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The Shaser Skin Beauty Intense Pulsed Light System Family for Acne is an over-the-counter home use device intended to provide phototherapeutic light to the body, specifically indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Shaser Skin Beauty Intense Pulsed Light System Family For Acne is an Over-The-Counter, Light-Based Acne Clearing Device. Emission activation is by finger switch. Device includes a limited life treatment head and battery charger/AC cord. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase. The Principle of Operation is both photochemical and photothermal. The Mechanism of Action is to stimulate oxygen production which attacks p.acne and to reduce inflammation due to acne.

The Shaser Skin Beauty Intense Pulsed Light System Family for Acne (K150282) is an over-the-counter home use device intended to provide phototherapeutic light to the body, specifically for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., a specific reduction percentage in acne). Instead, the clinical performance data focuses on label comprehension and usability to ensure safe and appropriate use of the device by consumers in a home setting.

2. Sample Size and Data Provenance for Test Set

• Sample Size: 84 study subjects were tested for label comprehension and usability.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the study was a "simulated home-use environment," implying a prospective study design for the usability and comprehension aspects.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document does not describe the use of experts to establish a "ground truth" for the test set in the traditional sense of medical image analysis or disease diagnosis. The assessments were focused on consumer understanding and ability to use the device, rather than expert diagnostic accuracy. Therefore, information on the number and qualifications of experts for ground truth is not applicable in this context.

4. Adjudication Method (Test Set)

No adjudication method is described, as the studies conducted focused on label comprehension and usability by the subjects themselves, rather than expert assessment of an outcome requiring adjudication.

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

No MRMC comparative effectiveness study was mentioned. The study focused on consumer (user) performance in understanding and operating the device, not on diagnostic accuracy or comparison of human readers with and without AI assistance for acne diagnosis.

6. Standalone Performance (Algorithm Only)

The device is an Intense Pulsed Light (IPL) system, not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. The device's performance is inherently tied to its physical operation and user interaction.

7. Type of Ground Truth Used (Test Set)

For the clinical performance data presented (label comprehension and usability), the "ground truth" was established by observing and evaluating the subjects' ability to understand the instructions and use the device correctly and safely. This is an assessment of human behavior and understanding in relation to the device, rather than a medical ground truth (e.g., pathology, clinical outcomes, expert consensus on disease state).

8. Sample Size for Training Set

The document describes a medical device study for 510(k) clearance, which typically involves demonstrating substantial equivalence to a predicate device and verifying safety and effectiveness through non-clinical and clinical performance testing. This is not a machine learning or AI algorithm submission that would have a distinct "training set." Therefore, information on the sample size for a training set is not applicable.

9. How Ground Truth for Training Set was Established

As there is no "training set" in the context of an AI algorithm, this question is not applicable.

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The Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family is a prescription home use device intended to provide phototherapeutic light to the body. It is specifically intended for:
The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosecea, erythema of rosacea, angiomas, poikiloderma of Civate, leg veins and venous malformations.

Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family devices are prescription home use, light-based skin care systems. The family includes an AC mains powered and battery powered version of the same device. The Principle of Operation is selective photothermolysis and the Mechanism of Action is to lighten or resolve lesions using light for preferentially heating. Emission activation is by finger switch. Device includes a limited life treatment head. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.

The provided text describes the Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family, a prescription home-use device for treating benign pigmented and vascular lesions. The document focuses on regulatory approval (510(k)) and demonstrates substantial equivalence to predicate devices.

However, the document does not contain the detailed information needed to construct a table of "acceptance criteria and reported device performance" as typically understood in a medical device study (e.g., sensitivity, specificity, accuracy, or specific clinical outcomes for lesion treatment). The acceptance criteria described are primarily related to label comprehension and safe usability in a simulated home-use environment, rather than the clinical efficacy of treating lesions.

Therefore, many of the requested fields cannot be filled directly from this document.

Here's an attempt to answer based on the available information:

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

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

• Label Comprehension Test Set Sample Size: 150 subjects
• Usability Test Set Sample Size: 123 subjects
• Data Provenance: The study was a "label comprehension and usability test of consumers" and was conducted in a "simulated home-use environment." The country of origin is not specified, but the submission is to the U.S. FDA. It would be considered a prospective study for regulatory purposes. The text explicitly mentions "Both test populations included low literacy subjects."

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 ground truth for label comprehension and usability would typically be established by defining correct understanding and safe operation, likely assessed by trained observers or evaluators, but no details on their number or qualifications are given.

4. Adjudication method for the test set

This information is not provided in the document. For label comprehension and usability tests, an adjudication method (like 2+1 or 3+1) is not typically used as it would for clinical diagnostic endpoints. Assessments are usually made based on objective criteria or observer ratings.

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 an Intense Pulsed Light System for direct treatment, not an AI-assisted diagnostic tool for "human readers." The document describes a usability and label comprehension study for a direct treatment device, not a diagnostic aid.

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

• This question is not applicable as the device described is a direct treatment device (Intense Pulsed Light System), not an algorithm or AI system. Its performance inherently involves human interaction for operation as a home-use device. The "standalone" performance here refers to its physical operation and energy output, which was subject to "Bench testing for performance verification."

7. The type of ground truth used

• For the label comprehension test: "Ground truth" was established by pre-defined correct answers/interpretations of the Instructions For Use (IFU) and safety warnings.
• For the usability test: "Ground truth" was established by pre-defined safe and appropriate operational steps and procedures for using the device.

8. The sample size for the training set

• This information is not provided. The document describes a usability and label comprehension study, which are typically evaluation studies, not "training set" development for machine learning models. The device's underlying technology (Intense Pulsed Light) relies on established principles of photothermolysis, not a machine learning model that requires a training set.

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

• This information is not applicable as there is no "training set" in the context of this device and study. The device's operation is based on physical principles, not a machine learning model.

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The Shaser Skin Beauty Intense Pulsed Light System Family is an over-the-counter device intended to provide phototherapeutic light to the body. It is also intended for removal of unwanted hair by using a selective photothermal treatment. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. The Shaser Skin Beauty Intense Pulsed Light System Family is also intended for permanent reduction in unwanted hair. Permanent hair reduction is 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 regimen.

Shaser Hair Skin Beauty Intense Pulsed Light System Family devices are Over-The-Counter, Light-Based Hair Removal Systems. The family includes an AC mains powered and battery powered version of the same device. The Principle of Operation is selective photothermolysis and the Mechanism of Operation is to disable hair growth using light to preferentially heat the hair bulb. Emission activation is by finger switch. Device includes a limited life treatment head. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.

This 510(k) summary describes a new version of an Intense Pulsed Light (IPL) system for hair removal, claiming substantial equivalence to previously cleared devices. It relies on the predicate devices' performance and does not present new acceptance criteria or device performance data for hair reduction efficacy. Instead, the study focuses on user comprehension and usability for safe operation.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria for hair reduction or phototherapeutic effect are provided in this submission for the new device. The submission references the predicate devices (Shaser V-MINI 2 and Shaser Lumena FH) as having "identical performance specifications" and "the same basic design and performance characteristics related to device safety and effectiveness."

The only "performance data" presented for the new device relates to user-friendliness:

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

• Label Comprehension: 150 study subjects.
• Usability Test: 123 study subjects.
• Data Provenance: Not explicitly stated, but the context of an OTC home-use device and consumer testing suggests the data is likely prospective and collected within the United States. The inclusion of "low literacy subjects" is noted.

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

There is no mention of "experts" establishing ground truth in the traditional sense (e.g., medical experts diagnosing conditions). For a label comprehension and usability study, the "ground truth" is typically established by:

• The instructions for use (IFU): This document defines the correct understanding and safe usage of the device.
• Study facilitators/observers: These individuals (whose qualifications are not specified) would assess whether subjects understood the label correctly and used the device safely according to predetermined criteria derived from the IFU.

4. Adjudication Method for the Test Set

Not applicable. This was not a study requiring adjudication of medical outcomes or interpretations. The assessment was based on direct observation of user interaction and responses to questions about the instructions.

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 IPL hair removal system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

Not applicable. This is a physical consumer-use device, not an algorithm. The "standalone performance" of the device itself (hair removal efficacy) is presumably based on the predicate devices, but no new standalone efficacy study was presented for this specific submission. The study described focuses on the human user's interaction with the device.

7. The Type of Ground Truth Used

• For label comprehension: The correct interpretation of the instructions for use (IFU) provided with the device.
• For usability: Safe and appropriate operation of the device according to the IFU, as observed by trained study personnel.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device that requires a training set. The clinical performance data described for this submission relates to human user comprehension and usability testing, not to training an algorithm.

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

Not applicable, as there was no training set for an algorithm.

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Lumena FH is an over the counter device intended to provide phototherapeutic light to the body. It is also intended for removal of unwanted hair by using a selective photothermal treatment. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. The Lumena FH is also intended for permanent reduction in unwanted hair. Permanent hair reduction is 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 regimen.

Over-The-Counter, AC Powered, Personal Light-Based Hair Removal System. Emission activation is by fingerswitch. Device includes a limited life lamp cartridge. Overall weight of the device is 1.0 Kg, and the size is 22 x 16 x 78 cm (HxWxD). The Principle of Operation is selective photothermolysis and the Mechanism of Operation is to disable hair growth using light to preferentially heat the hair bulb. Electrical Requirement is 115-230 VAC, 50-60 Hz, 1.3A single phase.

The Shaser Lumena FH Hair Removal System (K140631) is an over-the-counter device intended for the removal and permanent reduction of unwanted hair in adults with Fitzpatrick skin types I-IV.

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Label comprehension: 150 study subjects.
  • Usability test: 123 study subjects.
• Data Provenance: The document does not explicitly state the country of origin, but given the FDA submission, it is likely that the study subjects were from the United States. The study appears to be prospective as it involved testing subjects for comprehension and usability.

3. Number of Experts and Qualifications for Ground Truth

The document does not detail the use of experts to establish ground truth for this device's performance in hair removal. The "ground truth" here seems to be the participants' ability to comprehend instructions and use the device safely and appropriately, rather than a clinical outcome measured by experts.

4. Adjudication Method

The document does not describe any adjudication method. For label comprehension and usability tests, adjudication typically isn't applied in the same way as clinical outcome assessments. The "results of the two tests confirm sufficient label comprehension and safe and appropriate use" implies a pass/fail or statistical analysis of the subjects' performance.

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

No MRMC comparative effectiveness study was mentioned. The study focused on label comprehension and device usability by consumers, not on comparing human readers' performance with and without AI assistance for hair removal assessment. This device is a hair removal system, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a physical light-based hair removal system, not an algorithm. The "performance data" refers to its safety and usability when operated by a human user.

7. Type of Ground Truth Used

The ground truth for the clinical performance data (label comprehension and usability) was based on direct observation and assessment of study subjects' ability to understand instructions and safely operate the device. This is not expert consensus, pathology, or outcomes data in the traditional medical device sense, but rather a behavioral and functional assessment. For the "permanent reduction in unwanted hair" claim, the predicate device's efficacy, measured at 6, 9, and 12 months, serves as the benchmark, implying an outcomes-based ground truth for hair reduction itself, but the current submission focuses on equivalence in safety and usability for the new device.

8. Sample Size for the Training Set

The document does not mention a training set. The clinical performance data presented refers to the evaluation of the device itself (usability and label comprehension), not the training of an algorithm.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no training set or algorithm is mentioned.

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SHASER V-MINI 2 is intended to provide phototherapeutic light to the body. It is also intended for removal of unwanted hair by using a selective photothermal treatment. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. The Shaser V-MINI 2 is also intended for permanent reduction in unwanted hair. Permanent hair reduction is 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 regimen.

Shaser V-MINI 2 is an Over-The-Counter, Cordless, Rechargeable Light-Based Hair Removal System. Emission activation is by finger switch. Device includes a limited life treatment head and battery charger. Overall weight size is 2.1 x 0.6 x 0.8 cm. Charger electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.

The provided text describes the Shaser V-MINI 2 Hair Removal System. The study conducted to support its clearance was focused on label comprehension and usability, not on the effectiveness of hair removal itself, which is typically established through clinical trials measuring hair reduction. Since the submission is for substantial equivalence to predicate devices, the hair removal efficacy data from prior submissions for similar devices are likely referenced.

Here's an analysis based on the provided input:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided submission focuses on the safety and usability of the device for over-the-counter use, especially regarding label comprehension. It does not provide specific quantitative acceptance criteria (e.g., minimum percentage of users understanding instructions) or detailed performance metrics relating to hair removal efficacy. The statement "The V-MINI 2 is a safe and effective device for the intended use" is a conclusion, not a performance metric from the described clinical tests. The efficacy claims (e.g., "permanent reduction in unwanted hair") rely on the substantial equivalence to predicate devices.

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

• Label Comprehension Test Set Sample Size: 150 subjects
• Usability Test Set Sample Size: 123 subjects
• Data Provenance: The document does not explicitly state the country of origin but implies the study was conducted to support FDA clearance in the United States. The studies appear to be prospective as they involved testing subjects' comprehension and usability. The populations included "low literacy subjects."

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

Not applicable for this type of study. The ground truth for label comprehension and usability is typically established by observing user behavior and understanding, not by expert consensus on a medical diagnosis or outcome. The evaluation would be done by study administrators observing and recording participant responses and actions.

4. Adjudication Method for the Test Set

Not specified or applicable in the traditional sense for these types of studies. Label comprehension and usability studies typically involve direct observation and structured questionnaires, where participant responses are recorded and analyzed. There's no mention of multiple reviewers adjudicating conflicting interpretations from the subjects.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and their performance with and without AI assistance is compared. The Shaser V-MINI 2 is a hair removal device, and the described clinical performance data relates to label comprehension and usability, not diagnostic interpretation.

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

Yes, in a sense. The "clinical performance data" for this submission are focused on the human interface with the device (label comprehension and usability) rather than the standalone performance of a complex algorithm or diagnostic output. The device itself (the Shaser V-MINI 2 Hair Removal System) operates independently, and the tests assessed how effectively users could operate it alone based on instructions. The device's "standalone performance" in terms of hair removal efficacy is implicitly handled by its substantial equivalence to predicate devices, where such efficacy data would have been established.

7. The Type of Ground Truth Used

• For Label Comprehension: User understanding and correct verbalization/demonstration of instructions.
• For Usability: Safe and appropriate physical interaction with the device as observed and assessed against predetermined safe/correct usage criteria.

8. The Sample Size for the Training Set

Not applicable. The described studies are for testing the device's usability and label comprehension. This is not an AI/algorithm development and validation study requiring a specific training set.

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

Not applicable, as there is no training set in the context of this usability and label comprehension study for a physical device.

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The Shaser V-MINI RX Hair Removal System is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. It is also intended for removal of unwanted hair by using a selective photothermal treatment. The Shaser V-MINI RX Hair Removal System is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - VI. The Shaser V-MINI RX Hair Removal System is also intended for permanent reduction in unwanted hair. Permanent hair reduction is 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 regimen.

Shaser V-MINI RX is an IPL device with a wavelength range of 400- 1200 nm. The proposed device removes hair by way of Selective Photothermolysis; the preferential thermal treatment of target tissue without collateral effect of surrounding tissue. The pulsed light heats the hair bulb which disables hair growth. The proposed device is intended for males and females to remove unwanted hair from body sites (legs, arms, chest, underarms, stomach, and bikini line) and from facial sites (chin, cheek, chin, neck, side burns, and above the lips). The V-MINI RX is a battery powered, portable device. Electrical requirement (battery charger) is 115 VAC, 15A, 50-60 Hz, single phase.

Here's an analysis of the provided text regarding the Shaser V-MINI RX device's acceptance criteria and supporting studies:

1. Table of acceptance criteria and reported device performance:

   The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or reported device performance metrics in a table format. The "Intended Use" section describes the device's purpose, including "permanent reduction in unwanted hair," defined as "long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen." However, there are no numerical thresholds (e.g., "at least 50% reduction") provided as acceptance criteria, nor are there any corresponding performance results from a study presented to demonstrate that these criteria were met.

   Instead, the submission relies on the concept of "substantial equivalence" to predicate devices (Shaser V-MINI, Radiancy SpaTouch, Radiance SkinStation) rather than presenting new performance data against specific, pre-defined acceptance criteria.

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

   The document explicitly states: "Clinical Performance Data: None" and "Nonclinical Performance Data: None". This indicates that no new test set data was generated or analyzed for this submission. The basis for approval is solely substantial equivalence to predicate devices.

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):

   As no new clinical or nonclinical performance data was presented for the Shaser V-MINI RX, there were no experts involved in establishing ground truth for a test set within this specific 510(k) submission.

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

   Since no new test set data was presented, no adjudication method was used.

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

   No MRMC comparative effectiveness study was done. The device is a light-based hair removal instrument, not an AI diagnostic or assistance tool for human readers.

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

   Not applicable. The device is a physical light-based hair removal instrument, not an algorithm. Therefore, no standalone algorithm performance study was conducted.

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

   No new ground truth was established for the Shaser V-MINI RX as no new clinical or nonclinical studies were performed for this submission. The approval relies on the ground truth (safety and efficacy) established for the predicate devices.

8. The sample size for the training set:

   Not applicable. The device is not an AI algorithm that requires a training set.

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

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

Summary of the Acceptance Criteria and Study:

The 510(k) submission for the Shaser V-MINI RX does not present new acceptance criteria or new studies proving the device meets them. Instead, the basis for clearance is Substantial Equivalence to legally marketed predicate devices (Shaser V-MINI, Radiancy SpaTouch, Radiance SkinStation).

The argument made is that the Shaser V-MINI RX has the "same intended use, the same principle of operation and method of action, similar pulse energy range, and very similar wavelength range" as the predicates. The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None," indicating that no new studies were conducted to generate data for this specific device. The differences cited for the V-MINI RX (larger spot size, higher maximum energy level, wider wavelength range) are asserted not to raise "new issues of safety and efficacy."

Therefore, the "acceptance criteria" were met by demonstrating that the device is sufficiently similar to previously approved devices, implying it shares their established safety and efficacy profile, rather than by showing performance against specific, pre-defined metrics in a new study.

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The Shaser HRS2 RX Hair Removal System is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. It is also intended for removal of unwanted hair by using a selective photothermal treatment. The Shaser HRS2 RX Hair Removal System is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types 1 - IV. The Shaser HRS2 RX Hair Removal System is also intended for permanent reduction in unwanted hair. Permanent hair reduction is 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 regimen.

Shaser HRS2 RX is an IPL device with a wavelength range of 400-1200 nm. The HRS2 RX is an AC powered, portable device. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.

The Shaser HRS2 RX is a light-based hair removal device. The summary provided indicates that no nonclinical nor clinical performance data was submitted for this 510(k) application. Therefore, it is not possible to describe acceptance criteria or a study proving the device meets said criteria based on the provided text.

The submission relies on substantial equivalence to predicate devices (Shaser HRS2 (K120080), Radiancy SpaTouch (K020856), Radiance SkinStation (K051671)) based on having the same intended use, principle of operation, similar pulse energy range, and very similar wavelength range.

Therefore, the requested information cannot be extracted from the provided text as the device's performance was not evaluated through specific studies in this submission.

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The SHASER HRS3 hair removal system is an over the counter device intended for removal of unwanted hair. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is 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 regimen.

Over-The-Counter, Cordless, Rechargable, Personal Light-Based Hair Removal System For Permanent Hair Reduction. Emission activation is by fingerswitch. Includes limited life treatment head and battery charger. Overall weight of the device is 0.45 Kg, and the size is 2.1 x 0.6 x 0.8 cm (HxWxD). Charger Electrical Requirement is 115 VAC, 15A, 50-60 Hz, single phase.

This document describes a 510(k) submission for the Shaser V-MINI Hair Removal System. The information provided is primarily focused on the device's substantial equivalence to a predicate device and its intended use, rather than a detailed clinical study demonstrating its performance against specific acceptance criteria.

Therefore, many of the requested sections about clinical study details cannot be fully answered from the provided text.

Here is the information that can be extracted or reasonably inferred from the document regarding acceptance criteria and related studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a table of specific performance acceptance criteria for hair reduction or removal efficacy. Instead, it focuses on qualitative assessments related to label comprehension and usability for safe operation.

Note: The primary "performance" claims for this device are "removal of unwanted hair" and "permanent reduction in unwanted hair" (defined as long-term stable reduction at 6, 9, and 12 months post-treatment). However, the provided document DOES NOT contain clinical data or acceptance criteria specifically measuring hair reduction efficacy. The "study" mentioned pertains to label comprehension and usability, not clinical effectiveness.

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

• Sample size for Label Comprehension Test: 150 study subjects
• Sample size for Usability Test: 123 study subjects
• Data Provenance: The document does not explicitly state the country of origin. Given the company (Shaser, Inc.) and the submission to the FDA, it is highly likely that the study was conducted in the United States. The study was prospective in nature, as it involved subjects actively participating in tests.

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

This question is not applicable to the studies described. The studies were focused on consumer comprehension and usability, not on expert assessment of device efficacy against a ground truth (like pathology for disease). The "ground truth" for these studies would be whether the subjects correctly understood the label and could safely operate the device, as assessed by study administrators/observers, rather than independent experts establishing a medical ground truth.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. For label comprehension and usability tests, the outcome is typically determined by structured observations, questionnaires, and task completion metrics, and there isn't usually a need for a separate adjudication panel in the way medical imaging studies use them.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The described studies are label comprehension and usability tests, not clinical efficacy trials involving human readers assessing outcomes. The device is a direct-to-consumer hair removal system, not an AI-assisted diagnostic tool.

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

This question is not applicable. The device is a physical hair removal system, not an algorithm. The "standalone" performance here would refer to its physical function and safety, which was assessed through the usability test involving human interaction.

7. The Type of Ground Truth Used

For the label comprehension and usability tests, the "ground truth" was established by the study protocol's definition of correct understanding and safe/appropriate usage. This would typically involve:

• For Label Comprehension: Correct answers to questions about the instructions for use.
• For Usability: Successful and safe completion of tasks with the device according to predefined criteria, observed by study personnel.

There was no "expert consensus," "pathology," or "outcomes data" in the medical sense used to establish ground truth for these specific tests.

8. The Sample Size for the Training Set

This concept is not applicable here. The described studies are consumer-facing validation tests for label comprehension and usability, not a development of an algorithm that requires a training set. The device itself is electro-optical, not an AI/ML algorithm.

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

This question is not applicable, as there was no "training set" in the context of algorithm development.

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The SHASER HRS2 Hair Removal System is an over-the-counter device intended for removal of unwanted hair. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9, and12 months after the completion of a treatment regimen.

The SHASER HRS2 Hair Removal System is a personal, light-based, hair reduction system intended to be sold over-the-counter directly to the end user. The device provides permanent hair reduction as defined below using Intense Pulsed Light (IPL) technology.

The SHASER HRS2 Hair Removal System consists of a powered base unit and a tethered hand piece from which the IPL flashes are delivered to the patient's skin. The system will be sold with light carring a cloth, and user's manual.

Here's a breakdown of the acceptance criteria and the study details for the SHASER HRS2 Hair Removal System, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria itself is qualitative ("long-term stable reduction"). The clinical trial aims to demonstrate that the device achieves this by reporting quantitative hair reduction percentages at specified time points.

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

• Sample Size: Not explicitly stated as a single number, but the study was conducted on "a population of approximately 50% female and 50% male subjects from diverse demographic sub-groups." The specific number of subjects is not provided, but it implies a cohort designed to represent a diverse user base.
• Data Provenance: The document does not specify the country of origin of the data. It indicates a "clinical trial was conducted," suggesting prospective data collection.

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

This information is not provided in the given document. The summary focuses on hair count measurements without detailing expert involvement in establishing ground truth for the hair counts.

4. Adjudication Method for the Test Set

This information is not provided in the given document.

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

No, an MRMC comparative effectiveness study was not done. This type of study typically involves comparing human readers' performance with and without AI assistance, which is not applicable to this hair removal device.

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

This concept is not applicable to the SHASER HRS2 Hair Removal System. This device is a physical, light-based hair removal system, not an algorithm or AI system that would have a standalone performance measured independently of a human user. The "performance" here refers to the physical outcome of hair reduction on human subjects.

7. The type of ground truth used

The ground truth used was hair counts. These were "taken before treatment and 3, 6, and 12 months following the final treatment." This is a direct, objective measurement for assessing hair reduction.

8. The sample size for the training set

This information is not applicable as this device is a physical light-based hair removal system, not an AI/ML algorithm that would undergo training on a dataset.

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

This information is not applicable for the reasons stated above.

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The SHASER IPL Hair Removal System is an over the counter device intended for removal of unwanted hair.

The SHASER IPL Hair Removal System is a personal, light-based, hair reduction system intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. The SHASER IPL Hair Removal System consists of a powered base unit and a tethered handpiece from which the IPL flashes are delivered to the patient's skin. The system will be sold with light cartridges, cleaning cloth, and user's manual.

Here's an analysis of the provided text regarding the Shaser IPL Hair Removal System's acceptance criteria and study details:

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: 111 test sites from an unspecified number of subjects (approximately 50% female and 50% male). The exact number of individual subjects is not explicitly stated, but it implies more than one since "approximately 50% female and 50% male subjects" is mentioned.
   • Data Provenance: The document does not specify the country of origin. The study was a "clinical trial," which implies a prospective design. Diverse demographical sub-groups were included.

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

   • This information is not provided in the document. The method for assessing hair count reduction (ground truth) is stated as "Hair counts were taken before treatment and 3 and 6 months following the final treatment," but it does not specify who performed these counts or their qualifications.

3. Adjudication method for the test set:

   • This information is not provided in the document.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done. The study described is a clinical trial to demonstrate the device's standalone effectiveness, not a comparison involving human readers with and without AI assistance.

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

   • Yes, the described clinical trial evaluated the standalone performance of the Shaser IPL Hair Removal System. There is no mention of an algorithm or AI assistance; it's a device performance study.

6. The type of ground truth used:

   • The ground truth was based on measured hair counts ("Hair counts were taken before treatment and 3 and 6 months following the final treatment"). This is objective, quantitative data.

7. The sample size for the training set:

   • This device is an IPL hair removal system, not an AI or algorithm-based device that would typically have a "training set" in the machine learning sense. Therefore, this information is not applicable/provided. The clinical trial is the performance validation of the physical device.

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

   • As in point 7, this question is not applicable as there is no mention of a training set for an AI model.

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