 2 maintenance treatments," "3 months following treatment end") strongly suggests a prospective study.

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

• Number of Experts: 3 blinded dermatologists.
• Qualifications of Experts: They are referred to as "blinded dermatologists," indicating a medical specialization relevant to skin conditions and aesthetic evaluation. No specific experience (e.g., years) is mentioned.

4. Adjudication Method for the Test Set

The effectiveness criterion explicitly states "according to at least 2 out of 3 blinded dermatologists." This indicates a 2/3 majority consensus adjudication method for determining success on the Fitzpatrick scale.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted. This study focused on the effectiveness of the device itself (AI is not mentioned here as assisting human readers, rather the device is the treatment).

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

This device is a physical, home-use treatment device (combining RF and LED energies) for wrinkles, not an AI algorithm. Therefore, the concept of a "standalone algorithm-only performance" does not apply in the context of this submission. The performance measured is that of the device's effect on patients.

7. The Type of Ground Truth Used

The ground truth for effectiveness was established by expert consensus (at least 2 out of 3 blinded dermatologists) using the Fitzpatrick Wrinkle Severity Scale. User satisfaction and usability were derived from subject questionnaires and observed task performance.

8. The Sample Size for the Training Set

The document does not mention any "training set" in the context of machine learning or AI models. This device is a physical energy-based device, not a software algorithm that requires a training set. The clinical study described served as the primary test set for the device's safety and effectiveness.

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

As there is no mention of an AI algorithm or a training set, this question is not applicable. The device's performance was evaluated through a clinical study where outcomes were assessed by blinded dermatologists and participant feedback.

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HeatLux Pro II is an over the counter hand held device intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.

The HeatLux Pro II Device is an over the counter, hand held device, utilizing low power light spectrum, array of 24 LEDs, at wavelength of 630±10nm and 850±50nm, RF output power (1MHz. maximal output power 24W) and electrical heating. The HeatLux Pro II Device consists of an applicator and an adaptor. The applicator is a hand held unit used for treatment, as the treatment surface at the applicator tip comes in direct contact with the skin. The device applicator comprises temperature stabilizer, which constantly maintains the applicator temperature to 41ºc.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Preamble: This document describes the acceptance criteria and studies for the HeatLux Pro II Device, an over-the-counter handheld device intended for temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the device's compliance with several performance standards and safety tests rather than explicit quantitative acceptance criteria with numerical targets. However, the overall acceptance criterion is Substantial Equivalence to legally marketed predicate devices, which is demonstrated by meeting various technical specifications, safety standards, and performance characteristics.

Key Device Specifications (Relevant for comparison to predicates):

• RF frequency: 1MHz
• Maximal RF output power: 24W
• Maximal heating plates output power: 12W
• Maximal optical power density: 60mWatts/cm²
• LED Wavelengths: 630±10nm and 850±50nm

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

• Sample Size for Usability Study: Twenty eligible device users.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the study was conducted to evaluate user performance for this specific device, implying it was a prospective study. The applicant is Home Skinovations Ltd., located in Israel, so it's possible the study was conducted there.

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

• Usability Study: The document describes a "user performance (usability) study" with "device users." It does not mention the use of experts to establish a "ground truth" in the traditional sense of medical diagnosis. Instead, the study assessed the users' ability to operate the device and understand its labeling. The "ground truth" here would be the observed user interactions and safety outcomes. It tested if users could act safely and effectively, not if they could accurately diagnose a condition.

4. Adjudication Method for the Test Set

• Usability Study: No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The study's focus was on direct observation of user performance and comprehension of instructions, rather than expert judgment on ambiguous cases. The "study results showed that potential device users had successfully operated the device as intended with no safety issues reported," suggesting a clear outcome was observed for each participant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.

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

• This device is not an AI/algorithm-based diagnostic or assistive device. It is a physical medical device that emits energy. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The performance studies focus on the physical device's specifications, safety, and human interaction/usability.

7. The Type of Ground Truth Used

• Bench Tests (Thermal Profile, RF Depth, Temperature Stability): The ground truth was based on objective measurements against pre-defined system requirements and engineering specifications.
• Safety Standards (IEC series): The ground truth was compliance with the requirements set forth in the international voluntary standards.
• Biocompatibility (ISO 10993-1): The ground truth was compliance with the international standard for biological evaluation of medical devices, leveraging prior testing of the predicate device.
• Usability Study: The "ground truth" was the observed actual performance of users in operating the device and understanding its labeling, confirming safe and effective use.

8. The Sample Size for the Training Set

• This is not an AI/machine learning device; therefore, the concept of a "training set" in that context is not applicable.
• However, regarding device development and testing: The device's design and software modifications were likely guided by previous versions (like HeatLux Pro I) and engineering principles. The "training" or development data would be internal engineering data, prototypes, and iterative testing, which is not detailed in the summary.

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

• As this is not an AI/machine learning device, the concept of "ground truth for a training set" as typically understood in AI development is not applicable.
• For the development and optimization of the physical device, ground truth would have been established through engineering principles, physical laws, established safety standards, and iterative bench testing during the design and manufacturing process, to ensure the device met its intended specifications and safety profile.

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HeatLux Pro I is over the counter hand held device intended to emit energy in the visible and near IR spectrum to provide topical heating for the purpose of elevating tissue temperary relief of minor muscular and joint pan and stiffness, minor arthritis pam or muscle spasm, the temporary increase in local and blood carculation, and temporary relaxation of muscles.

The HeatLux Pro I device is a hand held device, using low power light spectrum, array of 24 LEDs, at wavelength of 630±10nm, combined with four metal heating plates (temperature stabilized to 41%). The HeatLux Pro I device consists of an applicator and an AC/DC power adaptor. The applicator is a hand held unit used for treatment, as the treatment surface at the applicator tip comes in direct contact with the skin.

I am sorry, but the provided text is a 510(k) summary for a medical device and does not contain the detailed information necessary to answer your request in the specified format. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria for performance, clinical study designs, or expert-based ground truth establishment for a machine learning algorithm.

Specifically, the document states:

• "Clinical Performance Data: Not Applicable"
• "Pre-Clinical (Animal Study) Performance Data: Not Applicable"
• "Non-Clinical (Bench) Performance Data: A set of bench tests were performed to evaluate the thermal profile and temperature stability of the HeatLux Pro I device and to compare them to the thermal profile and temperature stability of the HeatLux 1 device. The results of the bench tests demonstrated that the HeatLux Pro I device has the same thermal profile and temperature stability properties as those reported for the predicate device."

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance related to a diagnostic or AI-driven task.
2. Sample sizes, data provenance, or details on test sets.
3. Information on experts, ground truth establishment, or adjudication methods.
4. Details on MRMC studies or human reader improvement with AI.
5. Standalone algorithm performance.
6. Ground truth types for algorithm training or testing.
7. Training set sample size or how its ground truth was established.

This document describes a device that provides topical heating and relies on demonstrating similar thermal characteristics to a previously cleared device, rather than an AI/ML-driven diagnostic or treatment selection device that would require the information you've requested.

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The Glide™ device is an over the counter device intended for the removal of unwanted hair. The Glide™ device is also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The Glide device is a pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The Glide device is composed of a hand held applicator. The device contains 6 LEDs indicating 5 different energy levels and other device functions. The spot size in the Glide device is 2.7cm2. The device contains a lamp, a temperature sensor, a skin proximity sensor and a skin color sensor to detect appropriate skin tones. The skin sensor scans darker skin tones and will not pulse if the skin tone is not suitable for treatment.

This 510(k) submission (K141242) for the Home Skinovations Glide Device indicates that this device is identical to a previously cleared device (K131870). Therefore, the clinical performance data provided here actually refers to the study conducted for the K131870 submission.

Here's a breakdown of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format. However, the "Indications for Use" section defines the goal of the device, which implicitly sets the performance target. The reported performance is based on the findings of the clinical study.

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

• Sample Size: Not explicitly stated for the test set. The document mentions "a prospective clinical study," but does not provide the number of participants.
• Data Provenance: The study was "prospective," meaning data was collected specifically for the purpose of the study going forward. The country of origin for the data is inferable as likely being Israel, given the applicant and contact persons' addresses, but this is not explicitly stated.

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

This information is not provided in the document. The study simply states "evaluated hair removal," without detailing the method of assessment or the involvement of experts in establishing ground truth.

4. Adjudication Method 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, and the Effect Size

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a clinical study evaluating the device's performance, not a comparison of human readers with and without AI assistance. The device itself is a "pulsed light hair removal device," not an AI diagnostic tool.

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

This question is not applicable as the device is a physical hair removal device, not an algorithm.

7. The Type of Ground Truth Used

The type of ground truth is implicitly the observed hair regrowth/removal from the facial skin of participants in the clinical study. The method of quantifying this observation (e.g., hair counts, photographic assessment by experts) is not detailed.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical hair removal device, not an algorithm that requires a training set in the typical AI sense.

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

This question is not applicable, as there is no "training set" in the context of this physical device.

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The Glide™ device is an over the counter device intended for the removal of unwanted hair. The Glide™ device is also intended for permanent reduction in hair regrowth, defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The Glide device is a pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The Glide device is composed of a hand held applicator. The device contains 6 LEDs indicated 5 different energy levels and other device functions. The spot size in the Glide device is 2.7cm . The device contains a lamp, a temperature sensor, a skin proximity sensor and a skin color sensor to detect appropriate skin tones. The skin sensor scans darker skin tones and will not pulse if the skin tone is not suitable for treatment.

This document describes the premarket notification for the "Glide Device," a pulsed light hair removal device. The submission primarily relies on substantial equivalence to a previously cleared device rather than on extensive new clinical performance data. Therefore, many of the typical acceptance criteria and study details for AI/software-based devices are not applicable.

Here's an analysis of the provided information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria for clinical performance (e.g., hair reduction percentage). Instead, it focuses on demonstrating safety and functional equivalence to a predicate device. The primary "acceptance criteria" are compliance with voluntary recognized standards and successful usability testing.

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

• Usability Study: The test set for the usability study consisted of 20 potential device end users.
• Data Provenance: The study was likely conducted prospectively in a simulated home use environment for the usability assessment. The country of origin is not specified but the applicant is based in Israel.
• Clinical Performance: No specific clinical test set data from the Glide device is provided or used for evaluation as the submission relies on substantial equivalence.

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

• Usability Study: The document does not mention the use of "experts" to establish a ground truth for the usability study in the traditional sense of clinical experts (e.g., radiologists). The "ground truth" for usability was likely defined by successful completion of tasks by the 20 end users and their subjective feedback through questionnaires.
• Clinical Performance: For clinical performance (hair reduction), no new clinical studies with expert-established ground truth were performed for the Glide device, as the submission relies on substantial equivalence.

4. Adjudication Method for the Test Set

• Usability Study: No explicit adjudication method (like "2+1" or "3+1") is described. The assessment of "successful completion of tasks" for the 20 users appears to have been direct observation and possibly self-reporting via questionnaires.
• Clinical Performance: Not applicable, as no new clinical test set data from the Glide device was presented.

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 pulsed light hair removal device, not an AI or software-assisted diagnostic or interpretative tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this submission.

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

• Not Applicable. This is a hardware device. While it contains software for controlling its functions (like skin color sensing), it's not an "algorithm-only" or AI diagnostic device in the context typically discussed for standalone performance evaluations. The device's safety features (skin sensor, temperature sensor) operate automatically.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Usability Study: The "ground truth" was essentially the observed success of users completing device operation tasks and their qualitative feedback on usability. This is not a clinical ground truth like pathology or outcomes data.
• Clinical Performance: For the intended use of permanent hair reduction, the ground truth would typically be hair count reduction measured at specific time points. However, for the Glide device submission, this outcome data was not specifically collected for this device during the approval process. The claim of achieving permanent hair reduction relies on the substantial equivalence to the predicate device, which presumably demonstrated this through its own studies.

8. The Sample Size for the Training Set

• Not Applicable. This submission does not describe an AI/ML algorithm that requires a "training set" in the conventional sense. The device's software is related to control functions and safety features, which are typically validated through software testing and hardware integration rather than machine learning training.

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

• Not Applicable. As there is no described AI/ML training set, the establishment of ground truth for such a set is not relevant.

In Summary:

The K131870 submission for the Glide Device is a 510(k) premarket notification primarily based on substantial equivalence to an existing predicate device (Silk'n Flash N Go). Therefore, it largely emphasizes demonstrating that the new device shares similar technological characteristics, performance specifications, and safety features with the predicate, and complies with relevant safety standards.

A usability study was conducted with 20 end users to ensure safe and effective operation given minor design changes, and this served as a key performance data point for the new design. However, there were no new clinical trials with specific acceptance criteria for hair reduction performed for this particular submission, nor are there any AI/ML components requiring training sets or MRMC studies.

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The Silkn Blue is indicated as an over the counter phototherapy device for the treatment of mild to moderate acne.

Silkn Blue is a hand held device battery operated that uses low power light spectrum, LED, at wavelength of 415 ±15 nm, combine with tip temperature stabilizer at 41ºC. The emitting optical power is in a uniform distribution with no hot spots.

The provided text describes a clinical study to demonstrate the performance and safety of the Silkn Blue device for treating mild to moderate acne. However, it does not specify pre-defined acceptance criteria (e.g., a minimum percentage improvement or reduction in lesion count that the device needed to achieve to be considered successful).

The study aims to determine the ability of the device to treat mild to moderate inflammatory acne and to assess if users can operate it correctly.

Here's the information parsed from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Sample Size for Test Set: 50 subjects
• Data Provenance: Not explicitly stated, but the company is based in Israel, so it's likely the study was conducted there or a similar region. The study is prospective as it involves subjects using the device over a specified period with follow-up visits.

3. Number of Experts and Qualifications for Ground Truth:

• The document does not specify the number of experts used or their qualifications to establish the ground truth for the test set. It mentions "2 follow-up visits to evaluate the results," suggesting clinical evaluation, but doesn't detail who performed these evaluations.

4. Adjudication Method:

• The document does not specify an adjudication method (e.g., 2+1, 3+1).

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

• No, an MRMC comparative effectiveness study was not done. The study is a single-arm clinical trial evaluating the device's performance, not comparing human readers' performance with and without AI assistance. The Silkn Blue is a phototherapy device, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

• No, a standalone study was not done. The Silkn Blue is a physical phototherapy device with human-in-the-loop (the user operating it). It does not involve an algorithm working independently.

7. Type of Ground Truth Used:

• The ground truth used was based on clinical evaluation ("reduction in lesion count") performed during follow-up visits by unmentioned evaluators and self-reported usability via a questionnaire.

8. Sample Size for Training Set:

• The concept of a "training set" is not applicable here as the Silkn Blue is a physical medical device, not an AI or machine learning algorithm that requires training data.

9. How Ground Truth for Training Set Was Established:

• As above, the concept of a "training set" and establishing ground truth for it is not applicable for this device.

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