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

The Silk'n Titan AllWays is a cordless, hand-held device, utilizing RF energy and low power light spectrum. The device includes an RF generator, an array of 8 LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths respectively), and a temperature stabilizer. The Silk'n Titan AllWays consists of an applicator and an adaptor. The hand-held applicator delivers energy from the treatment surface at the applicator tip which comes in direct contact with the skin. The applicator is equipped with an ON/OFF switch (that also selects the energy level) and an indicators panel. The device can be powered by an internal rechargeable battery (cordless mode) or with the AC adaptor that connects the applicator to an electrical outlet.

The provided text describes the regulatory clearance for the Silk'n Titan AllWays device but does not present specific acceptance criteria or an explicit "study that proves the device meets the acceptance criteria" in the format typically used for performance claims. Instead, it outlines non-clinical performance testing and a clinical study to demonstrate safety and effectiveness for its intended use, which is the non-invasive treatment of mild to moderate facial wrinkles.

Here's an attempt to extract the information requested, interpreting "acceptance criteria" as general performance goals implied by the clinical study and the "study that proves the device meets the acceptance criteria" as the clinical trial described.

1. Table of Acceptance Criteria and Reported Device Performance

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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.

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Silkn FX is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

Silk'n FX is a hand held device battery operated that uses low power light spectrum at red and infrared LED, at wavelength of 633 ±5nm, 830 ±5nm emitting optical power in a uniform distribution with no hot spots.

The provided 510(k) summary for the Silk'n FX device does not include any acceptance criteria or a study demonstrating the device meets such criteria.

Instead, the submission outlines the device's technical specifications and claims substantial equivalence to a predicate device based on identical output and intended use. The FDA's letter concurs with this substantial equivalence.

Therefore, most of the requested information cannot be extracted from this document, as a detailed performance study with acceptance criteria was not presented as part of this particular FDA submission for the Silk'n FX.

Here's what can be stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided in the document. The submission claims substantial equivalence based on identical output and intended use to a predicate device, rather than meeting specific performance criteria.

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

Not applicable. No performance study data is presented.

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

Not applicable. No performance study data is presented.

4. Adjudication method for the test set:

Not applicable. No performance study data is 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 an LED device for wrinkle treatment, not an AI-powered diagnostic tool. The submission does not mention any MRMC studies or human reader involvement.

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

Not applicable. This device is an LED device; there is no algorithm or AI component mentioned.

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

Not applicable. No performance study data is presented.

8. The sample size for the training set:

Not applicable. No performance study data or machine learning component is mentioned.

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

Not applicable. No performance study data or machine learning component is mentioned.

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Flash N Go is an over the counter device intended for the removal of unwanted hair. Flash N Go is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.

The Flash N Go hair removal system is a pulsed light system composed of a base unit and hand held applicator.

The provided text describes the 510(k) summary for the Silk'n Flash N Go hair removal device. However, it does not contain the specific details required to answer your request regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, or specific study results.

The document only states:

• "Clinical data was collected in a prospective multisite clinical study."
• The intended use includes "permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime."
• The device complies with "21CRF § 1040.10 & 1040.11" (performance standards for light-emitting products).

The requested information (acceptance criteria table, sample sizes, ground truth details, MRMC study, standalone performance) is not available in the provided text. This type of detailed performance data and study design would typically be found in the full 510(k) submission or an associated clinical study report, which is not included here.

Therefore, I cannot fulfill your request with the given input.

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The Silk'n is intended for removal of unwanted hair by using selective photothermal treatment. The device is generally indicated for dermatological use. The Silk'n is specifically indicated for patient removal of unwanted hair by using selective photothremal treatment under the direction of a physician, after training by a healthcare professional.

The Silk'n hair removal system is composed of a base unit and hand held applicator.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Silk'n device, structured to answer your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not explicitly state quantitative acceptance criteria for safety or effectiveness (e.g., "efficacy rate > X%", "adverse event rate

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